Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-31 @ 10:03 AM
Study NCT ID:
NCT04145804
Status:
UNKNOWN
Last Update Posted:
2021-02-21
First Post:
2019-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hybrid Closed Loop System for Patients on Multiple Daily Insulin Injections
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2019-10-20', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The achievable percentage of time in range (TIR) 70 - 180 mg/dL for the whole study population after 3 months.', 'timeFrame': '3 months', 'description': 'The achievable Time in Range (TIR) in the first 3 months of MiniMed 670G following onboarding of MDI to HCL by the protocol in a real-life setting.'}], 'secondaryOutcomes': [{'measure': 'percentage of patients achieving TIR > 67% in Time in Range (70-180 mg/dl)', 'timeFrame': '3 months'}, {'measure': 'percentage of patients achieving TIR <3% Time below Range ( <70 mg/dl)', 'timeFrame': '3 months'}, {'measure': 'percentage of patients achieving both TIR > 67% and <3% Time below Range', 'timeFrame': '3 months'}, {'measure': 'Change in HBA1C from baseline', 'timeFrame': '3 months', 'description': 'Change in HbA1c levels from previous treatment (multiple daily injections) compared to Minimed 670G treatment'}, {'measure': 'Change in sensor glucose values from baseline', 'timeFrame': '3 months', 'description': 'Change in sensor glucose values from previous treatment (multiple daily injections) compared to Minimed 670G treatment'}, {'measure': 'Percentage of time above Range (>180 mg/dl) for the whole study population', 'timeFrame': '3 months', 'description': 'Percentage of glucose values more than 180 mg/dl on Minimed 670G'}, {'measure': 'Number of severe hypoglycemia episodes', 'timeFrame': '3 months'}, {'measure': 'Number of Diabetic Ketoacidosis episodes', 'timeFrame': '3 months'}, {'measure': 'Total daily insulin dose', 'timeFrame': '3 months'}, {'measure': 'Percentage of time spend in Auto Mode', 'timeFrame': '3 months', 'description': 'Percentage of time in Auto Mode, where Minimed 670G automatic adjusts the basal insulin dose according glucose levels'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Time in range', 'Hybrid closed loop system', 'Multiple daily insulin injection'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess structured group education onboarding protocol of the 670 G Hybrid Closed Loop (HCL) systems in achieving glucose control of patients on Multiple Daily Insulin Injections (MDI).', 'detailedDescription': 'Goal\n\nThe objective of this study is to assess structured group education onboarding protocol of the 670 G Hybrid Closed Loop systems in achieving glucose control of patients on MDI.\n\nMethods\n\nThis study is a single-arm, single-center, clinical investigation in subjects with type 1 diabetes on HCL insulin pump (Minimed 670G) in a period of 3 months. A total of 40 subjects (age 18-65) will be enrolled in order to reach 34 subjects who will complete the HCL study. The investigators will start the clinical process for initiating an insulin pump, which is typically done with pre-pump classes. HbA1c, derived from Continuous Glucose Monitoring (CGM) will be performed at baseline and at the end of the 3-month study period. The following parameters will be analyzed" % patients achieving glucose readings Time in Range (TIR) \\> 67% in (70-180 mg/dl); % patients achieving \\<3% Time below Range ( \\<70 mg/dl) and % patients achieving both TIR \\> 67% and \\<3% Time below Range.Collection of demographics and medical history, data for diabetes devices (eg meters, sensors, pumps) and brief clinical physical exam including vital signs and skin assessment will be obtained via Hospital Electronic Medical File (Cerner Millennium) and will be kept as electronic data on a separate research server.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Clinical diagnosis of type 1 diabetes. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.\n2. HbA1c \\< 12.5%\n3. Age18-65 years at the initiation of the 670G system\n4. Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1 week period\n5. Willing and able (access to internet from home) to download information into the Medtronic CareLink software\n6. Clinically planning to and be able to start the Medtronic 670G HCL system\n7. History of 3 clinic visits in the last year\n8. With history of cardiovascular event 1 year or more from the time of screening, must have clearance from a cardiologist.\n\nExclusion Criteria:\n\n1. Diabetic Ketoacidosis in the 6 months prior to screening visit\n2. Type 2 diabetes\n3. Hyperthyroidism at time of screening\n4. Using Pramlintide, Dipeptidyl peptidase 4 (DPP-4) inhibitor, Glucagon-like peptide-1 (GLP-1) agonists, metformin, sodium-glucose transport protein 2 (SGLT2) inhibitors at time of screening.\n5. Has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study."}, 'identificationModule': {'nctId': 'NCT04145804', 'briefTitle': 'Hybrid Closed Loop System for Patients on Multiple Daily Insulin Injections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hamad Medical Corporation'}, 'officialTitle': 'Evaluation Of Hybrid Closed Loop (HCL) System On-Boarding Protocol, For Patients With Type 1 Diabetes On Multiple Daily Insulin Injections (MDI) Therapy', 'orgStudyIdInfo': {'id': 'MRC-01-19-296'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Medtronic Minimed 670G insulin pump', 'type': 'DEVICE', 'description': 'It is an insulin pump to deliver insulin to the patient and associated with a sensor to monitor the glucose levels of the patient. The new feature in this device is the automode algorithm which regulates insulin delivery to the patient automatically to keep glucose levels within target.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Doha', 'status': 'RECRUITING', 'country': 'Qatar', 'contacts': [{'name': 'Dabia Almohanadi, MD, FRCPC', 'role': 'CONTACT', 'email': 'DAlMohanadi@hamad.qa', 'phone': '+97455524801'}, {'name': 'Khaled Baagar, MD, FACE', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hamda Ali, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hamad Medical Corporation', 'geoPoint': {'lat': 25.28545, 'lon': 51.53096}}], 'centralContacts': [{'name': 'Dabia Al Mohanadi, MD, FRCPC', 'role': 'CONTACT', 'email': 'DAlMohanadi@hamad.qa', 'phone': '+974-55524801'}, {'name': 'Goran Petrovski, MD, PhD', 'role': 'CONTACT', 'email': 'gpetrovski@sidra.org', 'phone': '+974-70745178'}], 'overallOfficials': [{'name': 'Dabia Al Mohanadi, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamad Medical Corporation'}, {'name': 'Goran Petrovski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sidra Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamad Medical Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sidra Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}