Effectiveness of Video Consultations in Type 1 Diabetes Patients Treated With Insulin Pumps in the Outpatient Clinic
Primary Purpose
Telemedicine, Insulin Dependent Diabetes Mellitus 1
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Intervention group video consultations
Sponsored by
About this trial
This is an interventional treatment trial for Telemedicine
Eligibility Criteria
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.
Sites / Locations
- Sygehus SoenderjyllandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group video consultations
No intervention
Arm Description
All appointments, scheduled and non-scheduled are by telemedicine using video to commutate with the health care professionals. Patients will follow their usual treatment.
All appointments, scheduled and non-scheduled are by face-face communication with the health care professionals. Patients will receive their usual treatment.
Outcomes
Primary Outcome Measures
Change from baseline of Time in Range (TiR)
% of TiR (3.9 -10.0 mmol/L)
Secondary Outcome Measures
Change from baseline of Glycaemic variability
(%GCV)
Change from baseline of Haemoglobin 1Ac
HbA1C %
Audit of Diabetes Dependent Quality of Life version 19
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.
Diabetes Treatment Satisfaction status
Diabetes treatment questionnaire, status (DTSQs) includes 8 items, each score from 0 to 6 with a higher score indicating better outcome
Diabetes Treatment Satisfaction Questionaire change
Diabetes treatment questionnaire, change (DTSQc) includes 8 items, each score from 3+ to -3 with a higher score indicating better outcome DTSQc
Change from baseline of time above target glucose range (TaR) level 1
% TaR (10.1-13.9 mmol/L)
Change from baseline of time above target glucose range (TaR) level 2
% TaR (>13.9 mmol/L)
Change from baseline of time spent below target glucose range (TbR ) level 1
%TbR (3.0-3.8 mmol/L)
Change from baseline of time spent below target glucose range (TbR) level 2
% TbR (<3.0 mmol/L)
Full Information
NCT ID
NCT04612933
First Posted
October 15, 2020
Last Updated
August 1, 2023
Sponsor
University of Southern Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04612933
Brief Title
Effectiveness of Video Consultations in Type 1 Diabetes Patients Treated With Insulin Pumps in the Outpatient Clinic
Official Title
Effectiveness of Video Consultations in Type 1 Diabetes Patients Treated With Insulin Pumps in the Outpatient Clinic
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Denmark
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telemedicine, Insulin Dependent Diabetes Mellitus 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group video consultations
Arm Type
Experimental
Arm Description
All appointments, scheduled and non-scheduled are by telemedicine using video to commutate with the health care professionals.
Patients will follow their usual treatment.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
All appointments, scheduled and non-scheduled are by face-face communication with the health care professionals.
Patients will receive their usual treatment.
Intervention Type
Other
Intervention Name(s)
Intervention group video consultations
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline of Time in Range (TiR)
Description
% of TiR (3.9 -10.0 mmol/L)
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Change from baseline of Glycaemic variability
Description
(%GCV)
Time Frame
52 weeks
Title
Change from baseline of Haemoglobin 1Ac
Description
HbA1C %
Time Frame
52 weeks
Title
Audit of Diabetes Dependent Quality of Life version 19
Description
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.
Time Frame
0 and 52 weeks
Title
Diabetes Treatment Satisfaction status
Description
Diabetes treatment questionnaire, status (DTSQs) includes 8 items, each score from 0 to 6 with a higher score indicating better outcome
Time Frame
0 and 52 weeks
Title
Diabetes Treatment Satisfaction Questionaire change
Description
Diabetes treatment questionnaire, change (DTSQc) includes 8 items, each score from 3+ to -3 with a higher score indicating better outcome DTSQc
Time Frame
52 weeks
Title
Change from baseline of time above target glucose range (TaR) level 1
Description
% TaR (10.1-13.9 mmol/L)
Time Frame
52 weeks
Title
Change from baseline of time above target glucose range (TaR) level 2
Description
% TaR (>13.9 mmol/L)
Time Frame
52 weeks
Title
Change from baseline of time spent below target glucose range (TbR ) level 1
Description
%TbR (3.0-3.8 mmol/L)
Time Frame
52 weeks
Title
Change from baseline of time spent below target glucose range (TbR) level 2
Description
% TbR (<3.0 mmol/L)
Time Frame
52 weeks
Other Pre-specified Outcome Measures:
Title
Changes in Quality of Life: EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Description
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.
Time Frame
0 and 52 weeks
Title
Semi-structured interviews
Description
intervention group and Healthcare professionals
Time Frame
0 and 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anders Ørsted Schultz, MD
Phone
+45 2614 6374
Email
anos@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Frans Brandt Kristensen, MD, Ph.D.
Phone
+ 4579973010
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frans Brandt Kristensen, MD, Ph.D.
Organizational Affiliation
Department of Endocrinology, Hospital of Southern Jutland
Official's Role
Study Director
Facility Information:
Facility Name
Sygehus Soenderjylland
City
Aabenraa
ZIP/Postal Code
6200
Country
Denmark
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Video Consultations in Type 1 Diabetes Patients Treated With Insulin Pumps in the Outpatient Clinic
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