Behavioral Programs for Diabetes Mellitus

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Results This chapter begins with a summary of our literature search. We then present the findings separately for type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM). Within each section we present a general description of the included studies followed by our findings by Key Question (KQ). Specific details for the organization of the sections for T1DM and T2DM are included below. Literature Search and Screening Our database and gray literature searches identified 47,141 citations, and 11 additional records were identified from reference lists of systematic reviews and included studies. For T1DM, we included 34 studies described in 44 publications. For T2DM, we included 132 studies described in 161 publications. Figure 3 describes the flow of literature through the screening process. Appendix D provides a complete list of articles excluded at the full-text screening stage, with reasons for exclusion. Figure 3. Flow diagram of study retrieval and selection T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus a One study was included for both T1DM and T2DM. 24
Type 1 Diabetes Mellitus This section begins with the results of our literature search, a general description of all included studies, separate summaries of studies that focused on youth followed by those that focused on adults, and a summary of the risk of bias (ROB) assessment. We then present results by KQ. We begin with results of behavioral programs compared with usual care, followed by studies comparing behavioral programs with an active control, and then by those comparing two or more behavioral programs (i.e., comparative effectiveness). The results are grouped first by outcome (e.g., HbA 1c ) and then by follow-up timepoint. For each outcome results are presented by age groups (youth and adults), where appropriate. We present results as mean differences (MD), standardized mean differences (SMD), or risk ratios (RR), with 95 percent confidence intervals (95% CI) in figures with meta-analyses or in summary tables. Where statistical heterogeneity was considered substantial (>50 percent) we report the I 2 Statistic (I 2 %). For each KQ, we give the key points and then present a detailed synthesis of the evidence. Appendix E (Table E2) includes the ROB assessments for each trial. Summary tables describing studies are found in Appendix F (Tables F1 and F2); they are organized alphabetically by author. For observational studies, we present a narrative summary of the results for HbA 1c . Other outcomes from the observational studies are documented in Appendix G. For KQs 1 and 2, we summarize the strength of evidence (SOE) assessments, which are provided in detail in Appendix H. Literature Search and Screening For T1DM, we included 34 studies described in 44 publications (Figure 3). Primary reports were identified for 30 randomized controlled trials (RCT), 82-111 1 non-RCT, 112 and 3 controlled before-after studies. 113-115 Ten additional publications contributed information related to the study methodology, outcomes, or descriptions of the interventions. 116-125 One of the studies included both T1DM (49 percent) and T2DM (51 percent) patients; results were reported for each patient group and the study is included in both T1DM and T2DM of this review. 107 Characteristics of Included Studies The majority of studies (30 trials, 2 observational studies) examined diabetes selfmanagement education (DSME); two studies (1 RCT, 105 1 observational study 114 ) focused on lifestyle programs (see Appendix A for operational definitions). For DSME, most trials (n=23) were two-arm trials comparing DSME to usual care. Three two-arm RCTs compared DSME to an active control. 87,91,92 The active controls included telephone support 87 and basic education. 91,92 Three RCTs were three-arm trials with one having two active control arms 107 and the other two each had a usual care and an active control arm. 83,108 For one, the authors combined the usual care and active control arms. 83 For the others, we analyzed the usual care and active control arms separately, 108 or combined the two active control arms. 107,108 One RCT evaluated the comparative effectiveness of the same DSME program delivered in person compared with delivery by internet-based videoconferencing (Skype). 90 Two observational studies compared DSME with usual care. 113,115 Both studies focusing on lifestyle programs compared them with usual care. One was a twoarm RCT 105 and the other was an observational study. 114 25
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Evidence Report/Technology Assessme
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This report is based on research co
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Key Informants In designing the stu
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Peer Reviewers Prior to publication
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HbA 1c reduction were more often de
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KQ 6. Subgroups for Factors Moderat
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Figure 13. Behavioral programs for
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glycemia in reducing the incidence
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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
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Page 27 and 28: duration of diabetes ranged from 2.
Page 29 and 30: Table B. Type 1 diabetes: summary o
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Page 39 and 40: Table D. Potential research needs b
Page 41 and 42: References 1. Renders CM, Valk GD,
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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
Page 57 and 58: Table 1. Inclusion criteria for typ
Page 59 and 60: S1 in the Supplementary File). The
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Page 63 and 64: Synthesis for T1DM (KQs 1-4) KQ 1:
Page 65 and 66: conducted for HbA 1c and body mass
Page 67: Applicability We followed the Metho
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Page 81 and 82: HbA 1c : Comparative Effectiveness
Page 83 and 84: Two trials reported on adherence to
Page 85 and 86: Table 4. Other clinical and behavio
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Page 89 and 90: Health-Related Quality of Life: Beh
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Page 95 and 96: Summary of Key Findings and Strengt
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Page 105 and 106: Key Points: Body Mass Index • Lif
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Page 117 and 118: 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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