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Spectrophon LTD Glucometry Monitor Accuracy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03359629
Recruitment Status : Completed
First Posted : December 2, 2017
Results First Posted : March 7, 2019
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
Ariel University
Information provided by (Responsible Party):
Anatoly Kreinin, MD, PHD, Tirat Carmel Mental Health Center

Study Description
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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


Condition or disease Intervention/treatment
Glucose Metabolism Disorders Diabetes Mellitus Device: Spectrophon Glucometry Monitor Device: YSI 2300 Stat Plus

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.

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Accuracy Evaluation of Glucometry Monitor Developed by Spectrophon LTD
Actual Study Start Date : September 27, 2017
Actual Primary Completion Date : October 15, 2017
Actual Study Completion Date : October 16, 2017
Groups and Cohorts
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Intervention Details:
  • Device: Spectrophon Glucometry Monitor
    Wearable smartwatch with integrated non-invasive glucose detection system
  • Device: YSI 2300 Stat Plus
    Reference commercial glucometer

Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Measurements With < 15% Error [ Time Frame: 1-3 hours ]
    Difference in measurements of blood glucose level obtained using Spectrophon glucometry monitor and commercially available glucose analyser YSI 2300


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Israeli and non-israeli citizens of age 18-75.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359629


Locations
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Israel
Tirat Carmel Mental Health Center
Tirat Karmel, Haifa, Israel, 30200
Sponsors and Collaborators
Tirat Carmel Mental Health Center
Ariel University
Investigators
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Principal Investigator: Anatoly Kreinin, MD, PHD Bruce Rappaport Medical Faculty, Technion, Haifa, Israel
  Study Documents (Full-Text)

Documents provided by Anatoly Kreinin, MD, PHD, Tirat Carmel Mental Health Center:
Study Protocol and Statistical Analysis Plan  [PDF] October 17, 2017

More Information
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Additional Information:

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Responsible Party: Anatoly Kreinin, MD, PHD, Clinical Assistant Professor, Tirat Carmel Mental Health Center
ClinicalTrials.gov Identifier: NCT03359629    
Other Study ID Numbers: SGM-1
First Posted: December 2, 2017    Key Record Dates
Results First Posted: March 7, 2019
Last Update Posted: March 7, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anatoly Kreinin, MD, PHD, Tirat Carmel Mental Health Center:
Spectrophon
Glucose
Biosensor
Non-invasive testing
Additional relevant MeSH terms:
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Metabolic Diseases
Glucose Metabolism Disorders