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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688778
• Other study ID #: H-2-2011-158
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: April 28, 2015

Study information

• Verified date: September 2018
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: April 28, 2015
• Est. primary completion date: April 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Medication Adherence
• Poor Glycemic Control
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Denmark	Endocrine Section, Dept. of Internal Medicine I, Bispebjerg Hospital	Copenhagen	Copenhagen NV

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	The Health and Care Committee, Copenhagen City Council

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of hospital admissions		32 weeks
Other	Number of visits at the emergency		32 weeks
Other	Number of visits at the outpatient department		32 weeks
Other	Number of visits at GP		32-weeks
Primary	Changes in HbA1c		Baseline, 16 weeks, 32 weeks, 6 months after intervention
Secondary	Fasting total cholesterol, LDL, HDL, triglycerides		Baseline, 32 weeks
Secondary	Beta-cell function test (HOMA)		Baseline, 32 weeks
Secondary	Weight		Baseline, 32 weeks
Secondary	Bloodpressure		Baseline, 32 weeks
Secondary	Physical activity		Baseline, 32 weeks
Secondary	Change in quality of life		Baseline, 32 weeks
Secondary	Waist circumference		Baseline, 32 weeks
Secondary	Hip circumference		Baseline, 32 weeks
Secondary	Body mass index		Baseline, 32 weeks
Secondary	Use of medication		Baseline, 32 weeks