Smart insulin system aims to tame Post-Meal blood sugar spikes

NCT ID NCT05528770

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a new feature for automated insulin delivery systems: a priming bolus that automatically delivers a small amount of insulin before a meal. The goal was to see if it helps keep blood sugar in a healthy range after eating. Fifteen adults with type 1 diabetes participated, comparing the system with and without the priming bolus feature.

What this could mean

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

Active substance
Automated insulin delivery system with Bolus Priming System (device)
What this could lead to
If successful, this could improve blood sugar control after meals for people with type 1 diabetes, making automated insulin systems safer and more effective.
What could go wrong
This was a small, early-stage study with only 15 participants. The results may not apply to everyone, and the system might not work 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

15 people

The number who actually took part.

Started

Oct 2022

Finished

Jan 2023

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 65 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 ≤65 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 for at least six months 4. Currently using insulin pump for at least three months 5. Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections 6. Current regular exercise (e.g. walk, bike, jog) and be able to participate in a high intensity interval training activity. 7. Access to internet and willingness to upload data during the study as needed 8. For females, not currently known to be pregnant or breastfeeding 9. If female and sexually active, 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. 10. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use 11. Willingness to use the UVa closed-loop system throughout study admission 12. Willingness to use personal lispro (Humalog) or aspart (Novolog) during the study admission. 13. 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, sulfonylureas and naturaceuticals) 14. Willingness to eat at least 1 g/kg of carbohydrate per day during the hotel admission 15. Willingness to reschedule if placed on oral steroids 16. An understanding and willingness to follow the protocol and signed informed consent 17. Willingness to follow COVID-19 protocols in place at the time of study. Exclusion Criteria: 1. History of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment 2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment 3. Pregnancy or intent to become pregnant during the trial 4. Currently being treated for a seizure disorder 5. Planned surgery during study duration. 6. Treatment with meglitinides/sulfonylureas at the time of hotel study. 7. Use of metformin/biguanides, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, or naturaceuticals with a change in dose in the past month. 8. Coronary artery disease or heart failure, unless written clearance is received from a cardiologist or personal health care provider allowing clearance for high-intensity interval training and documentation of a negative stress test within the year 9. History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted or previous ablation of arrhythmia without recurrence which may be permitted) 10. Clinically significant electrocardiogram (ECG) at time of Screening, as interpreted by the study medical physician. 11. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples: 1. Inpatient psychiatric treatment in the past 6 months 2. Presence of a known adrenal disorder 3. Abnormal liver function test results (Transaminase \>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function 4. Uncontrolled thyroid disease 5. Musculoskeletal or other condition that limits participation in exercise portion of study 12. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol. 13. Positive Covid-19 test result

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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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