Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-27 @ 6:36 AM
Study NCT ID:
NCT01100892
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2010-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cystic Fibrosis - Insulin Deficiency, Early Action
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069057', 'term': 'Insulin Detemir'}], '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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-29', 'studyFirstSubmitDate': '2010-03-31', 'studyFirstSubmitQcDate': '2010-04-08', 'lastUpdatePostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Weight SDS (Standard Deviation Score)', 'timeFrame': '12 months'}, {'measure': 'Change in lung function (FEV1, FVC)', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Reduced rate of decline in glycaemic category, comparing OGTT at baseline and 12 months.', 'timeFrame': '12 months', 'description': 'OGTT = Oral Glucose Tolerance Test'}, {'measure': 'Reduced frequency of hospitalisation for acute respiratory illness', 'timeFrame': '12 months'}, {'measure': 'Change in glycaemic status assessed by HbA1c and CGM', 'timeFrame': '12 months', 'description': 'CGM = Continuous Glucose Monitoring'}, {'measure': 'Body composition by DEXA. Patients at CHW will also have pQCT.', 'timeFrame': '12 months', 'description': 'DEXA = Dual Energy X-ray Absorptiometry\n\npQCT = peripheral Quantitative Computed Tomography'}, {'measure': 'Change in Grip-strength', 'timeFrame': '12 months'}, {'measure': 'Improved quality of life, measured by a validated CF QOL questionnaire', 'timeFrame': '12 months'}, {'measure': 'Bacterial colonisation of sputum', 'timeFrame': '12 months'}, {'measure': 'Change in effort-dependent lung function: MIP, MEP, SnIP', 'timeFrame': '12 months', 'description': 'MIP = Mouth Inspiratory Pressure\n\nMEP = Mouth Expiratory Pressure\n\nSnIP = Sniff Nasal Inspiratory Pressure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pediatrics', 'Pancreas'], 'conditions': ['Cystic Fibrosis', 'Diabetes']}, 'referencesModule': {'references': [{'pmid': '19910502', 'type': 'BACKGROUND', 'citation': 'Hameed S, Morton JR, Jaffe A, Field PI, Belessis Y, Yoong T, Katz T, Verge CF. Early glucose abnormalities in cystic fibrosis are preceded by poor weight gain. Diabetes Care. 2010 Feb;33(2):221-6. doi: 10.2337/dc09-1492. Epub 2009 Nov 12.'}, {'pmid': '21493664', 'type': 'BACKGROUND', 'citation': 'Hameed S, Morton JR, Field PI, Belessis Y, Yoong T, Katz T, Woodhead HJ, Walker JL, Neville KA, Campbell TA, Jaffe A, Verge CF. Once daily insulin detemir in cystic fibrosis with insulin deficiency. Arch Dis Child. 2012 May;97(5):464-7. doi: 10.1136/adc.2010.204636. Epub 2011 Apr 14.'}, {'pmid': '21626717', 'type': 'BACKGROUND', 'citation': 'Hameed S, Jaffe A, Verge CF. Cystic fibrosis related diabetes (CFRD)--the end stage of progressive insulin deficiency. Pediatr Pulmonol. 2011 Aug;46(8):747-60. doi: 10.1002/ppul.21495. Epub 2011 May 27.'}, {'pmid': '40379429', 'type': 'DERIVED', 'citation': 'Hameed S, Barnes EH, Briody J, Wainwright CE, Hilton J, Field PI, Tai A, Belessis Y, Chan CL, Selvadurai H, Prentice B, Katz T, McMahon SK, Neylan M, Pena A, Jaffe A, Verge CF. Insulin for early glycaemic abnormality in children with cystic fibrosis without cystic fibrosis-related diabetes (CF-IDEA): a randomised controlled trial. Lancet Child Adolesc Health. 2025 Jun;9(6):371-382. doi: 10.1016/S2352-4642(25)00099-9.'}]}, 'descriptionModule': {'briefSummary': 'Cystic Fibrosis (CF) is the most common life-threatening genetic condition affecting Australian children. As well as repeated lung infections, children with CF develop insulin deficiency and eventually diabetes. The CF-IDEA trial (Cystic Fibrosis - Insulin Deficiency, Early Action) will determine whether starting insulin treatment before the onset of diabetes (earlier than current practice) will improve the health of children with CF by improving body weight and lung function.', 'detailedDescription': 'As well as progressive lung disease, patients with Cystic Fibrosis (CF) suffer pancreatic destruction, leading to slow but progressive insulin deficiency. Deficiency of insulin, a powerful anabolic hormone, causes accelerated decline of weight and lung function (important predictors of early mortality in CF).\n\nWe analysed Oral Glucose Tolerance Tests sampled every 30 mins and defined stages of CF Insulin Deficiency (CFID) as early glucose abnormalities, CFID1 (BGmax \\>=8.2 and \\<11.1mmol/L) and CFID2 (BGmax \\>=11.1 and BG120min \\<11.1), progressing to diabetes without fasting hyperglycaemia (CFID3), and finally to diabetes with fasting hyperglycaemia (CFID4). Currently insulin treatment is standard only for CFID3 and 4, but we have data showing that the earlier stages (CFID1 and 2) are also associated with declining weight and lung function.\n\nIn the CF-IDEA Trial, subjects with CF aged \\>=5 years with early glucose abnormalities (CFID1 or 2) will be randomised to once-daily insulin detemir (Levemir) for 12 months, or to observation only. We aim to determine whether starting insulin earlier than current practice will prevent decline in weight and lung function, reduce frequency of hospitalisation, improve quality of life, and slow progression through CFID categories.\n\nOur pilot studies using once-daily Levemir in children with CFID1 and 2 found that this simple insulin regimen (rather than multiple daily injections) was well accepted by patients, with minimal hypoglycaemia, and resulted in significant weight gain and improved lung function (compared with 12 months prior to insulin). Sample size calculations for the CF-IDEA Trial are based on our pilot studies. When 70-80% of patients have completed the protocol, the study statistician will perform an interim analysis (blinded to the other investigators) to check the original power calculations.\n\nStages of CF Insulin Deficiency:\n\nCFID1 Peak BG on OGTT \\>=8.2mmol/L and \\<11.1mmol/l.\n\nCFID2 Peak BG on OGTT \\>=11.1mmol/L and 120 minute BG \\<11.1.\n\nCFID3 120 minute BG on OGTT \\>=11.1mmol/L.\n\nCFID4 Fasting hyperglycemia (Fasting BG \\>=7mmol/L).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with CF aged \\>=5 yrs attending one of the study sites.\n* CFID1 or CFID2 (defined as BGmax \\>=8.2 and BG120 \\<11.1mmol/l on OGTT performed within the last 6 months, when respiratory function stable as judged by the treating respiratory team, not taking fluoroquinolone antibiotics, and not taking systemic glucocorticoids).\n\nExclusion Criteria:\n\n* Cystic Fibrosis Related Diabetes, defined as CFID3 (BG120 \\>11.1mmol/L) or CFID4 (fasting BG \\>7mmol/L). Such patients will be offered insulin treatment as standard clinical care.\n* Unstable respiratory disease (hospital admission for treatment of respiratory exacerbation within the last month).\n* Treatment with systemic glucocorticoids of more than 1 month duration, within the last 12 months.'}, 'identificationModule': {'nctId': 'NCT01100892', 'acronym': 'CF-IDEA', 'briefTitle': 'Cystic Fibrosis - Insulin Deficiency, Early Action', 'organization': {'class': 'OTHER', 'fullName': "Sydney Children's Hospitals Network"}, 'officialTitle': 'Cystic Fibrosis - Insulin Deficiency, Early Action', 'orgStudyIdInfo': {'id': 'CF-IDEA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Observation only. Does not receive once-daily insulin detemir.'}, {'type': 'EXPERIMENTAL', 'label': 'Once-daily insulin detemir', 'description': 'Once-daily insulin detemir', 'interventionNames': ['Drug: Once-daily insulin detemir']}], 'interventions': [{'name': 'Once-daily insulin detemir', 'type': 'DRUG', 'otherNames': ['Levemir'], 'description': 'Insulin detemir is a long-acting insulin analog. Starting dose 0.1 units/kg/day (titrated according to the results of home blood glucose monitoring).', 'armGroupLabels': ['Once-daily insulin detemir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '2310', 'city': 'New Lambton', 'state': 'New South Wales', 'country': 'Australia', 'facility': "John Hunter Children's Hospital", 'geoPoint': {'lat': -32.92838, 'lon': 151.7085}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': "Sydney Children's Hospital", 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': "Children's Hospital at Westmead", 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4101', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': "Lady Cilento Children's Hospital", 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '5006', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': "Women's and Children's Hospital", 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'overallOfficials': [{'name': 'Charles Verge, MBBS PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Endocrinology, Sydney Children's Hospital Randwick; School of Women's and Children's Health, University of NSW"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Sydney Children's Hospitals Network", 'class': 'OTHER'}, 'collaborators': [{'name': "John Hunter Children's Hospital", 'class': 'OTHER'}, {'name': "Lady Cilento Children's Hospital, Brisbane", 'class': 'OTHER'}, {'name': "Women's and Children's Hospital, Adelaide", 'class': 'UNKNOWN'}, {'name': "Children's Hospital Colorado", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Head of Endocrinology, Sydney Children's Hospital, Randwick", 'investigatorFullName': 'Dr Charles Verge', 'investigatorAffiliation': "Sydney Children's Hospitals Network"}}}}