Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-02 @ 2:00 AM
Study NCT ID:
NCT04233203
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2020-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Faster Aspart on Insulin-pump Treated T1DM Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061267', 'term': 'Insulin Aspart'}, {'id': 'D007332', 'term': 'Insulin Infusion Systems'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-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'}, {'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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Other glycemic outcomes', 'timeFrame': '3 months', 'description': 'Other glycemic control differences from basal to 3 months after Faster Aspart initiation: capillary blood glucose, interstitial blood glucose, self-monitoring of blood glucose (SMBG) daily frequency, severe hypoglycemia frequency.'}, {'measure': 'Weigh', 'timeFrame': '3 months', 'description': 'Differences from basal to 3 months after Faster Aspart initiation on weight'}, {'measure': 'Insulin dose', 'timeFrame': '3 months', 'description': 'Daily insulin doses (basal and bolus) and bolus insulin daily frequency.'}, {'measure': 'Local adverse effects', 'timeFrame': '3 months', 'description': 'Faster Aspart related local adverse effects: itchiness, stinginess, pain, erythema, weal.'}, {'measure': 'Catheters problems', 'timeFrame': '3 months', 'description': 'Incidences on insulin-pump catheters: obstructions, deformations.'}, {'measure': 'Catheter change frequency', 'timeFrame': '3 months', 'description': 'Insulin-pump catheter change frequency'}, {'measure': 'Severe adverse effects', 'timeFrame': '3 months', 'description': 'Faster Aspart severe adverse effects: ketosis, diabetic ketoacidosis, death.'}], 'primaryOutcomes': [{'measure': 'MAGE', 'timeFrame': '3 months', 'description': 'Differences from basal to 3 months after Faster Aspart initiation on Mean Amplitude of Glucose Excursions (MAGE).'}], 'secondaryOutcomes': [{'measure': 'VCo', 'timeFrame': '3 months', 'description': 'Differences from basal to 3 months after Faster Aspart initiation Variation Coefficient (VCo).'}, {'measure': 'M100', 'timeFrame': '3 months', 'description': 'Differences from basal to 3 months after Faster Aspart initiation on M100.'}, {'measure': 'GRADE', 'timeFrame': '3 months', 'description': 'Differences from basal to 3 months after Faster Aspart initiation on Glycemia Risk Assessment Diabetes Equation (GRADE).'}, {'measure': 'J-index', 'timeFrame': '3 months', 'description': 'Differences from basal to 3 months after Faster Aspart initiation on J-index.'}, {'measure': 'MODD', 'timeFrame': '3 months', 'description': 'Differences from basal to 3 months after Faster Aspart initiation on MODD.'}, {'measure': 'CONGA', 'timeFrame': '3 months', 'description': 'Differences from basal to 3 months after Faster Aspart initiation on CONGA.'}, {'measure': 'HbA1c', 'timeFrame': '3 months', 'description': 'Differences from basal to 3 months after Faster Aspart initiation on Hemoglobin A1C (HbA1C).'}, {'measure': 'Hypoglycemic frequency', 'timeFrame': '3 months', 'description': 'Differences from basal to 3 months after Faster Aspart initiation on hypoglycemic frequency.'}, {'measure': 'TIR-TAR-TUR', 'timeFrame': '3 months', 'description': '9\\. Differences from basal to 3 months after Faster Aspart initiation on time in range, time above range and time under range.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['insulin pump', 'Faster aspart', 'insulin', 'glycemic variability'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '37356876', 'type': 'DERIVED', 'citation': 'Moreno-Fernandez J, Garcia-Seco JA, Virlaboa-Cebrian R, Seco AM, Munoz-Rodriguez JR, Gomez-Romero FJ. Faster-acting insulin aspart reduces glycaemic variability in sensor-augmented pump treated type 1 diabetes patients. Endocrinol Diabetes Nutr (Engl Ed). 2023 Jun-Jul;70(6):389-395. doi: 10.1016/j.endien.2021.12.012.'}]}, 'descriptionModule': {'briefSummary': 'Observational retrospective study about effectiveness and safety of insulin Faster Aspart on continuous subcutaneous insulin infusion treated adult Type 1 Diabetes Mellitus (T1DM) patients in routine clinical practice.', 'detailedDescription': "Cross-sectional retrospective analysis about effectiveness and safety of insulin Faster Aspart on continuous subcutaneous insulin infusion treated adult Type 1 Diabetes Mellitus (T1DM) patients in routine clinical practice.\n\nAll clinical variables are gathered from two EMR softwares (Mambrino XXI and Carelink Pro®).\n\nData analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. 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': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult (≥18 years of age) T1DM patients on CSII with Faster Aspart attended to care in our consults were eligible.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age.\n* Diagnosed of Type 1 Diabetes Mellitus.\n* Be attended in Ciudad Real General University Hospital.\n* Current treated with CSII (CSII cohort) during ≥6 months.\n* Current treated with insulin Faster Aspart during ≥3 months.\n\nExclusion Criteria:\n\n* Less than 18 years old.\n* Other types of diabetes mellitus.'}, 'identificationModule': {'nctId': 'NCT04233203', 'acronym': 'realFACI', 'briefTitle': 'Faster Aspart on Insulin-pump Treated T1DM Patients', 'organization': {'class': 'OTHER', 'fullName': 'Castilla-La Mancha Health Service'}, 'officialTitle': 'Effectiveness and Safety of Insulin Faster Aspart on Continuous Subcutaneous Insulin Infusion Treated Adult Type 1 Diabetes Mellitus Patients in Routine Clinical Practice', 'orgStudyIdInfo': {'id': 'C-302'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Faster Aspart', 'description': 'All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII and insulin Faster Aspart.', 'interventionNames': ['Drug: Insulin Faster Aspart', 'Device: Insulin pump']}], 'interventions': [{'name': 'Insulin Faster Aspart', 'type': 'DRUG', 'otherNames': ['Fiasp'], 'description': 'Currently receiving Faster Aspart during 3 or more months.', 'armGroupLabels': ['Faster Aspart']}, {'name': 'Insulin pump', 'type': 'DEVICE', 'otherNames': ['Medtronic 640G', 'Medtronic 670G', 'T Slim X2', 'Accucheck Insight'], 'description': 'Currently receiving CSII therapy during 6 or more months.', 'armGroupLabels': ['Faster Aspart']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13005', 'city': 'Ciudad Real', 'country': 'Spain', 'facility': 'Obispo Rafael Torija, St.', 'geoPoint': {'lat': 38.98626, 'lon': -3.92907}}], 'overallOfficials': [{'name': 'Jose Alberto Garcia Seco, RN', 'role': 'STUDY_CHAIR', 'affiliation': 'Ciudad Real General University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jesús Moreno Fernández', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Castilla-La Mancha', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Endocrinology and Nutrition Service, MD, PhD Affiliation: Castilla-La Mancha Health Service', 'investigatorFullName': 'Jesús Moreno Fernández', 'investigatorAffiliation': 'Castilla-La Mancha Health Service'}}}}