Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm (AIDANET+BPS_RL)

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Automated Insulin Delivery Adaptive NETwork (AIDANET); Device: AIDANET+ BPS_RL→AIDANET

Detailed Description

After receiving training on the study equipment, participants will use the AIDANET system at home for 7 days/6 nights to establish a baseline and initialize the control algorithm. Participants will then be studied at a hotel session for 3 days/2 nights. Participants will transition to home use of AIDANET+ BPS_RL for 7 days/6 nights.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Center for Diabetes Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AIDANET→AIDANET+ BPS_RL; Group A: AIDANET followed by AIDANET+ BPS_RL during the hotel session	Device: Automated 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.; Other Names: AIDANET→AIDANET+ BPS_RL
Active Comparator: AIDANET+ BPS_RL→AIDANET; Group B: AIDANET+BPS_RL followed by AIDANET during the hotel session	Device: AIDANET+ 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.; Other Names: Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM-measured Time in Range (TIR, 70-180 mg/dL) During the 18-hour Hotel Sessions.	CGM-measured time in range (TIR, 70-180 mg/dL) during the 18-hour hotel sessions on AIDANET or AIDANET+BPS_RL. The time periods begin at 6 PM and end at noon on the next day, thereby covering two meals - dinner and breakfast.	36 hours total (18 hours for Group A and 18 hours for Group B)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM-measured Time Below Range <70mg/dL During Hotel Session	CGM-measured Time below range <70mg/dL during the 18-hour hotel session on AIDANET or AIDANET+BPS_RL	18 hours
CGM-measured Time in Range (70-180 mg/dL) for At-home	CGM-measured Time in range (70-180 mg/dL) for at-home sessions using AIDANET	7 days
CGM-measured Time Below Range 70 mg/dL for At-home	CGM-measured Time below range 70 mg/dL for at-home sessions using AIDANET or AIDANET BPS-RL	1 week

Collaborators and Investigators

• Sponsor: Sue Brown
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); DexCom, Inc.
• Investigators: Principal Investigator: Sue Brown, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2025
• Primary Completion (Actual): May 7, 2025
• Study Completion (Actual): May 14, 2025

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Type 1 Diabetes; Continuous Glucose Monitor (CGM); Diabetes Assistant (DiAs); Bolus Priming System (BPS); Automated insulin delivery as Adaptive Network (AIDANET); Fully Closed-Loop; Remote Learning (RL)
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Physiological Effects of Drugs; Hypoglycemic Agents; Insulin
• Other Study ID Numbers: 301989; R01DK133148 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
• IPD Sharing Time Frame: Data will be made available after the publication of the manuscript.
• IPD Sharing Access Criteria: The Data Sharing Agreements will be formulated by the study team
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No