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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
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 belowSelect...
I have type 2 diabetes with an HbA1c level of 6.5% or higher and am taking oral medication for it.
Select...
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
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Baylor College of MedicineOTHER
1,018 Previous Clinical Trials
6,031,109 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,571 Total Patients Enrolled
University of TexasOTHER
189 Previous Clinical Trials
142,819 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have type 2 diabetes with an HbA1c level of 6.5% or higher and am taking oral medication for it.I speak Spanish.You are not able to receive care in a group setting, such as if you are pregnant or have severe memory or thinking problems.I am 18 years old or older.You identify yourself as Latino or Latina.You have a condition that may change your HbA1c levels, like having had a recent blood transfusion.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care (UC)
- Group 2: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT04835493 — N/A
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