Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 10:30 PM
Study NCT ID:
NCT06915194
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-17
First Post:
2025-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMART Pilot Trial of Glycemic Screening Outreach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-11-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2025-04-01', 'studyFirstSubmitQcDate': '2025-04-01', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c', 'timeFrame': '90 days', 'description': 'Receipt of hemoglobin A1c screening for dysglycemia'}], 'secondaryOutcomes': [{'measure': 'Acceptability survey', 'timeFrame': '90 days', 'description': 'Participants will receive a Qualtrics survey with the following 5 items:\n\n1. How did you feel about the messages recommending that you come in for a blood test to check your hemoglobin A1c (blood sugar) level?\n2. How clear were the messages recommending that you come in for a blood test to check your hemoglobin A1c (blood sugar) level?\n3. Did the messages affect the chances that you would get the hemoglobin A1c (blood sugar) level?\n4. Did the messages cause you any anxiety or stress?\n5. How concerned were you that the messages were from scammers not associated with UCLA?'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes screening'], 'conditions': ['Overweight (BMI > 25)', 'Obesity']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight or obese\n\nExclusion Criteria:\n\n* Existing type 2 diabetes, A1c drawn within past 3 years'}, 'identificationModule': {'nctId': 'NCT06915194', 'briefTitle': 'SMART Pilot Trial of Glycemic Screening Outreach', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'SMART Pilot Trial of Glycemic Screening Outreach', 'orgStudyIdInfo': {'id': 'IRB-24-6330'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Initial text, follow-up text, letter', 'description': '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.', 'interventionNames': ['Behavioral: Text message', 'Behavioral: Mailed letter']}, {'type': 'EXPERIMENTAL', 'label': 'Initial portal, follow-up portal, letter', 'description': '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.', 'interventionNames': ['Behavioral: Patient portal message', 'Behavioral: Mailed letter']}, {'type': 'EXPERIMENTAL', 'label': 'Initial text, follow-up portal, letter', 'description': '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.', 'interventionNames': ['Behavioral: Text message', 'Behavioral: Patient portal message', 'Behavioral: Mailed letter']}, {'type': 'EXPERIMENTAL', 'label': 'Initial portal, follow-up text, letter', 'description': '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.', 'interventionNames': ['Behavioral: Text message', 'Behavioral: Patient portal message', 'Behavioral: Mailed letter']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Patients do not receive any glycemic screening invitations'}], 'interventions': [{'name': 'Text message', 'type': 'BEHAVIORAL', 'description': 'Participants receive a text message encouraging glycemic screening', 'armGroupLabels': ['Initial portal, follow-up text, letter', 'Initial text, follow-up portal, letter', 'Initial text, follow-up text, letter']}, {'name': 'Patient portal message', 'type': 'BEHAVIORAL', 'description': 'Participants receive a patient portal message encouraging glycemic screening', 'armGroupLabels': ['Initial portal, follow-up portal, letter', 'Initial portal, follow-up text, letter', 'Initial text, follow-up portal, letter']}, {'name': 'Mailed letter', 'type': 'BEHAVIORAL', 'description': 'Participants receive a mailed letter encouraging glycemic screening', 'armGroupLabels': ['Initial portal, follow-up portal, letter', 'Initial portal, follow-up text, letter', 'Initial text, follow-up portal, letter', 'Initial text, follow-up text, letter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Obidiugwu K Duru, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We may or may not attempt to publish this pilot trial'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Kenrik Duru', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}