Diabetes Mellitus, Type 2NCT05730582
Increasing Uptake of EHR-enabled Population Health Outreach Strategies to Improve Diabetes Screening
A study testing Parkland Diabetes Detection Program (PDDP) Screening Invitation in people with Diabetes Mellitus, Type 2 and Pre Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Pre Diabetes
- What is being tested?
- Parkland Diabetes Detection Program (PDDP) Screening Invitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500,000 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2024to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is alive at time of data extraction
- Age >= 18 at time of data extraction and <76
- Visit with PCP at Parkland clinic in the last 18 months (548 days), where Encounter type = Virtual Visit or Encounter type = Office Visit
- Patient NOT included in Parkland Diabetes Registry
- Preferred language is Spanish or English
- Ethnicity is Hispanic or Non-Hispanic
Show all 17Show fewer
- Race is White or Black
- Patient is not pregnant in last 12 months
- Exclusion Criteria for Study Population 1: Prediabetes Glycemic Risk Group
- Last A1C value <5.7 (normal)
- Last A1C value >6.4 (diabetes)
- Last A1C value = blank (unchecked)
- Last A1C date occurred within last 12 months from date of export
- Exclusion Criteria for Study Population 2: Score-Based Glycemic Risk Group
- Risk score <9
- Last A1C date occurred in last 30 months from date of export
- Last A1C value was >5.7 (PDM/DM)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
The research team will conduct a pragmatic, split cluster randomized controlled trial (clinic=cluster; patient randomization) in 12 community-based primary care clinics in an integrated safety net health system serving a high-risk, racially/ethnically diverse population.
- Conditions
- Diabetes Mellitus, Type 2, Pre Diabetes
- Being tested
- Parkland Diabetes Detection Program (PDDP) Screening Invitation
- Keywords
- Diagnostic Screening Program, Health System Intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parkland Diabetes Detection Program (PDDP) Screening InvitationBehavioural
The PDDP is designed to supplement and close screening gaps that persist despite opportunistic screening. Program staff order diabetes screening tests for randomized patients, then mail screening invitation letters to inform patients that they are at risk for diabetes. The letter informs them that a screening test has been ordered, and requests that they complete testing at their clinic lab. Patients who were mailed the letter but have not completed screening after 30 days are tracked and are send a second "reminder" invitation. Patients randomized to the targeted-tailored intervention study arm receive an additional phone call after 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Generic Screening Invitation | Active comparator | 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. Receives: Behavioral: Parkland Diabetes Detection Program (PDDP) Screening Invitation |
| Targeted-Tailored Screening Invitation | Experimental | 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. Receives: Behavioral: Parkland Diabetes Detection Program (PDDP) Screening Invitation |
| Standard of Care | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invitation efficacy
Invitation efficacy will be assessed by comparing the proportion of patients completing HgA1c or Fasting Blood Glucose screening tests at Day 60 in the targeted-tailored invitation intervention compared to the generic invitation intervention.
Measured: 60 days
Program effectiveness
Program effectiveness will be assessed by comparing the proportion of patients completing HgA1c or Fasting Blood Glucose screening tests at Day 365 across intervention and control arms.
Measured: 12 months
Direct costs
Direct costs of diabetes screening compared across study arms
Measured: 12 months
Cost effectiveness as measured by costs per patient screened
Cost effectiveness will be assessed by comparing the costs per patient screened across study arms
Measured: 12 months
Cost effectiveness as measured by cost per case found
Cost effectiveness will be assessed by comparing the costs per case found across study arms
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start5 Mar 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Parkland Health and Hospital System
- Responsible party
- Principal investigator, Michael Edward Bowen, University of Texas Southwestern Medical Center
- Investigators
- Michael Bowen, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730582
- Sponsor's protocol ID
- STU 2022-0996
- Other IDs
- R01MD016101
- Status last verified
- Aug 2026
- First submitted
- 11 Jan 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Uptake of EHR-enabled Population Health Outreach Strategies to Improve Diabetes Screening
- ClinicalTrials.gov ID
- NCT05730582
- Acronym / sponsor ID
- STU 2022-0996
- Conditions
- Diabetes Mellitus, Type 2, Pre Diabetes
- Keywords
- Diagnostic Screening Program, Health System Intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500,000 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Parkland Health and Hospital System
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research team will conduct a pragmatic, split cluster randomized controlled trial (clinic=cluster; patient randomization) in 12 community-based primary care clinics in an integrated safety net health system serving a high-risk, racially/ethnically diverse population.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Generic Screening Invitation | Active comparator | Behavioral: Parkland Diabetes Detection Program (PDDP) Screening InvitationPatients 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. |
| Targeted-Tailored Screening Invitation | Experimental | Behavioral: Parkland Diabetes Detection Program (PDDP) Screening InvitationPatients 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. |
| Standard of Care | No 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 may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient is alive at time of data extraction
- Age >= 18 at time of data extraction and <76
- Visit with PCP at Parkland clinic in the last 18 months (548 days), where Encounter type = Virtual Visit or Encounter type = Office Visit
- Patient NOT included in Parkland Diabetes Registry
- Preferred language is Spanish or English
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parkland Diabetes Detection Program (PDDP) Screening InvitationThe PDDP is designed to supplement and close screening gaps that persist despite opportunistic screening. Program staff order diabetes screening tests for randomized patients, then mail screening invitation letters to inform patients that they are at risk for diabetes. The letter informs them that a screening test has been ordered, and requests that they complete testing at their clinic lab. Patients who were mailed the letter but have not completed screening after 30 days are tracked and are send a second "reminder" invitation. Patients randomized to the targeted-tailored intervention study arm receive an additional phone call after 30 days. | Behavioural | Generic Screening Invitation, Targeted-Tailored Screening Invitation |
Primary outcome
Invitation efficacy
Time frame: 60 days
Invitation efficacy will be assessed by comparing the proportion of patients completing HgA1c or Fasting Blood Glucose screening tests at Day 60 in the targeted-tailored invitation intervention compared to the generic invitation intervention.
Program effectiveness
Time frame: 12 months
Program effectiveness will be assessed by comparing the proportion of patients completing HgA1c or Fasting Blood Glucose screening tests at Day 365 across intervention and control arms.
Direct costs
Time frame: 12 months
Direct costs of diabetes screening compared across study arms
Cost effectiveness as measured by costs per patient screened
Time frame: 12 months
Cost effectiveness will be assessed by comparing the costs per patient screened across study arms
Cost effectiveness as measured by cost per case found
Time frame: 12 months
Cost effectiveness will be assessed by comparing the costs per case found across study arms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Bowen, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parkland Diabetes Detection Program (PDDP) Screening Invitation in people with Diabetes Mellitus, Type 2 and Pre Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invitation efficacy (time frame: 60 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.