DiabetesNCT05833100
Method Comparison/User Evaluation of the i-SENS Self-Monitoring Blood Glucose / β-Ketone System
A study testing CareSens PRO GK Blood Glucose/b-Ketone Monitoring system in people with Diabetes, run by i-SENS, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- CareSens PRO GK Blood Glucose/b-Ketone Monitoring system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 23 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rainier Clinical Research Center
Renton, Washington, 98057
About this study
Official title: Method Comparison/User Evaluation of the i-SENS Self-Monitoring Blood Glucose / β-Ketone System (CareSens PRO GK BT)
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- CareSens PRO GK Blood Glucose/b-Ketone Monitoring system
- Keywords
- Self-Monitoring Blood Glucose (SMBG)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareSens PRO GK Blood Glucose/b-Ketone Monitoring systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CareSens PRO GK Blood Glucose/b-Ketone Monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Within 20 minuates of centrifugation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start15 Aug 2022
- Primary completion26 Sep 2022
- Study completion23 Feb 2023
Why it stopped: Due to a change in the marketing strategy of the device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- i-SENS, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania, Rainier Clinical Research Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833100
- Sponsor's protocol ID
- BGM-2205084
- Status last verified
- Jan 2024
- First submitted
- 17 Apr 2023
- Last updated
- 29 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Method Comparison/User Evaluation of the i-SENS Self-Monitoring Blood Glucose / β-Ketone System (CareSens PRO GK BT)
- ClinicalTrials.gov ID
- NCT05833100
- Acronym / sponsor ID
- BGM-2205084
- Conditions
- Diabetes
- Keywords
- Self-Monitoring Blood Glucose (SMBG)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a change in the marketing strategy of the device.
- Enrolment
- 76 participants (actual)
- Lead sponsor
- i-SENS, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Avania, Rainier Clinical Research Center
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Posted 29 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Users of the Blood Glucose/b-Ketone Monitoring System | Experimental | Device: CareSens PRO GK Blood Glucose/b-Ketone Monitoring systemParticipants are individuals who have either been diagnosed with diabetes or not and are naive users of CareSens PRO GK BT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CareSens PRO GK Blood Glucose/b-Ketone Monitoring systemAll 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. | Device | Users of the Blood Glucose/b-Ketone Monitoring System |
Primary outcome
Hematocrit Measurement
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.
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.
2 secondary outcomes
Glucose Testing of Subject Plasma Samples
Time frame: Within 20 minuates of centrifugation
β-Ketone Testing of Subject Plasma Samples
Time frame: Within 20 minuates of centrifugation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CareSens PRO GK Blood Glucose/b-Ketone Monitoring system in people with Diabetes, run by i-SENS, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematocrit Measurement (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.