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Completed

NCT Number: NCT01688778

Telemedicine as a Means to Achieving 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.

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Key information

Conditions

Type 2 Diabetes Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Medication Adherence Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Poor Glycemic Control Treatment Adherence and Compliance

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endocrine Section, Dept. of Internal Medicine I, Bispebjerg Hospital

Copenhagen, Copenhagen NV, DK-2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine

Behavioral

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.

Primary outcomes

  1. Changes in HbA1c

    Time frame: Baseline, 16 weeks, 32 weeks, 6 months after intervention

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • The Health and Care Committee, Copenhagen City Council

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 20, 2012
Registry last updated
Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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