NCT03675919

TeLIPro Health Program - Active With Diabetes

The Telemedical Lifestyle Intervention Program TeLIPro (TeLIPro Health Program - Active With Diabetes)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,163 (actual)
• Sponsor: West German Center of Diabetes and Health · Academic / Other
• Sex: All
• Age: 25 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

In a randomized-controlled trial the hypothesis should be tested that the Telemedical Lifestyle Intervention Program TeLIPro could significantly improve HbA1c (primary outcome), body weight and composition, cardiovascular risk factors, quality of life, eating behavior, and medication demand (secondary outcomes) in type 2 diabetes mellitus (T2DM) patients.

Detailed description

T2DM patients, assured at the health insurance AOK Rhineland / Hamburg will be randomized into two parallel groups. In addition to routine care both groups will be provided a scale as well as a step counter and access to a secured online portal. The TeLIPro group will additionally got a glucose meter with test stripes fpr self-monitoring of blood glucose and telemedical coaching. Participants of both groups will enter their anthropometric and metabolic data into a database on quarterly basis. In addition, the costs for diabetes-specific treatment, inpatient and outpatient treatment costs and drug costs will be analyzed on the basis of the routine data of the AOK Rhineland / Hamburg. Patient preference for type 2 diabetes intervention will be recorded using Discrete Choice Experiment (DCE) questionnaires at the beginning of the program and at the end of the intervention. As part of the development and validation of the DCE, focus groups are used to determine the DCE attributes. In addition, focus groups should also be used during the data collection in order to obtain additional information on patient preferences by means of qualitative analysis.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	Scale	self-monitoring of body weight; with automatic data transfer into the personalized and secured online portal
DEVICE	Step counter	self-monitoring of physical activity; with automatic data transfer into the personalized and secured online portal
DEVICE	Blood glucose meter with test stripes	self-monitoring of blood glucose; with automatic data transfer into the personalized and secured online portal
OTHER	Access to the online portal	self-monitoring of health parameters
OTHER	Telemedical coaching	regular telephone calls providing information about T2DM, healthy lifestyle, low-carbohydrate diet and physical activity

Timeline

• Start date: 2018-09-15
• Primary completion: 2021-09-21
• Completion: 2022-09-30
• First posted: 2018-09-18
• Last updated: 2023-01-20

Locations

1 site across 1 country: Germany