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Feasibility of Remote Data Collection With a Point of Care Device to Measure HbA1c

Enhancing Cardiovascular Health Equity in Mothers and Children Through Home Visiting

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05725746
Enrollment
18
Registered
2023-02-13
Start date
2023-02-24
Completion date
2024-04-25
Last updated
2025-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum, Pregnant

Brief summary

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

Detailed description

The foundation for cardiovascular health (CVH) is laid in early life by intergenerational interactions, passed from parent to child, that have long-lasting biological and behavioral consequences. Lifestyle interventions can promote CVH among mothers and their children over time. Academic partnerships with home visiting organizations that reach families experiencing health disparities advance intergenerational CVH equity. For this pilot study we are testing the feasibility of doing remote data collection with a point of care device that measures HbA1c to use in the main study.

Interventions

DIAGNOSTIC_TESTPoint of care device to measure HbA1c

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.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Feasibility to Obtain HbA1c Through Remote Data CollectionBaselineFeasibility 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Point of Care Device
Test the feasibility of doing remote data collection with a point of care device that measures HbA1c.
18
Total18

Baseline characteristics

CharacteristicPoint of Care Device
Age, Continuous30 Years
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
6 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
White
9 Participants
Sex: Female, Male
Female
18 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 18
other
Total, other adverse events
0 / 18
serious
Total, serious adverse events
0 / 18

Outcome results

Primary

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.

Time frame: Baseline

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Point of Care DeviceFeasibility to Obtain HbA1c Through Remote Data CollectionAble to use point of care device17 Participants
Point of Care DeviceFeasibility to Obtain HbA1c Through Remote Data CollectionAgreed or strongly agreed instructions were helpful16 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026