Spectrophon LTD Glucometry Monitor Accuracy

• Sponsor: Tirat Carmel Mental Health Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03359629
• Collaborator: Ariel University (Other)
• Enrollment: 210
• Location: 1
• Actual Duration (Days): 19
• Patients Per Site Per Month: 336.4

Study Details

Study Description

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	Phase
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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 210 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Accuracy Evaluation of Glucometry Monitor Developed by Spectrophon LTD
• Actual Study Start Date: Sep 27, 2017
• Actual Primary Completion Date: Oct 15, 2017
• Actual Study Completion Date: Oct 16, 2017

Outcome Measures

Primary Outcome Measures

1. Percentage of Measurements With < 15% Error [1-3 hours]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Tirat Carmel Mental Health Center	Tirat Karmel	Haifa	Israel	30200

Sponsors and Collaborators

• Tirat Carmel Mental Health Center
• Ariel University

Investigators

• Principal Investigator: Anatoly Kreinin, MD, PHD, Bruce Rappaport Medical Faculty, Technion, Haifa, Israel

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 17, 2017

More Information

Publications

None provided.

• 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: Dec 2, 2017
• Last Update Posted: Mar 7, 2019
• Last Verified: Nov 1, 2018

• 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, Clinical Assistant Professor, Tirat Carmel Mental Health Center: Spectrophon; Glucose; Biosensor; Non-invasive testing
• Additional relevant MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders

Study Results

Participant Flow

Arm/Group Title	Blood Collection (Healthy Individuals)	Blood Collection (Diabetic Patients)
Arm/Group Description	Participants's blood was collected and measured for glucose level before and after food intake	Participants's blood was collected and measured for glucose level
Period Title: Overall Study
STARTED	200	10
COMPLETED	200	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Blood Collection (Healthy Individuals)	Blood Collection (Diabetic Patients)	Total
Arm/Group Description	Participants's blood was collected and measured for glucose level before and after food intake	Participants's blood was collected and measured for glucose level	Total of all reporting groups
Overall Participants	200	10	210
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	188 94%	7 70%	195 92.9%
>=65 years	12 6%	3 30%	15 7.1%
Sex: Female, Male (Count of Participants)
Female	114 57%	7 70%	121 57.6%
Male	86 43%	3 30%	89 42.4%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Israel	200 100%	10 100%	210 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Measurements With < 15% Error
Description	Difference in measurements of blood glucose level obtained using Spectrophon glucometry monitor and commercially available glucose analyser YSI 2300
Time Frame	1-3 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Blood Collection (Healthy Individuals)	Blood Collection (Diabetic Patients)
Arm/Group Description	Participants's blood was collected and measured for glucose level before and after food intake	Participants's blood was collected and measured for glucose level
Measure Participants	200	10
Algorithm 1.7	95.25	100
Algorithm 1.6	94.5	100

Adverse Events

Time Frame	1 day
Arm/Group Title	Blood Collection (Healthy Individuals)		Blood Collection (Diabetic Patients)
Arm/Group Description	Participants's blood was collected and measured for glucose level before and after food intake		Participants's blood was collected and measured for glucose level
All Cause Mortality
	Blood Collection (Healthy Individuals)		Blood Collection (Diabetic Patients)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/200 (0%)		0/10 (0%)
Serious Adverse Events
	Blood Collection (Healthy Individuals)		Blood Collection (Diabetic Patients)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/200 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Blood Collection (Healthy Individuals)		Blood Collection (Diabetic Patients)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/200 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.