RECRUITING

AIDANET Pediatrics

Conditions

Type 1 Diabetes Adaptive NETwork (AIDANET) system Fully Closed Loop (FCL)Specifically modified Mobi system

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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

AIDANET algorithm with smart-phone based control system (study smart phone), specifically modified Tandem insulin system (study insulin pump), and Dexcom G6 CGM (study CGM).

Official Title

Safety and Feasibility Testing of AIDANET in Children Age 6-13 Years

Quick Facts

Study Start:2025-07-21

Study Completion:2026-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07020936

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:6 Years to 13 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Age ≥6.0 and ≤13 years old at time of consent 2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year 3. Currently using insulin pump for at least three months; Any pump, either open loop or hybrid closed loop may be used. 4. Currently using insulin for at least six months. 5. Willingness to use lispro/aspart in the insulin pump during the study. 6. Currently using a Dexcom G6 or G7 CGM. 7. Has one or more parent/guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff that live with participant. 8. Participant not currently known to be pregnant or breastfeeding. 9. 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. 10. Willingness to use the study FCL system (CGM, pump, and phone) during the relevant study period. 11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial. 12. Willingness to participate in all study procedures including the house/hotel session and to consume approximately 3 unannounced meals per day during the relevant portion of the supervised hotel session. 13. Access to internet at-home and willingness to upload data during the study as needed. 14. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol. 15. 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 Diabetic ketoacidosis (DKA). 3. Hemophilia or any other bleeding disorder. 4. History of severe hypoglycemic events with seizure or loss of consciousness in the last 6 months. 5. History of diabetic ketoacidosis (DKA) event in the last 6 months. 6. History of chronic renal disease (Stage 4 or unstable Stage 3b per investigator judgment) or currently on peritoneal or hemodialysis. 7. History of adrenal insufficiency. 8. Currently being treated for a seizure disorder. 9. Hypothyroidism or hyperthyroidism that is not adequately treated. 10. Coronary artery disease or other heart condition that would prevent participation in moderate intensity exercise. 11. Use of oral or injectable steroids at the time of enrollment or within the last 4 weeks. 12. Planned surgery during the study period. 13. Known ongoing adhesive intolerance that is not well managed. 14. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. 15. Participation in another interventional trial at the time of enrollment. 16. Participant with a direct supervisor involved in the conduct of the trial.

Inclusion Criteria

Exclusion Criteria

1. Age ≥6.0 and ≤13 years old at time of consent
2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
3. Currently using insulin pump for at least three months; Any pump, either open loop or hybrid closed loop may be used.
4. Currently using insulin for at least six months.
5. Willingness to use lispro/aspart in the insulin pump during the study.
6. Currently using a Dexcom G6 or G7 CGM.
7. Has one or more parent/guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff that live with participant.
8. Participant not currently known to be pregnant or breastfeeding.
9. 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.
10. Willingness to use the study FCL system (CGM, pump, and phone) during the relevant study period.
11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
12. Willingness to participate in all study procedures including the house/hotel session and to consume approximately 3 unannounced meals per day during the relevant portion of the supervised hotel session.
13. Access to internet at-home and willingness to upload data during the study as needed.
14. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.
15. 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 Diabetic ketoacidosis (DKA).
3. Hemophilia or any other bleeding disorder.
4. History of severe hypoglycemic events with seizure or loss of consciousness in the last 6 months.
5. History of diabetic ketoacidosis (DKA) event in the last 6 months.
6. History of chronic renal disease (Stage 4 or unstable Stage 3b per investigator judgment) or currently on peritoneal or hemodialysis.
7. History of adrenal insufficiency.
8. Currently being treated for a seizure disorder.
9. Hypothyroidism or hyperthyroidism that is not adequately treated.
10. Coronary artery disease or other heart condition that would prevent participation in moderate intensity exercise.
11. Use of oral or injectable steroids at the time of enrollment or within the last 4 weeks.
12. Planned surgery during the study period.
13. Known ongoing adhesive intolerance that is not well managed.
14. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
15. Participation in another interventional trial at the time of enrollment.
16. Participant with a direct supervisor involved in the conduct of the trial.

Contacts and Locations

Study Contact

Lianna Smith

CONTACT

(434) 284-0893

lhs7px@uvahealth.org

Sara Prince, RN

CONTACT

(434) 320-5599

sp4sa@uvahealth.org

Principal Investigator

Mark DeBoer, MD

STUDY_CHAIR

University of Virginia Center for Diabetes Technology

Study Locations (Sites)

University of California San Francisco

San Francisco, California, 94158

United States

Barbara Davis Center, University of Colorado

Aurora, Colorado, 80045

United States

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: Mark D. DeBoer, MD, MSc., MCR

Mark DeBoer, MD, STUDY_CHAIR, University of Virginia Center for Diabetes Technology

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 Date2025-07-21

Study Completion Date2026-01-31

Study Record Updates

Study Start Date2025-07-21

Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

Adaptive NETwork (AIDANET) system
Fully Closed Loop (FCL)
Specifically modified Mobi system

Additional Relevant MeSH Terms

Type 1 Diabetes