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TeLIPro Health Program - Active With Diabetes (TeLIPro)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Scale
Step counter
Blood glucose meter with test stripes
Access to the online portal
Telemedical coaching
Sponsored by
West German Center of Diabetes and Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2

Eligibility Criteria

25 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West German Centre of Diabetes and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

TeLIPro group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

HbA1c change
estimated treatment difference between groups of HbA1c change (in T2DM patients with diabetes duration of ≥ 5 years)
remission rate
number of participants with an HBA1c <6.5% (in T2DM patients with diabetes duration of < 5 years)

Secondary Outcome Measures

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

Full Information

First Posted
September 11, 2018
Last Updated
January 19, 2023
Sponsor
West German Center of Diabetes and Health
Collaborators
AOK Rheinland/Hamburg, German Institute for Telemedicine and Health Promotion, German Diabetes Center
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1. Study Identification

Unique Protocol Identification Number
NCT03675919
Brief Title
TeLIPro Health Program - Active With Diabetes
Acronym
TeLIPro
Official Title
The Telemedical Lifestyle Intervention Program TeLIPro (TeLIPro Health Program - Active With Diabetes)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
September 21, 2021 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West German Center of Diabetes and Health
Collaborators
AOK Rheinland/Hamburg, German Institute for Telemedicine and Health Promotion, German Diabetes Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
TeLIPro group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Scale
Intervention Description
self-monitoring of body weight; with automatic data transfer into the personalized and secured online portal
Intervention Type
Device
Intervention Name(s)
Step counter
Intervention Description
self-monitoring of physical activity; with automatic data transfer into the personalized and secured online portal
Intervention Type
Device
Intervention Name(s)
Blood glucose meter with test stripes
Intervention Description
self-monitoring of blood glucose; with automatic data transfer into the personalized and secured online portal
Intervention Type
Other
Intervention Name(s)
Access to the online portal
Intervention Description
self-monitoring of health parameters
Intervention Type
Other
Intervention Name(s)
Telemedical coaching
Intervention Description
regular telephone calls providing information about T2DM, healthy lifestyle, low-carbohydrate diet and physical activity
Primary Outcome Measure Information:
Title
HbA1c change
Description
estimated treatment difference between groups of HbA1c change (in T2DM patients with diabetes duration of ≥ 5 years)
Time Frame
12 months
Title
remission rate
Description
number of participants with an HBA1c <6.5% (in T2DM patients with diabetes duration of < 5 years)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
fasting blood glucose change
Description
estimated treatment difference between groups of fasting blood glucose change
Time Frame
12 months
Title
weight change
Description
estimated treatment difference between groups of weight change
Time Frame
12 months
Title
body mass index change
Description
estimated treatment difference between groups of body mass index change
Time Frame
12 months
Title
systolic blood pressure change
Description
estimated treatment difference between groups of systolic blood pressure change
Time Frame
12 months
Title
diastolic blood pressure change
Description
estimated treatment difference between groups of diastolic blood pressure change
Time Frame
12 months
Title
total cholesterol change
Description
estimated treatment difference between groups of total cholesterol change
Time Frame
12 months
Title
high-density lipoprotein (HDL) cholesterol change
Description
estimated treatment difference between groups of high-density lipoprotein (HDL) cholesterol change
Time Frame
12 months
Title
low-density lipoprotein (LDL) cholesterol change
Description
estimated treatment difference between groups of low-density lipoprotein (LDL) cholesterol change
Time Frame
12 months
Title
triglyceride change
Description
estimated treatment difference between groups of triglyceride change
Time Frame
12 months
Title
number of steps
Description
estimated treatment difference between groups of number of steps
Time Frame
12 months
Title
antidiabetic medication change
Description
estimated treatment difference between groups of antidiabetic medication change
Time Frame
12 months
Title
diabetes-specific treatment costs
Description
estimated treatment difference between groups of diabetes-specific treatment costs
Time Frame
12 months
Title
inpatient costs
Description
estimated treatment difference between groups of inpatient costs
Time Frame
12 months
Title
outpatient costs
Description
estimated treatment difference between groups of outpatient costs
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernd Altpeter
Organizational Affiliation
Deutsches Institut für Telemedizin und Gesundheitsförderung
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sibel Altin
Organizational Affiliation
AOK Rheinland/Hamburg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andrea Icks, PhD
Organizational Affiliation
Deusches Diabetes Zentrum
Official's Role
Study Chair
Facility Information:
Facility Name
West German Centre of Diabetes and Health
City
Düsseldorf
ZIP/Postal Code
40591
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

TeLIPro Health Program - Active With Diabetes

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