Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-03-05 @ 5:41 AM
Study NCT ID:
NCT02548494
Status:
TERMINATED
Last Update Posted:
2020-09-23
First Post:
2015-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Administration of Long-acting Insulin Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D016883', 'term': 'Diabetic Ketoacidosis'}], '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': 'D007662', 'term': 'Ketosis'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D048909', 'term': 'Diabetes Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-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': 'D011384', 'term': 'Proinsulin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Project terminated due to insufficient resources for recruitment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-21', 'studyFirstSubmitDate': '2015-09-09', 'studyFirstSubmitQcDate': '2015-09-11', 'lastUpdatePostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of PICU Stay', 'timeFrame': '1-2 days'}, {'measure': 'Length of Hospital Stay', 'timeFrame': '1-5 days'}, {'measure': 'Hypoglycemic events', 'timeFrame': 'length of hospital stay, an expected average of 3 days', 'description': 'Hypoglycemia is defined as blood glucose less than 70 mg/dL.'}], 'primaryOutcomes': [{'measure': 'Blood glucose', 'timeFrame': 'Within 3 hrs of arrival'}], 'secondaryOutcomes': [{'measure': 'Blood glucose', 'timeFrame': '4 hours after intervention initiation', 'description': 'checking for changes in levels after intervention initiation'}, {'measure': 'blood pH', 'timeFrame': 'within 3 hours of arrival'}, {'measure': 'blood pH', 'timeFrame': '4 hours after intervention initiation', 'description': 'checking for changes in levels after intervention initiation'}, {'measure': 'blood bicarbonate level', 'timeFrame': 'Within 3 hrs of arrival'}, {'measure': 'blood bicarbonate level', 'timeFrame': '4 hours after intervention initiation', 'description': 'checking for changes in levels after intervention initiation'}, {'measure': 'Urinalysis for levels of ketones & glucosuria', 'timeFrame': 'Within 3 hrs of arrival'}, {'measure': 'Urinalysis for levels of ketones & glucosuria', 'timeFrame': '4 hours after intervention initiation', 'description': 'checking for changes in levels after intervention initiation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1', 'Diabetic Ketoacidosis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Levitsky LL et al. Epidemiology, presentation, and diagnosis of type 1 diabetes mellitus in children and adolescents. In: UpToDate, Wolfsdorf J (Ed), UpToDate, Waltham, MA. (Accessed on November 3, 2014.)'}, {'type': 'BACKGROUND', 'citation': 'Jeha GS, Haymond Mw. Treatment and complications of diabetic ketoacidosis in children. In: UpToDate, Waltham MA. (Accessed on November 4, 2014.)'}, {'pmid': '24840321', 'type': 'BACKGROUND', 'citation': 'Urakami T, Naito Y, Seino Y. Insulin glargine in pediatric patients with type 1 diabetes in Japan. Pediatr Int. 2014 Dec;56(6):822-828. doi: 10.1111/ped.12379. Epub 2014 Sep 16.'}, {'pmid': '17508198', 'type': 'BACKGROUND', 'citation': 'Shankar V, Haque A, Churchwell KB, Russell W. Insulin glargine supplementation during early management phase of diabetic ketoacidosis in children. Intensive Care Med. 2007 Jul;33(7):1173-1178. doi: 10.1007/s00134-007-0674-3. Epub 2007 May 17.'}, {'pmid': '22685233', 'type': 'BACKGROUND', 'citation': 'Hsia E, Seggelke S, Gibbs J, Hawkins RM, Cohlmia E, Rasouli N, Wang C, Kam I, Draznin B. Subcutaneous administration of glargine to diabetic patients receiving insulin infusion prevents rebound hyperglycemia. J Clin Endocrinol Metab. 2012 Sep;97(9):3132-7. doi: 10.1210/jc.2012-1244. Epub 2012 Jun 8.'}, {'type': 'BACKGROUND', 'citation': '6Lexicomp online'}]}, 'descriptionModule': {'briefSummary': 'The management goals of diabetic ketoacidosis (DKA) in the pediatric type 1 diabetes (T1DM) population are fluid and electrolyte repletion, insulin administration, and correction of acidosis in order to stabilize the patient. Traditionally, a rapid-acting insulin IV infusion is begun immediately and continued until the acidosis is corrected and hyperglycemia normalized. Once the acidosis is corrected, patients are able to be transitioned to a subcutaneous insulin regimen.\n\nThe role that a subcutaneous long-acting insulin such as glargine has in the acute treatment of DKA has not been extensively studied. While giving glargine during the treatment of DKA is becoming more common place, few studies have examined the potential risks and benefits of its use. This study will investigate the effects of early administration of glargine during DKA in patients with newly diagnosed TIDM.\n\nThe design of this study is a prospective, double-blind study of children ages 2-21 who are admitted to the hospital in DKA with a diagnosis of T1DM. The control group will receive all traditional methods of treatment for DKA, including a placebo subcutaneous injection. The study group will receive the same treatment, but will be supplemented with a subcutaneous glargine injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T1DM\n* Hyperglycemia \\>200 mg/dl\n* Bicarbonate ≤ 15 mmol/L\n* pH \\< 7.3\n* Ketonemia\n* Ketonuria\n* Glucosuria\n* Admission to PICU (Pediatric Intensive Care Unit)\n* Ages 1-21 years\n\nExclusion Criteria:\n\n* Patients who received glargine within the last 24 hours\n* Patients with sepsis'}, 'identificationModule': {'nctId': 'NCT02548494', 'briefTitle': 'Early Administration of Long-acting Insulin Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Chattanooga-Hamilton County Hospital Authority'}, 'officialTitle': 'Early Administration of Long-acting Insulin Glargine for the Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes: A Randomized Double Blind Trial', 'orgStudyIdInfo': {'id': '15-Lantus'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'The control group will receive all traditional methods of treatment for DKA including iv insulin, correction of fluid loss, and electrolyte correction, including a placebo subcutaneous injection.', 'interventionNames': ['Drug: IV insulin', 'Other: Electrolyte Correction', 'Other: Correction of Fluid Loss']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'The study group will receive the same treatment including iv insulin, correction of fluid loss, and electrolyte correction, but will be supplemented with a subcutaneous glargine injection.', 'interventionNames': ['Drug: Glargine', 'Drug: IV insulin', 'Other: Electrolyte Correction', 'Other: Correction of Fluid Loss']}], 'interventions': [{'name': 'Glargine', 'type': 'DRUG', 'otherNames': ['Lantus'], 'description': 'The control group will receive all traditional methods of treatment for DKA, including a placebo subcutaneous injection. The study group will receive the same treatment, but will be supplemented with a subcutaneous glargine injection.', 'armGroupLabels': ['Treatment Group']}, {'name': 'IV insulin', 'type': 'DRUG', 'description': 'The intravenous infusion of insulin at a weight-based fixed rate until ketosis has subsided.', 'armGroupLabels': ['Control Group', 'Treatment Group']}, {'name': 'Electrolyte Correction', 'type': 'OTHER', 'description': 'If the potassium level is greater than 6 mEq/L, do not administer potassium supplement. If the potassium level is 4.5-6 mEq/L, administer 10 mEq/h of potassium chloride. If the potassium level is 3-4.5 mEq/L, administer 20 mEq/h of potassium chloride.', 'armGroupLabels': ['Control Group', 'Treatment Group']}, {'name': 'Correction of Fluid Loss', 'type': 'OTHER', 'description': 'Initial correction of fluid loss is either by isotonic sodium chloride solution or by lactated Ringer solution. The recommended schedule for restoring fluids is as follows:\n\n* Administer 1-3 L during the first hour.\n* Administer 1 L during the second hour.\n* Administer 1 L during the following 2 hours\n* Administer 1 L every 4 hours, depending on the degree of dehydration and central venous pressure readings', 'armGroupLabels': ['Control Group', 'Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': "Children's @ Erlanger", 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}], 'overallOfficials': [{'name': 'Rita Shridharani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "UTCOMC/ Children's at Erlanger"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chattanooga-Hamilton County Hospital Authority', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Shridharani', 'investigatorFullName': 'Rita Shridharani', 'investigatorAffiliation': 'Chattanooga-Hamilton County Hospital Authority'}}}}