Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-31 @ 7:57 AM
Study NCT ID:
NCT01345435
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2011-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017216', 'term': 'Telemedicine'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 417}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-01', 'studyFirstSubmitDate': '2011-04-28', 'studyFirstSubmitQcDate': '2011-04-29', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Hemoglobin A1c', 'timeFrame': '0 and 24 weeks', 'description': 'Changes in Hemoglobin A1c from baseline to 24 weeks visit.\n\nReduce Hemoglobin A1c after study'}], 'secondaryOutcomes': [{'measure': 'Changes in FBS (Fasting blood sugar)', 'timeFrame': '0 and 24 weeks', 'description': 'Changes in FBS (Fasting blood sugar) from baseline to 24 weeks visit\n\nMaintains FBS within the normal range'}, {'measure': 'Changes in lipid profile', 'timeFrame': '0 and 24 weeks', 'description': 'Changes in lipid profile from baseline to 24 weeks visit\n\nMaintains normal lipid profile'}, {'measure': 'Percentage of subjects who achieved goal Hemoglobin A1c', 'timeFrame': '0 and 24 weeks', 'description': 'Goal Hemoglobin A1c \\<7%'}, {'measure': 'Changes in body mass index (BMI)', 'timeFrame': '0 and 24 weeks', 'description': 'Reduction of body mass index\n\n\\- BMI=Body weight (kg)/Height2(m)'}, {'measure': 'SMBG(Self-monitoring of blood glucose) compliance', 'timeFrame': 'up to 24 weeks', 'description': 'measurement of Self-monitoring of blood glucose'}, {'measure': 'Changes in body weight', 'timeFrame': '0 and 24 weeks', 'description': 'Reduce body weight from baseline to 24 weeks visit'}, {'measure': "Assessment of patients' satisfaction", 'timeFrame': '24 weeks', 'description': "Assessment of subjects' satisfaction, Only remote monitoring group and remote visit + remote monitoring group are applicable"}, {'measure': 'Medication compliance', 'timeFrame': 'up to 24 weeks', 'description': '* Patients diary will be recorded and medication compliance will be calculated by calculating the number of days administered Insulin or Oral Hypoglycemic Agents during the study\n* Drugs compliance = the number of days administered antihypertensive drugs / participated period in this study \\* 100%'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['telemonitoring', 'usual care', 'telemedicine', 'telehealth', 'home care', 'Health Care Quality', 'Access', 'Evaluation'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'A multi-center, randomized, parallel, interventional, open label trial to compare Hemoglobin A1C-lowering effect of conventional treatment and Smart Care Service in patients with type 2 diabetes.', 'detailedDescription': '1. Objectives : To evaluate superiority in the Hemoglobin A1C -lowering effect of Smart Care Service compared to the conventional treatment in patients with type 2 diabetes.\n2. Test and control group\n\n * Control group : The subject group who is receiving any conventional treatment (hospital visit).\n * Test groups\n\n * Conventional treatment + remote monitoring group: The subject group who is receiving the health care services using conventional treatment (hospital visit) and remote monitoring.\n * Remote visit + remote monitoring group: The subject group who is receiving remote visit and remote monitoring using videotelephony\n3. Target Subject: Type II diabetes patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. More than 20 years of age and under 60 years of age\n2. Patients who are able to receive outpatient treatment with type II diabetes mellitus.\n3. If the patients require using insulin, patients who are using basal insulin or premixed insulin less than 2 times a day are eligible.\n4. Patients with HbA1c above 7% and less than 11% (7%≤HbA1c≤11%).\n5. Patients who are able to understand the purpose of this trial and to read and write.\n6. Patients who are able to use the Smart Care PC for this study.\n7. Patients who have wired/wireless internet access at home.\n8. Patients who participate voluntarily and sign the informed consent.\n\nExclusion Criteria:\n\n1. Patients with type I diabetes mellitus\n2. Patients who are using Bolus insulin (short-acting insulin) or insulin pump.\n3. Patients who take medicines which can significantly affect glycemic control.\n4. Patients with acute illness, untreated other disease or diabetic complications required additional treatment.\n5. Patients currently being hospitalized or planning to hospitalize during the study period.\n6. Patients who have severe renal disease (above 1.5 times the upper limit of normal serum creatinine levels).\n7. Pregnant or lactating women.\n8. Patients with any severe liver disease including cirrhosis (AST or ALT: above 3 times the upper limit of normal).\n9. Patients with uncontrolled chronic lung disease.\n10. Patients with known history of alcoholism, mental illness, or drug dependency.\n11. Patients who have cognitive disorder or psychiatric problems\n12. Patients who have participated in other clinical trial within 12 weeks prior to screening visit.\n13. Any clinically significant medical condition including neurologic disease, gastrointestinal disease or malignant tumor, etc., which may affect the test results, or any other medical condition which in the opinion of the investigator makes the patients unsuitable for participation in the trial.'}, 'identificationModule': {'nctId': 'NCT01345435', 'acronym': 'Smart-DM', 'briefTitle': 'Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Electronics Inc.'}, 'officialTitle': 'A Multi-center, Randomized, Parallel, Interventional, Open Label Trial to Compare Hemoglobin A1C-lowering Effect of Conventional Treatment and Smart Care Service in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'Smartcare-DM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telemonitoring group', 'description': '* A Smart Care PC, blood glucose meter and body composition analyzer will be provided\n* transmitting the results to the Smart Care Server via Smart Care PC\n* At Smart care Center,care manager will provide remote blood glucose monitoring and individual diabetes case management', 'interventionNames': ['Procedure: Telemonitoring group']}, {'type': 'EXPERIMENTAL', 'label': 'Telemonitoring & Telemedicine group', 'description': '* A Smart Care PC, blood glucose meter and body composition analyzer will be provided\n* transmitting the results to the Smart Care Server via Smart Care PC\n* At Smart care Center,care manager will provide remote blood glucose monitoring and individual diabetes case management\n* taking telemedicine through video telephone instead of visiting hospital', 'interventionNames': ['Procedure: Telemonitoring & Telemedicine']}, {'type': 'OTHER', 'label': 'Control group', 'description': '* Blood glucose meter and body composition analyzer will be provided\n* Self-monitoring Blood Glucose (SMBG)', 'interventionNames': ['Other: SMBG']}], 'interventions': [{'name': 'Telemonitoring group', 'type': 'PROCEDURE', 'otherNames': ['Smartcare System : Telemonitoring'], 'description': 'The Telemonitoring group will be provided blood glucose meter, body composition analyzer, and remote monitoring PC. They should visit the site once per every 2 months (8 weeks), and measure their blood glucose using a provided blood glucose monitor twice a day during study period (once after first morning urination and once before going to bed). After measurement of blood glucose and body composition, the subjects should make transmit measured information through Smart Care PC into a centralized server of Smart Care Center. At Smart care Center, care manager will provide remote blood glucose monitoring and individual diabetes case management', 'armGroupLabels': ['Telemonitoring group']}, {'name': 'Telemonitoring & Telemedicine', 'type': 'PROCEDURE', 'otherNames': ['Smartcare System : Telemonitoring & Telemedicine'], 'description': 'The Telemonitoring \\& Telemedicine group will be provided blood glucose meter, body composition analyzer, and remote monitoring PC. They should measure their blood glucose using a provided blood glucose monitor twice a day during the study period. After measurement of blood glucose and body composition, the subjects should make transmit measured information through Smart Care PC into a centralized server of Smart Care Center. At Smart care Center, care manager will provide remote blood glucose monitoring and individual diabetes case management. A remote medical doctor should provide medical consultation to the subjects through videotelephony using the remote monitoring PC and then issue electronic prescriptions.', 'armGroupLabels': ['Telemonitoring & Telemedicine group']}, {'name': 'SMBG', 'type': 'OTHER', 'otherNames': ['Self blood glucose measurement'], 'description': 'The subjects who are assigned in the control group will be provided blood glucose Monitor. The subjects who are assigned in the control group should perform the same blood glucose measurement same as the test group during the study, and measured results should be recorded in a diary of self blood glucose measurement. In addition, the subjects should visit the site once per every two months (8 weeks).', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Yeungnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'In Kyu Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHANGHEE LEE', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'LG Electronics Inc.', 'class': 'INDUSTRY'}, {'name': 'Purdue University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Research Engineer', 'investigatorFullName': 'CHANGHEE LEE', 'investigatorAffiliation': 'LG Electronics Inc.'}}}}