SMART Pilot Trial of Glycemic Screening Outreach

NCT ID: NCT06915194

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-08

Study Completion Date

2025-11-08

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight (BMI > 25) Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Initial text, follow-up text, letter

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.

Group Type EXPERIMENTAL

Text message

Intervention Type BEHAVIORAL

Participants receive a text message encouraging glycemic screening

Mailed letter

Intervention Type BEHAVIORAL

Participants receive a mailed letter encouraging glycemic screening

Initial portal, follow-up portal, letter

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.

Group Type EXPERIMENTAL

Patient portal message

Intervention Type BEHAVIORAL

Participants receive a patient portal message encouraging glycemic screening

Mailed letter

Intervention Type BEHAVIORAL

Participants receive a mailed letter encouraging glycemic screening

Initial text, follow-up portal, letter

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.

Group Type EXPERIMENTAL

Text message

Intervention Type BEHAVIORAL

Participants receive a text message encouraging glycemic screening

Patient portal message

Intervention Type BEHAVIORAL

Participants receive a patient portal message encouraging glycemic screening

Mailed letter

Intervention Type BEHAVIORAL

Participants receive a mailed letter encouraging glycemic screening

Initial portal, follow-up text, letter

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.

Group Type EXPERIMENTAL

Text message

Intervention Type BEHAVIORAL

Participants receive a text message encouraging glycemic screening

Patient portal message

Intervention Type BEHAVIORAL

Participants receive a patient portal message encouraging glycemic screening

Mailed letter

Intervention Type BEHAVIORAL

Participants receive a mailed letter encouraging glycemic screening

Usual care

Patients do not receive any glycemic screening invitations

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Text message

Participants receive a text message encouraging glycemic screening

Intervention Type BEHAVIORAL

Patient portal message

Participants receive a patient portal message encouraging glycemic screening

Intervention Type BEHAVIORAL

Mailed letter

Participants receive a mailed letter encouraging glycemic screening

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Overweight or obese

Exclusion Criteria

* Existing type 2 diabetes, A1c drawn within past 3 years
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Kenrik Duru

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Obidiugwu K Duru, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-24-6330

Identifier Type: -

Identifier Source: org_study_id

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