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

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/m(2) 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 HbA1c 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 6 SD -1.1 +/- 1.2% vs. 20.2 6 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/m(2) vs. -0.3 +/- 1.1 kg/m(2)), 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.