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

Primary Purpose

Type 2 Diabetes, Poor Glycemic Control, Medication Adherence

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Telemedicine
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Quality of life, Lifestyle intervention, Telemedicine, Videoconference

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telemedicine

Standard treatment

Arm Description

Monthly video consultations with a nurse as add-on to standard treatment.

Standard diabetes control at a Diabetes Clinic or GP

Outcomes

Primary Outcome Measures

Changes in HbA1c

Secondary Outcome Measures

Fasting total cholesterol, LDL, HDL, triglycerides
Beta-cell function test (HOMA)
Weight
Bloodpressure
Physical activity
Change in quality of life
Waist circumference
Hip circumference
Body mass index
Use of medication

Full Information

First Posted
September 17, 2012
Last Updated
September 18, 2018
Sponsor
Bispebjerg Hospital
Collaborators
The Health and Care Committee, Copenhagen City Council
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1. Study Identification

Unique Protocol Identification Number
NCT01688778
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 28, 2015 (Actual)
Study Completion Date
April 28, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
The Health and Care Committee, Copenhagen City Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Poor Glycemic Control, Medication Adherence
Keywords
Type 2 diabetes, Quality of life, Lifestyle intervention, Telemedicine, Videoconference

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine
Arm Type
Experimental
Arm Description
Monthly video consultations with a nurse as add-on to standard treatment.
Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
Standard diabetes control at a Diabetes Clinic or GP
Intervention Type
Behavioral
Intervention Name(s)
Telemedicine
Intervention Description
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 Outcome Measure Information:
Title
Changes in HbA1c
Time Frame
Baseline, 16 weeks, 32 weeks, 6 months after intervention
Secondary Outcome Measure Information:
Title
Fasting total cholesterol, LDL, HDL, triglycerides
Time Frame
Baseline, 32 weeks
Title
Beta-cell function test (HOMA)
Time Frame
Baseline, 32 weeks
Title
Weight
Time Frame
Baseline, 32 weeks
Title
Bloodpressure
Time Frame
Baseline, 32 weeks
Title
Physical activity
Time Frame
Baseline, 32 weeks
Title
Change in quality of life
Time Frame
Baseline, 32 weeks
Title
Waist circumference
Time Frame
Baseline, 32 weeks
Title
Hip circumference
Time Frame
Baseline, 32 weeks
Title
Body mass index
Time Frame
Baseline, 32 weeks
Title
Use of medication
Time Frame
Baseline, 32 weeks
Other Pre-specified Outcome Measures:
Title
Number of hospital admissions
Time Frame
32 weeks
Title
Number of visits at the emergency
Time Frame
32 weeks
Title
Number of visits at the outpatient department
Time Frame
32 weeks
Title
Number of visits at GP
Time Frame
32-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Raun Hansen, MD
Organizational Affiliation
Endocrine Section, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endocrine Section, Dept. of Internal Medicine I, Bispebjerg Hospital
City
Copenhagen
State/Province
Copenhagen NV
ZIP/Postal Code
DK-2400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28325823
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.
Results Reference
derived
PubMed Identifier
24355450
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.
Results Reference
derived

Learn more about this trial

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

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