Type 2 Diabetes
Conditions
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.
Interventions
DEVICEH.G.R (GWave) non-invasive glucometer
Glucose tolerance test
Sponsors
Prof. Amir Tirosh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| difference between core lab and non invasive glucose measurements | 3 HOURS | difference between core lab and non invasive glucose measurements |
Countries
Israel
Outcome results
None listed