Can Open-Source insulin systems match commercial ones without meal announcements?
NCT ID NCT07758647
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 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: * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Type 1 diabetes (T1D) are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Institut de Recherches Cliniques de Montréal
Montreal, Quebec, H2H 1Y8, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Home c-peptide tests could reveal hidden insulin production in diabetes
- Tiny vesicles could hold the key to better islet transplants
- Can a bedtime snack tame overnight blood sugar swings in kids with diabetes?
- A glucose Monitor's second chance: can it tame type 1 diabetes in High-Risk teens?
- AI takes the wheel: could a smart algorithm optimize insulin pumps from home?
- Could a metabolic modulator help people with type 1 diabetes use insulin better?