Diabetes Coaching Study (DCS)

West German Center of Diabetes and Health

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Telemedicine; Behavioral: Telemedical coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT02066831

DCS

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: 25 to 79 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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202 participants in 2 patient groups

Telemedical Coaching

Experimental group

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.

Treatment:

Behavioral: Telemedical coaching

Other: Telemedicine

Telemedicine

Active Comparator group

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.

Treatment:

Behavioral: Telemedical coaching