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DIY insulin systems under the microscope: safe for exercise?

NCT ID NCT05626725

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how automated insulin delivery (AID) systems, including homemade DIY versions, perform in physically active adults with type 1 diabetes. Over six weeks, 76 participants wore their own AID systems and a fitness tracker while sharing glucose and insulin data. The goal was to see if these systems keep blood sugar stable during and after exercise, reducing the risk of dangerous lows.

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 (device)
What this could lead to
If successful, this study could show that DIY automated insulin systems are safe and effective for active adults, potentially expanding access to this technology.
What could go wrong
This is a small observational study with only 76 participants, so results may not apply to everyone. DIY systems are not regulated, and the study does not test a new treatment.

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.

Participants

76 people

The number who actually took part.

Started

Dec 2022

Finished

Aug 2025

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.

Who is studied

Type 1 diabetes using an AID system; Physically active

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: 1. Males and females aged ≥ 18 years old. 2. Clinical diagnosis of type 1 diabetes or latent autoimmune diabetes in adults (LADA) for at least one year. (The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.) 3. Using automated insulin delivery systems (Commercial or DIY) for at least 3 months. 4. Willing to share CGM data and insulin pump data with the research team. This access will be limited to the study period. 5. Exercising at least twice weekly (Questionnaire assessment MAQ) or willing to exercise at least twice weekly during the study period. 6. Willing to share physical activity tracker data with the research team and if applicable, data about the menstrual cycle. Exclusion Criteria: 1. Do not understand French or English 2. Anticipated therapeutic change (including change of insulin type \[switching to biosimilar is acceptable\] and/or type of CGM sensor) between admission and end of the study. 3. Anticipated need to use acetaminophen (dose above 1g every 6 hours) or vitamin C (dose above 500mg DIE) between admission and end of the study. 4. Pregnancy (ongoing or current attempt to become pregnant). 5. Breastfeeding. 6. Uncontrolled thyroid disease (recent less than 5 months TSH should be in target range and treatment stable for at least 6 weeks). 7. Severe hypoglycemic episode within two weeks of screening. 8. Severe hyperglycemic episodes requiring hospitalization in the last 3 months 9. Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®). 10. Current use of adjunct therapy such as SGLT-2 inhibitors or GLP\_1 receptor analog unless at a stable dose for at least 3 months, without anticipated change during the study and appropriate ketone testing is performed in case of off-label SGLT2 usage. 11. Anticipated radiologic examination incompatible with CGM wear for more than 10 days between admission and end of the study (e.g., repeated MRI). 12. Physically inactive participants (see inclusion criteria #5). 13. People with professional activities involving night shifts, as it may influence glycemic profiles differently compared to people working days and sleeping nights. 14. In the opinion of the investigator, a participant who is unable or unwilling to complete the study (e.g., recent injury, foot wound, etc.).

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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

  • Institut de Recherches Cliniques de Montréal (IRCM)

    Montreal, Quebec, H2W 1R7, Canada

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