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Evaluation of an Ascensia Blood Glucose Meter and App System

Ascensia Diabetes Care logo

Ascensia Diabetes Care

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Device: Onyx BG Meter / App System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02568384
GCA-2014-006-01

Details and patient eligibility

About

The purpose of this study is to assess the usability of the Onyx system in the hands of subjects with Insulin Dependent Diabetes Mellitus (IDDM) or insulin-using subjects with Non-IDDM.

Enrollment

45 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Be aged 18-75 years, male or female
  • Read and understand English
  • Have diagnosis of type 1 or insulin-using type 2 diabetes for at least 6 months
  • Be taking multiple daily injections (MDI) of at least two pre-meal bolus injections daily or using an insulin pump
  • Performing self-monitoring of blood glucose at home at least twice daily
  • Have an iOS mobile device or Android mobile device with blue tooth capability
  • iOS device: iPod or iPhone 5 or later version with iOS 8.0 software or higher (no tablets)
  • Android: smart phone, 4.4 version and higher (no tablets)
  • Be willing to utilize the ONYX App on personal mobile device which communicates to meter to manage diabetes (including use of the bolus calculator)
  • Be ambulatory and have transportation to the study site

Exclusion criteria

  • Hemophilia or any other bleeding disorder
  • Pregnancy
  • Physical, visual or neurological impairments that would make the person unable to perform testing with the BGM
  • Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.
  • A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee on the subject disposition form).
  • Proliferative retinopathy or history of retinal laser surgery

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

45 participants in 1 patient group

Users of Onyx BG Meter / App System
Experimental group
Description:
Subjects with diabetes used the Onyx Blood Glucose (BG) Meter / App System at home. The enrollment goal for the intended use population: 1. 40 to 70% of subjects will have type 1 diabetes 2. Not more than 30% of subjects will use an insulin pump
Treatment:
Device: Onyx BG Meter / App System

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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