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Completed

NCT Number: NCT02066831

Diabetes Coaching Study

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West-German Center of Diabetes and Health

Düsseldorf, 40591, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedical coaching

Behavioral

Telemedicine

Other

Primary outcomes

  1. HbA1c

    Time frame: 12 months

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

Secondary outcomes

  1. weight

    Time frame: 12 months

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

  2. antidiabetic medication

    Time frame: 12 months

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

  3. Cardiovascular risk parameters (blood pressure, blood lipids)

    Time frame: 12 months

    Difference in cardiovascular risk parameters (i.e. blood pressure, blood lipids) (at end of study vs. baseline) between the groups

  4. physical activity (step count)

    Time frame: 12 months

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

  5. nutrition

    Time frame: 12 months

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

  6. quality of life

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

West German Center of Diabetes and Health

Other

Collaborators

  • German Institute for Telemedicine and Health Promotion

Registry information

Acronym: DCS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 20, 2014
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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