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Completed

NCT Number: NCT04612933

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

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.

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Key information

Conditions

Telemedicine Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Insulin Dependent Diabetes Mellitus 1 Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sygehus Soenderjylland

Aabenraa, 6200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention group video consultations

Other

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

Patients will follow their usual treatment.

Primary outcomes

  1. Change from baseline of Time in Range (TiR)

    Time frame: 52 weeks

    % of TiR (3.9 -10.0 mmol/L)

Secondary outcomes

  1. Change from baseline of Glycaemic variability

    Time frame: 52 weeks

    (%GCV)

  2. Change from baseline of Haemoglobin 1Ac

    Time frame: 52 weeks

    HbA1C %

  3. 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.

  4. 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

  5. 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

  6. Change from baseline of time above target glucose range (TaR) level 1

    Time frame: 52 weeks

    % TaR (10.1-13.9 mmol/L)

  7. Change from baseline of time above target glucose range (TaR) level 2

    Time frame: 52 weeks

    % TaR (>13.9 mmol/L)

  8. Change from baseline of time spent below target glucose range (TbR ) level 1

    Time frame: 52 weeks

    %TbR (3.0-3.8 mmol/L)

  9. Change from baseline of time spent below target glucose range (TbR) level 2

    Time frame: 52 weeks

    % TbR (<3.0 mmol/L)

Other outcomes

  1. 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.

  2. Semi-structured interviews

    Time frame: 0 and 52 weeks

    intervention group and Healthcare professionals

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 3, 2020
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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