Type 1 DiabetesNCT04031599
Assessment of the Efficacy of the Artificial Pancreas Combined With a Qualitative Meal Size Estimation to Control Postprandial Glucose Levels
A study testing Single-hormone closed-loop system, Insulin pump and Continuous glucose monitoring system in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 2 sites in Canada.
Trial summary
Postprandial glycemic excursions are major determinants of overall glycemic control in type 1 diabetes. Carbohydrate content of ingested meals is the main determinant of post-meal glucose excursion. Accurate carbohydrate counting is a critical aspect of managing postprandial blood glucose levels. 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?
- Single-hormone closed-loop system, Insulin pump and Continuous glucose monitoring system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 10 Jul 2020to 14 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years of old.
- Clinical diagnosis of type 1 diabetes 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.
- The subject will have been on insulin pump therapy for at least 3 months.
- Currently using, or willing to switch to Lispro U100 or Aspart for the duration of the study.
- HbA1c < 10%.
Who cannot join
- Clinically significant nephropathy, neuropathy (e.g. known or suspected gastroparesis) or retinopathy (e.g. proliferative retinopathy) as judged by the investigator
- Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery
- Anticipated need to use acetaminophen during interventions with the closed-loop system
- Pregnancy (ongoing or current attempt to become pregnant)
- Breastfeeding
- No nearby third party for assistance if needed (e.g. severe hypoglycemia glucagon treatment)
Show all 16Show fewer
- Plans to go abroad or travel at more than 3 hours distance from Montreal during the trial period
- Severe hypoglycemic episode within two weeks of screening or during the run-in period
- Severe hyperglycemic episode requiring hospitalization in the last 3 months
- Current use of glucocorticoid medication (except low stable dose and inhaled steroids)
- Agents affecting gastric emptying (Motilium®, Victoza®, Ozempic®, Trulicity®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, Prandase®, DPP-4 inhibitors) if not at a stable dose for 3 months. Otherwise, these medications are acceptable and will be kept stable during the entire protocol.
- Current use of SGLT-2 inhibitors unless at a stable dose for at least 3 months and appropriate ketone testing performed.
- Known or suspected allergy to the trial products
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator
- Anticipation of a significant change in exercise regimen between admission and end of the trial (i.e. starting or stopping an organized sport)
- In the opinion of the investigator, a participant who in unable or unwilling to observed the contraindications of the study devices
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Montreal Clinical Research Institute
Montreal, Quebec, H2W 1R7
McGill University Health Center
Montreal, Quebec, H4A 3J1
About this study
Official title: An Open-label, Randomized, Crossover Trial to Assess the Efficacy of Single-hormone Closed-loop System With a Rapid Acting Insulin Analogue Combined With Either Conventional Carbohydrate Counting or a Simplified Qualitative Meal-size Estimation in Regulating Glucose Levels in Adults With Type 1 Diabetes
Postprandial glycemic excursions are major determinants of overall glycemic control in type 1 diabetes. Carbohydrate content of ingested meals is the main determinant of post-meal glucose excursion. Accurate carbohydrate counting is a critical aspect of managing postprandial blood glucose levels. accurate carbohydrate counting is considered by patients as a significant burden and frustrating task.
The closed-loop system (CLS) is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings.
Read more
The objective of this study is to compare the efficacy of two strategies to regulate glucose levels in outpatient settings in adults with type 1 diabetes: 1) single-hormone CLS with rapid acting insulin analogue combined with carbohydrate counting; 2) single-hormone CLS with rapid acting insulin analogue combined with simplified qualitative meal-size estimation.
A sub-study will also be proposed to participants. Postprandial exercise combines two situations complicating CLS operation: a high plasma insulin due to insulin on-board related to meal boluses and rapid blood glucose changes (postprandial blood glucose excursion and then drop during exercise) making input from the glucose sensor less accurate. The objective of this sub-study will be to explore the safety and efficacy of the CLS using the combined strategy of pre-meal exercise announcement and meal bolus reduction of 33% when exercise is performed 1 hour compared to 2 hours post meal time.
- Conditions
- Type 1 Diabetes
- Being tested
- Single-hormone closed-loop system, Insulin pump, Continuous glucose monitoring system, Aspart or Lispro, Carbohydrate counting
- Keywords
- Type 1 diabetes, Artificial pancreas, Closed-loop system, Insulin, Postprandial glucose, Exercise
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-hormone closed-loop systemDevice
Every 10 minutes, the glucose levels as measured by the sensor will be transferred automatically to a LG Google Nexus Smartphone that the algorithm is running on, which will calculate the recommended doses and will send them wirelessly to the infusion pump.
Insulin pumpDevice
Tandem Diabetes Care
Continuous glucose monitoring systemDevice
Dexcom G6
Aspart or LisproDrug
Aspart or lispro will be infused with the infusion pump
Carbohydrate countingOther
Participants will be required to enter an estimate of the carbohydrate content of their meal into the phone. Insulin boluses will be calculated based on grams of carbohydrates and participant's insulin-to-carbohydrate ratio. Carbohydrate-matching full prandial bolus will be given 5 to 10 minutes before the meal.
Simplified qualitative meal-size estimation strategyOther
A pre-meal partial prandial bolus will be given 5-10 minutes before the meal. The partial bolus will be based on the estimated meal size (small, regular, large and extra-large). The closed-loop system will give the remaining insulin needed based on the sensor readings. For this strategy, meal size will be defined as: small as any meal less than 30g, regular meal as any meal between 30g and 60g CHO, large meal as any meal between 60g and 90g CHO, extra-large meal for anything above 90g CHO.
3-week interventionOther
Glucose levels will be regulated by the single-hormone closed-loop system for 3 consecutive weeks.
1-hour postprandial exercise (sub-study)Other
60 minute exercise will be started one hour after the meal time.
2-hour postprandial exercise (sub-study)Other
60 minute exercise will be started two hours after meal time
Exercise announcement and meal bolus reduction (sub-study)Other
Meal bolus reduction of 33% at meal time and exercise announcement (increased target glucose from 6 to 9mmolL) to the CLS algorithm
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate counting | Active comparator | Rapid acting insulin analogue with carbohydrate counting Receives: Device: Single-hormone closed-loop system; Device: Insulin pump; Device: Continuous glucose monitoring system; Drug: Aspart or Lispro; Other: Carbohydrate counting; Other: 3-week intervention; Other: 1-hour postprandial exercise (sub-study); Other: 2-hour postprandial exercise (sub-study); Other: Exercise announcement and meal bolus reduction (sub-study) |
| Simplified qualitative meal size estimation | Active comparator | Rapid acting insulin analogue with simplified qualitative meal size estimation Receives: Device: Single-hormone closed-loop system; Device: Insulin pump; Device: Continuous glucose monitoring system; Drug: Aspart or Lispro; Other: Simplified qualitative meal-size estimation strategy; Other: 3-week intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L
Measured: 504 hours
Relative decrease in glucose levels during exercise compared to pre-breakfast levels (sub-study)
Difference between pre-breakfast levels and the lowest glucose level from the start of the exercise until the end of exercise
Measured: 3.5 or 4.5 hours
Secondary outcomes (51)
Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L
Measured: 504 hours
Percentage of time of glucose levels spent below 3.9 mmol/L
Measured: 504 hours
Percentage of time of glucose levels spent below 3.3 mmol/L
Measured: 504 hours
Percentage of time of glucose levels spent below 2.8 mmol/L
Measured: 504 hours
Percentage of time of glucose levels spent above 10.0 mmol/L
Measured: 504 hours
Percentage of time of glucose levels spent above 13.9 mmol/L
Measured: 504 hours
Percentage of time of glucose levels spent above 16.7 mmol/L
Measured: 504 hours
Mean glucose levels
Measured: 504 hours
Fasting glucose levels
Measured: 504 hours
Standard deviation of glucose levels
Measured: 504 hours
Standard deviation of insulin delivery
Measured: 504 hours
Coefficient of variance of glucose levels
Measured: 504 hours
Coefficient of variance of insulin delivery
Measured: 504 hours
Between-day variability in glucose levels
Measured: 504 hours
Between-day variability in insulin delivery
Measured: 504 hours
Total insulin delivery
Measured: 504 hours
Number of hypoglycemic events less than 3.1 mmol/L
Measured: 504 hours
Number of nights with hypoglycemic events less than 3.1 mmol/L
Measured: 126 hours
Number of days with hypoglycemic events less than 3.1 mmol/L
Measured: 252 hours
Total number of hours of sensor availability
Measured: 378 hours
Percentage of time of sensor availability
Measured: 504 hours
2-hour postprandial glucose levels over the last 3 days of the intervention.
Measured: 18 hours
Average number of days per participant requiring study team support for at least one technical problem
Measured: 21 days
Number of hours and percentage of time in open-loop and closed-loop modes
Measured: 504 hours
Average number of phone calls per participant related to CLS technical issues
Measured: 504 hours
Decrease in plasma glucose levels during exercise (sub-study)
Difference between glucose levels at the beginning of the exercise and the lowest glucose levels from the start of the exercise until the end of exercise
Measured: 1 hour
Relative decrease in glucose levels during exercise compared to pre-breakfast levels (sub-study)
Difference between pre-breakfast levels and the lowest glucose level from the start of the exercise until the end of exercise
Measured: 2 or 3 hours
Percentage of time of plasma glucose levels spent below 3.9 mmol/L (sub-study)
Pre-exercise period (from mealtime to exercise onset)
Measured: 1 or 2 hours
Percentage of time of plasma glucose levels spent below 3.3 mmol/L (sub-study)
Pre-exercise period (from mealtime to exercise onset)
Measured: 1 or 2 hours
Percentage of time of plasma glucose levels spent below 3.0 mmol/L (sub-study)
Pre-exercise period (from mealtime to exercise onset)
Measured: 1 or 2 hours
Percentage of time of plasma glucose levels spent between 3.9 and 10.0 mmol/L (sub-study)
Pre-exercise period (from mealtime to exercise onset)
Measured: 1 or 2 hours
Percentage of time of plasma glucose levels spent above 10.0 mmol/L (sub-study)
Pre-exercise period (from mealtime to exercise onset)
Measured: 1 or 2 hours
Percentage of time of plasma glucose levels spent above 13.9 mmol/L (sub-study)
Pre-exercise period (from mealtime to exercise onset)
Measured: 1 or 2 hours
Percentage of time of plasma glucose levels spent above 16.7 mmol/L (sub-study)
Pre-exercise period (from mealtime to exercise onset)
Measured: 1 or 2 hours
Percentage of time of plasma glucose levels spent below 3.9 mmol/L (sub-study)
Exercise period
Measured: 1 hour
Percentage of time of plasma glucose levels spent below 3.3 mmol/L (sub-study)
Exercise period
Measured: 1 hour
Percentage of time of plasma glucose levels spent below 3.0 mmol/L (sub-study)
Exercise period
Measured: 1 hour
Number of patients experiencing hypoglycemia requiring treatment (sub-study)
Exercise period
Measured: 1 hour
Percentage of time of plasma glucose levels spent between 3.9 and 10.0 mmol/L (sub-study)
Exercise period
Measured: 1 hour
Percentage of time of plasma glucose levels spent above 10.0 mmol/L (sub-study)
Exercise period
Measured: 1 hour
Percentage of time of plasma glucose levels spent above 13.3 mmol/L (sub-study)
Exercise period
Measured: 1 hour
Percentage of time of plasma glucose levels spent above 16.7 mmol/L (sub-study)
Exercise period
Measured: 1 hour
Percentage of time of plasma glucose levels spent below 3.9 mmol/L (sub-study)
Post-exercise period
Measured: 1.5 hour
Percentage of time of plasma glucose levels spent below 3.3 mmol/L (sub-study)
Post-exercise period
Measured: 1.5 hour
Percentage of time of plasma glucose levels spent below 3.0 mmol/L (sub-study)
Post-exercise period
Measured: 1.5 hour
Percentage of time of plasma glucose levels spent between 3.9 and 10.0 mmol/L (sub-study)
Post-exercise period
Measured: 1.5 hour
Percentage of time of plasma glucose levels spent above 10.0 mmol/L (sub-study)
Post-exercise period
Measured: 1.5 hour
Percentage of time of plasma glucose levels spent above 13.3 mmol/L (sub-study)
Post-exercise period
Measured: 1.5 hour
Percentage of time of plasma glucose levels spent above 16.7 mmol/L (sub-study)
Post-exercise period
Measured: 1.5 hour
Number of patients experiencing hypoglycemia requiring treatment (sub-study)
Overall study period
Measured: 3.5 or 4.5 hours
Mean time (minutes) to the first hypoglycemic event (sub-study)
Exercise period
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start10 Jul 2020
- Primary completion27 Nov 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
- Investigators
- Rémi Rabasa-Lhoret, Principal investigator, Montreal Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031599
- Sponsor's protocol ID
- CLASS18
- Status last verified
- Jan 2022
- First submitted
- 22 Jul 2019
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Myette-Cote E, Molveau J, Wu Z, Raffray M, Devaux M, Tagougui S, Rabasa-Lhoret R. A Randomized Crossover Pilot Study Evaluating Glucose Control During Exercise Initiated 1 or 2 h After a Meal in Adults with Type 1 Diabetes Treated with an Automated Insulin Delivery System. Diabetes Technol Ther. 2023 Feb;25(2):122-130. doi: 10.1089/dia.2022.0338. Epub 2022 Dec 6.
PubMed 36399114
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Crossover Trial to Assess the Efficacy of Single-hormone Closed-loop System With a Rapid Acting Insulin Analogue Combined With Either Conventional Carbohydrate Counting or a Simplified Qualitative Meal-size Estimation in Regulating Glucose Levels in Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04031599
- Acronym / sponsor ID
- CLASS18
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Artificial pancreas, Closed-loop system, Insulin, Postprandial glucose, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 27 Nov 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 24 Jul 2019 (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.
Postprandial glycemic excursions are major determinants of overall glycemic control in type 1 diabetes. Carbohydrate content of ingested meals is the main determinant of post-meal glucose excursion. Accurate carbohydrate counting is a critical aspect of managing postprandial blood glucose levels. accurate carbohydrate counting is considered by patients as a significant burden and frustrating task.
The closed-loop system (CLS) is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings.
The objective of this study is to compare the efficacy of two strategies to regulate glucose levels in outpatient settings in adults with type 1 diabetes: 1) single-hormone CLS with rapid acting insulin analogue combined with carbohydrate counting; 2) single-hormone CLS with rapid acting insulin analogue combined with simplified qualitative meal-size estimation.
A sub-study will also be proposed to participants. Postprandial exercise combines two situations complicating CLS operation: a high plasma insulin due to insulin on-board related to meal boluses and rapid blood glucose changes (postprandial blood glucose excursion and then drop during exercise) making input from the glucose sensor less accurate. The objective of this sub-study will be to explore the safety and efficacy of the CLS using the combined strategy of pre-meal exercise announcement and meal bolus reduction of 33% when exercise is performed 1 hour compared to 2 hours post meal time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate counting | Active comparator | Device: Single-hormone closed-loop system, Device: Insulin pump, Device: Continuous glucose monitoring system, Drug: Aspart or Lispro, Other: Carbohydrate counting, Other: 3-week intervention, Other: 1-hour postprandial exercise (sub-study), Other: 2-hour postprandial exercise (sub-study), Other: Exercise announcement and meal bolus reduction (sub-study)Rapid acting insulin analogue with carbohydrate counting |
| Simplified qualitative meal size estimation | Active comparator | Device: Single-hormone closed-loop system, Device: Insulin pump, Device: Continuous glucose monitoring system, Drug: Aspart or Lispro, Other: Simplified qualitative meal-size estimation strategy, Other: 3-week interventionRapid acting insulin analogue with simplified qualitative meal size estimation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females ≥ 18 years of old.
- Clinical diagnosis of type 1 diabetes 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.
- The subject will have been on insulin pump therapy for at least 3 months.
- Currently using, or willing to switch to Lispro U100 or Aspart for the duration of the study.
- HbA1c < 10%.
Key exclusion criteria (16 listed)
- Clinically significant nephropathy, neuropathy (e.g. known or suspected gastroparesis) or retinopathy (e.g. proliferative retinopathy) as judged by the investigator
- Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery
- Anticipated need to use acetaminophen during interventions with the closed-loop system
- Pregnancy (ongoing or current attempt to become pregnant)
- Breastfeeding
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 |
|---|---|---|
| Single-hormone closed-loop systemEvery 10 minutes, the glucose levels as measured by the sensor will be transferred automatically to a LG Google Nexus Smartphone that the algorithm is running on, which will calculate the recommended doses and will send them wirelessly to the infusion pump. | Device | Carbohydrate counting, Simplified qualitative meal size estimation |
| Insulin pumpTandem Diabetes Care | Device | Carbohydrate counting, Simplified qualitative meal size estimation |
| Continuous glucose monitoring systemDexcom G6 | Device | Carbohydrate counting, Simplified qualitative meal size estimation |
| Aspart or LisproAspart or lispro will be infused with the infusion pump | Drug | Carbohydrate counting, Simplified qualitative meal size estimation |
| Carbohydrate countingParticipants will be required to enter an estimate of the carbohydrate content of their meal into the phone. Insulin boluses will be calculated based on grams of carbohydrates and participant's insulin-to-carbohydrate ratio. Carbohydrate-matching full prandial bolus will be given 5 to 10 minutes before the meal. | Other | Carbohydrate counting |
| Simplified qualitative meal-size estimation strategyA pre-meal partial prandial bolus will be given 5-10 minutes before the meal. The partial bolus will be based on the estimated meal size (small, regular, large and extra-large). The closed-loop system will give the remaining insulin needed based on the sensor readings. For this strategy, meal size will be defined as: small as any meal less than 30g, regular meal as any meal between 30g and 60g CHO, large meal as any meal between 60g and 90g CHO, extra-large meal for anything above 90g CHO. | Other | Simplified qualitative meal size estimation |
| 3-week interventionGlucose levels will be regulated by the single-hormone closed-loop system for 3 consecutive weeks. | Other | Carbohydrate counting, Simplified qualitative meal size estimation |
| 1-hour postprandial exercise (sub-study)60 minute exercise will be started one hour after the meal time. | Other | Carbohydrate counting |
| 2-hour postprandial exercise (sub-study)60 minute exercise will be started two hours after meal time | Other | Carbohydrate counting |
| Exercise announcement and meal bolus reduction (sub-study)Meal bolus reduction of 33% at meal time and exercise announcement (increased target glucose from 6 to 9mmolL) to the CLS algorithm | Other | Carbohydrate counting |
Primary outcome
Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L
Time frame: 504 hours
Relative decrease in glucose levels during exercise compared to pre-breakfast levels (sub-study)
Time frame: 3.5 or 4.5 hours
Difference between pre-breakfast levels and the lowest glucose level from the start of the exercise until the end of exercise
51 secondary outcomes
Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L
Time frame: 504 hours
Percentage of time of glucose levels spent below 3.9 mmol/L
Time frame: 504 hours
Percentage of time of glucose levels spent below 3.3 mmol/L
Time frame: 504 hours
Percentage of time of glucose levels spent below 2.8 mmol/L
Time frame: 504 hours
Percentage of time of glucose levels spent above 10.0 mmol/L
Time frame: 504 hours
Percentage of time of glucose levels spent above 13.9 mmol/L
Time frame: 504 hours
Percentage of time of glucose levels spent above 16.7 mmol/L
Time frame: 504 hours
Mean glucose levels
Time frame: 504 hours
Fasting glucose levels
Time frame: 504 hours
Standard deviation of glucose levels
Time frame: 504 hours
Standard deviation of insulin delivery
Time frame: 504 hours
Coefficient of variance of glucose levels
Time frame: 504 hours
Coefficient of variance of insulin delivery
Time frame: 504 hours
Between-day variability in glucose levels
Time frame: 504 hours
Between-day variability in insulin delivery
Time frame: 504 hours
Total insulin delivery
Time frame: 504 hours
Number of hypoglycemic events less than 3.1 mmol/L
Time frame: 504 hours
Number of nights with hypoglycemic events less than 3.1 mmol/L
Time frame: 126 hours
Number of days with hypoglycemic events less than 3.1 mmol/L
Time frame: 252 hours
Total number of hours of sensor availability
Time frame: 378 hours
Percentage of time of sensor availability
Time frame: 504 hours
2-hour postprandial glucose levels over the last 3 days of the intervention.
Time frame: 18 hours
Average number of days per participant requiring study team support for at least one technical problem
Time frame: 21 days
Number of hours and percentage of time in open-loop and closed-loop modes
Time frame: 504 hours
Average number of phone calls per participant related to CLS technical issues
Time frame: 504 hours
Decrease in plasma glucose levels during exercise (sub-study)
Time frame: 1 hour
Relative decrease in glucose levels during exercise compared to pre-breakfast levels (sub-study)
Time frame: 2 or 3 hours
Percentage of time of plasma glucose levels spent below 3.9 mmol/L (sub-study)
Time frame: 1 or 2 hours
Percentage of time of plasma glucose levels spent below 3.3 mmol/L (sub-study)
Time frame: 1 or 2 hours
Percentage of time of plasma glucose levels spent below 3.0 mmol/L (sub-study)
Time frame: 1 or 2 hours
Percentage of time of plasma glucose levels spent between 3.9 and 10.0 mmol/L (sub-study)
Time frame: 1 or 2 hours
Percentage of time of plasma glucose levels spent above 10.0 mmol/L (sub-study)
Time frame: 1 or 2 hours
Percentage of time of plasma glucose levels spent above 13.9 mmol/L (sub-study)
Time frame: 1 or 2 hours
Percentage of time of plasma glucose levels spent above 16.7 mmol/L (sub-study)
Time frame: 1 or 2 hours
Percentage of time of plasma glucose levels spent below 3.9 mmol/L (sub-study)
Time frame: 1 hour
Percentage of time of plasma glucose levels spent below 3.3 mmol/L (sub-study)
Time frame: 1 hour
Percentage of time of plasma glucose levels spent below 3.0 mmol/L (sub-study)
Time frame: 1 hour
Number of patients experiencing hypoglycemia requiring treatment (sub-study)
Time frame: 1 hour
Percentage of time of plasma glucose levels spent between 3.9 and 10.0 mmol/L (sub-study)
Time frame: 1 hour
Percentage of time of plasma glucose levels spent above 10.0 mmol/L (sub-study)
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Derived from this study: PubMed 36399114Myette-Cote E, Molveau J, Wu Z, Raffray M, Devaux M, Tagougui S, Rabasa-Lhoret R. A Randomized Crossover Pilot Study Evaluating Glucose Control During Exercise Initiated 1 or 2 h After a Meal in Adults with Type 1 Diabetes Treated with an Automated Insulin Delivery System. Diabetes Technol Ther. 2023 Feb;25(2):122-130. doi: 10.1089/dia.2022.0338. Epub 2022 Dec 6.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Rémi Rabasa-Lhoret principal investigator
Montreal Clinical Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-hormone closed-loop system, Insulin pump and Continuous glucose monitoring system in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 2 sites 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 5 inclusion and 16 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 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L (time frame: 504 hours). The study lists 2 primary outcomes in all. 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 NCT04031599, which also lists 1 linked publication.
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 28 Jan 2022.