NCT04163874

Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas

Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas: a Randomized Controlled Crossover Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: McGill University · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Type 1 Diabetes
• Type 1 Diabetes Mellitus
• Hyperglycemia, Postprandial

Interventions

Type	Name	Description
DRUG	Fiasp	Fiasp Insulin delivered in a basal-bolus manner.
DRUG	Pramlintide Acetate	Pramlintide delivered in a basal-bolus manner with a fixed ratio with insulin.
DRUG	Placebo	Placebo delivered in a basal-bolus manner with a fixed ratio with insulin.
DEVICE	Artificial Pancreas	Tandem insulin pump, dexcom G5 sensor, Nexus 5 cellphone running the iMAP algorithm.

Timeline

• Start date: 2020-02-14
• Primary completion: 2022-01-30
• Completion: 2022-01-30
• First posted: 2019-11-15
• Last updated: 2022-10-10

Locations

1 site across 1 country: Canada