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

Launched by JOSLIN DIABETES CENTER · Feb 22, 2023

Keywords

ClinConnect Summary

The PRECISION II Study is looking at a new glucose sensing system called the LabPatch, created by Cambridge Medical Technologies, to see how accurate it is when measuring blood sugar levels in people with type 1 or type 2 diabetes. Researchers will compare the results from the LabPatch to results from a standard laboratory machine and two well-known glucometers (OneTouch Verio and Freestyle Lite) during a six-hour visit. This study aims to find out how closely the LabPatch readings match these established methods.

To participate in this study, you need to be between 18 and 75 years old and have been diagnosed with diabetes for at least three months, using insulin injections or an insulin pump for treatment. You must also be a male or a non-pregnant female who is not currently breastfeeding. If you decide to join, you will sign some forms to ensure you understand the study, and then you’ll have your blood sugar levels measured with the LabPatch and other devices during your visit. It's important to know that certain medical conditions, like being pregnant, having untreated diabetes, or recent serious health issues, may prevent you from participating.

Gender

ALL

Eligibility criteria

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