Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics

NCT06469593 | Recruiting

• 1 other identifier: H-23074743
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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

Keywords

Closed-loop insulin pump; Automated insulin delivery; AID systems; Artificial pancreas; Type 1 Diabetes; T1D; Sleep; Cognition; Cardiovascular risk; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and week 18

Secondary Outcomes (23)

• Total sleep duration

  Baseline and week 18

• Time in sleep stages

  Baseline and week 18

• Time in sleep stages

  Baseline and week 18

• Sleep latency

  Baseline and week 18

• Waking after sleep onset

  Baseline and week 18

Other Outcomes (19)

• HbA1c

  Baseline and week 18

• Time with glucose values in range of 3.9 -10.0 mmol/L

  Baseline and week 18

• Time with glucose values < 3.9 mmol/l

  Baseline and week 18

Study Arms (4)

Adults with type 1 diabetes (intervention)

EXPERIMENTAL

Device: Automated insuling delivery system

Adults with type 1 diabetes (control)

NO INTERVENTION

Children with type 1 diabetes (intervention)

EXPERIMENTAL

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

Device: Automated insuling delivery system

Children with type 1 diabetes (control)

NO INTERVENTION

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

Interventions

Automated insuling delivery system DEVICE

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

Also known as: Closed-loop insulin pumps

Adults with type 1 diabetes (intervention); Children with type 1 diabetes (intervention)

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Aarhus University Hospital: collaborator

Study Sites (3)

Steno Diabetes Center Copenhagen

Herlev, Greater Copenhagen, 2730, Denmark

RECRUITING

Steno Diabetes Center Aarhus

Aarhus, 8200, Denmark

RECRUITING

Diagnostisk Center, Regionshospitalet Silkeborg

Silkeborg, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Inflammation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kirsten Nørgaard, MD, Prof.

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

• Kurt Kristensen, MD, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Z Sørensen, MD

CONTACT

26836584; michael.zaucha.soerensen.02@regionh.dk

Natalie V Olesen, MD

CONTACT

31627437; nataol@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, open-label study comparing type-1 diabetes patients receiving usual treatment, with patients transitioning to AID systems

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 21, 2024
• Study Start: June 15, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)