SMART Pilot Trial of Glycemic Screening Outreach

NCT06915194 | Enrolling By Invitation

• 1 other identifier: IRB-24-6330
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight (BMI > 25); Obesity

Keywords

diabetes screening

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  Receipt of hemoglobin A1c screening for dysglycemia

  90 days

Secondary Outcomes (1)

• Acceptability survey

  90 days

Study Arms (5)

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.

Behavioral: Text message; Behavioral: Mailed letter

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.

Behavioral: Patient portal message; Behavioral: Mailed letter

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.

Behavioral: Text message; Behavioral: Patient portal message; Behavioral: Mailed letter

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.

Behavioral: Text message; Behavioral: Patient portal message; Behavioral: Mailed letter

Usual care

NO INTERVENTION

Patients do not receive any glycemic screening invitations

Interventions

Text message BEHAVIORAL

Participants receive a text message encouraging glycemic screening

Initial portal, follow-up text, letter; Initial text, follow-up portal, letter; Initial text, follow-up text, letter

Patient portal message BEHAVIORAL

Participants receive a patient portal message encouraging glycemic screening

Initial portal, follow-up portal, letter; Initial portal, follow-up text, letter; Initial text, follow-up portal, letter

Mailed letter BEHAVIORAL

Participants receive a mailed letter encouraging glycemic screening

Initial portal, follow-up portal, letter; Initial portal, follow-up text, letter; Initial text, follow-up portal, letter; Initial text, follow-up text, letter

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight or obese

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Obidiugwu K Duru, MD, MS

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: July 8, 2025
• Primary Completion: October 8, 2025
• Study Completion: November 8, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-04

Locations

US (1)