Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-31 @ 12:34 PM
Study NCT ID:
NCT01490151
Status:
COMPLETED
Last Update Posted:
2017-09-29
First Post:
2011-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Medtronic Treat to Range (TTR) Closed-Loop Control
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Medtronic Treat to Range (TTR) Closed-Loop Control: Tuning a Treat-to-Range Controller for the Effects of High and Low Glycemic Index Meals
Status:
COMPLETED
Status Verified Date:
2017-08
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:
The purpose of this study is to evaluate a treat-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes.
Detailed Description:
The purpose of this study is to demonstrate the safety and efficacy of a closed-loop "treat-to-range" (TTR) system in an inpatient clinical research center setting. The TTR system only effects insulin delivery when the glucose is projected to be above or below specified target ranges. These initial studies will assess the safety of this algorithm (mathematical equation) under the extreme conditions of a missed meal insulin bolus and meal over-insulinization. This is a "hybrid" system, which allows the research team to deliver insulin boluses manually with the TTR controller only becoming active when blood glucose levels are projected to be out of the specified range.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SPO 53117 | OTHER_GRANT | Medtronic | View |