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Diabetes Coaching Study (DCS)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Telemedical coaching
Telemedicine
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 Type 2 Diabetes Mellitus

Eligibility Criteria

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

Inclusion Criteria:

  • type 2 diabetes mellitus
  • hemoglobin A1c (HbA1c) >7.5%
  • at leat two different antidiabetic drugs
  • body mass index >27kg/m2

Exclusion Criteria:

  • acute infections
  • diagnosed chronic diseases other than type 2 diabetes and hypertension, e.g. cancer, chronic obstructive pulmonary disease (COPD), asthma, dementia, chronic gut diseases, psychoses, liver cirrhosis, (macro-) nephropathy, kidney insufficiency with glomerular filtration rate (eGFR) < 30ml / min / 1.73 m2
  • acute chemotherapy or chronic cortisol treatment
  • smoking cessation for less than 3 months and or planned smoking cessation during study
  • known intolerance of any ingredient of Almased (especially soy protein)
  • pregnancy or breast feeding, lack of contraception (women)
  • other study participation in the last 6 months prior to study start

Sites / Locations

  • West-German Center of Diabetes and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telemedical Coaching

Telemedicine

Arm Description

Patients will receive telemedical devices i.e. for the measurement of blood glucose, weight and physical activity. These devices will transfer the data to a data collector with a SIM card which sends the data to a data portal, which can be monitored by the participant and the coach. Health coaches which will have close phone contact to patients, supporting them to reduce weight and increase physical activity. In the first 12 weeks, patients will follow a formula diet (Almased) to achieve an initial weight reduction.

Patients will receive telemedical devices i.e. for the measurement of blood glucose, weight and physical activity. These devices will transfer the data to a data collector with a SIM card which sends the data to a data portal which can be monitored by the participant.

Outcomes

Primary Outcome Measures

HbA1c
Difference in HbA1c (at end of study vs. baseline) between the groups

Secondary Outcome Measures

weight
Difference in weight (at end of study vs. baseline) between the groups
antidiabetic medication
Difference in antidiabetic medication (at end of study vs. baseline) between the groups
Cardiovascular risk parameters (blood pressure, blood lipids)
Difference in cardiovascular risk parameters (i.e. blood pressure, blood lipids) (at end of study vs. baseline) between the groups
physical activity (step count)
Difference in physical activity (at end of study vs. baseline) between the groups
nutrition
Difference in nutrition (at end of study vs. baseline) between the groups
quality of life
Difference in quality of life (at end of study vs. baseline) between the groups

Full Information

First Posted
February 17, 2014
Last Updated
February 22, 2016
Sponsor
West German Center of Diabetes and Health
Collaborators
German Institute for Telemedicine and Health Promotion
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1. Study Identification

Unique Protocol Identification Number
NCT02066831
Brief Title
Diabetes Coaching Study
Acronym
DCS
Official Title
Diabetes Coaching Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West German Center of Diabetes and Health
Collaborators
German Institute for Telemedicine and Health Promotion

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to compare the effect of telemedical coaching versus telemedical control on HbA1c, weight, BMI, blood pressure, blood lipids, medication, nutrition, physical activity and quality of life in type 2 diabetes patients with poor glycaemic control.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemedical Coaching
Arm Type
Experimental
Arm Description
Patients will receive telemedical devices i.e. for the measurement of blood glucose, weight and physical activity. These devices will transfer the data to a data collector with a SIM card which sends the data to a data portal, which can be monitored by the participant and the coach. Health coaches which will have close phone contact to patients, supporting them to reduce weight and increase physical activity. In the first 12 weeks, patients will follow a formula diet (Almased) to achieve an initial weight reduction.
Arm Title
Telemedicine
Arm Type
Active Comparator
Arm Description
Patients will receive telemedical devices i.e. for the measurement of blood glucose, weight and physical activity. These devices will transfer the data to a data collector with a SIM card which sends the data to a data portal which can be monitored by the participant.
Intervention Type
Behavioral
Intervention Name(s)
Telemedical coaching
Intervention Type
Other
Intervention Name(s)
Telemedicine
Primary Outcome Measure Information:
Title
HbA1c
Description
Difference in HbA1c (at end of study vs. baseline) between the groups
Time Frame
12 months
Secondary Outcome Measure Information:
Title
weight
Description
Difference in weight (at end of study vs. baseline) between the groups
Time Frame
12 months
Title
antidiabetic medication
Description
Difference in antidiabetic medication (at end of study vs. baseline) between the groups
Time Frame
12 months
Title
Cardiovascular risk parameters (blood pressure, blood lipids)
Description
Difference in cardiovascular risk parameters (i.e. blood pressure, blood lipids) (at end of study vs. baseline) between the groups
Time Frame
12 months
Title
physical activity (step count)
Description
Difference in physical activity (at end of study vs. baseline) between the groups
Time Frame
12 months
Title
nutrition
Description
Difference in nutrition (at end of study vs. baseline) between the groups
Time Frame
12 months
Title
quality of life
Description
Difference in quality of life (at end of study vs. baseline) between the groups
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 hemoglobin A1c (HbA1c) >7.5% at leat two different antidiabetic drugs body mass index >27kg/m2 Exclusion Criteria: acute infections diagnosed chronic diseases other than type 2 diabetes and hypertension, e.g. cancer, chronic obstructive pulmonary disease (COPD), asthma, dementia, chronic gut diseases, psychoses, liver cirrhosis, (macro-) nephropathy, kidney insufficiency with glomerular filtration rate (eGFR) < 30ml / min / 1.73 m2 acute chemotherapy or chronic cortisol treatment smoking cessation for less than 3 months and or planned smoking cessation during study known intolerance of any ingredient of Almased (especially soy protein) pregnancy or breast feeding, lack of contraception (women) other study participation in the last 6 months prior to study start
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Martin, MD
Organizational Affiliation
West German Center of Diabetes and Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
West-German Center of Diabetes and Health
City
Düsseldorf
ZIP/Postal Code
40591
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28500214
Citation
Kempf K, Altpeter B, Berger J, Reuss O, Fuchs M, Schneider M, Gartner B, Niedermeier K, Martin S. Efficacy of the Telemedical Lifestyle intervention Program TeLiPro in Advanced Stages of Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2017 Jul;40(7):863-871. doi: 10.2337/dc17-0303. Epub 2017 May 12.
Results Reference
derived
Links:
URL
http://www.vkkd-kliniken.de
Description
Homepage

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Diabetes Coaching Study

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