LeIKD
Trial question
What is the effect of telemedicine-supported lifestyle intervention in patients with coronary heart disease and T2DM?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
16.0% female
84.0% male
N = 499
499 patients (81 female, 418 male).
Inclusion criteria: patients with coronary heart disease and T2DM.
Key exclusion criteria: mental and behavioral disorders; NYHA class IV HF; malignant neoplasm; Parkinson's disease; Alzheimer's disease; infantile cerebral palsy; CKD; trisomy 21; blindness/visual impairment; hearing loss.
Interventions
N=251 telemedicine-supported lifestyle intervention (telemedicine-supported lifestyle intervention through individual structured exercise training, increase in daily physical activity, and individual nutritional recommendations).
N=248 usual care (general exercise and nutritional recommendations according to current guidelines).
Primary outcome
Reduction in hemoglobin A1C after 6 months
0.13%
0%
0.1 %
0.1 %
0.1 %
0.0 %
0.0 %
Telemedicine-supported lifestyle
intervention
Usual
care
Significant
increase ▲
NNT = 769
Significantly greater reduction in HbA1c after 6 months (0.13% vs. 0%; MD 0.13, 95% CI 0.01 to 0.25).
Secondary outcomes
Significantly greater reduction in body weight at 6 months (2.2 kg vs. 0.8 kg; MD 1.4, 95% CI 0.8 to 2.1).
Significantly greater improvement in QoL mental component score at 6 months (1 points vs. -1.6 points; MD 2.7, 95% CI 0.8 to 4.6).
No significant difference in reduction in waist circumference at 6 months (1.5 cm vs. 0.7 cm; MD 0.7, 95% CI -0.3 to 1.8).
Safety outcomes
No significant difference in major adverse cardiovascular event.
Conclusion
In patients with coronary heart disease and T2DM, telemedicine-supported lifestyle intervention was superior to usual care with respect to reduction in HbA1c after 6 months.
Reference
Stephan Mueller, Sophia M T Dinges, Felix Gass et al. Telemedicine-supported lifestyle intervention for glycemic control in patients with CHD and T2DM: multicenter, randomized controlled trial. Nat Med. 2025 Apr;31(4):1203-1213.
Open reference URL