Efficacy of the Telemedical Lifestyle intervention Program TeLiPro in Advanced Stages of Type 2 Diabetes: A Randomized Controlled Trial

Abstract

Objective: Lifestyle interventions are the foundation of treatment in newly diagnosed type 2 diabetes. However, their therapeutic potential in advanced disease stages is unknown. We evaluated the efficacy of the Telemedical Lifestyle intervention Program (TeLiPro) in improving metabolic control in advanced-stage type 2 diabetes.

Research design and methods: In this single-blind, active comparator, intervention study, patients with type 2 diabetes (with glycated hemoglobin [HbA_1c] ≥7.5% [58.5 mmol/mol]), and BMI ≥27 kg/m² and on ≥2 antidiabetes medications) were recruited in Germany and randomized 1:1 using an electronically generated random list and sealed envelopes into two parallel groups. The data analyst was blinded after assignment. The control group (n = 100) got weighing scales and step counters and remained in routine care. The TeLiPro group (n = 102) additionally received telemedical coaching including medical-mental motivation, a formula diet, and self-monitored blood glucose for 12 weeks. The primary end point was the estimated treatment difference in HbA_1c reduction after 12 weeks. All available values per patient (n = 202) were analyzed. Analyses were also performed at 26 and 52 weeks of follow-up.

Results: HbA_1c reduction was significantly higher in the TeLiPro group (mean ± SD -1.1 ± 1.2% vs. -0.2 ± 0.8%; P < 0.0001). The estimated treatment difference in the fully adjusted model was 0.8% (95% CI 1.1; 0.5) (P < 0.0001). Treatment superiority of TeLiPro was maintained during follow-up (week 26: 0.6% [95% CI 1.0; 0.3], P = 0.0001; week 52: 0.6% [0.9; 0.2], P < 0.001). The same applies for secondary outcomes: weight (TeLiPro -6.2 ± 4.6 kg vs. control -1.0 ± 3.4 kg), BMI (-2.1 ± 1.5 kg/m² vs. -0.3 ± 1.1 kg/m²), systolic blood pressure (-5.7 ± 15.3 mmHg vs. -1.6 ± 13.8 mmHg), 10-year cardiovascular disease risk, antidiabetes medication, and quality of life and eating behavior (P < 0.01 for all). The effects were maintained long-term. No adverse events were reported.

Conclusions: In advanced-stage type 2 diabetes, TeLiPro can improve glycemic control and may offer new options to avoid pharmacological intensification.

Trial registration: ClinicalTrials.gov NCT02066831.