A New Glucose Meter With Alternative Site Testing

Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Alternative Site Testing [Commercial Name is CONTOUR® USB]

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Apollo Blood Glucose Monitoring System

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Kalamazoo, Michigan, United States, 49007
      • Jasper Clinic, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Subjects with diabetes; Subjects with diabetes use a new Apollo Blood Glucose Monitoring System with blood obtained from the palm and forearm	Device: Apollo Blood Glucose Monitoring System; 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.; Other Names: Commercial name is CONTOUR® USB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Rated as <=3 (Labeling Comprehension)	Study staff rated participants as to their success at performing meter testing. The rating scale was: Successful; Successful after being referred to user instructions; Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.); Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)	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).	One hour

Collaborators and Investigators

• Sponsor: Ascensia Diabetes Care
• Investigators: Principal Investigator: Vimala Sethy, MD, PhD, Jasper Clinic, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: November 24, 2008
• First Submitted That Met QC Criteria: November 24, 2008
• First Posted (Estimate): November 25, 2008

Study Record Updates

• Last Update Posted (Estimate): November 3, 2016
• Last Update Submitted That Met QC Criteria: September 29, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CTD-2008-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES