Accuracy and User Performance Evaluation of PixoTest HbA1c Measurement System

To evaluate the accuracy user performance of PixoTest HbAc1 measurement system and to collect feedback from subjects.

Study Overview

• Status: Completed
• Conditions: Diabetes; HbA1c
• Intervention / Treatment: Diagnostic test: in-vitro

Detailed Description

According to WHO report, the number of people with diabetes has risen from 108 million in 1980 to 422 million in 2014. Diabetes is a major cause of blindness, kidney failure, heart attacks, stroke and lower limb amputation. In 2012 alone diabetes caused 1.5 million death. Tight glucose control is essential for prevention of complications in people with diabetes. The Diabetes Control and Complications Trial (DCCT) provided direct evidence the relationship between HbA1c level and risks for diabetic complications in diabetes. Based on the results of the DCCT, the American Diabetes Association (ADA) has published recommendations for HbA1c and plasma glucose levels that are widely used. HbA1c testing can be performed at any time of day and without special patient preparation, it is more convenient for patients and even measuring fasting plasma glucose.

The ADA recommends measurement of HbA1c (typically 3-4 times per year for type 1 and poorly controlled type 2 diabetic patients, and 2 times per year for well-controlled type 2 diabetic patients) to determine whether a patient's metabolic control has remained continuously within the target range. .Most diabetes patients will go to hospital to measurement HbA1c, but should wait few days for test result. Most diabetes patient maybe not measurement HbA1c so many time per year. The PixoTest HbA1c measurement system can give result for a few minutes at home. The diabetes patient can measure HbA1c at home don't need go to hospital.

The PixoTest HbA1c measurement system is defined as the respective reagent system and the corresponding smartphone. It is intended for quantitative measurement of HbA1c in capillary whole blood and use in the home by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control.

This study is designed to test the accuracy and user performance of the Pixotest HbA1c measurement system.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years or older.
2. Willing to participate in the study, able to read and provide written informed consent form.
3. HCT 25~65%.
4. Subjects including healthy subjects, outpatients and inpatients.

Exclusion Criteria:

1. An individual who does not meet the inclusion criteria will be excluded from enrollment.Taking prescription anticoagulants (such as Warfarin or Heparin) or have clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded.
2. Hemophilia or any other bleeding disorder
3. Reports having an infection with a blood borne pathogen (e.g. HIV, hepatitis)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Type 2 diabetic patients; 20 years or older.; Willing to participate in the study, able to read and provide written informed consent form.; HCT 25~65%.; Subjects including healthy subjects, outpatients, and inpatients.	Diagnostic test: in-vitro; responding smartphone. It is intended for quantitative measurement of HbA1c in capillary whole blood and use in the home by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	HbA1c testing can be performed at any time of day and without special patient preparation.	3 minutes

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Shi-Yann Cheng, M.D, China Medical University Beigang Hospital

Publications and helpful links

Helpful Links

• NGSP Manufacturer Certified Methods

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): May 17, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: HbA1c
• Other Study ID Numbers: CMUH105-REC1-080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No