Accuracy and User Performance Evaluation of PixoTest HbA1c Measurement System

Not Applicable

Completed

• Conditions: HbA1c; Diabetes
• Interventions: Diagnostic Test: in-vitro

• Registration Number: NCT06575231
• Lead Sponsor: China Medical University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2016-07-01
• Primary Completion: 2017-05-17
• Study Completion: 2017-06-30
• Status Verified: 2024-08
• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-26
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Type 2 diabetic patients	in-vitro	1. 20 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.

Primary Outcome Measures

Name	Time	Method
HbA1c	3 minutes	HbA1c testing can be performed at any time of day and without special patient preparation.