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New insulin timing trick may tame blood sugar after pizza and burgers

NCT ID NCT05454891

Disease control Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether giving insulin as an extended bolus (over time) instead of all at once helps control blood sugar after high-fat, high-protein meals in teens with type 1 diabetes. Thirty teens using a closed-loop insulin pump ate a standardized breakfast and received either an extended or standard bolus on different mornings. The goal was to see if the extended bolus reduces prolonged high blood sugar or early low blood sugar.

What this could mean

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

Active substance
insulin (extended bolus via Tandem t:slim X2 insulin pump)
What this could lead to
If it works, this could give people with type 1 diabetes a better way to manage blood sugar after rich meals, reducing highs and lows.
What could go wrong
This is a small, early study in 30 teens, so results may not apply to everyone. The benefit may be small or not work for all meal types.

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

30 people

The number who actually took part.

Started

Jul 2022

Finished

Dec 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

13 to 19 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 * Age between 13 and 19 years old, A1C \> 6% at screening * Diagnosed with type 1 diabetes for at least one year * Total daily dose (TDD) of insulin ≥ 0.3 units/kg/day * Currently using the Control IQ closed-loop system * Willing to abide by meal recommendations and study procedures * Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF * Use an Android or Apple smartphone * Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial * Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff * Parent/guardian proficient in reading and writing English * Live in the United States, with no plans to move outside the United States during the study period Exclusion Criteria * A1C \>10% * One or more episodes of severe hypoglycemia or DKA requiring ER visit or hospitalization within the past three months * Used non-insulin anti-diabetic medication within the last 30 days other than metformin * Known history of gastroparesis, seizure disorder, adrenal insufficiency, or ongoing renal or hepatic disease * Pregnancy or lactation * Untreated or unstable hypothyroidism * Currently undergoing cancer treatment or systemic treatment with steroids * Untreated or inadequately treated mental illness * Current alcohol abuse * Current illness that would interfere with participation in the study * Delayed gastric emptying or any concurrent conditions that can be associated with delayed gastric emptying or altered digestion; and the use of any medication that affects gastric emptying * Celiac Disease

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 1 diabetes

Contacts and locations

Locations

  • University of California San Francisco

    San Francisco, California, 94158, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.