Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587087
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
A Proof of Concept PoC Randomized Controlled Study to Validate the Algorithm and Evaluate the Accuracy Safety and Pain Level of the Smartest-AE in Comparison to Self-measure Blood Glucose Levels
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Proof of Concept PoC Randomized Controlled Study to Validate the Algorithm and Evaluate the Accuracy Safety and Pain Level of the Smartest-AE in Comparison to Self-measure Blood Glucose Levels
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is conducted in Israel so plain language for the study is exist in Hebrew only
Detailed Description:
Protocol Title
A Proof of Concept PoC Randomized Controlled study to validate the algorithm and evaluate the accuracy safety and pain level of the Smartest-AE in comparison to self-measure Blood Glucose Levels
Investigational Device
The Smartest-AE
Device Description
The Smartests System is intended to measure blood glucose levels in home environment The Smartests System consists of a disposable single-use device and a mobile app
At this study Smartest-AE Smartest-AE will be tested
Study Overview
The subjects will be enrolled from the Diabetes Mellitus DM clinics in the hospitals endocrinological clinic Internal divisions obstetrics and gynecology department diabetes in pregnancy and maternal and fetal medicine clinics
Study subjects will be consecutively screened and enrolled into the study The study will include up to 300 subjects men and women aged 18 to 80
The trial will encompass two distinct populations
Group 1- Diabetes Mellitus Patients At least 100 subjects who diagnosed with Type IType II DM or GDM Gestational Diabetes Mellitus who regularly prick their fingers to monitor blood glucose levels and willing to participate in the study and
Group 2- High risk individuals at least 100 individuals who do not typically engage in finger pricking but are at high risk of developing prediabetes or diabetes due to to one of the following various risk factors
BMI gt 25
Age 45 or older
Have a parent or sibling with type 2 diabetes
Have ever had gestational diabetes
Hypercholesterolemia - according to blood level andor using medication for lowering cholesterol
Dyslipidemia - according to blood level andor using medication for lowering lipids Or any other risk factor according to the staffs discretion
The study will be conducted in 2 stages
Stage I- Algorithm verification- Blood glucose levels will be taken from the first 30 subjects in order to verify the algorithm At the end of the enrollment of the first 30 cases an analysis will be done by Smartests RampD If the algorithm yields correlation of R2gt09 based on the calibration curves the study will proceed to the second phase In case the calibration does not show the expected R2 the Smartests RampD will re-assess the algorithm If correction modification to the algorithm will be implemented another 30 subjects will be enrolled to verify the updated algorithm
If the analysis following algorithm update yields satisfying results R2gt09 the study will proceed to the second stage and the results of the 30 subjects used for verification will be included in the final analysis If not the study will be temporarily paused and the device algorithm will be re-assessed by Smartests RampD for accuracy and precision Following that another 30 subjects will be enrolled for algorithm verification If the expected R2 is not obtained the study will be terminated
Blood glucose levels will be measured for all 306090 subjects using 2 devices
1 The Smartest-AE blood sample analyzer and
2 A commercial standard reference approved glucometer including approved needles and strips
The lancet that will be used for all subjects will be the Vitrex Soft Lite lll 28G
All Subjects will complete a Numeric Rating Scale NRS questionnaire Appendix A to determine their level of pain from each device NRS will be completed following each fingers pricking
Following NRS completion blood will be taken from the subjects veins for blood glucose level that will be measured by the sites local lab
NRS will not be completed following blood taken from the vein
Stage II- Following algorithm verification and Smartests approval to continue to stage II at least 200 subjects will be recruited
Blood Glucose levels will be taken from each subject using the 2 devices the Smartest-AE and the commercial glucometer
The blood levels results of the Smartest-AE will be compared to the commercial approved glucometer in order to assess accuracy Subjects comfortpain level will be assessed following each fingers pricking using the Numeric Rating Scale NRS questionnaire
All Subjects will complete the NRS questionnaire to determine their level of pain from each device
Following NRS completion blood will be taken from the subjects veins for blood glucose level that will be measured by the sites local lab
NRS will not be completed following blood taken from the vein No follow-up period is expected
Fingers III middle and IV ring of the non-dominant hand will be pricked Randomization will be used to allocate subjects that will be first tested with the Smartest-AE device and subjects that will be first tested with the commercial device Finger III will always be the first to be pricked
It was decided that subject IDs even numbers will have the first prick with the Smartest-AE and subject IDs odd numbers will have the first prick with the commercial device at each of the groups 1 and 2
In case the device shows error or the results seems objectively to be unreasonable for eg extremely high or low blood glucose level result that does not reflect subject physical condition at the time of test another attempt will be done to achieve the blood glucose level If the error will be obtained in the first test then NRS will be completed by the subject subsequently to the test and the second attempt will be done only after the second reference device test will be performed Up to 2 attempts are allowed for each system Subject that has measurement results only from one system will be excluded from the analysis
In case failings will be occurred in the venous blood test either during the blood taking problematic veins etc or error received from the lab hemolytic blood etc a second attempt will not be done and the result will be indicated as missing
Study Population
Adults volunteers men and women at least 25 of each gender at each group at the ages of 18- 80 years old diagnosed with Type IType II DM or GDM Gestational diabetes Mellitus who regularly prick their fingers to monitor blood glucose levels Group 1 Diabetes Mellitus patients and High risk individuals who do not typically engage in finger pricking but are at high risk of developing prediabetes or diabetes due to various risk factors Group 2
Hospital personnel are allowed to participate in this study as long they are not subjected directly to the principal investigator
All subjects will confirm their willingness to participate in the study by signing an Informed Consent Form ICF
Study Objective
To validate the algorithm and to evaluate the accuracy safety and pain level of the Smartest-AE
Inclusion Criteria
1 Man or Woman 18 through 80 years of age
2 Diagnosed with either
Group 1 Type III Diabetes Melitus GDM who regularly prick hisher fingers to monitor blood glucose levels or
Group 2 High risk individuals who do not typically engage in finger pricking but are at high risk of developing prediabetes or diabetes due to one of the following various risk factors
BMI gt 25
Age 45 or older
Have a parent or sibling with type 2 diabetes
Have ever had gestational diabetes
Hypercholesterolemia - according to blood level andor using medication for lowering cholesterol
Dyslipidemia- according to blood level andor using medication for lowering lipids
Or any other risk factor according to the staffs discretion
3 Able to self-test using a glucose level device
4 Subject is willing and able to comply with protocol requirements and has provided a signed informed consent form ICF
Exclusion Criteria
1 Subject suffers from neuropathy chronic pains pain diseases impaired sensation in the fingers39 area
2 Subject diagnosed with dementia
3 Subject diagnosed with major psychiatric disorders
4 Subject use Narcotics or Analgesics chronically or at the time of enrollment to the study and up to 4 hours prior to first test of the study
5 Any other medical condition that is considered not eligible by the medical team members
6 Subject Is not capable to report pain levels objectively
7 Participation in an interventional study at the time of enrollment to this study
Study Duration
One year depending on rate of subject recruitment Duration for each participant A single visit for couple of hours in the clinic or at the department during hospitalization
Primary Endpoints
Stage I- Smartest-AE system algorithm verification R2gt09 Stage II- Assess the accuracy of the Smartest-AE glucose measurements results in comparison to the results received from a commercial approved glucometer
Secondary Efficacy Endpoints
1 Subjects pain level of the Smartest-AE vs the commercial lancet using the NRS questionnaire
2 Assess the accuracy of the Smartest-AE glucose measurements results and the commercial glucometer results in comparison to the blood glucose level results of the venous blood test received from the local sites lab
Safety Endpoint
Any adverse events reported throughout the study following finger pricking will be recorded including severity Adverse events such as infection exceptional bleeding blisters etc
Sample size
The sample size was calculated based on the expected correlation between the commercial glucometer and the Smartest-AE using the GPower software version 3196 focusing on the Pearson correlation coefficient The following parameters were used
Test Type Exact Correlation Bivariate normal model Tails Two-tailed test Effect Size ρ H1 A correlation coefficient of 03 reflecting a realistic expectation of the correlation between the variables
α Error Probability The alpha level was set at 005 maintaining the standard criterion for statistical significance where there is a 5 chance of a Type I error
Power 1-β Error Probability The power was set at 80 08 indicating that there is an 80 probability of correctly rejecting the null hypothesis when it is false
Correlation ρ H0 The null hypothesis correlation was set to 0 assuming no correlation between the variables
The calculation results yielded a total sample size of 84 samples
Smartest company received a grant from the Israel Innovation Authority IIA As part of the grant the IIA set a milestone of conducting a clinical trial in 200 subjects for this study purposes Therefore the study population size is higher than the necessary sample size
Statistical Analysis
Descriptive Statistics Data will be described by group using mean standard deviations median minimum and maximum for continuous variables and counts and proportions for categorical variables
Subgroup Analysis Stratification by Experience Differences in reported pain levels between experienced Group 1 and naïve Group 2 subjects will be tested using a regression analysis
Gender Analysis Differences in reported pain levels will be tested across gender ensuring at least 25 representation from each gender in both groups
Software and Data Management Software All statistical analyses will be conducted using R software R packages such as ggplot2 for data visualization and dplyr for data manipulation will be utilized to handle and analyze the study data
Data Management Data will be coded and stored securely with access restricted to authorized personnel only
Tables and Figures Table 1 Demographic and Baseline Characteristics by Group Table 2 Summary Statistics of Blood Glucose Measurements from Smartest-AE Commercial Glucometer and Blood Tests
Table 3 Subgroup Analysis of Pain Levels Figure 1 correlation plot of Blood Glucose Measurements from Smartest-AE Commercial Glucometer and Blood Tests
Figure 2 Raincloud plots of Pain Levels Reported on NRS by gender
Handling of Missing Data Missing Data Policy Subjects missing measurements from either the Smartest-AE or the commercial glucometer will be excluded from the analysis
Data Imputation No imputation will be performed for missing glucose measurements only complete case analysis will be used
A Proof of Concept PoC Randomized Controlled study to validate the algorithm and evaluate the accuracy safety and pain level of the Smartest-AE in comparison to self-measure Blood Glucose Levels
Investigational Device
The Smartest-AE
Device Description
The Smartests System is intended to measure blood glucose levels in home environment The Smartests System consists of a disposable single-use device and a mobile app
At this study Smartest-AE Smartest-AE will be tested
Study Overview
The subjects will be enrolled from the Diabetes Mellitus DM clinics in the hospitals endocrinological clinic Internal divisions obstetrics and gynecology department diabetes in pregnancy and maternal and fetal medicine clinics
Study subjects will be consecutively screened and enrolled into the study The study will include up to 300 subjects men and women aged 18 to 80
The trial will encompass two distinct populations
Group 1- Diabetes Mellitus Patients At least 100 subjects who diagnosed with Type IType II DM or GDM Gestational Diabetes Mellitus who regularly prick their fingers to monitor blood glucose levels and willing to participate in the study and
Group 2- High risk individuals at least 100 individuals who do not typically engage in finger pricking but are at high risk of developing prediabetes or diabetes due to to one of the following various risk factors
BMI gt 25
Age 45 or older
Have a parent or sibling with type 2 diabetes
Have ever had gestational diabetes
Hypercholesterolemia - according to blood level andor using medication for lowering cholesterol
Dyslipidemia - according to blood level andor using medication for lowering lipids Or any other risk factor according to the staffs discretion
The study will be conducted in 2 stages
Stage I- Algorithm verification- Blood glucose levels will be taken from the first 30 subjects in order to verify the algorithm At the end of the enrollment of the first 30 cases an analysis will be done by Smartests RampD If the algorithm yields correlation of R2gt09 based on the calibration curves the study will proceed to the second phase In case the calibration does not show the expected R2 the Smartests RampD will re-assess the algorithm If correction modification to the algorithm will be implemented another 30 subjects will be enrolled to verify the updated algorithm
If the analysis following algorithm update yields satisfying results R2gt09 the study will proceed to the second stage and the results of the 30 subjects used for verification will be included in the final analysis If not the study will be temporarily paused and the device algorithm will be re-assessed by Smartests RampD for accuracy and precision Following that another 30 subjects will be enrolled for algorithm verification If the expected R2 is not obtained the study will be terminated
Blood glucose levels will be measured for all 306090 subjects using 2 devices
1 The Smartest-AE blood sample analyzer and
2 A commercial standard reference approved glucometer including approved needles and strips
The lancet that will be used for all subjects will be the Vitrex Soft Lite lll 28G
All Subjects will complete a Numeric Rating Scale NRS questionnaire Appendix A to determine their level of pain from each device NRS will be completed following each fingers pricking
Following NRS completion blood will be taken from the subjects veins for blood glucose level that will be measured by the sites local lab
NRS will not be completed following blood taken from the vein
Stage II- Following algorithm verification and Smartests approval to continue to stage II at least 200 subjects will be recruited
Blood Glucose levels will be taken from each subject using the 2 devices the Smartest-AE and the commercial glucometer
The blood levels results of the Smartest-AE will be compared to the commercial approved glucometer in order to assess accuracy Subjects comfortpain level will be assessed following each fingers pricking using the Numeric Rating Scale NRS questionnaire
All Subjects will complete the NRS questionnaire to determine their level of pain from each device
Following NRS completion blood will be taken from the subjects veins for blood glucose level that will be measured by the sites local lab
NRS will not be completed following blood taken from the vein No follow-up period is expected
Fingers III middle and IV ring of the non-dominant hand will be pricked Randomization will be used to allocate subjects that will be first tested with the Smartest-AE device and subjects that will be first tested with the commercial device Finger III will always be the first to be pricked
It was decided that subject IDs even numbers will have the first prick with the Smartest-AE and subject IDs odd numbers will have the first prick with the commercial device at each of the groups 1 and 2
In case the device shows error or the results seems objectively to be unreasonable for eg extremely high or low blood glucose level result that does not reflect subject physical condition at the time of test another attempt will be done to achieve the blood glucose level If the error will be obtained in the first test then NRS will be completed by the subject subsequently to the test and the second attempt will be done only after the second reference device test will be performed Up to 2 attempts are allowed for each system Subject that has measurement results only from one system will be excluded from the analysis
In case failings will be occurred in the venous blood test either during the blood taking problematic veins etc or error received from the lab hemolytic blood etc a second attempt will not be done and the result will be indicated as missing
Study Population
Adults volunteers men and women at least 25 of each gender at each group at the ages of 18- 80 years old diagnosed with Type IType II DM or GDM Gestational diabetes Mellitus who regularly prick their fingers to monitor blood glucose levels Group 1 Diabetes Mellitus patients and High risk individuals who do not typically engage in finger pricking but are at high risk of developing prediabetes or diabetes due to various risk factors Group 2
Hospital personnel are allowed to participate in this study as long they are not subjected directly to the principal investigator
All subjects will confirm their willingness to participate in the study by signing an Informed Consent Form ICF
Study Objective
To validate the algorithm and to evaluate the accuracy safety and pain level of the Smartest-AE
Inclusion Criteria
1 Man or Woman 18 through 80 years of age
2 Diagnosed with either
Group 1 Type III Diabetes Melitus GDM who regularly prick hisher fingers to monitor blood glucose levels or
Group 2 High risk individuals who do not typically engage in finger pricking but are at high risk of developing prediabetes or diabetes due to one of the following various risk factors
BMI gt 25
Age 45 or older
Have a parent or sibling with type 2 diabetes
Have ever had gestational diabetes
Hypercholesterolemia - according to blood level andor using medication for lowering cholesterol
Dyslipidemia- according to blood level andor using medication for lowering lipids
Or any other risk factor according to the staffs discretion
3 Able to self-test using a glucose level device
4 Subject is willing and able to comply with protocol requirements and has provided a signed informed consent form ICF
Exclusion Criteria
1 Subject suffers from neuropathy chronic pains pain diseases impaired sensation in the fingers39 area
2 Subject diagnosed with dementia
3 Subject diagnosed with major psychiatric disorders
4 Subject use Narcotics or Analgesics chronically or at the time of enrollment to the study and up to 4 hours prior to first test of the study
5 Any other medical condition that is considered not eligible by the medical team members
6 Subject Is not capable to report pain levels objectively
7 Participation in an interventional study at the time of enrollment to this study
Study Duration
One year depending on rate of subject recruitment Duration for each participant A single visit for couple of hours in the clinic or at the department during hospitalization
Primary Endpoints
Stage I- Smartest-AE system algorithm verification R2gt09 Stage II- Assess the accuracy of the Smartest-AE glucose measurements results in comparison to the results received from a commercial approved glucometer
Secondary Efficacy Endpoints
1 Subjects pain level of the Smartest-AE vs the commercial lancet using the NRS questionnaire
2 Assess the accuracy of the Smartest-AE glucose measurements results and the commercial glucometer results in comparison to the blood glucose level results of the venous blood test received from the local sites lab
Safety Endpoint
Any adverse events reported throughout the study following finger pricking will be recorded including severity Adverse events such as infection exceptional bleeding blisters etc
Sample size
The sample size was calculated based on the expected correlation between the commercial glucometer and the Smartest-AE using the GPower software version 3196 focusing on the Pearson correlation coefficient The following parameters were used
Test Type Exact Correlation Bivariate normal model Tails Two-tailed test Effect Size ρ H1 A correlation coefficient of 03 reflecting a realistic expectation of the correlation between the variables
α Error Probability The alpha level was set at 005 maintaining the standard criterion for statistical significance where there is a 5 chance of a Type I error
Power 1-β Error Probability The power was set at 80 08 indicating that there is an 80 probability of correctly rejecting the null hypothesis when it is false
Correlation ρ H0 The null hypothesis correlation was set to 0 assuming no correlation between the variables
The calculation results yielded a total sample size of 84 samples
Smartest company received a grant from the Israel Innovation Authority IIA As part of the grant the IIA set a milestone of conducting a clinical trial in 200 subjects for this study purposes Therefore the study population size is higher than the necessary sample size
Statistical Analysis
Descriptive Statistics Data will be described by group using mean standard deviations median minimum and maximum for continuous variables and counts and proportions for categorical variables
Subgroup Analysis Stratification by Experience Differences in reported pain levels between experienced Group 1 and naïve Group 2 subjects will be tested using a regression analysis
Gender Analysis Differences in reported pain levels will be tested across gender ensuring at least 25 representation from each gender in both groups
Software and Data Management Software All statistical analyses will be conducted using R software R packages such as ggplot2 for data visualization and dplyr for data manipulation will be utilized to handle and analyze the study data
Data Management Data will be coded and stored securely with access restricted to authorized personnel only
Tables and Figures Table 1 Demographic and Baseline Characteristics by Group Table 2 Summary Statistics of Blood Glucose Measurements from Smartest-AE Commercial Glucometer and Blood Tests
Table 3 Subgroup Analysis of Pain Levels Figure 1 correlation plot of Blood Glucose Measurements from Smartest-AE Commercial Glucometer and Blood Tests
Figure 2 Raincloud plots of Pain Levels Reported on NRS by gender
Handling of Missing Data Missing Data Policy Subjects missing measurements from either the Smartest-AE or the commercial glucometer will be excluded from the analysis
Data Imputation No imputation will be performed for missing glucose measurements only complete case analysis will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None