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Spectrophon LTD Glucometry Monitor Accuracy

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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

Tracking Information
First Submitted Date November 23, 2017
First Posted Date December 2, 2017
Results First Submitted Date December 18, 2017
Results First Posted Date March 7, 2019
Last Update Posted Date March 7, 2019
Actual Study Start Date September 27, 2017
Actual Primary Completion Date October 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 9, 2018)
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
Original Primary Outcome Measures
 (submitted: November 30, 2017)
Comparison of Spectrophon LTD glucometry monitor with a commercial test [ Time Frame: 1-3 hours ]
Difference in measurements of blood glucose level obtained using Spectrophon glucometry monitor and commercially available glucose analyser YSI 2300
Change History Complete list of historical versions of study NCT03359629 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Spectrophon LTD Glucometry Monitor Accuracy
Official Title Accuracy Evaluation of Glucometry Monitor Developed by Spectrophon LTD
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Israeli and non-israeli citizens of age 18-75.
Condition
  • Glucose Metabolism Disorders
  • Diabetes Mellitus
Intervention
  • Device: Spectrophon Glucometry Monitor
    Wearable smartwatch with integrated non-invasive glucose detection system
  • Device: YSI 2300 Stat Plus
    Reference commercial glucometer
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 9, 2018)
210
Original Actual Enrollment
 (submitted: November 30, 2017)
200
Actual Study Completion Date October 16, 2017
Actual Primary Completion Date October 15, 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT03359629
Other Study ID Numbers SGM-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Anatoly Kreinin, MD, PHD, Tirat Carmel Mental Health Center
Study Sponsor Tirat Carmel Mental Health Center
Collaborators Ariel University
Investigators
Principal Investigator: Anatoly Kreinin, MD, PHD Bruce Rappaport Medical Faculty, Technion, Haifa, Israel
PRS Account Tirat Carmel Mental Health Center
Verification Date November 2018