Diabetes Coaching Study

Type 2 Diabetes Mellitus Clinical Trial

— DCS  

Official title:

Diabetes Coaching Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066831
• Other study ID #: DCS
• Status: Completed
• Phase: N/A
• First received: February 17, 2014
• Last updated: February 22, 2016
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: West German Center of Diabetes and Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 79 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Telemedical coaching

Other:
• Telemedicine

Locations

Country	Name	City	State
Germany	West-German Center of Diabetes and Health	Düsseldorf

Sponsors (2)

Lead Sponsor	Collaborator
West German Center of Diabetes and Health	Deutsches Institut für Telemedizin und Gesundheitsförderung (DITG)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Difference in HbA1c (at end of study vs. baseline) between the groups	12 months	No
Secondary	weight	Difference in weight (at end of study vs. baseline) between the groups	12 months	No
Secondary	antidiabetic medication	Difference in antidiabetic medication (at end of study vs. baseline) between the groups	12 months	No
Secondary	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	12 months	No
Secondary	physical activity (step count)	Difference in physical activity (at end of study vs. baseline) between the groups	12 months	No
Secondary	nutrition	Difference in nutrition (at end of study vs. baseline) between the groups	12 months	No
Secondary	quality of life	Difference in quality of life (at end of study vs. baseline) between the groups	12 months	No

External Links

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