Diabetes Coaching Study

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: Telemedical coaching; Other: Telemedicine

• Registration Number: NCT02066831
• Lead Sponsor: West German Center of Diabetes and Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-17
• Study First Submitted QC: 2014-02-17
• Study First Posted: 2014-02-20
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedical Coaching	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 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	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.
Telemedicine	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.

Primary Outcome Measures

Name	Time	Method
HbA1c	12 months	Difference in HbA1c (at end of study vs. baseline) between the groups

Secondary Outcome Measures

Name	Time	Method
antidiabetic medication	12 months	Difference in antidiabetic medication (at end of study vs. baseline) between the groups
Cardiovascular risk parameters (blood pressure, blood lipids)	12 months	Difference in cardiovascular risk parameters (i.e. blood pressure, blood lipids) (at end of study vs. baseline) between the groups
weight	12 months	Difference in weight (at end of study vs. baseline) between the groups
physical activity (step count)	12 months	Difference in physical activity (at end of study vs. baseline) between the groups
nutrition	12 months	Difference in nutrition (at end of study vs. baseline) between the groups
quality of life	12 months	Difference in quality of life (at end of study vs. baseline) between the groups

Trial Locations

Locations (1)

West-German Center of Diabetes and Health; 🇩🇪 Düsseldorf, Germany