A Pilot Trial of the Non-invasive H.G.R Glucometer
Not Applicable
Completed
- Conditions
- Type 2 Diabetes
- Interventions
- Device: H.G.R (GWave) non-invasive glucometer
- Registration Number
- NCT04658082
- Lead Sponsor
- Prof. Amir Tirosh
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Non invasive glucose monitor H.G.R (GWave) non-invasive glucometer Single arm. All subjects will have glucose levels measured both by non invasive glucometer and by core lab
- Primary Outcome Measures
Name Time Method difference between core lab and non invasive glucose measurements 3 HOURS difference between core lab and non invasive glucose measurements
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sheba Medical Center
🇮🇱Tel-Hashomer, Israel