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

Prof. Amir Tirosh

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Device: H.G.R (GWave) non-invasive glucometer

Study type: Interventional

Funder types: Other

Identifiers

NCT04658082

Sheba-19-6335-at-ctil

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Non invasive glucose monitor

Other group

Description:

Single arm. All subjects will have glucose levels measured both by non invasive glucometer and by core lab

Treatment:

Device: H.G.R (GWave) non-invasive glucometer