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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Health and Care Committee, Copenhagen City Council
Information provided by (Responsible Party):
Caroline Raun Hansen, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01688778
First received: September 17, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Changes in HbA1c [ Time Frame: Baseline, 16 weeks, 32 weeks, 6 months after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting total cholesterol, LDL, HDL, triglycerides [ Time Frame: Baseline, 32 weeks ] [ Designated as safety issue: No ]
  • Beta-cell function test (HOMA) [ Time Frame: Baseline, 32 weeks ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: Baseline, 32 weeks ] [ Designated as safety issue: No ]
  • Bloodpressure [ Time Frame: Baseline, 32 weeks ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: Baseline, 32 weeks ] [ Designated as safety issue: No ]
  • Change in quality of life [ Time Frame: Baseline, 32 weeks ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: Baseline, 32 weeks ] [ Designated as safety issue: No ]
  • Hip circumference [ Time Frame: Baseline, 32 weeks ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: Baseline, 32 weeks ] [ Designated as safety issue: No ]
  • Use of medication [ Time Frame: Baseline, 32 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of hospital admissions [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
  • Number of visits at the emergency [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
  • Number of visits at the outpatient department [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
  • Number of visits at GP [ Time Frame: 32-weeks ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Bispebjerg Hospital

Additional 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
Study First Received: September 17, 2012
Last Updated: March 27, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on October 20, 2014