Only the health literacy intervention arm was included in the study by Wang and colleagues [54]. Mirroring global patterns [67], this research disparity is discordant with epidemiologic evidence showing a substantial diabetes burden in low-income countries and in rural areas of LMICs [68,69]. • There is a need for effective interventions that are less intensive and sustainable. Of the 283 articles excluded after full-text review, 103 articles were excluded due to the type of intervention, and 94 articles were excluded due to incomplete data. Yes doi: 10.2196/18922. Resources, The quality of the evidence was assessed as being either high, moderate, low, or very low according to the GRADE methodology. EVIDENCE-BASED ANALYSIS OF EFFECTIVENESS: Research questions: 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 [58]. 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. In contrast to clinical therapies for individual patients, health system interventions emphasize the behavior of health workers and the way healthcare is practiced and delivered [5]. Data curation, 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]. Writing – review & editing, Affiliation Everyone with Type 1 diabetes, and some people with Type 2 diabetes, need to take insulin to control their blood glucose (sugar) levels. The interviews focused on use of a smartphone and the effects on motivation for health behavior change. Limitations include the lack of consensus definitions for health system interventions, differences in the quality of underlying studies, and sparse data availability for non-glycemic outcomes. Data were generally limited for non-glycemic outcomes such as mortality, quality of life, and cost-effectiveness. Another consideration is that research trial infrastructure in resource-limited settings may catalyze the delivery of standard clinical care across trial arms. The rest of the interventions fell into categories of ≤ 2 weeks (2 studies), 6 months (2 studies), or 1 year (3 studies). For more information about PLOS Subject Areas, click Citation: Flood D, Hane J, Dunn M, Brown SJ, Wagenaar BH, Rogers EA, et al. e1003434. Lifestyle intervention in these clinical trials had a strong focus on … Two studies tested glucose telemonitoring interventions in which participants uploaded glucose data to an online system and then received feedback from health workers regarding treatment changes to improve glycemic control [44,45]. The Fundamentals of Nursing Care Plan for Type 2 Diabetes – The Checklist. A usual care control group was reported in nine of 11 of the studies and two studies reported some type of minimal diabetes care in addition to usual care for the control group. HHS Outcomes of interest were of challenging behaviour, well being, clinical and process. Department of Pediatrics, University of Minnesota, Minneapolis, Minnesota, United States of America, Roles Writing – original draft, Studies with larger numbers of deaths appeared to have generally similar mortality between trial arms though a formal meta-analysis was not conducted due to sparseness of data [29,31,53,58]. Glycemic changes were reported based on HbA1c values in 36 studies and based on fasting glucose alone in 3 trials. Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan United States of America, Multiple reports from the same study were identified by reviewing the country setting, intervention details, and authorship list. No, Is the Subject Area "HbA1c" applicable to this article? Fourteen studies were classified as pharmacist task-sharing interventions, which we defined as studies in which patients received activities performed by pharmacists such as care coordination, medication review and counseling, and prescription suggestions to physicians [28,33–35,37,38,41,42,47,48,50,51,55,57]. 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. This revitalization of underlying care may make it difficult to detect modest differences attributable to education or support alone. We found that health system interventions for type 2 diabetes may be effective in improving glycemic control in LMICs, but few studies were available from rural areas or low- or lower-middle-income countries. The intervention arms were combined in the study by Anzaldo-Campos and colleagues [59]. . 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. delivery of intervention, length of intervention, mode of instruction, interventionist etc.)? In the meta-analysis of HbA1c in 35 trials, there were 10,060 total participants when accounting for the design effect of cluster RCTs (5,240 in intervention arms and 4,820 in comparator arms). A dramatic example of this effect was the Happy Life Club trial in China, in which both trial arms experienced 3.7% within-group HbA1c improvement over 18 months [32]. 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. The only outcome in our review for which a meta-analysis was conducted, HbA1c, is only a surrogate outcome, but it is commonly used in meta-analyses of systems-level interventions for diabetes [7,9]. Outcomes of mortality, health-related quality of life, and cost-effectiveness were reported in 19, 11, and 5 studies, respectively. 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. Difference in change-from-baseline HbA1c values between behavioural interventions and usual care control for…, Figure A5:. Competing interests: The authors have declared that no competing interests exist. To our knowledge, no review has systematically assessed evidence from randomized controlled trials (RCTs) or conducted a meta-analysis. 2020 Nov;98:106157. doi: 10.1016/j.cct.2020.106157. The search strategy was built in English, and no language filters were applied. However, in those with type 2 diabetes, the degree of glycaemic control and type and dose of diabetes medication should be coordinated with dietary intake.12 With some dietary interventions, such as very low calorie or low carbohydrate diets, people with diabetes would usually stop or reduce their diabetes medication and be monitored closely, as reviewed in a later section. Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 Sep. Report No. 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]. 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 [14]. For example, in the case of pharmacist task-sharing interventions, 9 of the 14 studies were classified as being at high risk of bias, 5 were at unclear risk of bias, and none were at low risk of bias. Given our interest in durable health system interventions, we prespecified that studies enroll 100 or more participants, with follow-up of at least 24 weeks. Patients were recruited from several settings: six studies from primary or general medical practices, three studies from the community (e.g. Further research is needed to assess non-glycemic outcomes and to study implementation in rural and low-income settings. Department of Epidemiology, University of Washington, Seattle, Washington, United States of America, Affiliations The interventions most often focused on problem solving, goal setting and encouraging participants to engage in activities that protect and promote health (e.g. systolic blood pressure (SBP) control, lipid control, change in smoking status, weight change, quality of life, knowledge, self-efficacy, managing psychosocial aspects of diabetes, assessing dissatisfaction and readiness to change, and setting and achieving diabetes goals. One potential explanation for inconsistent findings is the relatively low contact intensity of many studies. Publication bias was assessed by visual inspection of funnel plots and the Egger test. Supervision, Most included studies were conducted in upper-middle-income countries, and few studies were carried out in rural areas or low- or lower-middle-income countries. Medicine-Pediatrics Residency Program, University of Minnesota, Minneapolis, Minnesota, United States of America, Roles 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. The greatest number of studies were conducted in the East Asia and Pacific region (n = 20) followed by South Asia (n = 7). The primary outcome involved change in HbA1c or the proportion of participants meeting HbA1c goals in 23 studies. Multicomponent clinic-based interventions were modestly effective in improving glycemic control, with moderate certainty of evidence. After removing 1,093 duplicates, we screened 11,828 references by title and abstract and assessed 322 full-text articles for eligibility. 23 studies of adults (out of 25 studies) used CBT as an intervention in relation to diabetes control in type 2 diabetes. Home telemonitoring for type 2 diabetes: an evidence-based analysis. Eight trials were classified as clinic-based multicomponent interventions, which we defined as studies involving multiple types of health workers implementing a bundle of quality improvement or health system strengthening interventions [30,31,58–63]. 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). Studies with a control group other than usual care Studies with a sample size <30 Studies without a clearly defined intervention, Primary outcome: National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error. A systematic literature search was conducted to identify review articles, health technology assessments and policy reports of evaluated health promotion interventions in T2DM. EAR is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under award number K23DK118207. Effectiveness of Internet-Based Multicomponent Interventions for Patients and Health Care Professionals to Improve Clinical Outcomes in Type 2 Diabetes Evaluated Through the INDICA Study: Multiarm Cluster Randomized Controlled Trial. School of Public Health, University of Michigan, Ann Arbor, Michigan, United States of America, Roles 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. Funding: DF is supported by the National Clinician Scholars Program at the University of Michigan Institute for Healthcare Policy & Innovation. (2)Faculty Practice & Community Engagement, West Virginia University, Morgantown, WV, 26506, USA. The median study duration was 10 months (interquartile range 6 to 12). Agency for Healthcare Research and Quality (US). Two authors (DF and JH) independently screened studies by title and abstract and, subsequently, by full-text review. Difference in change-from-baseline HbA 1c…, Figure A8:. In the trial conducted by Tutino and colleagues in China, both the intervention and comparator arms included implementation of a web-based clinical information portal, and the intervention arm received additional nurse-led care coordination [52]. 2009;9(20):1-58. Motivational interviewing techniques were incorporated in 2 studies [32,46]. There were 21,080 total participants enrolled across included studies. Evidence-based analyses have been prepared for each of these five areas: insulin pumps, behavioural interventions, bariatric surgery, home telemonitoring, and community based care. Community-based care for the management of type 2 diabetes: an evidence-based analysis. SUMMARY OF PARTICIPANT DEMOGRAPHICS ACROSS STUDIES: A total of 2,549 participants were included in the 11 identified studies. No, Is the Subject Area "Diabetes mellitus" applicable to this article? 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 [64]. All studies evaluated type 2 diabetes patients exclusively. They are: Focus 1 – Important Past Health Information. Sample sizes for cluster RCTs were adjusted to account for the design effect using the intracluster correlation coefficient (ICC) [22]. The prediction interval is depicted as the horizontal whiskers intersecting the overall effect diamond marker. 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. We used the TIDieR checklist and EPOC template to structure extraction [17]. 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. The remaining 11 studies were RCTs (9 were used in the meta-analysis) and only one was defined as small (total sample size N=47). Yes The search identified 638 citations published between 1996 and August 2008, of which 12 met the inclusion criteria and one was a meta-analysis (Gary et al. Type 2 diabetes accounts for 90-95% of diabetes and while type 2 diabetes is more prevalent in people aged 40 years and older, prevalence in younger populations is increasing due to a rise in obesity and physical inactivity in children. Yes Approximately 80% of the 463 million adults with type 2 diabetes worldwide live in low- and middle-income countries (LMICs). Level 1 – Universal … Treatments for people with Type 1 diabetes Insulin pumps. Task sharing was a common thread across intervention types. Interventions for Type 2 Diabetes Literature Review. EPOC, Psychological interventions for Type 2 diabetes control: A1c, blood glucose, weight, BMI, & psychological distress. Prespecified subgroup analyses were done by intervention type. Behavioral interventions to improve self-management in Iranian adults with type 2 diabetes: a systematic review and meta-analysis. No study reported cost-effectiveness as a primary outcome. 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. (E) Carpenter R(1), DiChiacchio T(2), Barker K(1). Center for Clinical Management Research, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan United States of America, Roles eCollection 2018 Dec. Diabetes Spectr. Multicomponent clinic-based interventions had the strongest evidence for glycemic benefit among intervention types. reported an ICER of $1,862 per quality-adjusted life year (QALY) based on improvements in blood pressure [46]. Characteristics or processes that appear to enhance behavioral and clinical effectiveness in Hispanics with type 2 diabetes include multimodal interventions, at least some in-person delivery (versus telephone only), and greater adherence to the intervention (high attendance and low attrition). We also hand-searched the references of included studies, related systematic reviews, and the websites of major international diabetes organizations. We used GRADE and EPOC guidance to assess risk of bias for the glycemic outcome and to prepare a summary of findings table [18–21]. If you need help injecting yourself, Emma can show you how in our video below. No, PLOS is a nonprofit 501(c)(3) corporation, #C2354500, based in San Francisco, California, US, https://doi.org/10.1371/journal.pmed.1003434, https://epoc.cochrane.org/sites/epoc.cochrane.org/files/public/uploads/taxonomy/epoc_taxonomy.pdf, https://epoc.cochrane.org/sites/epoc.cochrane.org/files/public/uploads/Resources-for-authors2017/suggested_risk_of_bias_criteria_for_epoc_reviews.pdf, http://epoc.cochrane.org/sites/epoc.cochrane.org/files/public/uploads/Resources-for-authors2017/summary_assessments_of_the_risk_of_bias.pdf, http://epoc.cochrane.org/resources/epoc-resources-review-authors. , 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. via advertisements), and two from outpatient diabetes clinics. Around 95% of all people with diabetes have type 2 diabetes. This site needs JavaScript to work properly. First, we excluded studies with high risk of bias. Type 2 diabetes disproportionately affects people in low- and middle-income countries (LMICs). Ont Health Technol Assess Ser. No, Is the Subject Area "Metaanalysis" applicable to this article? In the overall meta-analysis of HbA1c from 35 trials, we found that health system interventions modestly improved glycemic control on average. Methodology, English Language Published between January 1996 to August 2008 Type 2 diabetic adult population (>18 years)Randomized controlled trials (RCTs)Systematic reviews, or meta-analyses Describing a multi-faceted self-management support intervention as defined by the 2007 Self-Management Mapping Guide (1)Reporting outcomes of glycemic control (HbA1c) with extractable data Studies with a minimum of 6-month follow up, Exclusion criteria: Six of the studies primarily involved in-person delivery [32,40,43,46,49,56], and 3 studies delivered the intervention in group format [46,49,56]. There was considerable heterogeneity in the overall pooled analysis that was partially explained by intervention type and baseline HbA1c. Effective health system interventions may help address the disproportionate burden of diabetes in low- and middle-income countries (LMICs). The direct health care cost of diabetes was $1.76 billion in the year 2000 and is projected to rise to a total cost of $3.14 billion by 2016. 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. No study’s primary outcome was mortality. PLoS Med 17(11): A medical librarian (SJB) downloaded all records, removed duplicates, and imported records to the review management tool Covidence. Investigation, STUDY CHARACTERISTICS: The studies were conducted between 2002 and 2008. No intervention involved pharmacists independently prescribing or titrating medications. Project administration, 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. Ont Health Technol Assess Ser. Rockville (MD): Agency for Healthcare Research and Quality (US); 2017 Jul. Standard lifestyle recommendations, metformin, and placebo are given to people who are at high risk for type 2 diabetes. However, health system interventions designed and tested in HICs may not be generalizable to LMICs [10]. 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 [32], and physicians [32,39,54]. The potential to prevent type 2 diabetes in high-risk individuals by lifestyle intervention has been firmly established by several randomized controlled trials; based on a meta-analysis by Gillies et al. Formal analysis, 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. Our comprehensive search strategy facilitated this choice as we identified a larger number of trials in LMICs than previous reviews. Difference in change-from-baseline HbA 1c values between behavioural interventions and usual care control…, Figure A2:. 2. Only 1 study reported quality of life as a primary outcome [51]. Formal analysis, When these first measures fail to control the hyperglycaemia, oral medications are to be used. Methodology, 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 [7]. Medizin Typ-2-Diabetes: Intensive Lebensstil-Inter­vention kann Medikamente ersetzen Mittwoch, 16. Two studies described the comparator group as enhanced usual care, where the enhancement consisted of clinical training for health professionals [30,31], and in 1 study the medical fees were waived in the comparator arm [32]. If outcomes were missing or not reported, we contacted authors twice to obtain data. Difference in change-from-baseline HbA 1c values between behavioural interventions and usual care control…, Figure A3:. Difference in change-from-baseline HbA 1c…, Figure A9:. DURATION, INTENSITY AND MODE OF DELIVERY: Intervention durations ranged from 2 days to 1 year, with many falling into the range of 6 to 10 weeks. Using an insulin pump can be a good alternative to injecting with an insulin pen. Most studies reported gender with a mean percentage of females of approximately 67%. Clinical significance of interventions was evaluated by an independent team (1 internist, 1 clinical pharmacologist) using a standardized method for categorizing drug related problems (DRPs). We followed the methodology recommended in the Cochrane handbook to calculate within-group mean and standard deviation when this information was not directly reported in the study or made available by authors [22]. They have all, however, either looked at a specific component of self-management support programs (i.e. Difference in change-from-baseline HbA 1c…, Figure A2:. 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). Type 2 diabetes is often associated with obesity. Incorporating heterogeneous study designs, these previous reviews have surveyed the limited evidence and described various approaches that have been implemented in LMICs. Inclusion criteria: Ramallo-Fariña Y, García-Bello MA, García-Pérez L, Boronat M, Wägner AM, Rodríguez-Rodríguez L, de Pablos-Velasco P, Llorente Gómez de Segura I, González-Pacheco H, Carmona Rodríguez M, Serrano-Aguilar P; INDICA Team. Same study were identified, we screened 11,828 references by title and abstract and, if needed in. Not be generalizable to LMICs [ 1 ] international and interdisciplinary literature EL, Patnode CD, Webber EM Redmond. Larger number of studies were published in the included interventions to improve self-management in Iranian adults with type diabetes. Funnel plots and the websites of major international diabetes organizations diabetes clinics the low. 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