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The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System

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ClinicalTrials.gov Identifier: NCT05754281
Recruitment Status : Recruiting
First Posted : March 3, 2023
Last Update Posted : March 8, 2024
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 of the Cambridge Medical Technologies, LLC second generation (2nd Gen) LabPatch glucose sensing system compared to a laboratory glucose analyzer (YSI 2300 STAT Plus) and 2 commercial glucometers, OneTouch Verio and Freestyle Lite. The primary endpoint of this study is the mean absolute relative difference (MARD) for 2nd Gen LabPatch system compared to each of the above mentioned glucose references over a 6 hour outpatient visit.

Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Device: 2nd Gen LabPatch Glucose Sensing System

Detailed Description:

In a pilot study conducted previously by our group using the prototype 1st generation LabPatch system (PRECISION study, 2016-31), we found that LabPatch glucose measurements strongly correlated with those of YSI, OneTouch Verio, and Freestyle lite in a sample of 30 subjects (Tomah et al Diabetes Jun 2020, 69 (Supplement 1) 885-P). However, we observed significant inter- and intra-subject variability of LabPatch glucose measurements. Factors that may have contributed to this variability include: manual manufacturing of the 1st Gen LabPatch circuit chips and/or variability in the pressure applied by subjects on the circuit chip at each measurement. To control for these variables with the goal of improving overall accuracy, Cambridge Medical Technologies, LLC significantly improved and completely automated the manufacturing process of the circuit chips. In addition, the system has been miniaturized to a more user-friendly layout and with a clasp unit to control for pressure applied by the subject finger on the circuit chip.

The 2nd Gen LabPatch system consists of:

I. The 2nd Gen LabPatch chip which lies in the center of a clasp unit. The chip measures approximately 15.7 mm [0.618"] x 15.7 mm [0.618"]. 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 II. A LabPatch clasp device III. A wire that connects the clasp unit to a Windows tablet which will communicate with the clasp via an application. Each data point will be viewed on the tablet and the application will also have some limited graphing capabilities to view trends of previous measurements The system has been previously tested on 10 human subjects with type 1 diabetes, each for six hours, at the Georgetown University Medical Center under clinical conditions supervised by a medical team including an endocrinologist and dermatologist. The test confirmed the absence of pain or abnormal physical sensation and that the operation of the device causes no tissue damage,instigates no neural sensation for the subject, and leaves no blemish on the skin. No skin damage incurred by the LabPatch operation was detected.

The 2nd Gen LabPatch system is an in vitro diagnostic device (IVD), does not have significant risk and is therefore exempted from the IDE requirements. In addition, the device uses an in vitro diagnostic technology that does not create adverse events and therefore a data safety monitoring board (DSMB) is not requited.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System in Insulin-treated Patients With Diabetes
Actual Study Start Date : February 3, 2023
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Group/Cohort Intervention/treatment
Study Cohort
60 adult subjects with type 1 or type 2 diabetes treated with insulin. The accuracy of the 2nd Gen LabPatch Continuous Glucose Sensing will be evaluated during the study visit, comparing to YSI 2300 STAT Plus, OneTouch Verio and FreeStyle Lite.
Device: 2nd Gen LabPatch Glucose Sensing System

I. The 2nd Gen LabPatch chip which lies in the center of a clasp unit. The chip measures approximately 15.7 mm [0.618"] x 15.7 mm [0.618"]. 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

II. A LabPatch clasp device

III. A wire that connects the clasp unit to a Windows tablet which will communicate with the clasp via an application. Each data point will be viewed on the tablet and the application will also have some limited graphing capabilities to view trends of previous measurements





Primary Outcome Measures :
  1. Mean absolute relative difference (MARD) [ Time Frame: Baseline, every 15 minutes for a total of 6 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 (%).



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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:

  1. 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.
  2. Subject is between 18 and 75 years of age.
  3. Subject is diagnosed with type 1 diabetes or type 2 diabetes for ≥3 months and is being treated with insulin injections in the form of multiple daily injections or through insulin infusion pump.
  4. 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:

  1. Subject is pregnant or lactating.
  2. Subject is not treated with insulin.
  3. Subject has/had acute or chronic, contagious, infectious disease
  4. Subjects with history of blood-born chronic viral infection (e.g. Hepatitis C and HIV)
  5. Subject has/had clotting or bleeding disorders or other hematological disease.
  6. Subject has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
  7. Subject had a recent cardiovascular event (e.g., myocardial infarction, stroke) ≤ six months prior to screening visit; or stated history of congestive heart failure.

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): NCT05754281


Locations
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United States, Massachusetts
Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Shilton Dhaver, BS    617-309-4152    shilton.dhaver@joslin.harvard.edu   
Contact: Karim Kibaa, MD    6173094157    karim.kibaa@joslin.harvard.edu   
Principal Investigator: Osama Hamdy, MD, PhD         
Sub-Investigator: Karim Kibaa, MD         
Sub-Investigator: Tareq Salah, MD         
Sub-Investigator: Marwa Al-Badri, MD         
Sub-Investigator: Abdelrahman Khater, MD         
Sponsors and Collaborators
Joslin Diabetes Center
Cambridge Medical Technologies, LLC
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Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT05754281    
Other Study ID Numbers: STUDY00000130
First Posted: March 3, 2023    Key Record Dates
Last Update Posted: March 8, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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