Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-01-16 @ 5:23 PM
Study NCT ID:
NCT03671161
Status:
COMPLETED
Last Update Posted:
2020-05-20
First Post:
2018-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Poorly Controlled Diabetes Type 1 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '19 patients with type 1 diabetes, HbA1c \\>9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-18', 'studyFirstSubmitDate': '2018-09-07', 'studyFirstSubmitQcDate': '2018-09-13', 'lastUpdatePostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c ≥1%', 'timeFrame': '6 months', 'description': 'Blood samples at baseline and 6 months'}, {'measure': 'Number of severe hypoglycemia episodes', 'timeFrame': '6 months', 'description': 'Number of severe hypoglycemia episodes, evaluated by flash glucose monitoring'}, {'measure': 'Number of ketoacidosis episodes', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Any positive change in DTSQ scale (ΔDTSQM6-DTSQM0>0) (Diabetes Treatment Satisfaction Questionnaire)', 'timeFrame': '6 months', 'description': 'Filling questionnaires at baseline and 6 months. DTSQ (Diabetes treatment questionnaire) includes 8 items, each score from 0 to 6 with a higher score indicating better outcome'}, {'measure': 'Any positive change in HFS scale (Hypoglycemia Fear Scale)', 'timeFrame': '6 months', 'description': "Filling questionnaires at baseline and 6 months. HFS (Hypoglycemia fear scale) assesses participant's fear of hypoglycemia both overall and separately for behavior (10 items) and worry (17 items), both items scoring from 1 to 5, with lower score indicating better outcome"}, {'measure': 'Number of Hypoglycemia episodes', 'timeFrame': '6 months', 'description': 'Number of hypoglycemia episodes, evaluated by Flash glucose monitoring'}, {'measure': 'Frequency of hypoglycemia episodes', 'timeFrame': '6 months', 'description': 'Frequency of hypoglycemia episodes, evaluated by Flash glucose monitoring'}, {'measure': 'Frequency of severe hypoglycemia episodes', 'timeFrame': '6 months', 'description': 'Frequency of severe hypoglycemia episodes, evaluated by Flash glucose monitoring'}, {'measure': 'Frequency of ketoacidosis episodes', 'timeFrame': '6 months'}, {'measure': 'Any changes in Weight', 'timeFrame': '6 months', 'description': 'Weight measures at baseline 2 months and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Type 1', 'Insulin Pump', 'flash glucose monitoring', 'hypoglycemia', 'ketoacidocetosis', 'DTSQ', 'HFS'], 'conditions': ['Glucose Metabolism Disorders (Including Diabetes Mellitus)', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '31265349', 'type': 'RESULT', 'citation': 'Halbron M, Bourron O, Andreelli F, Ciangura C, Jacqueminet S, Popelier M, Bosquet F, Rouanet S, Amouyal C, Hartemann A. Insulin Pump Combined with Flash Glucose Monitoring: A Therapeutic Option to Improve Glycemic Control in Severely Nonadherent Patients with Type 1 Diabetes. Diabetes Technol Ther. 2019 Jul;21(7):409-412. doi: 10.1089/dia.2019.0041.'}]}, 'descriptionModule': {'briefSummary': 'Patients with diabetes type 1 with poor glycemic control will be switched to insulin pump and FGM system (Flash Glucose Monitoring) during 6 months, correlated to the hypothesis that they could benefit from this intervention by being reengaged in diabetes self-management.', 'detailedDescription': 'This is a non-controlled proof of concept prospective pilot study in adults with type 1 diabetes, HbA1c \\>9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day. Patients will be switched to insulin pump and started a FGM system (Free Style Libre®) during 6 months, hoping this intervention can reengage patients in self-management, reduce HbA1c without increasing the risk of ketoacidocetosis (DKA) and severe hypoglycemia (SH), and keep the DTSQ (Diabetes Treatment Satisfaction Questionnaire) and HFS (Hypoglycemia Fear Scale) at good levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults with type 1 diabetes, aged between 18 and 55, HbA1c \\>9% (75 mmol/mol), multi daily insulin injections (MDI) treatment, maximum 2 SMBG /day\n\nExclusion Criteria:\n\n* diabetes with less than 1 year duration, severe active retinopathy requiring laser therapy, severe psychiatric illness, pregnancy, inability to communicate in French, concomitant severe active disease, patients already using a FGM or a CGM'}, 'identificationModule': {'nctId': 'NCT03671161', 'acronym': 'FREESTYLE', 'briefTitle': 'Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Poorly Controlled Diabetes Type 1 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier Pitie-Salpetriere'}, 'officialTitle': 'Combination of Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Patients With Type 1 Diabetes and Poor Glycemic Control Related to Very Few Self-blood Glucose Measurements', 'orgStudyIdInfo': {'id': 'CIC1421-18-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with poorly controlled diabetes type 1', 'description': 'Adults with type 1 diabetes, HbA1c \\>9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day swithced to Insulin Pump and flash glucose monitoring', 'interventionNames': ['Device: Insulin Pump and flash glucose monitoring']}], 'interventions': [{'name': 'Insulin Pump and flash glucose monitoring', 'type': 'DEVICE', 'description': 'Adults with type 1 diabetes, HbA1c \\>9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day. Patients will be switched to insulin pump and start a FGM system (Free Style Libre®) during 6 months.', 'armGroupLabels': ['Patients with poorly controlled diabetes type 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier Pitie-Salpetriere', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant director, clinical investigation center Paris Est', 'investigatorFullName': 'Joe Elie Salem', 'investigatorAffiliation': 'Groupe Hospitalier Pitie-Salpetriere'}}}}