Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-04-14 @ 12:01 PM
Study NCT ID:
NCT02049359
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2014-01-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Short Messaging Service for Optimizing Hemoglobin A1C Management in Low-Income Diabetics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jsmith@cfhcnc.org', 'phone': '2522439800', 'title': 'Jennifer Smith', 'phoneExt': '224', 'organization': 'Campbell University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'Care as usual; no bidirectional texting', 'otherNumAtRisk': 95, 'otherNumAffected': 0, 'seriousNumAtRisk': 95, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Texting', 'description': 'Bidirectional texting weekly for 12 weeks\n\nTexting: Bidirectional texting once weekly for 12 weeks', 'otherNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline A1C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Care as usual; no bidirectional texting'}, {'id': 'OG001', 'title': 'Texting', 'description': 'Bidirectional texting weekly for 12 weeks\n\nTexting: Bidirectional texting once weekly for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '1.6'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change in A1C from baseline', 'unitOfMeasure': 'percentage of A1C decrease', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Care as usual; no bidirectional texting'}, {'id': 'OG001', 'title': 'Texting', 'description': 'Bidirectional texting weekly for 12 weeks\n\nTexting: Bidirectional texting once weekly for 12 weeks'}], 'classes': [{'title': 'Age 18-35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '4.0'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '2.0'}]}]}, {'title': '36-55 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.8'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '2.1'}]}]}, {'title': '56-65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.2'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '2.6'}]}]}, {'title': '>65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.33', 'upperLimit': '1.9'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.2'}]}]}, {'title': 'African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.7'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '1.8'}]}]}, {'title': 'Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.7'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '2.0'}]}]}, {'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'comment': 'Sample inadequate to describe 95% confidence intervals', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.9', 'comment': 'Sample inadequate to describe 95% confidence intervals', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'comment': 'Sample inadequate to describe 95% confidence intervals', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3.0', 'comment': 'Sample inadequate to describe 95% confidence intervals', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.4'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.7'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '2.4'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '2.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Change in A1C from baseline based on age, gender, race, type and duration of diabetes', 'unitOfMeasure': 'percentage of A1C decrease', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in A1C percentage from baseline by demographic characteristics'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'Care as usual; no bidirectional texting'}, {'id': 'FG001', 'title': 'Texting', 'description': 'Bidirectional texting weekly for 12 weeks\n\nTexting: Bidirectional texting once weekly for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '19'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'Care as usual; no bidirectional texting'}, {'id': 'BG001', 'title': 'Texting', 'description': 'Bidirectional texting weekly for 12 weeks\n\nTexting: Bidirectional texting once weekly for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.4', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '52.5', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '51.3', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'African American', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': 'Caucasian', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-05', 'studyFirstSubmitDate': '2014-01-28', 'resultsFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2014-01-28', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-05', 'studyFirstPostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline A1C', 'timeFrame': '12 weeks', 'description': 'Change in A1C from baseline'}], 'secondaryOutcomes': [{'measure': 'Change in A1C Based on Age, Gender, Race, Type and Duration of Diabetes', 'timeFrame': '12 weeks', 'description': 'Change in A1C from baseline based on age, gender, race, type and duration of diabetes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the impact of two-way short message service (SMS) on glycemic control in low-income, poorly-controlled adult diabetic patients.', 'detailedDescription': 'This multi-center, unblinded, prospective randomized controlled trial will enroll adult diabetic patients of the Wilson Community Health Center, Harvest Family Health Center, and Freedom Hill Community Health Center living below 200% of 2013 poverty level with a serum hemoglobin A1C \\>9% and who currently own a mobile device with text messaging capacity. After written informed consent has been obtained, subjects will be randomized to intervention or control group (1:1), stratified based on insulin initiation within 1 week of study inclusion. Participants randomized to the intervention group will be further divided into subgroups as "insulin user" or "non-insulin user" and both will receive SMS messages every 7 days. The content of the message consist of medication reminders, reporting of blood glucose results, insulin technique assessment (if applicable), or d) medication adherence assessment. Participants will be asked to respond with a simple text within 7 days. The intervention group will receive the standard medical appointment reminder via telephone one to two business days prior to the appointment at the Health Center PLUS a unidirectional text message two business days prior to scheduled health center appointments. Control group participants will receive the standard medical appointment reminder via telephone one to two business days prior to the appointment at the health center. All participants in the study (control and intervention) will undergo venipuncture at 3 months (+/-) 2 weeks for the determination of hemoglobin A1C. Demographic information, and frequency of hemoglobin A1C concentrations in the past 6 months will be assessed at baseline. Each week for 12 weeks, the number of texts sent per week and by type, percent of respondents weekly by text or by phone, content of participant responses, number of patients unable to be reached via text, total investigator time spent per week, and time spent per contact will be recorded. At the three month visit, the hemoglobin A1C concentration, blood transfusions since study initiation, and medication changes will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New or existing patient of Carolina Family Health Centers Inc. (Wilson Community Health Center, Harvest Family Health Center, Freedom Hill Community Health Center)\n* Diagnosis of diabetes\n* Single serum hemoglobin A1C equal to or greater than 9% within 2 weeks of study enrollment\n* Below 200% of 2013 poverty level\n* Currently own a mobile device with text messaging capacity and anticipated service for duration of 12 week study period\n\nExclusion Criteria:\n\n* Anemia diagnosed within past 3 months\n* Blood transfusion within the past 3 months\n* unable to read English at the fifth grade level'}, 'identificationModule': {'nctId': 'NCT02049359', 'acronym': 'SAMI', 'briefTitle': 'Short Messaging Service for Optimizing Hemoglobin A1C Management in Low-Income Diabetics', 'organization': {'class': 'OTHER', 'fullName': 'Campbell University, Incorporated'}, 'officialTitle': 'Use of a Short Messaging Service for Optimizing Hemoglobin A1C Management in Low-Income Diabetic Patients (SAMI TRIAL)', 'orgStudyIdInfo': {'id': '49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Care as usual; no bidirectional texting'}, {'type': 'EXPERIMENTAL', 'label': 'Texting', 'description': 'Bidirectional texting weekly for 12 weeks', 'interventionNames': ['Other: Texting']}], 'interventions': [{'name': 'Texting', 'type': 'OTHER', 'description': 'Bidirectional texting once weekly for 12 weeks', 'armGroupLabels': ['Texting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27822', 'city': 'Elm City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Harvest Family Health Center', 'geoPoint': {'lat': 35.80655, 'lon': -77.86332}}, {'zip': '27886', 'city': 'Tarboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Freedom Hill Community Health Center', 'geoPoint': {'lat': 35.89682, 'lon': -77.5358}}, {'zip': '27893', 'city': 'Wilson', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wilson Community Health Center', 'geoPoint': {'lat': 35.72127, 'lon': -77.91554}}], 'overallOfficials': [{'name': 'Jennifer D Smith, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Campbell University/Wilson Community Health Center'}, {'name': 'Richard Drew, PharmD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Campbell University/Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Campbell University, Incorporated', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}