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Can Open-Source insulin systems match commercial ones without meal announcements?

NCT ID NCT07758647

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial tests whether open-source automated insulin delivery (AID) systems can control blood sugar as well as commercial systems in adults with type 1 diabetes, even when meals are not announced. Participants will use both types of systems for four weeks each, with a focus on glucose levels after unannounced meals. The goal is to see if open-source systems can reduce the burden of carbohydrate counting while maintaining good glucose control.

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 systems (open-source and commercial)
What this could lead to
If open-source systems match commercial ones, people with type 1 diabetes may have more flexible, less burdensome options for managing blood sugar without meal announcements.
What could go wrong
This is a small crossover trial, and results may not apply to everyone. Unannounced meals could lead to high blood sugar, and the study doesn't test long-term outcomes.

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 33 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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: * Males and females ≥ 18 years old currently residing in Canada or the United States of America (USA) * Having a clinical diagnosis of T1D for at least one year (based on the investigator's judgment; C peptide level and antibody determinations are not needed.) * Having been on OS-AID therapy for at least 2 weeks and using a Dexcom G6 or G7 CGM. * If using an ultra-rapid acting insulin, be willing to switch to a rapid-acting insulin, as the former are not recommended in the C-AID systems used in the study (due to the risk of cannula or pod blockage). * Accepting that personal pump setting parameters will be collected by the research team. This access will be limited to the study period. Exclusion Criteria: * Using regular insulin (Novolin ge Toronto or Humulin R) or U200 or U500 concentrated insulin (e.g. Humalog U200, Entuzity U500) * Participant-reported clinically significant nephropathy (eGFR \< 25 ml/min/1.73m2, planned or on dialysis), neuropathy (e.g., known uncontrolled gastroparesis) or retinopathy (e.g., proliferative retinopathy with ongoing active treatment such as laser photocoagulation or planned surgery) as judged by the investigator * Recent (\<3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery) * Anticipated therapeutic change (including change of CGM sensor \[other than Dexcom sensors\] or AID system type, new antidiabetic drug initiation) between admission and end of the study * % of time spent out of automated mode exceeding 10% in last month's trial start * Anticipated need to use hydroxyurea during the study period (as it can interfere with CGM readings) * Pregnancy (ongoing or current attempt to become pregnant) * Breastfeeding * Plan to go abroad in a foreign country during the study period * Severe hypoglycemic episode within one month of screening * Severe hyperglycemic episode (including DKA) requiring hospitalization in the last 3 months * Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®) * Current use of SGLT-2 inhibitors or GLP1 agonists or other antidiabetic agents (Metformin, DPP-4 inhibitors) unless at a stable dose for at least 3 months, without anticipated change during the study and appropriate ketone testing is performed (for iSGLT2 treatment). * Known or suspected allergies to study products (e.g., Dexcom adhesive) * Other serious medical illnesses likely to interfere with study participation or with the ability to complete the study by the judgment of the investigator * Anticipation of a significant change in exercise or diet regimen between admission and end of the study (i.e., starting or stopping an organized sport; planned significant diet change) * Anticipated radiologic examination at the time of study assessment incompatible with CGM wear (e.g., MRI) * In the opinion of the investigator, a participant who is unable or unwilling to observe the contraindications of the study device.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Institut de Recherches Cliniques de Montréal

    Montreal, Quebec, H2H 1Y8, Canada

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