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TeLIPro Health Program - Active With Diabetes (TeLIPro)

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ClinicalTrials.gov Identifier: NCT03675919
Recruitment Status : Not yet recruiting
First Posted : September 18, 2018
Last Update Posted : September 25, 2018
Sponsor:
Collaborators:
AOK Rhineland / Hamburg
Deutsches Institut für Telemedizin und Gesundheitsförderung (DITG)
German Diabetes Center
Information provided by (Responsible Party):
Stephan Martin, West German Center of Diabetes and Health

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Device: Scale Device: Step counter Device: Blood glucose meter with test stripes Other: Access to the online portal Other: Telemedical coaching Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 2018 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Telemedical Lifestyle Intervention Program TeLIPro (TeLIPro Health Program - Active With Diabetes)
Estimated Study Start Date : September 15, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : September 2022

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   25 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675919


Contacts
Contact: Stephan Martin, MD +49-(0)211-5660360 ext 70 stephan.martin@uni-duesseldorf.de
Contact: Kerstin Kempf, PhD +49-(0)211-5660360 ext 16 kerstin.kempf@wdgz.de

Locations
Germany
West German Centre of Diabetes and Health
Düsseldorf, Germany, 40591
Sponsors and Collaborators
West German Center of Diabetes and Health
AOK Rhineland / Hamburg
Deutsches Institut für Telemedizin und Gesundheitsförderung (DITG)
German Diabetes Center
Investigators
Study Chair: Bernd Altpeter Deutsches Institut für Telemedizin und Gesundheitsförderung
Study Chair: Sibel Altin AOK Rhineland / Hamburg
Study Chair: Andrea Icks, PhD Deusches Diabetes Zentrum

Responsible Party: Stephan Martin, Director, West German Center of Diabetes and Health
ClinicalTrials.gov Identifier: NCT03675919     History of Changes
Other Study ID Numbers: TeLIPro
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stephan Martin, West German Center of Diabetes and Health:
Diabetes Mellitus, Type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases