Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT06794658
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2024-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EFFICACY OF REMOTE MONITORING OF PATIENTS WITH DIABETES UNDER INSULIN TREATMENT, BY USING Caaring SOFTWARE
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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2025-01-21', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determinate the efficacy of the remote monitoring in insulin-treated diabetic patients with a software called Caaring®.', 'timeFrame': '12 weeks', 'description': "% acceptable Time in Range (TIR) of glucose measurements defined as the percentage of how long the patient's glucose value was within the target range (70-180 mg/dL)"}], 'secondaryOutcomes': [{'measure': 'PROs. Changes in Health-related quality of life (HRQOL): EsDQOL', 'timeFrame': 'Day 0 and week 12', 'description': "Change in the patient's quality of life scale the study compared to baseline: EsDQOL questionnaire for adults (Value 0-100). A higher score reflects a higher health-related quality of life (HRQoL)."}, {'measure': 'PROs. in Health-related quality of life (HRQOL): KINDL', 'timeFrame': 'Day 0 and week 12', 'description': "Change in the patient's quality of life scale the study compared to baseline: KINDL and Diabetes-related quality of life questionnaire for pediatrics for the pediatric population (Value 0-100). A higher score reflects a higher health-related quality of life (HRQoL)."}, {'measure': 'PROs. Patient satisfaction with the software Caaring', 'timeFrame': 'Week 12', 'description': 'The patient satisfaction will be measured through a specific satisfaction questionnaire created for this purpose. (Value 3-15). A higher score reflects greater satisfaction with software care.'}, {'measure': 'PROs. Variation in clinical parameters of glycemic control: HbA1c', 'timeFrame': 'Day 0 and Week 12', 'description': 'Variation in clinical parameters of glycemic control, HbA1c'}, {'measure': 'PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR', 'timeFrame': 'Day 0 and Biweekly up to 12 weeks', 'description': 'Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR (time in range)(70-180 mg/dl)'}, {'measure': 'PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR', 'timeFrame': 'Day 0 and Biweekly up to 12 weeks', 'description': 'Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR (time below range) Time \\< 70 mg/dL'}, {'measure': 'PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIT', 'timeFrame': 'Day 0 and Biweekly up to 12 weeks', 'description': 'Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIT (Time in target range), (70-140 mg/dL).'}, {'measure': 'PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV', 'timeFrame': 'Day 0 and Biweekly up to 12 weeks', 'description': 'Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV (Coefficient of Variation)'}, {'measure': 'PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI', 'timeFrame': 'Day 0 and Biweekly up to 12 weeks', 'description': 'Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI (Glycemic Risk Index).'}, {'measure': 'PROs. Number of Medical Visits', 'timeFrame': 'Day 0 and Monthly up to 12 weeks', 'description': 'Number of medical visits, calls or interactions with specialist healthcare personnel'}, {'measure': 'PROs. Adherence of treatment', 'timeFrame': 'Day 0 and Weekly up to 12 weeks', 'description': 'Adherence to therapy (insulin)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus (DM)', 'Remote patient monitoring', 'glycemic control', 'Caaring', 'Time in Range (TIR)', 'Online telemonitoring', 'Digital Health', 'DTx', 'PROMs', 'Patient-reported data', 'real-world data'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial investigation with device is to determinate the efficacy of the remote monitoring in insulin-treated diabetic patients with a software called Caaring®.\n\nThe main question it aims to answer is if the development of a self-management platform (Caaring®) that enhances the role of the patient with diabetes in the course of their disease will increase the TIR and/or reduce the number of in-person and telephone visits assisted by specialized medical and nursing personnel.\n\nThis is two arms, randomized study. Online telemonitoring group: The follow-up of these patients will be carried out prospectively remotely through the Caaring® platform. And Retrospective Control group: The data of these patients are collected retrospectively from the last 12 weeks prior to their inclusion.\n\nResearchers will compare the assessments between the two groups to see if the software Caaring® improve the TIR and/or reduce the number of visits to the specialist personnel.\n\nParticipants with diabetes will:\n\nUse of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) systems. In addition,\n\nControl group patients must have clinical and glucometry data from the 12 weeks prior to their inclusion date available in the Medical Record, and/or through the monitoring platforms of the continuous glucose monitoring devices Caaring group patients must have sufficient technological skills to use a smartphone.', 'detailedDescription': 'This is a longitudinal, comparative non-inferiority, multicenter, with 2 arms Medical Device Clinical Trial.\n\nThe protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with diabetes mellitus treated with insulin.\n* Patients treated with subcutaneous insulin in multiple daily doses or patients treated with subcutaneous insulin in continuous subcutaneous infusion systems\n* Patients using a glucose monitoring system\n* Patients who are able to complete the study questionnaires\n* Informed consent is obtained from the patient.\n* For Control group: Patients must have clinical and glucometry data from the 12 weeks prior to their inclusion date available in the Medical Record, and/or through the monitoring platforms of the continuous glucose monitoring devices - For Caaring group: Patients must have sufficient technological skills to use a smartphone.\n\nExclusion Criteria:\n\n* Patients with cognitive or sensory difficulties or with insufficient command of Spanish who, in the opinion of the investigator, makes it difficult to understand the questions or the scales, as long as they do not have a legally authorized representative capable of participating in the study.\n* Transient patients in whom it may be anticipated that follow-up will not be completed due to a change of residence.\n* Patients Who are participating at the time of recruitment in any other clinical trial. Participation in observational studies will not be an exclusion criteria.\n* Patients whose main diagnosis is a poorly controlled mental disorders or other medical illness.\n* Patients with terminal illness and/or in palliative care according to the criteria of the SECPAL (Spanish Society of Palliative Care).\n* Institutionalized patients\n* Patients who are pregnant or breastfeeding.\n* Patients whose inclusion is not considered advisable by the investigator's assessment due to they are under specific follow-up in other hospital units (hemodialysis, transplants, etc.) that require mandatory hospital attendance less frequently than once every two months."}, 'identificationModule': {'nctId': 'NCT06794658', 'acronym': 'GluCaaring', 'briefTitle': 'EFFICACY OF REMOTE MONITORING OF PATIENTS WITH DIABETES UNDER INSULIN TREATMENT, BY USING Caaring SOFTWARE', 'organization': {'class': 'OTHER', 'fullName': 'Persei Vivarium'}, 'officialTitle': 'DETERMINATION OF THE EFFICACY OF REMOTE MONITORING OF PATIENTS WITH DIABETES UNDER INSULIN TREATMENT, BY USING Caaring(r) SOFTWARE', 'orgStudyIdInfo': {'id': 'GluCaaring'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Online telemonitoring group (G_CAARING)', 'description': 'The monitoring and control of these patients will be carried out remotely through the Caaring® platform. Patients will connect to an APP on a mobile phone. They will have to complete the data and questionnaires related to the study variables.', 'interventionNames': ['Device: software']}, {'type': 'NO_INTERVENTION', 'label': 'Retrospective Control group', 'description': 'The data of these patients are collected retrospectively from the medical history, from the last 12 weeks prior to their inclusion.'}], 'interventions': [{'name': 'software', 'type': 'DEVICE', 'otherNames': ['Caaring'], 'description': "Caaring is an electronic data collection notebook that allows patients to confidentially fill out data/questionnaires on their mobile phone and report them through an application that will be installed on the patient's mobile phone. Besides, This group (G\\_CAARING) will receive educational and prevention recommendations relative to diabetes.", 'armGroupLabels': ['Online telemonitoring group (G_CAARING)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47003', 'city': 'Valladolid', 'state': 'Castille and León', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'María del Pilar Bahíllo Curieses, PhD', 'role': 'CONTACT', 'email': 'pilarbahilloc@yahoo.es', 'phone': '+34-983420000'}, {'name': 'María del Pilar Bahíllo Curieses, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '28009', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Patricia Enes Romero, Dr.', 'role': 'CONTACT', 'email': 'patricia.enes@salud.madrid.org', 'phone': '+34 91 503 59 15'}], 'facility': 'Hospital Infantil Universitario Niño Jesús', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Patricia Dominguez', 'role': 'CONTACT', 'email': 'patricia.dominguez@perseivivarium.com', 'phone': '+34 915 004 013'}, {'name': 'Roberto Bravo', 'role': 'CONTACT', 'email': 'roberto.bravo@perseivivarium.com', 'phone': '+34 915 004 013'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Persei Vivarium', 'class': 'OTHER'}, 'collaborators': [{'name': 'Effice Servicios Para la Investigacion S.L.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}