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A Fully-closed Loop, Pramlintide and Insulin, Artificial Pancreas Clinical Trial for Adults With Type 1 Diabetes

NCT05199714 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-10-25

No results posted yet for this study

Summary

The investigators aim to assess the glycemic outcomes of a fully automated insulin-and-pramlintide artificial pancreas and a comparator insulin-alone artificial pancreas with carbohydrate matched boluses.

Conditions

Interventions

DRUG

Fiasp

Fiasp Insulin delivered in a basal-bolus manner.

DEVICE

Artificial Pancreas

Medtronic insulin pump, Dexcom G6 continuous glucose sensor, tablet running the Artificial Pancreas Algorithm.

DRUG

Pramlintide

Pramlintide delivered in a basal-bolus manner.

DRUG

Aspart

Aspart insulin delivered in a basal-bolus manner.

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Michael Tsoukas, M.D. · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-21
Primary Completion
2023-03-25
Completion
2023-03-25

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT05199714 on ClinicalTrials.gov