Telemedicine as a Means to Achieving Good Diabetes Control Among Patients With Type 2 Diabetes

September 18, 2018 updated by: Caroline Raun Hansen, Bispebjerg Hospital

The Copenhagen Rehabilitation Trial Part 2: Telemedicine as a Means to Achieve Good Diabetes Control Among Patients With Type 2 Diabetes

The aim of the study is to investigate the effect of telemedicine among the group of type-2-diabetics who, despite rehabilitation, remain poorly regulated. To describe the patients with regards to vulnerability and social resources and to determine wich groups benefit the most from telemedicine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Type-2-diabetes is a growing healthcare problem. Both because of the increasing amount of patients and because of the complications of diabetes.

Non-pharmacological treatment is considered fundamental in the treatment of patients with type-2-diabetes.

In the Community of Copenhagen, all patients diagnosed with diabetes receive rehabilitation. The rehabilitation consists of counseling with regards to nutrition, physical activity, smoking cessation and education about diabetes.

Some patients however, remain poorly regulated despite rehabilitation as well as pharmacological treatment.

A total number of 165 patients will be randomized to intervention group or standard care.

Study Type

Interventional

Enrollment (Anticipated)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen NV
      • Copenhagen, Copenhagen NV, Denmark, DK-2400
        • Endocrine Section, Dept. of Internal Medicine I, Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HbA1c > 7,5%
  • BMI > 25
  • Spoken danish
  • Completed a rehabilitation program more than 6 months ago

Exclusion Criteria:

  • HbA1c < 7,5%
  • BMI < 25
  • Need of interpreter

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telemedicine
Monthly video consultations with a nurse as add-on to standard treatment.
Behavioral: Telemedicine

Monthly video consultations with a nurse as add-on to standard treatment. The nurse has access to bloodsugar- bloodpressure and weight measurements uploaded by the participants to a tablet computer directly from the devices.

Patients on Insulin measure bloodsugar twice a day (fasting and before their evening meal). Patients not on Insulin measure bloodsugar once a week (fasting and before their evening meal). All participants measure bloodpressure and weight once a week. The intervention lasts 32 weeks.
No Intervention: Standard treatment
Standard diabetes control at a Diabetes Clinic or GP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in HbA1c
Time Frame: Baseline, 16 weeks, 32 weeks, 6 months after intervention
Baseline, 16 weeks, 32 weeks, 6 months after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting total cholesterol, LDL, HDL, triglycerides
Time Frame: Baseline, 32 weeks
Baseline, 32 weeks
Beta-cell function test (HOMA)
Time Frame: Baseline, 32 weeks
Baseline, 32 weeks
Weight
Time Frame: Baseline, 32 weeks
Baseline, 32 weeks
Bloodpressure
Time Frame: Baseline, 32 weeks
Baseline, 32 weeks
Physical activity
Time Frame: Baseline, 32 weeks
Baseline, 32 weeks
Change in quality of life
Time Frame: Baseline, 32 weeks
Baseline, 32 weeks
Waist circumference
Time Frame: Baseline, 32 weeks
Baseline, 32 weeks
Hip circumference
Time Frame: Baseline, 32 weeks
Baseline, 32 weeks
Body mass index
Time Frame: Baseline, 32 weeks
Baseline, 32 weeks
Use of medication
Time Frame: Baseline, 32 weeks
Baseline, 32 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Number of hospital admissions
Time Frame: 32 weeks
32 weeks
Number of visits at the emergency
Time Frame: 32 weeks
32 weeks
Number of visits at the outpatient department
Time Frame: 32 weeks
32 weeks
Number of visits at GP
Time Frame: 32-weeks
32-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

The Health and Care Committee, Copenhagen City Council

Investigators

  • Principal Investigator: Caroline Raun Hansen, MD, Endocrine Section, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

April 28, 2015

Study Completion (Actual)

April 28, 2015

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 19, 2012

First Posted (Estimate)

September 20, 2012

Study Record Updates

Last Update Posted (Actual)

September 19, 2018

Last Update Submitted That Met QC Criteria

September 18, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2011-158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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