Spectrophon LTD Glucometry Monitor Accuracy
Accuracy Evaluation of Glucometry Monitor Developed by Spectrophon LTD
1 other identifier
observational
210
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2017
CompletedFirst Submitted
Initial submission to the registry
November 23, 2017
CompletedFirst Posted
Study publicly available on registry
December 2, 2017
CompletedResults Posted
Study results publicly available
March 7, 2019
CompletedMarch 7, 2019
November 1, 2018
18 days
November 23, 2017
December 18, 2017
November 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Measurements With < 15% Error
Difference in measurements of blood glucose level obtained using Spectrophon glucometry monitor and commercially available glucose analyser YSI 2300
1-3 hours
Interventions
Wearable smartwatch with integrated non-invasive glucose detection system
Reference commercial glucometer
Eligibility Criteria
Israeli and non-israeli citizens of age 18-75.
You may qualify if:
- must be between ages 18 and 75
- must be able to sign informed consent form.
You may not qualify if:
- Acute psychotic state
- Hepatitis
- HIV
- Tuberculosis
- Haemophilia and other serious coagulation disorders
- Significant impaired venous access
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tirat Carmel Mental Health Centerlead
- Ariel Universitycollaborator
Study Sites (1)
Tirat Carmel Mental Health Center
Tirat Carmel, Haifa District, 30200, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anatoly Kreinin
- Organization
- Maale Carmel Mental Health Center
Study Officials
- PRINCIPAL INVESTIGATOR
Anatoly Kreinin, MD, PHD
Bruce Rappaport Medical Faculty, Technion, Haifa, Israel
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
November 23, 2017
First Posted
December 2, 2017
Study Start
September 27, 2017
Primary Completion
October 15, 2017
Study Completion
October 16, 2017
Last Updated
March 7, 2019
Results First Posted
March 7, 2019
Record last verified: 2018-11