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

NCT05754281 | Recruiting

• 1 other identifier: STUDY00000130
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Keywords

LabPatch Continuous Glucose Monitoring (CGM)

Outcome Measures

Primary Outcomes (1)

• Mean absolute relative difference (MARD)

  Blood glucose values (mg/dL) from the LabPatch system and reference YSI, One Touch Verio, and FreeStyle Lite will be used to report the mean absolute relative difference (MARD) in Percentage (%).

  Baseline, every 15 minutes for a total of 6 hours

Study Arms (1)

Study Cohort

60 adult subjects with type 1 or type 2 diabetes treated with insulin. The accuracy of the 2nd Gen LabPatch Continuous Glucose Sensing will be evaluated during the study visit, comparing to YSI 2300 STAT Plus, OneTouch Verio and FreeStyle Lite.

Device: 2nd Gen LabPatch Glucose Sensing System

Interventions

2nd Gen LabPatch Glucose Sensing System DEVICE

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

Study Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects with type 1 or type 2 diabetes treated with insulin.

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.

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• Cambridge Medical Technologies, LLC: collaborator

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 3, 2023
• Study Start: February 3, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)