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NCT03359629

Spectrophon LTD Glucometry Monitor Accuracy

Completed Results posted Last updated 7 March 2019
What this trial tests

trial testing Spectrophon Glucometry Monitor in Glucose Metabolism Disorders in 210 participants. Completed in 16 October 2017.

Timeline
27 September 2017
Primary endpoint
15 October 2017
16 October 2017

Quick facts

Lead sponsorTirat Carmel Mental Health Center
StatusCompleted
Study typeOBSERVATIONAL
Enrollment210
Start date27 September 2017
Primary completion15 October 2017
Estimated completion16 October 2017
Sites1 location across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Tirat Carmel Mental Health Center — full company profile →

Who can join

Adults 18 to 75, any sex, with Glucose Metabolism Disorders or Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Measurements With < 15% Error Primary · 1-3 hours

Difference in measurements of blood glucose level obtained using Spectrophon glucometry monitor and commercially available glucose analyser YSI 2300

Algorithm 1.7
GroupValue95% CI
Blood Collection (Healthy Individuals)95.25
Blood Collection (Diabetic Patients)100
Algorithm 1.6
GroupValue95% CI
Blood Collection (Healthy Individuals)94.5
Blood Collection (Diabetic Patients)100

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Glucose Metabolism Disorders

Currently open trials in the same condition.

Other Tirat Carmel Mental Health Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03359629.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing