Diabetes Coaching Study

NCT ID: NCT02066831

Last Updated: 2016-02-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

Telemedical coaching

Intervention Type BEHAVIORAL

Telemedicine

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Telemedical coaching

Intervention Type BEHAVIORAL

Interventions

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Telemedical coaching

Intervention Type BEHAVIORAL

Telemedicine

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Institute for Telemedicine and Health Promotion

OTHER

Sponsor Role collaborator

West German Center of Diabetes and Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Germany

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.

Reference Type DERIVED
PMID: 28500214 (View on PubMed)

Related Links

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Other Identifiers

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DCS

Identifier Type: -

Identifier Source: org_study_id

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