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

Steno Diabetes Centers

Status: Enrolling

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: Automated insuling delivery system

Study type: Interventional

Funder types: Other

Identifiers

NCT06469593

H-23074743

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Adults):

• 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

Inclusion Criteria (Children):

• 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

Exclusion Criteria:

• 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
• Alcohol or drug abuse
• Severe cardiac disease
• Retinopathy contraindicating HbA1c <53 mmol/mol
• Other concomitant medical or psychological condition that, according to the investigator's assessment, makes the person unsuitable for study participation
• Lack of compliance with key study procedures at the discretion of the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Adults with type 1 diabetes (intervention)

Experimental group

Treatment:

Device: Automated insuling delivery system

Adults with type 1 diabetes (control)

No Intervention group

Children with type 1 diabetes (intervention)

Experimental group

Description:

Pediatric population of 7-17 years, stratified 1:1 to two groups of 7-11 and ≥12 years accordingly

Treatment:

Device: Automated insuling delivery system

Children with type 1 diabetes (control)

No Intervention group

Description:

Pediatric population of 7-17 years, stratified 1:1 to two groups of 7-11 and ≥12 years accordingly