Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2025-07-21
2026-03-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Usual Care before experimental system; system with Normal Glycemia Goal
Participants will complete two weeks Usual Care Control Period before the use of the AIDANET system, with system employing Normal Glycemia Goal.
Normal Glycemia Goal
Participants will use the normal AIDANET system aggressivity adjustment to achieve target glucose for both the hotel and AIDANET at home periods.
Usual Care before experimental system; system with Tight Glycemia Goal
Participants will complete two weeks Usual Care Control Period before the use of the AIDANET system, with system employing Tight Glycemia Goal.
Tight Glycemia Goal
Participants will have the AIDANET system controller target set to have higher aggressivity adjustment to maintain target glucose for both the hotel and AIDANET at home periods.
Usual Care after experimental system; system with Normal Glycemia Goal
Participants will complete two weeks Usual Care Control Period after the use of the AIDANET system, with system employing Normal Glycemia Goal.
Normal Glycemia Goal
Participants will use the normal AIDANET system aggressivity adjustment to achieve target glucose for both the hotel and AIDANET at home periods.
Usual Care after experimental system; system with Tight Glycemia Goal
Participants will complete two weeks Usual Care Control Period after the use of the AIDANET system, with system employing Tight Glycemia Goal.
Tight Glycemia Goal
Participants will have the AIDANET system controller target set to have higher aggressivity adjustment to maintain target glucose for both the hotel and AIDANET at home periods.
Interventions
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Normal Glycemia Goal
Participants will use the normal AIDANET system aggressivity adjustment to achieve target glucose for both the hotel and AIDANET at home periods.
Tight Glycemia Goal
Participants will have the AIDANET system controller target set to have higher aggressivity adjustment to maintain target glucose for both the hotel and AIDANET at home periods.
Eligibility Criteria
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Inclusion Criteria
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
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.
6 Years
13 Years
ALL
No
Sponsors
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Tandem Diabetes Care, Inc.
INDUSTRY
DexCom, Inc.
INDUSTRY
Mark D. DeBoer, MD, MSc., MCR
OTHER
Responsible Party
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Mark D. DeBoer, MD, MSc., MCR
Principal Investigator
Principal Investigators
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Mark DeBoer, MD
Role: STUDY_CHAIR
University of Virginia Center for Diabetes Technology
Locations
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University of California San Francisco
San Francisco, California, United States
Barbara Davis Center, University of Colorado
Aurora, Colorado, United States
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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302210
Identifier Type: -
Identifier Source: org_study_id
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