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A Pilot Trial to Evalute the Precision and Accuracy of the Non-invasive HGR Glucometer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04658082
Recruitment Status : Completed
First Posted : December 8, 2020
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Amir Tirosh, Sheba Medical Center

Study Description
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Brief Summary:

A pilot study evaluating the accuracty of a non-invasive glucose monitor (GWave) with venous glucose measured by core laboratory during a glucose tolerance test (GTT) in patients with type 2 diabetes.

The study is conducted on 5 subjects undergoing a 75gr GTT, with blood glucose measured at baseline and at 8 time points up to 180 minutes post glucose ingestion both by GWave non-invasive glucometer and by core lab glucose measurement.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Device: H.G.R (GWave) non-invasive glucometer Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Trial to Evalute the Precision and Accuracy of the Non-invasive HGR Glucometer
Actual Study Start Date : October 7, 2020
Actual Primary Completion Date : November 16, 2020
Actual Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Non invasive glucose monitor
Single arm. All subjects will have glucose levels measured both by non invasive glucometer and by core lab
 Device: H.G.R (GWave) non-invasive glucometer
Glucose tolerance test


Outcome Measures
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Primary Outcome Measures :
  1. difference between core lab and non invasive glucose measurements [ Time Frame: 3 HOURS ]
    difference between core lab and non invasive glucose measurements


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 years and over with the diagnosis of Type 2 diabetes mellitus , HbA1c between 6.0-8.0% regardless of treatment

Exclusion Criteria:

  • Participants under the age of 18 years, pregnant women or patients with normal blood glucose).
Contacts and Locations
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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): NCT04658082


Locations
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Israel
Sheba Medical Center
Tel-Hashomer, Israel
Sponsors and Collaborators
Prof. Amir Tirosh
Investigators
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Principal Investigator: Amir Tirosh, MD PhD Sheba Medical Center
More Information
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Responsible Party: Prof. Amir Tirosh, Director, Division of Endocrinology, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT04658082    
Other Study ID Numbers: Sheba-19-6335-at-ctil
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
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