AlbuminuriaNCT05838872
Evaluation of the Accuracy and Usability of the Minuteful - Kidney Urine Analysis Test System in the Lay User Hands
A study testing Minuteful - Kidney Urine Analysis Test System in people with Albuminuria and Chronic Kidney Diseases, run by Healthy.io Ltd. at 1 site in United States.
Trial summary
The purpose of this study was to collect additional performance and clinical data on the Minuteful - Kidney test device (previously "ACR | U.S. Urine Analysis Test System"), following the original data collection (NCT04626271). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Albuminuria, Chronic Kidney Diseases, Diabetes
- What is being tested?
- Minuteful - Kidney Urine Analysis Test System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2021to 15 Jul 2022
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females 18-80 years of age
- Subjects with a known, well-established medical condition and/or risk factor for kidney damage, that can potentially present as an abnormal concentration of urine albumin:
- Diabetes (Type I/Type II, or Gestational Diabetes)
- High Blood Pressure (i.e., Hypertension)
- Cardiovascular Diseases
- Family History of Kidney Disease
Show all 19Show fewer
- History of Acute Kidney Injury (AKI)
- Or; subjects with other medical conditions and/or risk factors that impact kidney function:
- Dyslipidemia
- Heavy smoking
- Obesity
- Inherited kidney disease (e.g. Polycystic kidney disease)
- Prolonged obstruction of the urinary tract from different conditions (e.g. enlarged prostate)
- Malignancies
- Recurrent kidney infections
- Other relevant conditions
- Subjects who are able to use both hands
- Subjects who are familiar with the use of a smartphone
- Subjects who are capable of comprehending and following instructions in English
Who cannot join
- Subjects with a major cognitive impairment (e.g.: dementia, memory loss, severe mental disorder)
- Subjects who are not able to collect urine in a receptacle
- Subjects who are visually impaired (i.e., cannot read the user manual)
- Any additional reason that disqualifies the subject from participating in the study according to the study physician
Trial locations and contacts
1 site in 1 country.
United States1 site
AccuMed research associates
Garden City, New York, 11530
About this study
Official title: Comparative, Controlled Study to Evaluate the Clinical Accuracy and Usability Performance of the Minuteful - Kidney Urine Analysis Test System Conducted by Lay Users
The purpose of this study was to collect additional performance and clinical data on the Minuteful - Kidney test device (previously "ACR | U.S. Urine Analysis Test System"), following the original data collection (NCT04626271).
This method comparison and usability study was designed to evaluate the agreement levels of the Minuteful - Kidney Test with the comparator device (URiSCAN Optima) as well as the device's usability including the lay user's ability to understand and implement the device instructions. It also evaluates the ease of use of the device under actual use conditions in a simulated home environment.
Read the detailed description
Eligible subjects meeting the inclusion criteria were recruited at the designated site by the study personnel. Following subject consent, the Minuteful - Kidney test kit, in its original packaging, along with the Minuteful - Kidney smartphone application were provided to the subject in a simulated home- use environment. All subjects were requested to follow the in-app instructions to complete the test, without any guidance from the study staff before, during or after testing. After each subject completed the test, the urine sample was tested by a professional user at the clinical site on the URiSCAN Optima device. Each urine sample was tested twice: once using the Minuteful - kidney test by the lay user and once using the comparator device (URiSCAN Optina) by the professional user.
To evaluate the usability of the device, study staff on-site were asked to observe and document the user performance on key tasks in the study flow as well as information regarding the user behavior while performing the test. Subjects were also asked to answer a usability post-test questionnaire.
- Conditions
- Albuminuria, Chronic Kidney Diseases, Diabetes, Hypertension
- Being tested
- Minuteful - Kidney Urine Analysis Test System
- Medical subject headings
- Albuminuria, Renal Insufficiency, Chronic, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minuteful - Kidney Urine Analysis Test SystemDevice
Also called Minuteful - Kidney, Minuteful - Kidney Test Device, ACR | U.S. Urine Analysis Test System
Urine samples were collected and tested by a lay user, using the Minuteful - Kidney test device. The lay user test results were compared to the results obtained by testing the same urine sample on the comparison device, the URiSCAN Optima.
| Study group | Role | What they receive |
|---|---|---|
| Minuteful - Kidney Urine Analysis Test System | Experimental | Not described Receives: Device: Minuteful - Kidney Urine Analysis Test System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy Evaluation: The Degree of Agreement (%) of the Minuteful - Kidney Urine Analysis Test System as Compared to the Comparator Device
The primary objective of the study is to evaluate the % exact match (percent agreement) and the % ±1 block match (percent agreement) of Minuteful - kidney test (tested by the lay user) compared to the URiSCAN Optima Urine Analyzer (the comparator device, tested by a healthcare professional user), for all reported values (blocks).
Measured: 10 months
Secondary outcomes (1)
Usability Evaluation: User Performance Analysis
The usability of the Minuteful - Kidney Urine Analysis Test System will be determined by evaluating the percentage of study subjects able to perform all required steps and successfully complete the test given only the instructions and training materials provided. In addition, each subject was asked to complete a post test questionnaire to assess the device ease of use by rating the various test steps on a scale of 1 to 5, with 5 being the easiest ("very easy") and 1 the hardest ("very hard"). This questionnaire also included understanding questions in a multiple-choice, quiz-like format, to assess the participants' understanding of essential information and key test procedures in the study.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start9 Dec 2021
- Primary completion28 Feb 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlbuminuriaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthy.io Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838872
- Sponsor's protocol ID
- ACR-US-MCU-SUP
- Status last verified
- Apr 2023
- First submitted
- 15 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Controlled Study to Evaluate the Clinical Accuracy and Usability Performance of the Minuteful - Kidney Urine Analysis Test System Conducted by Lay Users
- ClinicalTrials.gov ID
- NCT05838872
- Acronym / sponsor ID
- ACR-US-MCU-SUP
- Conditions
- Albuminuria, Chronic Kidney Diseases, Diabetes, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Healthy.io Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 3 May 2023 (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 purpose of this study was to collect additional performance and clinical data on the Minuteful - Kidney test device (previously "ACR | U.S. Urine Analysis Test System"), following the original data collection (NCT04626271).
This method comparison and usability study was designed to evaluate the agreement levels of the Minuteful - Kidney Test with the comparator device (URiSCAN Optima) as well as the device's usability including the lay user's ability to understand and implement the device instructions. It also evaluates the ease of use of the device under actual use conditions in a simulated home environment.
Detailed description
Eligible subjects meeting the inclusion criteria were recruited at the designated site by the study personnel. Following subject consent, the Minuteful - Kidney test kit, in its original packaging, along with the Minuteful - Kidney smartphone application were provided to the subject in a simulated home- use environment. All subjects were requested to follow the in-app instructions to complete the test, without any guidance from the study staff before, during or after testing. After each subject completed the test, the urine sample was tested by a professional user at the clinical site on the URiSCAN Optima device. Each urine sample was tested twice: once using the Minuteful - kidney test by the lay user and once using the comparator device (URiSCAN Optina) by the professional user.
To evaluate the usability of the device, study staff on-site were asked to observe and document the user performance on key tasks in the study flow as well as information regarding the user behavior while performing the test. Subjects were also asked to answer a usability post-test questionnaire.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minuteful - Kidney Urine Analysis Test System | Experimental | Device: Minuteful - Kidney Urine Analysis Test System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Males and Females 18-80 years of age
- Subjects with a known, well-established medical condition and/or risk factor for kidney damage, that can potentially present as an abnormal concentration of urine albumin:
- Diabetes (Type I/Type II, or Gestational Diabetes)
- High Blood Pressure (i.e., Hypertension)
- Cardiovascular Diseases
Key exclusion criteria (4 listed)
- Subjects with a major cognitive impairment (e.g.: dementia, memory loss, severe mental disorder)
- Subjects who are not able to collect urine in a receptacle
- Subjects who are visually impaired (i.e., cannot read the user manual)
- Any additional reason that disqualifies the subject from participating in the study according to the study physician
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 |
|---|---|---|
| Minuteful - Kidney Urine Analysis Test SystemAlso: Minuteful - Kidney, Minuteful - Kidney Test Device, ACR | U.S. Urine Analysis Test SystemUrine samples were collected and tested by a lay user, using the Minuteful - Kidney test device. The lay user test results were compared to the results obtained by testing the same urine sample on the comparison device, the URiSCAN Optima. | Device | Minuteful - Kidney Urine Analysis Test System |
Primary outcome
Accuracy Evaluation: The Degree of Agreement (%) of the Minuteful - Kidney Urine Analysis Test System as Compared to the Comparator Device
Time frame: 10 months
The primary objective of the study is to evaluate the % exact match (percent agreement) and the % ±1 block match (percent agreement) of Minuteful - kidney test (tested by the lay user) compared to the URiSCAN Optima Urine Analyzer (the comparator device, tested by a healthcare professional user), for all reported values (blocks).
1 secondary outcome
Usability Evaluation: User Performance Analysis
Time frame: 10 months
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 3 May 2023.
- Individual participant dataSharing planned: No
Related trials for Albuminuria
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
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 Minuteful - Kidney Urine Analysis Test System in people with Albuminuria and Chronic Kidney Diseases, run by Healthy.io Ltd. 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 19 inclusion and 4 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 3 May 2023. 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?
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?
Accuracy Evaluation: The Degree of Agreement (%) of the Minuteful - Kidney Urine Analysis Test System as Compared to the Comparator Device (time frame: 10 months). 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 3 May 2023.