A New Glucose Meter With Alternative Site Testing

Ascensia Diabetes Care50 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus

Interventions

Apollo Blood Glucose Monitoring SystemDEVICE

Subjects with diabetes use a new blood glucose monitoring system with blood taken from the palm and forearm. These blood glucose AST results are compared with results obtained by healthcare professionals (HCPs) from subject fingersticks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Jasper Clinic, Inc.

Kalamazoo, Michigan, United States

Outcomes

Primary Outcomes

Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results

Performance of the blood glucose monitoring system when the system is used for alternative site testing (AST) with samples from the palm and forearm compared with BGMS fingerstick capillary blood results obtained by an HCP

Time frame: One hour

Secondary Outcomes

Percentage of Participants Rated as <=3 (Labeling Comprehension)

Study staff rated participants as to their success at performing meter testing. The rating scale was: 1. Successful 2. Successful after being referred to user instructions 3. Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.) 4. Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)

Time frame: One hour

Percentage of Participant Ratings for Overall Testing Experience With This Meter

Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitor System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).

Time frame: One hour

Data from ClinicalTrials.gov

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