Type 1 DiabetesGUARDIANCT05821322
Blood Glucose Target Before and During Exercise in Adults With Type 1 Diabetes Using an Artificial Pancreas
A study testing Physical activity trial intervention in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial summary
Despite major technological advances in type 1 diabetes (artificial pancreas), the management of hypoglycemia remains a major challenge, especially during and after physical activity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Physical activity trial intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2023to 30 Apr 2025
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged between 18 and 65 years old.
- Clinical diagnosis of type 1 diabetes for 1 year. (Note: The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
- Treatment using DIY-AID system for 3 months.
- Own a smartphone or tablet to use the mobile application: Keenoa, Fitbit App
- Using Dexcom G6 and willing to share CGM data with the research team.
- Using rapid- (e.g., Aspart, Lispro or Glulisine) or ultra-rapid (e.g., FiAsp) acting insulin analogs.
- HbA1c < 8.5%.
Who cannot join
- Major complication within the previous 3 months (e.g., severe hypoglycemia requiring assistance, diabetic ketoacidosis, or cardiovascular event).
- Restriction in PA due to significant diabetes complications (e.g., severe peripheral neuropathy, active proliferative retinopathy, etc.) or other type of limitations (e.g., orthopedic, severe arthritis, etc.). Uncontrolled hypertension (e.g., blood pressure > 150 mmHg systolic or > 95 mmHg diastolic).
- Ongoing pregnancy or breastfeeding.
- Inability to give consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W1R7
About this study
Official title: Evaluating the Appropriate Blood Glucose Target Before and During Moderate Intensity Aerobic Exercise in Adults With Type 1 Diabetes Using Do-it-yourself Automated Insulin Delivery (AID) Systems (the GUARDIA [GlUcose tARget DIY-AID] Trial)"
Despite major technological advances in type 1 diabetes (artificial pancreas), the management of hypoglycemia remains a major challenge, especially during and after physical activity. The primary outcome is to determine the temporary blood glucose (BG) target to be set 60 minutes before aerobic exercise in people with type 1 diabetes (PWT1D) using do-it-yourself automated insulin delivery (DIY-AID) systems. Three glycemic thresholds to be applied 60 minutes before physical activity will be tested in 32 people on AID-DIY: 8.3 (current target for commercial AID systems), 8.8, and 9.3 mmol/L. Each participant will perform 3 sessions of moderate aerobic physical activity (ergocycle) at 60% of vo2peak with a different glycemic target each time (random order). Plasma glucose will be measured every 20 minutes before and during physical activity, and blood glucose measured by continuous glucose reading (DEXCOM) for 24 hours post-intervention. Once the best glycemic target is selected, participants could come to the research center for 1 or 2 more voluntary interventions to test the threshold during 1) fasting exercise and 2) late luteal phase of the menstrual cycle.
Read the detailed description
This study follows a randomized, cross-over design and aims to test tree temporary BG targets (8.3, 8.8 and 9.3 mmol/L), resulting in 3 intervention visits per participants. A total of 32 participants will be recruited and randomized for this study.
Intervention visit:
- Participants will be admitted at the research center (IRCM; Montréal or Alberta) at 15:30.
- A venous catheter will be installed for plasma glucose and insulin measurements.
- At 16:00, the temporary BG target will be set in the DIY-AID system and blood sampling will begin.
- At 16:40, if glucose is < 5.5 mmol/L, 16g carbohydrate (CHO; 4 Dex4®) will be provided.
- At 16:55, a smaller sample will be taken only to verify glucose level. If glucose is < 5.5 mmol/L, 16g CHO (4 Dex4®) will be provided and exercise start will be postponed by at least 15 minutes or until glucose level is > 5.5 mmol/L. If more than three CHO intake are needed, the test will be canceled and rescheduled.
- At 17:00, exercise will be started if glucose is > 5.5 mmol/L. The exercise will consist of 60 minutes on the ergocycle at 60% of pre-determined VO2peak (moderate intensity).
- At 18:00, exercise and temporary BG target will be stopped. Blood sampling will continue for 1-hr during recovery.
- At 19:00, participant will be discharged. If glucose level is below 5.0 mmol/L, a snack of 16g CHO (4 Dex4®) will be offered. Participants will have the option to bring their dinner and eat it at the research facility before leaving if they prefer.
- Conditions
- Type 1 Diabetes
- Being tested
- Physical activity trial intervention
- Keywords
- Artificial pancreas, Exercice, Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity trial interventionOther
60 minutes aerobic ergocyle exercice at 60% VO2 Peak
| Study group | Role | What they receive |
|---|---|---|
| Temporary target of 8.3 mmol/L | Active comparator | Current commercial artificial pancreas thresholds. Temporary target set 60 minutes before the intervention. Receives: Other: Physical activity trial intervention |
| Temporary target of 8.8 mmol/L | Experimental | Temporary target set 60 minutes before the intervention Receives: Other: Physical activity trial intervention |
| Temporary target of 9.3 mmol/L | Experimental | Temporary target set 60 minutes before the intervention Receives: Other: Physical activity trial intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma glucose during exercise
To determine the temporary blood glucose (BG) target to be set 60 minutes before aerobic exercise in PWT1D using DIY-AID systems which will be associated with the smallest change in glucose during exercise by testing the targets of 8.3 (current target for commercial AID systems), 8.8, and 9.3 mmol/L.
Measured: 60 minutes (during exercice)
Secondary outcomes (22)
Time in range during exercice: menstrual cycle phases
Volunteer participants will return in the luteal phase of the menstrual cycle to repeat the intervention at the glycemic threshold targeted during the primary outcome.
Measured: 60 minutes (during exercice)
Time in range (during fasting exercice)
The intervention will be repeated at the glycemic threshold targeted during the primary outcome
Measured: 60 minutes (during exercice)
Number of hypoglycemic episodes
number of hypoglycemic episodes (plasma glucose < 4.0 mmol/L) during exercise.
Measured: 60 minutes (during exercice)
Number of participants who required oral treatment during exercise
Number of participants who required oral treatment during exercise for: a) plasma glucose value < 4.5 mmol/L and b) plasma glucose value < 4.0 mmol/L.
Measured: 60 minutes (during exercice)
Lowest plasma glucose
Lowest plasma glucose level during exercise
Measured: 60 minutes (during exercice)
Plasma glucose at 60 minutes
plasma glucose level at the end of exercise
Measured: 60 minutes
Carbohydrate consumption (g)
amount of carbohydrate (CHO) needed to increase glucose value
Measured: 60 minutes (during exercice)
Insulin on board (units)
Insulin on board or active insulin at exercise onset (Units will be collected on insulin pump) from start to finish
Measured: 60 minutes (during exercice)
Plasma insulin
plasma insulin changes from exercise start to finish (uU/mL)
Measured: 60 minutes (during exercice)
Percent time in range, in hypoglycemia and in hyperglycemia
Percentage of time < 3.0 mmol/L, between 3.0-3.9 mmol/L, between 3.9-10.0 mmol/L, between 10.1-13.9 mmol/L, and > 13.9 mmol/L post-exercice until 6 am
Measured: 6 hours post-exercice
Percent time in range, in hypoglycemia and in hyperglycemia
Percentage of time < 3.0 mmol/L, between 3.0-3.9 mmol/L, between 3.9-10.0 mmol/L, between 10.1-13.9 mmol/L, and > 13.9 mmol/L post-exercice until 6 am
Measured: midnight to 6 am
Mean CGM glucose
post-exercice until 6 am
Measured: 24 hours post-exercice
Glucose variability
post-exercice until 6 am; assessed by the CGM standard deviation
Measured: midnight to 6 am
Coefficient of variation
post-exercice until 6 am; assessed by the coefficient of variation
Measured: midnight to 6 am
Coefficient of variation
post-exercice until 6 am; assessed by the coefficient of variation
Measured: 24 hours post-exercice
Glucose variability
post-exercice until 6 am; assessed by the CGM standard deviation
Measured: 24 hours post-exercice
Number of participants requiring an oral treatment for hypoglycemia
Number of participants requiring an oral treatment for hypoglycemia (< 3.9 mmol/L) until 6 am.
Measured: midnight to 6 am
Number of participants requiring an oral treatment for hypoglycemia
Number of participants requiring an oral treatment for hypoglycemia (< 3.9 mmol/L) until 6 am.
Measured: 24 hours post-exercice
Hypoglycemia with treatment
Total number of hypoglycemia episodes requiring treatment
Measured: 24 hours post-exercice
Hypoglycemia with treatment
Total number of hypoglycemia episodes requiring treatment
Measured: midnight to 6 am
Carbohydrate needed (g)
total amount of carbohydrate (CHO) needed to treat hypoglycemic events.
Measured: midnight to 6 am
Carbohydrate needed (g)
total amount of carbohydrate (CHO) needed to treat hypoglycemic events.
Measured: 24 hours post-exercice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Jul 2023
- Primary completion31 Mar 2025
- Study completion30 Apr 2025
Why it stopped: The protocol did not work.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
- Investigators
- Remi Rabasa-Lhoret, MD, PhD, Principal investigator, IRCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821322
- Sponsor's protocol ID
- 2023-1223
- Acronym
- GUARDIA
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Appropriate Blood Glucose Target Before and During Moderate Intensity Aerobic Exercise in Adults With Type 1 Diabetes Using Do-it-yourself Automated Insulin Delivery (AID) Systems (the GUARDIA [GlUcose tARget DIY-AID] Trial)"
- ClinicalTrials.gov ID
- NCT05821322
- Acronym / sponsor ID
- GUARDIA / 2023-1223
- Conditions
- Type 1 Diabetes
- Keywords
- Artificial pancreas, Exercice, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The protocol did not work.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Collaborators
- University of Alberta
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite major technological advances in type 1 diabetes (artificial pancreas), the management of hypoglycemia remains a major challenge, especially during and after physical activity. The primary outcome is to determine the temporary blood glucose (BG) target to be set 60 minutes before aerobic exercise in people with type 1 diabetes (PWT1D) using do-it-yourself automated insulin delivery (DIY-AID) systems. Three glycemic thresholds to be applied 60 minutes before physical activity will be tested in 32 people on AID-DIY: 8.3 (current target for commercial AID systems), 8.8, and 9.3 mmol/L. Each participant will perform 3 sessions of moderate aerobic physical activity (ergocycle) at 60% of vo2peak with a different glycemic target each time (random order). Plasma glucose will be measured every 20 minutes before and during physical activity, and blood glucose measured by continuous glucose reading (DEXCOM) for 24 hours post-intervention. Once the best glycemic target is selected, participants could come to the research center for 1 or 2 more voluntary interventions to test the threshold during 1) fasting exercise and 2) late luteal phase of the menstrual cycle.
Detailed description
This study follows a randomized, cross-over design and aims to test tree temporary BG targets (8.3, 8.8 and 9.3 mmol/L), resulting in 3 intervention visits per participants. A total of 32 participants will be recruited and randomized for this study.
Intervention visit:
- Participants will be admitted at the research center (IRCM; Montréal or Alberta) at 15:30.
- A venous catheter will be installed for plasma glucose and insulin measurements.
- At 16:00, the temporary BG target will be set in the DIY-AID system and blood sampling will begin.
- At 16:40, if glucose is < 5.5 mmol/L, 16g carbohydrate (CHO; 4 Dex4®) will be provided.
- At 16:55, a smaller sample will be taken only to verify glucose level. If glucose is < 5.5 mmol/L, 16g CHO (4 Dex4®) will be provided and exercise start will be postponed by at least 15 minutes or until glucose level is > 5.5 mmol/L. If more than three CHO intake are needed, the test will be canceled and rescheduled.
- At 17:00, exercise will be started if glucose is > 5.5 mmol/L. The exercise will consist of 60 minutes on the ergocycle at 60% of pre-determined VO2peak (moderate intensity).
- At 18:00, exercise and temporary BG target will be stopped. Blood sampling will continue for 1-hr during recovery.
- At 19:00, participant will be discharged. If glucose level is below 5.0 mmol/L, a snack of 16g CHO (4 Dex4®) will be offered. Participants will have the option to bring their dinner and eat it at the research facility before leaving if they prefer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Temporary target of 8.3 mmol/L | Active comparator | Other: Physical activity trial interventionCurrent commercial artificial pancreas thresholds. Temporary target set 60 minutes before the intervention. |
| Temporary target of 8.8 mmol/L | Experimental | Other: Physical activity trial interventionTemporary target set 60 minutes before the intervention |
| Temporary target of 9.3 mmol/L | Experimental | Other: Physical activity trial interventionTemporary target set 60 minutes before the intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females aged between 18 and 65 years old.
- Clinical diagnosis of type 1 diabetes for 1 year. (Note: The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
- Treatment using DIY-AID system for 3 months.
- Own a smartphone or tablet to use the mobile application: Keenoa, Fitbit App
- Using Dexcom G6 and willing to share CGM data with the research team.
Key exclusion criteria (4 listed)
- Major complication within the previous 3 months (e.g., severe hypoglycemia requiring assistance, diabetic ketoacidosis, or cardiovascular event).
- Restriction in PA due to significant diabetes complications (e.g., severe peripheral neuropathy, active proliferative retinopathy, etc.) or other type of limitations (e.g., orthopedic, severe arthritis, etc.). Uncontrolled hypertension (e.g., blood pressure > 150 mmHg systolic or > 95 mmHg diastolic).
- Ongoing pregnancy or breastfeeding.
- Inability to give consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity trial intervention60 minutes aerobic ergocyle exercice at 60% VO2 Peak | Other | Temporary target of 8.3 mmol/L, Temporary target of 8.8 mmol/L, Temporary target of 9.3 mmol/L |
Primary outcome
Change in plasma glucose during exercise
Time frame: 60 minutes (during exercice)
To determine the temporary blood glucose (BG) target to be set 60 minutes before aerobic exercise in PWT1D using DIY-AID systems which will be associated with the smallest change in glucose during exercise by testing the targets of 8.3 (current target for commercial AID systems), 8.8, and 9.3 mmol/L.
22 secondary outcomes
Time in range during exercice: menstrual cycle phases
Time frame: 60 minutes (during exercice)
Time in range (during fasting exercice)
Time frame: 60 minutes (during exercice)
Number of hypoglycemic episodes
Time frame: 60 minutes (during exercice)
Number of participants who required oral treatment during exercise
Time frame: 60 minutes (during exercice)
Lowest plasma glucose
Time frame: 60 minutes (during exercice)
Plasma glucose at 60 minutes
Time frame: 60 minutes
Carbohydrate consumption (g)
Time frame: 60 minutes (during exercice)
Insulin on board (units)
Time frame: 60 minutes (during exercice)
Plasma insulin
Time frame: 60 minutes (during exercice)
Percent time in range, in hypoglycemia and in hyperglycemia
Time frame: 6 hours post-exercice
Percent time in range, in hypoglycemia and in hyperglycemia
Time frame: midnight to 6 am
Mean CGM glucose
Time frame: 24 hours post-exercice
Glucose variability
Time frame: midnight to 6 am
Coefficient of variation
Time frame: midnight to 6 am
Coefficient of variation
Time frame: 24 hours post-exercice
Glucose variability
Time frame: 24 hours post-exercice
Number of participants requiring an oral treatment for hypoglycemia
Time frame: midnight to 6 am
Number of participants requiring an oral treatment for hypoglycemia
Time frame: 24 hours post-exercice
Hypoglycemia with treatment
Time frame: 24 hours post-exercice
Hypoglycemia with treatment
Time frame: midnight to 6 am
Carbohydrate needed (g)
Time frame: midnight to 6 am
Carbohydrate needed (g)
Time frame: 24 hours post-exercice
Results and safety
The study was stopped early (reason given: The protocol did not work.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Remi Rabasa-Lhoret, MD, PhD principal investigator
IRCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity trial intervention in people with 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 7 inclusion and 4 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: stopped early, 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 was stopped early (reason given: The protocol did not work.). Results are not available in the source record.
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 plasma glucose during exercise (time frame: 60 minutes (during exercice)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 6 Nov 2026.