A Phase 2 interventional study of 14 hours intervention in Type 1 Diabetes, sponsored by Institut de Recherches Cliniques de Montreal. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-09.
Sponsored by Institut de Recherches Cliniques de Montreal · Phase 2, Interventional, and Treatment
Closed-loop strategy 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 dosage based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.
The objective of this project is to assess whether a dual-hormone closed-loop strategy would alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D) without a significant degradation in post-meal glucose control.
Our primary hypothesis is that meal-announcement strategy (pre-meal CHO-independent bolus) is equivalent to meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) during closed-loop regulation of glucose levels in adults with T1D. Our secondary hypothesis is that closed-loop strategy with meal-announcement strategy (pre-meal CHO-independent bolus) or meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) is better than conventional pump treatment in regulation of glucose levels in adults with T1D.
Closed-loop strategy 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. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.
Each patient will be admitted three times to a clinical research facility. In the meal-and-carbohydrate-announcement visit, patients will eat 3 meals accompanied with a matching insulin bolus (depending on the carbohydrate content of the meal) and glucose levels will be subsequently regulated using dual-hormone closed-loop system. In the meal-announcement visit, patients will eat the 3 same meals but will inject only a partial insulin bolus (not depending on carbohydrate content of the meal) and the remaining needed insulin will be delivered based on glucose sensor excursions as part of closed-loop operation. In the control visit, patients will use conventional pump therapy to regulate glucose levels.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 12 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Institut de Recherches Cliniques de Montreal is the lead sponsor of 61 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
An insulin bolus dependant of carbohydrate content will be given after each meal. Each subject insulin-to-carbohydrate ratio (U per 10g CHO) will be used to calculate the insulin bolus to be given. The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings.
Other: 14 hours intervention
An insulin bolus independent of carbohydrate content will be given after each meal. The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings.
Other: 14 hours intervention
Patients will use conventional pump therapy to regulate glucose levels
Other: 14 hours intervention
Subjects will be admitted at the IRCM at 6:30. Subjects will be asked to fast from midnight. At 8:00, a standardized (50g CHO for males; 30g CHO for females) meal will be served. At 12:00, a standardized (120g CHO for males; 90g CHO for females) meal will be served. At 17:00, a standardized (70g CHO for males; 50g CHO for females) meal will be served. Between meals, patients will be allowed to do sedentary activities (reading, watching television, and playing video games, etc).
The positive incremental area under the curve of postprandial glucose excursions
The positive incremental area under the curve (IAUC, as compared to pre-meal glucose value) of the 4-hr postprandial glucose excursions for the breakfast, lunch and dinner meals.
Time frame: 4 hours after meal intake
Mean plasma glucose
Time frame: 8h00 to 21h00
Incremental two hours postprandial glucose
Time frame: 2 hours after meal intake
Incremental postprandial peak-glucose values
Time frame: 8h00 to 21h00
Percentage of time of plasma glucose levels between 4.0 and 10.0 mmol/L
Time frame: 8h00 to 21h00
Percentage of time of plasma glucose levels spent above 10.0 mmol/L
Time frame: 8h00 to 21h00
Percentage of time of plasma glucose levels spent below 4.0 mmol/L
Time frame: 8h00 to 21h00
Total insulin delivery
Time frame: 8h00 to 21h00
Total glucagon delivery
Time frame: 8h00 to 21h00
Standard deviation of glucose levels
Time frame: 8h00 to 21h00
Percentage of time of plasma glucose concentrations below 3.5 mmol/L
Time frame: 8h00 to 21h00
Percentage of time of plasma glucose concentrations above 14 mmol/L
Time frame: 8h00 to 21h00
Mean plasma insulin concentration
Time frame: 8h00 to 21h00
Mean plasma glucagon concentration
Time frame: 8h00 to 21h00
Number of patients experiencing hypoglycemia requiring oral treatment
Time frame: 8h00 to 21h00
Incremental area under the curve of the 4-hr postprandial glucose excursions but the reference glucose is set to 5.0 mmol/L if premeal glucose is less than 5.0 mmol/L.
Time frame: 4 hours after meal intake
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Institut de Recherches Cliniques de Montreal