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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

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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Blood Collection (Healthy Individuals) Blood Collection (Diabetic Patients)
Hide 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
Arm/Group Title Blood Collection (Healthy Individuals) Blood Collection (Diabetic Patients) Total
Hide 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
Hide 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
200 10 210
1.Primary Outcome
Title Percentage of Measurements With < 15% Error
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Blood Collection (Healthy Individuals) Blood Collection (Diabetic Patients)
Hide 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
Time Frame 1 day
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Blood Collection (Healthy Individuals) Blood Collection (Diabetic Patients)
Hide 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%) 
Show Serious Adverse Events Hide 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%) 
Show Other (Not Including Serious) Adverse Events Hide 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%) 
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
Name/Title: Anatoly Kreinin
Organization: Maale Carmel Mental Health Center
Phone: (+972) -4-8559315
Responsible Party: Anatoly Kreinin, MD, PHD, Tirat Carmel Mental Health Center
ClinicalTrials.gov Identifier: NCT03359629     History of Changes
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