Skip to main content
OpenTrials
Completed

NCT Number: NCT03675919

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West German Centre of Diabetes and Health

Düsseldorf, 40591, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scale

Device

self-monitoring of body weight; with automatic data transfer into the personalized and secured online portal

step counter

Device

self-monitoring of physical activity; with automatic data transfer into the personalized and secured online portal

Blood glucose meter with test stripes

Device

self-monitoring of blood glucose; with automatic data transfer into the personalized and secured online portal

Access to the online portal

Other

self-monitoring of health parameters

Telemedical coaching

Other

regular telephone calls providing information about T2DM, healthy lifestyle, low-carbohydrate diet and physical activity

Primary outcomes

  1. HbA1c change

    Time frame: 12 months

    estimated treatment difference between groups of HbA1c change (in T2DM patients with diabetes duration of ≥ 5 years)

  2. remission rate

    Time frame: 12 months

    number of participants with an HBA1c <6.5% (in T2DM patients with diabetes duration of < 5 years)

Secondary outcomes

  1. fasting blood glucose change

    Time frame: 12 months

    estimated treatment difference between groups of fasting blood glucose change

  2. weight change

    Time frame: 12 months

    estimated treatment difference between groups of weight change

  3. body mass index change

    Time frame: 12 months

    estimated treatment difference between groups of body mass index change

  4. systolic blood pressure change

    Time frame: 12 months

    estimated treatment difference between groups of systolic blood pressure change

  5. diastolic blood pressure change

    Time frame: 12 months

    estimated treatment difference between groups of diastolic blood pressure change

  6. total cholesterol change

    Time frame: 12 months

    estimated treatment difference between groups of total cholesterol change

  7. high-density lipoprotein (HDL) cholesterol change

    Time frame: 12 months

    estimated treatment difference between groups of high-density lipoprotein (HDL) cholesterol change

  8. low-density lipoprotein (LDL) cholesterol change

    Time frame: 12 months

    estimated treatment difference between groups of low-density lipoprotein (LDL) cholesterol change

  9. triglyceride change

    Time frame: 12 months

    estimated treatment difference between groups of triglyceride change

  10. number of steps

    Time frame: 12 months

    estimated treatment difference between groups of number of steps

  11. antidiabetic medication change

    Time frame: 12 months

    estimated treatment difference between groups of antidiabetic medication change

  12. diabetes-specific treatment costs

    Time frame: 12 months

    estimated treatment difference between groups of diabetes-specific treatment costs

  13. inpatient costs

    Time frame: 12 months

    estimated treatment difference between groups of inpatient costs

  14. outpatient costs

    Time frame: 12 months

    estimated treatment difference between groups of outpatient costs

Sponsors and collaborators

Lead sponsor

West German Center of Diabetes and Health

Other

Collaborators

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

Registry information

Official study title

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

Acronym: TeLIPro

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Sep 18, 2018
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.