Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 7:49 PM
Study NCT ID:
NCT07423559
Status:
COMPLETED
Last Update Posted:
2026-02-20
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relapse Among Diabetic Ketoacidosis Patients Maintained Basal Bolus Insulin Administration in Combination With Continuous Intravenous Insulin Infusion VS Non Maintaining Basal Insulin Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016883', 'term': 'Diabetic Ketoacidosis'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of diabetic ketoacidosis', 'timeFrame': '4 days', 'description': 'Criteria of resolution of Diabetic Ketoacidosis The anion gap (AG) \\<12 mEq/L. Venous pH \\>7.3. Serum bicarbonate ≥15 mEq/L'}], 'secondaryOutcomes': [{'measure': 'Random blood sugar assessment', 'timeFrame': 'every 2 hours till 4 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intensive Care Unit', 'Diabetic Ketoacidosis', 'Basal Bolus Insulin', 'Intravenous Insulin Infusion'], 'conditions': ['Diabetic Ketoacidosis', 'Insulin', 'Intensive Care Unit Stay']}, 'descriptionModule': {'briefSummary': 'This study aimed to assess intensive care unit stay and relapse among patients of Diabetic ketoacidosis (type 1 diabetes mellitus) maintained basal bolus insulin and patients non maintaining along with intervenors insulin infusion.', 'detailedDescription': 'Diabetic ketoacidosis is one of the common, potentially serious, and avoidable acute complications of diabetes mellitus. Diabetic ketoacidosis is caused by a decrease in effective circulating insulin associated with elevations in counter-regulatory hormones . This potentially life-threatening complication of type 1.\n\ndiabetes mellitus is frequently mismanaged, leading to morbidity and increased length of stay. Advances in near-patient testing technology have improved patient care, by facilitating rapid diagnosis and closer monitoring of treatment response.\n\nDiabetic ketoacidosis most often occurs in people with type 1 diabetes, but can also occur in patients with poorly controlled type 2 diabetes under stressful conditions .\n\nManagement of Diabetic ketoacidosis requires reversing metabolic derangements by correcting volume depletion and electrolyte imbalances and administering insulin to correct acidosis while concurrently treating the precipitating illness .\n\nDiabetic ketoacidosis is traditionally managed using intravenous regular insulin infusion in intensive care unit /high dependency unit.\n\nFixed rate intravenous insulin infusion not only reduces blood glucose levels, but just as importantly, suppresses further ketogenesis, as well as correcting the electrolyte.\n\nBasal insulin combination with Intervenors insulin infusion in acute management of Diabetic ketoacidosis could be protective against relapse with Diabetic ketoacidosis when abrupt interruption of insulin infusion is needed as in case of development of hypoglycemia during course of treatment or as in case of development of hypokalemia but this theory should be evaluated clinically. In our work, we are going to evaluate the effect of basal insulin continuation in acute management of Diabetic ketoacidosis to test the hypothesis that basal insulin continuation in acute management of Diabetic ketoacidosis could protect against relapse of ketoacidosis, hence shorten intensive care unit stay period of patient.\n\nThis study aimed to assess intensive care unit stay and relapse among patients of Diabetic ketoacidosis (type 1 diabetes mellitus) maintained basal bolus insulin and patients non maintaining along with intervenors insulin infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged 21y or more\n* who are known to have type 1 diabetes on known basal bolus insulin regimen - presented with diabetic ketoacidosis.\n\nExclusion Criteria:\n\n* Patients with type 2 diabetes mellitus.\n* If hemodynamically unstable patients.\n* Patients with other metabolic problems (hepatic coma, renal failure, disturbed conscious level .'}, 'identificationModule': {'nctId': 'NCT07423559', 'briefTitle': 'Relapse Among Diabetic Ketoacidosis Patients Maintained Basal Bolus Insulin Administration in Combination With Continuous Intravenous Insulin Infusion VS Non Maintaining Basal Insulin Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparison of Intensive Care Unit Stay and Relapse Among Diabetic Ketoacidosis Patients Maintained Basal Bolus Insulin Administration in Combination With Continuous Intravenous Insulin Infusion VS Non Maintaining Basal Insulin Patients', 'orgStudyIdInfo': {'id': '36264MS408/11/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'Patients treated with insulin infusion without basal insulin.', 'interventionNames': ['Drug: insulin infusion without basal insulin']}, {'type': 'EXPERIMENTAL', 'label': 'Group II', 'description': 'Patients treated with insulin infusion with basal insulin.', 'interventionNames': ['Drug: insulin infusion with basal insulin']}, {'type': 'EXPERIMENTAL', 'label': 'Group III', 'description': 'Patients treated with insulin infusion with basal insulin and bolus.', 'interventionNames': ['Drug: Insulin infusion with basal insulin and bolus']}], 'interventions': [{'name': 'insulin infusion without basal insulin', 'type': 'DRUG', 'description': 'Group I : treated with insulin infusion without basal insulin.', 'armGroupLabels': ['Group I']}, {'name': 'insulin infusion with basal insulin', 'type': 'DRUG', 'description': 'Group II : treated with insulin infusion with basal insulin.', 'armGroupLabels': ['Group II']}, {'name': 'Insulin infusion with basal insulin and bolus', 'type': 'DRUG', 'description': 'Group III : treated with insulin infusion with basal insulin and bolus', 'armGroupLabels': ['Group III']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'All data will be obtained if it needed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Marwa Hashem Mahrous Saad', 'investigatorAffiliation': 'Tanta University'}}}}