Diabetes MellitusNCT05118061
StatStrip Glucose/Ketone Meter System Ketone Evaluation
An observational study of Diabetes Mellitus and Ketosis, Diabetic, run by Nova Biomedical at 3 sites in 2 countries.
Trial summary
The Nova StatStrip Glucose / Ketone Meter System is a fast, simple, whole blood system that can be used to quantify both glucose and ketones using two distinct test strips. This Protocol will describe an evaluation of the system's Ketone performance only. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Ketosis, Diabetic
- What is being tested?
- Ketone
- How many people
- 173 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 25 May 2022to 3 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: a minimum of 360 to a maximum of 500 individual subjects will be enrolled to test both capillary and venous whole blood. Subjects included in the study may be healthy, diabetic or suspected of ketonemia. The study will be conducted in at least three (3) separate study sites, with each site targeting 120 patients up to 200 patients. Adult subjects (≥ 18 years old) of both genders will be included in this study. Potential subjects may be screened prior to testing to assess their baseline ketone levels. The screening may be done by inspecting medical records, fingerstick ketone testing or urine dipstick testing. Each site shall follow their own specified procedures and protocols for the screening test method, if applicable.
Who may be able to join
- Adult subjects (≥ 18 years old) with diabetes or suspected ketonemia.
- Adult subjects (≥ 18 years old) that are healthy.
- Subjects willing and able to consent to participating in the study.
- Subjects whose pre-screen ketone value, if performed, is deemed valuable to the study.
Who cannot join
- Subjects unable to consent to participating in the study.
- Subjects possessing a cognitive disorder or other condition, which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Technical University of Munich - Diabetes Hospital
Munich, D-80333
Technical University of Munich - Emergency Reception
Munich, D-80333
United States1 site
South Florida Research Organization
Medley, Florida, 33166
About this study
The Nova StatStrip Glucose / Ketone Meter System is a fast, simple, whole blood system that can be used to quantify both glucose and ketones using two distinct test strips. This Protocol will describe an evaluation of the system's Ketone performance only. Ketone testing methods that quantify beta-hydroxybutyrate (β-OHB), the predominant ketone body, are used for diagnosing and monitoring ketoacidosis, a life-threatening complication of hyperglycemia. The performance of the StatStrip Ketone test strip using the Nova StatStrip Glucose / Ketone Hospital Meter System on venous and capillary whole blood will be assessed.
Read the detailed description
The primary objectives of this study are:
- To assess the performance of the StatStrip Ketone assay in the hands of CLIA-Waived Point-of-Care users in at least three (3) distinct Point-of-Care clinical settings on venous, and capillary blood and compare the performance characteristics to a traceable laboratory reference method.
- To assess the Ease of Use of the StatStrip Glucose / Ketone Meter System in the hands of the intended CLIA-Waived Point-of-Care users. CLIA-Waived operators will be provided with all package-insert sheets, a Quick Reference Guide and Instructions for Use (IFU) Manual. No training, coaching, or prompting will be provided to the CLIA-Waived POC Users other than clarifying the protocol.
- Conditions
- Diabetes Mellitus, Ketosis, Diabetic
- Being tested
- Ketone
- Keywords
- Ketone
- Medical subject headings
- Diabetes Mellitus, Diabetic Ketoacidosis, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoneDiagnostic test
compare diagnostic tests to reference methods
What is being measured
The primary outcome is the main question the study is designed to answer.
Analytical verification of StatStrip glucose/ketone meter system - ketone comparison
StatStrip ketone meter system, a point of care testing instrument is as effective as a reference laboratory method for ketone results in mmol/L
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start25 May 2022
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ocean Wellness Center
- Responsible party
- Sponsor
- Investigators
- Jeremy Bleicher, MD, Principal investigator, South Florida Research OrganizationPeter Luppa, Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118061
- Sponsor's protocol ID
- NB21-SSK-NA-FDA
- Status last verified
- Sep 2022
- First submitted
- 28 Jul 2021
- Last updated
- 30 Sep 2022
- Results posted
- No
- 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 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StatStrip Glucose/Ketone Meter System Ketone Evaluation
- ClinicalTrials.gov ID
- NCT05118061
- Acronym / sponsor ID
- NB21-SSK-NA-FDA
- Conditions
- Diabetes Mellitus, Ketosis, Diabetic
- Keywords
- Ketone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Nova BiomedicalIndustry (pharma, biotech, devices)
- Collaborators
- Ocean Wellness Center
- Study start
- 25 May 2022 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Nova StatStrip Glucose / Ketone Meter System is a fast, simple, whole blood system that can be used to quantify both glucose and ketones using two distinct test strips. This Protocol will describe an evaluation of the system's Ketone performance only. Ketone testing methods that quantify beta-hydroxybutyrate (β-OHB), the predominant ketone body, are used for diagnosing and monitoring ketoacidosis, a life-threatening complication of hyperglycemia. The performance of the StatStrip Ketone test strip using the Nova StatStrip Glucose / Ketone Hospital Meter System on venous and capillary whole blood will be assessed.
Detailed description
The primary objectives of this study are:
- To assess the performance of the StatStrip Ketone assay in the hands of CLIA-Waived Point-of-Care users in at least three (3) distinct Point-of-Care clinical settings on venous, and capillary blood and compare the performance characteristics to a traceable laboratory reference method.
- To assess the Ease of Use of the StatStrip Glucose / Ketone Meter System in the hands of the intended CLIA-Waived Point-of-Care users. CLIA-Waived operators will be provided with all package-insert sheets, a Quick Reference Guide and Instructions for Use (IFU) Manual. No training, coaching, or prompting will be provided to the CLIA-Waived POC Users other than clarifying the protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- a minimum of 360 to a maximum of 500 individual subjects will be enrolled to test both capillary and venous whole blood. Subjects included in the study may be healthy, diabetic or suspected of ketonemia. The study will be conducted in at least three (3) separate study sites, with each site targeting 120 patients up to 200 patients. Adult subjects (≥ 18 years old) of both genders will be included in this study. Potential subjects may be screened prior to testing to assess their baseline ketone levels. The screening may be done by inspecting medical records, fingerstick ketone testing or urine dipstick testing. Each site shall follow their own specified procedures and protocols for the screening test method, if applicable.
Key inclusion criteria (4 listed)
- Adult subjects (≥ 18 years old) with diabetes or suspected ketonemia.
- Adult subjects (≥ 18 years old) that are healthy.
- Subjects willing and able to consent to participating in the study.
- Subjects whose pre-screen ketone value, if performed, is deemed valuable to the study.
Key exclusion criteria (2 listed)
- Subjects unable to consent to participating in the study.
- Subjects possessing a cognitive disorder or other condition, which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study.
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 |
|---|---|---|
| Ketonecompare diagnostic tests to reference methods | Diagnostic test | – |
Primary outcome
Analytical verification of StatStrip glucose/ketone meter system - ketone comparison
Time frame: 20 days
StatStrip ketone meter system, a point of care testing instrument is as effective as a reference laboratory method for ketone results in mmol/L
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- 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.
Jeremy Bleicher, MD principal investigator
South Florida Research Organization
Peter Luppa principal investigator
Technical University of Munich
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Ketosis, Diabetic, run by Nova Biomedical at 3 sites in 2 countries.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Analytical verification of StatStrip glucose/ketone meter system - ketone comparison (time frame: 20 days). 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 30 Sep 2022.