Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT06056167
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2023-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Degludec Insulin Use in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571886', 'term': 'insulin degludec'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2023-09-24', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of blood glucose readings at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L).', 'timeFrame': 'until stopping the intervention and up to 28 days'}], 'secondaryOutcomes': [{'measure': 'The average or mean blood glucose in the whole cohort', 'timeFrame': 'until stopping the intervention and up to 28 days'}, {'measure': 'The proportions of patients achieving the target glycemic control', 'timeFrame': 'until stopping the intervention and up to 28 days'}, {'measure': 'The time-spent at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L).', 'timeFrame': 'until stopping the intervention and up to 28 days'}, {'measure': 'The rate of developing hypoglycemia during therapy', 'timeFrame': 'until stopping the intervention and up to 28 days'}, {'measure': 'Glucose variability during therapy', 'timeFrame': 'until stopping the intervention and up to 28 days'}, {'measure': 'To determine the covariates associated with failure to achieve target glycemic control', 'timeFrame': 'During therapy and up to 28 days', 'description': 'To assess the factors that are associated with failure to achieve the target glycemic control (using regression analysis).'}, {'measure': 'To determine the covariates associated with the development of hypoglycemia', 'timeFrame': 'During therapy and up to 28 days', 'description': 'To assess the factors that are associated with the development of hypoglycemia (using regression analysis).'}, {'measure': 'The rate of 28-day Mortality', 'timeFrame': 'Censored at day 28', 'description': 'Death rate at day 28'}, {'measure': 'Intensive care unit (ICU) length of stay', 'timeFrame': 'Censored at day 28'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Critical Illness', 'Hyperglycemia']}, 'descriptionModule': {'briefSummary': "Background:\n\nDysglycemia in critically ill patients is common, where 40% to 54% of patients were found to be hyperglycemic on intensive care unit admission. Several randomized controlled trials (RCT) were conducted to address the importance of glycemic control during critical illness on patient's outcomes.\n\nThe American association of diabetes recommends initiation of insulin infusion for critically ill patients aiming to target glucose levels 140-180 mg/dl. However, several limitations prevent the use of insulin infusion in critically ill such as the requirements of frequent blood glucose measurement and nursing staff workload, which in turn led to the use of the subcutaneous rapid acting and basal insulin during critical illness. The evidence on the use of subcutaneous insulin therapy compared to insulin infusion is mainly derived from observational studies that showed conflicting results.\n\nMultiple RCTs demonstrated the comparable efficacy of degludec versus glargine in blood glycemic control and better safety profile in terms of nocturnal hypoglycemia and severe hypoglycemia in the outpatient/inpatient diabetic population. Studies addressing the role, safety, and efficacy of degludec in critically ill patients are lacking.\n\nStudy aim:\n\nTo assess the effectiveness of using insulin degludec as basal insulin in conjunction with subcutaneous regular insulin sliding scale (ISS) in the glycemic control in critically ill patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years and above\n* Newly admitted critically ill patients with diabetes and expected ICU stay ≥ 48 hours\n* Medical or surgical ICU patients\n\nExclusion Criteria:\n\n* Patients who were already started on insulin infusion based on physician discretion.\n* Postoperative patients with expected ICU stay less than 48 hours\n* Diabetic ketoacidosis or hyperosmolar hyperglycemic state.\n* Patients with Do-Not-Attempt-Resuscitation (DNAR) status or imminent plan to palliation due to terminal disease.\n* Refusal of the treating physician to enroll the patient into the study.\n* Patients with diabetes mellitus Type 1.\n* Patients who already eating prior to study enrollment'}, 'identificationModule': {'nctId': 'NCT06056167', 'briefTitle': 'Degludec Insulin Use in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'King Faisal Specialist Hospital & Research Center'}, 'officialTitle': 'The Efficacy and Safety of Degludec Insulin Use for Glycemic Control in Critically Ill Patients: A Prospective Interventional Study (Protocol)', 'orgStudyIdInfo': {'id': 'KingFaisal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Degludec', 'interventionNames': ['Drug: Degludec insulin']}], 'interventions': [{'name': 'Degludec insulin', 'type': 'DRUG', 'description': 'Enrolled patients will be initiated on regular insulin sliding scale (ISS) every 6 hours, administrated subcutaneously at 0600, 1200, 1800 and 2400 in patients who are nil per os and on intravenous fluid or parenteral nutrition or continuous tube feeding, according to King Faisal Specialist Hospital \\& Research Center (KFSH\\&RC) protocol.\n\nPatients with two capillary point of care glucose levels of \\> 10 mmol/L (180 mg/dl) will be initiated on insulin degludec at dose of 0.2 units/ kg.\n\nDose adjustments will be carried out on daily basis based on blood glucose levels following a written protocol.', 'armGroupLabels': ['Degludec']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Faisal Specialist Hospital & Research Centre', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Faisal Specialist Hospital & Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Critical Care Medicine', 'investigatorFullName': 'Zainab Alduhailib', 'investigatorAffiliation': 'King Faisal Specialist Hospital & Research Center'}}}}