PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor
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|ClinicalTrials.gov Identifier: NCT03262415|
Recruitment Status : Completed
First Posted : August 25, 2017
Last Update Posted : June 1, 2020
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:
- 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.
- A Lab Patch holding device (blue box).
- A wire that connects the chip to a laptop that continuously captures glucose data.
|Condition or disease||Intervention/treatment|
|Type1 Diabetes Mellitus Type 2 Diabetes Mellitus||Device: LabPatch Continuous Glucose Monitoring (CGM)|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor|
|Actual Study Start Date :||February 17, 2017|
|Actual Primary Completion Date :||May 22, 2019|
|Actual Study Completion Date :||May 22, 2019|
30 adult subjects with type 1 or type 2 diabetes treated with insulin. The accuracy of the LabPatch Continuous Glucose Monitoring (CGM) will be evaluated during the study visit, comparing to YSI 2300 STAT Plus, OneTouch Verio and FreeStyle Lite.
Device: LabPatch Continuous Glucose Monitoring (CGM)
- Mean absolute relative difference (MARD) [ Time Frame: Baseline, every 15 minutes after breakfast for 2 hours, every 30 minutes until lunch time, and every 30 minutes after lunch for 2 hours ]Blood glucose values (mg/dL) from the LabPatch system and reference YSI, One Touch Verio, and FreeStyle Lite will be used to report the mean absolute relative difference (MARD) in Percentage (%).
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262415
|United States, Massachusetts|
|Joslin Diabetes Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Osama Hamdy, M.D.,Ph.D||Joslin Diabetes Center|