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

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ClinicalTrials.gov Identifier: NCT03262415
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
Cambridge Medical Technologies, LLC
Information provided by (Responsible Party):
Joslin Diabetes Center

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. 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.

Condition or disease Intervention/treatment
Type1 Diabetes Mellitus Type 2 Diabetes Mellitus Device: LabPatch Continuous Glucose Monitoring (CGM)

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor
Actual Study Start Date : February 17, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Group/Cohort Intervention/treatment
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)
  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.




Primary Outcome Measures :
  1. Mean absolute relative difference (MARD) [ Time Frame: Baseline, every 15 minutes after breakfast for 2 hours, every 30 minutes until lunch time, and every 30 minutes after lunch for 2 hours ]
    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 (%).


Biospecimen Retention:   Samples Without DNA
20 to 22 blood sample( A total of about 110 mL of blood will be drawn during the visit).


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult subjects with type 1 or type 2 diabetes treated with insulin.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262415


Contacts
Contact: Sahar Ashrafzadeh, AB 617-309-4131 sahar.ashrafzadeh@joslin.harvard.edu
Contact: Shaheen Tomah, MD 617-309-4144 shaheen.tomah@joslin.harvard.edu

Locations
United States, Massachusetts
Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sahar Ashrafzadeh, AB    617-309-4131    sahar.ashrafzadeh@joslin.harvard.edu   
Contact: Shaheen Tomah, M.D.    617-309-4144    shaheen.tomah@joslin.harvard.edu   
Principal Investigator: Osama Hamdy, M.D.         
Sub-Investigator: Adham Mottalib, M.D.         
Sub-Investigator: Shaheen Tomah, M.D.         
Sub-Investigator: Khaled Alsibai, M.D.         
Sponsors and Collaborators
Joslin Diabetes Center
Cambridge Medical Technologies, LLC
Investigators
Principal Investigator: Osama Hamdy, M.D.,Ph.D Joslin Diabetes Center

Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT03262415     History of Changes
Other Study ID Numbers: CHS #: 2016-31
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joslin Diabetes Center:
LabPatch Continuous Glucose Monitoring (CGM)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases