Effectiveness of Video Consultations in Type 1 Diabetes Patients Treated With Insulin Pumps in the Outpatient Clinic

August 1, 2023 updated by: University of Southern Denmark
Telemedicine is a solution to overcome distance and ensure the provision of healthcare services. This study aims to investigate the effects of conducting outpatient clinic visits remotely, for patients living with insulin pumps.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Telemedicine also has the potential to be a cost-effective solution due to reductions in travelling costs and saved working days, as well as increased patient satisfaction due to the reduction in transportation time.

Several studies have evaluated telemedicine for use in Diabetes Mellitus patients with an insulin pump. In all of these studies, the telemedicine group scheduled more contacts with the health care professionals than in the standard care group. To the investigator's knowledge, no one has investigated telemedicine, compared to standard care with the same number of scheduled contacts. The investigators believe telemedicine should increase the level of service and not increase the workload for health care professionals. A telemedical solution can provide patients with a more flexible alternative for visiting their health care provider rather having the burden of extra telemedicine appointments plus regular treatment.

Patients in rural Denmark may have a travelling time of 70 km (1 hour by car or several hours by public transport) to a specialised Diabetes Mellitus specialist centre. This may result in some patients choosing not to start or not being offered insulin pump treatment despite indications that an insulin pump is an optimal treatment choice. The challenge of distance also poses problems for patients in relation to technical problems or medical issues with the insulin pump. Telemedicine should be a solution for both patients and their Health Care Providers.

In this randomised controlled study, the effects of conducting clinical visits remotely, for patients living with insulin pumps will be investigated. Participants will be allocated to either Intervention (Standard care provide by video consultations) or standard care.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Anders Ørsted Schultz, MD
  • Phone Number: +45 2614 6374
  • Email: anos@rsyd.dk

Study Contact Backup

  • Name: Frans Brandt Kristensen, MD, Ph.D.
  • Phone Number: + 4579973010

Study Locations

  • Denmark
      • Aabenraa, Denmark, 6200
        • Recruiting
        • Sygehus Soenderjylland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients over 18 years of age
  • Diagnosed with diabetes Type 1
  • Patient has used insulin pump for at least 6 months

Exclusion Criteria:

  • No internet access
  • Unable to adhere to protocol.
  • Unable to speak or read Danish.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group video consultations

All appointments, scheduled and non-scheduled are by telemedicine using video to commutate with the health care professionals.

Patients will follow their usual treatment.
Other: Intervention group video consultations

All appointments, scheduled and non-scheduled are by telemedicine using video to commutate with the health care professionals.

Patients will follow their usual treatment.
No Intervention: No intervention

All appointments, scheduled and non-scheduled are by face-face communication with the health care professionals.

Patients will receive their usual treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of Time in Range (TiR)
Time Frame: 52 weeks
% of TiR (3.9 -10.0 mmol/L)
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of Glycaemic variability
Time Frame: 52 weeks
(%GCV)
52 weeks
Change from baseline of Haemoglobin 1Ac
Time Frame: 52 weeks
HbA1C %
52 weeks
Audit of Diabetes Dependent Quality of Life version 19
Time Frame: 0 and 52 weeks
Audit of Diabetes Dependent Quality of Life version 19 (ADDQoL 19) includes19 items each score from -9 to 3, with lower scores reflecting maximum negative impact.
0 and 52 weeks
Diabetes Treatment Satisfaction status
Time Frame: 0 and 52 weeks
Diabetes treatment questionnaire, status (DTSQs) includes 8 items, each score from 0 to 6 with a higher score indicating better outcome
0 and 52 weeks
Diabetes Treatment Satisfaction Questionaire change
Time Frame: 52 weeks
Diabetes treatment questionnaire, change (DTSQc) includes 8 items, each score from 3+ to -3 with a higher score indicating better outcome DTSQc
52 weeks
Change from baseline of time above target glucose range (TaR) level 1
Time Frame: 52 weeks
% TaR (10.1-13.9 mmol/L)
52 weeks
Change from baseline of time above target glucose range (TaR) level 2
Time Frame: 52 weeks
% TaR (>13.9 mmol/L)
52 weeks
Change from baseline of time spent below target glucose range (TbR ) level 1
Time Frame: 52 weeks
%TbR (3.0-3.8 mmol/L)
52 weeks
Change from baseline of time spent below target glucose range (TbR) level 2
Time Frame: 52 weeks
% TbR (<3.0 mmol/L)
52 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Quality of Life: EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time Frame: 0 and 52 weeks
EQ-5D-5L includes 5 domains each score from 1 to 5 with level 1 indicating no problem and level 5 indicating unable to/extreme problems.
0 and 52 weeks
Semi-structured interviews
Time Frame: 0 and 52 weeks
intervention group and Healthcare professionals
0 and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Investigators

  • Study Director: Frans Brandt Kristensen, MD, Ph.D., Department of Endocrinology, Hospital of Southern Jutland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 3, 2020

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHS-MS-09-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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