Smartphone system aims to simplify diabetes care for kids
NCT ID NCT07020936
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a smartphone-based system called AIDANET that works with an insulin pump and continuous glucose monitor to automatically adjust insulin for children aged 6-13 with type 1 diabetes. The goal is to see if the system is safe and works as well as usual care in keeping blood sugar levels in a healthy range. The study involves 42 children who will use the system at home for two weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 13 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Barbara Davis Center, University of Colorado
Aurora, Colorado, 80045, United States
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University of California San Francisco
San Francisco, California, 94158, United States
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University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903, United States
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Other studies related to the condition(s) this trial covers.
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