CClinicalTrials.gg
CompletedNCT02066831DCSUpdated Feb 23, 2016

Diabetes Coaching Study

An interventional study of Telemedical coaching and Telemedicine in Type 2 Diabetes Mellitus, sponsored by West German Center of Diabetes and Health. Completed at 1 site in Germany. Open to participants aged 25 Years to 79 Years. Per ClinicalTrials.gov, last updated 2016-02-23.

Sponsored by West German Center of Diabetes and Health · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
202
Allocation
Randomized
Ages
25 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 202 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

West German Center of Diabetes and Health is the lead sponsor of 18 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
202 participants (actual)

Study arms

  • Experimental
    Telemedical Coaching

    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.

    Behavioral: Telemedical coaching · Other: Telemedicine

  • Active comparator
    Telemedicine

    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.

    Behavioral: Telemedical coaching

Interventions

  • BehavioralTelemedical coaching
  • OtherTelemedicine
06

What researchers measure

Primary outcomes

  1. HbA1c

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

    Time frame: 12 months

Secondary outcomes

  1. weight

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

    Time frame: 12 months

  2. antidiabetic medication

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

    Time frame: 12 months

  3. 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

    Time frame: 12 months

  4. physical activity (step count)

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

    Time frame: 12 months

  5. nutrition

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

    Time frame: 12 months

  6. quality of life

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

    Time frame: 12 months

07

Study locations

1 site
  • West-German Center of Diabetes and Health
    Düsseldorf, 40591, Germany
08

References and documents

Publications

  • 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. PubMed 28500214 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02066831
Lead sponsor
West German Center of Diabetes and Health
Collaborators
German Institute for Telemedicine and Health Promotion
Responsible party
Sponsor
First posted
Feb 20, 2014
Start date
Feb 2014
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Feb 23, 2016

Study contacts

Stephan Martin, MD
principal investigator · West German Center of Diabetes and Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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