Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-02-03 @ 7:29 AM
Study NCT ID:
NCT02536950
Status:
COMPLETED
Last Update Posted:
2018-06-21
First Post:
2015-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas
Sponsor:
Bruce A. Buckingham
Organization:
Study Overview
Official Title:
An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label, non-randomized, pilot study to determine the safety and feasibility of the insulin-only bionic pancreas.
Detailed Description:
A total of 16 subjects, ages 18-45, will be enrolled in this crossover study. The study will consist of three 7-day study arms in the following order, one usual care arm, one bionic pancreas insulin only arm with a static glucose target, and one bionic pancreas insulin only arm with at dynamic glucose target.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: