AIDANET Pediatrics

Mark D. DeBoer, MD, MSc., MCR

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: Device: Normal Glycemia Goal; Device: Tight Glycemia Goal

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07020936

302210

Details and patient eligibility

About

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).

Full description

This study aims to demonstrate the safety and feasibility of the Automated insulin delivery as Adaptive NETwork (AIDANET) system among children age 6-13 years. This includes use of new features allowing requested correction boluses and setting a tighter glycemia goal.

The proposed work is a safety and feasibility study of the FCL system and is not intended to be powered to fully demonstrate efficacy of the system. The sample size of up to 24 completed participants was selected based on previous experience of the feasible number of individuals to supervise at one time under similar study conditions.

Enrollment: 36 estimated patients

Sex: All

Ages: 6 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion 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.

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

Usual Care before experimental system; system with Normal Glycemia Goal

Other group

Description:

Participants will complete two weeks Usual Care Control Period before the use of the AIDANET system, with system employing Normal Glycemia Goal.

Treatment:

Device: Normal Glycemia Goal

Usual Care before experimental system; system with Tight Glycemia Goal

Other group

Description:

Participants will complete two weeks Usual Care Control Period before the use of the AIDANET system, with system employing Tight Glycemia Goal.

Treatment:

Device: Tight Glycemia Goal

Usual Care after experimental system; system with Normal Glycemia Goal

Other group

Description:

Participants will complete two weeks Usual Care Control Period after the use of the AIDANET system, with system employing Normal Glycemia Goal.

Treatment:

Device: Normal Glycemia Goal

Usual Care after experimental system; system with Tight Glycemia Goal

Other group

Description:

Participants will complete two weeks Usual Care Control Period after the use of the AIDANET system, with system employing Tight Glycemia Goal.

Treatment:

Device: Tight Glycemia Goal