Status:
COMPLETED
PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor
Lead Sponsor:
Joslin Diabetes Center
Collaborating Sponsors:
Cambridge Medical Technologies, LLC
Conditions:
Type1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Brief 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 analy...
Detailed Description
Study design: This is a cross-sectional, pilot, precision, single center, single-arm study, enrolling 30 adult subjects with type 1 or type 2 diabetes treated with insulin. The study will include bo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 17 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 22 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03262415
Start Date
February 17 2017
End Date
May 22 2019
Last Update
February 24 2023
Active Locations (1)
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1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215