Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT04211220
Status:
COMPLETED
Last Update Posted:
2022-08-22
First Post:
2019-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Assess the Metabolic Impact of IRTA© and Patients Satisfaction in Type 1 Diabetic Patients, Treated by Either Insulin Pump or Multiple Daily Insulin Injections, and Using Freestyle Libre®, a Real-time Continuous Glucose Monitoring
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': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A decision support software'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-19', 'studyFirstSubmitDate': '2019-12-20', 'studyFirstSubmitQcDate': '2019-12-24', 'lastUpdatePostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of time spent in 70-180mg/dl (time in range) in the last month of each period of the study (without and then with IRTA©)', 'timeFrame': '6 months', 'description': 'Assessment of the metabolic impact of IRTA© on "time in range" (time spent in the standard glucose range between 70-180mg/dl, ie 3.9-10mmol/l) in type 1 diabetic patients, treated by either insulin pump or multiple daily insulin injections, and using Freestyle Libre®.'}], 'secondaryOutcomes': [{'measure': 'Comparison of HbA1c level at the end of each period of the study (without / with IRTA©)', 'timeFrame': '6 months', 'description': 'Blood sample at inclusion, 3 months and 6 months'}, {'measure': 'Time spent in glucose level higher than 250 mg/dl', 'timeFrame': '6 months'}, {'measure': 'Time spent in glucose level higher than 180 mg/dl', 'timeFrame': '6 months'}, {'measure': 'Time spent in glucose level lower than 70 mg/dl', 'timeFrame': '6 months'}, {'measure': 'Time spent in glucose level lower than 54 mg/dl', 'timeFrame': '6 months'}, {'measure': 'Number of incidents (severe hypoglycemia, diabetic ketoacidosis, hospitalizations related to poor glycemic control)', 'timeFrame': '6 months'}, {'measure': 'Percentage of time spent with or without CGM', 'timeFrame': '6 months'}, {'measure': 'Glycemic variability', 'timeFrame': '6 months'}, {'measure': "Patients' satisfaction related to CGM and the impact of IRTA© on this satisfaction", 'timeFrame': '6 months', 'description': 'CGM Satisfaction (CGM-SAT) 44-item questionnaire. Higher scores reflect more favorable impact of, and satisfaction with, CGM use.'}, {'measure': "Patients' satisfaction related to IRTA©", 'timeFrame': '6 months', 'description': 'Satisfaction questionnaire: 5-point Likert scale (1 = strongly agree; 5 = strongly disagree) with each of 18 items.'}, {'measure': 'Number of connections to the IRTA system', 'timeFrame': '6 months'}, {'measure': 'Number of advice given by the IRTA system', 'timeFrame': '6 months'}, {'measure': 'Type of advice given by the IRTA system that is more often asked', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Real time continuous glucose monitoring', 'Decision support software'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'A prospective monocentric " before and after " study, ruled in 2 periods of 3 months : during the first period, the patient will adjust insulin treatment as usual, during the second period, the patient will adjust insulin treatment with IRTA support', 'detailedDescription': 'Freestyle Libre® continuous glucose monitoring (CGM) system may improve glycemic control. However, this system contributes to the complexity of insulin adjustment by the diversity of the data delivered by CGM system.\n\nInsulin Real-Time Advisor (IRTA©), a decision support software, has been developed in order to guide patients in the adaptation of their treatment according to CGM data. IRTA© provides advice applicable to thousand situations according to six parameters: glucose level, trend arrows, meals, physical activity, before bedtime, time since the previous bolus.\n\nType of advice :\n\n* Insulin injection (carb and correction)\n* To continue treatment without modification\n* To lower the insulin dose (temporary basal rate)\n* Sugar intake advice\n* Glucose level control with CGM, self-monitor blood glucose, blood ketones monitor\n* To change catheter for patients treated by insulin pump.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women ≥ 18 years of age\n* Patients with type 1 diabetes mellitus for more than 2 years\n* Treated by either insulin pump for more than 6 months or multiple daily insulin injections.\n* Using Freestyle Libre® for more than 3 months\n* Accepting IRTA use\n* Patient able to provide free and informed consent\n* Patient able to provide written non-disclosure agreement\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding or pregnancy project in the future 6 months\n* Patients with no smart phone or internet access\n* Patients legally protected (under judicial protection, guardianship or supervision)\n* Patients with acute illness (psychiatric, infection, cancer,…)\n* Patients using another CGM system (Enlite® or Dexcom G4®)'}, 'identificationModule': {'nctId': 'NCT04211220', 'acronym': 'IRTA', 'briefTitle': 'Study to Assess the Metabolic Impact of IRTA© and Patients Satisfaction in Type 1 Diabetic Patients, Treated by Either Insulin Pump or Multiple Daily Insulin Injections, and Using Freestyle Libre®, a Real-time Continuous Glucose Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Clinical Evaluation of Insulin Real-Time Advisor (IRTA©): a Decision Support Software for Insulin Therapy Combined With Freestyle Libre®, a Continuous Glucose Monitoring System: Glycemic Impact and Satisfaction in Type 1 Diabetic Patients', 'orgStudyIdInfo': {'id': '35RC19_8858_IRTA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Type 1 diabetes', 'interventionNames': ['Other: A decision support software']}], 'interventions': [{'name': 'A decision support software', 'type': 'OTHER', 'description': 'Insulin pump Continuous glucose monitoring', 'armGroupLabels': ['Type 1 diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}