Overview

This trial is active, not recruiting.

Conditions type 2 diabetes, poor glycemic control, medication adherence
Treatment telemedicine
Sponsor Bispebjerg Hospital
Collaborator The Health and Care Committee, Copenhagen City Council
Start date June 2012
End date April 2014
Trial size 165 participants
Trial identifier NCT01688778, H-2-2011-158

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Monthly video consultations with a nurse as add-on to standard treatment.
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 diabetes control at a Diabetes Clinic or GP

Primary Outcomes

Measure
Changes in HbA1c
time frame: Baseline, 16 weeks, 32 weeks, 6 months after intervention

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 30 years up to 75 years old.

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

Additional Information

Official title The Copenhagen Rehabilitation Trial Part 2: Telemedicine as a Means to Achieve Good Diabetes Control Among Patients With Type 2 Diabetes
Principal investigator Caroline Raun Hansen, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Bispebjerg Hospital.