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

Running, not enrolling

Conditions studied: Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT05754281

Run by

Joslin Diabetes Center

People needed

60

Starts

2023-02-03

Expected to finish

2027-12-31

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Subject is between 18 and 75 years of age.
• 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.
• Subject is a male or a non-pregnant and non-lactating female, at least 6 weeks postpartum prior to screening visit. A urine pregnancy test is required for all female subjects unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to screening visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

You may not qualify if…

• Subject is pregnant or lactating.
• Subject is not treated with insulin.
• Subject has/had acute or chronic, contagious, infectious disease
• Subjects with history of blood-born chronic viral infection (e.g. Hepatitis C and HIV)
• Subject has/had clotting or bleeding disorders or other hematological disease.
• Subject has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
• Subject had a recent cardiovascular event (e.g., myocardial infarction, stroke) ≤ six months prior to screening visit; or stated history of congestive heart failure.

Where it is running

• Joslin Diabetes Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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