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Warming up to Sensors: Does Site Warming Improve Continuous Glucose Monitor Performance?

Type 1 Diabetes Clinical Trial

Official title:
Warming up to Sensors: Does Site Warming Improve Continuous Glucose Monitor Performance?

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01954459
Study type Interventional
Source Yale University
Contact
Status Terminated
Phase Early Phase 1
Start date September 2013
Completion date June 2016
View Details
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