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

September 17, 2012
March 27, 2014
June 2012
April 2014   (final data collection date for primary outcome measure)
Changes in HbA1c [ Time Frame: Baseline, 16 weeks, 32 weeks, 6 months after intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01688778 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
  • 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 ]
Same as current
 
Telemedicine as a Means to Achieving Good Diabetes Control Among Patients With Type 2 Diabetes
The Copenhagen Rehabilitation Trial Part 2: Telemedicine as a Means to Achieve Good Diabetes Control Among Patients With Type 2 Diabetes

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Type 2 Diabetes
  • Poor Glycemic Control
  • Medication Adherence
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.

  • Experimental: Telemedicine
    Monthly video consultations with a nurse as add-on to standard treatment.
    Intervention: Behavioral: Telemedicine
  • No Intervention: Standard treatment
    Standard diabetes control at a Diabetes Clinic or GP
Hansen CR, Perrild H, Koefoed BG, Faurschou P, Høst D, Zander M. Effects of telemedicine in the treatment of patients with type 2 diabetes--a study protocol. Dan Med J. 2013 Dec;60(12):A4743.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
165
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01688778
H-2-2011-158
No
Caroline Raun Hansen, Bispebjerg Hospital
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
Bispebjerg Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP