Insulin Dependent Diabetes Mellitus 1, Telemedicine
Conditions
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.
Interventions
OTHERIntervention 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.
Sponsors
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of Time in Range (TiR) | 52 weeks | % of TiR (3.9 -10.0 mmol/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of time spent below target glucose range (TbR ) level 1 | 52 weeks | %TbR (3.0-3.8 mmol/L) |
| Change from baseline of time spent below target glucose range (TbR) level 2 | 52 weeks | % TbR (\<3.0 mmol/L) |
| Change from baseline of Glycaemic variability | 52 weeks | (%GCV) |
| 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. |
| 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) |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Quality of Life: EuroQol 5-Dimension 5-Level (EQ-5D-5L) | 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. |
| Semi-structured interviews | 0 and 52 weeks | intervention group and Healthcare professionals |
Countries
Denmark
Outcome results
None listed