About this trial
The goal of this clinical trial is to determine if transitioning to automated insulin delivery (AID) systems, can improve objectively measured sleep quality and quantity and alleviate cardiovascular risk factors in both children and adults diagnosed with type 1 diabetes. The main questions it aims to answer are:
* Does the intervention improve sleep efficiency as measured by the HomeSleepTest, EEG based device, 4 months after initiation? * Can the use of AID treatment alleviate cardiovascular risk measured by heart rate variability (HRV), blood pressure and inflammatory markers? * Researchers will compare AID systems to usual treatment, including both multiple daily injections and sensor augmented pumps to see if the above benefits can be achieved with AID in comparison. Participants will be randomized 1:1 to either start AID treatment or to continue their usual care. The study will be open label.
Participants will, at baseline and after 4 months:
* Have taken blood and urine samples to measure metabolic and inflammatory parameters * Perform digital cognitive testing using the CANTAB software * Fill out questionnaires related to quality of life, fear of hypoglycemia, hypoglycemia awareness, eating habits and sleep quality * Wear a blinded CGM for 10 days * Monitor sleep at home using the HomeSleepTest for 3 consecutive nights * Wear a Holter monitor for 24 hours to determine HRV parameters * Measure blood pressure for 24 hours at 30 min intervals * Wear an ActiGraph for 7 days to assess sleep and activity, supported by daily electronic sleep diaries
Participants randomized to AID treatment will receive education in the use of the systems.
Virtual follow-up visits are scheduled at week 1, 5 and 9 for both control and intervention groups during the study, following baseline examinations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Type 1 diabetes ≥3 years
CGM or intermittently scanned CGM (isCGM) use ≥6 months
Approval from the responsible health care provider (HCP) to start AID
Disqualifiers
Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
Use of commercial or open-source AID systems prior to study participation
Daily use of paracetamol (acetaminophen)
Breast-feeding, pregnancy or planning to become pregnant within 4 months
Trial design
Parallel
Treatments tested in this trial
Automated insuling delivery system
DeviceClosed-loop insulin pumps including MiniMed 780G, Tandom T2-slim x2 and YpsoCamAPS
Treatment groups
Trial outcomes
Primary outcomes
Difference in change from baseline to study end in sleep efficiency between the two groups.
Measured by HomeSleepTest for 3 consecutive days. Expressed in percentage.
Secondary outcomes
Total sleep duration
As measured by HomeSleepTest for 3 consequtive days. Expressed in minutes.
Time in sleep stages
As measured by HomeSleepTest for 3 consequtive days. Expressed in minutes.
Time in sleep stages
As measured by HomeSleepTest for 3 consequtive days. Expressed in percentages.
Sleep latency
As measured by HomeSleepTest and ActiGraph for 3 consequtive days.Expressed in minutes
Other outcomes
HbA1c
Time with glucose values in range of 3.9 -10.0 mmol/L
Measured in percentage.
Time with glucose values < 3.9 mmol/l
Measured in percentage.
Time with glucose values < 3.0 mmol/l
Measured in percentage.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Steno Diabetes Center Copenhagen
Lead sponsor
Aarhus University Hospital
Collaborator