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Due to a change in the marketing strategy of the device.
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| Name | Class |
|---|---|
| Avania | INDUSTRY |
| Rainier Clinical Research Center | OTHER |
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The goal of this clinical trial is to assess the accuracy and usability of the blood glucose meter in untrained participants, both with or without diabetes, as well as those with pre-diabetes.
Participants will personally date and sign the informed consent before engaging in any study-related activity. Participants use a single-use lancing device to lance their finger and perform a blood glucose test with glucose test strips on the meter. Trained staff collects more blood samples for YSI and hematocrit measurement (approx. 300-350μL) using a specified lancet within 5 minutes of the first evaluable meter reading. Follow the same process to measure Ketones using the β-Ketone test strip on the same meter. The staff collects more blood samples for Imola and hematocrit measurement (approx. 500-550μL).
After subjects have completed the testing, they are then asked to complete usability questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Users of the Blood Glucose/b-Ketone Monitoring System | Experimental | Participants are individuals who have either been diagnosed with diabetes or not and are naive users of CareSens PRO GK BT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CareSens PRO GK Blood Glucose/b-Ketone Monitoring system | Device | All BG results were compared to YSI 2300 reference method results obtained from subjects' capillary blood. All Ketone results were compared to Randox Imola D-3-Hydroxybutyrate analyzer. |
| Measure | Description | Time Frame |
|---|---|---|
| Hematocrit Measurement | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Testing of Subject Plasma Samples | The 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. |
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Inclusion Criteria:
Note: The study group consists of naive SMBG users and non-naive SMBG users. At least 10% of study participants should be naive for SMBG, including subjects without diabetes.
Exclusion Criteria:
Note 1: In the event of a physical, visual or neurological impairment that makes it difficult for a subject to complete the questionnaire, the subject's verbal responses will be accepted and should be appropriately documented as such within the subject records form.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
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Termination resulted from a change in the marketing strategy of the clinical trial.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1(August 15th) |
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| Day 2(August 16th) |
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| Day 3(August 23rd) |
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| Day 4(August 24th) |
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| Day 5(August 29th) |
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| Day 6(August 31st) |
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| Day 7(September 6th) |
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| Day 8(September 9th) |
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| Day 9(September 13th) |
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| Day 10(September 19th) |
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| Day 11(September 21st) |
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The order of measurements is as follows: PRO GK (BG) > YSI > PRO GK (b-Ketone) > Randox
For BG monitoring system analysis excluding
For b-Ketone monitoring system analysis excluding
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| ID | Title | Description |
|---|---|---|
| BG000 | Users of the Blood Glucose Monitoring System (Only) | 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. |
| BG001 | CareSens Pro GK Blood Glucose and b-Ketone Monitoring System. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hematocrit Measurement | 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. | BG monitoring system data excludings>
| Posted | Mean | Full Range | Percentage of hematocrit | 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. |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Users of the Blood Glucose 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Moon Hwan Kim | i-SENS, Inc. | +82 (0)2 910 0521 | mhkim@i-sens.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2022 | Jan 8, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 21, 2022 | Nov 19, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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A minimum of 350 different subjects, both naive and non-naive SMBG users, is required. At least 10% of the study participants should be naive to SMBGs and may include non-diabetic subjects.
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| Within 20 minuates of centrifugation |
| β-Ketone Testing of Subject Plasma Samples | The 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. | Within 20 minuates of centrifugation |
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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. |
| BG002 | Users of the b-Ketone Monitoring System (Only) | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Conditions | Number | participants |
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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. |
| OG001 | Users of the b-Ketone Monitoring System | 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. |
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| Secondary | Glucose Testing of Subject Plasma Samples | The 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. | Not Posted | Within 20 minuates of centrifugation | Participants |
| Secondary | β-Ketone Testing of Subject Plasma Samples | The 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. | Not Posted | Within 20 minuates of centrifugation | Participants |
| 0 |
| 71 |
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | Users of the Blood 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 Ketone results were compared to Randox Imola D-3-Hydroxybutyrate analyzer. | 0 | 62 | 0 | 62 | 0 | 62 |
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