Evaluating the LabPatch Glucose Sensing System for Diabetes Management

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

This study is testing a new glucose monitoring device for people with diabetes to see if it gives more accurate readings compared to standard methods.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Joslin Diabetes Center (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05754281 on ClinicalTrials.gov

What this trial studies

This study aims to assess the accuracy of the 2nd Generation LabPatch glucose sensing system developed by Cambridge Medical Technologies, LLC, by comparing its measurements to those obtained from a laboratory glucose analyzer and two commercial glucometers. Participants will undergo a 6-hour outpatient visit where their glucose levels will be monitored using the LabPatch system. The study builds on previous findings that highlighted variability in glucose measurements from the first generation of the LabPatch system, and it seeks to improve accuracy through enhanced manufacturing and design. The primary outcome will be the mean absolute relative difference (MARD) between the LabPatch system and the reference glucose measurements.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with type 1 or type 2 diabetes who have been on insulin therapy for at least three months.

Not a fit: Patients who are pregnant or lactating will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a more accurate and user-friendly glucose monitoring system for diabetes patients.

How similar studies have performed: Previous studies using similar glucose monitoring technologies have shown promising results, but this specific approach with the 2nd Gen LabPatch is novel.

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.

Where this trial is running

Boston, Massachusetts

• Joslin Diabetes Center — Boston, Massachusetts, United States (RECRUITING)

Conditions: Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, LabPatch Continuous Glucose Monitoring