Comparison of Aurora Lancing Device and Commercially Available Devices for Blood Glucose Testing
This observational study aims to compare the Aurora lancing device with commercially available devices for blood glucose testing, focusing on the blood glucose reading and the associated pain levels when used on different body parts such as the palm and forearm.
Data Collection
Collected at a single point in time - Cross-sectionalAutoimmune Diseases+6
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 1
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: August 1, 2009
Actual date on which the first participant was enrolled.A low-pain lancing is being developed code name Aurora) for use with a 33g proprietary lancet (code name Velvet). This study evaluates the pain associated with finger lancing using this device and compares that pain to other commercially available lancing devices and associated lancets. All lancets used in the study are currently commercially available except the Facet 33g lancet, which is a prototype version of commercially available lancets. The Roche Multiclix, Roche Softclix, One Touch Comfort and Bayer Microlet 2 lancing devices are all commercially available. The Aurora Lancing Device is effective in obtaining a sufficient blood sample for performing an accurate blood glucose measurement; and the benefits of using the Aurora Lancing Device outweighs any residual risks associated with the product. Literature concerning blood glucose testing was researched by using popular medical databases such as pubmed.gov, diabeteshealth.com, clinicaltrial.gov and search terms lancing device, clinical study, blood volume and pain. Using other popular search engines such as Google was beneficial in helping to support claims concerning safety and efficacy. A commercial database company, NERAC was used as a part of the literature research effort. Our review, together with preliminary in-house bench testing, shows that the Aurora Lancing Device should be able to: * Obtain enough blood volume for a meter reading that measures blood glucose levels; * Is as safe as comparative lancing devices currently on the market; * Produces no more pain than comparative lancing devices currently on the market using a 28 gauge needle; and * Is representative of "current state of the art" The Aurora Lancing Device uses a 33 gauge, uniquely designed lancet developed under project Velvet. The blood lancet is designed so that it can only be used in the Aurora lancing device. The lancing device features multiple depth settings and includes alternate site test capability. The lancet guidance system is designed to maximize lancet control thereby increasing comfort and reducing pain perception. The Aurora lancing device is comparable to the Roche Softclix and other lancing devices already in commercial distribution. Like Aurora the Roche Softclix lancing device offers diabetics a unique lancet design and precise lancet motion. Roche Softclix uses a 28 gauge lancet and has eleven depth settings as well as alternative site test capability.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Inclusion Criteria: Must have been diagnosed with type 1 or type 2 diabetes for at least 1 year Must be doing SMBG, at least twice daily for at least 6 months Must be 18 years of age and older Must have healthy fingers and hands Must be able to read instructions in English. Must be able to perform all tasks in the protocol. Exclusion Criteria: Subjects with neuropathy or any other nerve damage in the hand or fingers (this will be discovered through the monofilament test) Subjects who are taking prescription anti-coagulants or more than one full aspirin per day during the past week or have clotting problems that may prolong bleeding (persons taking Plavix or a daily low dose aspirin will not be excluded but this will be recorded). Subjects taking prescription medications for neuropathy. Subjects with hemophilia or any other bleeding disorder. subjects with infection with a blood borne pathogen (e.g., HIV, hepatitis). Subjects having a condition such as a cognitive disorder, which in the opinion of the Investigator would put the person at risk or seriously compromise the integrity of the study (PI will sign CRF if subject is excluded). Subjects with missing digits. Subjects who are pregnant or nursing. Subjects on chemotherapy.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives