Comparison of the effect of a compact vs a conventional, long-term education program on metabolic control in children and adolescents with type 1 diabetes: A pilot, randomized clinical trial

Background: Effective education is considered essential for people with type 1 diabetes mellitus (T1DM) to adhere to a complex and long-term medical regimen and to delay or prevent the onset of diabetes-related complications.

Objective: We compared the effect of a compact, cost-effective, education program (CEPT1) vs a long-term program on the metabolic control of children and adolescents with T1DM.

Methods: Young people aged 8 to 21 years with T1DM were randomized to a short-term (experimental) or an extensive education program (control). The experimental group participated in three sessions of 90 minutes, with one session per week, containing five short videos. The control group attended an extended program delivered through 45-minute PowerPoint lectures, with one class every 3 months. The primary outcome was change in glycated hemoglobin A1c (HbA1c) levels from baseline to endpoint (baseline, 3, 6, 9, and 12 months).

Results: In total, 62 patients were randomized to the experimental (CEPT1) (n = 32) or control (n = 30) groups. Both groups showed comparable improvement in HbA1c levels at the end of 12 months (P = .183). In a per-protocol analysis, the mean HbA1c level reduction was -2.3% (-2.6, -2.0) in the experimental group and - 1.8% (-2.0, -1.5) in the control group (P = .008).

Conclusion: CEPT1 was comparable with an extensive education program in reducing HbA1c levels. In a per-protocol analysis, the CEPT1 was more effective than the control program in reducing HbA1c levels. CEPT1 is a simple and cost-effective tool that can equally be used in settings with limited resources and specialized centers.