gms | German Medical Science

Background: A high-caloric diet and lack of physical activity are associated with an increased risk for the development of type 2 diabetes mellitus.

Lifestyle interventions are the basic treatment in newly diagnosed type 2 diabetes. However, their therapeutic potential in advanced stages of the disease is unknown. This study evaluated the efficacy of the Telemedical Lifestyle Intervention Program (TeLiPro) in improving metabolic control in advanced stage type 2 diabetes.

Objective: What is the effective difference between treating advanced type 2 diabetics with telemedical coaching alongside telemedical devices and treating with only telemedical devices? I.e. what is the efficacy of adding coaching in order to achieve lifestyle change. Primary endpoint is HbA1c reduction after 12 weeks.

Methods: In this single-blind, active comparator, intervention study, patients with type 2 diabetes (glycated haemoglobin [HbA1c] ≥ 7.5% (58.5 mmol/mol), body-mass index [BMI] ≥ 27kg/m2, ≥ 2 anti-diabetes medications) were recruited in Germany via their attending physicians and newspaper articles and randomised 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 protein-rich meal replacement therapy, and structured self-monitoring of blood glucose for 12 weeks. The coaching was delivered in structured routine telephone calls by trained diabetes coaches. The conversations included information about type 2 diabetes, anti-diabetes medication, healthy diet, physical activity and subjective possibilities for lifestyle changes, allowing each participant to receive individualised care. Target agreements were discussed and jointly agreed upon.

The primary endpoint was the difference in HbA1c reduction after 12 weeks, secondary endpoints were differences in body weight and composition, cardiovascular disease risk factors, anti-diabetes medication use and improvements in quality of life and eating behavior. All available values per patient (n=202) were analysed. Analyses were also performed at 26 and 52 weeks of follow-up.

Results: HbA1c reduction was significantly higher in the TeLiPro group (mean ± standard deviation (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% with 95% confidence interval [1.1; 0.5] (p<0.0001). Treatment superiority of TeLiPro was maintained during follow-up (week 26: 0.6% [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, anti-diabetes medication, quality of life and eating behavior was significantly improved in the TeLiPro group and not in the control group (p<0.01 for all). The effects were maintained long-term. No adverse events were reported.

Discussion: In advanced stage type 2 diabetes, TeLiPro can improve glycaemic control and may offer new options to avoid pharmacological intensification. The increasing prevalence of type 2 diabetes and the concomitant increase in anti-diabetes medication costs are a considerable burden for national healthcare systems. Consequently, there is a strong need for alternative lifestyle-based therapeuticapproaches.

Practical Implications: The reduction in HbA1c in the TeLiPro group (–1.1% after 12 weeks, –0.9% after 26 weeks, and –0.7% after 52 weeks) is comparable with the therapeutic efficacy of new anti-diabetes medications. Two studies of glucagon-like peptide (GLP)-1 receptor agonists either alone or in a fixed combination with the insulin degludec, which included patients with a similar duration of diabetes as participants in the present study, reported HbA1c reductions of 0.8% (exenatide), 1.1% (liraglutide), and 1.9% (insulin degludec plus liraglutide (IDegLira)) after 26 weeks of intervention.

Because the effects of TeLiPro remain in the long term, unlike pharmacological intervention that needs to be continuously administered, the telemedical approach is associated with higher efficiency in terms of cost-effectiveness. The total cost for 12 weeks of TeLiPro intervention and follow-up until week 26 was $1300 per patient, with a concomitant 50% reduction in the use of anti-diabetes medication. The annual drug cost for GLP-1 receptor agonist therapies is between $1765 and $6338.