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

NCT04658082 | Completed

• 1 other identifier: Sheba-19-6335-at-ctil
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• difference between core lab and non invasive glucose measurements

  difference between core lab and non invasive glucose measurements

  3 HOURS

Study Arms (1)

Non invasive glucose monitor

OTHER

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

Interventions

H.G.R (GWave) non-invasive glucometer DEVICE

Glucose tolerance test

Non invasive glucose monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Male or female.
• Age above or equal to 18 years at the time of signing informed consent.
• Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
• HbA1c of 6.0-8.0% .

You may not qualify if:

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

Sponsors & Collaborators

• Prof. Amir Tirosh: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Amir Tirosh, MD PhD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Division of Endocrinology

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: October 7, 2020
• Primary Completion: November 16, 2020
• Study Completion: December 1, 2020
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)