Insulet Artificial Pancreas Early Feasibility Study
NCT02897557 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2021-04-09
Summary
The purpose is to perform an early investigation on the safety and performance of an Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and gather clinical data that will be used to make improvements or modifications to the algorithm for subsequent studies in adults, adolescents and children with type 1 diabetes.
Conditions
Interventions
- DEVICE
-
Insulet Artificial Pancreas (AP) System
Sponsors & Collaborators
-
Insulet Corporation
lead INDUSTRY
Principal Investigators
-
Bruce Buckingham, MD · Stanford University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 6 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-30
- Primary Completion
- 2017-02-28
- Completion
- 2017-03-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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