Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2026-03-09 @ 8:18 AM
Study NCT ID:
NCT06769906
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-10
First Post:
2025-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Individualized Automatic Coaching Message for Glycemic Management and Depressive Symptom
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 ratio'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2025-01-06', 'studyFirstSubmitQcDate': '2025-01-06', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Level of Albuminuria', 'timeFrame': 'Week 12', 'description': 'Urine creatinine-to-albumin ratio'}, {'measure': 'Level of Glycated albumin', 'timeFrame': 'Week 12', 'description': 'Glycated albumin'}, {'measure': 'Level of triglycerides', 'timeFrame': 'Week 12', 'description': 'Level of triglycerides from blood measurement'}, {'measure': 'Level of total cholesterol', 'timeFrame': 'Week 12', 'description': 'Level of total cholesterol from blood measurement'}, {'measure': 'Level of HDL (high density lipoprotein) cholesterol', 'timeFrame': 'Week 12', 'description': 'Level of HDL cholesterol from blood measurement'}, {'measure': 'Level of LDL (low density lipoprotein) cholesterol', 'timeFrame': 'Week 12', 'description': 'Level of LDL cholesterol from blood measurement'}], 'primaryOutcomes': [{'measure': 'Time In Range', 'timeFrame': 'Week 12', 'description': 'Derived from continuous glucose monitoring (CGM)'}], 'secondaryOutcomes': [{'measure': 'Diabetes treatment satisfaction', 'timeFrame': 'Week 12', 'description': 'Diabetes Treatment Satisfaction Questionnaire (DTSQ);\n\nMinimum and Maximum Values: The DTSQ consists of eight items, with six items measuring satisfaction scored on a 0-6 scale (where 0 is very dissatisfied and 6 is very satisfied). The scores for these six items are summed, giving a total score range from 0 to 36.\n\nHigher Scores: Higher scores on the DTSQ indicate better satisfaction with diabetes treatment. A higher total score suggests greater satisfaction, while a lower score indicates dissatisfaction.'}, {'measure': 'Depressive symptoms', 'timeFrame': 'Week 12', 'description': 'Patient Health Questionnaire-9 (PHQ-9); Minimum and Maximum Values: The PHQ-9 consists of nine items, each scored from 0 (not at all) to 3 (nearly every day). The scores for each item are summed to give a total score, resulting in a range from 0 to 27.\n\nHigher Scores: Higher scores on the PHQ-9 indicate worse outcomes, meaning greater severity of depressive symptoms. Lower scores suggest fewer symptoms of depression or none at all.\n\nInterpretation of Scores:\n\n0-4: Minimal or no depression; 5-9: Mild depression; 10-19: Moderate depression; 20-27: Severe depression'}, {'measure': 'Time In Tight Range', 'timeFrame': 'Week 12', 'description': 'Derived from CGM'}, {'measure': 'Level of glycated Hemoglobin', 'timeFrame': 'Week 12', 'description': 'Derived from blood measurement'}, {'measure': 'Time Above Range', 'timeFrame': 'Week 12', 'description': 'Derived from CGM'}, {'measure': 'Time Below Range', 'timeFrame': 'Week 12', 'description': 'Derived from CGM'}, {'measure': 'Coefficient of Variation', 'timeFrame': 'Week 12', 'description': 'Derived from CGM'}, {'measure': 'Glycemic Management Indicator', 'timeFrame': 'Week 12', 'description': 'Derived from CGM'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Behavioral Symptom', 'Glucose Metabolism Disorders', 'Endocrine System Diseases', 'Diabetes Mellitus, Type 2', 'Continuous glucose monitoring', 'Depression', 'Diabetes Mellitus', 'Metabolic Diseases'], 'conditions': ['Diabetes Mellitus Type 2', 'Continuous Glucose Measurement', 'Depressive Symptom']}, 'descriptionModule': {'briefSummary': 'This is a 12-week, single-center, randomized, prospective, confirmatory study of effectiveness of the individualized automatic coaching messages for glycemic management based on continuous glucose monitoring and depressive symptom in insulin-treated patients with type 2 diabetes.', 'detailedDescription': 'This study will enroll patients with type 2 diabetes who are insulin-treated outpatient care at the Department of Endocrinology and Metabolism, Samsung Medical Center. For 12 weeks, both intervention and control groups will apply continuous glucose monitoring system. The intervention group will receive weekly personalized coaching messages for glycemic management based on data from continuous glucose monitoring and bi-weekly personalized coaching messages for depressive symptoms based on depression questionnaires. The control group will not receive the coaching messages. The aim of this study is to evaluate whether the efficacy of individualized automatic target coaching messages based on continuous glucose monitoring metrics and depressive symptom assessments is superior to those who do not receive the messages in insulin-treated patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients for whom the use of a continuous glucose monitor has been determined based on the medical judgment of the attending physician.\n* Insulin-treated type 2 diabetes patients, age 18-80 years old.\n* Patients who have not changed their diabetes medication in the past 2 months.\n* Patients with a glycated hemoglobin level between 6.5% and 12.0% within the last 3 months.\n* Patients currently receiving insulin injection therapy, including basal insulin.\n* Patients who have access to KakaoTalk via smartphone and are able to communicate with it.\n* Voluntarily agreed to participate in this clinical study.\n\nExclusion Criteria:\n\n* Steroid and immunosuppressant users. But it can be included if patients continuously maintain same drug dose at least three months.\n* Patients who are currently taking weight control medications.\n* Breastfeeding or pregnant patients\n* Patients who do not voluntarily consent to the study\n* Anyone deemed unsuitable by the investigator to participate in the study'}, 'identificationModule': {'nctId': 'NCT06769906', 'briefTitle': 'Effectiveness of Individualized Automatic Coaching Message for Glycemic Management and Depressive Symptom', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Effectiveness of Individualized Automatic Target Coaching Message Based on the Metrics of Continuous Glucose Monitoring and Depressive Symptom in Patients With Insulin-treated Type 2 Diabetes: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SamsungMC_ENDO_3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individualized automatic coaching message for glycemic management and depressive symptoms', 'description': 'The study will enroll insulin-treated patients with type 2 diabetes who are already receiving standard care and diabetes management through outpatient visits. For 12 weeks, the intervention group and control will apply continuous glucose monitoring. The intervention group will receive weekly personalized coaching messages for glycemic management based on data from continuous glucose monitoring and bi-weekly personalized coaching messages for depressive symptoms based on depression questionnaires for 12 weeks.', 'interventionNames': ['Other: Individualized automatic coaching message for glycemic management and depressive symptom']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group will continue their existing treatment and wear a continuous glucose monitoring device, responding to both surveys by accessing the survey link sent to their cell phone. This will allow for the assessment of baseline satisfaction (DTSQ) and depressive symptoms (PHQ-9).'}], 'interventions': [{'name': 'Individualized automatic coaching message for glycemic management and depressive symptom', 'type': 'OTHER', 'description': 'For 12 weeks, the intervention group will apply continuous glucose monitoring system and receive weekly personalized coaching messages for glycemic management based on data from continuous glucose monitoring and bi-weekly personalized coaching messages for depression symptoms based on depression questionnaires.', 'armGroupLabels': ['Individualized automatic coaching message for glycemic management and depressive symptoms']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Kim', 'role': 'CONTACT', 'email': 'gyuri5.kim@samsung.com', 'phone': '82-3410-0859'}], 'overallOfficials': [{'name': 'GYURI KIM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Samsung Medical Center', 'investigatorFullName': 'Gyuri Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}