Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT03182569
Status:
COMPLETED
Last Update Posted:
2018-04-12
First Post:
2017-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flexible Catheter for Insulin in Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-22', 'releaseDate': '2025-08-06'}, {'resetDate': '2025-10-10', 'releaseDate': '2025-09-23'}], 'estimatedResultsFirstSubmitDate': '2025-08-06'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016883', 'term': 'Diabetic Ketoacidosis'}], 'ancestors': [{'id': 'D007662', 'term': 'Ketosis'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-11', 'studyFirstSubmitDate': '2017-03-14', 'studyFirstSubmitQcDate': '2017-06-07', 'lastUpdatePostDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort measured by a visual analogue scale for pain', 'timeFrame': 'between 10 to 14 hours', 'description': 'Comfort measured by a visual analogue scale for pain (10cm = 0 meaning no pain and 10 meaning maximum pain) shown hourly after insulin administration until metabolic stability is achieved.'}], 'secondaryOutcomes': [{'measure': 'Associated complications', 'timeFrame': '24 hours', 'description': 'complications associated with the insulin administration device (local infection, extravasation)'}, {'measure': 'Metabolic stability according to lab determinations', 'timeFrame': 'between 10 to 14 hours', 'description': 'Time to reach the metabolic stability defined by: glycemia ≤250 mg/dl, pH ≥ 7.3, bicarbonate ≥ 15 mmol/L);'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetic Ketoacidosis']}, 'referencesModule': {'references': [{'pmid': '11953729', 'type': 'BACKGROUND', 'citation': 'Hanas R, Adolfsson P, Elfvin-Akesson K, Hammaren L, Ilvered R, Jansson I, Johansson C, Kroon M, Lindgren J, Lindh A, Ludvigsson J, Sigstrom L, Wiik A, Aman J. Indwelling catheters used from the onset of diabetes decrease injection pain and pre-injection anxiety. J Pediatr. 2002 Mar;140(3):315-20. doi: 10.1067/mpd.2002.122470.'}, {'pmid': '33687988', 'type': 'DERIVED', 'citation': 'Beaudoin ML, Torrents M, Tittarelli MF, Hamui M, Ibarra M, Ferraro M, Ferreira JP. Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis: A Feasibility Controlled Clinical Trial. Hosp Pediatr. 2021 Apr;11(4):396-400. doi: 10.1542/hpeds.2020-0063. Epub 2021 Mar 9.'}]}, 'descriptionModule': {'briefSummary': 'Use of a flexible subcutaneous catheter improves comfort in patients with DKA compared to the usual treatment with a metal needle.', 'detailedDescription': 'Assess whether the use of a flexible subcutaneous catheter improves comfort in patients with DKA compared to the usual treatment with a metal needle.\n\nCompare the metabolic evolution of patients with DKA using a flexible subcutaneous catheter for insulin administration vs. a metal needle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 5 to 18 years, admitted with diagnoses of DKA. DKA is defined when patients meets all the following biochemical baseline criteria (before initial hydration):\n* Glucose\\> 200 mg / dl\n* pH \\< 7.3\n* Bicarbonate \\< 15mmol/l.\n\nExclusion Criteria:\n\n* Patients referred from another institution with a different treatment, and those who requires intensive care on admission.'}, 'identificationModule': {'nctId': 'NCT03182569', 'briefTitle': 'Flexible Catheter for Insulin in Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General de Niños Pedro de Elizalde'}, 'officialTitle': 'Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis', 'orgStudyIdInfo': {'id': 'HGNPE-247-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'flexible catheter', 'description': 'The flexible Subcutaneous catheter for insulin administration', 'interventionNames': ['Device: FLEXIBLE CATHETER']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hourly rigid needle puncture', 'description': 'Hourly rigid needle puncture for Subcutaneous insulin administration', 'interventionNames': ['Device: hourly rigid needle puncture']}], 'interventions': [{'name': 'FLEXIBLE CATHETER', 'type': 'DEVICE', 'armGroupLabels': ['flexible catheter']}, {'name': 'hourly rigid needle puncture', 'type': 'DEVICE', 'armGroupLabels': ['hourly rigid needle puncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1270AAN', 'city': 'Buenos Aires', 'state': 'Constitucion', 'country': 'Argentina', 'facility': 'Hospital General de Niños Pedro de Elizalde', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Laura Beaudoin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General de Niños Pedro de Elizalde'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General de Niños Pedro de Elizalde', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-06', 'type': 'RELEASE'}, {'date': '2025-08-22', 'type': 'RESET'}, {'date': '2025-09-23', 'type': 'RELEASE'}, {'date': '2025-10-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hospital General de Niños Pedro de Elizalde'}}}}