Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-01-24 @ 1:21 PM
Study NCT ID:
NCT01787318
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2013-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the InsuPatch on Automated Closed-loop Glucose Control in Type 1 Diabetes
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Effect of the Insupatch on Automated Closed-loop Glucose Control in Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2016-04
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:
IPCL
Brief Summary:
This research study designed to look at how well adolescents' and young adults' blood sugars can be controlled with a "closed loop artificial pancreas" using a continuous glucose sensor, an insulin pump, and a computer program that automatically determines how much insulin to give based on the glucose level. The investigators will also study the effect of wearing a small heating patch, the InsuPatch, at the site of insulin infusion, on the ability of the closed loop system to control the blood sugar levels and to reduce the rise in glucose levels after meals.
Detailed Description:
This is an open-label, single-center, randomized crossover study evaluating the performance of a closed-loop (CL) insulin delivery system using a subcutaneous glucose sensor and an external insulin pump comparing the peak post-prandial glucose levels and the post-prandial glucose AUC during either CL control alone or CL control with the InsuPatch in an inpatient hospital research unit (HRU) setting. The closed loop visit consists of approximately 67 hours over 4 days and 3 nights.
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?: