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OpenTrials
Completed

NCT Number: NCT04658082

A Pilot Trial 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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Medical Center

Tel Litwinsky, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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% .

Exclusion criteria

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

Treatment and study plan

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

Device

Glucose tolerance test

Primary outcomes

  1. difference between core lab and non invasive glucose measurements

    Time frame: 3 HOURS

    difference between core lab and non invasive glucose measurements

Sponsors and collaborators

Lead sponsor

Prof. Amir Tirosh

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 8, 2020
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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