TeLIPro Health Program - Active With Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— TeLIPro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03675919
• Other study ID #: TeLIPro
• Status: Completed
• Phase: N/A
• Start date: September 15, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2023
• Source: West German Center of Diabetes and Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1163
• Est. completion date: September 30, 2022
• Est. primary completion date: September 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 79 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus
• body mass index of et least 27 kg/m2

Exclusion Criteria:

• acute infections
• chronic diseases other than type 2 diabetes and hypertension (e.g., cancer, chronic obstructive pulmonary disease, asthma, dementia, chronic gut diseases, psychoses, liver cirrhosis, macronephropathy/nephropathy, kidney insufficiency with glomerular filtration rate <30 ml/min/1.73 m2)
• acute chemotherapy or chronic cortisol treatment
• smoking cessation for <3 months and/or planned smoking cessation during study
• pregnancy or breast-feeding

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• Scale
self-monitoring of body weight; with automatic data transfer into the personalized and secured online portal
• Step counter
self-monitoring of physical activity; with automatic data transfer into the personalized and secured online portal
• 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
• Telemedical coaching
regular telephone calls providing information about T2DM, healthy lifestyle, low-carbohydrate diet and physical activity

Locations

Country	Name	City	State
Germany	West German Centre of Diabetes and Health	Düsseldorf

Sponsors (4)

Lead Sponsor	Collaborator
West German Center of Diabetes and Health	AOK Rheinland/Hamburg, German Diabetes Center, German Institute for Telemedicine and Health Promotion

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c change	estimated treatment difference between groups of HbA1c change (in T2DM patients with diabetes duration of = 5 years)	12 months
Primary	remission rate	number of participants with an HBA1c <6.5% (in T2DM patients with diabetes duration of < 5 years)	12 months
Secondary	fasting blood glucose change	estimated treatment difference between groups of fasting blood glucose change	12 months
Secondary	weight change	estimated treatment difference between groups of weight change	12 months
Secondary	body mass index change	estimated treatment difference between groups of body mass index change	12 months
Secondary	systolic blood pressure change	estimated treatment difference between groups of systolic blood pressure change	12 months
Secondary	diastolic blood pressure change	estimated treatment difference between groups of diastolic blood pressure change	12 months
Secondary	total cholesterol change	estimated treatment difference between groups of total cholesterol change	12 months
Secondary	high-density lipoprotein (HDL) cholesterol change	estimated treatment difference between groups of high-density lipoprotein (HDL) cholesterol change	12 months
Secondary	low-density lipoprotein (LDL) cholesterol change	estimated treatment difference between groups of low-density lipoprotein (LDL) cholesterol change	12 months
Secondary	triglyceride change	estimated treatment difference between groups of triglyceride change	12 months
Secondary	number of steps	estimated treatment difference between groups of number of steps	12 months
Secondary	antidiabetic medication change	estimated treatment difference between groups of antidiabetic medication change	12 months
Secondary	diabetes-specific treatment costs	estimated treatment difference between groups of diabetes-specific treatment costs	12 months
Secondary	inpatient costs	estimated treatment difference between groups of inpatient costs	12 months
Secondary	outpatient costs	estimated treatment difference between groups of outpatient costs	12 months