Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
202 participants
INTERVENTIONAL
2014-02-28
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
Telemedical coaching
Telemedicine
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.
Telemedical coaching
Interventions
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Telemedical coaching
Telemedicine
Eligibility Criteria
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Inclusion Criteria
* hemoglobin A1c (HbA1c) \>7.5%
* at leat two different antidiabetic drugs
* body mass index \>27kg/m2
Exclusion Criteria
* 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
25 Years
79 Years
ALL
No
Sponsors
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German Institute for Telemedicine and Health Promotion
OTHER
West German Center of Diabetes and Health
OTHER
Responsible Party
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Principal Investigators
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Stephan Martin, MD
Role: PRINCIPAL_INVESTIGATOR
West German Center of Diabetes and Health
Locations
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West-German Center of Diabetes and Health
Düsseldorf, , Germany
Countries
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References
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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.
Related Links
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Homepage
Other Identifiers
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DCS
Identifier Type: -
Identifier Source: org_study_id
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