One of the main challenges in maintaining tight glucose control in a closed-loop system occurs at meal times. Amylin is a gluco-regulatory beta-cell hormone that is co-secreted with insulin in response to nutrient stimuli, and is deficient in patients with type 1 diabetes. Amylin, in the postprandial period, contributes to regulating glucose levels by delaying gastric emptying, suppressing nutrient-stimulated glucagon secretion, and increasing satiety. Pramlintide is a synthetic analog of the hormone amylin. A closed-loop system that delivers both insulin and pramlintide, based on glucose sensor readings, has the potential to better normalize glucose levels, especially during the post-prandial period. The aim of this project is to assess whether co-administration of pramlintide with the improved insulin aspart formulation - Fiasp, in an artificial pancreas system, will alleviate the need for carb counting by replacing it with a simple meal announcement, without degrading the quality of glycemic control in a closed-loop therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
Fiasp Insulin delivered in a basal-bolus manner.
Pramlintide delivered in a basal-bolus manner with a fixed ratio with insulin.
Placebo delivered in a basal-bolus manner with a fixed ratio with insulin.
Tandem insulin pump, dexcom G5 sensor, Nexus 5 cellphone running the iMAP algorithm.
3555 University Street
Montreal, Quebec, Canada
Each participant's time in target range
Time in target range (3.9-10mmol/L)
Time frame: 12 days
Mean score of the Emotional Burden section of the Diabetes Distress Scale
Average of all question's scores (from 1-6). Higher score means more emotional burden.
Time frame: 12 days
Each participant's percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L
Time frame: 12 days
Each participant's percentage of time of glucose levels spent between 3.9 and 10 mmol/L
Time frame: 12 days
Each participant's percentage of time of glucose levels spent below 3.9, 3.3, and 2.8 mmol/L
Time frame: 12 days
Each participant's percentage of time of glucose levels spent above 7.8, 10, 13.9 and 16.7 mmol/L
Time frame: 12 days
Each participant's mean glucose level
Time frame: 12 days
Each participant's standard deviation of glucose levels as a measure of glucose variability
Time frame: 12 days
Each participant's number of hypoglycemia events defined as at least 15 min below 3.0 mmol/L
Time frame: 12 days
Each participant's number of Gastrointestinal symptoms
Time frame: 12 days
Each participant's total insulin delivery
Time frame: 12 days
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