Behavioral Programs for Diabetes Mellitus

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Behavioral Programs for Diabetes Mellitus Structured Abstract Objectives. To conduct a systematic review focusing on the effectiveness of behavioral programs for type 1 diabetes (T1DM) and identifying factors contributing to program effectiveness for type 2 diabetes (T2DM). Data sources. MEDLINE ® , Cochrane Central Register of Controlled Trials, Embase ® , CINAHL, PsycINFO ® (January 1, 1993, to January 2015), and PubMed ® (2015); ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform, conference proceedings (2011–14); reference lists of relevant studies. Methods. Two reviewers independently assessed studies for fit with predetermined selection criteria and assessed risk of bias. We included prospective controlled studies and randomized controlled trials (RCTs) for T1DM and RCTs for T2DM, evaluating behavioral programs compared with usual care, active controls (e.g., didactic education), or other behavioral programs. One reviewer extracted data, with verification by a second reviewer. For T1DM, we conducted pairwise meta-analysis to assess program effectiveness; subgroup analyses to examine patient variables (e.g., age, race/ethnicity, glycemic control); and metaregressions to assess potential moderators of effectiveness, such as program components (i.e., diabetes selfmanagement education [DSME], DSME plus support, lifestyle), intensity, delivery format, and personnel. For T2DM, we conducted network meta-analysis (incorporating direct and indirect comparisons) to assess potential moderation of program effectiveness, and subgroup analyses to assess the impact of patient variables. Strength of evidence (SOE) for key outcomes in T1DM was assessed to determine our confidence in the results. Results. The searches identified 47,149 citations, of which we included 34 studies for T1DM and 132 RCTs for T2DM. All trials had a medium or high overall risk of bias. For T1DM, there was moderate SOE showing greater reductions in percent hemoglobin A 1c (HbA 1c ) levels at 6-month postintervention followup for individuals receiving a behavioral program compared with usual care (0.31) or an active control (0.44); both were statistically significant, and the latter was considered clinically important based on our prespecified threshold of ≥0.4 unit change in percent HbA 1c . There was low SOE showing no difference in HbA 1c at end of intervention and at 12-month or longer followup. Generic health-related quality of life was no different at end of intervention in comparisons with usual care (moderate SOE). There was either low SOE or insufficient SOE for all other outcomes, including self-management and lifestyle behaviors, body composition, diabetes-specific quality of life, diabetes distress, and complications. From the subgroup analysis for percent HbA 1c by age in comparison with usual care, the effect for the adult subgroup appeared to be greater (0.28) than the effect for the youth subgroup (0.00) at end of intervention, although neither result reached statistical significance. In comparisons with active controls, the SOE of the findings for youths and adults was insufficient. Program intensity (duration, contact hours, frequency of contacts) appeared not to influence program effectiveness for T1DM; individual delivery (vs. group) may be beneficial. For T2DM, relative to usual care, the effect sizes for all minimally intensive (≤10 contact hours) DSME programs were not considered clinically important based on our prespecified threshold of ≥0.4 unit change in percent HbA 1c for glycemic control. Programs having greater benefit for vii
HbA 1c reduction were more often delivered in person. For body mass index, lifestyle programs (usually combining structured diet and exercise) provided the most benefit. In subgroup analyses, results for reduced HbA 1c favored participants with suboptimal baseline glycemic control (≥7% HbA 1c ), adults
Page 1 and 2: Evidence Report/Technology Assessme
Page 3 and 4: This report is based on research co
Page 5 and 6: Key Informants In designing the stu
Page 7: Peer Reviewers Prior to publication
Page 11 and 12: KQ 6. Subgroups for Factors Moderat
Page 13 and 14: Figure 13. Behavioral programs for
Page 15 and 16: glycemia in reducing the incidence
Page 17 and 18: together with one or more additiona
Page 19 and 20: Figure A. Analytic framework for be
Page 21 and 22: Methods Literature Search Strategy
Page 23 and 24: With input from our Technical Exper
Page 25 and 26: participants had suboptimal baselin
Page 27 and 28: duration of diabetes ranged from 2.
Page 29 and 30: Table B. Type 1 diabetes: summary o
Page 31 and 32: T2DM: Description and Risk of Bias
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Page 35 and 36: The positive findings for behaviora
Page 37 and 38: elated to the Human Development Ind
Page 39 and 40: Table D. Potential research needs b
Page 41 and 42: References 1. Renders CM, Valk GD,
Page 43 and 44: 37. Chodosh J, Morton SC, Mojica W,
Page 45 and 46: Introduction Background The high bu
Page 47 and 48: Factors other than blood glucose co
Page 49 and 50: may include interventions related t
Page 51 and 52: programs. The overarching boxes (co
Page 53 and 54: Figure 2. Analytic framework for be
Page 55 and 56: American Diabetes Association, Amer
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S1 in the Supplementary File). The
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clinically significant); we refer t
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Synthesis for T1DM (KQs 1-4) KQ 1:
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conducted for HbA 1c and body mass
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Applicability We followed the Metho
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Type 1 Diabetes Mellitus This secti
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therapy, 90,99,108 motivational enh
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and a peer (with diabetes and train
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followup (low SOE for both); there
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Figure 6. Behavioral programs for t
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similar results were found for yout
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HbA 1c : Comparative Effectiveness
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Two trials reported on adherence to
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Table 4. Other clinical and behavio
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Figure 14. Behavioral programs for
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Health-Related Quality of Life: Beh
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estimated effects were imprecise an
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Table 8. Type 1 diabetes: summary o
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Summary of Key Findings and Strengt
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studies 82,94,95,105,109,112 were n
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studied a DSME program in patients
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I 2 =74%), 135,137,139,141,142,145,
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Aerobic Fitness Test which estimate
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Key Points: Body Mass Index • Lif
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Table 12. Network meta-analysis for
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Figure 20. Plot of network meta-ana
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active comparator (20 trials, 7,709
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Discussion Key Findings and Discuss
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to be tempered by the findings of n
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compared with usual care. There was
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Our finding that single-topic, non-
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In their systematic review and meta
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For studies targeting adults, the m
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environmental contextual factors—
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assessors was also rarely reported,
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Tailoring programs to ethnic minori
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17. Centers for Disease Control and
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53. Medical Advisory Secretariat. B
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88. Ellis DA, Templin T, Naar-King
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122. Nansel TR, Iannotti RJ, Simons
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158. Cooper H, Booth K, Gill G. A t
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191. Koo BK, Han KA, Ahn HJ, et al.
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224. Sevick MA, Korytkowski M, Ston
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260. Yuan C, Lai CW, Chan LW, et al
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295. Ayling K, Brierley S, Johnson
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Appendix A. Operational Definitions
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the structured diet or physical act
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Appendix B. Literature Search Strat
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1. MeSH descriptor: [Diabetes Melli
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35. “blood glucose” N2 monitor*
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35. (behavio?r adj2 therap*).mp. 36
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52. exp animals/ not humans.sh. 53.
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57. "Follow-Up Studies"[Mesh] 58. "
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URL provided by Michelle Crain, AAD
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WHO ICTRP Trial Registry: WHO ICTRP
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Appendix D. Studies Excluded After
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Health. 2006;6:134. PMID: 16709243.
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November/December;24(9):450-6. PMID
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89. Dinneen SF, O'hara MC, Byrne M,
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119. Fitzpatrick SL, Jeffery R, Joh
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Aug;19(8):835-42. PMID: 8842601. Ex
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adherence and metabolic control. Di
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May;36(5):1297-303. PMID: 23223405.
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244. Korytkowski MT, Koerbel GL, Ko
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275. Maljanian R, Grey N, Staff I,
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306. Naccashian Z. The impact of di
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led structured program on blood glu
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Engineering. 2014;75(1-B E). PMID:
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395. Skoro-Kondza L, Tai SS, Gadelr
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426. Torbjornsen A, Jenum AK, Smast
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Americans with type 2 diabetes. J A
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patients. Diabetes Res Clin Pract.
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Table E1. Risk of bias for studies
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Weinger, 2011 L M NA M NA L NA L L
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Cramer, 2007 M M H M H L H H L M H
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Ridgeway, 1999 M M H M H L H H M L
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Appendix F. Description of Studies
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Author, Year & Country Comparison &
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Table F3. Description of studies an
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Appendix H. Strength of Evidence Ta
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Outcome # Trials (# Subjects); Tool
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Table H3. Behavioral programs compa
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16. Mayer-Davis EJ, Seid M, Crandel
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Table I1. Effectiveness of behavior
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Category Health Outcomes Outcomes A
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Table I2. Effectiveness of behavior
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Category Outcomes Timepoint Health
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Outcome Change in Body Composition
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Outcome Change in Physical Activity
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References for Appendix I 1. Adachi
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32. Rock CL, Flatt SW, Pakiz B, et
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follow-up study. Diabetes Res Clin
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98. Johnson ST, Bell GJ, Mccargar L
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Appendix J. Network Meta-Analysis R
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5 11-26h In person Group only NA -0
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9 11-26h In person Group only NA -0
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Behavioral Programs for Diabetes Mellitus

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