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New AI-Powered insulin system could free people with diabetes from constant meal calculations

NCT ID NCT07039617

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 17, 2026 · Updated 3 times

Summary

This study tests AIDANET, an automated insulin delivery algorithm, in 40 adults with type 1 diabetes. Participants will use the system in three modes: fully automatic (no meal announcements), hybrid (with meal announcements), or a mix. The goal is to see which mode keeps blood sugar in a healthy range more consistently, potentially making diabetes management easier.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AIDANET automated insulin delivery algorithm (device-based intervention)
What this could lead to
If successful, this could improve blood sugar control for people with type 1 diabetes by reducing the need for manual meal boluses.
What could go wrong
This is a small, early-stage trial with only 40 participants, so results may not apply to everyone. The algorithm may not perform as well in real-world conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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 Food and Drug Administration (FDA) approved AID system within the last six months (can be intermittent use). 4. Currently using insulin for at least six months. 5. Willingness to switch to use an FDA-approved personal insulin for the study pump (e.g., lispro or aspart, or biosimilar FDA-approved products) 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 who 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 participants 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 wear a Dexcom CGM during each of the four study phases. 10. Willingness to use the study AIDANET system (CGM, pump, and phone) during the relevant study periods. 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 in person training. 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 verbal communication in English. Exclusion Criteria: 1. Plans to start a new non-insulin glucose-lowering agent (e.g. glucagon-like peptide-1 (GLP-1) receptor agonists, Symlin, (DPP-4 inhibitors, also known as dipeptidyl peptidase 4). Participants may be on a stable dose of such an agent for at least the past month. 2. Current use of sulfonylurea medications. 3. Current use of an Sodium-Glucose Cotransporter 2 (also known as a SGLT-2 or SGLT-1/2 inhibitor) due to risk of euglycemic diabetic ketoacidosis (DKA). 4. Hemophilia or any other bleeding disorder. 5. History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months. 6. History of DKA event in the last 12 months. 7. Currently on peritoneal or hemodialysis. 8. Currently being treated for adrenal insufficiency. 9. Currently being treated for a seizure disorder. 10. Hypothyroidism or hyperthyroidism is not adequately treated. 11. Use of oral or injectable steroids at the time of enrollment. 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 at work/school who is 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

  • University of Virginia Center for Diabetes Technology

    Charlottesville, Virginia, 22903, United States

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