NCT02066831

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

February 17, 2014

Last Update Submit

February 22, 2016

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c

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

    12 months

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Telemedical Coaching

EXPERIMENTAL

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.

Behavioral: Telemedical coachingOther: Telemedicine

Telemedicine

ACTIVE COMPARATOR

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.

Behavioral: Telemedical coaching

Interventions

Telemedical coachingBEHAVIORAL
Telemedical CoachingTelemedicine
TelemedicineOTHER
Telemedical Coaching

Eligibility Criteria

Age25 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes mellitus
  • hemoglobin A1c (HbA1c) \>7.5%
  • at leat two different antidiabetic drugs
  • body mass index \>27kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West-German Center of Diabetes and Health

Düsseldorf, 40591, Germany

Location

Related Publications (1)

  • Kempf K, Altpeter B, Berger J, Reuss O, Fuchs M, Schneider M, Gartner B, Niedermeier K, Martin S. Efficacy of the Telemedical Lifestyle intervention Program TeLiPro in Advanced Stages of Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2017 Jul;40(7):863-871. doi: 10.2337/dc17-0303. Epub 2017 May 12.

    PMID: 28500214DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Stephan Martin, MD

    West German Center of Diabetes and Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2014

First Posted

February 20, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

DE(1)