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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text message | Behavioral | Participants receive a text message encouraging glycemic screening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | Receipt of hemoglobin A1c screening for dysglycemia | 90 days |
| 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.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Obidiugwu K Duru, MD, MS | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90024 | United States |
We may or may not attempt to publish this pilot trial
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | Usual Care | Patients do not receive any glycemic screening invitations |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hemoglobin A1c | Receipt of hemoglobin A1c screening for dysglycemia | Posted | Count of Participants | Participants | 90 days |
|
90 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Obidiugwu Kenrik Duru, MD | University of California, Los Angeles | 3107942280 | kduru@mednet.ucla.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 28, 2025 | Apr 22, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| Usual care | No Intervention | Patients do not receive any glycemic screening invitations |
| Patient portal message | Behavioral | Participants receive a patient portal message encouraging glycemic screening |
|
| Mailed letter | Behavioral | Participants receive a mailed letter encouraging glycemic screening |
|
| 90 Days |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Usual Care | Patients do not receive any glycemic screening invitations |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | Usual Care | Patients do not receive any glycemic screening invitations |
|
|
| Secondary | 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.
| Two participants responded from the 4 intervention arms. | Posted | Mean | Full Range | score on a scale | 90 Days |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 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. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | 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. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG003 | 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. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG004 | Usual Care | Patients do not receive any glycemic screening invitations | 0 | 34 | 0 | 34 | 0 | 34 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |