Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT05657769
Status:
UNKNOWN
Last Update Posted:
2023-04-19
First Post:
2022-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preventive Care System Application Effectiveness Study on the Treatment of Diabetic Patients in Bandung
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is conducted with the primary hypothesis that the diabetes treatment with Medwell intervention can significantly reduce the HbA1c level better than without Medwell intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-17', 'studyFirstSubmitDate': '2022-12-12', 'studyFirstSubmitQcDate': '2022-12-12', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1C Changes', 'timeFrame': '3 months', 'description': 'Change in HbA1c from baseline to month 3 for all groups.\n\nChange in HbA1c from baseline to month 3 for all groups.\n\nChange in HbA1C from baseline to moth 3 of all group'}], 'secondaryOutcomes': [{'measure': 'Evaluate the exercise', 'timeFrame': '3 months', 'description': 'Mean weekly frequency of exercise'}, {'measure': 'Evaluate the exercise', 'timeFrame': '3 months', 'description': 'Proportion of exercise prescribed by physicians timely performed by subjects'}, {'measure': 'Evaluate the exercise', 'timeFrame': '3 months', 'description': 'Mean duration of each exercise'}, {'measure': 'Drug Adherence', 'timeFrame': '3 months', 'description': 'Proportion of administered drugs timely consumed by subjects'}, {'measure': 'Anthropometry I (BMI)', 'timeFrame': '3 months', 'description': 'Change in the BMI after 3 months'}, {'measure': 'Anthropometry II (Body Fat)', 'timeFrame': '3 months', 'description': 'Change in the Body Fat after 3 months'}, {'measure': 'Anthropometry III (Muscle Mass)', 'timeFrame': '3 months', 'description': 'Change in the Muscle Mass after 3 months'}, {'measure': 'Lab outcome I (Fasting glucose)', 'timeFrame': '3 months', 'description': 'Change in the lab measurement from baseline to month 3 for fasting glucose'}, {'measure': 'Lab outcome II (2 hours post prandial glucose)', 'timeFrame': '3 months', 'description': 'Change in the lab measurement from baseline to month 3 for 2 hours postprandial glucose'}, {'measure': 'Lab outcome III (total cholesterol)', 'timeFrame': '3 months', 'description': 'Change in the lab measurement from baseline to month 3 for total cholesterol'}, {'measure': 'Lab outcome IV (low density lipoprotein)', 'timeFrame': '3 months', 'description': 'Change in the lab measurement from baseline to month 3 for low density lipoprotein'}, {'measure': 'Lab outcome V (high density lipoprotein)', 'timeFrame': '3 months', 'description': 'Change in the lab measurement from baseline to month 3 for high density lipoprotein'}, {'measure': 'Lab outcome VI (triglyceride)', 'timeFrame': '3 months', 'description': 'Change in the lab measurement from baseline to month 3 for triglyceride'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Randomized, unblinded, controlled, two arms parallel group, prospective intervention study', 'detailedDescription': 'The objective of the study is to compare the progression of HbA1c in diabetic patients after applying a Medwell digital application in addition to regular diabetes treatment (treatment arm) with regular diabetes treatment of diabetic subjects alone (control arm).\n\nThe primary endpoint will be measured as the difference between 3 months HbA1c relative to baseline in eligible subjects. Normally, HbA1c in each subject is expected to either stable or slightly increase overtime. In this study we are interested in measuring the difference in HbA1c 3 months post randomization. It is expected that in the experimental arm, HbA1c will slightly decrease, while in the standard arm, HbA1c will either remain the same or will slightly increase after 3 months in the study. Previous study shows that the standard deviation of the difference in HbA1c within 1 year is 0.97%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects are in the diabetes type 2 status (based on Perkeni standard) HbA1c is ≥6.5%\n* Aged 18 - 60 years old\n* Have compatible smartphone (minimum android 8 or iOS 13) and internet connection\n* Receiving regular diabetes treatment\n* Giving consent and commitment to participate in the study until finish\n* Located in Bandung Area within the treatment period (up to 3 month after receiving the treatment)\n* Subject is determined to be able to complete daily physical activities.\n\nExclusion Criteria:\n\n* Pregnant (based on test pack)\n* Participation in other weight loss program\n* Use of other tracking application\n* Having any abnormalities that affecting blood erythrocyte age defined by laboratory examination\n* Have other severe diabetic complications that prevent subjects from participating in the prescribed program (Such as stroke, cardiac diseases (CHF stage III-IV), COPD or asthma with acute exacerbation and other respiratory diseases, peripheral artery disease, CKD stage 3-5) and other severe diseases that by the investigator's judgment, could not participate in this study"}, 'identificationModule': {'nctId': 'NCT05657769', 'briefTitle': 'Preventive Care System Application Effectiveness Study on the Treatment of Diabetic Patients in Bandung', 'organization': {'class': 'INDUSTRY', 'fullName': 'PT Bio Farma'}, 'officialTitle': 'A Randomized Trial of Preventive Care System Application Effectiveness on the Treatment of Diabetic Patients in Bandung', 'orgStudyIdInfo': {'id': 'Medwell-01-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (Treatment)', 'description': 'Regular diabetes treatment with additional Medwell application and wearable device.', 'interventionNames': ['Device: Medwell Preventive Care Application']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (Control)', 'description': 'Regular diabetes treatment only with a diary card to record daily activities manually.', 'interventionNames': ['Device: Manual Records']}], 'interventions': [{'name': 'Medwell Preventive Care Application', 'type': 'DEVICE', 'description': 'Regular diabetes treatment with additional Medwell application and wearable device.', 'armGroupLabels': ['Group I (Treatment)']}, {'name': 'Manual Records', 'type': 'DEVICE', 'description': 'Regular diabetes treatment only with a diary card to record daily activities manually.', 'armGroupLabels': ['Group II (Control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40234', 'city': 'Bandung', 'state': 'West Java', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Indahwaty Indahwaty', 'role': 'CONTACT'}], 'facility': 'Immanuel Hospital', 'geoPoint': {'lat': -6.92222, 'lon': 107.60694}}], 'centralContacts': [{'name': 'Asep Irham, MD', 'role': 'CONTACT', 'email': 'asep.irham@biofarma.co.id', 'phone': '+62222033755'}, {'name': 'Salwa Halimatussadiy', 'role': 'CONTACT', 'email': 'salwa.halimatussadiy@biofarma.co.id', 'phone': '+62222033755'}], 'overallOfficials': [{'name': 'Ratih Nursiana', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RS Immanuel'}, {'name': 'Indahwaty Indahwaty', 'role': 'STUDY_DIRECTOR', 'affiliation': 'RS Immanuel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PT Bio Farma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Immanuel Hospital', 'class': 'UNKNOWN'}, {'name': 'Prodia the CRO', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}