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Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement

NCT03993366 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-04-01

No results posted yet for this study

Summary

The aim of this pilot study is to generate preliminary data of (i) Fiasp-plus-Pramlintide closed-loop system with a simple meal announcement, compared to (ii) Fiasp-alone closed-loop system with full carbohydrate counting, in preparation for an outpatient study over two weeks

Conditions

  • Type 1 Diabetes Mellitus

Interventions

COMBINATION_PRODUCT

Fiasp+Pramlintide Closed-Loop System

Closed-loop insulin delivery with Fiasp insulin and pramlintide

DEVICE

Fiasp Closed-Loop System

Closed-loop insulin delivery with Fiasp insulin alone

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • McGill University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-08-06
Completion
2019-08-06

Countries

  • Canada

Study Locations

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Entities

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 NCT03993366 on ClinicalTrials.gov