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 rapid insulin in an artificial pancreas system will improve glycemic control in adults with Type 1 Diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Novorapid or Humalog insulin delivered in a basal-bolus manner.
Placebo (saline) delivered in a basal-bolus manner at a fixed ratio with insulin.
Pramlintide acetate delivered in a basal-bolus manner at a fixed ratio with insulin.
Tandem insulin pump, Dexcom G6 sensor, study smartphone running the iMAP algorithm.
McGill University Health Centre
Montreal, Quebec, Canada
RECRUITINGTime in target range
Time each participant spent with glucose level in target range (3.9 - 10.0 mmol/L)
Time frame: 4 weeks
Time between 3.9 - 7.8 mmol/L
Percentage of time each participant spent with glucose levels between 3.9 - 7.8 mmol/L
Time frame: 4 weeks
Time below 3,9, 3.3, and 2.8 mmol/L
Percentage of time each participant spent with glucose levels below 3.9, 3.3, and 2.8 mmol/L
Time frame: 4 weeks
Time above 7.8, 10.0, 13.9, 16.7 mmol/L
Percentage of time each participant spent with glucose levels above 7.8, 10.0, 13.9, and 16.7 mmol/L
Time frame: 4 weeks
Mean glucose level
Each participant's mean glucose level
Time frame: 4 weeks
Total insulin delivery
Each participant's total insulin delivery
Time frame: 4 weeks
Standard deviation and coefficient of variance
Each participant's standard deviation and coefficient of variance of glucose levels as a measure of glucose variability
Time frame: 4 weeks
Gastrointestinal symptoms
Number of each participant's gastrointestinal symptoms
Time frame: 4 weeks
Number of hypoglycemia events
Each participant's number of hypoglycemia events defined as at least 15 min below 3.0 mmol/L with the end of the event being 15 minutes \> 3.9 mmol/L.
Time frame: 4 weeks
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