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Blood Glucose Target Before and During Exercise in Adults With Type 1 Diabetes Using an Artificial Pancreas (GUARDIA)

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physical activity trial intervention
Sponsored by
Institut de Recherches Cliniques de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 1 Diabetes focused on measuring Artificial pancreas, Exercice, Hypoglycemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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%. Exclusion Criteria: 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.

Sites / Locations

  • Institut de recherches cliniques de MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Temporary target of 8.3 mmol/L

Temporary target of 8.8 mmol/L

Temporary target of 9.3 mmol/L

Arm Description

Current commercial artificial pancreas thresholds. Temporary target set 60 minutes before the intervention.

Temporary target set 60 minutes before the intervention

Temporary target set 60 minutes before the intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Time in range (during fasting exercice)
The intervention will be repeated at the glycemic threshold targeted during the primary outcome
Number of hypoglycemic episodes
number of hypoglycemic episodes (plasma glucose < 4.0 mmol/L) during exercise.
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.
Lowest plasma glucose
Lowest plasma glucose level during exercise
Plasma glucose at 60 minutes
plasma glucose level at the end of exercise
Carbohydrate consumption (g)
amount of carbohydrate (CHO) needed to increase glucose value
Insulin on board (units)
Insulin on board or active insulin at exercise onset (Units will be collected on insulin pump) from start to finish
Plasma insulin
plasma insulin changes from exercise start to finish (uU/mL)
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
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
Mean CGM glucose
post-exercice until 6 am
Glucose variability
post-exercice until 6 am; assessed by the CGM standard deviation
Coefficient of variation
post-exercice until 6 am; assessed by the coefficient of variation
Coefficient of variation
post-exercice until 6 am; assessed by the coefficient of variation
Glucose variability
post-exercice until 6 am; assessed by the CGM standard deviation
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.
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.
Hypoglycemia with treatment
Total number of hypoglycemia episodes requiring treatment
Hypoglycemia with treatment
Total number of hypoglycemia episodes requiring treatment
Carbohydrate needed (g)
total amount of carbohydrate (CHO) needed to treat hypoglycemic events.
Carbohydrate needed (g)
total amount of carbohydrate (CHO) needed to treat hypoglycemic events.

Full Information

First Posted
March 20, 2023
Last Updated
July 6, 2023
Sponsor
Institut de Recherches Cliniques de Montreal
Collaborators
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT05821322
Brief Title
Blood Glucose Target Before and During Exercise in Adults With Type 1 Diabetes Using an Artificial Pancreas
Acronym
GUARDIA
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)"
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherches Cliniques de Montreal
Collaborators
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Artificial pancreas, Exercice, Hypoglycemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Temporary target of 8.3 mmol/L
Arm Type
Active Comparator
Arm Description
Current commercial artificial pancreas thresholds. Temporary target set 60 minutes before the intervention.
Arm Title
Temporary target of 8.8 mmol/L
Arm Type
Experimental
Arm Description
Temporary target set 60 minutes before the intervention
Arm Title
Temporary target of 9.3 mmol/L
Arm Type
Experimental
Arm Description
Temporary target set 60 minutes before the intervention
Intervention Type
Other
Intervention Name(s)
Physical activity trial intervention
Intervention Description
60 minutes aerobic ergocyle exercice at 60% VO2 Peak
Primary Outcome Measure Information:
Title
Change in plasma glucose during exercise
Description
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.
Time Frame
60 minutes (during exercice)
Secondary Outcome Measure Information:
Title
Time in range during exercice: menstrual cycle phases
Description
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.
Time Frame
60 minutes (during exercice)
Title
Time in range (during fasting exercice)
Description
The intervention will be repeated at the glycemic threshold targeted during the primary outcome
Time Frame
60 minutes (during exercice)
Title
Number of hypoglycemic episodes
Description
number of hypoglycemic episodes (plasma glucose < 4.0 mmol/L) during exercise.
Time Frame
60 minutes (during exercice)
Title
Number of participants who required oral treatment during exercise
Description
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.
Time Frame
60 minutes (during exercice)
Title
Lowest plasma glucose
Description
Lowest plasma glucose level during exercise
Time Frame
60 minutes (during exercice)
Title
Plasma glucose at 60 minutes
Description
plasma glucose level at the end of exercise
Time Frame
60 minutes
Title
Carbohydrate consumption (g)
Description
amount of carbohydrate (CHO) needed to increase glucose value
Time Frame
60 minutes (during exercice)
Title
Insulin on board (units)
Description
Insulin on board or active insulin at exercise onset (Units will be collected on insulin pump) from start to finish
Time Frame
60 minutes (during exercice)
Title
Plasma insulin
Description
plasma insulin changes from exercise start to finish (uU/mL)
Time Frame
60 minutes (during exercice)
Title
Percent time in range, in hypoglycemia and in hyperglycemia
Description
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
Time Frame
6 hours post-exercice
Title
Percent time in range, in hypoglycemia and in hyperglycemia
Description
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
Time Frame
midnight to 6 am
Title
Mean CGM glucose
Description
post-exercice until 6 am
Time Frame
24 hours post-exercice
Title
Glucose variability
Description
post-exercice until 6 am; assessed by the CGM standard deviation
Time Frame
midnight to 6 am
Title
Coefficient of variation
Description
post-exercice until 6 am; assessed by the coefficient of variation
Time Frame
midnight to 6 am
Title
Coefficient of variation
Description
post-exercice until 6 am; assessed by the coefficient of variation
Time Frame
24 hours post-exercice
Title
Glucose variability
Description
post-exercice until 6 am; assessed by the CGM standard deviation
Time Frame
24 hours post-exercice
Title
Number of participants requiring an oral treatment for hypoglycemia
Description
Number of participants requiring an oral treatment for hypoglycemia (< 3.9 mmol/L) until 6 am.
Time Frame
midnight to 6 am
Title
Number of participants requiring an oral treatment for hypoglycemia
Description
Number of participants requiring an oral treatment for hypoglycemia (< 3.9 mmol/L) until 6 am.
Time Frame
24 hours post-exercice
Title
Hypoglycemia with treatment
Description
Total number of hypoglycemia episodes requiring treatment
Time Frame
24 hours post-exercice
Title
Hypoglycemia with treatment
Description
Total number of hypoglycemia episodes requiring treatment
Time Frame
midnight to 6 am
Title
Carbohydrate needed (g)
Description
total amount of carbohydrate (CHO) needed to treat hypoglycemic events.
Time Frame
midnight to 6 am
Title
Carbohydrate needed (g)
Description
total amount of carbohydrate (CHO) needed to treat hypoglycemic events.
Time Frame
24 hours post-exercice

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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%. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie Boudreau, PhD
Phone
514 987-5643
Email
valerie.boudreau@ircm.qc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Roxane St-Amand, Mec
Phone
514 987-5500
Ext
3318
Email
roxane.st-amand@ircm.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Remi Rabasa-Lhoret, MD, PhD
Organizational Affiliation
IRCM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de recherches cliniques de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W1R7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rémi Rabasa-Lhoret, MD, PhD
Phone
5149875666
Email
remi.rabasa-lhoret@ircm.qc.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Blood Glucose Target Before and During Exercise in Adults With Type 1 Diabetes Using an Artificial Pancreas

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