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

NCT04163874 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-10-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • McGill University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-14
Primary Completion
2022-01-30
Completion
2022-01-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04163874 on ClinicalTrials.gov