Trial Outcomes & Findings for Method Comparison/User Evaluation of the i-SENS Self-Monitoring Blood Glucose / β-Ketone System (NCT NCT05833100)
NCT ID: NCT05833100
Last Updated: 2024-02-29
Results Overview
The subject's hematocrit measurement should be within the range of 20-60% for the result to be considered evaluable. Two consecutive measurements are taken, and it determinds the analytical validity of a blood sample by the average value.
TERMINATED
NA
76 participants
The blood sample is immediately collected for hematocrit measurement within 5 minutes of the first evaluable BG meter reading and then, centrifuge the sample within 10 minutes of sample collection.
2024-02-29
Participant Flow
Between 5 and 10 participants are enrolled per day at one site. A total of 76 participants were recruited in 11 sessions; 2 screening failed and 74 completed.
Termination resulted from a change in the marketing strategy of the clinical trial.
Participant milestones
| Measure |
Users of the Blood Glucose Monitoring System (Only)
Participants are individuals who have either been diagnosed with diabetes or not and are naive users of CareSens PRO GK BT.
All BG results were compared to YSI 2300 reference method results obtained from subjects' capillary blood.
|
Users of the Blood Glucose and b-Ketone Monitoring System
Participants are individuals who have either been diagnosed with diabetes or not and are naive users of CareSens PRO GK BT.
All BG results were compared to YSI 2300 reference method results obtained from subjects' capillary blood. All Ketone results were compared to the Randox Imola D-3-Hydroxybutyrate analyzer.
|
Users of the b-Ketone Monitoring System (Only)
Participants are individuals who have either been diagnosed with diabetes or not and are naive users of CareSens PRO GK BT.
All Ketone results were compared to Randox Imola D-3-Hydroxybutyrate analyzer.
|
|---|---|---|---|
|
Day 1(August 15th)
STARTED
|
2
|
3
|
0
|
|
Day 1(August 15th)
COMPLETED
|
2
|
3
|
0
|
|
Day 1(August 15th)
NOT COMPLETED
|
0
|
0
|
0
|
|
Day 2(August 16th)
STARTED
|
5
|
0
|
0
|
|
Day 2(August 16th)
COMPLETED
|
4
|
0
|
0
|
|
Day 2(August 16th)
NOT COMPLETED
|
1
|
0
|
0
|
|
Day 3(August 23rd)
STARTED
|
5
|
3
|
0
|
|
Day 3(August 23rd)
COMPLETED
|
5
|
3
|
0
|
|
Day 3(August 23rd)
NOT COMPLETED
|
0
|
0
|
0
|
|
Day 4(August 24th)
STARTED
|
0
|
2
|
0
|
|
Day 4(August 24th)
COMPLETED
|
0
|
2
|
0
|
|
Day 4(August 24th)
NOT COMPLETED
|
0
|
0
|
0
|
|
Day 5(August 29th)
STARTED
|
0
|
5
|
1
|
|
Day 5(August 29th)
COMPLETED
|
0
|
5
|
1
|
|
Day 5(August 29th)
NOT COMPLETED
|
0
|
0
|
0
|
|
Day 6(August 31st)
STARTED
|
0
|
6
|
0
|
|
Day 6(August 31st)
COMPLETED
|
0
|
6
|
0
|
|
Day 6(August 31st)
NOT COMPLETED
|
0
|
0
|
0
|
|
Day 7(September 6th)
STARTED
|
0
|
7
|
1
|
|
Day 7(September 6th)
COMPLETED
|
0
|
7
|
1
|
|
Day 7(September 6th)
NOT COMPLETED
|
0
|
0
|
0
|
|
Day 8(September 9th)
STARTED
|
0
|
8
|
0
|
|
Day 8(September 9th)
COMPLETED
|
0
|
8
|
0
|
|
Day 8(September 9th)
NOT COMPLETED
|
0
|
0
|
0
|
|
Day 9(September 13th)
STARTED
|
0
|
10
|
0
|
|
Day 9(September 13th)
COMPLETED
|
0
|
10
|
0
|
|
Day 9(September 13th)
NOT COMPLETED
|
0
|
0
|
0
|
|
Day 10(September 19th)
STARTED
|
0
|
8
|
0
|
|
Day 10(September 19th)
COMPLETED
|
0
|
8
|
0
|
|
Day 10(September 19th)
NOT COMPLETED
|
0
|
0
|
0
|
|
Day 11(September 21st)
STARTED
|
0
|
8
|
0
|
|
Day 11(September 21st)
COMPLETED
|
0
|
8
|
0
|
|
Day 11(September 21st)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Method Comparison/User Evaluation of the i-SENS Self-Monitoring Blood Glucose / β-Ketone System
Baseline characteristics by cohort
| Measure |
Users of the Blood Glucose Monitoring System (Only)
n=11 Participants
Untrained subjects used the CareSens Pro GK Blood Glucose/b-Ketone Monitoring System.
All BG results were compared to YSI 2300 reference method results obtained from subjects' capillary blood.
|
CareSens Pro GK Blood Glucose and b-Ketone Monitoring System.
n=60 Participants
Untrained subjects used the CareSens Pro GK Blood Glucose/b-Ketone Monitoring System.
BG and b-Ketone results from PRO GK were compared to YSI 2300 and the Randox Imola D-3-Hydroxybutyrate analyzer.
|
Users of the b-Ketone Monitoring System (Only)
n=2 Participants
Untrained subjects used the CareSens Pro GK Blood Glucose/b-Ketone Monitoring System.
All Ketone results were compared to the Randox Imola D-3-Hydroxybutyrate analyzer.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Conditions
Type 1 Diabetes
|
4 participants
n=5 Participants
|
20 participants
n=7 Participants
|
0 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Conditions
Type 2 Diabetes
|
6 participants
n=5 Participants
|
37 participants
n=7 Participants
|
2 participants
n=5 Participants
|
45 participants
n=4 Participants
|
|
Conditions
Pre-Diabetes
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Conditions
No Diabetes
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: The blood sample is immediately collected for hematocrit measurement within 5 minutes of the first evaluable BG meter reading and then, centrifuge the sample within 10 minutes of sample collection.Population: BG monitoring system data excludings\> * Console mode measurements (#8) * CRF has not been confirmed \& staff is unable to collect 300uL of blood sample (#23) * Screening fail (#30,33) * YSI calibration fail (#41) b-Ketone monitoring system data excludings\> * Randox value \<0.07 for weeks 1 and 2 (#2,5,6,9,10,12,13,15,17,18) * Measurement with glucose strips (#7) * Console mode measurements (#8) * Screening fail (#30,33)
The subject's hematocrit measurement should be within the range of 20-60% for the result to be considered evaluable. Two consecutive measurements are taken, and it determinds the analytical validity of a blood sample by the average value.
Outcome measures
| Measure |
Users of the Blood Glucose Monitoring System
n=71 Participants
Untrained subjects with diabetes used the CareSens Pro GK Blood Glucose/b-Ketone Monitoring System.
CareSens PRO GK Blood Glucose/b-Ketone Monitoring system: All BG results were compared to YSI 2300 reference method results obtained from subjects' capillary blood.
|
Users of the b-Ketone Monitoring System
n=62 Participants
Untrained subjects with diabetes used the CareSens Pro GK Blood Glucose/b-Ketone Monitoring System.
CareSens PRO GK Blood Glucose/b-Ketone Monitoring system: All Ketone results were compared to Randox Imola D-3-Hydroxybutyrate analyzer.
|
|---|---|---|
|
Hematocrit Measurement
1st meaasurement
|
44.27 Percentage of hematocrit
Interval 36.0 to 52.0
|
44.10 Percentage of hematocrit
Interval 36.0 to 52.0
|
|
Hematocrit Measurement
2nd measurement
|
44.65 Percentage of hematocrit
Interval 36.0 to 53.0
|
44.65 Percentage of hematocrit
Interval 36.0 to 53.0
|
|
Hematocrit Measurement
Average of duplicated measurements
|
44.46 Percentage of hematocrit
Interval 36.0 to 52.5
|
44.56 Percentage of hematocrit
Interval 36.0 to 52.5
|
SECONDARY outcome
Timeframe: Within 20 minuates of centrifugationThe subject capillary plasma samples will be tested in duplicate. If the average of replicates 1\&2 do not fall within range (within 4% for readingsabove100mg/dL or 4 mg/dL for samples less than or equal to 100mg/dL) the sample will be run a third time and the 2 average replicate readings that fall within range (4% for readings above 100mg/dL or 4 mg/dL for samples less than or equal to 100mg/dL) will be recorded as evaluable. In general, duplicates will be averaged for each subject. If the sample is insufficient or missing and have only a single YSI value, it will be used as the YSI determination. If none of the 3 average replicates fall within (4% for readings above 100mg/dL or 4 mg/dL for samples less than or equal to 100mg/dL) will be recorded as non-evaluable. If the YSI autocals between subject sample duplicates, then another YSI 2747 standard will be run before completing the subject sample cycle.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 20 minuates of centrifugationThe subject capillary plasma sample will be tested in duplicate using Rx Imola analyzer. If the measured values differ by \> 0.075 mmol/L at ketone \< 1.5 mmol/L or \> 5% at ketone ≥ 1.5 mmol/L, the sample will be run a third time and the 2 average replicate readings that fall within range will be recorded as evaluable. In general, duplicates will be averaged for each subject. If the sample is insufficient or missing and has only a single Rx Imola value, it will be used as the Rx Imola determination. If none of the 3 average replicates fall within \> 0.075 mmol/L at ketone \< 1.5 mmol/L or \> 5% at ketone ≥ 1.5 mmol/L for readings, it will be recorded as non-evaluable.
Outcome measures
Outcome data not reported
Adverse Events
Users of the Blood Glucose Monitoring System
Users of the Blood b-Ketone Monitoring System
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