Using machine learning to improve insulin delivery for Type 1 Diabetes

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

This study is testing if a new machine-learning system can improve insulin delivery and blood sugar control for people with Type 1 Diabetes compared to the current method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Virginia (Academic / other)
• Locations: 1 site (Charlottesville, Virginia)
• Trial ID: NCT06728059 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and feasibility of a machine-learning-based bolus priming system (BPS_RL) integrated with an existing automated insulin delivery algorithm (AIDANET) for individuals with Type 1 Diabetes. Participants will first establish a baseline using the AIDANET system at home before transitioning to a controlled hotel environment for further assessment. The goal is to determine if the addition of the BPS_RL can enhance glycemic control compared to the standard AIDANET algorithm. The study involves a randomized crossover design, allowing participants to experience both treatment conditions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of Type 1 Diabetes for at least one year who have experience using an automated insulin delivery system.

Not a fit: Patients who are not currently using insulin or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved glycemic control and better management of Type 1 Diabetes for patients.

How similar studies have performed: Other studies have shown promise in using machine learning for insulin delivery, but this specific approach is novel.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18.0 years old at time of consent
2. Clinical diagnosis, based on investigator assessment, of Type 1 Diabetes for at least one year.
3. 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).
4. Currently using insulin for at least six months.
5. 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.
6. 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.
7. Participant not currently known to be pregnant or breastfeeding.
8. 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.
9. Willingness to use the study AIDANET system (CGM, pump, and phone) during the study period.
10. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
11. Willingness to participate in all study procedures including the house/hotel sessions.
12. Access to internet at home and willingness to upload data during the study as needed.
13. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.
14. Participant is proficient in reading and writing English.

Exclusion Criteria:

1. 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.
2. Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic DKA.
3. Hemophilia or any other bleeding disorder.
4. History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.
5. History of DKA event in the last 12 months.
6. Stage 4 chronic renal disease or currently on peritoneal or hemodialysis.
7. Currently being treated for adrenal insufficiency.
8. Currently being treated for a seizure disorder.
9. Hypothyroidism or hyperthyroidism that is not adequately treated.
10. Use of oral or injectable steroids at the time of enrollment or within the last 4 weeks.
11. Planned surgery during the study period.
12. Known ongoing adhesive intolerance that is not well managed.
13. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
14. Participation in another interventional trial at the time of enrollment.
15. Participant with a direct supervisor involved in the conduct of the trial.

Where this trial is running

Charlottesville, Virginia

• University of Virginia Center for Diabetes Technology — Charlottesville, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Sue Brown, MD — University of Virginia
• Study coordinator: Sara Prince, RN

Conditions Type 1 Diabetes; Automated insulin delivery as Adaptive Network; Diabetes Assistant; Fully Closed-Loop; Bolus Priming System; Remote Learning; Continuous Glucose Monitor