Clinical trial NCT01688778: Telemedicine as a Means to Achieving Good Diabetes Control Among Patients With Type 2 Diabetes
Official title: The Copenhagen Rehabilitation Trial Part 2: Telemedicine as a Means to Achieve Good Diabetes Control Among Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Poor Glycemic Control
Medication Adherence
Keywords: Type 2 diabetes
Quality of life
Lifestyle intervention
Telemedicine
Videoconference
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: The Health and Care Committee, Copenhagen City Council
First posted: 2012-09-20
Enrollment: 165
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: Changes in HbA1c
timeFrame: Baseline, 16 weeks, 32 weeks, 6 months after intervention
Secondary outcomes:
measure: Fasting total cholesterol, LDL, HDL, triglycerides
timeFrame: Baseline, 32 weeks
measure: Beta-cell function test (HOMA)
timeFrame: Baseline, 32 weeks
measure: Weight
timeFrame: Baseline, 32 weeks
measure: Bloodpressure
timeFrame: Baseline, 32 weeks
measure: Physical activity
timeFrame: Baseline, 32 weeks
measure: Change in quality of life
timeFrame: Baseline, 32 weeks
measure: Waist circumference
timeFrame: Baseline, 32 weeks
measure: Hip circumference
timeFrame: Baseline, 32 weeks
measure: Body mass index
timeFrame: Baseline, 32 weeks
measure: Use of medication
timeFrame: Baseline, 32 weeks
Other outcomes:
measure: Number of hospital admissions
timeFrame: 32 weeks
measure: Number of visits at the emergency
timeFrame: 32 weeks
measure: Number of visits at the outpatient department
timeFrame: 32 weeks
measure: Number of visits at GP
timeFrame: 32-weeks
Locations:
city: Copenhagen
country: Denmark
facility: Endocrine Section, Dept. of Internal Medicine I, Bispebjerg Hospital
state: Copenhagen NV
Study officials:
affiliation: Endocrine Section, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
name: Caroline Raun Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hansen CR, Perrild H, Koefoed BG, Zander M. Video consultations as add-on to standard care among patients with type 2 diabetes not responding to standard regimens: a randomized controlled trial. Eur J Endocrinol. 2017 Jun;176(6):727-736. doi: 10.1530/EJE-16-0811. Epub 2017 Mar 21.
citation: Hansen CR, Perrild H, Koefoed BG, Faurschou P, Host 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.