Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-31 @ 10:21 AM
Study NCT ID:
NCT01594060
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2012-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Basal Bolus vs. Sliding Scale for Treatment of Diabetic Patients in Medical Wards
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}, {'id': 'C479079', 'term': 'insulin glulisine'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'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': 'D049528', 'term': 'Insulin, Long-Acting'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-27', 'studyFirstSubmitDate': '2012-05-07', 'studyFirstSubmitQcDate': '2012-05-07', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 2']}, 'descriptionModule': {'briefSummary': "A comparison of two treatment approaches for hyperglycemia in diabetic patients hospitalized in the medical department. The first approach is called basal-bolus in which 4 insulin shots are given daily ( 3 short acting before meals and one long acting before bed time). The second approach is called sliding scale in which short acting insulin alone is given before meals and before bed time according to the patient's glucose values. The aim is to keep fasting glucose between 140-180 mg/dl."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to internal medicine ward with blood glucose (BG) between 140-400 mg/dl.\n* Known history (\\>6months) of diabetes.\n* Aged 18-80 years old.\n* Previous therapy including either diet alone or any combination of oral hypoglycemia agents, glucagon-like peptide 1 (GLP-1) analogs and long acting insulin analogs or Neutral Protamine Hagedorn (NPH).\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients with ketoacidosis\n* Patients with unknown history of diabetes\n* Patients with type 1 diabetes mellitus\n* Patients with clinically relevant hepatic disease or renal impairment ( serum creatinine≥2.5 mg/dl)\n* Use of corticosteroid therapy\n* Patient with any mental disorder preventing him to cooperate and give informed consent.\n* Patients on multiple daily doses of insulin regimen.'}, 'identificationModule': {'nctId': 'NCT01594060', 'briefTitle': 'Basal Bolus vs. Sliding Scale for Treatment of Diabetic Patients in Medical Wards', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'A Randomized, Comparative Study of Basal-bolus Insulin Versus Conventional Sliding-scale Regular Insulin Therapy in Management of Non-critically Ill Patients Hospitalized in the Medical Ward.', 'orgStudyIdInfo': {'id': '0042-12-EMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'sliding scale', 'interventionNames': ['Drug: Insulin, regular - act rapid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'basal bolus', 'interventionNames': ['Drug: Insulin glulisine, Insulin glargine']}], 'interventions': [{'name': 'Insulin, regular - act rapid', 'type': 'DRUG', 'description': '4 shots of regular insulin: 3 before meals and one at bedtime.', 'armGroupLabels': ['sliding scale']}, {'name': 'Insulin glulisine, Insulin glargine', 'type': 'DRUG', 'description': '1 shot glargine at bedtime 3 shots glulisine before meals', 'armGroupLabels': ['basal bolus']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}