Clinical trial NCT06864728: Diabetes Prevention in Hispanic Adults Using Constant Glucose Monitors
Official title: The Impact of Social Determinates of Health on Risk for Diabetes in the Hispanic Community: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prediabetes / Type 2 Diabetes
Keywords: diabetes risk
constant glucose monitoring
diabetes knowledge
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: No additional details.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnant Type 1 diabetes

Primary outcomes:
measure: Diabetes Knowledge
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
References: