Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics

NCT06469593 · tracked via the Priya Life Science Denmark tracker

Sponsor

Steno Diabetes Center Copenhagen

Phase

Not applicable

Started

2024-06-15

Last updated

2024-06-21

Condition(s) studied

Diabetes Mellitus, Type 1

Investigational drug(s) / intervention(s)

Automated insuling delivery system

Automated insuling delivery system: Closed-loop insulin pumps including MiniMed 780G, Tandom T2-slim x2 and YpsoCamAPS

Study 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

Sex

ALL

Min age

7 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Difference in change from baseline to study end in sleep efficiency between the two groups. — Baseline and week 18
Measured by HomeSleepTest for 3 consecutive days. Expressed in percentage.

Trial sites (3)

Facility	City	Region	Status
Steno Diabetes Center Copenhagen	Herlev	Greater Copenhagen	Recruiting
Steno Diabetes Center Aarhus	Aarhus	Denmark	Recruiting
Diagnostisk Center, Regionshospitalet Silkeborg	Silkeborg	Denmark	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06469593 on ClinicalTrials.gov ↗ ← All trials in Denmark