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Clinical Trials/NCT02066831
NCT02066831
Completed
Not Applicable

Diabetes Coaching Study

West German Center of Diabetes and Health1 site in 1 country202 target enrollmentFebruary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
West German Center of Diabetes and Health
Enrollment
202
Locations
1
Primary Endpoint
HbA1c
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
West German Center of Diabetes and Health
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

HbA1c

Time Frame: 12 months

Difference in HbA1c (at end of study vs. baseline) between the groups

Secondary Outcomes

  • weight(12 months)
  • antidiabetic medication(12 months)
  • Cardiovascular risk parameters (blood pressure, blood lipids)(12 months)
  • physical activity (step count)(12 months)
  • nutrition(12 months)
  • quality of life(12 months)

Study Sites (1)

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