Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT04620967
Status:
UNKNOWN
Last Update Posted:
2021-02-16
First Post:
2020-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fast-Acting Insulin Aspart and Insulin Pump Settings
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': 'D061267', 'term': 'Insulin Aspart'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Group allocation is concealed to participants as well as investigators until all participants have completed the study. The allocation for a participant may be revealed in a medical emergency if knowledge about the treatment allocation would influence the treatment of the person.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A randomized, double-blind, cross-over study with two 16-week intervention periods separated by a 3-week washout period comparing Fiasp with Iasp in adults with type 1 diabetes treated with insulin pump and CGM.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-12', 'studyFirstSubmitDate': '2020-11-03', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in range', 'timeFrame': 'Last two weeks of the 16-week interventions', 'description': 'Difference in time spent with glucose values in the range 3.9-10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring'}], 'secondaryOutcomes': [{'measure': 'Mean glucose', 'timeFrame': 'Last two weeks of the 16-week interventions', 'description': 'Difference in mean glucose between Fiasp and Iasp treatment assessed by continuous glucose monitoring'}, {'measure': 'Coefficient of variation', 'timeFrame': 'Last two weeks of the 16-week interventions', 'description': 'Difference in coefficient of variation between Fiasp and Iasp treatment assessed by continuous glucose monitoring'}, {'measure': 'Time below range level 1', 'timeFrame': 'Last two weeks of the 16-week interventions', 'description': 'Difference in time spent with glucose values below 3.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring'}, {'measure': 'Time below range level 2', 'timeFrame': 'Last two weeks of the 16-week interventions', 'description': 'Difference in time spent with glucose values below 3.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring'}, {'measure': 'Time above range level 1', 'timeFrame': 'Last two weeks of the 16-week interventions', 'description': 'Difference in time spent with glucose values above 10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring'}, {'measure': 'Time above range level 2', 'timeFrame': 'Last two weeks of the 16-week interventions', 'description': 'Difference in time spent with glucose values above 13.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring'}, {'measure': 'Fructosamine', 'timeFrame': '16 weeks', 'description': 'Difference in change in fructosamine between Fiasp and Iasp treatment'}, {'measure': 'Total daily insulin dose', 'timeFrame': 'Last two weeks of the 16-week interventions', 'description': 'Difference between Fiasp and Iasp treatment in total daily insulin dose'}, {'measure': 'Total daily basal insulin dose', 'timeFrame': 'Last two weeks of the 16-week interventions', 'description': 'Difference between Fiasp and Iasp treatment in total daily basal insulin dose'}, {'measure': 'Total daily bolus insulin dose', 'timeFrame': 'Last two weeks of the 16-week interventions', 'description': 'Difference between Fiasp and Iasp treatment in total daily bolus insulin dose'}, {'measure': 'Severe hypoglycemia', 'timeFrame': '16 weeks', 'description': 'Difference between Fiasp and Iasp treatment in number of severe hypoglycemia events'}, {'measure': 'Ketoacidosis', 'timeFrame': '16 weeks', 'description': 'Difference between Fiasp and Iasp treatment in number of ketoacidosis events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Insulin pump'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'To clarify the role of fast-acting insulin aspart (Fiasp) in insulin pump-treated type 1 diabetes more research is needed.\n\nThe aim of this study is twofold:\n\n1. to compare the effects of Fiasp and Iasp in adults with type 1 diabetes who are using insulin pump and CGM and who are attending a diabetes out-patient clinic with extensive expertise in insulin pump and CGM therapy.\n2. to determine differences in insulin pump settings when insulin pumps are optimally adjusted to each of the two insulin types.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 1 diabetes for ≥ 5 years\n* HbA1c 53-75 mmol/mol (7.0-9.0%)\n* Insulin pump treatment for ≥ 6 months (all insulin pump makes except hybrid closed-loop systems are eligible for inclusion)\n* CGM use for ≥ 6 months (all CGM makes are eligible for inclusion)\n* Carbohydrate counting for all snacks and meals\n* Use of the insulin pump bolus calculator for all meals and snacks\n\nExclusion Criteria:\n\n* Breast-feeding, pregnant, planning to become pregnant or of child-bearing potential and not using adequate contraceptive methods\n* Gastroparesis (clinical assessment)\n* Shift work\n* Changing insulin needs throughout the menstrual cycle that requires different basal rate patterns\n* Use of a hybrid closed-loop system\n* Use of flash glucose monitoring\n* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start\n* Chronic paracetamol use\n* Alcohol or drug abuse\n* Severe cardiac disease or retinopathy contraindicating HbA1c below 53 mmol/mol\n* Impaired renal function (eGFR\\< 60 ml/min/1.73 m2)\n* History of local skin reactions to Fiasp and/or Iasp\n* Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation\n* Lack of compliance with key study procedures at the discretion of the investigator\n* Unacceptable adverse events at the discretion of the investigator\n* Less than 40 weeks guarantee remaining on insulin pump"}, 'identificationModule': {'nctId': 'NCT04620967', 'briefTitle': 'Fast-Acting Insulin Aspart and Insulin Pump Settings', 'organization': {'class': 'OTHER', 'fullName': 'Steno Diabetes Center Copenhagen'}, 'officialTitle': 'Fast-Acting Insulin Aspart and Insulin Pump Settings: THE FAST PUMP SETTING STUDY', 'orgStudyIdInfo': {'id': '2020-001158-23'}, 'secondaryIdInfos': [{'id': 'H-20022359', 'type': 'OTHER', 'domain': 'Scientific Ethical Committee of the Capital Region of Denmark'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iasp-Fiasp', 'description': 'First period: Insulin pump with Iasp Second period: Insulin pump with Fiasp', 'interventionNames': ['Drug: Insulin aspart', 'Drug: Fast-acting insulin aspart']}, {'type': 'EXPERIMENTAL', 'label': 'Fiasp-Iasp', 'description': 'First period: Insulin pump with Fiasp Second period: Insulin pump with Iasp', 'interventionNames': ['Drug: Insulin aspart', 'Drug: Fast-acting insulin aspart']}], 'interventions': [{'name': 'Insulin aspart', 'type': 'DRUG', 'description': 'Insulin aspart (Iasp) in insulin pump', 'armGroupLabels': ['Fiasp-Iasp', 'Iasp-Fiasp']}, {'name': 'Fast-acting insulin aspart', 'type': 'DRUG', 'description': 'Fast-acting insulin aspart (Fiasp) in insulin pump', 'armGroupLabels': ['Fiasp-Iasp', 'Iasp-Fiasp']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Gentofte Municipality', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Signe Schmidt, MD PhD', 'role': 'CONTACT', 'email': 'signe.schmidt@regionh.dk', 'phone': '+45 51174785'}, {'name': 'Ajenthen Ranjan, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hanne-Charlotte Andersen, RN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Signe Schmidt, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Steno Diabetes Center Copenhagen', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}], 'centralContacts': [{'name': 'Signe Schmidt, MD PhD', 'role': 'CONTACT', 'email': 'signe.schmidt@regionh.dk', 'phone': '+45 51174785'}], 'overallOfficials': [{'name': 'Kirsten Nørgaard, MD DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Steno Diabetes Center Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirsten Nørgaard', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant', 'investigatorFullName': 'Kirsten Nørgaard', 'investigatorAffiliation': 'Steno Diabetes Center Copenhagen'}}}}