Effectiveness of Video Consultations in Type 1 Diabetes Patients Treated With Insulin Pumps in the Outpatient Clinic
- Conditions
- TelemedicineInsulin Dependent Diabetes Mellitus 1
- Registration Number
- NCT04612933
- Lead Sponsor
- University of Southern Denmark
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- Adult patients over 18 years of age
- Diagnosed with diabetes Type 1
- Patient has used insulin pump for at least 6 months
- No internet access
- Unable to adhere to protocol.
- Unable to speak or read Danish.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline of Time in Range (TiR) 52 weeks % of TiR (3.9 -10.0 mmol/L)
- Secondary Outcome Measures
Name Time Method Change from baseline of time spent below target glucose range (TbR) level 2 52 weeks % TbR (\<3.0 mmol/L)
Change from baseline of Haemoglobin 1Ac 52 weeks HbA1C %
Audit of Diabetes Dependent Quality of Life version 19 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.
Diabetes Treatment Satisfaction status 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
Change from baseline of time spent below target glucose range (TbR ) level 1 52 weeks %TbR (3.0-3.8 mmol/L)
Diabetes Treatment Satisfaction Questionaire change 52 weeks 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 Glycaemic variability 52 weeks (%GCV)
Change from baseline of time above target glucose range (TaR) level 1 52 weeks % TaR (10.1-13.9 mmol/L)
Change from baseline of time above target glucose range (TaR) level 2 52 weeks % TaR (\>13.9 mmol/L)
Trial Locations
- Locations (1)
Sygehus Soenderjylland
🇩🇰Aabenraa, Denmark
Sygehus Soenderjylland🇩🇰Aabenraa, Denmark