User Study for Enhanced Meter Feature

• Sponsor: AgaMatrix, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01889355
• Collaborator: (none)
• Enrollment: 121
• Location: 1
• Arm: 1
• Duration (Months): 1.9
• Patients Per Site Per Month: 62.4

Study Details

Study Description

Brief Summary

This enhanced meter feature raises awareness among patients by providing additional information regarding their glycemic control in between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professional and can remind patients of the importance of glycemic control.

This study will evaluate a user's ability to use the enhanced meter feature.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Device: AgaMatrix Blood Glucose Monitor	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 121 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: User Study for the Evaluation of an Enhanced Meter Feature Using an AgaMatrix BGMS
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Enhanced meter feature usability Home diabetes monitoring by patient using provided blood glucose monitoring system.	Device: AgaMatrix Blood Glucose Monitor

Outcome Measures

Primary Outcome Measures

1. Enhanced Meter Feature Usability [4 weeks]

   The primary objective of this study is to evaluate that the intended users are able to obtain accurate blood glucose measurements when operating the blood glucose monitoring system, given only the training materials routinely provided with the system (ISO 15197:2013 8.1).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

IC 1. Age of subject is 18 years or older

IC 2. Type I or type II diabetes inclusive of the following populations:

1. Mixed insulin therapies

2. Basal insulin therapies

3. Bolus insulin therapies

4. CSII therapies

5. MDI therapies

6. Non-insulin diabetic treatments (oral and injectable)

7. Life style (exercise and diet) diabetes management IC 3. Able to speak and read English proficiently

Exclusion criteria EC 1. Pregnant EC 2. Hct <20 or >60 EC 3. Work for BGM competitor company (including, but not limited to Lifescan, Roche, Abbott) EC 4. Homeless EC 5. Incarcerated EC 6. Institutionalized EC 7. Employees or students of the Research Site, including the Principal Investigator, directly involved in the conduct of the protocol.

EC 8. Has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.

EC 9. Previous experience using the MyStar Extra BGMS

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atlanta Diabetes Associates	Atlanta	Georgia	United States	30318

Sponsors and Collaborators

• AgaMatrix, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AgaMatrix, Inc.
• ClinicalTrials.gov Identifier: NCT01889355
• Other Study ID Numbers: AGAFPGM01
• First Posted: Jun 28, 2013
• Last Update Posted: Aug 6, 2018
• Last Verified: Mar 1, 2014

• Keywords provided by AgaMatrix, Inc.: diabetes; glucose; glucometer

Study Results

Participant Flow

Arm/Group Title	Study Procedure
Arm/Group Description	5.5 Evaluation Procedure The evaluation shall be performed in the following sequence and be supervised by one or more healthcare providers trained in the use of the device under evaluation (ISO 15197:2013 8.1). Briefly describe to the subject that the goal of this study is to obtain a blood glucose reading, describe the study procedures, and obtain written informed consent ensuring all questions are answered. For each consenting study subject, assign a sequential User ID number and obtain inclusion criteria, exclusion criteria, and user demographics. Perform a urine pregnancy test for women of childbearing potential if pregnancy status unknown. Locate subjects to a private area where they are not able to see others performing the test. The trained technician will put on a new pair of gloves. Provide the subject with an AgaMatrix meter, test strips, the system kit lancing device and lancets. Prior to performing self-testing, each study subject shall
Period Title: Overall Study
STARTED	115
COMPLETED	113
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Demographics
Arm/Group Description	Age group ranged from ages 18-86, Male and female with both Type 1 and Type 2 diabetics. Race was both white, black/African American and Hispanic who are able to read and understand English per the subject consent form.
Overall Participants	113
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	75 66.4%
>=65 years	38 33.6%
Sex: Female, Male (Count of Participants)
Female	55 48.7%
Male	58 51.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 0.9%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	5 4.4%
White	107 94.7%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Enhanced Meter Feature Usability
Description	The primary objective of this study is to evaluate that the intended users are able to obtain accurate blood glucose measurements when operating the blood glucose monitoring system, given only the training materials routinely provided with the system (ISO 15197:2013 8.1).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

All diabetic subjects who volunteer for the study and qualify in accordance with the study inclusion and exclusion criteria, the user requirements established by the manufacturer for the blood-glucose system, and applicable regulatory requirements, shall be eligible to participate in the study

Arm/Group Title	Subject Population, Inclusion and Exclusion
Arm/Group Description	This clinical study will consist of at least 50 evaluable subjects who meet all inclusion/exclusion criteria. Subjects shall be selected using the consecutive sampling method. All diabetic subjects who volunteer for the study and qualify in accordance with the study inclusion and exclusion criteria, the user requirements established by the manufacturer for the blood-glucose system (e.g. packed cell volume within the system's specified limits), and applicable regulatory requirements (e.g. written informed consent), shall be eligible to participate in the study (ISO 15197:2013 8.3). 3.2 Inclusion Criteria Potential participants may be enrolled in the study if they satisfy the following inclusion criteria: IC 1. Age of subject is 18 years or older IC 2. Has been diagnosed with Type1 or Type 2 diabetes IC 3. Able to speak and read English proficiently IC 4. Must be physically able to self-test 3.3 Exclusion Criteria Potential subjects who display any o
Measure Participants	50
Count of Participants [Participants]	50 44.2%

Adverse Events

Arm/Group Title	Adverse and Serious Events
Arm/Group Description	No adverse or serious events occurred during this study
All Cause Mortality
	Adverse and Serious Events
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Adverse and Serious Events
	Affected / at Risk (%)	# Events
Total	0/113 (0%)
Other (Not Including Serious) Adverse Events
	Adverse and Serious Events
	Affected / at Risk (%)	# Events
Total	0/113 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.