A Pilot Trial of the Non-invasive H.G.R Glucometer

May 16, 2022 updated by: Prof. Amir Tirosh

A Pilot Trial to Evaluate the Precision and Accuracy of the Non-invasive H.G.R Glucometer

A pilot study evaluating the accuracy 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Hashomer, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  2. Male or female.
  3. Age above or equal to 18 years at the time of signing informed consent.
  4. Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
  5. HbA1c of 6.0-8.0% .

Exclusion Criteria:

  1. Participants under the age of 18 years
  2. pregnant women or patients with normal blood glucose.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference between core lab and non invasive glucose measurements
Time Frame: 3 HOURS
difference between core lab and non invasive glucose measurements
3 HOURS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Amir Tirosh

Investigators

  • Principal Investigator: amir Tirosh, MD PhD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2020

Primary Completion (Actual)

November 16, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

December 1, 2020

First Submitted That Met QC Criteria

December 1, 2020

First Posted (Actual)

December 8, 2020

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Sheba-19-6335-at-ctil

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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