Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-31 @ 8:34 AM
Study NCT ID:
NCT04051632
Status:
COMPLETED
Last Update Posted:
2019-08-09
First Post:
2019-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-07', 'studyFirstSubmitDate': '2019-08-06', 'studyFirstSubmitQcDate': '2019-08-07', 'lastUpdatePostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful implementation of hybrid closed loop technology', 'timeFrame': '0-24 months', 'description': 'Percent of Type 1 Diabetes patients who were properly trained on the use of the 670G that continue to use Hybrid Closed Loop technology at 0, 6, 12, 18 and 24 months post training.'}], 'secondaryOutcomes': [{'measure': 'Impact of hybrid closed loop technology on glycemic control', 'timeFrame': '0-24 months', 'description': 'Assess impact of hybrid closed loop technology on glycemic control by comparing hemoglobin A1c measurements 0-6 months prior to treatment versus 0-6, 6-12, 12-18, 18-24 months post treatment'}, {'measure': 'Assess impact of hybrid closed loop technology on glycemic control by analysis of sensor glucose data.', 'timeFrame': '0-24 months.', 'description': 'Compare sensor glucose data: 1) percent time in range (70-180 mg/dl), 2)percent time in auto-mode, 3) percent time sensor usage versus hemoglobin A1c data over time.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Medtronic 670G'], 'conditions': ['Biomedical Technology', 'Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'Observational study of patients at Boston Childrens Hospital with type 1 diabetes (T1D) who elected to treat their diabetes with the Medtronic 670 G hybrid closed loop insulin pump.', 'detailedDescription': 'Outcome study of 90-100 patients with type 1 diabetes who elected to use the Medtronic 670G.\n\nMajor outcome measure was to assess the percent of patients who were able to successfully continue to use the 670G technology over time.\n\nAdditional outcome variables included hemoglobin A1c pre and post treatment with the 670G, time in desired glucose range 70-180.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Single institution clinic population.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of T1D\n* patient of Boston Childrens Hospital diabetes program\n* deemed to be adequate candidates for hybrid closed loop technology by their diabetes health care team\n* patient received Medtronic 670G training at Boston Childrens Hospital\n* patient received follow up diabetes care at Boston Childrens Hospital for at least 3 months after starting on the 670G\n\nExclusion Criteria:\n\n* patients not trained at Boston Childrens Hospital or self started'}, 'identificationModule': {'nctId': 'NCT04051632', 'briefTitle': 'Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)', 'orgStudyIdInfo': {'id': 'IRB-P00028472'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type 1 Diabetes patients treated with the Medtronic 670G', 'description': 'Type 1 Diabetes patients treated with the Medtronic 670G at Boston Childrens Hospital', 'interventionNames': ['Device: Medtronic 670G insulin pump']}], 'interventions': [{'name': 'Medtronic 670G insulin pump', 'type': 'DEVICE', 'description': '* percent of patients who continue to use Medtronic 670G over time\n* impact of 670G on glycemic control: hemoglobin A1c, time in range', 'armGroupLabels': ['Type 1 Diabetes patients treated with the Medtronic 670G']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Childrens Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Gregory Goodwin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Associate Physician in Medicine', 'investigatorFullName': 'Gregory Goodwin', 'investigatorAffiliation': "Boston Children's Hospital"}}}}