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

500000 Participants Needed

Trial Summary

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 data supports the effectiveness of the Parkland Diabetes Detection Program (PDDP) Screening Invitation treatment?

Research shows that community-based and collaborative screening programs can effectively identify people with prediabetes and diabetes, allowing for early prevention and intervention. This suggests that the PDDP Screening Invitation could be effective in detecting these conditions early. ^{1 2 3 4 5}

Is the Parkland Diabetes Detection Program (PDDP) Screening Invitation safe for humans?

The research articles do not provide specific safety data for the Parkland Diabetes Detection Program (PDDP) Screening Invitation, but they discuss diabetes screening programs in general, which are typically non-invasive and involve risk assessments and blood tests. These methods are generally considered safe for humans. ^{4 6 7 8 9}

How is the Parkland Diabetes Detection Program (PDDP) Screening Invitation treatment different from other diabetes treatments?

The Parkland Diabetes Detection Program (PDDP) Screening Invitation is unique because it focuses on early detection of prediabetes and type 2 diabetes through screening invitations, rather than direct medical treatment. This approach aims to identify individuals at risk and guide them towards preventive measures, which is different from traditional treatments that typically involve medication or lifestyle changes after diagnosis. ^{3 8 10 11 12}

What is the purpose of this trial?

The study team's central hypothesis is that the Parkland Diabetes Detection Program (PDDP) screening invitations targeted by race/ethnicity with culturally concordant messaging and tailored by glycemic risk (known PDM vs. unknown glycemic state) plus phone-based navigation of non-responders will be more effective at closing screening gaps than PDDP generic screening invitations and usual care, opportunistic screening alone.

Research Team

Michael Bowen, MD

Principal Investigator

University of Texas Southwestern Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Screening for type 2 diabetes in primary care using a stepwise protocol: the Diabscreen study. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

Community-based screening for diabetes in Michigan. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Detecting type 2 diabetes and prediabetes among asymptomatic adults in the United States: modeling American Diabetes Association versus US Preventive Services Task Force diabetes screening guidelines. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Can a screening programme for diabetes be applied to another population? [2006]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a collaborative diabetes screening campaign between community pharmacies and general practitioners. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Outcome and cost of a statewide diabetes screening and awareness initiative in New York. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The feasibility, acceptability, and preliminary effectiveness of a Promotora-Led Diabetes Prevention Program (PL-DPP) in Latinas: a pilot study. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Screening for diabetes. [2012]

9. England pubmed.ncbi.nlm.nih.gov

Scaling-up from an implementation trial to state-wide coverage: results from the preliminary Melbourne Diabetes Prevention Study. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

A new public health tool for risk assessment of abnormal glucose levels. [2021]

11. Canada pubmed.ncbi.nlm.nih.gov

Nova Scotia Prediabetes Project: upstream screening and community intervention for prediabetes and undiagnosed type 2 diabetes. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

The Effectiveness of a Proactive, Three-Level Strategy to Identify People With Prediabetes in a Large Workforce With Employer-Sponsored Health Insurance. [2023]