RECRUITING

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

Conditions

Type 1 Diabetes Automated insulin delivery as Adaptive Network (AIDANET)Diabetes Assistant (DiAs)Fully Closed-Loop Bolus Priming System (BPS)Remote Learning (RL)Continuous Glucose Monitor (CGM)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-01

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06728059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Carlene Alix

CONTACT

434-249-8961

uax8yx@uvahealth.org

Emma Emory, RN

CONTACT

434-327-0725

ee9m@uvahealth.org

Principal Investigator

Sue Brown, MD

PRINCIPAL_INVESTIGATOR

University of Virginia

Study Locations (Sites)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: Sue Brown

Sue Brown, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-01

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-02-01

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Type 1 Diabetes
Automated insulin delivery as Adaptive Network (AIDANET)
Diabetes Assistant (DiAs)
Fully Closed-Loop
Bolus Priming System (BPS)
Remote Learning (RL)
Continuous Glucose Monitor (CGM)

Additional Relevant MeSH Terms

Type 1 Diabetes