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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
All appointments, scheduled and non-scheduled are by telemedicine using video to commutate with the health care professionals. Patients will follow their usual treatment.
Sygehus Soenderjylland
Aabenraa, Denmark
Change from baseline of Time in Range (TiR)
% of TiR (3.9 -10.0 mmol/L)
Time frame: 52 weeks
Change from baseline of Glycaemic variability
(%GCV)
Time frame: 52 weeks
Change from baseline of Haemoglobin 1Ac
HbA1C %
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 52 weeks
Change from baseline of time above target glucose range (TaR) level 1
% TaR (10.1-13.9 mmol/L)
Time frame: 52 weeks
Change from baseline of time above target glucose range (TaR) level 2
% TaR (\>13.9 mmol/L)
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Time frame: 52 weeks
Change from baseline of time spent below target glucose range (TbR ) level 1
%TbR (3.0-3.8 mmol/L)
Time frame: 52 weeks
Change from baseline of time spent below target glucose range (TbR) level 2
% TbR (\<3.0 mmol/L)
Time frame: 52 weeks