Actively Recruiting
Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm
Led by Sue Brown · Updated on 2025-05-15
16
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
S
Sue Brown
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age ≥18.0 years old at time of consent
- Clinical diagnosis, based on investigator assessment, of Type 1 Diabetes for at least one year.
- Having used an AID system equipped with Dexcom G6 or G7 CGM within the last three months (does not need to be continuous use if CGM was unavailable for instance).
- Currently using insulin for at least six months.
- Willingness to switch to use a commercially approved personal insulin (e.g., lispro or aspart, or biosimilar approved products) within the study pump as directed by the study team.
- Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff that either lives with participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency.
- Participant not currently known to be pregnant or breastfeeding.
- If participant capable of becoming pregnant, must agree to use a form of contraception to prevent pregnancy while a participant in the study (e.g. hormonal contraception, abstinence from heterosexual intercourse). A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- Willingness to use the study AIDANET system (CGM, pump, and phone) during the study period.
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
- Willingness to participate in all study procedures including the house/hotel sessions.
- Access to internet at home and willingness to upload data during the study as needed.
- Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.
- Participant is proficient in reading and writing English.
You will not qualify if you...
- Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors, sulfonylureas). Participants may be on a stable dose of such an agent for at least the past month.
- Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic DKA.
- Hemophilia or any other bleeding disorder.
- History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.
- History of DKA event in the last 12 months.
- Stage 4 chronic renal disease or currently on peritoneal or hemodialysis.
- Currently being treated for adrenal insufficiency.
- Currently being treated for a seizure disorder.
- Hypothyroidism or hyperthyroidism that is not adequately treated.
- Use of oral or injectable steroids at the time of enrollment or within the last 4 weeks.
- Planned surgery during the study period.
- Known ongoing adhesive intolerance that is not well managed.
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
- Participation in another interventional trial at the time of enrollment.
- Participant with a direct supervisor involved in the conduct of the trial.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
S
Sara Prince, RN
CONTACT
C
Carlene Alix
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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