AID-BEYOND: Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 7
Healthy Volunteers: f
View:

• 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

• Specific AID system chosen ahead of screening after participant has been thoroughly informed

• Age 7-17 years

• Type 1 diabetes ≥6 months

• CGM or isCGM use ≥6 months

• Approval from the responsible HCP to start AID

• Specific AID system chosen ahead of screening after participant has been thoroughly informed

Locations
Other Locations
Denmark
Steno Diabetes Center Aarhus
RECRUITING
Aarhus
Steno Diabetes Center Copenhagen
RECRUITING
Herlev
Diagnostisk Center, Regionshospitalet Silkeborg
RECRUITING
Silkeborg
Contact Information
Primary
Michael Z Sørensen, MD
michael.zaucha.soerensen.02@regionh.dk
26836584
Backup
Natalie V Olesen, MD
nataol@rm.dk
31627437
Time Frame
Start Date: 2024-06-15
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 200
Treatments
Experimental: Adults with type 1 diabetes (intervention)
No_intervention: Adults with type 1 diabetes (control)
Experimental: Children with type 1 diabetes (intervention)
Pediatric population of 7-17 years, stratified 1:1 to two groups of 7-11 and ≥12 years accordingly
No_intervention: Children with type 1 diabetes (control)
Pediatric population of 7-17 years, stratified 1:1 to two groups of 7-11 and ≥12 years accordingly
Related Therapeutic Areas
Sponsors
Leads: Steno Diabetes Center Copenhagen
Collaborators: Aarhus University Hospital

This content was sourced from clinicaltrials.gov

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