Clinical trial NCT03359629: Spectrophon LTD Glucometry Monitor Accuracy
Official title: Accuracy Evaluation of Glucometry Monitor Developed by Spectrophon LTD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glucose Metabolism Disorders
Diabetes Mellitus
Keywords: Spectrophon
Glucose
Biosensor
Non-invasive testing
Lead sponsor: Tirat Carmel Mental Health Center
Sponsor class: OTHER_GOV
Collaborators: name: Ariel University
First posted: 2017-12-02
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Israeli and non-israeli citizens of age 18-75.

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

Detailed description: Diabetes is a chronic, life-long disease that represents a major public health challenge at a world level (Matthews et al 1985). It is important to note that diabetes is common among mentally ill patients, especially among patients with schizophrenia that are treated with new generation antipsychotic drugs (Nielsen et al 2010, Vancampfort et al 2016).

To maintain blood glucose level homeostasis, repeated blood glucose testing is needed. The vast majorities of currently available methods for blood glucose testing are invasive and cause discomfort for patients. However, biosensors have recently become a promising solution for non-invasive glucose blood testing (Bandodkar et al 2014; Zhang et al 2015). Spectrophon LTD has developed a technology that allows measurement of even the smallest amounts of various compounds contained in sweat. Using unique algorithm developed by Spectrophon LTD, these data provides the possibility of evaluating the levels of chemicals in the bloodstream. Based on this technology, Spectrophone LTD has developed a glucometer biosensor that is able to non-invasively detect the blood glucose level. This glucometer biosensor can be easily incorporated into most commercially available smartwatches. Development of this technology will allow real-time, non-invasive measurement of blood glucose level and will dramatically facilitate effective treatment of diabetes. In addition, this technology will enable monitoring of glucose levels in patients with mental disorders that will facilitate the early detection of metabolic syndrome.

Study Design: this naturalistic study will examine the accuracy of Spectrophon NIGM incorporated in smart watch Samsung Gear S2 that non-invasively and indirectly detect the level of glucose in human blood. The study will be held in Maale Carmel Mental Health Center (MCMHC). Adult participants (n=200) will be recruited for the study from the staff of MCMHC (including doctors, nurses and administrative workers; no psychiatric in-patients will be recruited for the study). In parallel to glucose measurements with NIGM, blood will be collected and the glucose level will be checked using commercially available blood glucose analyzers.

The participants will be able to select between two options for blood collection:

The first option: intravenous cannula (Venflon) will be inserted in cubital vein and blood will be collected twice in the beginning and at the end of the procedure (within 1-3 hours) and checked for the glucose level with commercially available blood glucose analyzers.

The second option: The blood will be collected twice from the cubital vein at the beginning and at the end of the procedure (within 1-3 hours) and checked for the glucose level using commercially available blood glucose analyzers .

The measurements will be performed twice: before meal (subject should be in fasting state) and after meal with one hour interval between two measurements.

The results of the measurements of the NIGM will be compared to the results obtained from commercially available blood glucose analyzers.

The application automatically saves every measurement into archive. To better control the process, the manual fixation of data obtained by NIGM is performed.

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

Primary outcomes:
measure: Percentage of Measurements With < 15% Error
timeFrame: 1-3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tirat Karmel
country: Israel
facility: Tirat Carmel Mental Health Center
state: Haifa
Study officials:
affiliation: Bruce Rappaport Medical Faculty, Technion, Haifa, Israel
name: Anatoly Kreinin, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: