NCT06864728

Brief Summary

The purpose of the study is twofold: to see the impact of your environmental stress on daily glucose changes and to create an intervention using CGM to potentially decrease risk for diabetes. The aim of this study to develop an intervention to prevent diabetes in the Hispanic community and inform policies about social determinants of health.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

January 28, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2026

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 3, 2025

Last Update Submit

March 6, 2025

Conditions

Keywords

diabetes riskconstant glucose monitoringdiabetes knowledge

Outcome Measures

Primary Outcomes (1)

  • Diabetes Knowledge

    measured by the Diabetes Knowledge questionnaire - Revised

    4 weeks

Study Arms (2)

In Person patient education

ACTIVE COMPARATOR

Participants will receive patient education in person or virtually. They will get the results from their tests

Behavioral: In person or virtual diabetes education

Video Intervention

EXPERIMENTAL

Patients will receive a link to a video of a nurse explaining their results.

Behavioral: Video Diabetes Education

Interventions

Participants will receive a link to a short video explaining their findings. They can use the link as often as they'd like. They will get the results for the CGM and the laboratory findings. They will be linked to their 2 week diet diary

Video Intervention

Participants will meet with a nurse to discuss their CGM results and their lab results and get appropriate education.

In Person patient education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • self- identify as Hispanic Has a parent diagnosed with diabetes type 2

You may not qualify if:

  • Pregnant Type 1 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic StateDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Julie Zuniga, PhD

CONTACT

Alexandra Garcia, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: No additional details.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2025

First Posted

March 7, 2025

Study Start

January 28, 2025

Primary Completion

August 1, 2025

Study Completion

January 28, 2026

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Data will be deidentified. Formal request to the PI of the study will be considered.

Locations