An observational study in Pregnant and Postpartum, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-15.
Sponsored by Washington University School of Medicine · Observational
Conduct a pilot study to test feasibility of doing remote data collection with a point of care device that measures HbA1c.
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.
Washington University School of Medicine is the lead sponsor of 1,764 studies on the registry; 270 are open to participants now.
Of its 325 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pregnant or postpartum women who are currently or have recently participated in the Parents as Teachers home visiting program.
Exclusion Criteria:
-
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
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
| Milestone | Point of Care Device |
|---|---|
| Started | 18 |
| Completed | 18 |
| Not completed | 0 |
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.
| Participants | Point of Care Device |
|---|---|
| Able to use point of care device | 17 |
| Agreed or strongly agreed instructions were helpful | 16 |
Collected over Adverse events were collected during the data collection visit, about 20 minutes.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Point of Care Device | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Continuous(Years) | Point of Care Device |
|---|---|
| Mean | 30 (19 to 37) |
| Sex: Female, Male(Participants) | Point of Care Device |
|---|---|
| Female | 18 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Point of Care Device |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 15 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Point of Care Device |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — Only data with identifiers removed will be shared publicly. Any identified data to be shared will only be done so in coordination with the Human Research Protection Office at Washington University in St. Louis and the Institutional Review Board (IRB) at the requesting investigator's institution. Datasets with identifiers will only be accessible to study team members with appropriate Human Subjects training.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine