Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT02241993
Status:
COMPLETED
Last Update Posted:
2014-09-16
First Post:
2013-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Multi-Sensor Distance Accuracy Study
Sponsor:
Oregon Health and Science University
Organization:
Study Overview
Official Title:
The Accuracy Benefit of Dual vs Single Amperometric Glucose Sensors in Persons With Type 1 Diabetes: Effect of Inter-sensor Distance
Status:
COMPLETED
Status Verified Date:
2014-09
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 the study is to test the accuracy benefit of having two glucose sensors (over one sensor alone) when they are positioned: 2mm, 10mm, 20mm, or 30mm apart. It is not yet known how close two sensors can be and still work correctly.
Detailed Description:
An artificial pancreas system will likely require multiple glucose sensing elements to function safely. It is not yet known how close two glucose sensors can be placed and still work properly. Meaning, if one is reading inaccurately,and the other is positioned adjacent to it, will it read inaccurately also, defeating the purpose of having two sensors. Twenty adult subjects with Type 1 diabetes will wear four Medtronic REAL-Time glucose sensors during two separate 10-hour studies. The inter-sensor distances of each pair to be tested will be: 2, 10, 20, and 30mm apart. The sensors will be inserted the day prior to the study day to allow for signal stabilization and calibration. During the study day, arterialized venous blood will be drawn every 15 minutes to measure blood glucose. The sensor values and interstitial values will be recorded from each sensor receiver at each time point. Subjects will be fed two standardized meals and given pre-meal insulin based on their typical insulin to carbohydrate ratio.
Study Oversight
Has Oversight DMC:
False
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?: