SMART Pilot Trial of Glycemic Screening Outreach

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 Overview

• Status: Completed
• Conditions: Obesity; Overweight (BMI > 25)
• Intervention / Treatment: Behavioral: Text message; Behavioral: Mailed letter; Behavioral: Patient portal message

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • University of California, Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Overweight or obese

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Text message; Participants receive a text message encouraging glycemic screening; Behavioral: Mailed letter; Participants receive a mailed letter encouraging glycemic screening
Experimental: 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.	Behavioral: Mailed letter; Participants receive a mailed letter encouraging glycemic screening; Behavioral: Patient portal message; Participants receive a patient portal message encouraging glycemic screening
Experimental: 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.	Behavioral: Text message; Participants receive a text message encouraging glycemic screening; Behavioral: Mailed letter; Participants receive a mailed letter encouraging glycemic screening; Behavioral: Patient portal message; Participants receive a patient portal message encouraging glycemic screening
Experimental: 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.	Behavioral: Text message; Participants receive a text message encouraging glycemic screening; Behavioral: Mailed letter; Participants receive a mailed letter encouraging glycemic screening; Behavioral: Patient portal message; Participants receive a patient portal message encouraging glycemic screening
No Intervention: Usual care; Patients do not receive any glycemic screening invitations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c	Receipt of hemoglobin A1c screening for dysglycemia	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability Survey	The survey contained 5 questions, in Likert response format, and possible total scores ranged from 0 - 24 , with higher scores indicating better satisfaction.; How did you feel about the messages recommending that you come in for a blood test to check your hemoglobin A1c (blood sugar) level - Likert responses (Very positive, positive, neutral, negative, very negative); How clear were the messages recommending that you come in for a blood test to check your hemoglobin A1c (blood sugar) level - Likert responses (Very clear, somewhat clear, neutral, somewhat unclear, very unclear); Did the messages affect the chances that you would get the hemoglobin A1c (blood sugar) level - Likert responses (Major effect, moderate effect, neutral, minor effect, no effect); Did the messages cause you any anxiety or stress - Likert responses (To a great extent, somewhat, very little, not at all); How concerned were you that the messages were from scammers not associated with	90 Days

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Obidiugwu K Duru, MD, MS, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2025
• Primary Completion (Actual): October 8, 2025
• Study Completion (Actual): November 8, 2025

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: diabetes screening
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: IRB-24-6330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We may or may not attempt to publish this pilot trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No