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Co-administration of Pramlintide and Insulin Via an Automated Dual-hormone Artificial Pancreas System in Adults With Type 1 Diabetes

NCT04243629 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-03-15

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 rapid insulin in an artificial pancreas system will improve glycemic control in adults with Type 1 Diabetes.

Conditions

Interventions

DRUG

Rapid-Acting Insulin

Novorapid or Humalog insulin delivered in a basal-bolus manner.

DRUG

Placebo

Placebo (saline) delivered in a basal-bolus manner at a fixed ratio with insulin.

DRUG

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • McGill University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-12
Primary Completion
2024-04-30
Completion
2024-04-30

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 NCT04243629 on ClinicalTrials.gov