Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT01101867
Status:
COMPLETED
Last Update Posted:
2018-01-31
First Post:
2010-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Prandial Insulin Dosing in Hospitalized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kathleen.dungan@osumc.edu', 'phone': '614-685-3333', 'title': 'Dr. Kathleen Dungan', 'organization': 'The Ohio State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Miscalculation of meal doses, mistimed doses, lack of complete documentation of carbohydrate intake, and dosing conducted by an experienced clinician may have contributed to the findings.'}}, 'adverseEventsModule': {'timeFrame': '72 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Flexible Dose', 'description': 'aspart dose determined based upon carbohydrate intake.', 'otherNumAtRisk': 62, 'otherNumAffected': 24, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fixed Dose', 'description': 'fixed meal dose of aspart (based upon weight or total daily insulin dose)', 'otherNumAtRisk': 59, 'otherNumAffected': 14, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypoglycemia (BG <70 mg/dl)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 14}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible Dose', 'description': 'aspart dose determined based upon carbohydrate intake.'}, {'id': 'OG001', 'title': 'Fixed Dose', 'description': 'fixed meal dose of aspart (based upon weight or total daily insulin dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '158', 'spread': '47', 'groupId': 'OG000'}, {'value': '171', 'spread': '49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 3', 'description': 'Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status.'}, {'type': 'SECONDARY', 'title': 'Postprandial Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible Dose', 'description': 'aspart dose determined based upon carbohydrate intake.'}, {'id': 'OG001', 'title': 'Fixed Dose', 'description': 'fixed meal dose of aspart (based upon weight or total daily insulin dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '175', 'spread': '51', 'groupId': 'OG000'}, {'value': '203', 'spread': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 3', 'description': 'Mean postprandial glucose was calculated per participant from the average of glucose values (post-breakfast, lunch, dinner) at day 3.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status.'}, {'type': 'SECONDARY', 'title': 'Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible Dose', 'description': 'aspart dose determined based upon carbohydrate intake.'}, {'id': 'OG001', 'title': 'Fixed Dose', 'description': 'fixed meal dose of aspart (based upon weight or total daily insulin dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 hour', 'description': 'Number of patients with any hypoglycemic event (\\<70 mg/dl or \\<40 mg/dl)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspart Flexible Dose', 'description': 'aspart dose determined based upon carbohydrate intake.\n\nAspart flexible dose: dose based upon carbohydrate intake and total daily requirements'}, {'id': 'OG001', 'title': 'Aspart Fixed Dose', 'description': 'fixed meal dose of aspart (based upon weight or total daily insulin dose)\n\nAspart fixed dose: fixed dose'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.2', 'spread': '35', 'groupId': 'OG000'}, {'value': '-8.1', 'spread': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hour', 'description': 'Change in mean glucose from day 1 to day 3, measured as difference in mean glucose day 3 minus mean glucose day 1.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat population'}, {'type': 'SECONDARY', 'title': 'Treatment Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible Dose', 'description': 'Insulin Aspart dose is determined based upon carbohydrate intake and is administered immediately post-meal. Prandial insulin was based upon the formula: CIR=400/TDD where CIR refers to the carbohydrate-to-insulin ratio and TDD refers to the total daily calculated dose of insulin (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively).'}, {'id': 'OG001', 'title': 'Fixed Dose', 'description': 'Fixed meal dose of Insulin Aspart (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively). Half of the TDD was divided into three equal fixed doses given immediately after each meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'spread': '14', 'groupId': 'OG000'}, {'value': '68', 'spread': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 3', 'description': 'treatment satisfaction questionnaire validated in-hospital, 19 item questionnaire using 0-6 point likert scale, for minimum zero to maximum of 102 points (with 102 indicating best satisfaction). Items are summed to find the total score.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants who completed the survey'}, {'type': 'SECONDARY', 'title': '1,5-anhydroglucitol Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexible Dose', 'description': 'Insulin Aspart dose is determined based upon carbohydrate intake and is administered immediately post-meal. Prandial insulin was based upon the formula: CIR=400/TDD where CIR refers to the carbohydrate-to-insulin ratio and TDD refers to the total daily calculated dose of insulin (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively).'}, {'id': 'OG001', 'title': 'Fixed Dose', 'description': 'Fixed meal dose of Insulin Aspart (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively). Half of the TDD was divided into three equal fixed doses given immediately after each meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.41', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '3.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 1 to day 3', 'description': 'change in short-term measure of glycemia', 'unitOfMeasure': 'mcg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'subjects with complete data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Flexible Dose', 'description': 'Insulin Aspart dose is determined based upon carbohydrate intake and is administered immediately post-meal. Prandial insulin was based upon the formula: CIR=400/TDD where CIR refers to the carbohydrate-to-insulin ratio and TDD refers to the total daily calculated dose of insulin (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively).'}, {'id': 'FG001', 'title': 'Fixed Dose', 'description': 'Fixed meal dose of Insulin Aspart (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively). Half of the TDD was divided into three equal fixed doses given immediately after each meal.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Flexible Dose', 'description': 'aspart dose determined based upon carbohydrate intake.'}, {'id': 'BG001', 'title': 'Fixed Dose', 'description': 'fixed meal dose of aspart (based upon weight or total daily insulin dose)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '10', 'groupId': 'BG000'}, {'value': '56', 'spread': '12', 'groupId': 'BG001'}, {'value': '57', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-03', 'studyFirstSubmitDate': '2010-04-08', 'resultsFirstSubmitDate': '2013-04-09', 'studyFirstSubmitQcDate': '2010-04-08', 'lastUpdatePostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-05-28', 'studyFirstPostDateStruct': {'date': '2010-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Glucose', 'timeFrame': 'day 3', 'description': 'Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3'}], 'secondaryOutcomes': [{'measure': 'Postprandial Glucose', 'timeFrame': 'day 3', 'description': 'Mean postprandial glucose was calculated per participant from the average of glucose values (post-breakfast, lunch, dinner) at day 3.'}, {'measure': 'Hypoglycemia', 'timeFrame': '72 hour', 'description': 'Number of patients with any hypoglycemic event (\\<70 mg/dl or \\<40 mg/dl)'}, {'measure': 'Change in Glucose', 'timeFrame': '72 hour', 'description': 'Change in mean glucose from day 1 to day 3, measured as difference in mean glucose day 3 minus mean glucose day 1.'}, {'measure': 'Treatment Satisfaction', 'timeFrame': 'day 3', 'description': 'treatment satisfaction questionnaire validated in-hospital, 19 item questionnaire using 0-6 point likert scale, for minimum zero to maximum of 102 points (with 102 indicating best satisfaction). Items are summed to find the total score.'}, {'measure': '1,5-anhydroglucitol Change', 'timeFrame': 'day 1 to day 3', 'description': 'change in short-term measure of glycemia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'glucose', 'hospital'], 'conditions': ['Diabetes', 'Admitting Hospital', 'Non-critically Ill']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether mealtime insulin results in better control of blood sugar than a fixed meal dose in hospitalized patients.', 'detailedDescription': 'The purpose of this study is to determine whether mealtime insulin, dosed to match the intake of carbohydrates (starches or sugars) results in better control of blood sugar than a fixed meal dose in hospitalized patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* general medical or minor surgical hospitalized patients\n* type 2 diabetes\n* blood glucose 150-400 on at least 2 occasions within 24 hours or requiring at least 20 units of insulin/day in the 24 hours prior to enrollment\n\nExclusion Criteria:\n\n* • Major surgery, occurring within the previous 2 weeks or planned within 72 hours of study entry, including cardiothoracic, neurosurgical, and open intra-abdominal procedures (in particular, any surgery lasting over 2 hours).\n\n * Patients receiving glucocorticoids, total parental nutrition (TPN), or tube feeds.\n * Pregnancy (glucose targets differ in pregnancy). Premenopausal women not on pharmacologic contraceptives, inrauterine device (IUD), or surgical menopause will undergo pregnancy testing.\n * Patients currently on IV insulin (must wait to enroll) or with planned surgical procedures in the next 72 hours for whom intravenous insulin will be likely\n * Prolonged (\\>24 hour) strict nil per os (NPO-nothing by mouth) status (eg. small bowl obstruction). Liquid or modified consistency diets are acceptable.\n * Patients for whom expected length of stay will be less than 48 hours\n * Patients using subcutaneous insulin pumps\n * Diabetic ketoacidosis\n * End-stage renal disease on dialysis\n * End-stage liver disease with cirrhosis\n * Mental conditions precluding informed consent\n * Potentially sensitive admissions: prisoners, HIV, suicidality\n * Unable to give consent in English'}, 'identificationModule': {'nctId': 'NCT01101867', 'acronym': 'ICHO', 'briefTitle': 'Prandial Insulin Dosing in Hospitalized Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Prandial Insulin Dosing Using the Carbohydrate Counting Technique in Hospitalized Patients With Diabetes', 'orgStudyIdInfo': {'id': 'Novo Nordisk xxxx'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aspart flexible dose', 'description': 'aspart dose determined based upon carbohydrate intake.', 'interventionNames': ['Drug: Aspart flexible dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aspart fixed dose', 'description': 'fixed meal dose of aspart (based upon weight or total daily insulin dose)', 'interventionNames': ['Drug: Aspart fixed dose']}], 'interventions': [{'name': 'Aspart fixed dose', 'type': 'DRUG', 'otherNames': ['Novolog'], 'description': 'fixed dose', 'armGroupLabels': ['Aspart fixed dose']}, {'name': 'Aspart flexible dose', 'type': 'DRUG', 'otherNames': ['Novolog'], 'description': 'dose based upon carbohydrate intake and total daily requirements', 'armGroupLabels': ['Aspart flexible dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Kathleen M Dungan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kathleen Dungan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kathleen Dungan', 'investigatorAffiliation': 'Ohio State University'}}}}