RecruitingNot ApplicableNCT06469593

Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics

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


Sponsor

Steno Diabetes Center Copenhagen

Enrollment

200 participants

Start Date

Jun 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 7 Years

Plain Language Summary

Simplified for easier understanding

This study is following people with type 1 diabetes who are starting an automated insulin delivery (AID) system — a device that automatically adjusts insulin levels based on continuous glucose monitoring. The study looks at health outcomes beyond just blood sugar numbers. **You may be eligible if...** - Adults: You are 18 or older with type 1 diabetes for at least 3 years and have used a continuous glucose monitor for at least 6 months - Children: You are 7-17 years old with type 1 diabetes for at least 6 months and have used a glucose monitor for at least 6 months - Your doctor has approved you to start an AID system **You may NOT be eligible if...** - You take medications other than insulin that affect blood sugar (including steroids) - You have already been using an automated insulin delivery system - You were using such a system within 30 days before enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAutomated insuling delivery system

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


Locations(3)

Steno Diabetes Center Copenhagen

Herlev, Greater Copenhagen, Denmark

Steno Diabetes Center Aarhus

Aarhus, Denmark

Diagnostisk Center, Regionshospitalet Silkeborg

Silkeborg, Denmark

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NCT06469593


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