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CompletedNCT01688778Updated Sep 19, 2018

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

An interventional study of Telemedicine in Type 2 Diabetes, Poor Glycemic Control and Medication Adherence, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-09-19.

Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes
  • Poor Glycemic Control
  • Medication Adherence

Keywords

  • Type 2 diabetes
  • Quality of life
  • Lifestyle intervention
  • Telemedicine
  • Videoconference
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 165 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Bispebjerg Hospital is the lead sponsor of 281 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • HbA1c > 7,5%
  • BMI > 25
  • Spoken danish
  • Completed a rehabilitation program more than 6 months ago

Exclusion criteria

Exclusion Criteria:

  • HbA1c \< 7,5%
  • BMI \< 25
  • Need of interpreter
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
165 participants (estimated)

Study arms

  • Experimental
    Telemedicine

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

    Behavioral: Telemedicine

  • No intervention
    Standard treatment

    Standard diabetes control at a Diabetes Clinic or GP

Interventions

  • BehavioralTelemedicine

    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.

06

What researchers measure

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

07

Study locations

1 site
  • Endocrine Section, Dept. of Internal Medicine I, Bispebjerg Hospital
    Copenhagen, Copenhagen NV DK-2400, Denmark
08

References and documents

Publications

  • 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. PubMed 28325823 ↗
  • 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. PubMed 24355450 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01688778
Lead sponsor
Bispebjerg Hospital
Collaborators
The Health and Care Committee, Copenhagen City Council
Responsible party
Caroline Raun Hansen (MD, Bispebjerg Hospital) — Principal investigator
First posted
Sep 20, 2012
Start date
Jun 2012
Primary completion
Apr 28, 2015
Completion
Apr 28, 2015
Last update
Sep 19, 2018

Study contacts

Caroline Raun Hansen, MD
principal investigator · Endocrine Section, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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