NCT05725746

Brief Summary

Conduct a pilot study to test feasibility of doing remote data collection with a point of care device that measures HbA1c.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

February 24, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 15, 2025

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

February 1, 2023

Results QC Date

April 23, 2025

Last Update Submit

July 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility to Obtain HbA1c Through Remote Data Collection

    Feasibility will be measured by how many participants are able to obtain HbA1c measure through remote data collection and participant's satisfaction with this means of data collection.

    Baseline

Interventions

After consent the participant will meet with the research team virtually to obtain HbA1c. The HbA1c self check equipment will be sent to the participant. During the video call the research team will talk the participant through obtaining their HbA1c with the point of care device.

Also known as: A1C Now self check

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFor the participants only women will be included: Including only female participants is scientifically justified, as the main study focus is addressing cardiovascular health of prenatal and postpartum women.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant or postpartum women who are currently or have recently participated in the Parents as Teachers home visiting program.

You may qualify if:

  • English speaking
  • Screened or participating in NCT04253977
  • Able to give informed consent for participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

Results Point of Contact

Title
Cindy Schwarz
Organization
Washington University in St. Louis

Study Officials

  • Debra Haire-Joshu, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR
  • Victor G Davila-Roman, MD,FACC,FASE

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR
  • Rachel G Tabak, PhD, RD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 13, 2023

Study Start

February 24, 2023

Primary Completion

April 25, 2024

Study Completion

April 25, 2024

Last Updated

July 15, 2025

Results First Posted

July 15, 2025

Record last verified: 2025-07

Locations