Clinical Project: Synthesis of Knowledge

Posted: January 5th, 2023

Clinical Project: Synthesis of Knowledge

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Clinical Project: Synthesis of Knowledge

Introduction

Background

Diabetes is a non-communicable disease (NCD) that continues to raise increasing concerns among healthcare professionals, policy makers and the public because of its increasing prevalence and adverse effects on the quality of life. The global situation is dire because the world population was aging gradually, nutrition preferences were becoming more westernized, and lifestyles were becoming more sedentary owing to technological advancements and globalization of food cultures, particularly in developing countries (Alouki et al., 2016). The latest estimates by the International Diabetes Foundation (IDF) indicate that about 8.8% of the global population has diabetes and the prevalence is expected to reach 10.4% of this population by the year 2040, which means that the number of people with diabetes across the world is projected to increase from 415 million to 642 million (Cefalu et al., 2016). If this trend continues, the World Health Organization expected this disease to become the seventh leading cause of mortalities by the year 2030 (Lopes, Andrade, & Valentão, 2017). In the United States, the adverse health effects, fatalities and financial burden of diabetes are significant and growing. Already, Americans living with diabetes had tripled between 1990 and 2010 and new incidences doubled every year in this period (Rowley et al., 2016). In turn, the financial burden of the disease was high and increasing. The International Diabetes Foundation estimated the expenditure in treating diabetes was between $673 billion and $1.2 trillion and was expected to reach between $802 billion and $1.5 trillion by 2040 (Cefalu et al., 2016). Better identification and prevention of the disease may bring down the costs managing it when it has become fully established in the body.

Prediabetes is a condition afflicting people whose blood sugar levels are moderately elevated, meaning that they are at a heightened risk of developing diabetes, especially type II diabetes that afflicts about between 90% and 95% of all diabetic patients worldwide (Lopes, Andrade, & Valentão, 2017; Madsen et al., 2019). According to the Centers for Disease Control and Prevention (CDC) (2020) about 88 million adults in the United States were prediabetic in 2018, and this number is expected to rise as the American population ages. Unfortunately, young people with prediabetes are at high risk of developing diabetes as adults later in life unless drastic measures are taken to reduce the worsening of the condition. The young adults are at a high risk of developing type II diabetes, especially when their combine poor eating habits with inactivity. Adolescents and young adults have a full life ahead of them and diabetes would endanger their endeavor to grow and develop into healthy adults with a full, active and prosperous life. In this regard, the young adults could contribute to the increasing prevalence of diabetes if their prediabetic condition develops in full-blown type II diabetes. Moreover, they are likely to develop health complication that accompany diabetes, such as cardiovascular diseases, cerebrovascular disease, renal failure, loss of vision, peripheral neuropathy, and cancer (American Diabetes Association, 2019).

Already, the most accepted interventions of preventing and slowing the onset of diabetes among prediabetic individuals include lifestyle change and pharmacological interventions. Various studies have demonstrated the effectiveness of each intervention and even compared the efficaciousness of both. Unfortunately, some of the pharmacological strategies cause adverse effects in some individuals, increasing the incidences of noncompliance to the prescribed medication regime. The knowledge about the effectiveness of the lifestyle modification and medication approaches is scattered and therefore likely to confuse healthcare professionals, especially nurses who are in the frontline in implementing them. Therefore, there is need to consolidate this knowledge in a manner that is usable, especially by Advanced Practice Registered Nurses (APRNs) and Family Nurse Practitioners (FNPs) who are expected to implement these initiatives as the first healthcare professional to encounter the at-risk population. To this end, a PICOT question was formulated to guide the search and consolidation of knowledge, and facilitate its translation from theory into practice by the APRNs and FNPs. The PICO question is: In young adults diagnosed with prediabetes, do lifestyle interventions effectively prevent or delay type 2 diabetes (T2D) compared to pharmacologic strategies?  This question has the elements of a clinical research question, including the patient, or problem or population, the suggested intervention, the comparison, and the expected outcome (Dang & Dearholt, 2018). In this regard, the targeted population and problem in this question is the young adults with prediabetes. The intervention is lifestyle modification and pharmacological strategies. The comparison is between lifestyle modification and pharmacological interventions. The expected outcome of the intervention is the effective and successful prevention or delay of developing type II diabetes. However, the question does not propose a time-frame within which the effective or successful outcomes are expected.

Significance of the Problem

Young adults are considered the future of any country and therefore, anything that threatens their health endangers the productive future of a nation. Moreover, the way a nation treats its youth is an indication of its commitment to prepare future generations for life’s challenges and secure the country’s future.  Prediabetes presents a high risk of developing type II diabetes among young people, who are looked upon to become productive citizens, however, such a dream may be far-fetched is the young adults are debilitated by disease. Diabetes is capable of devastating the prospects and livelihoods of patients in an era when the proportion of older people is increasing in developed countries, like the United States, where the labor dynamics are changing fast due to demographic changes and increased adoption of modern digital technologies, alongside other globalization effects (). From another perspective, people with prediabetes and diabetes are less productive that those without a blood sugar complication. Diabetic people tire fast, feel thistly always, have blurry vision and experience numbness in their hands and feet, thus making work to be a gruesome task. Therefore, a diabetic individual becomes a burden rather than a reliever of burdens. Similarly, prediabetic people become obsessed with the health condition once they have been diagnosed and worry that they may develop diabetes at any time in their lives, thus lowering their quality of life and the drive to engage actively in productive life.  

Likewise, diabetes places a heavy financial burden on the individual and their families, and a country’s healthcare resources. The American Diabetes Association (ADA) (2018) revealed that in 2017, the economic cost of diabetes in the United States was $327 billion, comprising $237 and $90 billion in direct medical costs and reduced productivity respectively. In the same vein, Rowley et al. (2017) noted that diabetic adults 50% more at risk of death compared to healthy adults. This means that people with diabetes were more likely to be unproductive in the long-term, leading to the loss of productivity, which can be expressed in monetary terms.

Theoretical/Conceptual Framework

Evidence-based decision-making a clinical setting is a critical activity undertaken by all healthcare professionals. This has been driven by the demand for high-quality healthcare, transparency about the intervention used, and the paradigm shift towards patient-center care, in which the patient is a critical decision-making partner (Orta et al., 2016). The APRNs and FNPs targeted in are active participants in research and frequent producers and consumer of new nursing approaches. Since this study promotes the application of evidence-based practice in healthcare settings, the Academic Center for Evidence Based Practice (ACE Star Model) was selected as the fitting theoretical model for evidence-based practice of APRNs and FNPs related to the management of prediabetes and type II diabetes among young adults. The ACE Star Model was selected because of its approach of translating evidence-based research findings into nursing practice in a hospital setting. Notably, this model is commonly known as the model of knowledge transformation because it elucidates the characteristics, nature and cycles of knowledge that are applied in various facets of evidence-based practice (Orta et al., 2016). This model is renowned for its simplicity, making it applicable by novice nurses with advanced academic credentials, such as the newly-accredited APRNs and FNPs. It also provides a concise description and interpretation of the relationships between the various phases of knowledge transformation. Moreover, the knowledge transformation approach is consistent with nursing practice and therefore, can be easily understood and adopted by practicing nursing practitioners.

The ACE Star Model of knowledge transformation approaches the translation of theory into practice through five critical phases. The first phase involves knowledge discovery. In this process, the nursing practitioners discover new knowledge from various sources. Knowledge sources include theoretical principles that have been established in nursing theory, perceptions provided by authorities in nursing practice, such as educators and nursing managers, evidence from research and published in existing credible peer-reviewed sources, experiential encounters with clinical issues, and trial and error by the individual nurses. In this phase, nursing practitioners are advices to upgrade their electronic search skills to help them access the wide repository of knowledge residing in digital databases, some of which are freely available online (Indira, 2018). The second face focuses of summarizing the evidence obtained from credible and relevant sources addressing the targeted clinical issue. This involves the synthesizing of the retrieved knowledge into concise meaningful statements that highlight the state of science on the area of interest. The process in this phase compresses the available knowledge into comprehensible and manageable segments while helping reduce bias from systematic and random errors. This stage makes the decision-making process more time and cost efficient and accommodates the continuous emergence of new evidence (Indira, 2018). The third phase concentrates on the translation of evidence obtained from the sources into practice. In this phase, practice guidelines related to the translation and integration of evidence into practice are provided. The practice guidelines are consolidated into protocols, clinical pathways, and care standards that can be used to guide evidence-based clinical practice (Indira, 2018). The fourth phase focuses on the integration of the clinical recommendations into practice. In this stage, the new evidence transforms individual and organizational practices using formal and informal channels. Innovation is required to accelerate and improve the efficiency and effectiveness of the practice integration process (Indira, 2018). The fifth phase completes the knowledge transformation process by focusing on the evaluation of the evidence-based practice and its efficaciousness in addressing the targeted clinical issue. In this phase, a variety of outcomes and endpoints are evaluated, and focus is commonly on the patient outcomes such as the rate of recovery or return to health and patient satisfaction, economic outcomes, such as cost-effectiveness and time-effectiveness, institutional outcomes, such as reduced length-of-stay in hospitals, and the overall impact on the health status.

However, the lack of consideration about organizational culture and context, and individual prejudices are commonly highlighted in the limitations of ACE Star Model in nursing practice. Moreover, it does not address patient expertise, considering that patients are now pertinent partners in the clinical decision-making process in the patient-centered care. Nonetheless, the model is adaptable to include patient consideration (Indira, 2018).

Search Strategy

This study endeavors to answer the question whether in young adults diagnosed with prediabetes, do lifestyle interventions effectively prevent or delay type II diabetes (T2D) compared to pharmacologic strategies? In this regard, the researcher sought high quality and recent peer reviewed articles as sources of existing and new knowledge that would be useful to APRNs and FNPs as they attend to prediabetic young adults. An online sources search strategy was developed that outlined the databases queried, the keywords used in the search engines, the inclusion and exclusion criteria used to select the most suitable sources to help answer the PICO question.

Several databases, such as Cochrane Library, CINAHL, MEDLINE, PubMed, AND EMBASE were queried using Google Scholar and Microsoft Academic as the search engines. The search strategy involved the use of key words and phrases that were related to the PICO question. This included words like, prediabetes, type II diabetes, and phrases, such as prevention of diabetes, compare medication and lifestyle interventions for type II diabetes, new development in the pharmacological intervention of prediabetes and type II diabetes, and new development in the lifestyle intervention for prediabetes and type II diabetes.  

The inclusion criteria used to sieve out the most relevant peer-reviewed articles included i) they should have been published within the last five years (2016-2021), ii) they should contain information about either pharmacological or lifestyle interventions, either singly of a combination of the two, and iii) they should be relevant to nursing practice, and therefore target APRNs and FNPs as a critical audience. In the exclusion criteria, articles published in any other language other than English were rejected. 

Review of the Literature

Medication and lifestyle interventions of prediabetes and type II diabetes have been studies widely. Some studies have focused on one of the two interventions while others have addressed both of them simultaneously, and event compared their efficaciousness and cost effectiveness. During the electronic search, more peer-reviewed articles that were ranked favorably focused on medication interventions for type II diabetes than those addressing lifestyle approaches. 

Alum et al. (2018), Balbi et al. (2018), Erpeldinger et al. (2016), Lind et al. (2019), Luo et al. (2018) document findings concentrating on medication interventions in patients with type II diabetes mellitus.

Luo et al. (2018) studied the efficaciousness of novel antidiabetic medications, such as dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide 1 (GLP-1) receptor agonists, and sodium-glucose cotransporter 2 (SGLT-2) inhibitors, which targeted lowering of albuminuria, a condition brought about by high levels of the protein albumin, which is associated with elevated risks of kidney and cardiovascular disease that are common in diabetic patients. Their systematic review and meta-analysis findings revealed that although GLP-1 receptor agonists and SGLT-2 inhibitors were more effective in reducing albuminuria is diabetic patients compared to conventional medication therapies, DPP-4 inhibitors did not deliver any more efficaciousness than other conventional drug therapies. However, despite inconclusive findings, GLP-1 receptor agonists and SGLT-2 inhibitors had most promise in reducing albuminuria in patients with type II diabetes; bur more conclusive studies were needed to support their use in regular medication administration practice.

Erpeldinger et al. (2016) studied the efficaciousness and safety of medication approaches of managing type II diabetes, and focused specifically on insulin and hypoglycemic drugs. According to their findings, although they did not find any significant evidence supporting the long-term efficaciousness of insulin on the clinical outcomes on patients with type II diabetes mellitus, they note that insulin therapy had a trend of adverse effects associated with clinical harm, specifically, weight gain and hypoglycemia. The only benefit conferred to the individual with type II diabetes was the control of hyperglycemia in the short term. This is a critical finding considering that insulin therapy is one of the most commonly used interventions against diabetes by nursing professionals. However, Alum et al. (2018) unearthed that because some individuals are sensitive or resistant towards insulin, other medication were available, and Pioglitazone, which is the only thiazolidinedione drug recommended for the management of type II diabetes, was often recommended and prescribed by physicians.

Balbi et al. (2018) discussed vitamins as essential micronutrients usually recommended for controlling blood glucose and glycated hemoglobin in patients with type II diabetes mellitus. Their meta-analysis of randomized clinical trials revealed that vitamins B, C, D, and E are most commonly recommended for these patients. Specifically, vitamin E yielded the most significant reduction of glycated hemoglobin and blood sugar, while vitamins C and E yielded reductions in malondialdehyde (MDA) and thiobarbituric acid reactive substances (TBARS) while elevating the levels of total antioxidant capacity (TAC), superoxide dismutase enzyme (SOD), and glutathione superoxidase (GPx). This study concluded that supplemeting type II diabetes patients with vitamin E could be a valuable medication strategy for controlling the diabetes-related complications while improving antioxidant capacity in patients. Similarly, Lind et al. (2019) investigated the efficaciousness of folate supplements in type II diabetic patients with insulin resistance. From their meta-analysis of randomized clinical trials, Lind et al. (2019) found that although folate supplements were administered to diabetic patients exhibiting insulin resistance to lower homocycsteine, which was associated with the risk cardiovascular diseases, especially stroke, it had not been found to reduce the development of type II diabetes conclusively because of insufficient data.  

However, the studies by Balbi et al. (2018) and Lind et al. (2019) noted that the knowledge about the use of folate and vitamin supplements, respectively, was inconsistent in regulating blood glucose in diabetic patients due to lack of lack of sufficient data and measurement standards, thus deserving further research effort.

Kempf et al. (2017), Taheri et al. (2020), Zhang et al. (2020) focused on lifestyle interventions. For instance, Zhang et al. (2020) provided valuable insights in the efficaciousness of lifestyle modification in the management of type II diabetes in patients across diverse baseline characteristics and socioeconomic backgrounds. He findings of their systematic review and meta-analysis of randomized clinical trials revealed that diabetic individuals with unhealthy lifestyles were 75% more prone experiencing adverse effect of type II diabetic, such as cancer and cardiovascular diseases, which caused fatalities, compared to those living healthily. However, they recommended that lifestyle modification interventions should focus on multiple risky lifestyle factors rather than delving into single-factor interventions. However, prior to developing chronic diseases such as cardiovascular diseases, renal diseases, and cancers, young patients first experience weight gain and hyperglycemia, which contribute to the development of these chronic diseases. Therefore, Taheri et al. (2020) investigated the efficaciousness of aggressive lifestyle interventions comprising formula low-energy meals, gradual reintroduction to regular food, and intensive physical activity, accompanied by a structured lifestyle support program. This lifestyle modification regimen yielded significant weight reduction, and remission of diabetes and normal blood sugar levels in in over 60 % and 30% of the therapy participants respectively. Taheri et al. (2020) noted that this approach could deliver improved cardiometabolic outcomes in young adults, who comprise a large proportion of people being diagnosed with early diabetes or prediabetes. Contrastingly, Kempf et al. (2017) delved into delivery of lifestyle modification programs, and studied the efficaciousness of telemedicine using a randomized controlled trial. They specifically studied the efficaciousness of TeLiPro, a telemedical lifestyle intervention program that leverages digital technologies and applies a multimodal approach that addresses different aspects of lifestyle modification such as coaching, diet replacement, and monitoring. Their findings indicated that telemedical-based lifestyle intervention was a promising alternative to pharmacological intervention controlling blood glucose levels in prediabetic and diabetic individuals.  

Nonetheless, some of these sources provided insights into the efficaciousness of the pharmacological and lifestyle approaches against type II diabetes, thus enabling the comparison of the two types of therapies. For instance, Erpeldinger et al. (2016) noted that insulin therapy, which is a medication intervention, was often recommended and used when diet recommendations and lifestyle modification approaches could not deliver the desired blood glucose level targets. Similarly, Kempf et al. (2017) in investing the efficaciousness of the telemedical approach included a medication component into their study. The study revealed that in addition to lifestyle medication, the telemedical lifestyle intervention program reduced significantly the demand for antidiabetes drugs.

These literature evidence the richness of knowledge about the management of type II diabetes and prevention of diabetes, which is critical for prediabetic young adults that are newly diagnosed. From the overall findings of the study, pharmacological and lifestyle interventions are effective in preventing and managing diabetes. However, although there was avid research activity in innovative approaches in both types of intervention, the new knowledge was still inconsistent and could not be applied in nursing practice by APRNs and FNPs, unless on an experimental basis. In this regard, APRNs and FNPs had a critical role in developing this inconsistent knowledge further by participating in the administration of randomized controlled or clinical trials. Nonetheless, a comprehensive multimodal lifestyle intervention is recommended as a viable intervention for preventing and slowing down the onset of type II diabetes among young adults.

Implementation Plan

Implementing evidence-based practice is challenging many nursing practitioners and healthcare institutions. As provided by the ACE Star Model in which the fourth phase is the integration of evidence-based knowledge to practice, the proposed implementation plan is compatible with this model, making it familiar to advanced nursing practitioners. Moreover, since the implementation of evidence-based practice of preventing or slowing down the onset of type II diabetes in prediabetic young adults involves not only the individual APRNs and FNPs but the entire healthcare institution, the Plan-Do-Study-Act (PDSA) approach is recommended, as advised by Coury et al. (2017) and Tucker and Gallagher-Ford (2019). In this regard, the first step is a planning phase in which the objectives of the intervention are formulated and predictions of outcomes made. In this case, the objective is to prevent or slow down the onset of type II diabetes among prediabetic young adults. The second step is doing, in which lifestyle interventions found to be most effective from the literature are implemented by the APRNs and FNPs, and their hospitals. In this step, the APRNs and FNPs will document the unexpected observations and problems encountered when administering the comprehensive multimodal lifestyle intervention. The third step involves the studying of the findings as elucidated by the analysis of data from the second step. The last step involves acting, in which the intervention is refined from the lessons learned in step 3 and evidence based practice is entrenched in the APRN and FNP fraternity. However, this 4-step cycle will be repeated until the most efficacious lifestyle modification strategy is formulated and found appropriate for adoption into nursing practice.

Conclusion

Literature in diabetes interventions is rich with the knowledge about established and novel interventions. The literature analysis revealed that lifestyle modification was more effective than pharmacological approaches. Therefore, a comprehensive multimodal lifestyle intervention was recommended to be implemented using the Plan-Do-Study-Act (PDSA) approach.

References

Alam, F., Islam, M. A., Mohamed, M., Ahmad, I., Kamal, M. A., Donnelly, R., … & Gan, S. H. (2019). Efficacy and safety of pioglitazone monotherapy in type 2 diabetes mellitus: a systematic review and meta-analysis of randomised controlled trials. Scientific Reports, 9(1), 1-13. https://doi.org/10.1038/s41598-019-41854-2.

Alouki, K., Delisle, H., Bermúdez-Tamayo, C., & Johri, M. (2016). Lifestyle interventions to prevent type 2 diabetes: a systematic review of economic evaluation studies. Journal of Diabetes Research, 2016, 1-14. https://doi.org/10.1155/2016/2159890.

American Diabetes Association (2019). Standards of Medical Care in Diabetes—2019: Abridged for Primary Care Providers, Clinical Diabetes, 37(1): 11-34. https://dx.doi.org/10.2337/cd18-0105.

Andes, L. J., Cheng, Y. J., Rolka, D. B., Gregg, E. W., & Imperatore, G. (2020). Prevalence of prediabetes among adolescents and young adults in the United States, 2005-2016. JAMA Pediatrics, 174(2), e194498-e194498. https://doi.org/10.1001/jamapediatrics.2019.4498.

Balbi, M. E., Tonin, F. S., Mendes, A. M., Borba, H. H., Wiens, A., Fernandez-Llimos, F., & Pontarolo, R. (2018). Antioxidant effects of vitamins in type 2 diabetes: a meta-analysis of randomized controlled trials. Diabetology & metabolic syndrome, 10(1), 1-12. https://doi.org/10.1186/s13098-018-0318-5.

Cefalu, W. T., Buse, J. B., Tuomilehto, J., Fleming, G. A., Ferrannini, E., Gerstein, H. C., … & Kahn, S. E. (2016). Update and next steps for real-world translation of interventions for type 2 diabetes prevention: Reflections from a diabetes care editors’ expert forum. Diabetes Care, 39(7), 1186-1201. https://doi.org/10.2337/dc16-0873.

Centers for Disease Control and Prevention. (2020). National diabetes statistics report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services.

Dang, D., & Dearholt, S.L. (2018). Johns Hopkins nursing evidence-based practice : Model & guidelines (3rd ed.). Sigma Theta Tau International.

Erpeldinger, S., Rehman, M. B., Berkhout, C., Pigache, C., Zerbib, Y., Regnault, F., … & Boussageon, R. (2016). Efficacy and safety of insulin in type 2 diabetes: meta-analysis of randomised controlled trials. BMC Endocrine Disorders, 16(1), 1-15. https://doi.org/10.1186/s12902-016-0120-z.

Kempf, K., Altpeter, B., Berger, J., Reuß, O., Fuchs, M., Schneider, M., … & Martin, S. (2017). Efficacy of the telemedical lifestyle intervention program TeLiPro in advanced stages of type 2 diabetes: a randomized controlled trial. Diabetes Care, 40(7), 863-871. https://doi.org/10.2337/dc17-0303.

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Lind, M. V., Lauritzen, L., Kristensen, M., Ross, A. B., & Eriksen, J. N. (2019). Effect of folate supplementation on insulin sensitivity and type 2 diabetes: a meta-analysis of randomized controlled trials. The American Journal of Clinical Nutrition, 109(1), 29-42. https://doi.org/10.1093/ajcn/nqy234.

Lopes, G., Andrade, P. B., & Valentão, P. (2017). Phlorotannins: Towards new pharmacological interventions for diabetes mellitus type 2. Molecules, 22(1), 1-21.

Luo, Y., Lu, K., Liu, G., Wang, J., Laurent, I., & Zhou, X. (2018). The effects of novel antidiabetic drugs on albuminuria in type 2 diabetes mellitus: A systematic review and meta-analysis of randomized controlled trials. Clinical Drug Investigation, 38(12), 1089-1108. https://doi.org/10.1007/s40261-018-0707-4.

Madsen, K. S., Chi, Y., Metzendorf, M. I., Richter, B., & Hemmingsen, B. (2019). Metformin for prevention or delay of type 2 diabetes mellitus and its associated complications in persons at increased risk for the development of type 2 diabetes mellitus. Cochrane Database of Systematic Reviews, 12, 1-217. https://doi.org/10.1002/14651858.cd008558.pub2.

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Appendix

Appendix 1: Literature sources matrix

Author, yr.	Sample, purpose	Sampling/data collection method	Study design	Inclusion/exclusion criteria	Summary of Findings	Strengths/weakness	Evidence Level Ranking
Alam et al. (2019)	Sample: 7,612 articles retrieved, 18 met the inclusion criteria, 2 excluded for lack of meta-analysis availability Purpose: comparing pioglitazone monotherapy with monotherapies of other oral antidiabetic drugs for assessing its efficacy and safety in T2DM patients	Authors searched Web of Science, Medline through PubMed, Embase, Scopus, Cochrane database (Cochrane Central Register of Controlled Trials), ClinicalTrials.gov and Science Direct	Systematic review and meta-analysis of RCTs	Inclusion: Up to 30 May 2018Randomized controlled trials (RCTs) conducted on T2DM subjects with no reporting of comorbid diseases or diabetes-associated complicationsComparing pioglitazone monotherapy with monotherapies of other FDA approved oral AD drugsTreatment duration of  ≥12 weeks at least reported treatment effects on glycated haemoglobin (HbA1c) levelNo prior history of T2DM patients treated with any AD drugs or discontinued monotherapy or combination therapy of AD drugs before starting the trials with or without washout period Exclusion: Reviews, systematic reviews, meta-analysis, case reports, editorials, letters, erratum, comments, in vivo and in vitro studies	Pioglitazone was an effective drug treatment option for  >90% of patients with type II diabetes because it reduces hyperglycemia and adverse lipid metabolism.Since approximately >90% of T2DM patients are obese, pioglitazone-mediated BW gain can be ameliorated by lifestyle intervention including nutrition therapy and regular physical activitycombination of pioglitazone with FDA approved anti-obesity drug can be explored on T2DM obese patients	Strengths: Large sample sizeTwo independent investigators screened sourceStudies conducted in diverse regions Weaknesses: Risk of bias assessment	I
Balbi et al. (2018)	Sample: Retrieved 1570 records and 196 were excluded as duplicates. 1243 records were excluded and 104 were considered for full-text appraisal, of which 25 articles were suitable for final analyses. Six articles were added from manual searches, finally yielding 31 articles representing 30 RCTs Purpose: assess the effect of vitamin supplementation on the antioxidant status and glycemic index of type 2 diabetes mellitus patients	Authors conducted electronic searches in PubMed, Scopus, and Web of Science published up to December 2017	Meta-analysis of CRTs	Inclusion: Relevant articles published up to 18 December 2017RCTs with individuals over 18 years from diverse populations with any stage if T2DM Exclusion: Articles published later than December 2017 non-randomized controlled trialsinterventions other than vitaminswith individuals aged under 18 yearsdifferent populationsother type of diabetes (prediabetes, type 1 diabetes mellitus, gestational diabetes mellitus Trials published in nonroman characters	Vitamin supplements therapy is a promising strategy for controlling diabetes complications Vitamin E reduces the damaging effects of free radicals on the structural and functional components of cells and vessel walls Vitamins C and E and glutathione interrupt free radical chain reactions thus reducing patients’ blood glucose while increasing SOD and glutathione levels	Strengths: Sources screening by two independent researchersRisk of bias assessed using the Jadad score and the Cochrane Collaboration’s toolInvolved individuals over 18 years from diverse populationsTwo-tailed p-value used to indicate statistical significant different between two groupsinconsistency index value (I2) used to assess between-trial homogeneityRCTs diverse countries Weaknesses: Small sample sizeExcluded prediabetic participants	I
Erpeldinger et al. (2016)	Sample: Authors identified 1632 studies initially with 20 RCTs retained in the final sample. 18 599 patients were analysed Purpose: Determining the efficacy and safety of insulin vs. hypoglycaemic drugs or diet/placebo on clinically relevant endpoints	Authors searched Pubmed, Embase and Cochrane Library	Meta-analysis of RCTs	Inclusion: All randomised clinical trials (RCT) analysing insulin vs. hypoglycaemic drugs or diet/placebo, Published between 1950 and 2013 Exclusion: Patients aged below 18 years and over 80 years	Insulin therapy has no long-term clinical outcomes in type II diabetes but has short-time retrieve of hypoglycemia Severe hypoglycaemia was more frequent with insulin compared to hypoglycaemic drugs	Strengths: Large number of participantsInvolved 2 independent reviewers Risk of bias assessed using Cochrane Collaboration’s tool Heterogeneity was investigated with the I2 statistic Weaknesses: Small number of RCTs	I
Kempf et al. (2017)	Sample: 202 patients were randomized into the control (n = 100) or TeLiPro (n = 102) groups Purpose: Evaluating the efficacy of the Telemedical Lifestyle intervention Program (TeLiPro) in improving metabolic control in advanced-stage type 2 diabetes.	Authors recruited patients from Germany (West- German Centre of Diabetes and Health in Dusseldorf), Control group (n=100) TeLiPro group (n=102)	CRT	Inclusion: Overweight or obese patients with type 2 diabetesResided in GermanyMale or female patients aged between 25 and 79 years Patients with insufficient glycemic control (HbA1c $7.5% (58.5 mmol/mol), had a BMI $27 kg/m2, and were being treated with at least two different antidiabetes drugs. Exclusion: Acute infections, chronic diseases other  than type 2 diabetes and hypertension	Telemedical lifestyle intervention program improve control of metabolism in advanced type II diabetic patients HbA1c reduction was significantly higher in the TeLiPro group (mean  ± SD -1.1 ± 1.2% vs ±0.2 ± 0.8%; p < 0.0001)Treatment superiority of TeLiPro was maintained during follow-up (week 26: 0.6% [95% CI 1.0; 0.3], P = 0.0001; week 52: 0.6% [0.9; 0.2], P < 0.001)The effects were maintained long-term.No adverse events were reportedThe TeLiPro group reported a significant improvement in quality of life, a beneficial change in eating behavior, and a decrease in the demand for antidiabetes medication	Strengths: 1:1 ratio randomization using an electronically generated random into two parallel groupsUse of digital technology in intervention Weaknesses: Small number of participants (n=202)	I
Lind et al. (2019)	Sample: 1185 publications identified and 29 studies included constituting 17,765 participants Purpose:	Authors searched MEDLINE via PubMed from 1953,Web of Science from 1900, and EMBASE from 1974	Meta-analysis of RCTs	Inclusion: Human studies published in Englishparticipants above 18 yearspatients administered with parallel and crossoverInterventions of >24-h duration Exclusion: No restriction on medication use or baseline health condition, including status of insulin sensitivity	Folate supplementation therapy is promising in lowering insulin resistance although there is inconclusive evidence on it ability to slow the development of type II diabetes	Strengths: Large number of participantsInvolved 2 independent reviewers Risk of bias assessed using Cochrane Collaboration’s tool Participants of both genders from diverse countries Weaknesses: Small number of studies	I
Luo et al. (2018)	Sample: 26 RCTs involving 14,929 patients Purpose: evaluating the effects of novel antidiabetic drugs on albuminuria in patients with T2DM	Authors searched MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials databases up to 16 August 2018	Systematic review and meta-analysis of RCTs	Inclusion: RCT designTreatment witha novel antidiabetic drug (an SGLT-2 inhibitor, a GLP-1 receptor agonist, or a DPP-4 inhibitor) compared with placebo or other conventional therapiesadult participants (age ≥ 18 years) with T2DMassessment of the effectsof novel antidiabetic drugs on albuminuria in each treatment arm and data reported for changes in albuminuria from baseline to follow-uptreatment and follow-up duration no restriction Exclusion: Non-RCT designPatients who had used novel antidiabetic drugs (SGLT-2 inhibitors, GLP-1 receptor agonists or DPP-4 inhibitors) within 1 month prior to screeninginclusion of ineligible patients, such as children, adolescents, and patients with type 1 diabetes, renal hemodialysis, renal transplantation and acute kidney injury hemoglobin A1c (HbA1c) < 7.0%Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2 (according to the Modification of Diet in Renal Disease criteria) body mass index (BMI) < 18.5Reported insufficient data	SGLT-2 inhibitors and GLP-1 receptor agonists reduce albuminuria, which elevates the risk of cardiovascular and renal diseases	Strengths: Large number of participantsInvolved 2 independent reviewers Risk of bias reduced using the Jadad scoreReports on novel medication Weaknesses: Small number of studiesShort follow-up periodIndirect extraction of data in changes in albuminuriaSome data biasIgnored the effect of dosages	I
Taheri et al. (2020)	Sample: 158 participants randomly assigned to intervention group (79)and control group (79) Purpose: Assess whether an intensive lifestyle intervention would lead to significant weight loss and improved glycaemia in young individuals with early diabetes.	Authors recruited participants from one primary healthcare centre and one community health-care centre in Doha in Qatar	RCT	Inclusion: Age between 18-50 years Reported a diagnosis of type 2 diabetes within the previous 3 yearsHad a BMI of 27·0 kg/m² or more, originated from the Middle East and north Africa region, and who were resident in Qatar Exclusion: Had type I diabetesHad an ischaemic cardiovascular event in the previous 6 monthsHad stage 3b or higher chronic kidney disease, were pregnant, lactating, or planning a pregnancy, Had any condition precipitating fluid overload, such as heart failure or liver cirrhosisHad been diagnosed with a severe psychiatric disorderHad uncontrolled depressionHad uncontrolled epilepsyHadknown lactose intolerancehad severe arthritis that prevented walking, had active goutHad active gallstone disease or known asymptomatic gallstones	Intensive lifestyle intervention reduces significantly weight gain and elevated blood glucose levels in young prediabetic adultsBetween baseline and 12 months, the mean reduction  in bodyweight of participants was 11·98 kg (95% CI  9.72 to 14.23; SD 9.46) in the intervention group and 3·98 kg (2.78 to 5.18; 5·29)  in the control groupDiabetes remission occurred in 61% of participants in the intervention group compared with 12% of those in the control group (odds ratio [OR] 12.03 [95% CI 5.17 to 28.03], p<0.0001)33% of participants in the intervention group had normoglycaemia compared with 4% of participants in the control group (OR 12.07 [3.43 to 42.45], p<0.0001)Five serious adverse events were reported in four participants in the control group; four admissions to hospital because of unanticipated events (supraventricular tachycardia, abdominal pain, pneumonia, and epididymo-orchitis), and one admission to hospital for an anticipated event (hyperglycaemia)	Strengths: Resolved all adverse effects Weaknesses: Small number of participantsFocused on one country	I
Zhang et al. (2020)	Sample: 14 studies with approximately 1 million participants Purpose: Summarizing the relationship between combined lifestyle factors (including, but not limited to, smoking, alcohol drinking, physical activity, diet and being overweight or obese) and incident type 2 diabetes and risk of health outcomes among diabetic individuals	Authors searched EMBASE and PubMedwere up to April 2019 without language restrictions	Systematic review and meta-analysis of quasi-experimental studies	Inclusion: Studies reporting the relations of combined lifestyle factors with pre-determined outcomes Exclusion: the study was unrelated to the exposures or pre-defined outcomes;the study was from a different publication type (such as protocol, review, cross-sectional study, case–control study or animal experiment) or was not from a peer-reviewed publication (such as meeting abstract, editorial or commentary)the study focused on a single lifestyle factor or combinations of only two lifestyle factors (we assumed that two factors could not reflect the overall lifestyle)the study had less than 1 year of follow-upthe study was a formulation or validation of prediction modelsduplicate publications or duplicate reporting from the same cohort studiesthe study investigated the association between combined lifestyle factors and mortality, incident CVD or incident cancer in participants without diabetesthe study did not have necessary or sufficient data	Lifestyle interventions lower significantly the risk of type II diabetes. Effective lifestyle intervention programs should be multimodalParticipants with the healthiest lifestyles have a 75% lower risk of type II diabetes compared with those with the lease healthy lifestyles	Strengths: Large number of participants Reviewers worked in pairs Weaknesses: Small number of studies	II

Key:    Ranking of level of evidence (LOE)

            Level I: RCTs, experimental studies and associated systematic reviews and meta-analysis

Level II: At least one well-designed RCT

Level III: Quasi-experimental studies and associated systematic reviews

Level IV: Well-designed case-control or cohort studies

Level V: Systematic reviews of descriptive and qualitative studies (meta-synthesis)

Level VI: Single descriptive or qualitative study

Level VII: Opinion of authorities and reports of expert committees (Ackley et al., 2008)