Screening Invitations for Prediabetes and Type 2 Diabetes

Overseen By Molly McGuire, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if personalized letters encouraging diabetes screening, as part of the Parkland Diabetes Detection Program (PDDP) Screening Invitation, can better identify individuals at risk for Type 2 Diabetes compared to generic messages. These letters will be tailored based on race, ethnicity, and specific health information, and will include instructions for a screening test. The trial is ideal for those who have visited a Parkland clinic in the past 18 months, have not been diagnosed with diabetes, but may be at risk. Participants must speak English or Spanish and belong to specific racial or ethnic groups. The goal is to improve early detection of diabetes by closing screening gaps. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance diabetes screening methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the Parkland Diabetes Detection Program (PDDP) Screening Invitation is safe?

Research shows no specific safety data for the Parkland Diabetes Detection Program (PDDP) Screening Invitation. This program sends letters to individuals at risk for type 2 diabetes, encouraging them to get screened. Since the "treatment" involves only a letter, not medication or a medical procedure, it is generally considered safe. The letters, personalized with the individual's health information and signed by their primary care doctor, are sent in both English and Spanish to ensure clear understanding. Overall, this non-invasive method aims to motivate individuals to take proactive steps for their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for the Parkland Diabetes Detection Program (PDDP) because it explores innovative ways to encourage diabetes screening through personalized communication. Unlike the standard of care, which relies on routine clinical visits, the PDDP uses targeted and tailored letters to inform patients about their risk of Type 2 Diabetes. These letters are developed using patient feedback and clinical data, making the communication more relevant and engaging. By potentially increasing screening rates, this approach could lead to earlier detection and management of diabetes, improving patient outcomes.

What evidence suggests that this trial's screening invitations could be effective for closing screening gaps in prediabetes and type 2 diabetes?

Research has shown that early detection of prediabetes and type 2 diabetes can greatly improve health outcomes. This trial compares different approaches to screening invitations. One arm of the trial uses the Parkland Diabetes Detection Program (PDDP) generic screening invitation, which informs patients of their risk and encourages screening. Another arm uses targeted-tailored screening invitations, incorporating personal health information to effectively identify those at risk. Both types of invitations are available in English and Spanish. By focusing on individual risk factors, the PDDP aims to increase the number of people who get tested. Early detection through these methods can lead to timely interventions, potentially lowering the risk of developing full diabetes. ^{1 2 4 6 7}

Who Is on the Research Team?

Michael Bowen, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Preferred language is Spanish or English

Patient is alive at time of data extraction

Visit with PCP at Parkland clinic in the last 18 months (548 days), where Encounter type = Virtual Visit or Encounter type = Office Visit

Exclusion Criteria

Exclusion Criteria for Study Population 1: Prediabetes Glycemic Risk Group - Last A1C value >6.4 (diabetes)

Exclusion Criteria for Study Population 1: Prediabetes Glycemic Risk Group - Last A1C value <5.7 (normal)

Exclusion Criteria for Study Population 1: Prediabetes Glycemic Risk Group - Last A1C value = blank (unchecked)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either a generic or targeted-tailored screening invitation to complete diabetes screening tests

60 days

No in-person visits required; communication via mail

Follow-up

Participants are monitored for completion of diabetes screening tests and program effectiveness

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Parkland Diabetes Detection Program (PDDP) Screening Invitation

Trial Overview 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.

How Is the Trial Designed?

Group I: Targeted-Tailored Screening Invitation Experimental Treatment 1 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 Invitation Active Control 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Citations

1. withpower.com withpower.com/trial/phase-diabetes-mellitus-7-2023-2eb37

Screening Invitations for Prediabetes and Type 2 Diabetes The Parkland Diabetes Detection Program (PDDP) Screening Invitation is unique because it focuses on early detection of prediabetes and type 2 diabetes through ...

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2783414

Screening for Prediabetes and Type 2 Diabetes: US ... Prediabetes and type 2 diabetes can be detected by measuring fasting plasma glucose or HbA1c level, or with an oral glucose tolerance test. A fasting plasma ...

3. withpower.com withpower.com/clinical-trials/for-prediabetes

Top Prediabetes Clinical Trials | Power Power is an online platform that helps thousands of Prediabetes patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12178622/

The Diabetes Prevention Program and Its Outcomes Study After mean 2.8 years, ILS reduced diabetes risk by 58% and metformin by 31%, leading to study termination ahead of schedule due to demonstrated efficacy of both ...

5. diabetesjournals.org diabetesjournals.org/care/article/48/5/703/157723/Derivation-and-Validation-of-D-RISK-An-Electronic

Derivation and Validation of D-RISK: An Electronic Health ... The primary outcome was dysglycemia (prediabetes + type 2 diabetes) defined by HbA1c ≥5.7%. We used HbA1c to define our primary outcome because ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10115755/

Parkland Diabetes Clinic - PMC The no-show rate among primary care clinics is estimated to be between 14 and 50% (1). Additionally, these missed appointments are estimated to cost the U.S. ...

7. diabetes.org diabetes.org/newsroom/new-data-from-diabetes-prevention-program-outcomes-study-shows-persistent-reduction-of-t2d-development-over-22-year-average-follow-up

New Data from Diabetes Prevention Program Outcomes ... The DPP demonstrated lifestyle intervention, aimed at achieving weight loss, and metformin treatment reduced the risk of T2D development by 58% and 31%, ...