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The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System
Sponsor: Joslin Diabetes Center
Summary
The purpose of this study is to evaluate the accuracy of the Cambridge Medical Technologies, LLC second generation (2nd Gen) LabPatch glucose sensing system compared to a laboratory glucose analyzer (YSI 2300 STAT Plus) and 2 commercial glucometers, OneTouch Verio and Freestyle Lite. The primary endpoint of this study is the mean absolute relative difference (MARD) for 2nd Gen LabPatch system compared to each of the above mentioned glucose references over a 6 hour outpatient visit.
Official title: The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System in Insulin-treated Patients With Diabetes
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2023-02-03
Completion Date
2026-12-31
Last Updated
2025-09-05
Healthy Volunteers
No
Interventions
2nd Gen LabPatch Glucose Sensing System
I. The 2nd Gen LabPatch chip which lies in the center of a clasp unit. The chip measures approximately 15.7 mm \[0.618"\] x 15.7 mm \[0.618"\]. The chip has a telescopic micropipette which draws interstitial fluid to be analyzed for glucose levels. The chip is also able to measure skin temperature to ensure appropriate skin contact II. A LabPatch clasp device III. A wire that connects the clasp unit to a Windows tablet which will communicate with the clasp via an application. Each data point will be viewed on the tablet and the application will also have some limited graphing capabilities to view trends of previous measurements
Locations (1)
Joslin Diabetes Center
Boston, Massachusetts, United States