AI boosts insulin timing for better diabetes control
NCT ID NCT06728059
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding a smart, AI-powered insulin boost before meals could improve blood sugar control in adults with type 1 diabetes. Nineteen participants used either a standard automated insulin system or the same system with the AI boost during hotel stays and at home. The goal was to see if the AI system helped keep blood sugar in a healthy range without increasing dangerous lows.
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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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19 people
The number who actually took part.
- Started
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Feb 2025
- Finished
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May 2025
- 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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18 years and older
- 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 ≥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. 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 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.
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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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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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