- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02909829
Safety and Efficacy of Artificial Pancreas With and Without a Meal Detection Module on Glycemic Control in Adolescents With Type 1 Diabetes After a Missed Bolus
An Open-label, Randomized, Three-way, Crossover Study to Assess the Safety and Efficacy of Closed-loop Delivery With and Without Meal Detection Module and Conventional Pump Therapy in Regulating Glucose Levels After a Missed Bolus in Adolescents With Type 1 Diabetes in Inpatient Settings
Despite current treatments for type 1 diabetes, maintaining blood glucose levels within a good range is a difficult task. A primary source for poor glucose control in adolescents is skipping insulin boluses at mealtimes. Advances in glucose sensors have motivated the research towards closed-loop delivery systems to automatically regulate glucose levels. Closed-loop delivery (artificial pancreas) is composed of an insulin pump, a continuous glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on sensor readings. The performance of a closed-loop delivery after a missed bolus may be improved if the computer program that calculates the insulin is enhanced with a meal detection module. The meal detection module will automatically detect the meal (which had no bolus delivered), and signal the delivery of more insulin.
The aim of this study is to assess the safety and efficacy of a closed-loop delivery with and without meal detection module compared to conventional pump therapy in regulating post-prandial glycemic levels after omission of a meal bolus.
The primary hypothesis is that closed-loop delivery with no meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to conventional pump therapy.
Study Overview
Status
Conditions
Detailed Description
Despite current treatments for type 1 diabetes, maintaining blood glucose levels within a good range is a difficult task. A primary source for poor glucose control in adolescents is skipping insulin boluses at mealtimes. Advances in glucose sensors have motivated the research towards closed-loop delivery systems to automatically regulate glucose levels. Closed-loop delivery (artificial pancreas) is composed of an insulin pump, a continuous glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on sensor readings. The performance of a closed-loop delivery after a missed bolus may be improved if the computer program that calculates the insulin is enhanced with a meal detection module. The meal detection module will automatically detect the meal (which had no bolus delivered), and signal the delivery of more insulin.
The aim of this study is to conduct a randomized, three-way, cross-over trial to compare the efficacy of closed-loop delivery, closed-loop delivery with a meal detection module, and conventional pump therapy. The study aims to compare these three interventions for 9 hours in adolescents with poorly controlled type 1 diabetes.
Each 9 hours will include two meals of different carbohydrate content, of which one will not have a carbohydrate-matched prandial bolus. This study will allow for the assessment of the safety and efficacy of closed-loop delivery with and without a meal detection module compared to conventional pump therapy in regulating post-prandial glycaemia.
The aim of this study is to assess the safety and efficacy of a closed-loop delivery with and without meal detection module compared to conventional pump therapy in regulating post-prandial glycemic levels after omission of a meal bolus.
The primary hypothesis is that closed-loop delivery with no meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to conventional pump therapy.
The secondary hypotheses are:
- Closed-loop delivery with meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to conventional pump therapy.
- Closed-loop delivery with meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to closed-loop delivery with no meal detection module.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Quebec
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Montréal, Quebec, Canada
- McGill University Health Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of type 1 diabetes for at least 12 months. (The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
- The participant will have been on insulin pump therapy for at least 3 months.
- HbA1c 7.5% to 12%.
- Self-reported or documented history of missed-bolus for meals during the previous 6 months.
Exclusion Criteria:
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Severe hypoglycemic episode within one month of screening.
- Pregnancy.
- Current use of oral glucocorticoid medication (except low stable dose). Stable doses of inhaled steroids are acceptable.
- Known or suspected allergy to the trial products, including the meal content.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Closed Loop Delivery
Insulin will be delivered by subcutaneous insulin infusion pump.
Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor.
The computer generated recommendations are based on a predictive algorithm.
Participants will eat breakfast and bolus, then eat lunch and not bolus.
|
Insulin will be delivered by subcutaneous insulin infusion pump.
Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor.
The computer generated recommendations are based on a predictive algorithm.
|
Experimental: Closed Loop Delivery with Meal Detection Module
Insulin will be delivered by subcutaneous insulin infusion pump.
Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor.
The computer generated recommendations are based on a predictive algorithm with an overlying meal detection module which detects missed meals and will increase insulin infusion rates based on a predictive meal detection algorithm.
Participants will eat breakfast and bolus, then eat lunch and not bolus.
|
Closed Loop Delivery with Meal Detection Module Insulin will be delivered by subcutaneous insulin infusion pump.
Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor.
The computer generated recommendations are based on a predictive algorithm with an overlying meal detection module which detects missed meals and will increase insulin infusion rates based on a predictive meal detection algorithm
|
Active Comparator: Conventional Pump Therapy
Insulin will be delivered by subcutaneous insulin infusion pump with participants usual infusion rate.
Participants will eat breakfast and bolus as per usual, then eat lunch and not bolus.
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Insulin will be delivered by subcutaneous insulin infusion pump with participants usual infusion rate
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUCinc: The incremental area under the curve (as compared to pre-meal glucose value) of the postprandial glucose excursions for the lunch meal.
Time Frame: 0 - 240 min postprandial lunch meal
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0 - 240 min postprandial lunch meal
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUCinc: The incremental area under the curve (as compared to pre-meal glucose value) of the postprandial glucose excursions: a. >10.0 mmol/L; b. >13.9 mmol/L; c. >16.7 mmol/L
Time Frame: 0 - 240 min postprandial lunch meal
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0 - 240 min postprandial lunch meal
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Percentage of postprandial time of sensor glucose measurements spent: a. <3.9 mmol/L; b. between 3.9 and 7.8 mmol/L; c. between 3.9 and 10.0 mmol/L; d. >10.0 mmol/L; e. >13.9 mmol/L; f. >16.7 mmol/L.
Time Frame: 0 - 240 min postprandial lunch meal
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0 - 240 min postprandial lunch meal
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Mean sensor glucose concentration.
Time Frame: 9 hours
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9 hours
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Total insulin delivery
Time Frame: 9 hours
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9 hours
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Glucose concentration as measured by CGM at 2 hours (120 min) post-meal.
Time Frame: 120 min postprandial lunch meal
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120 min postprandial lunch meal
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Incremental glucose concentration as measured by CGM at 2 hours (120 min) post-meal.
Time Frame: 120 min postprandial lunch meal
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120 min postprandial lunch meal
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Incremental postprandial peak of glucose concentration as measured by CGM.
Time Frame: 0 - 240 min postprandial lunch meal
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0 - 240 min postprandial lunch meal
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Number of hyperglycemic events > 18.0mmol/L.
Time Frame: 0 - 240 min postprandial lunch meal
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0 - 240 min postprandial lunch meal
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1. Glucose concentration as measured by CGM at 5 hours (300 min) post-meal. Glucose concentration as measured by CGM at 5 hours (300 min) post-meal
Time Frame: 300 min postprandial lunch meal
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300 min postprandial lunch meal
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Missed Bolus 9h
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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