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NCT03262415 · ClinicalTrials.gov registry record
PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor
A clinical trial, sponsored by Joslin Diabetes Center.
- Completed
- Registry status
- 30
- Enrollment target
NCT03262415: Completed study, sponsored by Joslin Diabetes Center.
NCT03262415 is a clinical trial that has completed, run by Joslin Diabetes Center. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03262415 has completed, sponsored by Joslin Diabetes Center.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the accuracy and efficacy of the Cambridge Medical Technologies, LLC LabPatch Continuous Glucose Monitoring (CGM) System compared to a laboratory glucose analyzer (YSI 2300 STAT Plus) and 2 commercial glucometers, OneTouch Verio and Freestyle Lite. The LabPatch system includes: 1. The LabPatch circuit chip which lies in the center of a circular push-button. The circuit is in the form of a small chip (approximately 15.7 mm \[0.618"\] x 15.7 mm \[0.618"\]) placed in contact with the skin. 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. 2. A Lab Patch holding device (blue box). 3. A wire that connects the chip to a laptop that continuously captures glucose data.
Primary Outcome
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 (%).
Interventions
- DEVICE LabPatch Continuous Glucose Monitoring (CGM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-02-17 |
| Est. Completion | 2019-05-22 |
What the finished NCT03262415 record still lists
NCT03262415 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which LabPatch Continuous Glucose Monitoring (CGM) is the first listed.
NCT03262415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03262415 about?
NCT03262415 is a clinical study titled "PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor". The purpose of this study is to evaluate the accuracy and efficacy of the Cambridge Medical Technologies, LLC LabPatch Continuous Glucose Monitoring (CGM) System compared to a laboratory glucose analyzer (YSI 2300 STAT Plus) and 2 commercial glucometers, OneTouch Verio and Freestyle Lite. The LabPa...
What is the current status of trial NCT03262415?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2017-02-17. Estimated completion is 2019-05-22.
What interventions are being tested in trial NCT03262415?
The interventions under investigation include: LabPatch Continuous Glucose Monitoring (CGM) (DEVICE).
Who is sponsoring clinical trial NCT03262415?
This trial is sponsored by Joslin Diabetes Center, which has 73 total clinical trials registered on ClinicalTrials.gov.
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