Triple-hormone (Insulin-pramlintide-glucagon) Closed-loop Strategy to Regulate Glucose Levels Without Carbohydrate Counting (Triple)
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|ClinicalTrials.gov Identifier: NCT03800875|
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Drug: Insulin-pramlintide-glucagon closed-loop delivery Drug: Insulin-alone closed-loop delivery||Phase 2|
Meal carbohydrate content is the main determinant of prandial insulin needs, and consequently, accurate carbohydrate counting is recommended for type 1 diabetes. Advances in glucose sensors have motivated the development of the closed-loop system to automatically regulate glucose levels in individuals with type 1 diabetes. In the closed-loop system, a dosing algorithm adjusts the pump insulin infusion rate based on continuous glucose sensor readings.
Closed-loop system systems that are shown to alleviate the burden of carbohydrate counting without degrading glucose control are still lacking. In this proposal, the investigators aim to develop a novel, fully-automated, triple-hormone, closed-loop system that delivers insulin, pramlintide, and glucagon that controls postprandial glucose levels without any input from the user. Thus, the three hormones' role in the postprandial state will be as follows:
- Insulin: to reduce plasma glucose levels. Insulin delivery needs to be aggressive to counter-act fast increase in post-meal glucose levels.
- Glucagon: to reduce the risk late postprandial hypoglycemia to the aggressive insulin delivery.
- Pramlintide: to slow gastric emptying and aim insulin in efficiently controlling postprandial glucose levels.
The aim of this study is to assess a fully automated, triple-hormone, closed-loop system that delivers insulin, pramlintide, and glucagon to control glucose levels without degrading overall glycemic control compared to an insulin-alone closed-loop system with carbohydrate-matched boluses.
The investigators hypothesize that the triple-hormone closed-loop system will alleviate carbohydrate-counting burden (fully reactive system) without degrading glucose control compared to the insulin-alone closed-loop system.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Controlled, Crossover Trial to Assess a Triple-hormone (Insulin-pramlintide-glucagon) Closed-loop Delivery Without Carbohydrate Counting in Regulating Glucose Levels in Adults With Type 1 Diabetes|
|Actual Study Start Date :||November 10, 2018|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Triple-Hormone Closed-Loop Strategy
Subcutaneous delivery of insulin, pramlintide, and glucagon via infusion pump.
Intervention: Insulin-pramlintide-glucagon closed-loop delivery system
Drug: Insulin-pramlintide-glucagon closed-loop delivery
Fast-acting insulin, glucaon, and pramlintide will be delivered using three separate infusion pumps. The pumps' infusion rates will then be changed manually based on the computer-generated recommendation. The computer-generated recommendations are based on a dosing algorithm. With no-meal announcement or carbohydrate counting, the triple-hormone closed-loop system will be fully reactive, and insulin, pramlintide and glucagon dosages will be based solely on sensor readings
Other Name: Triple-Hormone closed-loop delivery
Active Comparator: Insulin-alone Closed Loop Strategy
Subcutaneous delivery of insulin via infusion pump.
Intervention: Insulin-alone closed-loop delivery system
Drug(s): Insulin (FiAsp)
Drug: Insulin-alone closed-loop delivery
The pumps infusion rates will then be changed manually based on the computer-generated recommendation. The computer-generated recommendations are based on a dosing algorithm. The carbohydrate content for every ingested meal will be entered into the algorithm to calculate the insulin prandial bolus based on each participant's insulin-to-carbohydrate ratio. The carbohydrate content will be entered at the onset of the meal.
- Mean glucose level over the 24-hr period [ Time Frame: Up to 24 hours ]
- Percentage of time (22:00-22:00) of glucose levels spent: [ Time Frame: Up to 24 hours ]a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.
- Percentage of overnight time (24:00-8:00) of glucose levels: [ Time Frame: Up to 8 hours ]a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.
- Total insulin delivery measured by the closed-loop system [ Time Frame: Up to 24 hours ]
- Mean glucose level during overnight period. [ Time Frame: Up to 8 hours ]
- Number of participants experiencing hypoglycemia requiring oral treatment during: a. the overall study period; b. the night; c. the day [ Time Frame: Up to 27 hours ]
- Gastrointestinal symptoms during the 27-hour closed-loop visits. [ Time Frame: Up to 27 hours ]
- Mean daytime insulin concentration [ Time Frame: Up to 14 hours ]
- Mean daytime glucagon concentration [ Time Frame: Up to 14 hours ]
- Mean daytime amylin concentration [ Time Frame: Up to 14 hours ]
- Total glucagon delivery [ Time Frame: Up to 24 hours ]
- Total amylin delivery [ Time Frame: Up to 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800875
|Contact: Dorsa Majdpouremail@example.com|
|McGill University Health Centre||Recruiting|
|Montréal, Quebec, Canada, H4A 3J1|
|Contact: Jennifer Rene 418-558-0742 firstname.lastname@example.org|
|Sub-Investigator: Ahmad Haidar, Eng., PhD|
|Principal Investigator: Michael Tsoukas, MD|
|Sub-Investigator: Laurent Legault, MD|
|Sub-Investigator: Jean- François Yale, MD|
|Principal Investigator:||Ahmad Haidar||McGill University|
|Principal Investigator:||Michael Tsoukas||McGill University Health Center|