Brain-like software upgrade helps insulin pumps outsmart diabetes

NCT ID NCT05610111

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests a software upgrade for an automated insulin pump system (Control-IQ) in adults with type 1 diabetes. The upgrade adds an adaptive biobehavioral control module that learns from the user's patterns to improve blood sugar management. Participants use the standard system for a few weeks and then the upgraded version for 16 weeks, and researchers compare how much time blood sugar stays in the healthy range.

What this could mean

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

Active substance
Closed-loop insulin pump system with adaptive biobehavioral control software
What this could lead to
If successful, this software upgrade could help people with type 1 diabetes spend more time in their target blood sugar range and reduce dangerous highs and lows.
What could go wrong
This is a relatively small crossover trial testing a software modification, not a new drug or cure. The improvement may be modest, and results may not apply to all insulin pump users.

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

73 people

The number who actually took part.

Started

Jan 2023

Finished

Sep 2024

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 to 70 years

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 and ≤70 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 an insulin pump for at least six months 4. Currently using insulin for at least six months 5. Currently using the t:slim X2 insulin pump for at least two months 6. Currently using or anticipated to be using the t:slim X2 insulin pump with Control-IQ technology at randomization (Visit 3). 7. Using or willing to use insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections 8. Access to internet and willingness to upload data during the study as needed 9. Willing to use an app on a smart phone during the study. 10. For females, not currently known to be pregnant or breastfeeding 11. If female, sexually active, and of childbearing potential, must agree to use a form of contraception to prevent pregnancy while a participant in the study. 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. 12. Willingness to use only insulin analogs approved for use in the t:slim X2 pump such as lispro (Humalog) or as part (Novolog) and not use ultra-rapid acting insulin analogs (e.g., FiAsp) during the study 13. Total daily insulin dose (TDD) at least 10 units per day 14. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin (biguanides), GLP-1 receptor agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) 15. An understanding and willingness to follow the protocol and signed informed consent Exclusion Criteria: 1. Concurrent use of any non-insulin glucose-lowering agent other than metformin or GLP-1 receptor agonists following screening (including pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) 2. A condition, which in the opinion of the investigator or designee, would put the participant at risk or interfere with the completion of the protocol. 3. History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment 4. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment 5. Currently being treated for a seizure disorder 6. Hemophilia or any other bleeding disorder 7. Planned surgery during study duration 8. Participation in another pharmaceutical or device trial at the time of enrollment or during the study 9. Having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (e.g., study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical 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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