Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by Caroline Raun Hansen, Bispebjerg Hospital.
Recruitment status was:  Active, not recruiting
The Health and Care Committee, Copenhagen City Council
Information provided by (Responsible Party):
Caroline Raun Hansen, Bispebjerg Hospital Identifier:
First received: September 17, 2012
Last updated: March 27, 2014
Last verified: March 2014
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.

Condition Intervention
Type 2 Diabetes
Poor Glycemic Control
Medication Adherence
Behavioral: Telemedicine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Copenhagen Rehabilitation Trial Part 2: Telemedicine as a Means to Achieve Good Diabetes Control Among Patients With Type 2 Diabetes

Further study details as provided by Caroline Raun Hansen, Bispebjerg Hospital:

Primary Outcome Measures:
  • Changes in HbA1c [ Time Frame: Baseline, 16 weeks, 32 weeks, 6 months after intervention ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • Number of hospital admissions [ Time Frame: 32 weeks ]
  • Number of visits at the emergency [ Time Frame: 32 weeks ]
  • Number of visits at the outpatient department [ Time Frame: 32 weeks ]
  • Number of visits at GP [ Time Frame: 32-weeks ]

Estimated Enrollment: 165
Study Start Date: June 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01688778

Endocrine Section, Dept. of Internal Medicine I, Bispebjerg Hospital
Copenhagen, Copenhagen NV, Denmark, DK-2400
Sponsors and Collaborators
Bispebjerg Hospital
The Health and Care Committee, Copenhagen City Council
Principal Investigator: Caroline Raun Hansen, MD Endocrine Section, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Caroline Raun Hansen, MD, Bispebjerg Hospital Identifier: NCT01688778     History of Changes
Other Study ID Numbers: H-2-2011-158
Study First Received: September 17, 2012
Last Updated: March 27, 2014

Keywords provided by Caroline Raun Hansen, Bispebjerg Hospital:
Type 2 diabetes
Quality of life
Lifestyle intervention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on May 25, 2017