The study setting was primarily urban in 27 trials and primarily rural in 5 trials. Lifestyle intervention in these clinical trials had a strong focus on … Outcomes of mortality, health-related quality of life, and cost-effectiveness were reported in 19, 11, and 5 studies, respectively. Formal analysis, Our comprehensive search strategy facilitated this choice as we identified a larger number of trials in LMICs than previous reviews. Yes The search strategy was built in English, and no language filters were applied. Writing – review & editing, Affiliations We synthesized evidence of outcomes by focusing on RCTs and performing a meta-analysis of HbA1c. Joshi A, Mitra A, Anjum N, Shrivastava N, Khadanga S, Pakhare A, Joshi R. Med Sci (Basel). Our findings imply a need for implementation research to investigate the details of health system interventions that confer durable improvements in clinical and patient-centered outcomes in LMICs, especially in rural areas and in low- and lower-middle-income countries. Writing – review & editing, Affiliations self-management education) or have been conducted in specific populations. The primary outcome involved change in HbA1c or the proportion of participants meeting HbA1c goals in 23 studies. We also did not systematically assess important implementation science outcomes such as reach, fidelity, or acceptability. Randomised controlled trials with a pre-test/post-test design that evaluated a diabetes self-management programme compared with no intervention in adults (at least 18 years) with type 2 diabetes were eligible for inclusion. Data from the United Kingdom Prospective Diabetes Study (UKPDS) has shown that tight glycemic control can significantly reduce the risk of developing serious complications in type 2 diabetics. Treatments for people with Type 1 diabetes Insulin pumps. We inferred an ICC from the literature if one was not reported in the study or its trial protocol . Type 2 diabetes is often associated with obesity. Using the trim-and-fill method, we estimated that there were 8 missing studies, and inclusion of these imputed studies resulted in an estimated overall HbA1c mean difference of −0.28% (95% CI −0.43% to −0.13%; S10 Appendix). Resources, The objective of this report is to determine whether behavioural interventions are effective in improving glycemic control in adults with type 2 diabetes. We defined these interventions as diabetes education or support alone. Visualization, For more information about PLOS Subject Areas, click No intervention involved pharmacists independently prescribing or titrating medications. We registered the review in PROSPERO (CRD42018106765; S1 Appendix) and followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines (S2 Appendix) . low- and middle-income countries; RCT, Psychobehavioural model of variables influencing…, Figure 1:. This intervention is based on a medium-range nursing theory of individual and family self-management. The EPOC domains of delivery arrangements and implementation strategies were most commonly involved in the included interventions. Type 2 diabetes is often associated with obesity. We performed systematic searches in several bibliographic databases. No, Is the Subject Area "Type 2 diabetes" applicable to this article? Formal analysis, The health workers in these studies varied between and within studies and included peers [49,53,56], community health workers [43,46,53], nurses [32,39,40,53,54], psychologists , and physicians [32,39,54]. 4-6 Numerous intervention studies have focused on improving one specific self‐management activity in people with type 2 diabetes (physical activity [PA] 7 or dietary behaviour 8, for example). This statistic … Epub 2009 Oct 1. Patterns of Glycemic Variability During a Diabetes Self-Management Educational Program. Our review was supplemented with unpublished data received from multiple study authors, and we were able to pool HbA1c statistical estimates reported differently across studies. Logistical challenges in conducting randomized studies within health systems likely explain why we identified few interventions testing financial or governance arrangements. To ensure high search quality, a second reference librarian peer-reviewed the search terms. Only 1 intervention incorporated a change in governance , and no study tested changes in financial arrangements. Therefore, we conducted a systematic review and meta-analysis to examine the impact of health system interventions that aimed to improve outcomes of glycemic (i.e., blood glucose) change, mortality, health-related quality of life, or cost-effectiveness for adults with type 2 diabetes in LMICs. Interventions focusing solely on implementing diabetes education or support within the health system also were effective in improving glycemic control, but the certainty of evidence was low. No, Is the Subject Area "HbA1c" applicable to this article? Type 2 diabetes is a chronic disease characterised by an inability to effectively utilise insulin (insulin resistance), often associated with a concomitant reduction in insulin production, resulting in elevated blood sugar (hyperglycaemia) (1). Further research is needed to assess other outcomes beyond glycemic control, especially in rural areas and in low- or lower-middle-income countries. We investigated the experience of individuals diagnosed with type 2 diabetes mellitus (T2DM) who participated in an intervention in which the key elements were the provision of a smartphone and self-monitoring software. Clipboard, Search History, and several other advanced features are temporarily unavailable. INTERVENTION CHARACTERISTICS: All of the interventions examined in the studies were mapped to the 2007 Self-management Mapping Guide. Difference in change-from-baseline HbA 1c values between behavioural interventions and usual care control…, Figure A9:. This is not an example of the work produced by our Literature Review Service. Seven different scales were used to assess quality of life, and only the EuroQol EQ-5D was used in more than 1 study [29,45,46,52,58]. (2)Faculty Practice & Community Engagement, West Virginia University, Morgantown, WV, 26506, USA. Consistent with EPOC, we excluded studies of patient behavior change alone if the intervention did not primarily target healthcare professionals . Abstracts were reviewed by a single author and studies meeting the inclusion criteria outlined above were obtained. Using an insulin pump can be a good alternative to injecting with an insulin pen. Department of Pediatrics, University of Minnesota, Minneapolis, Minnesota, United States of America, Roles high-income countries; LMICs, Inclusion criteria: Both trials varied intervention intensity by a patient’s risk factors. However, it’s unclear how these treatments would work in a real-life setting. We systematically reviewed the literature and identified 39 RCTs of health system interventions for adults with type 2 diabetes in LMICs that assessed glycemic control, mortality, health-related quality of life, or cost-effectiveness. In the meta-analysis of HbA1c from 35 of the included studies, the mean difference was −0.46% (95% CI −0.60% to −0.31%, I2 87.8%, p < 0.001) overall, −0.37% (95% CI −0.64% to −0.10%, I2 60.0%, n = 7, p = 0.020) in multicomponent clinic-based interventions, −0.87% (−1.20% to −0.53%, I2 91.0%, n = 13, p < 0.001) in pharmacist task-sharing studies, and −0.27% (−0.50% to −0.04%, I2 64.1%, n = 7, p = 0.010) in trials of diabetes education or support alone. Department of Epidemiology, University of Washington, Seattle, Washington, United States of America, Affiliations In order to provide comprehensive pathway of weight management support for those at risk and with type 2 diabetes, we recommend adopting a tiered approach to weight management programmes which relates to the level of risk for an individual. Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan United States of America, We searched Ovid MEDLINE, Cochrane Library, EMBASE, African Index Medicus, LILACS, and Global Index Medicus from inception of each database through February 24, 2020. Further research is needed to assess non-glycemic outcomes and to study implementation in rural and low-income settings. Further studies in LMICs are needed to assess non-glycemic outcomes and, given the wide prediction intervals, to determine the specific components and details of health system interventions most likely to promote effectiveness and limit potential harms. A 2019 meta-analysis by Anand and colleagues concluded that task-sharing interventions were effective in improving blood pressure in LMICs . Agency for Healthcare Research and Quality (US). Epub 2009 Oct 1. • There is a need for effective interventions that are less intensive and sustainable. Task sharing also was a fundamental component in the nurse-led intervention by Fairall and colleagues in South Africa , a nurse care coordination trial , and multicomponent clinic-based studies [31,58,59]. . Psychobehavioural model of variables influencing self-management and clinical outcome in diabetes, Figure 2:. Investigation, The absence of high-quality trials resulted in a low certainty of evidence for pharmacist task-sharing studies despite their sizeable pooled HbA1c estimate in the meta-analysis. As quantitative data were reliably reported for only 1 of our 4 included outcomes, we limited our meta-analysis to the glycemic outcome of hemoglobin A1c (HbA1c) change. Division of General Internal Medicine, Department of Medicine, University of Minnesota, Minneapolis, Minnesota, United States of America, Methodology, , the number needed to treat to prevent one case of type 2 diabetes is 6.4 when the duration of intervention ranges from 1.8 to 4.6 years. Despite the homogeneity in the aims of the interventions, there was substantial clinical heterogeneity in other intervention characteristics such as duration, intensity, setting, mode of delivery (group vs. individual), interventionist, and outcomes of interest (discussed below). The overall HbA1c prediction interval was −1.19% to 0.28%. If you have type 2 diabetes, you may be able to control your symptoms simply by eating a healthy diet, and monitoring your blood glucose level. RCTs are not the only form of evidence generation in the field of health policy and research , and diverse research strategies are needed in conditions like type 2 diabetes that have a strong clinical evidence base yet weak evidence on implementation [3,78]. Prevention of type 2 diabetes in relatives and partners of people with the condition is under researched. Effective Practice and Organisation of Care; HbA1c, Endocrine Today reports on five interventions that reduced mortality, comorbid illness, symptoms and critical outcomes in adult patients being treated for type 2 diabetes. Our search strategy identified 12,921 references (Fig 1). https://doi.org/10.1371/journal.pmed.1003434, Academic Editor: Andre P. Kengne, South African Medical Research Council, SOUTH AFRICA, Received: April 28, 2020; Accepted: October 19, 2020; Published: November 12, 2020. Ethical approval was not required as the research used publicly available data. This review has notable strengths. Methodology, EVIDENCE-BASED ANALYSIS OF EFFECTIVENESS: Research questions: Conversely, in the case of multicomponent clinic-based interventions, only 1 of the 8 studies was deemed to be at high risk of bias, and 3 of the studies were at low risk of bias. To present the most common quality criteria in health promotion interventions in type 2 diabetes mellitus (T2DM). Our findings support the scaling up of diabetes health system interventions to improve patients’ glycemic control in LMICs. Moreover, heterogeneity in the interventions has led to conflicting evidence on the components of effective programs. Much of this cost arises from the serious long-term complications associated with the disease including: coronary heart disease, stroke, adult blindness, limb amputations and kidney disease. BHW is supported by grant number K01MH110599 from the National Institute of Mental Health. No study’s primary outcome was mortality. One study was classified as an mHealth screening and quality improvement intervention . While these studies showed that depending on the progression of the disease, Type 2 diabetes remission may be possible with intense, medically-supervised interventions. The meta-analysis was performed with random effects using the DerSimonian–Laird method for mean between-group HbA1c difference. https://doi.org/10.1371/journal.pmed.1003434.s001, https://doi.org/10.1371/journal.pmed.1003434.s002, https://doi.org/10.1371/journal.pmed.1003434.s003, https://doi.org/10.1371/journal.pmed.1003434.s004, https://doi.org/10.1371/journal.pmed.1003434.s005, https://doi.org/10.1371/journal.pmed.1003434.s006, https://doi.org/10.1371/journal.pmed.1003434.s007, https://doi.org/10.1371/journal.pmed.1003434.s008, https://doi.org/10.1371/journal.pmed.1003434.s009, https://doi.org/10.1371/journal.pmed.1003434.s010, https://doi.org/10.1371/journal.pmed.1003434.s011, https://doi.org/10.1371/journal.pmed.1003434.s012, https://doi.org/10.1371/journal.pmed.1003434.s013, https://doi.org/10.1371/journal.pmed.1003434.s014, https://doi.org/10.1371/journal.pmed.1003434.s015, https://doi.org/10.1371/journal.pmed.1003434.s016. Non-glycemic outcomes of mortality, health-related quality of life, and cost-effectiveness were less frequently reported. In HICs, components with the largest effect sizes have been team change, patient education or patient self-management, electronic registries, and promotion of patient–provider communication . Everyone with Type 1 diabetes, and some people with Type 2 diabetes, need to take insulin to control their blood glucose (sugar) levels. Only the health literacy intervention arm was included in the study by Wang and colleagues . The 16-lesson curriculum of the intensive program of lifestyle modifications focused on weight reduction of greater than 7% of initial body weight and physical activity of moderate intensity. Importantly, we included diabetes education or support trials that primarily changed the behavior of health workers within the health system, and we excluded lifestyle trials focusing on patient behavior alone without systems-level change. . Difference in change-from-baseline HbA 1c values between behavioural interventions and usual care control…, Figure A2:. The greatest number of studies were conducted in the East Asia and Pacific region (n = 20) followed by South Asia (n = 7). They are: Focus 1 – Important Past Health Information. The mean age of participants reported was approximately 58 years and the mean duration of diabetes was approximately 6 years. https://doi.org/10.1371/journal.pmed.1003434.t001. Despite physicians' and patients' knowledge of the importance of glycemic control, Canadian data has shown that only 38% of patients with diabetes have HbA1C levels in the optimal range of 7% or less. Methodology, (ABSTRACT TRUNCATED), Figure 1:. Difference in change-from-baseline HbA 1c…, Figure A8:. This trial involved an intervention for diabetes and hypertension involving SMS educational messages and appointment reminders, community-based screening, and deployment of electronic clinical tools for physicians and nurses . Excellent examples of implementation research include the portfolio of ongoing projects funded by the Global Alliance for Chronic Disease . We used the EPOC review group’s definition of health system interventions as those designed to “improve the professional practice and the delivery of effective health services” through changes in healthcare delivery, financing, governance, and implementation [5,14]. Around 95% of all people with diabetes have type 2 diabetes. Yes Writing – review & editing, Affiliation Most reviews are also qualitative and do not clearly define the interventions of interest, making findings difficult to interpret. There was statistical evidence for publication bias and substantial differences in the quality of underlying studies that limited the certainty of evidence of glycemic benefit for intervention types including pharmacist task-sharing interventions. The intervention arms were combined in the study by Anzaldo-Campos and colleagues . Author information: (1)West Virginia University School of Nursing, Morgantown, WV, 26506, USA. Kobe EA, Edelman D, Tarkington PE, Bosworth HB, Maciejewski ML, Steinhauser K, Jeffreys AS, Coffman CJ, Smith VA, Strawbridge EM, Szabo ST, Desai S, Garrett MP, Wilmot TC, Marcano TJ, Overby DL, Tisdale GA, Durkee M, Bullard S, Dar MS, Mundy AC, Hiner J, Fredrickson SK, Majette Elliott NT, Howard T, Jeter DH, Danus S, Crowley MJ. Non-glycemic outcomes of mortality, health-related quality of life, and cost-effectiveness had sparse data availability that precluded quantitative pooling. Level 1 – Universal … Intensity of the interventions varied widely from 6 hours over 2 days, to 52 hours over 1 year; however, the majority consisted of interventions of 6 to 15 hours. Obesity, nutrition, and physical activity programs in the workplace are critical elements in addressing type 2 diabetes Research suggests that the progression from prediabetes to type 2 diabetes can be prevented or delayed. A descriptive analysis of study characteristics and evaluation criteria are pre- sented. Writing – review & editing, Affiliation In LMICs, prior reviews draw from diverse study designs and together suggest a modest yet increasing number of studies on the implementation of evidence-based type 2 diabetes care into health systems in LMICs [11–13]. Roles Yes Criteria for self-management support intervention, Figure A1:. Incorporating heterogeneous study designs, these previous reviews have surveyed the limited evidence and described various approaches that have been implemented in LMICs. Data curation, diet, physical activity, blood glucose monitoring, foot care, etc.). In 2005, an estimated 8.8% of Ontario's population had diabetes, representing more than 816,000 Ontarians. Formal analysis, Difference in change-from-baseline HbA1c values…, Figure A6:. At the same time, the wide prediction interval overlapping 0 in the meta-analysis of HbA1c showed that there was a wide range of effectiveness across studies, and some health system interventions may not be effective in all settings. Our review shows an increase in research incorporating task sharing into health system interventions for type 2 diabetes in these settings. Only 1 study reported quality of life as a primary outcome . Interventions like optimization of rational drug use and physician acceptance of these recommendations were documented. Two other trials calculated an ICER between trial arms [33,59]. Agency for Healthcare Research and Quality (US). When these first measures fail to control the hyperglycaemia, oral medications are to be used. Nine studies involved health workers primarily implementing diabetes education or support without additional services [32,39,40,43,46,49,53,54,56]. Get the latest public health information from CDC: https://www.coronavirus.gov, Get the latest research information from NIH: https://www.nih.gov/coronavirus, Find NCBI SARS-CoV-2 literature, sequence, and clinical content: https://www.ncbi.nlm.nih.gov/sars-cov-2/, In June 2008, the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project, an evidence-based review of the literature surrounding strategies for successful management and treatment of diabetes. When multiple reports were identified, we linked the reports together for extraction and analysis. The proportion of participants from low- and middle-income countries was inferred to be 60% in the study by Reutens and colleagues . One author (DF) extracted summary data into a customized electronic spreadsheet, and 2 other authors (JH and MD) independently verified the extracted data. The prediction interval is depicted as the horizontal whiskers intersecting the overall effect diamond marker. hemoglobin A1c; HICs, We found that pharmacist task-sharing interventions appeared to improve glycemic control in the pooled analysis, but the certainty of evidence was low for these types of interventions, primarily due to concerns about studies’ risk of bias. These findings may reflect differences in participants, setting, or the implementation of different components in the bundle. Project administration, Community-based care for the management of type 2 diabetes: an evidence-based analysis. An ICER of $1,121 per 1% decrease in HbA1c was reported in the trial by DePue and colleagues  and $1,850 in the study by Ali and colleagues . Finally, although there were substantial similarities within intervention types, individual studies varied by setting and population, limiting our ability to make conclusions with high degrees of certainty. Second, we assessed the influence of individual studies by using the leave-one-out method to recalculate estimates omitting 1 study at a time . Supervision, Health system interventions can help address this priority. Writing – original draft, The effect sizes of other intervention types with 2 or fewer studies reporting HbA1c are summarized in Fig 2. Of the 19 studies reporting mortality, 14 studies had 10 or fewer deaths combined in the intervention and comparator groups (S6 Appendix). Methods. Center for Research in Indigenous Health, Wuqu’ Kawoq, Tecpán, Guatemala, https://doi.org/10.1371/journal.pmed.1003434.g001. A medical librarian (SJB) downloaded all records, removed duplicates, and imported records to the review management tool Covidence. 2009;9(23):1-40. Our review was restricted to studies with at least 6 months of follow-up and 100 enrolled participants. Formal analysis, Further research is needed to assess non-glycemic … Of the 11 studies reporting quality of life, 6 studies reported no significant differences between the intervention and comparator arms [29,32,45,46,52,59], and 5 studies showed improved quality of life in the intervention arm [33,40,51,58,62]. Visualization, Difference in change-from-baseline HbA 1c…, Figure A2:. Most studies incorporated primary care doctors in a team-based intervention [30,31,59,60,62,63], and the study by Ali and colleagues incorporated endocrinologists . Behavioral interventions to improve self-management in Iranian adults with type 2 diabetes: a systematic review and meta-analysis. Approximately six of 11 studies were carried out within the USA, with the remaining studies conducted in the UK, Sweden, and Israel (sample size ranged from 47 to 824 participants). There were 21,080 total participants enrolled across included studies. No, Is the Subject Area "Quality of life" applicable to this article? Three studies were based on the Chronic Care Model [60,62,63]. They have all, however, either looked at a specific component of self-management support programs (i.e. Glycemic changes were reported based on HbA1c values in 36 studies and based on fasting glucose alone in 3 trials. Difference in change-from-baseline HbA 1c…, Figure A1:. Publication bias was assessed by visual inspection of funnel plots and the Egger test. Health system interventions can help address this gap by improving the delivery of diabetes care within health systems. The quality of the evidence was assessed as being either high, moderate, low, or very low according to the GRADE methodology. This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry's newly released Diabetes Strategy.After an initial review of the strategy and consultation with experts, the secretariat identified five key areas in which evidence was needed. This systematic review and meta-analysis was conducted based on guidance from Cochrane Effective Practice and Organisation of Care (EPOC), a group focusing on reviews of the delivery of health services . GRADE and Cochrane Effective Practice and Organisation of Care methods were used to assess risk of bias for the glycemic outcome and to prepare a summary of findings table. We observed differences across studies relating to task sharing such as type of health worker, training, and assigned tasks. Prior reviews of task shifting for chronic diseases in LMICs have identified few trials in type 2 diabetes [72,73]. Formal analysis, Difference in change-from-baseline HbA1c values…, Figure A4:. Conceptualization, Azami G, Soh KL, Sazlina SG, Salmiah MS, Aazami S. J Diabetes Metab Disord. Despite the existence of cost-effective and evidence-based clinical treatments for type 2 diabetes , health systems in LMICs have difficulty meeting the rising need for quality care . We defined LMICs using the 2019 World Bank income groups. Multiple trials were included within some countries, but we did not formally account for a potential lack of independence among studies conducted within the same health system context. Findings will be evaluated using the nursing outcomes "self-management: diabetes" and "social support" from the Nursing Outcomes Classification (NOC). PLoS Med 17(11): The overall funnel plot and Egger test for the HbA1c meta-analysis suggested possible bias (Egger p < 0.001; S8 Appendix), but there was little evidence of bias within subgroups of intervention types (S9 Appendix). Most studies reported gender with a mean percentage of females of approximately 67%. Despite physicians' and patients' knowledge of the importance of glycemic control, Canadian data has shown that only 38% of patients with diabetes have HbA1C levels in the optimal range of 7% or less. A 2012 meta-analysis of 142 randomized trials primarily conducted in HICs found that interventions targeting the health system rather than healthcare providers or patients alone were most effective . Each intervention included self-management education or support delivered by peers , non-physician care coordinators , clinicians [30,59,60,62,63], or an automated short message service (SMS) text-messaging system . (2020) Health system interventions for adults with type 2 diabetes in low- and middle-income countries: A systematic review and meta-analysis. Study selection. The median study duration was 10 months (interquartile range 6 to 12). A search was performed in OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), The Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published between January 1996 and August 2008. Impact of health system interventions for type 2 diabetes disproportionately affects people in low- and middle-income countries LMICs... By our literature review Service only Hispanic individuals first, we found that health system interventions help... Pharmacists independently prescribing or interventions for diabetes type 2 medications at: https: //doi.org/10.7910/DVN/NIESKT from trials. Self-Management Educational Program each study by EPOC domain ( S4 Appendix ) [ ]... And EPOC template to structure interventions for diabetes type 2 [ 17 ] of rational drug use physician. 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