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Screening Invitations for Prediabetes and Type 2 Diabetes

N/A

Waitlist Available

Led By Michael Bowen, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if using personalized screening invitations for diabetes, based on race/ethnicity and glycemic risk, along with phone-based assistance for those who don't respond, will be more effective

Who is the study for?

This trial is for adults aged 18-75 who have visited a Parkland clinic PCP within the last 18 months, are not in the Parkland Diabetes Registry, speak English or Spanish, and identify as Hispanic/Non-Hispanic White or Black. Pregnant individuals or those already diagnosed with diabetes are excluded.

What is being tested?

The study is testing if personalized invitations to screen for diabetes based on race/ethnicity and glycemic risk can improve screening rates compared to generic invites and usual care. It includes phone follow-ups for those who don't respond initially.

What are the potential side effects?

Since this trial involves outreach strategies rather than medications, there aren't direct physical side effects. However, participants may experience inconvenience or privacy concerns related to receiving communications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

Cost effectiveness as measured by cost per case found

Cost effectiveness as measured by costs per patient screened

Direct costs

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Targeted-Tailored Screening InvitationExperimental Treatment1 Intervention

Patients randomized to this study arm will receive the tailored letter, which uses messaging developed collaboratively by patients and clinical stakeholders under a prior NIH-funded research study (STU 2021-0743), in addition to available EHR data, to inform patients that they are at risk for Type 2 Diabetes based on specific clinical characteristics and that they are not up to date on screening. The letter also informs them that a screening test has been ordered, and requests that they fast and complete testing at their clinic lab within 60 days. Fasting instructions will specify nothing to eat or drink except water for at least 8 hours. The letter will be signed electronically by the patient's primary care provider and sent in both English and Spanish.

Group II: Generic Screening InvitationActive Control1 Intervention

Patients randomized to this study arm will receive the generic letter to inform them that they are at risk for T2D and that they are not up to date on screening. The letter also informs them that a screening test has been ordered, and requests that they complete testing at their clinic lab. The letter is signed by the patient's primary care provider and sent in both English and Spanish. This letter was previously developed and has been in use by the Parkland Diabetes Detection Program.

Group III: Standard of CareActive Control1 Intervention

Patients randomized to this study arm will receive opportunistic screening based on routine clinical activities. Patients will be assigned a study number for tracking purposes, but no intervention activities via the Parkland Dysglycemia Detection Program will occur for this study arm.

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