Evaluation of an Ascensia Blood Glucose Meter and App System

Diabetes Mellitus Clinical Trial

Official title:

Open Label, Single-center Study of the Onyx Meter and App System for Blood Glucose Monitoring in Insulin-Dependent and Insulin-using, Non-Insulin-Dependent Diabetes Mellitus Patients to Demonstrate Usability in a Clinical Setting.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02568384
• Other study ID #: GCA-2014-006-01
• Status: Completed
• Phase: N/A
• First received: October 2, 2015
• Last updated: August 24, 2017
• Start date: October 2015
• Est. completion date: November 2015

Study information

• Verified date: August 2017
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• Onyx BG Meter / App System
Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions.

Locations

Country	Name	City	State
United States	AMCR Institute	Escondido	California

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HbA1c% From Study Start to End of Study	Laboratory reports were used to compare HbA1c results from subjects at visit 1 with HbA1c results at Visit 2 (end of study).	3 weeks
Other	Average Change in Subject Fructosamine From Study Start to End of Study	Laboratory reports were used to compare Fructosamine results from subjects at visit 1 with Fructosamine results at Visit 2 (end of study).	3 weeks
Other	Average Change in Subject Body Weight From Study Start to End of Study	Subject Body Weight results at visit 1 were compared with Body Weight results at Visit 2 (end of study).	3 weeks
Other	Average Change in Total Daily Insulin Dose From Study Start to End of Study	Subjects' self-reported Total Daily Insulin Doses at visit 1 were compared with their self-reported Total Daily Insulin Doses at Visit 2 (end of study).	3 weeks
Primary	Percent of Responses From Persons Who Performed Each "Software Operations" Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree.	For "software operations" tasks, subjects rated statements about software operations tasks as 1Strongly Agree, 2Agree, 3Neither Agree nor Disagree, 4Disagree, 5Strongly Disagree, or 6No opinion. Software operations tasks included: Obtain a synced blood glucose reading; Initiation and use of insulin bolus calculator; Access and interpret glucose displays such as expanded graph (modal day) and sequential views.	3 weeks
Secondary	Percent of Responses From Persons With Diabetes That Rated Ease of Use For Onyx Glucose Meter and App System as Either Very Simple or Simple or Neither Simple Nor Difficult	Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the basic operation of the Onyx Glucose Meter and App System. Subjects could respond '1Very Simple' or '2Simple' or '3Neither Simple nor Difficult' or '4Difficult' or '5Very Difficult' or '6No Opinion'.	3 weeks
Secondary	Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Clarity and Utility of User Instructions For Onyx Glucose Meter and App System	Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the clarity and utility of user instructions for the Onyx Glucose Meter and App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or '6No Opinion'.	3 weeks