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SMART Pilot Trial of Glycemic Screening Outreach

SMART Pilot Trial of Glycemic Screening Outreach

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06915194
Enrollment
102
Registered
2025-04-08
Start date
2025-07-08
Completion date
2025-11-08
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight (BMI > 25), Obesity

Keywords

diabetes screening

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.

Interventions

BEHAVIORALText message

Participants receive a text message encouraging glycemic screening

Participants receive a patient portal message encouraging glycemic screening

BEHAVIORALMailed letter

Participants receive a mailed letter encouraging glycemic screening

Sponsors

University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Overweight or obese

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin A1c90 daysReceipt of hemoglobin A1c screening for dysglycemia

Secondary

MeasureTime frameDescription
Acceptability Survey90 DaysThe survey contained 5 questions, in Likert response format, and possible total scores ranged from 0 - 24 , with higher scores indicating better satisfaction. 1. 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) 2. 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) 3. 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) 4. Did the messages cause you any anxiety or stress - Likert responses (To a great extent, somewhat, very little, not at all) 5. How concerned were you that the messages were from scammers not associated with

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORObidiugwu K Duru, MD, MS

University of California, Los Angeles

Participant flow

Pre-assignment details

PCPs requested that we not enroll 12 potential participants, so while we recruited 113 participants only 102 received the intervention. Because this intervention was consistent with standard of care, we had IRB approval to waive informed consent. Therefore, we sent messages to all 102 individuals who were approved to participate by their PCP

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
96 Participants
Race/Ethnicity, Customized
Asian
4 Participants
Race/Ethnicity, Customized
Black
1 Participants
Race/Ethnicity, Customized
White, Hispanic
2 Participants
Race/Ethnicity, Customized
White, Non-Hispanic
64 Participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 160 / 170 / 170 / 180 / 34
other
Total, other adverse events
0 / 160 / 170 / 170 / 180 / 34
serious
Total, serious adverse events
0 / 160 / 170 / 170 / 180 / 34

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026