Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:17 AM
Study NCT ID:
NCT07320495
Status:
RECRUITING
Last Update Posted:
2026-01-06
First Post:
2025-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-06-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-25', 'studyFirstSubmitDate': '2025-12-03', 'studyFirstSubmitQcDate': '2025-12-25', 'lastUpdatePostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in glycated haemoglobin (HbA1c)', 'timeFrame': 'Up to 24 months', 'description': 'Differences between HbA1c values in the Visit 0 and Visit 24'}, {'measure': 'Changes in percentage of time in target ranges 3,9-10,0 mmol/L (70-180 mg/dl)', 'timeFrame': 'Up to 24 months', 'description': 'Differences between percentage of time in target ranges in the Visit 0 and Visit 24'}], 'secondaryOutcomes': [{'measure': 'Changes in percentage of time in hypoglycemic ranges <3.9 mmol/L (70 mg/dl) and <3.0 mmol/L (54 mg/dl)', 'timeFrame': 'Up to 24 months', 'description': 'Differences between percentage of time in hypoglycemic ranges in the Visit 0 and Visit 24'}, {'measure': 'Changes in percentage of time in hyperglycemic ranges >10,0 mmol/L (180 mg/dl) and >13,9 mmol/L (250 mg/dl)', 'timeFrame': 'Up to 24 months', 'description': 'Differences between percentage of time in hyperglycemic ranges in the Visit 0 and Visit 24'}, {'measure': 'Changes in percentage of time in tight target ranges 3,9-7,8 mmol/L (70-140 mg/dl)', 'timeFrame': 'Up to 24 months', 'description': 'Differences between percentage of time in tight target ranges in the Visit 0 and Visit 24'}, {'measure': 'Changes in average glycemia (mmol/L)', 'timeFrame': 'Up to 24 months', 'description': 'Differences between average glycemia in the Visit 0 and Visit 24'}, {'measure': 'Changes in estimated glycated haemoglobin GMI (%)', 'timeFrame': 'Up to 24 months', 'description': 'Differences between estimated glycated haemoglobin GMI in the Visit 0 and Visit 24'}, {'measure': 'Changes in glycemic variability expressed as the coefficient of variation (%)', 'timeFrame': 'Up to 24 months', 'description': 'Differences between glycemic variability in the Visit 0 and Visit 24'}, {'measure': 'Time spent in automated insulin delivery mode', 'timeFrame': 'Up to 24 months', 'description': 'Expressed as percentage of time'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['automated insulin delivery system', 'patch pump'], 'conditions': ['Diabetes Mellitus Type 1']}, 'referencesModule': {'references': [{'pmid': '39065641', 'type': 'RESULT', 'citation': 'Rimon MTI, Hasan MW, Hassan MF, Cesmeci S. Advancements in Insulin Pumps: A Comprehensive Exploration of Insulin Pump Systems, Technologies, and Future Directions. Pharmaceutics. 2024 Jul 15;16(7):944. doi: 10.3390/pharmaceutics16070944.'}, {'pmid': '30070604', 'type': 'RESULT', 'citation': 'Ginsberg BH. Patch Pumps for Insulin. J Diabetes Sci Technol. 2019 Jan;13(1):27-33. doi: 10.1177/1932296818786513. Epub 2018 Aug 2.'}, {'pmid': '35367523', 'type': 'RESULT', 'citation': 'Kulzer B, Freckmann G, Heinemann L, Schnell O, Hinzmann R, Ziegler R. Patch Pumps: What are the advantages for people with diabetes? Diabetes Res Clin Pract. 2022 May;187:109858. doi: 10.1016/j.diabres.2022.109858. Epub 2022 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'The Medtrum TouchCare Nano system with the APGO algorithm is the only patch pump-based automated insulin delivery system available in the Czech Republic. However, until now, no prospective clinical study has evaluated its efficacy and safety under real-world conditions. The RENEW study is the first to address this topic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with T1D\n* type 1 diabetes for ≥1 years\n* ≥ 18 years old\n* written informed consent prior to starting study related activity\n\nExclusion Criteria:\n\n* severe noncompliance\n* lactation, pregnancy, intending to become pregnant during study\n* use of medication with effects on carbohydrate metabolism'}, 'identificationModule': {'nctId': 'NCT07320495', 'briefTitle': 'Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Efficacy and Safety of the APGO Algorithm for Automated Insulin Delivery: The RENEW Study', 'orgStudyIdInfo': {'id': 'RENEW'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with TouchCare Nano A8 insulin pump with the APGO system', 'description': 'Patients with type 1 diabetes, who initiated use of the TouchCare Nano A8 insulin pump with the APGO system.', 'interventionNames': ['Device: Device: Insulin pump TouchCare Nano A8 with the APGO system']}], 'interventions': [{'name': 'Device: Insulin pump TouchCare Nano A8 with the APGO system', 'type': 'DEVICE', 'description': 'Insulin pump Medtrum TouchCare Nano A8 with the APGO algorithm is the only patch pump-based automated insulin delivery system available in the Czech Republic.', 'armGroupLabels': ['Patients with TouchCare Nano A8 insulin pump with the APGO system']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Jan Soupal', 'role': 'CONTACT', 'email': 'jan.soupal@seznam.cz', 'phone': '+420775654343'}, {'name': 'Jan Soupal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': '3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Jan Soupal', 'role': 'CONTACT', 'email': 'jan.soupal@seznam.cz', 'phone': '+420775654343'}, {'name': 'Dat Do', 'role': 'CONTACT', 'email': 'datdoquoc@seznam.cz', 'phone': '+420608220784'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}