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

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Poor Glycemic Control; Medication Adherence
• Interventions: Behavioral: Telemedicine

• Registration Number: NCT01688778
• Lead Sponsor: Bispebjerg Hospital

Brief 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.

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-19
• Study First Posted: 2012-09-20
• Primary Completion: 2015-04-28
• Study Completion: 2015-04-28
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedicine	Telemedicine	Monthly video consultations with a nurse as add-on to standard treatment.

Primary Outcome Measures

Name	Time	Method
Changes in HbA1c	Baseline, 16 weeks, 32 weeks, 6 months after intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Endocrine Section, Dept. of Internal Medicine I, Bispebjerg Hospital; 🇩🇰 Copenhagen, Copenhagen NV, Denmark