Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT01781533
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2013-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Test Software Algorithm for Insulin Therapy and New Glucose Sensor
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': 'D000465', 'term': 'Algorithms'}], 'ancestors': [{'id': 'D055641', 'term': 'Mathematical Concepts'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2013-01-23', 'studyFirstSubmitQcDate': '2013-01-30', 'lastUpdatePostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the percentage of glucose values obtained every 15 min in predefined glucose ranges', 'timeFrame': '15 minutes'}], 'secondaryOutcomes': [{'measure': 'Injected insulin dose', 'timeFrame': '24 hours'}, {'measure': 'Accuracy of the glucose monitoring unit', 'timeFrame': '24 hours', 'description': 'The absolute and relative difference between glucose monitoring readings and reference values (blood glucose) will be used to determine the accuracy of the monitoring unit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'To investigate the performance of a software-algorithm based insulin therapy to control blood glucose in Type 1 diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female aged 18 to 75 years (both inclusive)\n* Informed consent obtained after being advised of the nature of the study\n* The subject has Type 1 diabetes (as defined by WHO) for at least 24 months\n* The subject's HbA1c \\<= 10%\n* Body Mass Index (BMI) \\<= 35 kg/m2\n* The subject is treated with continuous subcutaneous insulin infusion for at least 3 month\n\nExclusion Criteria:\n\n* Subject is actively enrolled in another clinical trial or took part in a study within 30 days\n* Experienced recurrent severe hypoglycaemic unawareness\n* Total daily insulin dose \\>= 1.4 IU/kg\n* Subject is using a medication that significantly impacts glucose metabolism (oral or topical steroids) except if stable for at least the last three months and expected to remain stable for the study duration\n* Allergy against insulin Lispro\n* A history of drug or alcohol dependence\n* Any other significant concomitant disease such as endocrine, cardiac, neurological, malignant, other pancreatic disease or uncontrolled hypertension as judged by the investigator\n* Uncontrolled hypertension with resting blood pressure over 140/90 mmHg\n* Patient is pregnant, or breast feeding during the period of the study\n* Patient donated blood in the last 3 months"}, 'identificationModule': {'nctId': 'NCT01781533', 'briefTitle': 'Study to Test Software Algorithm for Insulin Therapy and New Glucose Sensor', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'An Open, Single-centre, Non-controlled Feasibility Study Using a Software-algorithm Based Insulin Therapy to Control Blood Glucose in Type 1 Diabetic Patients', 'orgStudyIdInfo': {'id': 'REACTbyALGO-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'algorithm', 'interventionNames': ['Procedure: algorithm']}], 'interventions': [{'name': 'algorithm', 'type': 'PROCEDURE', 'armGroupLabels': ['algorithm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Thomas R Pieber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ. Prof. Dr. med.', 'investigatorFullName': 'Pieber Thomas, MD', 'investigatorAffiliation': 'Medical University of Graz'}}}}