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

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Primary completion date: Sep 30, 2026 to Sep 30, 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    • Site details revised
    v5
  2. Primary completion date: Sep 30, 2025 to Sep 30, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Site contact updated
    v4
  3. Study description shortened, about 8 words
    • Site contact updated
    v3
  4. Primary completion date: Sep 30, 2024 to Sep 30, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    • Study title shortened, about 5 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05754281
Lead Sponsor Joslin Diabetes Center
Collaborators: Cambridge Medical Technologies, LLC
Conditions
(from sponsor)		 Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Related terms Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov