Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-03-11 @ 9:13 PM
Study NCT ID:
NCT01954459
Status:
TERMINATED
Last Update Posted:
2020-03-09
First Post:
2013-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Warming up to Sensors: Does Site Warming Improve Continuous Glucose Monitor Performance?
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Warming up to Sensors: Does Site Warming Improve Continuous Glucose Monitor Performance?
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unable to complete due to lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate the effect of wearing a small warming patch, the InsuPatch, at the site of the continuous glucose monitor (CGM), also called a sensor. Specifically, we will be looking to see if using the InsuPatch (IP) improves the accuracy of the continuous glucose monitor.
Detailed Description:
Hypotheses:
1. Warming of the skin and subcutaneous tissue with the InsuPatch device will improve the accuracy of a CGM as compared to a CGM used alone when both are calibrated with a standard laboratory quality glucose measuring reference standard.
2. Warming of the skin and subcutaneous tissue with the InsuPatch device will reduce the lag time of the CGM, as compared to a CGM used alone when both are calibrated with a standard laboratory quality glucose measuring reference standard.
3. The combination of the InsuPatch device and a CGM will be well-tolerated and not cause skin irritation.
1. Warming of the skin and subcutaneous tissue with the InsuPatch device will improve the accuracy of a CGM as compared to a CGM used alone when both are calibrated with a standard laboratory quality glucose measuring reference standard.
2. Warming of the skin and subcutaneous tissue with the InsuPatch device will reduce the lag time of the CGM, as compared to a CGM used alone when both are calibrated with a standard laboratory quality glucose measuring reference standard.
3. The combination of the InsuPatch device and a CGM will be well-tolerated and not cause skin irritation.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DK085618-01 | NIH | None | https://reporter.nih.gov/quic… | View |