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OpenTrials
Active, Not Recruiting

NCT Number: NCT06864728

Diabetes Prevention in Hispanic Adults Using Constant Glucose Monitors

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas at Austin

Austin, Texas, 78712, United States

About this study

Social determinants of health are associated with developing diabetes mellitus type 2 (diabetes) onset, progression, and adverse outcomes. Hispanics have a 50% lifetime risk of developing diabetes. They also transition from pre-diabetes to diabetes faster and have an earlier onset of diabetes and its complications than the general population. People with a family history of diabetes are 7.6 times more likely to develop diabetes than individuals without such a history. Diabetes research uses hemoglobin A1C (A1C), the accumulation of glucose on hemoglobin molecules during the past three months, as the measure of diabetes control. However, A1C is an insensitive measure of glucose for those at risk for developing diabetes because glucose spikes and variability are often masked in an average glucose level by A1C. Glucose spikes should rarely occur and can be an early indicator of insulin insufficiency. Constant glucose monitors (CGM) can detect glucose spikes and have successfully lowered A1C in people with diabetes.

Using CGM, Hispanic adults with familial risk factors of diabetes can obtain a more detailed assessment of their glucose levels and identify foods, activities, emotions, and stress that impact their glucose levels. Time constraints can often be a barrier to participating in an intervention. The proposed intervention will test an asynchronous nurse-led intervention. To address this gap and create an intervention, glucose variability in Hispanics at risk for diabetes will be investigate to identify glucose variability predictors and create a culturally tailored intervention to prevent diabetes.

Diagnosis of glucose intolerance, or prediabetes, can be evaluated using an oral glucose tolerance test (oGTT) to illustrate a person's ability to produce and use insulin in response to glucose consumption. The medical community uses these lab values as benchmarks. Knowing the starting level of participants' glucose tolerance will allow us to better interpret the CGM findings. Additionally, it will provide validity for using CGMs in the population at risk for diabetes.

Therefore, the specific aims are as follows:

  • To examine the relationship between social determinants and glucose control. These analyses estimate the associations between economic instability, neighborhood vulnerability, food insecurity, and healthcare quality with glucose variability.
  • To determine the feasibility and acceptability of a CGM intervention for Hispanics at risk of diabetes. The study compares synchronous or asynchronous diabetes education intervention. The participants will receive education and feedback based on their CGM results, either in person or via videos.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant Type 1 diabetes

Treatment and study plan

Video Diabetes Education

Behavioral

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

In person or virtual diabetes education

Behavioral

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

Primary outcomes

  1. Diabetes Knowledge

    Time frame: 4 weeks

    measured by the Diabetes Knowledge questionnaire - Revised

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Official study title

The Impact of Social Determinates of Health on Risk for Diabetes in the Hispanic Community: a Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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