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

Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Conditions	Glucose Metabolism Disorders Diabetes Mellitus
Interventions	Device: Spectrophon Glucometry Monitor Device: YSI 2300 Stat Plus
Enrollment	210

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Blood Collection (Healthy Individuals)	Blood Collection (Diabetic Patients)
Arm/Group Description	Participants's blood was collected ...	Participants's blood was collected ...
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 ...	Participants's blood was collected ...	Total of all reporting groups
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 Number of Baseline Participants		200	10	210
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	200 participants	10 participants	210 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	188 94.0%	7 70.0%	195 92.9%
	>=65 years	12 6.0%	3 30.0%	15 7.1%
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	200 participants	10 participants	210 participants
	Female	114 57.0%	7 70.0%	121 57.6%
	Male	86 43.0%	3 30.0%	89 42.4%
Race and Ethnicity Not Collected ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment Measure Type: Number Unit of measure: Participants
Israel	Number Analyzed	200 participants	10 participants	210 participants
Israel		200	10	210

Outcome Measures

1.Primary Outcome


Title	Percentage of Measurements With < 15% Error
Description	Difference in measurements of blood glucose level obtained using Spect...
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 ...	Participants's blood was collected ...
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
Overall Number of Participants Analyzed	200	10
Measure Type: Number Unit of Measure: Percentage of measures with error <15%
Algorithm 1.7	95.25	100
Algorithm 1.6	94.5	100

Adverse Events

Time Frame	1 day
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Blood Collection (Healthy Individuals)	Blood Collection (Diabetic Patients)
Arm/Group Description	Participants's blood was collected ...	Participants's blood was collected ...
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 (%)	Affected / at Risk (%)
Total	0/200 (0.00%)	0/10 (0.00%)
Serious Adverse Events Serious Adverse Events
	Blood Collection (Healthy Individuals)	Blood Collection (Diabetic Patients)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/200 (0.00%)	0/10 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Blood Collection (Healthy Individuals)	Blood Collection (Diabetic Patients)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/200 (0.00%)	0/10 (0.00%)

Limitations and 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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Anatoly Kreinin
Organization:	Maale Carmel Mental Health Center
Phone:	(+972) -4-8559315
EMail:	kranata@gmail.com

Layout table for additonal information

Responsible Party:	Anatoly Kreinin, MD, PHD, Tirat Carmel Mental Health Center
ClinicalTrials.gov Identifier:	NCT03359629
Other Study ID Numbers:	SGM-1
First Submitted:	November 23, 2017
First Posted:	December 2, 2017
Results First Submitted:	December 18, 2017
Results First Posted:	March 7, 2019
Last Update Posted:	March 7, 2019

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