The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System in Insulin-treated Patients With Diabetes
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.
Description
In a pilot study conducted previously by our group using the prototype 1st generation LabPatch system (PRECISION study, 2016-31), the investigators found that LabPatch glucose measurements strongly correlated with those of YSI, OneTouch Verio, and Freestyle lite in a sample of 30 subjects. However, the investigators observed significant inter- and intra-subject variability of LabPatch glucose measurements. Factors that may have contributed to this variability include: manual manufacturing of the 1st Gen LabPatch circuit chips and/or variability in the pressure applied by subjects on the circui…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study. 2. Subject is between 18 and 75 years of age. 3. Subject is diagnosed with type 1 diabetes or type 2 diabetes for ≥3 months and is being treated with insulin injections in the form of multiple daily injections or through insulin infusion pump. 4. Subject is a male or a non-pregnant…
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
Location
- Joslin Diabetes CenterBoston, Massachusetts