Brain-like software upgrade helps insulin pumps outsmart diabetes
NCT ID NCT05610111
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
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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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73 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Sep 2024
- 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 to 70 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 ≥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
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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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