Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-27 @ 12:22 AM
Study NCT ID:
NCT05434559
Status:
COMPLETED
Last Update Posted:
2022-12-21
First Post:
2022-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Glycemic Control in Adults With Type 1 Diabetes When Switching to Insulin Degludec
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571886', 'term': 'insulin degludec'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 475}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-20', 'studyFirstSubmitDate': '2022-06-14', 'studyFirstSubmitQcDate': '2022-06-21', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hospital visits and/or admissions due to hypoglycemia or ketoacidosis', 'timeFrame': '12 months', 'description': 'difference in number of hospital visits and/or admissions due to hypoglycemia or ketoacidosis between 12 \\[±2\\] months before switch to 12 \\[±2\\] months after switch to Insulin Degludec'}, {'measure': 'Participants who discontinue the use of Insulin Degludec', 'timeFrame': '12 months', 'description': 'number of participants who discontinue the use of Insulin Degludec'}, {'measure': 'Reason for discontinuation of Insulin Degludec', 'timeFrame': '12 months', 'description': 'overview of reasons to discontinue Insulin Degludec (in tabular view)'}, {'measure': 'Indication for use of Insulin Degludec', 'timeFrame': 'baseline', 'description': 'overview of reasons to start Insulin Degludec (in tabular view)'}, {'measure': 'Glycemic consensus targets', 'timeFrame': '12 months', 'description': 'proportion of people reaching HbA1c and glucose consensustargets 12 \\[±2\\] months after switch to Insulin Degludec'}], 'primaryOutcomes': [{'measure': 'Time in range', 'timeFrame': '12 months', 'description': 'the change in time in range (TIR: 70-180 mg/dL, averaged per month) over 24 hours between 12 (±2) months before switch to 12 (±2) months after switch to Insulin Degludec'}], 'secondaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '12 months', 'description': 'difference in HbA1c between 12 \\[±2\\] months before switch to 12 \\[±2\\] months after switch to Insulin Degludec'}, {'measure': 'Time below 54 mg/dL', 'timeFrame': '12 months', 'description': 'difference in time in clinically significant hypoglycemia (\\<54 mg/dL averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 \\[±2\\] months before switch to 12 \\[±2\\] months after switch to Insulin Degludec'}, {'measure': 'Time in range', 'timeFrame': '12 months', 'description': 'difference in TIR (70-180 mg/dL, averaged per month) from 6 am to 10 pm, and from 10 pm to 6 am between 12 \\[±2\\] months before switch to 12 \\[±2\\] months after switch to Insulin Degludec'}, {'measure': 'Time below 70 mg/dL', 'timeFrame': '12 months', 'description': 'difference in time below range (\\<70 mg/dL averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 \\[±2\\] months before switch to 12 \\[±2\\] months after switch to Insulin Degludec'}, {'measure': 'Time above 180 mg/dL', 'timeFrame': '12 months', 'description': 'difference in time above range (\\>180 mg/dL averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 \\[±2\\] months before switch to 12 \\[±2\\] months after switch to Insulin Degludec'}, {'measure': 'Time above 250 mg/dL', 'timeFrame': '12 months', 'description': 'difference in time in significant hyperglycemia (\\>250 mg/dL averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 \\[±2\\] months before switch to 12 \\[±2\\] months after switch to Insulin Degludec'}, {'measure': 'Mean glucose', 'timeFrame': '12 months', 'description': 'difference in mean glucose (averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 \\[±2\\] months before switch to 12 \\[±2\\] months after switch to Insulin Degludec'}, {'measure': 'Glycemic variability', 'timeFrame': '12 months', 'description': 'difference in glycemic variability (standard deviation, coefficient of variation; averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 \\[±2\\] months before switch to 12 \\[±2\\] months after switch to Insulin Degludec'}, {'measure': 'Insulin dose', 'timeFrame': '12 months', 'description': 'difference in insulin dose (total daily dose, basal dose, bolus dose) between 12 \\[±2\\] months before switch to 12 \\[±2\\] months after switch to Insulin Degludec'}, {'measure': 'Body mass index', 'timeFrame': '12 months', 'description': 'difference in body mass index (BMI) between 12 \\[±2\\] months before switch to 12 \\[±2\\] months after switch to Insulin Degludec'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Insulin Degludec', 'Continuous Glucose Monitoring'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '38512387', 'type': 'DERIVED', 'citation': 'De Groote R, Lefever E, Charleer S, Donne P, De Block C, Mathieu C, Gillard P. Continuous Glucose Monitoring-Derived Glucometrics in Adults with Type 1 Diabetes When Switching Basal Insulins. Diabetes Technol Ther. 2024 Aug;26(8):587-595. doi: 10.1089/dia.2023.0616. Epub 2024 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'Retrospective multicenter study analyzing data gathered from medical records and diabetes management platforms to assess the effect of using Insulin Degludec (Tresiba®) on measures of diabetes control.\n\nPeople with type 1 diabetes who switched to Insulin Degludec from another basal insulin between 1/5/2019 and 1/6/2021 will be included.\n\nGlycemic control from 12 months before the switch to Insulin Degludec will be compared to glycemic control of the 12 months after the switch.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Every person who meet the inclusion criteria and who is/was followed at the two participating centers during the sampling period will be included in the analysis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with T1D ≥18 years at the moment of switch to Insulin Degludec\n* Diagnosed with T1D ≥2 years before switch to Insulin Degludec\n* On basal-bolus insulin therapy with insulin pens ≥2 years before switch to Insulin Degludec\n* ≥6 months use of Insulin Degludec at moment of datacollection\n* Using continuous glucose monitoring ≥2 years before switch to Insulin Degludec\n\nExclusion Criteria:\n\n* People with T1D \\<18 years at the moment of switch to Insulin Degludec\n* People without T1D or with T1D \\<2 years before switch to Insulin Degludec\n* Women with T1D who are pregnant or planning pregnancy during -12 and +12 months\n* Not using basal-bolus insulin therapy with insulin pens during -24 and +6 months\n* Start to use non-insulin antidiabetic agents between -12 and +12 months\n* Having received treatment with oral or injectable corticosteroids during -12 and +12 months\n* Undergoing hemodialysis, renal transplantation, or beta cell transplantation during -12 and +12 months\n* \\<6 months use of Insulin Degludec at moment of datacollection\n* Not using continuous glucose monitoring or \\<2 years before switch to Insulin Degludec'}, 'identificationModule': {'nctId': 'NCT05434559', 'acronym': 'GLADE', 'briefTitle': 'Evaluation of Glycemic Control in Adults With Type 1 Diabetes When Switching to Insulin Degludec', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Evaluation of Glycemic Control in Adults With Type 1 Diabetes When Switching to Insulin Degludec: a Retrospective Study', 'orgStudyIdInfo': {'id': 'S66239'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study cohort', 'description': 'People with type 1 diabetes who switched to Insulin Degludec from another basal insulin between 1/5/2019 and 1/6/2021 in the two participating sensors', 'interventionNames': ['Drug: Insulin Degludec']}], 'interventions': [{'name': 'Insulin Degludec', 'type': 'DRUG', 'description': 'Switch during standard routine care to Insulin Degludec.', 'armGroupLabels': ['Study cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Universitaire Ziekenhuizen Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '2650', 'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'University Hospital Antwerp', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'prof dr Pieter Gillard', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Antwerp', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Coordinating Investigator', 'investigatorFullName': 'prof dr Pieter Gillard', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}