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Clinical Trials/NCT06915194
NCT06915194CompletedNot Applicable

SMART Pilot Trial of Glycemic Screening Outreach

University of California, Los Angeles1 site in 1 country102 target enrollmentStarted: July 8, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
102
Locations
1
Primary Endpoint
Hemoglobin A1c

Study Overview

Brief Summary

Approximately 130 million Americans have prediabetes or type 2 diabetes (T2D) but remain unscreened and/or unaware of their diagnosis. While prediabetes/T2D screening, also known as glycemic screening, is endorsed in national guidelines, there is almost no research on how to increase screening rates, or evaluations of interventions testing the effectiveness of screening promotion strategies. The American Medical Association has published prediabetes quality measures that apply to UCLA Health as well as all other health systems, specifically tracking the percentage of adult patients with risk factors for T2D due for glycemic screening for whom the screening process was initiated. However, there is no current systemic effort underway at UCLA, or most other health systems, to encourage glycemic screening. We are proposing a pilot trial of the first SMART (Sequential Multiple Assignment Randomized Trial) for glycemic screening. Our SMART experiment will provide preliminary feasibility and acceptability data for a larger, multisite trial that will provide vital guidance to optimize screening approaches for a growing number of screening-eligible patients so that they may seek earlier detection, treatment, and/or access to lifestyle programs and interventions for T2D or prediabetes.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
35 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Overweight or obese

Exclusion Criteria

  • •Existing type 2 diabetes, A1c drawn within past 3 years

Arms & Interventions

Usual care

No Intervention

Patients do not receive any glycemic screening invitations

Initial text, follow-up text, letter

Experimental

Participants are initially randomized to glycemic screening invitations by text, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by text. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Intervention: Text message (Behavioral)

Initial text, follow-up text, letter

Experimental

Participants are initially randomized to glycemic screening invitations by text, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by text. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Intervention: Mailed letter (Behavioral)

Initial portal, follow-up portal, letter

Experimental

Participants are initially randomized to glycemic screening invitations by patient portal, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by patient portal. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Intervention: Patient portal message (Behavioral)

Initial portal, follow-up portal, letter

Experimental

Participants are initially randomized to glycemic screening invitations by patient portal, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by patient portal. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Intervention: Mailed letter (Behavioral)

Initial text, follow-up portal, letter

Experimental

Participants are initially randomized to glycemic screening invitations by text, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by patient portal. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Intervention: Text message (Behavioral)

Initial text, follow-up portal, letter

Experimental

Participants are initially randomized to glycemic screening invitations by text, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by patient portal. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Intervention: Patient portal message (Behavioral)

Initial text, follow-up portal, letter

Experimental

Participants are initially randomized to glycemic screening invitations by text, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by patient portal. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Intervention: Mailed letter (Behavioral)

Initial portal, follow-up text, letter

Experimental

Participants are initially randomized to glycemic screening invitations by patient portal, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by text. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Intervention: Text message (Behavioral)

Initial portal, follow-up text, letter

Experimental

Participants are initially randomized to glycemic screening invitations by patient portal, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by text. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Intervention: Patient portal message (Behavioral)

Initial portal, follow-up text, letter

Experimental

Participants are initially randomized to glycemic screening invitations by patient portal, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by text. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Intervention: Mailed letter (Behavioral)

Outcomes

Primary Outcomes

Hemoglobin A1c

Time Frame: 90 days

Receipt of hemoglobin A1c screening for dysglycemia

Secondary Outcomes

  • Acceptability Survey(90 Days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kenrik Duru

Professor of Medicine

University of California, Los Angeles

Study Sites (1)

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