NCT01688778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2015

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

2.9 years

First QC Date

September 17, 2012

Last Update Submit

September 18, 2018

Conditions

Type 2 DiabetesPoor Glycemic ControlMedication Adherence

Keywords

Type 2 diabetesQuality of lifeLifestyle interventionTelemedicineVideoconference

Outcome Measures

Primary Outcomes (1)

  • Changes in HbA1c

    Baseline, 16 weeks, 32 weeks, 6 months after intervention

Secondary Outcomes (10)

  • Fasting total cholesterol, LDL, HDL, triglycerides

    Baseline, 32 weeks

  • Beta-cell function test (HOMA)

    Baseline, 32 weeks

  • Weight

    Baseline, 32 weeks

  • Bloodpressure

    Baseline, 32 weeks

  • Physical activity

    Baseline, 32 weeks

  • +5 more secondary outcomes

Other Outcomes (4)

  • Number of hospital admissions

    32 weeks

  • Number of visits at the emergency

    32 weeks

  • Number of visits at the outpatient department

    32 weeks

  • +1 more other outcomes

Study Arms (2)

Telemedicine

EXPERIMENTAL

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

Behavioral: Telemedicine

Standard treatment

NO INTERVENTION

Standard diabetes control at a Diabetes Clinic or GP

Interventions

TelemedicineBEHAVIORAL

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.

Telemedicine

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen, Copenhagen NV, DK-2400, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 28325823DERIVED

  • 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.

    PMID: 24355450DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Medication Adherence

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Caroline Raun Hansen, MD

    Endocrine Section, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 20, 2012

Study Start

June 1, 2012

Primary Completion

April 28, 2015

Study Completion

April 28, 2015

Last Updated

September 19, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)