Completed
Performance of the Ninja 3 Plus Blood Glucose Monitoring System
What is being tested
Ninja 3 PLUS Investigational BG Monitoring System
Device
Who is being recruted
Endocrine System Diseases+2
+ Metabolic Diseases
+ Nutritional and Metabolic Diseases
Over 18 Years
+7 Eligibility Criteria
How is the trial designed
Diagnostic Study
Interventional
Study Start: March 2013
Summary
Principal SponsorAscensia Diabetes Care
Last updated: February 29, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.The purpose of this study was to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
Principal SponsorAscensia Diabetes Care
Last updated: February 29, 2016
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
113 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes Mellitus
Criteria
7 exclusion criteria prevent from participating
A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk
Hemophilia or any other bleeding disorder
Physical, visual or neurological impairments that would make the person unable to perform testing with the BGM
Pregnancy
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalUntrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population:
At least 60% of subjects were younger than 65 years of age.
At least 20% had type 1 diabetes.
At least 50% with type 2 diabetes were insulin users.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Consumer Product Testing Co.
Fairfield, United StatesOpen Consumer Product Testing Co. in Google MapsCompletedOne Study Center