Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-25 @ 1:44 PM
Study NCT ID:
NCT03504592
Status:
COMPLETED
Last Update Posted:
2020-02-13
First Post:
2018-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Smartphone Utilization for Glucose Monitoring and Antenatal Reporting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2018-03-09', 'studyFirstSubmitQcDate': '2018-04-11', 'lastUpdatePostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completeness and accuracy of blood glucose record', 'timeFrame': 'Every 2 weeks through study completion, up to 42 weeks', 'description': 'The number of values reported to the provider out of the number that should have been collected during the time period, expressed as a percent, as well as the number of values reported that were verified accurate by the meter out of the total number of values reported in the time frame expressed as a percent.'}], 'secondaryOutcomes': [{'measure': 'Patient Satisfaction', 'timeFrame': 'Once prior to exiting the study, an average of 42 weeks', 'description': 'Responses to patient satisfaction survey'}, {'measure': 'Glucose values at goal', 'timeFrame': 'Every 2 weeks through study completion, up to 42 weeks', 'description': '% of glucose values at goal during the study period'}, {'measure': '% Change in Hemoglobin A1C', 'timeFrame': 'Once prior to exiting the study, up to 42 weeks', 'description': '% of change in values of HbA1C during the study period'}, {'measure': 'Clinic visits', 'timeFrame': 'through study completion, up to 42 weeks', 'description': 'Number of clinic visits during the study period'}, {'measure': 'Unscheduled health care access episodes', 'timeFrame': 'through study completion, up to 42 weeks', 'description': 'Number of unanticipated or unscheduled health care visits during the study period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gestational Diabetes', 'Pregestational Diabetes']}, 'descriptionModule': {'briefSummary': 'This project will utilize MHealth technology to address the barriers providers and obstetric patients experience when reporting blood glucose results. Half of the participants will record their blood glucose values with the assistance of a smartphone device, the other half will continue in the traditional care method of the clinic.', 'detailedDescription': 'This will be a prospective single center randomized trial piloting the use of mHealth applications in an obstetric population with diabetes. Participants will be enrolled in the study after the diagnosis of diabetes is made in pregnancy for those with gestational diabetes, or for patients with preexisting diabetes they will be enrolled upon initiation of prenatal care. Participants will be randomized to traditional care or mHealth intervention. Outcomes will include completeness and accuracy of the participant glucose log, unscheduled health care access episodes in the pregnancy, patient satisfaction, percentage of glucose values at goal and percent change in Hemoglobin A1C.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Patients must be pregnant to be enrolled in this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant, English speaking, Diagnosed with diabetes during pregnancy or with known preexisting diabetes, has smartphone, sees URMC OBGYN for obstetric care in pregnancy.\n\nExclusion Criteria:\n\n* Not English speaking, does not have smartphone, unable to consent.'}, 'identificationModule': {'nctId': 'NCT03504592', 'acronym': 'SUGAR', 'briefTitle': 'Smartphone Utilization for Glucose Monitoring and Antenatal Reporting', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Utilizing mHealth to Improve Diabetes in an Obstetric Population', 'orgStudyIdInfo': {'id': 'RSRB00068149'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glooko App', 'description': 'Glooko application and meter compatibility device (if required)', 'interventionNames': ['Behavioral: Completion of Glucose logs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Care', 'description': 'Traditional clinic reporting system: paper/MyChart/emailed glucose logs', 'interventionNames': ['Behavioral: Completion of Glucose logs']}], 'interventions': [{'name': 'Completion of Glucose logs', 'type': 'BEHAVIORAL', 'description': 'Glucose logs will be assessed by provider for completeness and accuracy', 'armGroupLabels': ['Glooko App', 'Traditional Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'UR Medicine Obstetrics and Gynecology', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Lisa Gray', 'investigatorAffiliation': 'University of Rochester'}}}}