Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-25 @ 2:07 PM
Study NCT ID:
NCT02723968
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2016-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cystic Fibrosis Related Diabetes Screening.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-23', 'studyFirstSubmitDate': '2016-03-21', 'studyFirstSubmitQcDate': '2016-03-24', 'lastUpdatePostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of the sensitivity and the specificity of IGTT (intravenous glucose tolerance test) for the diagnosis of diabetes mellitus in comparison to a continuous glucose monitoring system', 'timeFrame': 'Day 3'}, {'measure': 'Measurement of the sensitivity and the specificity of HOMA-%IR (homeostasis model assessment index of insulin resistance) for the diagnosis of diabetes mellitus in comparison to a continuous glucose monitoring system.', 'timeFrame': 'Day 3'}], 'secondaryOutcomes': [{'measure': 'Measurement of the prevalence of diabetes mellitus.', 'timeFrame': 'Day 3'}, {'measure': 'Correlation between IGTT and HOMA-%IR data and HbA1C dosage (glycated haemoglobin A1C).', 'timeFrame': 'Day 3'}, {'measure': 'Measurement of glucose intolerance', 'timeFrame': 'Day 3'}, {'measure': 'Correlation between IGTT and HbA1C dosage (glycated haemoglobin A1C).', 'timeFrame': 'Day 3'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis-related Diabetes']}, 'referencesModule': {'references': [{'pmid': '27977404', 'type': 'RESULT', 'citation': 'Mainguy C, Bellon G, Delaup V, Ginoux T, Kassai-Koupai B, Mazur S, Rabilloud M, Remontet L, Reix P. Sensitivity and specificity of different methods for cystic fibrosis-related diabetes screening: is the oral glucose tolerance test still the standard? J Pediatr Endocrinol Metab. 2017 Jan 1;30(1):27-35. doi: 10.1515/jpem-2016-0184.'}]}, 'descriptionModule': {'briefSummary': 'Cystic fibrosis-related diabetes is a late cystic fibrosis (CF) associated comorbidity whose prevalence is increasing sharply lifelong. Guidelines for glucose metabolism (GM) monitoring relies on oral glucose tolerance test . However, this test is neither sensitive nor specific.\n\nThe aim of this study is to compare sensitivity and specificity of different methods for GM monitoring in children and adolescents with CF.\n\nContinuous GM system (CGMS) will be used as the reference method. Results will be compared to those of oral glucose tolerance test (OGTT), intravenous glucose tolerance test (IGTT), homeostasis model assessment index of insulin resistance (HOMA-%IR) , homeostasis model assessment index of beta-cell function (HOMA-%B) and HbA1C dosage (glycated haemoglobin A1C). Patients will be classified into three groups according to CGMS: normal glucose tolerance, impaired glucose tolerance and diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with confirmed diagnosis of Cystic Fibrosis with a sweat chloride \\> 60 mmol/L.\n* Subjects will be aged between 10 and 18 years with at least one class 1 or 2 Cystic fibrosis transmembrane conductance regulator (CFTR) mutation.\n* Subjects will be pancreatic insufficient.\n* Subjects must have a forced expiratory volume 1 (FEV1)\\> 40 % of predicted normal for age, sex and height at the screening visit.\n* Stable CF disease as judged by the investigator\n\nExclusion Criteria:\n\n* Subjects with glucose intolerance abnormalities\n* Subjects with pulmonary exacerbation within 4 weeks before screening\n* History of lung or hepatic transplantation or awaiting transplantation'}, 'identificationModule': {'nctId': 'NCT02723968', 'acronym': 'D2M', 'briefTitle': 'Cystic Fibrosis Related Diabetes Screening.', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Sensitivity and Specificity of Different Methods for Cystic Fibrosis-related Diabetes Screening.', 'orgStudyIdInfo': {'id': '2008.527'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Continuous glucose monitoring system', 'description': 'OGTT followed by continuous glucose monitoring system and finally IGTT and HbA1C dosage', 'interventionNames': ['Other: glucose solution at a dose of 1.75 g/kg (up to a maximum of 75 g) for the OGTT and glucose solution at a dose of 0.5 g/kg (up to a maximum of 35 g) was injected in 2.5-3 min for the IGTT', 'Procedure: HGPIV diagnosis test', 'Procedure: HOMAR-IR diagnosis test']}], 'interventions': [{'name': 'glucose solution at a dose of 1.75 g/kg (up to a maximum of 75 g) for the OGTT and glucose solution at a dose of 0.5 g/kg (up to a maximum of 35 g) was injected in 2.5-3 min for the IGTT', 'type': 'OTHER', 'description': 'At the first visit at day 1an OGTT will be performed then the CGMS is implanted. Capillary glycaemia will be taken four times a day to set up the CGMS. A second visit is scheduled at day 4, where the intravenous glucose tolerance test is performed as well as the HbA1C level.', 'armGroupLabels': ['Continuous glucose monitoring system']}, {'name': 'HGPIV diagnosis test', 'type': 'PROCEDURE', 'armGroupLabels': ['Continuous glucose monitoring system']}, {'name': 'HOMAR-IR diagnosis test', 'type': 'PROCEDURE', 'armGroupLabels': ['Continuous glucose monitoring system']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}