Diabetes Prevention in Hispanic Adults Using Constant Glucose Monitors

NCT ID: NCT06864728

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-28
• Study Completion Date: 2026-01-28

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.

Detailed Description

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:

1. 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.

2. 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.

Conditions

Prediabetes / Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

In Person patient education

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

Group Type: ACTIVE_COMPARATOR

In person or virtual diabetes education

Intervention Type: BEHAVIORAL

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

Video Intervention

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

Group Type: EXPERIMENTAL

Video Diabetes Education

Intervention Type: 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

Interventions

Video Diabetes Education

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

Intervention Type: BEHAVIORAL

In person or virtual diabetes education

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pregnant Type 1 diabetes

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Texas at Austin

Austin, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Julie Zuniga, PhD

Role: CONTACT

jzuniga@nursing.utexas.edu

5124714696

Alexandra Garcia, PhD

Role: CONTACT

Facility Contacts

Julie Zuniga, PhD

Role: primary

jzuniga@nursing.utexas.edu

512-471-4696

Other Identifiers

00005535

Identifier Type: -

Identifier Source: org_study_id