Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hyperglycemia, Postprandial
- Type 1 Diabetes
- Type 1 Diabetes Mellitus
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: This is a three-way, randomized, blinded, crossover trial to compare the following strategies: (i) Fiasp-plus-Pramlintide closed-loop delivery with a simple meal announcement (pressing a button, no carbohydrate counting) (ii) Fiasp-plus-placebo closed-loop delivery with conventional carbohydrate counting (iii) Fiasp-plus-placebo closed-loop delivery with a simple meal announcementMasking: Triple (Participant, Care Provider, Investigator)Masking Description: This study will be a double-blinded study, where the participants and researchers will be blinded to the study drugs. Participants will wear two pumps for all interventions, one for insulin and the other for pramlintide/placebo (saline solution).Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04163874
- Collaborators
- Juvenile Diabetes Research Foundation
- Investigators
- Not Provided
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