A New Glucose Meter With Alternative Site Testing

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Apollo Blood Glucose Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00797212

CTD-2008-19

Details and patient eligibility

About

The purpose of the study was to evaluate the performance of the blood glucose monitoring system when used with samples taken from the palm and forearm for alternative site testing (AST).

Full description

The blood glucose monitoring system may be used for alternative site testing. The blood glucose results obtained by subjects with samples taken from the palm and forearm were compared with fingerstick capillary blood glucose results obtained from subjects by an HCP. Product labeling was evaluated for comprehension of performing alternative site testing as well as for additional meter features. User feedback about the system and its features was obtained.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have type 1 or type 2 diabetes
• Be >18<76 years of age at time of consent, with approximately 50% (+10%) being less than 55 years of age
• Be willing to complete all study procedures
• Be routinely testing their blood sugar at home (at least once per day)
• Be able to speak, read, and understand English and understand the Informed Consent document
• Be able to read the labeling instructions

Exclusion criteria

• Minors <18 years of age and adults >75 years of age
• Pregnancy
• Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGMS
• Disorders in the fingertip lancing areas
• Acute or chronic infections, particularly skin infections
• Infection with a blood borne pathogen
• Taking prescription anti-coagulants or having clotting problems that may prolong bleeding. Taking aspirin daily (81mg or 325 mg) is not reason for exclusion.
• Hemophilia or any other bleeding disorder
• Having a condition which, in the opinion of the Principal Investigator or designee, would put the person at risk or seriously compromise the integrity of the study
• Working for a competitive medical device company

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Subjects with diabetes

Other group

Description:

Subjects with diabetes use a new Apollo Blood Glucose Monitoring System with blood obtained from the palm and forearm

Treatment:

Device: Apollo Blood Glucose Monitoring System