Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT01137058
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2010-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ubiquitous Healthcare for Elderly Patients With Type 2 Diabetes Mellitus
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-25', 'studyFirstSubmitDate': '2010-06-02', 'studyFirstSubmitQcDate': '2010-06-03', 'lastUpdatePostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target goal of HbA1c (< 7.0%) without hypoglycemia', 'timeFrame': '24 weeks', 'description': 'Percent of patients who reach target goal of HbA1c (\\< 7.0%) without hypoglycemia'}], 'secondaryOutcomes': [{'measure': 'quality of life', 'timeFrame': '24 weeks'}, {'measure': 'amount of exercise', 'timeFrame': '24 weeks'}, {'measure': 'Body mass index (BMI) changes', 'timeFrame': 'Body mass index', 'description': 'Comparison of body mass index changes among control, self monitoring of blood glucose (SMBG) and ubiquitous healthcare groups'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '25936739', 'type': 'DERIVED', 'citation': 'Lim S, Kang SM, Kim KM, Moon JH, Choi SH, Hwang H, Jung HS, Park KS, Ryu JO, Jang HC. Multifactorial intervention in diabetes care using real-time monitoring and tailored feedback in type 2 diabetes. Acta Diabetol. 2016 Apr;53(2):189-98. doi: 10.1007/s00592-015-0754-8. Epub 2015 May 5.'}, {'pmid': '21270188', 'type': 'DERIVED', 'citation': 'Lim S, Kang SM, Shin H, Lee HJ, Won Yoon J, Yu SH, Kim SY, Yoo SY, Jung HS, Park KS, Ryu JO, Jang HC. Improved glycemic control without hypoglycemia in elderly diabetic patients using the ubiquitous healthcare service, a new medical information system. Diabetes Care. 2011 Feb;34(2):308-13. doi: 10.2337/dc10-1447.'}]}, 'descriptionModule': {'briefSummary': 'Ubiquitous healthcare service for elderly patients with type 2 diabetes provides real-time glycemic monitoring and glucose control implemented by clinical decision support system (CDSS) using wire and wireless communication and information technology.\n\nTo evaluate the clinical efficacy of this system, researchers plan to compare the improvement of glycemic control, self-management, and quality of life among three study groups: control, self glucose monitoring, and U-healthcare group.', 'detailedDescription': 'Recently, the application of internet-based glucose control system showed better long term glucose control compared to the conventional treatment. This study has become the foundation of web-based methodology in the glucose control. In addition, the combined application of mobile device and web-based monitoring system for chronic diseases showed improvement in various metabolic parameters in obese patients with diabetes and hypertension.\n\nThus, the application of U-healthcare based on advanced information technology would be helpful in the diabetes management. We plan to provide an individualized U-healthcare service using advanced information technology that enables more effective glucose control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* age: 60 \\~ 85 yrs\n* HbA1c: 6.5%-11.0%\n* duration of diabetes: less than 30 years\n* BMI: 20-35\n\nExclusion Criteria:\n\n* systemic corticosteroid administered within previous 6 months\n* history of myocardial ischemia\n* Heart failure, NYHA Class II-IV\n* Thyroid disease with abnormal TFT\n* Anti-obesity drugs or slimming products within previous 3 months'}, 'identificationModule': {'nctId': 'NCT01137058', 'briefTitle': 'Ubiquitous Healthcare for Elderly Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Clinical Efficacy of Ubiquitous Healthcare System for Elderly Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'SNUBH_UH1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'U-healthcare', 'description': 'glucose meter and U-healthcare', 'interventionNames': ['Device: U-healthcare service']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SMBG group', 'description': 'Diabetic patients who do self monitoring of blood glucose only were categorized into self monitoring of blood glucose (SMBG) group.', 'interventionNames': ['Device: SMBG group']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'conventional treatment'}], 'interventions': [{'name': 'U-healthcare service', 'type': 'DEVICE', 'otherNames': ['U-healthcare group'], 'description': 'Public switched telephone network (PSTN)-connected glucometer with U-healthcare system.', 'armGroupLabels': ['U-healthcare']}, {'name': 'SMBG group', 'type': 'DEVICE', 'description': 'Glucose control with self monitoring of blood glucose.', 'armGroupLabels': ['SMBG group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}], 'overallOfficials': [{'name': 'Soo Lim, MD, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Soo Lim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}