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A New Glucose Meter With Alternative Site Testing

NCT ID: NCT00797212

Last Updated: 2016-11-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2008-11-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Subjects with diabetes

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

Group Type OTHER

Apollo Blood Glucose Monitoring System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Commercial name is CONTOUR® USB

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ascensia Diabetes Care

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vimala Sethy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jasper Clinic, Inc.

Locations

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Jasper Clinic, Inc.

Kalamazoo, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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CTD-2008-19

Identifier Type: -

Identifier Source: org_study_id