The effect of a structured behavioral intervention on poorly controlled diabetes: a randomized controlled trial

Abstract

Background: Although maintaining nearly normal glycemia delays onset and slows progression of diabetes complications, many patients with diabetes and their physicians struggle to achieve glycemic targets. The best methods to support patients as they follow diabetes prescriptions and recommendations are unclear.

Methods: To test the efficacy of a behavioral diabetes intervention in improving glycemia in long-duration, poorly controlled diabetes, we randomized 222 adults with diabetes (49% type 1) (mean [SD] age, 53 [12] years; mean [SD] disease duration 18 [12] years; mean [SD] hemoglobin A(1c) [HbA(1c)] concentration, 9.0% [1.1%]) to attend (1) a 5-session manual-based, educator-led structured group intervention with cognitive behavioral strategies (structured behavioral arm); (2) an educator-led attention control group education program (group attention control); or (3) unlimited individual nurse and dietitian education sessions for 6 months (individual control). Outcomes were baseline and 3-, 6-, and 12-month postintervention HbA(1c) levels (primary) and frequency of diabetes self-care, 3-day pedometer readings, 24-hour diet recalls, average number of glucose checks, physical fitness, depression, coping style, self-efficacy, and quality of life (secondary).

Results: Linear mixed modeling found that all groups showed improved HbA(1c) levels (P < .001). However, the structured behavioral arm showed greater improvements than the group and individual control arms (3-month HbA(1c) concentration changes: -0.8% vs -0.4% and -0.4%, respectively (P = .04 for group × time interaction). Furthermore, participants with type 2 disease showed greater improvement than those with type 1 (P = .04 for type of diabetes × time interaction). Quality of life, glucose monitoring, and frequency of diabetes self-care did not differ by intervention over time.

Conclusions: A structured, cognitive behavioral program is more effective than 2 control interventions in improving glycemia in adults with long-duration diabetes. Educators can successfully use modified psychological and behavioral strategies.

Trial registration: clinicaltrials.gov Identifier: NCT000142922.

Trial registration: ClinicalTrials.gov NCT00142922 NCT00142922.

Conflict of interest statement

Conflict of Interest

A. Enrique Caballero, MD serves on the advisory panels of the following companies: Eli Lilly and Company, Amylin Pharmaceuticals, Inc, Takeda Pharmaceuticals America, Inc, sanofi-aventis, Daiichi-Sankyo. No other author has anything to declare.

Figures

Figure 1

Study Flow Diagram

Figure 2

A–C. Mean Hemoglobin A1c Levels Over Time for the Three Intervention Groups for All Participants and then by Type of Diabetes Error bars present 1 standard error.