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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04243629
Other study ID # 2020-6258
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 12, 2021
Est. completion date April 2024

Study information

Verified date March 2023
Source McGill University
Contact Elisa Cohen, BSs
Phone 6472372366
Email elisa.cohen@mail.mcgill.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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Study Design


Intervention

Drug:
Rapid-Acting Insulin
Novorapid or Humalog insulin delivered in a basal-bolus manner.
Placebo
Placebo (saline) delivered in a basal-bolus manner at a fixed ratio with insulin.
Pramlintide Acetate
Pramlintide acetate delivered in a basal-bolus manner at a fixed ratio with insulin.
Device:
Artificial Pancreas
Tandem insulin pump, Dexcom G6 sensor, study smartphone running the iMAP algorithm.

Locations

Country Name City State
Canada McGill University Health Centre Montreal Quebec

Sponsors (2)

Lead Sponsor Collaborator
McGill University Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time in target range Time each participant spent with glucose level in target range (3.9 - 10.0 mmol/L) 4 weeks
Secondary Time between 3.9 - 7.8 mmol/L Percentage of time each participant spent with glucose levels between 3.9 - 7.8 mmol/L 4 weeks
Secondary 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 4 weeks
Secondary 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 4 weeks
Secondary Mean glucose level Each participant's mean glucose level 4 weeks
Secondary Total insulin delivery Each participant's total insulin delivery 4 weeks
Secondary Standard deviation and coefficient of variance Each participant's standard deviation and coefficient of variance of glucose levels as a measure of glucose variability 4 weeks
Secondary Gastrointestinal symptoms Number of each participant's gastrointestinal symptoms 4 weeks
Secondary 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. 4 weeks
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