A New Glucose Meter With Alternative Site Testing

NCT00797212 | Completed Results

• 1 other identifier: CTD-2008-19
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  One hour

• Percentage of Participant Ratings for Overall Testing Experience With This Meter

  One hour

Study Arms (1)

Subjects with diabetes

OTHER

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

Interventions

Apollo Blood Glucose Monitoring System 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.

Also known as: Commercial name is CONTOUR® USB

Subjects with diabetes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ascensia Diabetes Care: lead

Study Sites (1)

Jasper Clinic, Inc.

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Carmine Greene, Senior Clinical Research Scientist
• Organization: Ascensia Diabetes Care

carmine.greene@ascensia.com

574-257-3040

Study Officials

• Vimala Sethy, MD, PhD

  Jasper Clinic, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: November 3, 2016
• Results First Posted: December 14, 2009

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)