Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics

NCT ID: NCT06469593

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-15
• Study Completion Date: 2027-12-31

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adults with type 1 diabetes (intervention)

Group Type: EXPERIMENTAL

Automated insuling delivery system

Intervention Type: DEVICE

Closed-loop insulin pumps including MiniMed 780G, Tandom T2-slim x2 and YpsoCamAPS

Adults with type 1 diabetes (control)

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Automated insuling delivery system

Intervention Type: DEVICE

Closed-loop insulin pumps including MiniMed 780G, Tandom T2-slim x2 and YpsoCamAPS

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Automated insuling delivery system

Closed-loop insulin pumps including MiniMed 780G, Tandom T2-slim x2 and YpsoCamAPS

Intervention Type: DEVICE

Other Intervention Names

Closed-loop insulin pumps

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Kirsten Nørgaard

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kirsten Nørgaard, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Copenhagen

Kurt Kristensen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Steno Diabetes Center Copenhagen

Herlev, Greater Copenhagen, Denmark

Site Status: RECRUITING

Steno Diabetes Center Aarhus

Aarhus, , Denmark

Site Status: RECRUITING

Diagnostisk Center, Regionshospitalet Silkeborg

Silkeborg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Michael Z Sørensen, MD

Role: CONTACT

michael.zaucha.soerensen.02@regionh.dk

26836584 ext. +45

Natalie V Olesen, MD

Role: CONTACT

nataol@rm.dk

31627437 ext. +45

Facility Contacts

Kirsten Nørgaard

Role: primary

Kurt Kristensen

Role: primary

Klavs W Hansen

Role: primary

Other Identifiers

H-23074743

Identifier Type: -

Identifier Source: org_study_id