PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor

Description

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.

Study Start Date

February, 17 2017

Estimated Completion Date

February 2018

Interventions

  • Device: LabPatch Continuous Glucose Monitoring (CGM)

Study ID

Joslin Diabetes Center -- CHS #: 2016-31

Status

Recruiting

Trial ID

NCT03262415

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

30

Sponsor

Joslin Diabetes Center

Inclusion Criteria

  • 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 for ?3 months and is being treated with insulin injections in the form of multiple daily injections or through insulin infusion pump.
  • Subject is diagnosed with type 2 diabetes for ?3 months and is being treated with insulin 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).

Exclusion Criteria

  • 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.
  • Subject has known allergy to adhesive material present in commercial bandages

Gender

All

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Joslin Diabetes Center - Boston, Massachusetts 2.4 miles Taha Elseaidy 617-309-4145 Taha.Elseaidy@joslin.harvard.edu

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