TeLIPro Health Program - Active With Diabetes (TeLIPro)

January 19, 2023 updated by: Stephan Martin, West German Center of Diabetes and Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Düsseldorf, Germany, 40591
        • West German Centre of Diabetes and Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
The control group will be provided a scale, a step counter as well as access to the online portal and will remain in routine care.
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
Other: Access to the online portal
self-monitoring of health parameters
Experimental: TeLIPro group
The TeLIPro group will be provided a scale, a step counter, a blood glucose meter with test stripes as well as access to the online portal and will get telemedical coaching.
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
Other: Access to the online portal
self-monitoring of health parameters
Device: Blood glucose meter with test stripes
self-monitoring of blood glucose; with automatic data transfer into the personalized and secured online portal
Other: Telemedical coaching
regular telephone calls providing information about T2DM, healthy lifestyle, low-carbohydrate diet and physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c change
Time Frame: 12 months
estimated treatment difference between groups of HbA1c change (in T2DM patients with diabetes duration of ≥ 5 years)
12 months
remission rate
Time Frame: 12 months
number of participants with an HBA1c <6.5% (in T2DM patients with diabetes duration of < 5 years)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fasting blood glucose change
Time Frame: 12 months
estimated treatment difference between groups of fasting blood glucose change
12 months
weight change
Time Frame: 12 months
estimated treatment difference between groups of weight change
12 months
body mass index change
Time Frame: 12 months
estimated treatment difference between groups of body mass index change
12 months
systolic blood pressure change
Time Frame: 12 months
estimated treatment difference between groups of systolic blood pressure change
12 months
diastolic blood pressure change
Time Frame: 12 months
estimated treatment difference between groups of diastolic blood pressure change
12 months
total cholesterol change
Time Frame: 12 months
estimated treatment difference between groups of total cholesterol change
12 months
high-density lipoprotein (HDL) cholesterol change
Time Frame: 12 months
estimated treatment difference between groups of high-density lipoprotein (HDL) cholesterol change
12 months
low-density lipoprotein (LDL) cholesterol change
Time Frame: 12 months
estimated treatment difference between groups of low-density lipoprotein (LDL) cholesterol change
12 months
triglyceride change
Time Frame: 12 months
estimated treatment difference between groups of triglyceride change
12 months
number of steps
Time Frame: 12 months
estimated treatment difference between groups of number of steps
12 months
antidiabetic medication change
Time Frame: 12 months
estimated treatment difference between groups of antidiabetic medication change
12 months
diabetes-specific treatment costs
Time Frame: 12 months
estimated treatment difference between groups of diabetes-specific treatment costs
12 months
inpatient costs
Time Frame: 12 months
estimated treatment difference between groups of inpatient costs
12 months
outpatient costs
Time Frame: 12 months
estimated treatment difference between groups of outpatient costs
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West German Center of Diabetes and Health

Collaborators

German Diabetes Center
AOK Rheinland/Hamburg
German Institute for Telemedicine and Health Promotion

Investigators

  • Study Chair: Bernd Altpeter, Deutsches Institut für Telemedizin und Gesundheitsförderung
  • Study Chair: Sibel Altin, AOK Rheinland/Hamburg
  • Study Chair: Andrea Icks, PhD, Deusches Diabetes Zentrum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2018

Primary Completion (Actual)

September 21, 2021

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

September 11, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TeLIPro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Scale

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe