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Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics

NCT06469593 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-06-21

No results posted yet for this 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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Automated insuling delivery system

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

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Steno Diabetes Center Copenhagen

    lead OTHER

Principal Investigators

  • Kirsten Nørgaard, MD, Prof. · Steno Diabetes Center Copenhagen

  • Kurt Kristensen, MD, PhD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2025-12-31
Completion
2027-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06469593 on ClinicalTrials.gov