RecruitingNCT05754281

The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System

The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System in Insulin-treated Patients With Diabetes

Sponsor

Joslin Diabetes Center

Enrollment

60 participants

Start Date

Feb 3, 2023

Study Type

OBSERVATIONAL

Conditions

Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the accuracy of the LabPatch system — a wearable glucose sensor worn on the skin — by comparing its readings to standard blood glucose measurements in people with diabetes who use insulin. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with type 1 or type 2 diabetes for at least 3 months - You are currently using insulin injections (either multiple daily injections or an insulin pump) **You may NOT be eligible if...** - You have not been using insulin as part of your diabetes treatment - You were diagnosed with diabetes less than 3 months ago - You have a skin condition or other factor that would prevent wearing the sensor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICE2nd 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

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NCT05754281

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