Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT05109520
Status:
COMPLETED
Last Update Posted:
2022-08-30
First Post:
2021-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
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': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 867}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-29', 'studyFirstSubmitDate': '2021-10-14', 'studyFirstSubmitQcDate': '2021-11-03', 'lastUpdatePostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Insulin dose', 'timeFrame': 'maximum 24 months', 'description': 'difference in insulin dose (basal, bolus and total)'}, {'measure': 'Body mass index', 'timeFrame': 'maximum 24 months', 'description': 'difference in body mass index (BMI)'}, {'measure': 'Severe hypoglycemia rate', 'timeFrame': 'maximum 24 months', 'description': 'difference in self-reported severe hypoglycemic events'}, {'measure': 'Hypoglycemic coma rate', 'timeFrame': 'maximum 24 months', 'description': 'difference in self-reported hypoglycemic comas'}, {'measure': 'Hospitalization', 'timeFrame': 'maximum 24 months', 'description': 'difference in hospitalizations due to hypoglycemia or ketoacidosis'}], 'primaryOutcomes': [{'measure': 'Time in range (TIR, 70-180 mg/dL)', 'timeFrame': 'maximum 24 months', 'description': 'The difference in evolution of TIR (70-180 mg/dL, averaged per month) over 24 hours since switch to Gla-300'}], 'secondaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'maximum 24 months', 'description': 'difference in HbA1c'}, {'measure': 'Time in range (TIR, 70-180 mg/dL)', 'timeFrame': 'maximum 24 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'}, {'measure': 'Hypoglycemia', 'timeFrame': 'maximum 24 months', 'description': 'difference in time in hypoglycemia (\\<54 mg/dL, \\<70 mg/dL, ≥54-\\<70 mg/dL; averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am'}, {'measure': 'Hyperglycemia', 'timeFrame': 'maximum 24 months', 'description': 'difference in time in hyperglycemia (\\>180 mg/dL, \\>250 mg/dL, \\>180-≤250 mg/dL; averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am'}, {'measure': 'Mean glycemia', 'timeFrame': 'maximum 24 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'}, {'measure': 'Glycemic variability', 'timeFrame': 'maximum 24 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'}, {'measure': 'Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire', 'timeFrame': 'maximum 24 months', 'description': 'Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life))'}, {'measure': 'Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry', 'timeFrame': 'maximum 24 months', 'description': 'Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))'}, {'measure': 'Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire', 'timeFrame': 'maximum 24 months', 'description': 'Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))'}, {'measure': 'Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs)', 'timeFrame': 'maximum 24 months', 'description': 'Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs) (scale: 0 (low satisfaction) - 36 (high satisfaction))'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Insulin Glargine 300 U/mL', 'Continuous glucose monitoring'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '38386438', 'type': 'DERIVED', 'citation': 'Charleer S, Fieuws S, De Block C, Bolsens N, Nobels F, Mikkelsen K, Mathieu C, Gillard P. Evaluation of Glucose Metrics in Adults with Type 1 Diabetes Switching to Insulin Glargine 300 U/mL: A Retrospective, Propensity-Score Matched Study. Diabetes Technol Ther. 2024 Jul;26(7):488-493. doi: 10.1089/dia.2023.0371. Epub 2024 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'Retrospective multicenter study analyzing data gathered during the FUTURE study (S59342) to assess the effect of using Insulin Glargine 300 U/mL (Gla-300) on measures of diabetes control and quality of life.\n\nOf the FUTURE participants, data about the type of insulin the participants used will be gathered. On the basis of these data participants will be divided in two groups (control or investigational).\n\nChange in glycemic control and quality of life from before to after the switch to Gla-300 (investigational group) will be compared to the change of glycemic control and quality of life of the FUTURE participants who did not switch to Gla-300 (control group).\n\nThe FUTURE study was a 24-month during multicenter observational cohort study analyzing data on the use of the Abbott Freestyle Libre in people with diabetes. Data were gathered during standard clinical follow-up, and from questionnaires that were presented to the participants at defined time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with type 1 diabetes who participated in the FUTURE study.', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Investigational group\n\n Inclusion Criteria:\n * participant in the FUTURE study\n * diagnosed with type 1 diabetes ≥3 months before start of the FUTURE study\n * use of insulin pens for the entirety of the FUTURE study\n * used Insulin Detemir (Levemir®), Insulin Glargine 100 U/mL (Lantus®) or an equivalent as basal insulin before switch to Gla-300 (Toujeo®)\n * switched to Gla-300 (Toujeo®) during the FUTURE study for a sufficient amount of time (at least two consecutive diabetes consultations = 8 months)\n\n Exclusion Criteria:\n * use of Fast-acting insulin aspart (Fiasp®) before or after switch to Gla-300\n * not using bolus insulin (only basal insulin)\n * for women: pregnant or planning pregnancy during the FUTURE study\n2. Control group\n\nInclusion Criteria:\n\n* participant in the FUTURE study for at least 18 months\n* diagnosed with type 1 diabetes ≥3 months before start of the FUTURE study\n* use of insulin pens for the entirety of the FUTURE study\n* use Insulin Detemir (Levemir®), Insulin Glargine 100 U/mL (Lantus®) or an equivalent as basal insulin during the entirety of the FUTURE study\n\nExclusion Criteria:\n\n* use of Fast-acting insulin aspart (Fiasp®)\n* not using bolus insulin (only basal insulin)\n* for women: pregnant or planning pregnancy during the FUTURE study\n* switch to Gla-300 (Toujeo®) or Insulin Degludec (Tresiba®) before 18 months in FUTURE study (if switched after 18 months, only data up to switch to Gla-300 \\[Toujeo®\\] or Insulin Degludec \\[Tresiba®\\] will be used for this control participant)'}, 'identificationModule': {'nctId': 'NCT05109520', 'acronym': 'FUTURE-GLARE', 'briefTitle': 'Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL: A FUTURE Substudy', 'orgStudyIdInfo': {'id': 'S65399'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'investigational group', 'description': 'Participants of the FUTURE study who switched during the study to Gla-300', 'interventionNames': ['Drug: Insulin Glargine 300 UNT/ML [Toujeo]']}, {'label': 'control group', 'description': 'Participants of the FUTURE study who did not switch to Insulin Gla-300'}], 'interventions': [{'name': 'Insulin Glargine 300 UNT/ML [Toujeo]', 'type': 'DRUG', 'description': 'Switch during standard routine care to Gla-300.', 'armGroupLabels': ['investigational group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'Onze Lieve Vrouw Ziekenhuis Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Universitaire Ziekenhuizen Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Pieter Gillard, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD can be shared upon a genuine request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'prof dr Pieter Gillard', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, {'name': 'Onze Lieve Vrouw Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigators', 'investigatorFullName': 'prof dr Pieter Gillard', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}