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NCT04658082 Clinical Trial

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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04658082
Other study ID # Sheba-19-6335-at-ctil
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 7, 2020
Est. completion date December 1, 2020

Study information
Verified date May 2022
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date December 1, 2020
Est. primary completion date November 16, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• H.G.R (GWave) non-invasive glucometer
Glucose tolerance test

Locations
Country Name City State
Israel Sheba Medical Center Tel-Hashomer

Sponsors (1)
Lead Sponsor Collaborator
Prof. Amir Tirosh

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary difference between core lab and non invasive glucose measurements difference between core lab and non invasive glucose measurements 3 HOURS
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