Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-01 @ 10:19 AM
Study NCT ID:
NCT00764556
Status:
COMPLETED
Last Update Posted:
2009-10-14
First Post:
2008-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-13', 'studyFirstSubmitDate': '2008-10-01', 'studyFirstSubmitQcDate': '2008-10-01', 'lastUpdatePostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The frequency of severe hypoglycaemia - Neuroglycopenic symptoms (other than mild agitation) responsive to administration of carbohydrate', 'timeFrame': 'During trial'}], 'secondaryOutcomes': [{'measure': 'The frequency of symptomatic hypoglycaemia (capillary glucose≤3.3mM AND symptoms consistent with hypoglycaemia)', 'timeFrame': 'During trial'}, {'measure': 'The frequency of asymptomatic hypoglycaemia (capillary glucose≤3.3mM without any symptoms consistent with hypoglycaemia).', 'timeFrame': 'During treatment'}, {'measure': 'Mean 24 hour capillary glucose concentrations', 'timeFrame': 'During treatment'}, {'measure': 'Proportion of capillary glucose measurements in target range (4.4-6.5mM)', 'timeFrame': 'During treatment'}, {'measure': 'Comparison of capillary blood glucose measurements to those obtained from the Guardian REAL®-time continuous glucose monitoring system', 'timeFrame': 'During monitoring'}, {'measure': 'Comparison of rates of detection of hypoglycaemia by capillary and continuous blood glucose monitoring', 'timeFrame': 'During monitoring'}, {'measure': 'Quantification of acceptability of the study intervention to patients', 'timeFrame': 'during study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Glucose', 'Insulin', 'COPD', 'Exacerbations', 'Tight glycaemic control', 'Acute hospital ward'], 'conditions': ['COPD', 'Hyperglycemia']}, 'referencesModule': {'references': [{'pmid': '16449265', 'type': 'BACKGROUND', 'citation': 'Baker EH, Janaway CH, Philips BJ, Brennan AL, Baines DL, Wood DM, Jones PW. Hyperglycaemia is associated with poor outcomes in patients admitted to hospital with acute exacerbations of chronic obstructive pulmonary disease. Thorax. 2006 Apr;61(4):284-9. doi: 10.1136/thx.2005.051029. Epub 2006 Jan 31.'}, {'pmid': '22021788', 'type': 'DERIVED', 'citation': 'Archer JR, Misra S, Simmgen M, Jones PW, Baker EH. Phase II study of tight glycaemic control in COPD patients with exacerbations admitted to the acute medical unit. BMJ Open. 2011 Jul 23;1(1):e000210. doi: 10.1136/bmjopen-2011-000210.'}]}, 'descriptionModule': {'briefSummary': 'Patients with chronic obstructive pulmonary disease (COPD) are commonly admitted to hospital with exacerbations of their lung disease. A combination of the acute illness and treatment with oral steroids causes a rise in blood sugar. Patients with high blood sugar do worse than those with normal blood sugar. The aim of this study is to develop a safe and effective protocol for tight control of blood glucose with insulin on acute medical wards outside the intensive care environment. This will allow us to perform a formal trial to determine whether blood glucose control with insulin reduces death and complications from COPD exacerbations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician diagnosis of AECOPD as primary cause for admission\n* Able to enter study within 24 hours of admission\n\nExclusion Criteria:\n\n* Intensive care unit admission\n* Moribund or not for active treatment\n* Admission expected to last \\<48 hours\n* Unable or unwilling to give informed consent\n* Known Type I diabetes mellitus\n* Patients with reduced awareness of hypoglycaemia including reduced Glasgow coma scale or those taking beta blockers\n* Patients with renal or hepatic failure at increased risk of hypoglycaemia'}, 'identificationModule': {'nctId': 'NCT00764556', 'acronym': 'IPS2008', 'briefTitle': 'Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards', 'organization': {'class': 'OTHER', 'fullName': "St George's, University of London"}, 'officialTitle': 'Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards', 'orgStudyIdInfo': {'id': 'SGH-ClinPharm-1'}, 'secondaryIdInfos': [{'id': 'EudraCT 2007-004956-35'}, {'id': 'Ethics 07/H0715/93'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tight glycaemic control', 'description': 'Intravenous or subcutaneous insulin to control blood glucose to 4.4-6.5mM', 'interventionNames': ['Drug: Insulin']}], 'interventions': [{'name': 'Insulin', 'type': 'DRUG', 'description': 'Intravenous insulin (actrapid) Subcutaneous insulin (aspart, glargine, detemir)', 'armGroupLabels': ['Tight glycaemic control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW17 0RE', 'city': 'London', 'country': 'United Kingdom', 'facility': "St George's Healthcare NHS Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Emma H Baker, PhD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St George's, University of London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St George's, University of London", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Emma Baker', 'oldOrganization': "St George's, University of London"}}}}