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

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ClinicalTrials.gov Identifier: NCT01688778
Recruitment Status : Unknown
Verified March 2014 by Caroline Raun Hansen, Bispebjerg Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2012
Last Update Posted : March 28, 2014
Sponsor:
Collaborator:
The Health and Care Committee, Copenhagen City Council
Information provided by (Responsible Party):
Caroline Raun Hansen, 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Poor Glycemic Control Medication Adherence Behavioral: Telemedicine Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2012
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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

Secondary Outcome Measures :
  1. Fasting total cholesterol, LDL, HDL, triglycerides [ Time Frame: Baseline, 32 weeks ]
  2. Beta-cell function test (HOMA) [ Time Frame: Baseline, 32 weeks ]
  3. Weight [ Time Frame: Baseline, 32 weeks ]
  4. Bloodpressure [ Time Frame: Baseline, 32 weeks ]
  5. Physical activity [ Time Frame: Baseline, 32 weeks ]
  6. Change in quality of life [ Time Frame: Baseline, 32 weeks ]
  7. Waist circumference [ Time Frame: Baseline, 32 weeks ]
  8. Hip circumference [ Time Frame: Baseline, 32 weeks ]
  9. Body mass index [ Time Frame: Baseline, 32 weeks ]
  10. Use of medication [ Time Frame: Baseline, 32 weeks ]

Other Outcome Measures:
  1. Number of hospital admissions [ Time Frame: 32 weeks ]
  2. Number of visits at the emergency [ Time Frame: 32 weeks ]
  3. Number of visits at the outpatient department [ Time Frame: 32 weeks ]
  4. Number of visits at GP [ Time Frame: 32-weeks ]


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688778


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Caroline Raun Hansen, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01688778     History of Changes
Other Study ID Numbers: H-2-2011-158
First Posted: September 20, 2012    Key Record Dates
Last Update Posted: March 28, 2014
Last Verified: March 2014

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases