Trials Sponsors Conditions Drugs Pricing

Conditions

CKD Diabete Mellitus ESRD

Keywords

DiabetesCKDESRDPOCT

Outcome Measures

Primary Outcomes (1)

Nova StatStrip A Glucose/Creatinine Meter System
The primary objective of this study is to assess the performance of the Nova StatStrip A Glucose/Creatinine Meter System in the hands of the subject (lay user) and compare the result to an accepted Glucose/Creatinine reference method in the hands of a trained technician. The two parameters for the outcome measure in this study are glucose and creatinine. The unit of measure for glucose and creatinine is mg/dL and mmol/L, respectively.
20 days

Interventions

Glucose, CreatinineDiagnostic test

Compare diagnostic tests to reference methods

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

A minimum of 150 to a maximum of 200 individual subjects (lay users) will be enrolled. Subjects included in the study may be healthy, diabetic or having kidney diseases. The study will be conducted at one study site. 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 glucose/creatinine levels. The screening may be done by inspecting medical records.

You may qualify if:

Sponsors & Collaborators

Excellence Medical and Research
Type not reportedcollaborator
Nova Biomedical
Industrylead

Study Sites (1)

Excellence Medical Research

Miami Gardens, Florida, 33169, United States

MeSH Terms

Conditions

Diabetes MellitusKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Enrollment

175 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 22, 2021

First Posted

December 6, 2021

Study Start

October 28, 2021

Actual (reported)

StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations