N/A
N=210
Spectrophon LTD Glucometry Monitor Accuracy
Glucose Metabolism Disorders · Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT03359629 ↗Enrolled (actual)
210
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Percentage of Measurements With < 15% Error — 95.25; 100; 94.5; 100 Percentage of measures with error <15%
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Spectrophon Glucometry Monitor (Device); YSI 2300 Stat Plus (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tirat Carmel Mental Health Center
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Measurements With < 15% Error |
95.25; 100; 94.5; 100 | — |
Summary
Diabetes mellitus (or diabetes) is a chronic, metabolic disease characterized by elevated levels of blood glucose. Patients with diabetes need to monitor their blood glucose level several times a day to control their medical state. Modern biosensors have become a promising solution for non-invasive blood glucose measurements. This study aims to validate the efficacy and the accuracy of Glucometry Monitor (NIGM) developed by Spectrophon LTD incorporated in smart watches.
Method Participants will use Spectrophon biosensors to non-invasively estimate the level of glucose in blood. Blood will also be collected and the glucose level will be checked with commercially available blood glucose analyzers . All sets of data will be compared to estimate the accuracy of measurements of Spectrophon NIGM
Eligibility Criteria
Inclusion Criteria
- must be between ages 18 and 75
- must be able to sign informed consent form.
Exclusion Criteria
- Acute psychotic state
- Hepatitis
- HIV
- Tuberculosis
- Haemophilia and other serious coagulation disorders
- Significant impaired venous access
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT03359629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.