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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Telemedicine, Insulin Dependent Diabetes Mellitus 1

Intervention / Treatment
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* Other: Intervention group video consultations


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group video consultations<br>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<br>* All appointments, scheduled and non-scheduled are by telemedicine using video to commutate with the health care professionals. Patients will follow their usual treatment.<br>|
| No Intervention: No intervention<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Time in Range (TiR) | % 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 | (%GCV) | 52 weeks | 
| Change from baseline of Haemoglobin 1Ac | HbA1C % | 52 weeks | 
| 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. | 0 and 52 weeks | 
| 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 | 0 and 52 weeks | 
| 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 | 52 weeks | 
| Change from baseline of time above target glucose range (TaR) level 1 | % TaR (10.1-13.9 mmol/L) | 52 weeks | 
| Change from baseline of time above target glucose range (TaR) level 2 | % TaR (>13.9 mmol/L) | 52 weeks | 
| Change from baseline of time spent below target glucose range (TbR ) level 1 | %TbR (3.0-3.8 mmol/L) | 52 weeks | 
| Change from baseline of time spent below target glucose range (TbR) level 2 | % TbR (<3.0 mmol/L) | 52 weeks |