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Telementoring for Diabetes Care Improvement

N/A

Waitlist Available

Led By Elizabeth Vaughan, DO

Research Sponsored by The University of Texas Medical Branch, Galveston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with type 2 diabetes (T2D) with HbA1c level of 6.5% or higher, provider-documented T2D, and on oral anti-hyperglycemic medication

Aged 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 36-months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether mentoring local clinics to start a diabetes care program called TIME via telehealth is an effective way to improve care and reduce disparities in vulnerable populations.

Who is the study for?

This trial is for Spanish-speaking adults over 18 with type 2 diabetes, an HbA1c level of at least 6.5%, and taking oral diabetes medication. Participants must be uninsured, below the poverty line, and self-identify as Latino(a). It's not for those who miss group visits, have conditions affecting HbA1c levels or need frequent clinic visits.

What is being tested?

The study tests a telementoring program called TIME that helps local clinics start a comprehensive diabetes care initiative. The focus is on integrating community health workers (CHWs), improving medication access, and providing group education through telehealth support.

What are the potential side effects?

Since this trial involves educational and mentoring interventions rather than medications or medical procedures, there are no direct side effects associated with typical drug trials. However, participants may experience stress or discomfort from changes in their routine diabetes care.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have type 2 diabetes with an HbA1c level of 6.5% or higher and am taking oral medication for it.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 36-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 36-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 36-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

HbA1c

Secondary study objectives

ADA adherence measures: B12 screening

ADA adherence measures: Diabetes eye exam

ADA adherence measures: flu vaccination

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual Care (UC)Experimental Treatment1 Intervention

We will define UC as usual clinical care, which consists of diabetes management provider encounters (mean quarterly) plus monthly individual appointments with a pharm-Ds or nutritionists as clinically indicated. In addition, clinics offer multiple other individual and group opportunities.

Group II: InterventionExperimental Treatment1 Intervention

Intervention individuals will receive the 12-month diabetes program

0 / 2Eligibility criteria met