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Type 1 DiabetesAIDE-1NCT05626725

Safety and Effectiveness of Automated Insulin Delivery (AID) Systems in Physically Active Adults With Type 1 Diabetes

An observational study of Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Despite recent medical and technological advances, optimal glycemic control (time in range; TIR) and prevention of hypoglycemia remain significant challenges for people living with type 1 diabetes (T1DM). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
Automated insulin delivery system
Type of treatment
Medical device
How many people
76 participants
Where
1 siteCanada
Study dates
1 Dec 2022to 31 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Type 1 diabetes using an AID system; Physically active

Who may be able to join

  • Males and females aged ≥ 18 years old.
  • 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.)
  • Using automated insulin delivery systems (Commercial or DIY) for at least 3 months.
  • Willing to share CGM data and insulin pump data with the research team. This access will be limited to the study period.
  • Exercising at least twice weekly (Questionnaire assessment MAQ) or willing to exercise at least twice weekly during the study period.
  • Willing to share physical activity tracker data with the research team and if applicable, data about the menstrual cycle.

Who cannot join

  • Do not understand French or English
  • 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.
  • 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.
  • Pregnancy (ongoing or current attempt to become pregnant).
  • Breastfeeding.
  • Uncontrolled thyroid disease (recent less than 5 months TSH should be in target range and treatment stable for at least 6 weeks).
Show all 14Show fewer
  • Severe hypoglycemic episode within two weeks of screening.
  • Severe hyperglycemic episodes 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 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.
  • Anticipated radiologic examination incompatible with CGM wear for more than 10 days between admission and end of the study (e.g., repeated MRI).
  • Physically inactive participants (see inclusion criteria #5).
  • People with professional activities involving night shifts, as it may influence glycemic profiles differently compared to people working days and sleeping nights.
  • In the opinion of the investigator, a participant who is unable or unwilling to complete the study (e.g., recent injury, foot wound, etc.).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Institut de Recherches Cliniques de Montréal (IRCM)

    Montreal, Quebec, H2W 1R7

Other trials in Canada

About this study

Official title: An Observational Study to Assess the Safety and Effectiveness of Automated Insulin Delivery (AID) Systems in Physically Active Adults With Type 1 Diabetes in Free-living Conditions (AIDE-1)

Despite recent medical and technological advances, optimal glycemic control (time in range; TIR) and prevention of hypoglycemia remain significant challenges for people living with type 1 diabetes (T1DM). Automated insulin delivery systems (AIDs) combine an insulin pump coupled via an algorithm with a continuous glucose monitor (CGM), allowing constant adjustment of insulin doses according to blood glucose levels. Despite the significant improvement in blood glucose parameters and quality of life with these systems, they are not available to everyone and more and more people with diabetes are resorting to home-made or do-it-yourself (DIY) systems to access this technology. DIY systems are not approved or regulated by Health Canada, despite the growing interest. There have been no studies looking at this type of system in active people living with DbT1, including the risk of exercise-induced hypoglycemia.

The primary objective of this study is to evaluate the safety and efficacy of IDA systems in physically active individuals living with type 1 diabetes.This is a real-life observational study in people with commercial IDA (control group) and IDA-DIY. This study includes only one inclusion visit (which may be virtual) and the observation period is 6 weeks.

Read more

Participants will be required to wear their own artificial pancreas system and give us access to blood glucose and insulin data at the end of the study. They will be required to wear a watch to record physical activity (FitBit). We will ask them to complete information about their diet at least twice a week for a whole day (Keenoa application).

Finally, participants will be asked to complete a physical activity diary to complete data (carbohydrates in prevention of activity, insulin suspension, hypoglycemia during or after exercise, etc.).

Conditions
Type 1 Diabetes
Being tested
Automated insulin delivery system
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Automated insulin delivery systemDevice

    This is an outpatient prospective observational study to evaluate the effect of DIY-AID use on maintaining glucose levels in physically active adult people living with T1D.

Study groups in NCT05626725
Study groupRoleWhat they receive
Observationnal cohortPatients with type 1 diabetes and using an AID system.
Receives: Device: Automated insulin delivery system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in blood glucose levels from start of exercise to nadir during or up to 30 min post exercise.

    nadir: the lowest point on a glucose curve

    Measured: 6 weeks

Secondary outcomes (10)

  1. Hypoglycemic events (n) 120-min before, during and 120-min after recorded structured PA sessions

    Number of hypoglycemic events

    Measured: 6 weeks

  2. Hypoglycemic events (n) during (at least 15-min) of habitual PA and 30-min after

    Number of hypoglycemic events

    Measured: 6 weeks

  3. Time in range 120-min before, during and 120-min after recorded structured PA sessions

    Time (min and percentage) with glucose levels a. between 3.9 and 10.0 mmol/L; b. below 3.9 mmol/L; c. below 3.0 mmol/L; d. above 10.0 mmol/L

    Measured: 6 weeks

  4. Time in range during (at least 15-min) of habitual PA and 30-min after

    Time (min and percentage) with glucose levels a. between 3.9 and 10.0 mmol/L; b. below 3.9 mmol/L; c. below 3.0 mmol/L; d. above 10.0 mmol/L

    Measured: 6 weeks

  5. CHO intake 120-min before, during and 120-min after recorded structured PA sessions

    Carbohydrate intake (g), timing and purpose of CHO intake prior to, during and within 30-min following PA.mmol/L; b. below 3.9 mmol/L; c. below 3.0 mmol/L; d. above 10.0 mmol/L

    Measured: 6 weeks

  6. CHO intake during (at least 15-min) of habitual PA and 30-min after

    Carbohydrate intake (g), timing and purpose of CHO intake prior to, during and within 30-min following PA.mmol/L; b. below 3.9 mmol/L; c. below 3.0 mmol/L; d. above 10.0 mmol/L

    Measured: 6 weeks

  7. Glucose variability 120-min before, during and 120-min after recorded structured PA sessions

    Glucose variability: Standard deviation (SD) and coefficient of variance (CV) of glucose levels

    Measured: 6 weeks

  8. Glucose variability during (at least 15-min) of habitual PA and 30-min after

    Glucose variability: Standard deviation (SD) and coefficient of variance (CV) of glucose levels

    Measured: 6 weeks

  9. Total insulin delivery 120-min before, during and 120-min after recorded structured PA sessions

    Insulin delivery

    Measured: 6 weeks

  10. Total insulin delivery during (at least 15-min) of habitual PA and 30-min after

    Insulin delivery

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2022
  2. Study start1 Dec 2022
  3. Primary completion31 Jul 2025
  4. Study completion31 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05626725
Sponsor's protocol ID
2023-1190
Acronym
AIDE-1
Status last verified
Mar 2026
First submitted
9 Sep 2022
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in blood glucose levels from start of exercise to nadir during or up to 30 min post exercise. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05626725.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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