Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT04761094
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2021-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy of Insulin Pumps in Type 1 Diabetes Mellitus Patients in Spain
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': 'D007332', 'term': 'Insulin Infusion Systems'}], 'ancestors': [{'id': 'D016503', 'term': 'Drug Delivery Systems'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007260', 'term': 'Infusion Pumps'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D001187', 'term': 'Artificial Organs'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2977}, 'targetDuration': '9 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-08', 'studyFirstSubmitDate': '2021-02-12', 'studyFirstSubmitQcDate': '2021-02-17', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1C', 'timeFrame': 'During the procedure', 'description': 'Glycated haemoglobin A1C'}], 'secondaryOutcomes': [{'measure': 'TIR', 'timeFrame': 'During the procedure', 'description': 'Time in range (TIR, 3.9-10 mmol/L, 70-180 mg/dL) of the interstitial glucose'}, {'measure': 'TAR', 'timeFrame': 'During the procedure', 'description': 'Time above range (TAR, \\>10 mmol/L, \\>180 mg/dL) of the interstitial glucose'}, {'measure': 'TUR', 'timeFrame': 'During the procedure', 'description': 'Time under range (TUR, \\<3.9 mmol/L, \\<70 mg/dL) of the interstitial glucose'}, {'measure': 'Clinical significant hypoglycemia', 'timeFrame': 'During the procedure', 'description': 'Time in clinical significant hypoglycemia (\\< 3 mmol/L, \\<54 mg/dL) of the interstitial glucose'}, {'measure': 'MIG', 'timeFrame': 'During the procedure', 'description': 'Mean interstitial glucose (mmol/L, mg/dL)'}, {'measure': '%CV', 'timeFrame': 'During the procedure', 'description': 'Percentage of the variation coefficient (%, \\>36% is considered high levels)'}, {'measure': 'Adherence to CGM', 'timeFrame': 'During the procedure', 'description': 'Time of use of continuous glucose monitoring (% possible time of use)'}, {'measure': 'Weight', 'timeFrame': 'During the procedure', 'description': 'Total corporal weight (Kg)'}, {'measure': 'Insulin dose', 'timeFrame': 'During the procedure', 'description': 'Daily insulin dose requirements (UI/Kg/d)'}, {'measure': 'DKA', 'timeFrame': 'During the procedure', 'description': 'Number of diabetic ketoacidosis (number of events)'}, {'measure': 'Severe hypoglycemia', 'timeFrame': 'During the procedure', 'description': 'Number of severe hypoglycemia (number of events)'}, {'measure': 'Hospital admission', 'timeFrame': 'During the procedure', 'description': 'Number of hospital admission due to insulin pump (number of events)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Type 1 diabetes', 'Treatment', 'Insulin pump', 'Continuous subcutaneous insulin infusion'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '3517648', 'type': 'BACKGROUND', 'citation': 'Eisenbarth GS. Type I diabetes mellitus. A chronic autoimmune disease. N Engl J Med. 1986 May 22;314(21):1360-8. doi: 10.1056/NEJM198605223142106. No abstract available.'}, {'pmid': '8040759', 'type': 'BACKGROUND', 'citation': 'Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group. J Pediatr. 1994 Aug;125(2):177-88. doi: 10.1016/s0022-3476(94)70190-3.'}, {'pmid': '22777524', 'type': 'BACKGROUND', 'citation': 'Yeh HC, Brown TT, Maruthur N, Ranasinghe P, Berger Z, Suh YD, Wilson LM, Haberl EB, Brick J, Bass EB, Golden SH. Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis. Ann Intern Med. 2012 Sep 4;157(5):336-47. doi: 10.7326/0003-4819-157-5-201209040-00508.'}, {'pmid': '23039989', 'type': 'BACKGROUND', 'citation': 'Sastre J, Pines PJ, Moreno J, Aguirre M, Blanco B, Calderon D, Herranz S, Roa C, Lopez J; Grupo de estudio DIACAM 1. Metabolic control and treatment patterns in patients with type 1 diabetes in Castilla-La Mancha: the DIAbetes tipo 1 in Castilla La Mancha study. Endocrinol Nutr. 2012 Nov;59(9):539-46. doi: 10.1016/j.endonu.2012.07.003. Epub 2012 Oct 4. English, Spanish.'}, {'pmid': '29278712', 'type': 'BACKGROUND', 'citation': 'Beato-Vibora P, Chico-Ballesteros A, Gimenez M, Guerrero-Vazquez R, Barrio-Castellanos R, Goni-Iriarte MJ, Diaz-Soto G, Merino-Torres JF, Moreno-Fernandez J, Martinez-Brocca MA; Diabetes Technology Working Group of the Spanish Diabetes Association. A national survey on the efficacy and safety of continuous subcutaneous insulin infusion in patients with type 1 diabetes in Spain. Diabetes Res Clin Pract. 2018 Mar;137:56-63. doi: 10.1016/j.diabres.2017.12.009. Epub 2017 Dec 24.'}, {'pmid': '31199682', 'type': 'BACKGROUND', 'citation': 'Moreno-Fernandez J, Gomez FJ, Pines P, Gonzalez J, Lopez J, Lopez LM, Blanco B, Roa C, Herranz S, Munoz-Rodriguez JR. Continuous Subcutaneous Insulin Infusion in Adult Type 1 Diabetes Mellitus Patients: Results from a Public Health System. Diabetes Technol Ther. 2019 Aug;21(8):440-447. doi: 10.1089/dia.2019.0097. Epub 2019 Jun 13.'}, {'pmid': '35947087', 'type': 'DERIVED', 'citation': 'Moreno-Fernandez J, Chico A, Martinez-Brocca MA, Beato-Vibora PI, Vidal M, Piedra M, Quiros C, Munoz-Rodriguez JR; SPAIP Registry Study. Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Mellitus Patients: Results from the Spanish National Registry. Diabetes Technol Ther. 2022 Dec;24(12):898-906. doi: 10.1089/dia.2022.0207. Epub 2022 Sep 6.'}]}, 'descriptionModule': {'briefSummary': 'Observational cross-sectional multicenter study about clinical efficacy of insulin pumps in type 1 diabetes mellitus patients.', 'detailedDescription': "Observational cross-sectional multicenter study about clinical efficacy of continuous subcutaneous insulin infusion in type 1 diabetes mellitus patients.\n\nAll clinical variables are gathered from the Spanish Insulin Pump National Registry.\n\nData analysis is conducted using SPSS (Chicago, IL) statistic software. Results are presented as mean +/- SD values. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value \\< 0.05 was considered statistically significant.\n\nThe protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All type 1 diabetes patients treated with continuous subcutaneous insulin infusion in Spain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes patients treated with insulin pump.\n* Medical treatment received in Spain.\n\nExclusion Criteria:\n\n\\- Any other kinds of diabetes.'}, 'identificationModule': {'nctId': 'NCT04761094', 'briefTitle': 'Clinical Efficacy of Insulin Pumps in Type 1 Diabetes Mellitus Patients in Spain', 'organization': {'class': 'OTHER', 'fullName': 'Castilla-La Mancha Health Service'}, 'officialTitle': 'Clinical Efficacy of Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Mellitus Patients in Spain', 'orgStudyIdInfo': {'id': 'C-386'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Insulin pump', 'description': 'All patient treated with insulin pump.', 'interventionNames': ['Device: Insulin pump']}], 'interventions': [{'name': 'Insulin pump', 'type': 'DEVICE', 'description': 'Treatment with continuous subcutaneous insulin infusion', 'armGroupLabels': ['Insulin pump']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08950', 'city': 'Esplugues de Llobregat', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital San Joan de Deu', 'geoPoint': {'lat': 41.37732, 'lon': 2.08809}}, {'zip': '08221', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario Mutua de Tarrasa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '11407', 'city': 'Jerez de la Frontera', 'state': 'Cadiz', 'country': 'Spain', 'facility': 'Hospital Universitario de Jerez', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'La Coruña', 'country': 'Spain', 'facility': 'Hospital Universitario de Santiago de Compostela', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '28703', 'city': 'San Sebastián de los Reyes', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Infanta Sofía', 'geoPoint': {'lat': 40.55555, 'lon': -3.62733}}, {'zip': '29010', 'city': 'Málaga', 'state': 'Malaga', 'country': 'Spain', 'facility': 'Hospital Universitario Carlos Haya', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '29010', 'city': 'Málaga', 'state': 'Malaga', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '06080', 'city': 'Badajoz', 'country': 'Spain', 'facility': 'Badajoz University Hospital', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic i Provincial', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '48013', 'city': 'Bilbao', 'country': 'Spain', 'facility': 'Hospital Universitario de Basurto', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '13005', 'city': 'Ciudad Real', 'country': 'Spain', 'facility': 'Obispo Rafael Torija, St.', 'geoPoint': {'lat': 38.98626, 'lon': -3.92907}}, {'zip': '28001', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Centro Medico D-Medical', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28702', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Clinica DiaLibre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '43005', 'city': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital Universitario Joan XXIII', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario y Politécnico La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '47003', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD will be available after studying each request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Castilla-La Mancha Health Service', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spanish Diabetes Association', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Endocrinologist', 'investigatorFullName': 'Jesús Moreno Fernández', 'investigatorAffiliation': 'Castilla-La Mancha Health Service'}}}}