Diabetes
Conditions
Keywords
Self-Monitoring Blood Glucose (SMBG)
Brief summary
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.
Detailed description
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.
Interventions
DEVICECareSens PRO GK Blood Glucose/b-Ketone Monitoring system
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.
Sponsors
Avania
Rainier Clinical Research Center
i-SENS, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Males and females, 18 years of age and older * People with type 1 diabetes, type 2 diabetes, pre-diabetes and no diabetes (self- reported) * Able to speak, read and understand English (subjects must demonstrate ability to read a sentence from a page of the draft device labeling instructions (user's manual) to qualify for the study) * Willing to complete all study procedures * Has read, understood, and signed the Informed Consent Form 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
* Hemophilia or any other bleeding disorder * Works for a medical laboratory, hospital, other clinical setting or a medical device company that involves training on or clinical use of blood glucose meters * Physical, visual or neurological impairments as determined by the investigator or designee that would make the subject unable to perform self-testing (reason for exclusion will be clearly documented by investigator or designee directly on the subject disposition form) * A condition, which in the opinion of the investigator or designee, would put the subject or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee on the subject disposition form). 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hematocrit Measurement | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Testing of Subject Plasma Samples | Within 20 minuates of centrifugation | 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. |
| β-Ketone Testing of Subject Plasma Samples | Within 20 minuates of centrifugation | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Termination resulted from a change in the marketing strategy of the clinical trial.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| CareSens Pro GK Blood Glucose and b-Ketone Monitoring System. 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. | 60 |
| 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. | 2 |
| Total | 73 |
Baseline characteristics
| Characteristic | Users of the Blood Glucose Monitoring System (Only) | CareSens Pro GK Blood Glucose and b-Ketone Monitoring System. | Users of the b-Ketone Monitoring System (Only) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 27 Participants | 2 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 33 Participants | 0 Participants | 43 Participants |
| Conditions No Diabetes | 1 participants | 3 participants | 0 participants | 4 participants |
| Conditions Pre-Diabetes | 0 participants | 0 participants | 0 participants | 0 participants |
| Conditions Type 1 Diabetes | 4 participants | 20 participants | 0 participants | 24 participants |
| Conditions Type 2 Diabetes | 6 participants | 37 participants | 2 participants | 45 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 58 Participants | 0 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 2 Participants | 2 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 8 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 7 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 8 Participants | 42 Participants | 2 Participants | 52 Participants |
| Sex: Female, Male Female | 5 Participants | 39 Participants | 1 Participants | 45 Participants |
| Sex: Female, Male Male | 6 Participants | 21 Participants | 1 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 62 |
| other Total, other adverse events | 0 / 71 | 0 / 62 |
| serious Total, serious adverse events | 0 / 71 | 0 / 62 |
Outcome results
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Users of the Blood Glucose Monitoring System | Hematocrit Measurement | 1st meaasurement | 44.27 Percentage of hematocrit |
| Users of the Blood Glucose Monitoring System | Hematocrit Measurement | 2nd measurement | 44.65 Percentage of hematocrit |
| Users of the Blood Glucose Monitoring System | Hematocrit Measurement | Average of duplicated measurements | 44.46 Percentage of hematocrit |
| Users of the b-Ketone Monitoring System | Hematocrit Measurement | 1st meaasurement | 44.10 Percentage of hematocrit |
| Users of the b-Ketone Monitoring System | Hematocrit Measurement | 2nd measurement | 44.65 Percentage of hematocrit |
| Users of the b-Ketone Monitoring System | Hematocrit Measurement | Average of duplicated measurements | 44.56 Percentage of hematocrit |
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.
Time frame: Within 20 minuates of centrifugation
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.
Time frame: Within 20 minuates of centrifugation