NCT06575231

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

August 22, 2024

Last Update Submit

August 26, 2024

Conditions

DiabetesHbA1c

Keywords

HbA1c

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    HbA1c testing can be performed at any time of day and without special patient preparation.

    3 minutes

Study Arms (1)

Type 2 diabetic patients

EXPERIMENTAL

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.

Diagnostic Test: in-vitro

Interventions

in-vitroDIAGNOSTIC_TEST

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.

Type 2 diabetic patients

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Hemophilia or any other bleeding disorder
  • Reports having an infection with a blood borne pathogen (e.g. HIV, hepatitis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

In Vitro Meat

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MeatFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Shi-Yann Cheng, M.D

    China Medical University Beigang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Each subject should draw two tubes of venous blood in the K2-EDTA. One tube should be tested by POC operator as a study participant using the PixoTest POCT System. The other tube takes 1c.c. blood sample from K2-EDTA to analyzed with a comparison method.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2024

First Posted

August 28, 2024

Study Start

July 1, 2016

Primary Completion

May 17, 2017

Study Completion

June 30, 2017

Last Updated

August 28, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share