Transforming Glycemic Control: A Multicenter Trial on Telemedicine-Enhanced Lifestyle Interventions for Patients with CHD and Type 2 Diabetes

Study Design and Participants

The LeIKD study is a multicenter clinical trial registered on ClinicalTrials.gov. It took place at 11 sites across Germany, including cities like Munich, Berlin, and Freiburg. Patients were selected from a health insurance fund’s database based on specific criteria.

• Participants had a diagnosis of coronary heart disease (CHD) and type 2 diabetes mellitus (T2DM), verified through repeated medical codes.

• Patients had to be part of a disease management program that included regular doctor visits and educational sessions.

• Participants needed to live within 50 km of a study site.

• All participants were 18 years or older.

However, several exclusion criteria were in place:

• Patients with certain mental disorders or conditions affecting exercise capability.
• Those with severe heart failure or late-stage cancer.
• Individuals with specific neurological conditions such as Parkinson’s or Alzheimer’s disease.
• Patients with chronic kidney disease or trisomy 21.
• Those unable to see or hear adequately.
• Patients requiring a high level of care or insured abroad.

If patients qualified, they were contacted and invited for an assessment to learn more about the study. During the screening, they provided consent and underwent further evaluations to meet additional criteria.

Randomization

Eligible participants were randomly assigned to either a lifestyle intervention group or a usual care group. This randomization was done through a secure online system and was balanced across study sites.

Ethics Approval

The ethics committees of various universities and medical associations approved the study, ensuring that all participants provided informed consent.

Interventions

Those in the lifestyle intervention group received a personalized exercise program. This included aerobic training like walking or cycling, along with strength training, aiming for a minimum of 150 minutes of exercise each week. They also received ongoing support through a smartphone app, allowing them to track their progress and receive feedback. Nutritional guidance was given based on food diaries submitted at various points during the study.

In contrast, the usual care group received standard recommendations for nutrition and activity without additional interventions. However, all participants were provided with devices to monitor their daily activities and blood glucose levels.

Conceptual Framework of the Intervention

The LeIKD trial builds on previous healthcare initiatives that combined exercise, nutritional support, and behavioral strategies. Designed to be adaptable for standard healthcare in Germany, this trial introduces a home-based approach supported by digital technology, aiming to facilitate sustainable lifestyle changes.

Assessments and Endpoints

Participants underwent evaluations at the start of the study, after 6 months, and again after 12 months. Assessments included medical history reviews, physical exams, and various questionnaires measuring health literacy, quality of life, and physical activity levels.

Adverse events were carefully monitored and reported to ensure participant safety throughout the trial.

The primary goal of the study was to examine changes in HbA1c levels after 6 months. Other health indicators included cholesterol levels, body weight, and overall wellness metrics.

Sample Size Calculation

The trial aimed to enroll around 750 patients based on specific calculations that took into account potential dropout rates. Ultimately, adjustments led to a revised target of at least 486 participants due to various logistical considerations.

Statistical Analysis

Data analysis included various statistical tests to evaluate the outcomes. This also included handling missing data through established methods to ensure the integrity of the results. All analyses were conducted using reliable statistical software with appropriate significance levels.

Conclusion

The LeIKD study represents a significant effort to explore how lifestyle interventions can improve health outcomes for patients with CHD and T2DM in a practical setting.