Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-03-02 @ 6:25 PM
Study NCT ID:
NCT01504620
Status:
COMPLETED
Last Update Posted:
2012-01-05
First Post:
2011-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance Evaluation of Blood Glucose Monitoring Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D007332', 'term': 'Insulin Infusion Systems'}], 'ancestors': [{'id': 'D016503', 'term': 'Drug Delivery Systems'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007260', 'term': 'Infusion Pumps'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D001187', 'term': 'Artificial Organs'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-03', 'studyFirstSubmitDate': '2011-12-27', 'studyFirstSubmitQcDate': '2012-01-03', 'lastUpdatePostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of the blood glucose meter in comparison to a standard reference', 'timeFrame': 'within 10 min up to 300 min after start of experiment', 'description': 'After start of the experiment, blood glucose will be measured by means of the test devices and blood will be drawn for assessment of venous blood glucose concentration with a standard laboratory reference method'}], 'secondaryOutcomes': [{'measure': 'Intra-Assay precision', 'timeFrame': 'within 10 min up to 300 min after start of experiment', 'description': 'Blood samples from 5 individuals with different levels of blood glucose were each measured with 10 meters of both investigational devices, the BGStar® and iBGStar®, ten times resulting in a total number of 500 measurements.'}, {'measure': 'Hematocrit Interference (Helios)', 'timeFrame': 'within 10 min up to 300 min after start of the experiment', 'description': 'One patient provided blood and artificial samples are generated from venous heparinized blood. These blood samples were adjusted to five different BG levels (2.8 mmol/L, 5.6 mmol/L, 8.3 mmol/L, 13.9 mmol/L, 19.4 mmol/L) at five different Hct levels (35%, 40%, 45%, 50%, 55%) to fulfill the range required by the TNO 2001 and tested by all devices.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'blood glucose self-assessment', 'Accuracy', 'Intra-Assay precision', 'Hematocrit interference'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The goal of this single-center, comparative, open label, in-vitro diagnostic device performance evaluation was to investigate the performance of two sanofi-aventis BGMSs (BGStar® and iBGStar®) with regard to system accuracy (Polaris), precision and Hct influence (Helios).', 'detailedDescription': 'The main study (Polaris) investigated blood glucose measuring accuracy and intra-assay precision while the substudy (Helios) investigated potential haematocrit interference of sanofi-aventis BGMSs BGStar® and iBGStar® and partly of competitor BGMSs according to ISO 15197 \\[1\\] and TNO 2001 Quality Guideline \\[2\\], respectively.\n\nThe primary objective of the system accuracy evaluation is to identify the number of blood glucose readings of both sanofi-aventis devices within the ISO 15197 area of acceptable accuracy of ± 20% \\[DEV%\\] for blood samples with glucose concentration \\> 75 mg/dL (4.2 mmol/L) and within the ISO 15197 area of acceptable accuracy of ± 15 mg/dL (± 0.83 mmol/L) for blood samples with glucose concentration \\< 75 mg/dL (4.2 mmol/L) as compared to the StatStrip® Connectivity reference method. The primary objective of the haematocrit interference evaluation is to demonstrate that the BGStar® and iBGStar® devices meet the Hct interference requirements according to TNO 2001 Quality Guideline when used to measure BG of venous whole blood as compared to a venous plasma reference method (YSI 2300 STAT Plus™) at Hct levels between 35 - 55% in terms of:(1) a mean deviation not exceeding ± 10% \\[DEV%\\] for hyperglycaemic glucose concentrations (150 - 180, 250 - 280, 320 - 350 mg/dL) and (2)a mean deviation not exceeding ± 18 mg/dL (1.0 mmol/L) \\[DEVtotal\\] for hypo- and normoglycaemic glucose values (50 - 60, 100 - 120 mg/dL) compared to the reference method at Hct levels between 35 - 55%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy subjects or patients with type 1 or type 2 diabetes\n* screening glucose levels fall into required glucose ranges\n* screening hematocrit values between 36 % to 55 %\n\nExclusion Criteria:\n\n* history of hypotension during blood draws\n* intake of drugs known to interfere with blood glucose readings\n* biochemical safety parameters outside of reference ranges\n* Hb \\< 11 g/dL\n* lack of compliance\n* history of frequent hypoglycemia'}, 'identificationModule': {'nctId': 'NCT01504620', 'acronym': 'Polaris', 'briefTitle': 'Performance Evaluation of Blood Glucose Monitoring Systems', 'organization': {'class': 'OTHER', 'fullName': 'IKFE Institute for Clinical Research and Development'}, 'officialTitle': 'Performance Evaluation of BGStar and iBGStar in Terms of Accuracy (Polaris), Intra-assay Precision, and Hematocrit Interference (Helios Substudy) Following ISO15197 and TNO Guidelines', 'orgStudyIdInfo': {'id': 'BGSTA_C_05445'}, 'secondaryIdInfos': [{'id': 'SAN-HCT-002 Helios', 'type': 'OTHER', 'domain': 'IKFE'}, {'id': 'SAN-BGM-002 Precision', 'type': 'OTHER', 'domain': 'IKFE'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sugar infusion', 'description': 'Diagnostic assessment of blood glucose by means of different devices', 'interventionNames': ['Other: Sugar infusion']}, {'type': 'EXPERIMENTAL', 'label': 'insulin infusion', 'description': 'infusion of insulin to achieve low glucose levels', 'interventionNames': ['Drug: insulin infusion']}], 'interventions': [{'name': 'Sugar infusion', 'type': 'OTHER', 'otherNames': ['5 % glucose solution'], 'description': 'Infusion of glucose to achieve high blood glucose levels', 'armGroupLabels': ['Sugar infusion']}, {'name': 'insulin infusion', 'type': 'DRUG', 'otherNames': ['insuman rapid'], 'description': 'i.v. infusion of insulin', 'armGroupLabels': ['insulin infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55116', 'city': 'Mainz', 'country': 'Germany', 'facility': 'IKFE - Institute for Clinical Research and Development', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'overallOfficials': [{'name': 'Andreas Pfützner, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IKFE Institute for Clinical Research and Development'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IKFE Institute for Clinical Research and Development', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi-Synthelabo', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}