Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-01 @ 6:01 AM
Study NCT ID:
NCT02083133
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2014-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulin Dosing in Diabetic Patients With End Stage Renal Disease (ESRD) or Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], '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': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 496}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-16', 'studyFirstSubmitDate': '2014-03-07', 'studyFirstSubmitQcDate': '2014-03-07', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypoglycemia', 'timeFrame': 'Last 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Renal Failure', 'Dialysis', 'End Stage Renal Disease', 'Hypoglycemia'], 'conditions': ['Diabetes', 'Hypoglycemia', 'Renal Dysfunction', 'Insulin Dosing']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether the current recommendation for a 50% dose reduction in insulin for diabetic patients with a creatinine clearance (CrCl) ≤15 mL/min or on hemodialysis results in an increased number of hypoglycemic episodes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'In patient hospitalized greater than or equal to three days, diabetic with CKD 3-5 or on dialysis on insulin therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatient men and women 18 years of age and older with a diagnosis of type 2 diabetes mellitus (T2DM) with CrCl ≥60, 16-59 or ≤15 milliliters/minute.\n\nExclusion Criteria:\n\n* Patients less than 18 years of age, pregnant patients'}, 'identificationModule': {'nctId': 'NCT02083133', 'acronym': 'DOSE-HD', 'briefTitle': 'Insulin Dosing in Diabetic Patients With End Stage Renal Disease (ESRD) or Hemodialysis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Cook County Health'}, 'officialTitle': 'Dosing Strategies in Diabetic Patients With End Stage Renal Disease (ESRD) or Hemodialysis (DOSE-HD Study)', 'orgStudyIdInfo': {'id': '13-188'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'End Stage Renal Disease', 'description': 'GFR 15 ml/min or less or on Dialysis'}, {'label': 'Chronic Kidney Disease Stage 4', 'description': 'GFR 15-30 ml/min'}, {'label': 'Chronic Kidney Disease Stage -3', 'description': 'GFR 30-60 ml/min'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'John H Stroger Hospital of Cook County', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Pete Antonopoulos, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cook County Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook County Health', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Pharmacist- Principal Investigator', 'investigatorFullName': 'Pete Antonopoulos', 'investigatorAffiliation': 'Cook County Health'}}}}