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Telementoring for Diabetes Care Improvement

N/A
Recruiting
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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
HbA1c
Secondary outcome measures
ADA adherence measures: B12 screening
ADA adherence measures: Diabetes eye exam
ADA adherence measures: flu vaccination
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Intervention individuals will receive the 12-month diabetes TIME program
Group II: Enhanced Usual Care (EUC)Experimental Treatment1 Intervention
We will define EUC 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. In addition for the EUC arm, we will provide three quarterly, 1-hour classes (nutrition medications, exercise). The classes will be led by a research-staff trained, bilingual healthcare professional e.g., nurse. EUC individuals will not have contact with CHWs.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineOTHER
1,001 Previous Clinical Trials
6,002,002 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,315,044 Total Patients Enrolled
University of TexasOTHER
187 Previous Clinical Trials
142,203 Total Patients Enrolled

Media Library

Telementoring Clinical Trial Eligibility Overview. Trial Name: NCT04835493 — N/A
Type 2 Diabetes Research Study Groups: Intervention, Enhanced Usual Care (EUC)
Type 2 Diabetes Clinical Trial 2023: Telementoring Highlights & Side Effects. Trial Name: NCT04835493 — N/A
Telementoring 2023 Treatment Timeline for Medical Study. Trial Name: NCT04835493 — N/A
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT04835493 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still opportunity to enroll in this clinical experiment?

"According to the data hosted on clinicaltrials.gov, this research is still actively recruiting participants as of today. The trial was first announced on September 1st 2022 and has been revised most recently on the 17th of that same month."

Answered by AI

How many participants are allowed to take part in this experiment?

"Correct. According to clinicaltrials.gov, this medical trial is presently enrolling patients after initially being posted on September 1st 2022 and last updated on the 17th of that month. A total of 250 subjects are needed between one site."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am interested in learning more about type 2 diabetes and how to control it as well Iam interested in helping medical research.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Evaluating Telementoring for CHW-centered Diabetes Initiatives
Elizabeth Vaughan 2022. "Evaluating Telementoring for CHW-centered Diabetes Initiatives". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04835493.
All > Diabetes Type 2
~147 spots leftby Jul 2026
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