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Current Advances in the Management of Diabetes Mellitus

Chinyere aloke.

1 Protein Structure-Function and Research Unit, School of Molecular and Cell Biology, Faculty of Science, University of the Witwatersrand, Braamfontein, Johannesburg 2050, South Africa

2 Department of Medical Biochemistry, Alex Ekwueme Federal University Ndufu-Alike, Abakaliki PMB 1010, Nigeria

Chinedu Ogbonnia Egwu

Patrick maduabuchi aja.

3 Department of Biochemistry, Faculty of Biological Sciences, Ebonyi State University, Abakaliki PMB 53, Nigeria

Nwogo Ajuka Obasi

Jennifer chukwu.

4 John Hopkins Program on International Education in Gynaecology and Obstetrics, Abuja 900281, Nigeria

Blessing Oluebube Akumadu

Patience nkemjika ogbu, ikechukwu achilonu, associated data.

Not applicable.

Diabetes mellitus (DM) underscores a rising epidemic orchestrating critical socio-economic burden on countries globally. Different treatment options for the management of DM are evolving rapidly because the usual methods of treatment have not completely tackled the primary causes of the disease and are laden with critical adverse effects. Thus, this narrative review explores different treatment regimens in DM management and the associated challenges. A literature search for published articles on recent advances in DM management was completed with search engines including Web of Science, Pubmed/Medline, Scopus, using keywords such as DM, management of DM, and gene therapy. Our findings indicate that substantial progress has been made in DM management with promising results using different treatment regimens, including nanotechnology, gene therapy, stem cell, medical nutrition therapy, and lifestyle modification. However, a lot of challenges have been encountered using these techniques, including their optimization to ensure optimal glycemic, lipid, and blood pressure modulation to minimize complications, improvement of patients’ compliance to lifestyle and pharmacologic interventions, safety, ethical issues, as well as an effective delivery system among others. In conclusion, lifestyle management alongside pharmacological approaches and the optimization of these techniques is critical for an effective and safe clinical treatment plan.

1. Introduction

Diabetes mellitus (DM) is a long-standing, complicated, and non-transmissible endocrine ailment that is growing rapidly and has posed clinical challenges globally, often linked with threats related to complicated metabolic development in patients. It is marked by elevated glucose and lipids in the blood as well as oxidative stress, which culminate in chronic complications involving diverse organs, mainly the kidneys, eyes, nerves, and blood vessels, among others, in the body. As reported by World Health Organization (WHO), DM is an outbreak prone to high malaise and death. Globally, approximately 387 million persons are affected by this disorder and it is estimated to be more than 640 million by 2040 [ 1 ].

According to a report in 2017 by International Diabetes Federation (IDF), 425 million persons suffer from diabetes mellitus out of which more than 90 percent are adults and 352 million had impaired glucose tolerance (IGT) [ 2 ]. In individuals suffering from type II diabetes mellitus (T2DM), hyperglycemia is not the only characteristic; it also involves multiple complications such as kidney failure, blindness, heart attack, stroke, and amputations of the lower limb [ 3 ]. Mounting evidence obtained from epidemiological studies has shown that T2DM is an ailment with numerous causes associated with both polygenic and various environmental factors [ 4 ]. T2DM is thus too complicated to cure due to genetic polymorphism and other numerous risk factors.

Despite the fact that most cases are a result of obesity-linked T2DM, the annual prevalence of T1DM is on the rise [ 5 ]. It has been reported that about 10 percent of people suffering from diabetes have T1DM. However, the two forms are linked with a prolonged risk of circulatory system complexities [ 6 ] and the threat of lowered blood glucose. Ample proof suggests that normoglycemia accomplishment will mitigate the risk of complications linked with DM [ 7 ]. However, hypoglycemia occurrences limit the attainment of near normoglycemia in subjects with T1DM. Diabetic individuals who are not aware of their hypoglycemic status are vulnerable to T1DM which then limits them from the attainment of the needed glycemic control. Globally, DM health centers have several individuals with T1DM who have recurrent low blood glucose and the idea of hypoglycemic unconsciousness poses critical clinical challenges. Providentially, many favorable and interesting gain ground exist in the perspective for subjects with the problem of DM, including gene therapy, as reported by Bosch and colleagues [ 8 ].

Currently, the main therapeutic regimens for T2DM are injection of insulin-like agents and oral administration of hypoglycaemic agents. However, these agents play crucial functions in T2DM treatment but are laden with side effects [ 9 , 10 ]. Insulin has taken the centerpiece for the management of unrestrained insulin-deficient DM since its invention [ 11 ]. Admittedly, due to the severe lack of beta cells, the injection of exogenous insulin is vital for survival. Notwithstanding the advances made in comprehending the etiology, effects, and continuance of DM, including the progress made in insulin development and its analogues, ensuring tight glycaemic modulation without negative side effects such as low blood glucose and gain in weight still poses significant problems [ 7 , 12 , 13 ]. Hence, this further accentuates the importance of alternative techniques or adjuncts to insulin [ 14 ].

Consequently, this narrative review exploits different alternative therapeutic regimen for the management of two forms of DM, including nanotechnology, stem cell technology, gene therapy, medical nutrition therapy, lifestyle modification and the challenges associated with these techniques.

To identify published works on recent advances in the management of DM, the literature search for this narrative review was carried out using different search engines including Scopus, Google Scholar, Pubmed/Medline and Web of Science databases. Keywords and subject headings employed include diabetes mellitus, hyperglyceamia, management of DM, T2DM, nanotechnology in diabetes, gene therapy in DM management and current treatment, etc. The titles and abstracts of the results after the search were painstakingly screened to select eligible articles for full-text reading. Articles that were found to be eligible were retrieved and full-text screening was performed independently by three of the authors to select studies for inclusion in the final analysis. Original research and review articles published between 1993 and 2022 (in English) were included. Unpublished articles and thesis were excluded. All authors confirmed the validity of the selected papers.

3. Risk Factors of Diabetes

There are several risk factors associated with diabetes. These risk factors contribute significantly to the progression of diabetes. They include but not limited to age; weight; family history of diabetes; smoking and race/ethnicity [ 15 , 16 ] (Asiimwe et al., 2020; Noh et al., 2018). While T1DM is mostly found in the young, T2DM is an adult-related condition. The risk of T2DM increases with age which is due to the deficiency of insulin secretion which develops with age, and growing insulin resistance caused by a change in body composition [ 17 ]. Increase in body weight which leads to obesity is closely associated with diabetes in a condition termed diabesity. This is because increase in body weight leads to increased insulin resistance [ 18 ].

According to the FDA, smokers are 30 to 40% more likely to come down with T2DM than nonsmokers. Smoking can also increase insulin resistance which makes the patients require more insulin for the control of their sugar level [ 19 ]. Diabetes is hereditary. Those with the family history are advised to adhere to lifestyles that reduce the risk of developing diabetes.

4. Management of Diabetes

There are several modern approaches involved in the management of diabetes. However, early diagnosis is central to achieving any targets set in DM management [ 20 ]. Each patient is treated with the aim of achieving a particular outcome. These outcomes are set out from the first day of clinic visit to ensure an individualized approach in the management of diabetes.

4.1. Internet Intervention for Lifestyle Modification in Diabetes

Lifestyle modification is an integral part of diabetes management. It is recommended for both patients in pre-diabetic and diabetic conditions, respectively. Reduced sedentary lifestyle, increased physical activities, and healthy diets are among the recommended lifestyle modifications. The right exercise may depend on the state of the patient. The exercise helps to bring down the plasma glucose level. For a healthy diet, it is recommended that diabetic subjects take a lot of vegetables, fruits, and whole grains; choose nonfat dairy and lean meats; and limit foods that are high in sugar and fat. Other lifestyle changes include stopping smoking and reduction in alcohol intake [ 21 , 22 ]. The lifestyle changes are usually individualized.

Even though the above strategies help in the effective management of diabetes, communicating or constantly reminding the subjects to complete them could be challenging. Web or internet-based program have been deployed to improve adherence to the lifestyle changes. These web-based strategies provide a viable option for facilitating diabetes self-management [ 23 ].

4.2. Nanotechnology and Diabetes

Nanotechnology involves the use of nanoparticles (<100 nm). These nanoparticles are developed through the manipulation of individual atoms or molecules in a substance. The application of nanotechnology in medicine is termed nanomedicine. Nanomedicine involves the combination of the knowledge of nanotechnology in the application of drugs or diagnostic molecules which generally improves their ability to target specific cells or tissues. Nanotechnology in diabetes research has played several roles in improving the outcome of diabetic management in diabetics through the deployment of novel nanotechnology-based glucose measurement and insulin delivery techniques [ 24 , 25 ]. Nanotechnology employs non-invasive approaches for insulin delivery and the development of a more efficacious vaccine including cell-based and gene-based therapies for T1DM [ 24 ]. The importance of nanotechnology in diabetes includes, but is not limited to, inventive diabetes diagnosis, detection of immune cell activity and beta-cell mass, monitoring of glucose level, and non-invasive insulin delivery, etc.

Early and accurate diagnosis of a disease may be as important as the treatment of the disease itself. Prompt diagnosis may prevent dysglycaemia and reduce the time to onset of diabetes [ 26 ]. Conventional approaches have been utilized in the different diagnostic needs in diabetes, such as detection of immune destruction that precedes T1DM and/or measurement of plasma glucose levels. However, the shortcomings of the conventional approaches which include, but are not limited to, non-early detection of the disease progression necessitate the need for a novel technology that can improve the diagnostic outcome.

The mass of the beta cell is an indication of the functionality of the beta-cell in secreting insulin. The progressive loss of the beta cells precipitates T1DM [ 27 ]. Prompt detection of the stage of beta cell loss through nanotechnology can allow for the immediate application of clinical interventions for its arrest. Magnetic nanoparticles (MNPs), for instance, have distinctive physical properties qualifying them as outstanding contrast media for magnetic resonance imaging (MRI). This can enable the early detection of the stages of beta-cell loss.

Glycaemic fluctuation should be avoided during diabetic management. Individuals have treatment goals set by their physicians. Regular or daily glucose monitoring is performed to ascertain the control achieved by the treatment and the diabetes progression [ 28 ]. However, this comes with some challenges including poor compliance as a result of the regular pricking of the patients and inability to monitor glucose levels at certain times of the day (e.g., sleeping and driving times). The overall impact is irregular monitoring of the glucose level which can lead to dangerous fluctuations that may worsen diabetic complications. To circumvent this challenge, continuous glucose monitoring (CGM) systems are essential. The implantation of biosensors (e.g., amperometric sensors) subcutaneously had been used to achieve CGM for 10 days; however, this has its drawbacks including instabilities and the need for a weekly change of the implantation [ 29 , 30 ].

Nanomedicine can overcome the aforementioned obstacles in CGM. The glucose-sensing device has three key components: a detector, a transducer, and a reporter. The detector measures the glucose level while the transducer converts the measurement into an output signal. The reporter finally processes the signal into an interpretable form. For an effective measure of the glucose level, the glucose sensors are usually made of nanoparticles in nanotechnology which are made from mainly three molecules: glucose oxidase, glucose-binding proteins, and glucose-binding small molecules [ 24 , 31 ]. The coupling of these nanoparticles as transducers enables the accurate detection of glucose in a patient-friendly and rapid manner [ 31 ].

Insulin shots are the mainstay in the management of T1DM and T2DM. The conventional approach of insulin delivery involves the use of needle injections. Even though some needles have been significantly improved to be painless during delivery, the thought of needles alone could be discouraging [ 32 ]. This significantly affects the compliance of patients to insulin use. Moreover, the lingering time between the time of glucose measurement and the insulin dosing in addition to the hindrance in the absorption of insulin ensuing the conventional subcutaneous injection, do not allow for a close plasma glucose control which leads to fluctuations and times of hyperglycemia [ 24 ]. An approach that is non-invasive will be well accepted by both patients and medical practitioners to improve compliance and the overall outcome of treatment.

To overcome the recent delivery challenges faced by the conventional approaches, microcomputer closed-loop or nano pumps are being developed to ensure the timely delivery of insulin while ensuring continuous glucose monitoring. In other words, this system is built to link insulin delivery to plasma glucose concentration. This will prevent the risk of plasma glucose fluctuations [ 26 , 33 ]. Other less invasive means of insulin delivery that involve the use of nanoparticles are also being explored to facilitate insulin delivery orally, transdermally, and/or via inhalation [ 26 ].

4.3. Medical Nutrition Therapy in Diabetes

Medical nutrition therapy (MNT) is a “nutrition-based treatment provided by a registered dietitian nutritionist.” It comprises nutrition diagnosis and therapeutic and professional counseling services that aid in the management of DM. MNT is a critical aspect of diabetes education and management. Recommendations on MNT by international collaborative groups for diabetes management have attempted to reform and provide courses for adverse nutritional transition [ 34 , 35 ]. For instance, MNT has been employed for the treatment of GDM because carbohydrate (CHO) is the main causative agent as a result of its impact on glycaemia. According to the Institute of Medicine, pregnant women require a minimum of 175 g CHO per day, and low-CHO diets already in use traditionally for the treatment of GDM have proven to be safe [ 36 ]. Moreover, MNT has been reported to be critical in the management of other types of DM and as such has significantly impacted patients, especially women and newborns [ 37 ]. Primarily, MNT ensures the maintenance of euglycemia via adequacy in weight gain in pregnancy and growth of fetus while avoiding ketogenesis and metabolic acidosis. Nonetheless, MNT is yet to establish the optimal diet in terms of energy content and macronutrient distribution, quality, and amount, among others, in DM [ 37 ]. Reports have shown that the nutritional requirements for GDM patients are the same for all pregnancy cases when their carbohydrate intake is taken into special cognizance. Currently, a low-glycemic index diet has been reported to be more favorable in the management of GDM than the traditional intervention of carbohydrates restriction even though the evidence is still restrained [ 37 ]. Caloric restrictions are very vital in the management of overweight or obesity.

Reports have charged MNT with the design of signature diet strategies that will be suitable medically as well as patient focused. By this, it is hoped that practicing diabetologists and registered dieticians (RDs) will partner to furnish nutritional guidelines based on evidence for use by MNT for the prevention and management of DM and related comorbidities [ 38 ]. Indications show that MNT may be a potent, easily available, and cheap therapeutic technique and could be an essential tool for DM prevention and management [ 35 ].

4.4. Gene Therapy and Diabetes Mellitus

Gene therapy is a technique that involves remedying the symptoms of an ailment orchestrated by a defective gene via the incorporation of the exogenous normal gene. Its advantage is that a single treatment can be used to cure any type of disease and currently, gene therapy is opening up novel treatment options in different branches of medicine [ 39 ]. At present, gene manipulation is not limited to the addition of a gene but also gene modulation and editing [ 40 , 41 ]. Gene therapy can also be explained as a method of introduction of a gene or gene manipulation within a cell as a curative regimen in the treatment of disease [ 42 ]. The objective of this approach is to remedy abnormal genes that have been implicated as the causative agent in any ailment and to successfully halt the beginning of the ailment or prevent its continuation. The gene therapy approach involves three major intervention methods: (i) delivery of a new gene into the body, (ii) substitution of the abnormal gene with a working gene, and (iii) disabling the malfunction genes responsible for the ailment [ 42 , 43 ]. Gene therapy can be further classified into somatic gene therapy or germline gene therapy. While the primary target in somatic gene therapy is the somatic cells often referred to as the diseased cells, the reproductive cells are the targets in germline gene therapy. Germline therapy halts the development of the disease in subsequent generations [ 43 ]. The application of gene therapies as trends in evolving therapeutics is due to its potential for the treatment of diverse ailments including DM, autoimmune disorders, heart diseases, and cancers among others that are difficult to manage using conventional therapies [ 44 ].

T1DM is an autoimmune ailment marked by T-cell-orchestrated self-damage of the islet beta cells responsible for the secretion of insulin. Its management is problematic and complex, particularly using conventional drugs. Thus, gene therapy is partly an emerging promising therapeutic alternative in its treatment [ 45 , 46 ]. The etiology of T1DM is multifactorial involving both environmental and genetic factors akin to any other autoimmune disease. In the recent past, researchers have favourably pointed out many genes accountable for the evolution of T1DM [ 47 ]. Thus, alteration or grappling with these genes employing gene therapy techniques will probably foster better comprehensible management of the ailment or even cure T1DM.

Even though gene therapy for DM majorly centres on T1DM, many genes have been evaluated as a probable treatment for T2DM as the ailment has a compelling genetic susceptibility [ 48 ]. About 75 independent genetic loci have been identified for T2DM via genetic linked studies and different novel therapeutic targets have also been determined [ 46 ]. Genetic loci might have a huge impact on drug response in contrast to the incidence and development of diseases whose effects are limited [ 49 ]. Many genetic loci exist with prospects for T2DM gene therapy. For instance, nucleotide-binding oligomerization domain-like receptor protein 3 (NLRP3) is a good example. NLRP3 inhibition mitigates inflammation, guard against apoptosis of pancreatic b-cells including the prevention of development of T2DM in mice [ 50 ]. Hypothetically, all genes associated with the beginning, evolution, and deterioration of T2DM are probable targets. In Table 1 [ 51 ], the genes that modulate the homeostasis of glucose, ameliorate insulin synthesis or/and responsiveness, and improve diabetic mellitus-induced complications are abridged for simplicity.

Promising targets that can be employed for T2DM gene therapy.

Legend: HSP70 = heat shock protein 70; NLRP3 = nucleotide-binding oligomerization domain-like receptor protein 3; SGLTs = sodium-glucose co-transporters; GLUTs, glucose transporters; SIRT6=Sirtuin 6; FGFs = fibroblast growth factors; GPGRs = G protein–coupled receptors; GLP-1= glycogen-like peptide 1; ADPN = adiponectin; CTB APSL = cholera toxin B subunit and active peptide from shark liver; TGF-a = transforming growth factor-alpha; DKD = diabetic kidney disease [ 51 ].

4.5. Stem Cell Therapy in Diabetes

The conventional approaches in the management of DM do not resolve the causes of the ailment and are laden with adverse effects. Hence, there is a quest for a desirable different therapeutic regimen. The cellular-based therapeutic technique currently in use in DM management is based on the pancreas or islet-cell transplantation to revive the beta cells for insulin secretion. This approach is restricted due to a lack of donor organs. These problems lead to the exploration of the possibility of constructing beta cells using stem cells. The peculiar rebuilding potential of stem cells might be an important tool that could be used in the management of DM. Development of replenishable islets source using stem cells might avert the recent supply/demand problems in the transplantation of islet and furnish DM subjects with a prolonged source of beta cells for insulin secretion. Hence, in the management of DM, stem cell investigation has become a promising approach [ 52 ].

The stem cell DM therapy is aimed at the replacement of malfunctioning or damaged pancreatic cells by employing pluripotent or multipotent stem cells. This technique has exploited the ability of various kinds of stem cells including induced pluripotent stem cells (iPSCs), embryonic stem cells (ESCs), and adult stem cells using diverse methods to produce surrogate beta cells or to bring back the physiologic role of the beta cell [ 53 ].

Advancement in technology has facilitated the development of stem cells using different kinds of tissue sources such as adipose tissue, skin, bone marrow, umbilical cord blood, periosteum, and dental pulp. In searching for promising stem cells, the first organ of choice is usually the pancreas. Studies with animal models have indicated that a small number of pancreatic tissue when made available could bring back the optimum pancreatic beta-cell mass [ 54 ]. This is sequel to the differentiated beta cells from the pancreatic duct undergoing replication and dedifferentiation culminating in the formation of pluripotent cells which in turn synthesize more beta cells. Additional study suggested that these ductal cells populations could be produced in vitro and directed to produce insulin synthesizing clusters [ 55 , 56 ].

Moreover, the haemopoietic adult stem cells such as HSCs and mesenchymal stem cells (MSCs) have the potential to transdifferentiate into so many cell lineages such as the brain, liver, and lung as well as gastrointestinal tract cells [ 57 , 58 , 59 ]. A different group of researchers experimented on the multipotent differentiation of haemapoietic progenitors to replenish the beta cell number in T1DM. It was reported that the bone marrow of mouse was differentiated ex vivo into functional beta cells [ 60 ]. Relatedly, studies using the mice model indicated that cells of the bone marrow could be amenable to the pancreas as a target and that elevated blood glucose could be normalized [ 61 ]. An experiment with autologous HSCs demonstrated an improvement in T1DM and T2DM [ 62 , 63 ]. These studies furnish potential outcomes for the usage of autologous HSCs in the management of DM.

4.6. Latest Inventions in Diabetes Management

In addition to the aforementioned innovations in the management of diabetes, several drugs are still at different stages of clinical trial for eventual use. Others are ready and have been recently introduced into the market.

4.6.1. Drugs Recently Introduced

Tirzepatide: The drug was recently approved by the FDA under the trade name mounjaro for the treatment of T2DM [ 64 ]. Tirzepatide is an injectable given under the skin once in a week which targets the receptors of hormones which play central role in the metabolism of glucose. These hormones are glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). While the GLP-1 reduces blood glucose by several mechanisms, including stimulating insulin secretion and suppressing glucagon release during hyperglycemia, GIP stimulates insulin release during hyperglycemia, but it also stimulates glucagon release during hypoglycemia.

Tirzepatide acts as agonist to their receptors [ 65 ], hence elongating their functions which results in blood glucose control. The efficacy of tirzepatide was established against a placebo, a GLP-1 receptor agonist (semaglutide) and two long-acting insulin analogs either as monotherapy or in combination with other antidiabetic agents [ 64 ]. In comparison to the placebo, it lowered the HbA1c by 11.6% and 1.5% as monotherapy and combination therapy, respectively. In comparison to other antidiabetic drugs, at the highest dose of 15 mg, it lowered the HbA1c 0.5% more than semaglutide, 0.9% more than insulin degludec and 1.0% more than insulin glargine [ 64 ]. Because of the efficacy therein and the once in a week dosing, tirzepatide provides a desirable paradigm shift in the management of T2DM.

4.6.2. Drugs in the Pipeline

Several drug candidates are at different phases of development for the management of DM. These are listed below.

LY3502970: LY3502970 is a partial agonist, biased toward G-protein activation over β-arrestin recruitment at the (GLP-1 receptor (GLP-1R). The molecule is highly potent and selective against other class B G-protein-coupled receptors (GPCRs) with a pharmacokinetic profile favorable for oral administration [ 66 ]. It is a product that is currently being developed by Eli lilly.

SCO-094: SCO-094 is a drug candidate identified by SCOHIA company which has a dual target of the receptors of GIP and GLP-1 [ 67 ]

Ladarixin (LDX): Ladarixin is an inhibitor of the interleukin-8 receptors CXCR1 and CXCR2, in new-onset T1DM [ 68 ]. It is a drug candidate developed by Dompe Farmaceutici. Short term LDX treatment of newly diagnosed patients with T1DM had no appreciable effect on preserving residual beta cell function [ 68 ].

5. Discussion of Major Findings

DM is a complex, progressive, and multifactorial metabolic disorder needing more complex treatments over time. Globally, researchers have worked assiduously in the discovery and development of novel drugs for the treatment of diabetes. There is significant progress in research into the cause and management of T1DM [ 69 ]. Mounting evidence indicates that modern insulin therapy in combination with glucose self-monitoring including blood pressure and lipid monitoring has profoundly improved the long-term prognosis of T1DM [ 70 ]. The literature indicates that regular exercise and improved diet may enhance the quality of life for diabetic subjects but in the absence of adequate exercise and diet, medications may help diabetic persons regulate their blood glucose level. Moreover, implantation of insulin producing cells could furnish the basal glucose level essential for maintaining glucose homeostasis in vivo and thus hinder long-term injury from occurring in different tissues regardless of hormone administration [ 71 ].

The attainment of the full potential of gene therapy technique could be obtained via the design of gene delivery vectors that are safe, efficient, and specific and/ or the development of a technique for engineering of cell, in which the stem cell seems to be of great importance. Thus, the establishment of a reliable, sensitive, and acutely monitored feedback system is needed for the generation of a safe and efficient vector to facilitate diabetes gene therapy for clinical trial. Probably, the curtailment of islet transplantation rejection is the first clinical technique to DM gene therapy approach. On the other hand, insulin gene therapy is carried out in concert with conventional insulin treatment culminating in tight glycemic regulation in the absence of fasting hypoglycemia in T1DM subjects, as reported in T1DM rats [ 72 ].

Physical activity and nutrition therapy could help individuals with DM achieve metabolic goals. Employing diverse lifestyle approaches might help. Regulation of metabolic parameters such blood pressure, glucose, glycated hemoglobin, lipids, and body weight including the assessment of life quality are critical in determining the level of treatment goals by lifestyle changes [ 73 ]. However, different countries have focused on DM management and its complications on the normalization of glycemic control as assessed by hemoglobin A1 or fasting blood glucose which only addresses the need of subjects who were already diabetic. Thus, it is imperative to design programs for the early detection of altered glucose metabolism and to carry out robust approaches for the normalization of this changed state. Furthermore, through robust prevention strategies, better diagnostic tests, early risk detection, and management of the risks will help mitigate the incidence of DM and reduce or prevent events associated with end-organ failure [ 73 ].

Besides glycemic control, multifactorial interventions using different treatment regimen, including nanotechnology, gene therapy, stem cell, medical nutrition therapy, and lifestyle modification have yielded significant results in ameliorating the impact of DM but not without some challenges. Regardless of the promising nature of nanotechnology and its projected ability to turn around the fortunes in diabetes management, it is still faced with some challenges. One of the major limitations is the cost. Most of the gadgets required for CGM, and insulin delivery are very expensive. This limits their use to the rich class even when diabetes cuts across different economic classes. More so, there is an increased risk of infection via the implantation of sensors and cannulas which increases inflammation and could be frightening sometimes [ 24 ].

Notwithstanding the merits linked with the gene therapy approach, there could equally be problems. For example, genes introduced employing a viral vector might provoke an immune response and aggravate the disease condition [ 74 ]. Additionally, gene therapy studies are still mostly carried out using animal models and their safety is yet to be validated in humans [ 46 ].

Currently, it is established that gene delivery technology is the primary hurdle for successful gene therapy. The prime factors for an effective gene delivery technique include efficiency, stability, specificity, safety, and convenience. Thus, the greatest obstacle in gene therapy is the method of delivery of the corrective gene to the target site safely and efficiently. There is, therefore, a requirement of desirable gene delivery technology or vector to furnish the therapeutic potential where required. The two main vectors currently employed are viral and non-viral vectors. The merit of the non-viral vector is that it has low immunity, a low financial burden, and its preparation is convenient but the major obstacles for its extensive use emanate from the inefficiency of delivery method and expression of gene transiently [ 75 ]. Contrastingly, reports show that viral vectors are more efficient in gene delivery as several of them use a distinct mechanism for DNA delivery to the cells. Viral vectors are arranged as viral particles having precisely the important modulated sequences of the virus and from which all the genes of the virus have been excised. These viruses, when prepared very well, are defective that after target cell infection, there is no probable replication or infection theoretically [ 76 ]. Viral DNA is integrated with the genome of the host cell, thereby bestowing the capability for sturdy therapeutic gene expression.

Despite the fact that viral vectors are more efficient in comparison to non-viral vectors as gene delivery systems, there are still challenges associated with them, including inflammation, cytotoxicity, and immunogenicity which are needed to be looked into during the construction of viral vector system [ 46 ].

Notwithstanding the huge and novel impacts recorded in the applicable areas of stem cell biology in the management of DM, it is still in its primitive stage. A lot of hurdles still hinder the progression of stem cell research technologically and ethically, including:

The use of ESCs is confronted with the formation of teratomas and the danger of malignancy [ 77 ], thus raising safety concerns. This makes it imperative for a thorough investigation and screening of the probable adverse effects prior to its deployment in clinical trials and human treatment.

The primary hurdle associated with transplantation is autoimmune rejection. This makes it necessary for a stable and appropriate regimen for immunosuppression. There is a need for the stabilization of current transplantation protocols with the standard testing module. The transplantation of stem cells needs a few experimental works to appraise the problems linked with the stability, durability, and the survival of the transplanted cell with appropriate vascular and neural support in the new microenvironment.

The challenges of scale-up problems arise after the optimization of the appropriate developmental procedures. The number of cells must be enough to cope with the requisite request for future research including clinical investigations. Hence, an efficient method is required for the maximization of the yield via an adjustment in the culture requirements. The stem cells’ scale-up ability is needed for future exploration for the provision of surplus transplanted cellular reserves in order to strike equilibrium between demand and usage.

As a result of where it is obtained from, the ESCs are the potential targets for the ethicists. Normally, ESCs are obtained from embryos not fertilized or used during ex vivo fertilization in hospitals. Informed consent is usually required in the procurement of these ESCs from the donor prior to the usage in clinical research. Sadly, though, in the majority of instances, there is the destruction of the embryo during the process of obtaining the cells from the embryo, and this questions the source of life and the ethical license to terminate the fetus. Adult stem cells are preferable to embryonic ones as the controversy about their usage is limited. The current advancement in technology in induced pluripotent stem cell research is to allow the use of ones’ stem cells for diverse uses [ 78 ]. The adult cells are reprogrammed in such cases to pluripotent conditions and thereafter transformed into working beta cells. This approach might eventually resolve the impasse linked with ESCs and contribute to further safety issues likely to be tackled later in the future.

6. Conclusions

DM has become a public clinical challenge that requires urgent attention and the increasing trend in its cases is suggested to continue for more decades. Currently, there is no permanent cure for DM. Many treatment regimens have shown promising results in DM management. Yet, notwithstanding the potential of these giant treatment plans, DM remains a serious challenge that may continue to threaten public health. Thus, the problems encountered in each of these approaches need to be addressed to achieve a robust, efficient, and safe clinical management plan. There is a need for optimal metabolic regulation of glucose, blood pressure, and body weight which requires proper education and support for the improvement of diet, physical activity, and reduction in body weight. To effectively and successfully manage the control of this disease, an emphasis on public policies to reinforce health care access and resources, the promotion of a patient-centred care approach, and health-promoting infrastructures at environmental level are required.

Funding Statement

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Author Contributions

Conception and Design: C.A., C.O.E. and I.A.; Data Collection: C.A., C.O.E., P.N.O. and N.A.O.; Data Analysis and Table Creation: C.A., P.M.A., J.C. and B.O.A. Writing the Manuscript: C.A., C.O.E., P.M.A., N.A.O., J.C., B.O.A., P.N.O. and I.A.; Vetting the manuscript for intellectual content: I.A.; Approval of the manuscript for submission: All the authors. All authors have read and agreed to the published version of the manuscript.

Institutional Review Board Statement

Informed consent statement, data availability statement, conflicts of interest.

The authors declare that they have no conflict of interest.

Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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Research design and methods, conclusions, article information, cost-effectiveness of interventions to manage diabetes: has the evidence changed since 2008.

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Karen R. Siegel , Mohammed K. Ali , Xilin Zhou , Boon Peng Ng , Shawn Jawanda , Krista Proia , Xuanping Zhang , Edward W. Gregg , Ann L. Albright , Ping Zhang; Cost-effectiveness of Interventions to Manage Diabetes: Has the Evidence Changed Since 2008?. Diabetes Care 1 July 2020; 43 (7): 1557–1592. https://doi.org/10.2337/dci20-0017

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To synthesize updated evidence on the cost-effectiveness (CE) of interventions to manage diabetes, its complications, and comorbidities.

We conducted a systematic literature review of studies from high-income countries evaluating the CE of diabetes management interventions recommended by the American Diabetes Association (ADA) and published in English between June 2008 and July 2017. We also incorporated studies from a previous CE review from the period 1985–2008. We classified the interventions based on their strength of evidence (strong, supportive, or uncertain) and levels of CE: cost-saving (more health benefit at a lower cost), very cost-effective (≤$25,000 per life year gained [LYG] or quality-adjusted life year [QALY]), cost-effective ($25,001–$50,000 per LYG or QALY), marginally cost-effective ($50,001–$100,000 per LYG or QALY), or not cost-effective (>$100,000 per LYG or QALY). Costs were measured in 2017 U.S. dollars.

Seventy-three new studies met our inclusion criteria. These were combined with 49 studies from the previous review to yield 122 studies over the period 1985–2017. A large majority of the ADA-recommended interventions remain cost-effective. Specifically, we found strong evidence that the following ADA-recommended interventions are cost-saving or very cost-effective: In the cost-saving category are 1 ) ACE inhibitor (ACEI)/angiotensin receptor blocker (ARB) therapy for intensive hypertension management compared with standard hypertension management, 2 ) ACEI/ARB therapy to prevent chronic kidney disease and/or end-stage renal disease in people with albuminuria compared with no ACEI/ARB therapy, 3 ) comprehensive foot care and patient education to prevent and treat foot ulcers among those at moderate/high risk of developing foot ulcers, 4 ) telemedicine for diabetic retinopathy screening compared with office screening, and 5 ) bariatric surgery compared with no surgery for individuals with type 2 diabetes (T2D) and obesity (BMI ≥30 kg/m 2 ). In the very cost-effective category are 1 ) intensive glycemic management (targeting A1C <7%) compared with conventional glycemic management (targeting an A1C level of 8–10%) for individuals with newly diagnosed T2D, 2 ) multicomponent interventions (involving behavior change/education and pharmacological therapy targeting hyperglycemia, hypertension, dyslipidemia, microalbuminuria, nephropathy/retinopathy, secondary prevention of cardiovascular disease with aspirin) compared with usual care, 3 ) statin therapy compared with no statin therapy for individuals with T2D and history of cardiovascular disease, 4 ) diabetes self-management education and support compared with usual care, 5 ) T2D screening every 3 years starting at age 45 years compared with no screening, 6 ) integrated, patient-centered care compared with usual care, 7 ) smoking cessation compared with no smoking cessation, 8 ) daily aspirin use as primary prevention for cardiovascular complications compared with usual care, 9 ) self-monitoring of blood glucose three times per day compared with once per day among those using insulin, 10 ) intensive glycemic management compared with conventional insulin therapy for T2D among adults aged ≥50 years, and 11 ) collaborative care for depression compared with usual care.

Complementing professional treatment recommendations, our systematic review provides an updated understanding of the potential value of interventions to manage diabetes and its complications and can assist clinicians and payers in prioritizing interventions and health care resources.

Diabetes is a serious, common, and costly disease, affecting 34 million Americans ( 1 ) and leading to $327 billion ( 2 ) in annual health expenditures in 2017. To better manage and lower the burdens of diabetes, the American Diabetes Association (ADA) annually publishes its Standards of Medical Care in Diabetes (SOC) ( 3 ), the most comprehensive and up-to-date clinical knowledge regarding diabetes care. Worldwide, the SOC provides clinicians, patients, researchers, and payers with the most current evidence-based screening, diagnostic, prevention, and management recommendations for diabetes. However, the cost-effectiveness (CE) of these strategies—in other words, the value they provide for these investments—varies greatly and should be considered in management or policy decisions.

CE analysis is an analytical framework that weighs the benefits and costs of an intervention by comparing it with standard care or other alternatives to see if the value of the intervention justifies its cost. The CE of different treatment options provides critical information to stakeholders at a variety of levels; this information helps in development of optimal treatment strategies or policies to lower current and future health and economic burdens and help determine use of limited health care resources.

In 2010, Li et al. ( 4 ) systematically reviewed all English-language studies published between January 1985 and May 2008 on the CE of diabetes prevention and management interventions recommended by the ADA’s SOC 2008 ( 5 ). The authors concluded that a large majority of the interventions recommended by ADA at that time were cost-saving or very cost-effective. Since then, however, many new technologies and medications have become available and have been added to updated iterations of the ADA’s SOC, leading to important changes in the ways diabetes care is delivered, how complications are managed, and the resulting costs. Recently published CE studies on these new technologies and medications can provide evidence on how to prioritize these novel interventions together with older strategies that remain cost-effective.

To provide up-to-date guidance that aligns with the 2019 SOC (the most up-to-date version at the time of data analysis) ( 6 , 7 ), we aggregated all available data published in English regarding the CE of ADA-recommended interventions to identify diabetes or gestational diabetes mellitus, manage diabetes, screen for diabetes complications, and manage complications and comorbidities. We included data from the previous review by Li et al. and systematically added data from the last decade to provide findings that are relevant to contemporary clinical practice. The result allows us to assess economic implications of changes that have occurred in the way diabetes care is delivered and how complications are managed. As a complement to the ADA’s 2019 SOC recommendations, findings from this review could assist clinicians and policy makers in selecting interventions that are not only effective but also deliver value.

Data Sources and Literature Search

We followed the same search strategy that was used in the 2010 review by Li et al. ( 4 ). Briefly, we performed a thorough literature search of seven databases (Cumulative Index to Nursing and Allied Health Literature [CINAHL], Cochrane, EMBASE, MEDLINE, PsycINFO, Scopus, and Sociological Abstracts [Soc Abs]) following the Cochrane Collaboration’s protocol ( 8 ) covering the period of June 2008 to July 2017. Medical subject headings matching the previous review’s search protocol were selected to create a search strategy. Our search terms were diabetes (indicating the disease of diabetes: “type 1,” “type 2,” “gestational,” “impaired glucose,” and “insulin resistance”), costs (“cost or expenditure,” “health care cost,” “costs or cost analysis”), effectiveness (“benefit” OR “life year” OR “quality-adjusted life years” OR “disability adjusted life years”), cost-effectiveness (indicating CE analysis, such as “cost-effectiveness analysis” OR “cost-utility analysis” OR “economic”). We also screened reference lists of all included articles and publications from leading medical and diabetes-focused journals during the period for additional articles that may have been missed.

Article Screening and Selection

We included studies from populations in high-income countries (based on World Bank classifications [ 9 ]) that assessed the economic value associated with diabetes management interventions included in the ADA’s SOC 2019 ( 7 ), the most up-to-date version available at the time of our analysis. We included studies of patients with undiagnosed or diagnosed diabetes, including type 1 diabetes (T1D), type 2 diabetes (T2D), and gestational diabetes mellitus.

We included studies that used one of the three major types of economic evaluations: cost-effectiveness analyses, cost-utility analyses, or cost-benefit analyses, with outcomes measured as cost per additional quality-adjusted life year (QALY) gained, cost per additional life year gained (LYG), or cost per additional disability-adjusted life year averted.

We included original research studies published in English and excluded review articles, commentaries or letters, conference abstracts, and dissertations. For this review, we also excluded studies that focused on preventing T2D. Each study was screened for eligibility by two authors (K.R.S., X.Zho., B.P.N., S.J., K.P., and X.Zha. all participated in this stage), with disagreements resolved by group discussion and consensus.

Data Abstraction

For studies from June 2008 through July 2017, we used the same detailed data extraction form used by Li et al. ( 4 ) to systematically gather the following information from each included study: publication information (title, first author’s name, publication year), study population, intervention and comparison, study method (within trial versus modeled/simulation), analytical time horizon and discounting, perspective used, costs, health outcome measures, survey instruments for measuring utility, incremental cost-effectiveness ratio (ICER), whether a sensitivity analysis was conducted, and study conclusion(s). For studies from January 1985 through May 2008, we used the previously abstracted data from Li et al.

Quality Assessment of Included Studies

To evaluate the quality of the included CE studies, we selected a widely used quality assessment tool based on The BMJ authors’ guide for economic studies ( 10 ), which was used in the 2010 review by Li et al. We considered four quality score items: source of cost-specific data, categories of costs, source of benefit-specific data, and categories of benefits. We classified studies that did not report all four items as “low quality.” Of studies that had all four components, we assessed nine additional items (analytical time horizon, study perspective, description of the CE model, diagram for constructing the decision tree, currency and year of cost, cost discounting, benefit discounting, ICERs, and sensitivity analysis) for further classification. We assigned one point for each item that was reported. We rated each study as “fair” if it scored 3 or less, “good” if it scored 4–6, and “excellent” if it scored 7–9 points. We restricted our analysis to articles rated as “excellent” or “good” quality. Our quality assessment methodology mirrored that used by Li et al. Figure 1 illustrates the complete process for screening articles.

Flowchart for article inclusion.

Data Analysis and Synthesis

To synthesize findings, we first grouped articles into four broad categories: 1 ) screening for undiagnosed diabetes (including T2D and gestational diabetes mellitus), 2 ) managing diabetes and risk factors to prevent diabetes-related complications (comprehensive lifestyle interventions; diabetes self-management education [DSME]; self-monitoring of blood glucose [SMBG]; intensive glycemic, blood pressure, and lipid control; integrated and coordinated care; smoking cessation), 3 ) screening for and early treatment of diabetes complications (cardiovascular disease [CVD], eye complications, foot ulcers, end-stage renal disease [ESRD]), or 4 ) treating diabetes-related complications and comorbidities (CVD, eye complications, foot ulcers, and comorbidities such as obesity, mental health, and sleep apnea). Within each of the four broader groups, we further classified studies into specific categories corresponding to each ADA-recommended intervention.

To facilitate comparisons across studies, we converted all costs and ICERs to 2017 U.S. dollars using the Consumer Price Index ( 11 ). If costs were reported in other currencies, we used the annual exchange rate from the Federal Reserve Bank ( 12 ) to convert them into U.S. dollars. If a study did not mention the year used in cost calculations, we assumed cost was for the one year prior to publication. ICERs were expressed as dollars per QALY or dollars per LYG and were rounded to the nearest hundred dollars. We calculated a range and median ICER for each intervention category.

Classifying the Interventions

We classified interventions based on their median levels of CE (five tiers) and strength of evidence (three levels). As there are no universally accepted thresholds to judge whether an intervention is cost-effective, we grouped the CE tiers of the intervention based on conventional norms according to their estimated ICERs: 1 ) cost-saving when the intervention generates better health outcomes and costs less than the comparison intervention or is cost neutral (ICER = 0), 2 ) very cost-effective if the ICER is greater than zero but less than or equal to $25,000 per QALY or LYG, 3 ) cost-effective if the ICER is greater than $25,000 but less than or equal to $50,000 per QALY or LYG, 4 ) marginally cost-effective if the ICER is greater than $50,000 but less than or equal to $100,000 per QALY or LYG, and 5 ) not cost-effective if the ICER is greater than $100,000 per QALY or LYG. Since there are no conventional norms for thresholds of cost per LYG, we used the same threshold for cost per QALY, which was the same approach used by Li et al. ( 4 ).

We classified the evidence level of the CE findings as strong, supportive, or uncertain. Strong evidence included findings from one of the following two categories:

Category 1:

The CE of the intervention was evaluated by two or more studies, AND

these studies were rated as at least “good” in quality, AND

the effectiveness of the interventions was based on either well-conducted, generalizable randomized clinical trials with adequate power or well-conducted meta-analyses or a diabetes disease simulation model that was validated, AND

the effectiveness of the intervention was also rated as level A or level B evidence by the ADA’s SOC 2019 ( 13 ), AND

the ICERs of the intervention from different studies consistently fell into the same CE tier.

Category 2:

CE assessment meets items 3 and 4 from category 1, but only one study evaluated the intervention, AND

the study was rated as “excellent” in quality.

We considered evidence on the CE of an intervention to be supportive if:

the CE of the intervention was evaluated by only one study AND this study was rated lower than “excellent” quality, OR

the effectiveness of the intervention was supported by level C evidence according to the ADA’s SOC 2019 ( 13 ) or by expert consensus only, OR

the CE was based on a simulation by a diabetes disease model that was not validated (a model was considered to be validated if it was explicitly stated in the text of the article or if the model was known to be validated based on previous literature).

For each ADA-recommended intervention within each evidence-CE level category, we described its comparison intervention, the study population in which the intervention was implemented, and the ADA’s level of evidence rating. We also reported the number of studies that evaluated the CE of this intervention (based on the current evidence and on the previous review), and the median and range of the ICERs across the studies.

Our initial search yielded 18,195 articles over the period of June 2008 to July 2017. After removal of duplicates and screening of all abstracts, 1,445 articles remained, of which we reviewed full texts to identify 73 CE studies that met our inclusion criteria. We added the 49 relevant studies on diabetes management from the 2010 review by Li et al. (encompassing 1985–2008), bringing the total number of studies to 122 over the period 1985–2017 ( Fig. 1 ). Table 1 describes the CE studies included in our final review by intervention category. Studies that evaluated multiple interventions or a single intervention in diverse subgroups were assigned to more than one intervention or population category, respectively.

Description of the CE studies for diabetes interventions

A1C, hemoglobin A 1c test; AIIRA, angiotensin II receptor antagonist; AusDiab, Australian Diabetes, Obesity, and Lifestyle Study; BP, blood pressure; CABG, coronary artery bypass graft; CDSS, clinical decision support system; CHD, coronary heart disease; DCCT, Diabetes Control and Complications Trial; DRVS, Diabetic Retinopathy Vitrectomy Study; ECG, electrocardiogram; EMR, electronic medical record; FPG, fasting plasma glucose; DM, diabetes; DME, diabetic macular edema; DPP, Diabetes Prevention Program; DPP-4, dipeptidyl peptidase 4; DR, diabetic retinopathy; GCT, glucose challenge test; GDM, gestational diabetes mellitus; GP, general practitioner; GTT, glucose tolerance test; HMO, health maintenance organization; IADPSB, International Association of the Diabetes and Pregnancy Study Groups; ISO, International Organization for Standardization; IT, information technology; LEADER, Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results; max, maximum; OGTT, oral glucose tolerance test; PHQ, patient health questionnaire; preDM, prediabetes; QALE, quality-adjusted life expectancy; RCT, randomized controlled trial; TZD, thiazolidinedione; UKPDS, UK Prospective Diabetes Study.

Supplementary Fig. 1 provides a summary of the numbers of studies across the four broad intervention categories—screening for undiagnosed diabetes (8 studies), managing diabetes and risk factors to prevent diabetes-related complications (71 studies), screening for and early treatment of diabetes complications (33 studies), and treating diabetes-related complications and comorbidities (19 studies)—as well as how the number of articles in each category changed from the previous review (1985–2008) to the current review (1985–2017). Except for smoking cessation, the number of articles in every category increased over time, and five new categories emerged: preventing CVD complications, treating CVD complications, and addressing comorbidities of obesity, mental health, and sleep apnea.

In Table 2 , we classified each of the ADA-recommended interventions based on their levels of CE and strength of evidence by intervention category, using all studies over the period 1985–2017. To facilitate use by clinicians and decision makers, we describe the findings across each of the four intervention categories from a health system perspective.

Summary of the CE studies by intervention (U.S. and non-U.S. high-income country studies)

ADA, American Diabetes Association Standards of Care 2018; DM, diabetes; DME, diabetic macular edema; DR, diabetic retinopathy; EHR, electronic health record; PDPN, painful diabetic peripheral neuropathy. Cost-saving is defined as an intervention that generates a better health outcome and costs less than the comparison intervention or is cost neutral (ICER = 0); very cost-effective , 0 < ICER ≤ $25,000 per QALY or LYG; cost-effective , $25,000 < ICER ≤ $50,000 per QALY or LYG; marginally cost-effective , $50,000 < ICER ≤ $100,000 per QALY or LYG; or not cost-effective , >$100,000 per QALY or LYG. A , as defined in Standards of Care 2018: clear evidence from well-conducted, generalizable, randomized controlled trials that are adequately powered; compelling nonexperimental evidence, i.e., “all or none” rule developed by the Centre for Evidence-Based Medicine at Oxford; supportive evidence from well-conducted randomized controlled trials that are adequately powered. B , as defined in Standards of Care 2018: supportive evidence from well-conducted cohort studies; supportive evidence from a well-conducted case-control study. C , as defined in Standards Care 2018: supportive evidence from poorly controlled or uncontrolled studies; conflicting evidence with the weight of evidence supporting the recommendation. E , as defined in Standards of Care 2018: expert consensus or clinical experience.

Strong Evidence

Screening for undiagnosed diabetes.

Screening for T2D every 3 years starting at age 45 years for the U.S. population without diabetes, compared with no screening, had strong evidence of being very cost-effective at $7,898/QALY (every 1 year compared with every 3 years was also very cost-effective at $8,139/QALY). On the other hand, there was strong evidence that universal opportunistic screening for undiagnosed T2D among the U.S. population (whether or not followed by treatment), compared with targeted screening in high-risk individuals, was not cost-effective (>$100,000/QALY).

Managing Diabetes and Risk Factors to Prevent Diabetes-Related Complications

For interventions to manage diabetes and risk factors to prevent complications, the evidence was mixed. We found strong evidence that DSME for individuals with diabetes, compared with usual care, is very cost-effective ($5,047/QALY). Additionally, there were several new studies on the daily frequency of SMBG, which led to the new finding that SMBG three times per day, compared with SMBG once per day, is very cost-effective ($3,719/QALY) among adults with T2D currently taking insulin.

The ICERs for intensively managing glycemia varied according to a patient’s age, duration of diabetes, and diabetes type (1 or 2). We found that intensive glycemic management compared with conventional management was very cost-effective among young individuals with newly diagnosed T2D ($4,318/QALY) and older individuals (aged ≥50 years) with T2D ($15,398/QALY) and was cost-effective when given to individuals with T1D regardless of age ($41,339/QALY).

For blood pressure management, ACE inhibitor (ACEI) and angiotensin receptor blocker (ARB) therapies, used either for intensive hypertension management (compared with suboptimal blood pressure management) or to prevent chronic kidney disease and/or ESRD in patients with albuminuria, compared with no ACEI/ARB therapy, emerged with strong evidence of being cost-saving.

Over the period 1985–2017, studies comparing multicomponent interventions (including behavior change and medication adherence to improve glycemia, blood pressure/CVD, lipids, and nephropathy/retinopathy prevention and screening together) with usual care have shown a range of value achieved from cost-effective to cost-saving. Overall, however, we found that these multicomponent interventions were on average very cost-effective ($2,315/QALY) for individuals with T1D and T2D compared with usual care.

Diabetes management interventions that remained consistent with the previous review as very cost-effective were 1 ) integrated, patient-centered care based on the Chronic Care Model for individuals with T2D compared with usual care ($11,339/QALY), and 2 ) smoking cessation for individuals with diabetes compared with no smoking cessation (<$31,750/QALY).

Screening for and Early Treatment of Diabetes-Related Complications

We found strong evidence for two cost-saving screening and early treatment interventions: 1 ) comprehensive foot care and patient education to prevent and treat foot ulcers among individuals with diabetes and at moderate/high risk of developing foot ulcers, compared with usual care, and 2 ) telemedicine for diabetic retinopathy screening among individuals with diabetes compared with office screening for diabetic retinopathy. Additionally, we found strong evidence that screening for eye complications every 1–2 years for individuals with diabetes, compared with no screening, is very cost-effective ($8,763/QALY).

Treatment of Diabetes-Related Complications and Comorbidities

Statin therapy for secondary prevention of CVD—i.e., in individuals with T2D and a history of CVD—compared with no statin therapy remained consistent from the previous review as very cost-effective ($4,627/QALY), while among individuals with T2D, hyperlipidemia, and no history of CVD, statin therapy was marginally cost-effective ($67,873/QALY). A new finding in this review was that daily aspirin use for primary prevention of CVD among individuals with T2D, compared with usual care, was very cost-effective ($2,395/QALY).

There were eight studies evaluating the CE of bariatric surgery in individuals with T2D and obesity (BMI ≥30 kg/m 2 ) compared with no bariatric surgery. All eight studies found this intervention to be cost-saving. Additionally, three studies evaluated the CE of collaborative care models to comanage depression in individuals with T2D and depression compared with usual care and found such treatment to be very cost-effective ($18,814/QALY).

Studies on two new ADA-recommended drugs (ranibizumab for diabetic retinopathy and duloxetine for painful diabetic peripheral neuropathy) were also included in this review. Both—ranibizumab compared with panretinal photocoagulation and duloxetine compared with desipramine—were found to be marginally cost-effective ($51,008/QALY and $67,188/QALY, respectively).

Supportive and Uncertain Evidence

There were nine specific interventions for which the level of CE was based on supportive evidence. Among these, cost-saving interventions are 1 ) reimbursement for ACEI by public insurance for individuals with diabetes compared with paying out of pocket and 2 ) group-based peer support for individuals with T2D compared with usual care. Very cost-effective interventions, based on supportive evidence, were both new findings in this updated review: 1 ) statin treatment at T2D diagnosis compared with no lipid-regulating treatment ($3,294/QALY) and 2 ) bariatric surgery for individuals with T2D and overweight compared with no surgery ($23,320/QALY). Continuous positive airway pressure (CPAP) therapy for individuals with T2D and obstructive sleep apnea compared with usual care was also cost-effective ($27,750/QALY). Adhering to the National Cholesterol Education Program Adult Treatment Panel III guidelines for adults with T2D and mixed dyslipidemia compared with usual care was marginally cost-effective ($67,873/QALY).

There were three specific interventions in the “uncertain evidence” category: 1 ) screening a 30-year-old pregnant woman between 24–28 weeks’ gestation (base case) for gestational diabetes mellitus compared with no screening (cost-saving); 2 ) SMBG once per day and provision of monitoring devices and strips for individuals with T1D and for those with T2D not using insulin compared with usual care (SMBG once per day without provision of devices and strips), at >$100,000/QALY; and 3 ) computerized decision-support systems linked to electronic health records and shared between patients and physicians ($190,417/QALY).

Our systematic review provides an updated understanding of the potential value of interventions to manage and treat diabetes from a health system perspective. Since the last review in 2010, the evidence that interventions to manage diabetes are cost-effective has grown in terms of additional evaluations to bolster existing evidence, as well as new economic evaluations of novel interventions and methods of care delivery. ACEI/ARB therapy compared with standard hypertension management, comprehensive foot care compared with usual care, and intensive glycemic management compared with conventional therapy are confirmed as very cost-effective interventions, while multicomponent interventions compared with usual care, statin therapy for secondary prevention compared with no statin therapy, T2D screening every 3 years compared with no screening, and screening for eye complications compared with no screening are confirmed as very cost-effective interventions. New findings include telemedicine for diabetic retinopathy screening and bariatric surgery for type 2 diabetes and BMI ≥30 kg/m 2 as cost-saving interventions and aspirin use for primary prevention of cardiovascular complications, SMBG three times per day for insulin-treated patients (compared with once per day), intensive glycemic management among those aged ≥50 years, and collaborative care for depression as very cost-effective interventions. This review complements professional treatment recommendations and can assist clinicians and payers in prioritizing interventions in an evidence-based manner that may lead to better allocation of health care resources.

Figure 2 is a comprehensive guide to our findings. Overall, the ADA-recommended interventions included in the previously published review remain cost-saving, very cost-effective, or cost-effective. The strength of the evidence improved from supportive to strong for both DSME (compared with usual care) and integrated, patient-centered care based on the Chronic Care Model (compared with usual care) due to additional studies on these topics during the 2008–2017 time period. Interventions that are cost-saving should be implemented, and those that are very cost-effective or cost-effective based on strong evidence warrant consideration for implementation. ADA-recommended interventions rated as cost-saving, very cost-effective, or cost-effective with supportive evidence should be adopted if extra resources are available or if similar interventions with strong evidence are unavailable or infeasible in a specific setting.

Summary of the CE of interventions (strong evidence only). CKD, chronic kidney disease; DM, diabetes; DR, diabetic retinopathy; PDPN, painful diabetic peripheral neuropathy; undx, undiagnosed.

Our review highlighted the value associated with new and innovative interventions to manage and treat diabetes, including technology-related innovations and those focused on addressing diabetes-related comorbidities. The focus on technological innovations and diabetes-related comorbidities is well-aligned with the ADA SOC 2019 ( 14 ) (as well as the recently updated ADA SOC 2020 [ 3 , 14 ]). In addition, the inclusion of collaborative care models for depression is a big step toward acknowledging and addressing the comorbid conditions of diabetes and depression, which is increasingly being seen as an important consideration in the care of people with diabetes ( 15 ).

Multicomponent interventions are also featured prominently in the current review and may have implications for delivery system design, especially in the context of persistent gaps in achievement of diabetes care goals ( 16 , 17 ). Among individuals with diabetes, interventions that included a combination of practice change, behavior change and education, pharmacologic therapy targeting hyperglycemia, hypertension, dyslipidemia, microalbuminuria, or nephropathy/retinopathy, and secondary prevention of CVD with aspirin were very cost-effective compared with usual care, based on strong evidence. Of note, our review predates the ASCEND (A Study of Cardiovascular Events in Diabetes) trial, which showed that the primary CVD prevention benefits of aspirin were offset by the increased risk of major bleeding events ( 18 ).

In some cases, CE evaluations may help to provide more insight into how ADA-recommended interventions might be prioritized for specific populations receiving the intervention. For example, bariatric surgery was cost-saving among individuals with T2D and obesity but only very cost-effective among individuals with T2D and overweight, likely due to larger health risks posed by obesity. We also noted differences in the CE of statin therapy for individuals with diabetes with and without CVD; when used as secondary prevention, there is clear value to statin use (cost-saving). However, for primary prevention, statin use has been found to be less cost-effective. We found that the CE of intensive glycemic management (with a goal of reducing A1C values) depends on age and duration since diabetes diagnosis. Among young individuals with newly diagnosed T2D, intensive glycemic management, compared with conventional insulin therapy, is cost-saving; indeed, recent research shows that earlier intensive management is associated with lower long-term risk of complications ( 19 ). For older individuals (aged ≥50 years) with T2D and shorter life expectancy, the ability to see benefits of intensive glycemic management is limited, in part because cardiovascular or mortality benefits may not be seen for at least 10 years ( 20 ). In individuals with T1D, intensive glycemic management compared with conventional insulin therapy remains cost-effective.

There are a few key areas that future economic evaluations of diabetes should consider. First, more studies are needed to evaluate the CE of interventions that fell in the “supportive” or “uncertain” evidence categories. In cases where interventions have uncertain value due to a small number of studies (i.e., incomplete knowledge), adding to the evidence base could help to clarify their value. There are also a number of new, efficacious medications and treatments for the management of glycemia (glucagon-like peptide 1 receptor agonists, sodium–glucose cotransporter 2 inhibitors), lipids (PSK9 inhibitors), and heart failure (sacubitril/valsartan [Entresto]) that were not included in this review because there are no published CE studies. For studies with weaker efficacy data, further efficacy studies are needed.

Second, more studies are needed that address interventions in real-world settings, as our current review is predominantly based on randomized controlled trials or computer simulation models. In real life, however, there are many factors to consider in addition to the CE of an intervention, such as 1 ) coverage for the intervention in question (determine access), 2 ) motivation (side effects or mode of delivery [e.g., injectable versus oral] may deter patients from taking specific medications), and 3 ) whether the risk reduction in real life is similar to what was observed in trials and models (i.e., effectiveness versus efficacy). These are many of the unknowns that clinicians and policy makers must consider as they attempt to use the data from this review in practice.

Third, there may be additional cost-effective interventions that exist but have not been studied or about which the right questions are not being asked. For example, the 2010 review included one article regarding the CE of smoking cessation, which was found to be very cost-effective. There were no additional articles in this category from 2008–2017, likely because it is universally understood that smoking cessation is good and thus no one would be compelled to argue its value; a more interesting contemporary economic question might be to inquire how often a smoking cessation intervention should be implemented for it to be most cost-effective and most adoptable by clinicians and their patients.

The CE of an intervention in decision- making is important, but it is not the only factor to consider. CE analysis does not address equity in the distribution of costs and the benefits of an intervention, societal or personal willingness to pay, social and legal aspects, or ethical issues associated with each intervention. However, with an eye toward finding diabetes management and treatment interventions that can best increase the value of our health care dollars, this review of the most up-to-date available evidence can help to guide clinicians and policy makers toward the most cost-effective use of their prescriptions and health care dollars.

The findings and conclusions are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

See accompanying article, p. 1593 .

This article contains supplementary material online at https://doi.org/10.2337/figshare.12081801 .

Acknowledgments. This work is a collaboration between the Centers for Disease Control and Prevention and the ADA. The authors thank the external and internal reviewers for their valuable comments during the review process. The authors thank Rui Li for generously sharing materials from her previous review and William Thomas for his timely help with the literature search (both from Centers for Disease Control and Prevention).

Duality of Interest. No potential conflicts of interest relevant to this article were reported.

Author Contributions. K.R.S., X.Zho., B.P.N., S.J., K.P., and X.Zha. reviewed the abstracts and full text of all articles for inclusion and abstracted the data. X.Zho. and B.P.N. performed the literature search and rated the quality of the studies for inclusion. K.R.S., M.K.A., X.Zho., E.W.G., A.L.A., and P.Z. interpreted the data and results. K.R.S. drafted the manuscript. All authors reviewed and edited the manuscript.

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Assessing perceptions of nursing knowledge, attitudes, and practices in diabetes management within Chinese healthcare settings

Affiliation.

• 1 Department of Endocrinology, The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture, Enshi, Hubei, China.
• PMID: 39188797
• PMCID: PMC11345264
• DOI: 10.3389/fpubh.2024.1426339

Background: Effective management of diabetes mellitus (DM) involves comprehensive knowledge, attitudes, and practices (KAP) by nurses, which is essential for optimal patient care and aiding patients in their self-management of the condition.

Method: This survey evaluates nurses' self-assessed knowledge, attitudes, and practices (KAP) related to diabetes management, focusing on their perceptions of personnel expertise and care approaches. Using a stratified sampling method, the survey was disseminated across various online platforms from January 2023 to February 2024 within China, including WeChat and Sina Weibo. We employed binary logistic regression and Chi-square tests to explore the statistical correlates of KAP related to DM.

Results: A total of 4,011 nurses participated, revealing significant perceived knowledge deficiencies in specialized DM management areas, with only 34% ( n = 1,360) proficient in current pharmacological treatments. Attitudinal assessments showed that 54% ( n = 2,155) recognized the importance of cultural competence in dietary counseling. Practices were strong in routine glucose monitoring (96%, n = 3,851) but weaker in psychological support (68%, n = 2,736). Regression analysis indicated significant effects of experience on KAP, where nurses with 1-5 years of experience were more likely to show better knowledge (OR = 1.09; p = 0.08), and those with advanced degrees demonstrated higher competence (OR = 1.52; p = 0.028). Marital status influenced attitudes, with single nurses more likely to exhibit positive attitudes (OR = 0.49; p < 0.001), and work environment impacted knowledge, with hospital-based nurses more knowledgeable (OR = 1.15; p = 0.14). Additionally, gender differences emerged, with male nurses showing greater knowledge (OR = 1.65; p = 0.03) and better practices in diabetes care (OR = 1.47; p = 0.04).

Conclusion: The study underscores the critical need for targeted educational programs and policy interventions to enhance nursing competencies in DM management. While the study provides valuable insights into nurses' perceptions of their competencies, future research should incorporate objective knowledge assessments to ensure a comprehensive understanding of their actual capabilities. Interestingly, the data also suggests a substantial opportunity to leverage technology and inter-professional collaboration to further enhance DM management efficacy among nurses, fostering an integrated care approach.

Keywords: KAP; diabetes management; diabetes mellitus; healthcare workers; nurses.

Copyright © 2024 Hu and Jiang.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Nurses' knowledge, attitudes, and practices…

Nurses' knowledge, attitudes, and practices on diabetes management.

Correlation between demographic characteristics, educational…

Correlation between demographic characteristics, educational background, work environment, and knowledge, attitudes, and practices.…

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Latest List of Best Diabetes Dissertation Topics

Published by Owen Ingram at January 2nd, 2023 , Revised On May 17, 2024

The prevalence of diabetes among the world’s population has been increasing steadily over the last few decades, thanks to the growing consumption of fast food and an increasingly comfortable lifestyle. With the field of diabetes evolving rapidly, it is essential to base your dissertation on a trending diabetes dissertation topic that fills a gap in research. 

Finding a perfect research topic is one of the most challenging aspects of dissertation writing in any discipline . Several resources are available to students on the internet to help them conduct research and brainstorm to develop their topic selection, but this can take a significant amount of time. So, we decided to provide a list of well-researched, unique and intriguing diabetes research topics and ideas to help you get started. 

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List of Diabetes Dissertation Topics

• Why do people recently diagnosed with diabetes have such difficulty accepting reality and controlling their health?
• What are the reactions of children who have recently been diagnosed with diabetes? What can be done to improve their grasp of how to treat the disease?
• In long-term research, people getting intensive therapy for the condition had a worse quality of life. What role should health professionals have in mitigating this effect?
• Why do so many individuals experience severe depression the months after their diagnosis despite displaying no other signs of deteriorating health?
• Discuss some of the advantages of a low-carbohydrate, high-fat diet for people with diabetes
• Discuss the notion of diabetes in paediatrics and why it is necessary to do this research regularly.
• Explain the current threat and difficulty of childhood obesity and diabetes, stressing some areas where parents are failing in their position as guardians to avoid the situation
• Explain some of the difficulties that persons with diabetes have, particularly when obtaining the necessary information and medical treatment
• Explain some of the most frequent problems that people with diabetes face, as well as how they affect the prevalence of the disease. Put out steps that can be implemented to help the problem.
• Discuss the diabetes problem among Asian American teens
• Even though it is a worldwide disease, particular ethnic groups are more likely to be diagnosed as a function of nutrition and culture. What can be done to improve their health literacy?
• Explain how self-management may be beneficial in coping with diabetes, particularly for people unable to get prompt treatment for their illness
• Discuss the possibility of better management for those with diabetes who are hospitalised
• What current therapies have had the most influence on reducing the number of short-term problems in patients’ bodies?
• How have various types of steroids altered the way the body responds in people with hypoglycemia more frequently than usual?
• What effects do type 1, and type 2 diabetes have on the kidneys? How do the most widely used monitoring approaches influence this?
• Is it true that people from specific ethnic groups are more likely to acquire heart disease or eye illness due to their diabetes diagnosis?
• How has the new a1c test helped to reduce the detrimental consequences of diabetes on the body by detecting the condition early?
• Explain the difficulty of uncontrolled diabetes and how it can eventually harm the kidneys and the heart
• Discuss how the diabetic genetic strain may be handed down from generation to generation
• What difficulties do diabetic people have while attempting to check their glucose levels and keep a balanced food plan?
• How have some individuals with type 1 or type 2 diabetes managed to live better lives than others with the disease?
• Is it true that eating too much sugar causes diabetes, cavities, acne, hyperactivity, and weight gain?
• What effect does insulin treatment have on type 2 diabetes?
• How does diabetes contribute to depression?
• What impact does snap participation have on diabetes rates?
• Why has the number of persons who perform blood glucose self-tests decreased? Could other variables, such as social or environmental, have contributed to this decrease?
• Why do patients in the United States struggle to obtain the treatment they require to monitor and maintain appropriate glucose levels? Is this due to increased healthcare costs?
• Nutrition is critical to a healthy lifestyle, yet many diabetic patients are unaware of what they should consume. Discuss
• Why have injuries and diabetes been designated as national health priorities?
• What factors contribute to the growing prevalence of type II diabetes in adolescents?
• Does socioeconomic status influence the prevalence of diabetes?
• Alzheimer’s disease and type 2 diabetes: a critical assessment of the shared pathological traits
• What are the effects and consequences of diabetes on peripheral blood vessels?
• What is the link between genetic predisposition, obesity, and type 2 diabetes development?
• Diabetes modifies the activation and repression of pro- and anti-inflammatory signalling pathways in the vascular system.
• Understanding autoimmune diabetes through the tri-molecular complex prism
• Does economic status influence the regional variation of diabetes caused by malnutrition?
• What evidence is there for using traditional Chinese medicine and natural products to treat depression in people who also have diabetes?
• Why was the qualitative method used to evaluate diabetes programs?
• Investigate the most common symptoms of undiagnosed diabetes
• How can artificial intelligence help diabetes patients?
• What effect does the palaeolithic diet have on type 2 diabetes?
• What are the most common causes of diabetes and what are the treatments?
• What causes diabetes mellitus, and how does it affect the United Kingdom?
• The impact of sociodemographic factors on the development of type II diabetes
• An examination of the link between gut microbiome and diabetes risk
• The effectiveness of lifestyle interventions in preventing type II diabetes
• The role of maternal diabetes in offspring’s risk of developing diabetes
• Artificial intelligence in diabetes diagnosis and management
• Continuous glucose monitoring
• Telehealth interventions for improving diabetes self-management
• The role of wearable technology in diabetes management
• Personalised medicine approaches for diabetes treatment
• The impact of diabetes on mental health and well-being
• The link between diabetes and cognitive decline
• The potential of stem cell therapy for diabetes treatment
• Advances in closed-loop insulin delivery systems
• The use of glucagon-like peptide-1 (GLP-1) receptor agonists in diabetes treatment
• Investigating the efficacy of new oral medications for type II diabetes
• The role of bariatric surgery in the management of type II diabetes
• Improving patient adherence to diabetes treatment regimens
• The role of social support in diabetes management
• Developing culturally sensitive diabetes education programs
• The role of dietary patterns in diabetes prevention and management
• Low-carbohydrate vs. Mediterranean diet for diabetes: A comparative study
• The use of artificial sweeteners in diabetes management: Benefits and risks
• The impact of the gut microbiome on dietary interventions for diabetes
• The role of exercise in improving glycemic control
• Developing effective exercise programs for individuals with diabetes
• The impact of physical activity on diabetic complications
• Promoting physical activity adherence in people with diabetes
• The use of exercise gamification to increase physical activity in diabetes
• The potential of CRISPR gene editing for diabetes treatment
• The role of the microbiome in the development and treatment of diabetes
• An analysis of the artificial Pancreas systems
• The use of big data analytics in diabetes research
• The impact of environmental factors on diabetes risk
• Cost-effectiveness of different diabetes treatment strategies
• Developing effective diabetes prevention programs for communities
• The role of government policies in addressing the diabetes epidemic
• Improving access to diabetes care in underserved populations
• The impact of social determinants of health on diabetes risk
• Management of diabetes in children and adolescents
• The unique challenges of diabetes management in older adults
• Diabetes in ethnic minorities: Disparities in prevalence and care
• The impact of diabetes on LGBTQ+ populations

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You can contact our 24/7 customer service for a bespoke list of customised diabetes dissertation topics , proposals, or essays written by our experienced writers . Each of our professionals is accredited and well-trained to provide excellent content on a wide range of topics. Getting a good grade on your dissertation course is our priority, and we make sure that happens. Find out more here . 

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• Consider cultural or demographic aspects.
• Consult experts or professors.
• Select a niche that resonates with you.

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Buy Rating on SAB Biotherapeutics: Promising Developments in Type 1 Diabetes Treatment

SAB Biotherapeutics ( SABS ) has received a new Buy rating, initiated by Oppenheimer analyst, Leland Gershell .

Leland Gershell has given his Buy rating due to a combination of factors pertaining to SAB Biotherapeutics’ promising developments and market potential. The company’s lead candidate, SAB-142, is a fully-human anti-thymocyte globulin which has been identified as a potentially best-in-class treatment for delaying the onset and progression of type 1 diabetes. Gershell notes the upcoming safety data expected to further de-risk the product’s development, drawing a parallel to clinical efficacy precedents set by an earlier, animal-derived version. The recent approval and acquisition of a related monoclonal antibody treatment for type 1 diabetes by Sanofi underscores the significant market opportunity, suggesting SAB-142 could command a strong presence with its greater potency, convenience, and broader label. Moreover, Gershell is optimistic about SAB Biotherapeutics’ proprietary immunotherapeutic platform, evidenced by the successful administration of their fully-human polyclonal antibodies in over 700 patients without adverse events. The platform’s capacity for amplifying potency and the absence of regulatory pathways for biosimilar competition further support the investment thesis. The analyst anticipates that the fourth quarter’s data release could serve as a catalyst for the stock, reflecting the substantial potential for disease-modifying therapies in the management of type 1 diabetes, which currently lacks interventions that alter the disease’s course.

SABS’s price has also changed dramatically for the past six months – from $5.000 to $2.516, which is a -49.68% drop .

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SAB Biotherapeutics (SABS) Company Description:

Blue Calypso Inc is engaged in the development, sales, delivery and licensing of technology and intellectual property focused on mobile shopper engagement, digital word of mouth and location-based marketing and advertising. Its solutions include mobile engagement, POP and merchandise tracking, mobile plant tag engagement. The company derives its revenues from the cloud-based consumption of its technology platform, consulting fees and licensing of its technologies.

Read More on SABS:

• SAB BIO Announces Second Quarter 2024 Financial Results and Provides Company Updates
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