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PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor
Sponsor: Joslin Diabetes Center
Summary
The purpose of this study is to evaluate the accuracy and efficacy of the Cambridge Medical Technologies, LLC LabPatch Continuous Glucose Monitoring (CGM) System compared to a laboratory glucose analyzer (YSI 2300 STAT Plus) and 2 commercial glucometers, OneTouch Verio and Freestyle Lite. The LabPatch system includes: 1. The LabPatch circuit chip which lies in the center of a circular push-button. The circuit is in the form of a small chip (approximately 15.7 mm \[0.618"\] x 15.7 mm \[0.618"\]) placed in contact with the skin. 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. 2. A Lab Patch holding device (blue box). 3. A wire that connects the chip to a laptop that continuously captures glucose data.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2017-02-17
Completion Date
2019-05-22
Last Updated
2026-05-29
Healthy Volunteers
No
Interventions
LabPatch Continuous Glucose Monitoring (CGM)
1. The patch device that will be applied to subjects' arms in this study is about 3 inches in length and one inch in width, with adhesive tape on the sides. 2. The LabPatch circuit chip lies on the underside of the bandage. The circuit is in the form of a small chip (approximately 15.7 mm \[0.618"\] x 15.7 mm \[0.618"\]) placed in contact with the skin. 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. 3. A wire that connects the chip to a laptop that continuously captures glucose data.
Locations (1)
Joslin Diabetes Center
Boston, Massachusetts, United States