Actively Recruiting
The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System
Led by Joslin Diabetes Center · Updated on 2025-09-05
60
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
Sponsors
J
Joslin Diabetes Center
Lead Sponsor
C
Cambridge Medical Technologies, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has voluntarily signed and dated an informed consent form approved by an Institutional Review Board/Independent Ethics Committee and provided privacy authorization before starting the study.
- Subject is between 18 and 75 years old.
- Subject has been diagnosed with type 1 or type 2 diabetes for at least 3 months and is treated with insulin injections or an insulin infusion pump.
- Subject is male or a non-pregnant, non-lactating female at least 6 weeks postpartum prior to screening. Female subjects must have a urine pregnancy test unless not of childbearing potential (postmenopausal for at least one year or surgically sterile).
You will not qualify if you...
- Subject is pregnant or breastfeeding.
- Subject is not treated with insulin.
- Subject has or had an acute or chronic contagious infectious disease.
- Subject has a history of blood-borne chronic viral infections such as Hepatitis C or HIV.
- Subject has or had clotting or bleeding disorders or other blood diseases.
- Subject has an active cancer, except certain skin cancers (basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
- Subject had a recent cardiovascular event (heart attack or stroke) within 6 months before screening or has a history of congestive heart failure.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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