RecruitingNot ApplicableNCT06728059

Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm


Sponsor

Sue Brown

Enrollment

16 participants

Start Date

Feb 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A randomized crossover trial assessing glycemic control using Reinforcement Learning trained Bolus Priming System (BPS\_RL) added to the the Automated Insulin Delivery as Adaptive NETwork (AIDANET algorithm) compared to the original AIDANET algorithm.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new machine-learning feature that can be added to an existing automated insulin delivery (AID) system to improve mealtime insulin dosing for people with type 1 diabetes. The goal is to make blood sugar control around meals safer and more effective. **You may be eligible if...** - You are 18 or older with type 1 diabetes for at least one year - You have used an automated insulin delivery system with a Dexcom G6 or G7 continuous glucose monitor (CGM) in the past 3 months - You have been using insulin for at least 6 months - You have someone nearby who knows how to handle a low blood sugar emergency - You are not pregnant or breastfeeding - You speak and read English - You have internet access at home and are willing to upload data as needed **You may NOT be eligible if...** - You are planning to start a new non-insulin glucose-lowering medication - You currently use an SGLT-2 inhibitor (like empagliflozin or dapagliflozin) - You have had a seizure or lost consciousness from low blood sugar in the past 12 months - You have had a diabetic ketoacidosis episode in the past 12 months - You have advanced kidney disease or are on dialysis - You are being treated for a seizure disorder or adrenal insufficiency - You are currently in another interventional trial 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 Insulin Delivery Adaptive NETwork (AIDANET)

Group A participants will use the AIDANET system at home for 7 days/6 nights. They will continue use of AIDANET system for 18 hours during the hotel session and then use AIDANET+BPS\_RL for 18 hours during the hotel session.

DEVICEAIDANET+ BPS_RL→AIDANET

Group B participant will use the AIDANET+BPS\_RL system for 18 hours during the hotel session and will then use AIDANET system for 18 hours during the hotel session. They will continue to use AIDANET+BPS\_RL system at home for 7 days/6 night and then use the AIDANET system at home for 7 days/6 nights.


Locations(1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

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NCT06728059


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