Assessment of the Efficacy of the Artificial Pancreas Combined With a Qualitative Meal Size Estimation to Control Postprandial Glucose Levels
NCT ID: NCT04031599
Last Updated: 2022-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2020-07-10
2021-12-14
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Carbohydrate counting
Rapid acting insulin analogue with carbohydrate counting
Single-hormone closed-loop system
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 pump
Tandem Diabetes Care
Continuous glucose monitoring system
Dexcom G6
Aspart or Lispro
Aspart or lispro will be infused with the infusion pump
Carbohydrate counting
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.
3-week intervention
Glucose levels will be regulated by the single-hormone closed-loop system for 3 consecutive weeks.
1-hour postprandial exercise (sub-study)
60 minute exercise will be started one hour after the meal time.
2-hour postprandial exercise (sub-study)
60 minute exercise will be started two hours after meal time
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
Simplified qualitative meal size estimation
Rapid acting insulin analogue with simplified qualitative meal size estimation
Single-hormone closed-loop system
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 pump
Tandem Diabetes Care
Continuous glucose monitoring system
Dexcom G6
Aspart or Lispro
Aspart or lispro will be infused with the infusion pump
Simplified qualitative meal-size estimation strategy
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 intervention
Glucose levels will be regulated by the single-hormone closed-loop system for 3 consecutive weeks.
Interventions
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Single-hormone closed-loop system
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 pump
Tandem Diabetes Care
Continuous glucose monitoring system
Dexcom G6
Aspart or Lispro
Aspart or lispro will be infused with the infusion pump
Carbohydrate counting
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 strategy
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 intervention
Glucose levels will be regulated by the single-hormone closed-loop system for 3 consecutive weeks.
1-hour postprandial exercise (sub-study)
60 minute exercise will be started one hour after the meal time.
2-hour postprandial exercise (sub-study)
60 minute exercise will be started two hours after meal time
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
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. The subject will have been on insulin pump therapy for at least 3 months.
4. Currently using, or willing to switch to Lispro U100 or Aspart for the duration of the study.
5. HbA1c \< 10%.
Exclusion Criteria
2. Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery
3. Anticipated need to use acetaminophen during interventions with the closed-loop system
4. Pregnancy (ongoing or current attempt to become pregnant)
5. Breastfeeding
6. No nearby third party for assistance if needed (e.g. severe hypoglycemia glucagon treatment)
7. Plans to go abroad or travel at more than 3 hours distance from Montreal during the trial period
8. Severe hypoglycemic episode within two weeks of screening or during the run-in period
9. Severe hyperglycemic episode requiring hospitalization in the last 3 months
10. Current use of glucocorticoid medication (except low stable dose and inhaled steroids)
11. 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.
12. Current use of SGLT-2 inhibitors unless at a stable dose for at least 3 months and appropriate ketone testing performed.
13. Known or suspected allergy to the trial products
14. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator
15. Anticipation of a significant change in exercise regimen between admission and end of the trial (i.e. starting or stopping an organized sport)
16. In the opinion of the investigator, a participant who in unable or unwilling to observed the contraindications of the study devices
18 Years
ALL
No
Sponsors
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Institut de Recherches Cliniques de Montreal
OTHER
Responsible Party
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Rémi Rabasa-Lhoret
Full professor
Principal Investigators
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Rémi Rabasa-Lhoret
Role: PRINCIPAL_INVESTIGATOR
Montreal Clinical Research Institute
Locations
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Montreal Clinical Research Institute
Montreal, Quebec, Canada
McGill University Health Center
Montreal, Quebec, Canada
Countries
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References
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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.
Other Identifiers
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CLASS18
Identifier Type: -
Identifier Source: org_study_id
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