Trial Outcomes & Findings for Spectrophon LTD Glucometry Monitor Accuracy (NCT NCT03359629)
NCT ID: NCT03359629
Last Updated: 2019-03-07
Results Overview
Difference in measurements of blood glucose level obtained using Spectrophon glucometry monitor and commercially available glucose analyser YSI 2300
Recruitment status
COMPLETED
Target enrollment
210 participants
Primary outcome timeframe
1-3 hours
Results posted on
2019-03-07
Participant Flow
Participant milestones
| Measure |
Blood Collection (Healthy Individuals)
Participants's blood was collected and measured for glucose level before and after food intake
|
Blood Collection (Diabetic Patients)
Participants's blood was collected and measured for glucose level
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
10
|
|
Overall Study
COMPLETED
|
200
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Blood Collection (Healthy Individuals)
n=200 Participants
Participants's blood was collected and measured for glucose level before and after food intake
|
Blood Collection (Diabetic Patients)
n=10 Participants
Participants's blood was collected and measured for glucose level
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=200 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=210 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
188 Participants
n=200 Participants
|
7 Participants
n=10 Participants
|
195 Participants
n=210 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=200 Participants
|
3 Participants
n=10 Participants
|
15 Participants
n=210 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=200 Participants
|
7 Participants
n=10 Participants
|
121 Participants
n=210 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=200 Participants
|
3 Participants
n=10 Participants
|
89 Participants
n=210 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Israel
|
200 participants
n=200 Participants
|
10 participants
n=10 Participants
|
210 participants
n=210 Participants
|
PRIMARY outcome
Timeframe: 1-3 hoursDifference in measurements of blood glucose level obtained using Spectrophon glucometry monitor and commercially available glucose analyser YSI 2300
Outcome measures
| Measure |
Blood Collection (Healthy Individuals)
n=200 Participants
Participants's blood was collected and measured for glucose level before and after food intake
|
Blood Collection (Diabetic Patients)
n=10 Participants
Participants's blood was collected and measured for glucose level
|
|---|---|---|
|
Percentage of Measurements With < 15% Error
Algorithm 1.7
|
95.25 Percentage of measures with error <15%
|
100 Percentage of measures with error <15%
|
|
Percentage of Measurements With < 15% Error
Algorithm 1.6
|
94.5 Percentage of measures with error <15%
|
100 Percentage of measures with error <15%
|
Adverse Events
Blood Collection (Healthy Individuals)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Blood Collection (Diabetic Patients)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place