Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT05592860
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2022-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Glycemic Control With Smartphone Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-09', 'size': 329473, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-10-19T09:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-20', 'studyFirstSubmitDate': '2022-10-20', 'studyFirstSubmitQcDate': '2022-10-20', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'at the end of 3 months follow-up', 'description': 'A1C is a lab test that shows the average level of blood sugar (glucose) over the previous 3 months. It shows how well a person is controlling their blood sugar to help prevent complications from diabetes.'}], 'secondaryOutcomes': [{'measure': 'Change in weight', 'timeFrame': 'baseline and 3 month', 'description': 'Change in weight'}, {'measure': 'Change in Body Mass Index (BMI)', 'timeFrame': 'baseline and 3 month', 'description': 'Change in BMI'}, {'measure': 'Change in blood pressure', 'timeFrame': 'baseline and 3 month', 'description': 'Change in blood pressure - systolic and diastolic'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The study is aimed to determine if a smartphone application based weekly glucose monitoring by a care provider is superior to the routine home glucose monitoring by patients in poorly controlled type 2 diabetes mellitus who are on insulin.', 'detailedDescription': 'The study is a randomized, prospective cohort study. Subjects will be enrolled randomly after fulfilling the meeting criteria into two groups. Group 1 (intervention group) will used mobile application to enter their glucose level and group 2 (control group) will record their glucose level on daily diary. Data collection will be standardized in order to eliminate bias. In addition, all statistical analyses will be performed by a departmental statistician and not the study investigators. Patients in each arm of the study will be selected form the same population in order to avoid selection bias.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult type 2 diabetes mellitus patients (≥ 18years of age) whose HbA1c is ≥8% on insulin.\n* At least three months of daily home glucose monitoring before including in the study\n* Willing to provide consent to participate in the study4. Uses a smartphone with cellular network and willing to and has ability to learn and use the Vivo vitals application on it.\n\nExclusion Criteria:\n\n* Patients who have Gestational diabetes or type 1 diabetes\n* Patients who have been admitted to the hospital in the last month for more than 3 days.\n* Patients who have adrenal disorders or taking exogenous glucocorticoids.\n* Patients who are mentally incompetent, having uncontrolled psychiatric conditions, inmates.\n* Patients with active malignancies including those on treatment'}, 'identificationModule': {'nctId': 'NCT05592860', 'briefTitle': 'Comparison of Glycemic Control With Smartphone Application', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Comparison of Glycemic Control With Smartphone Application (Vivovitals) - Based Glucose Monitoring to Routine Home Glucose Monitoring in Poorly Controlled T2DM Patients Treated With Insulin', 'orgStudyIdInfo': {'id': 'STUDY-20-01694'}, 'secondaryIdInfos': [{'id': 'FWA#00005656', 'type': 'OTHER', 'domain': 'Department of Health and Human Services'}, {'id': 'FWA#00005651', 'type': 'OTHER', 'domain': 'Department of Health and Human Services'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile application', 'description': 'Mobile application to enter glucose level', 'interventionNames': ['Device: Mobile application']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Daily Diary', 'description': 'Daily Diary to record glucose level', 'interventionNames': ['Behavioral: Daily Diary']}], 'interventions': [{'name': 'Mobile application', 'type': 'DEVICE', 'otherNames': ['device related insulin adjustment'], 'description': 'participants in intervention group will use smart phone application and update glucose level and investigator will adjust the insulin accordingly', 'armGroupLabels': ['Mobile application']}, {'name': 'Daily Diary', 'type': 'BEHAVIORAL', 'description': 'participants will use daily diary to record glucose level', 'armGroupLabels': ['Daily Diary']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11432', 'city': 'Jamaica', 'state': 'New York', 'country': 'United States', 'facility': 'Queens Hospital Center', 'geoPoint': {'lat': 40.69149, 'lon': -73.80569}}], 'overallOfficials': [{'name': 'Issac sachmechi, MD, FACE, FACP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn school of medicine Mount Sinai'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Immediately following publication. No end date.', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after deidentification.', 'accessCriteria': 'Investigators whose proposed use of the data has been approved by an independent review committee) identified for this purpose. To achieve aims in the approved proposal. Proposals should be directed to sachmeci@nychhc.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Diabetes Center of Excellence', 'investigatorFullName': 'Issac Sachmechi', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}