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

NCT03262415 | Completed

• 1 other identifier: CHS #: 2016-31
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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 analyzer (YSI 2300 STAT Plus) and 2 commercial glucometers, OneTouch Verio and Freestyle Lite. The LabPatch system includes:

1. 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. 2.A Lab Patch holding device (blue box).
3. 3.A wire that connects the chip to a laptop that continuously captures glucose data.

Conditions

Type1 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 after breakfast for 2 hours, every 30 minutes until lunch time, and every 30 minutes after lunch for 2 hours

Study Arms (1)

Study Cohort

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

Device: LabPatch Continuous Glucose Monitoring (CGM)

Interventions

LabPatch Continuous Glucose Monitoring (CGM) DEVICE

1. The patch device that will be applied to subjects' arms in this study is about 3 inches in length and one inch in width, with adhesive tape on the sides. 2. The LabPatch circuit chip lies on the underside of the bandage. 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. 3. A wire that connects the chip to a laptop that continuously captures glucose data.

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 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).

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

Sponsors & Collaborators

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

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

20 to 22 blood sample( A total of about 110 mL of blood will be drawn during the visit).

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Osama Hamdy, M.D.,Ph.D

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 25, 2017
• Study Start: February 17, 2017
• Primary Completion: May 22, 2019
• Study Completion: May 22, 2019
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)