Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-01-27 @ 2:21 PM
Study NCT ID:
NCT00284232
Status:
COMPLETED
Last Update Posted:
2015-07-28
First Post:
2006-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2006-01-27', 'studyFirstSubmitQcDate': '2006-01-27', 'lastUpdatePostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c %', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Hypoclycemic events', 'timeFrame': '9 months'}, {'measure': 'Measurement quality of blood glucose instrument', 'timeFrame': '9 months'}, {'measure': 'Frequency of SMBG', 'timeFrame': '9 months'}, {'measure': 'Satisfaction', 'timeFrame': '9 months'}, {'measure': 'New learning points for patients', 'timeFrame': '9 months'}, {'measure': 'Confidence in new instrument quality', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HbA1c', 'Self-monitoring blood glucose (SMBG)', 'Diabetes treatment', 'quality of care'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial in patients with type 1 diabetes, assessing the metabolic effects of accurate blood sugar results and education. A systematic approach in self-monitoring blood glucose will improve metabolic control in type 1 diabetes patients. Education in SMBG combined with a high analytical quality instrument for SMBG, introduced in a systematic and thorough way will improve HbA1c by 0,5% and keep it over a period of 9 months.', 'detailedDescription': '* Written informed consent 130 patients with type 1 diabetes to be included\n* age 18-70\n* HbA1c of 8% or higher, variation in HbA1c over the last 18 months sholuld be \\<1,5%\n* Treated with multiple insulin injections or insulin pumps\n* Variation in weight less than 5kg within last year\n* Using SMBG on a daily basis\n* Mental capacity and stability to participate\n* No hypoglycemia unawareness\n* No likelihood that patient will drop out or not perform according to protocol\n* Continious recruitment from the outpatient clinic at Stavanger University Hospital from October 2004-October 2005\n* 9 months follow-up\n* Possible 12 month extension after initial\n* Intervention group receives new SMBG instrument, education and advice on treatment changes at baseline, 1,2,3,6 and 9 months. Control group continues regular care following national guidelines of Norway. This includes visits usually every 3-6 months at the outpatient clinic and possibly with their GP in addition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hba1c 8% or higher, less than 1,5% variation within last year\n* Age 18-70\n* Multiinjections or insulin pumps\n* Stable weight (\\<5kg variation last year)\n* Mentally stable\n\nExclusion Criteria:\n\n* Hypoglycemia unawareness\n* Mental incapacity'}, 'identificationModule': {'nctId': 'NCT00284232', 'briefTitle': 'Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Helse Stavanger HF'}, 'officialTitle': 'Randomized Controlled Trial Studying the Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'Measure 2004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Use and interpretation of blood glucose results', 'type': 'BEHAVIORAL'}, {'name': 'Insulin dosing based on SMBG chart and education', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stavanger', 'country': 'Norway', 'facility': 'Stavanger University Hospital', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}], 'overallOfficials': [{'name': 'Svein Skeie, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stavanger Health Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}