NCT03993366

Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement

A Preliminary Pilot Study to Assess Insulin-plus-Pramlintide Closed-loop Delivery System in Pump Treated Patients With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: McGill University · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-08-06
• Completion: 2019-08-06
• First posted: 2019-06-20
• Last updated: 2021-04-01

Locations

1 site across 1 country: Canada