Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT06154135
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-12
First Post:
2023-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulin Delivery Using the DBLG1 Closed-loop on Glycemic Control and PROMs in Adults Living With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 165}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2023-11-06', 'studyFirstSubmitQcDate': '2023-11-30', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Composite endpoint of HbA1c and Time in Hypoglycemia', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Composite endpoint of the percentage of participants reaching HbA1c \\<7% AND time in hypoglycemia (sensor glucose \\< 70 mg/dL) less than 4% of time after start of the DBLG1 system'}, {'measure': 'Severe hypoglycemia', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Change in Severe Hypoglycemia frequency after start of the DBLG1 system'}, {'measure': 'Diabetic ketoacidosis', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Change in diabetic ketoacidosis frequency after start of the DBLG1 system'}, {'measure': 'Hospitals visits and/or admissions', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Evolution of number of hospitals visits and/or admissions because of severe hypoglycemia or diabetic ketoacidosis from before start to 12 months after start of the DBLG1 system'}, {'measure': 'Work and school absenteeism', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Evolution of work and school absenteeism (number of days) after start of the DBLG1 system'}, {'measure': 'Unplanned contacts with the diabetes team', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Evolution of frequency of unplanned contacts with the diabetes team after start of the DBLG1 system'}, {'measure': 'Change in body weight', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Evolution of body weight (kg) after start of the DBLG1 system'}, {'measure': 'Change in total daily dose of insulin', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Evolution of total daily dose of insulin after start of the DBLG1 system'}, {'measure': 'Indications for use of the DBLG-1 system (multiple options (non-ordinal))', 'timeFrame': 'before start', 'description': 'Indications for use of the DBLG-1 system measured by a self-developed questionnaire (multiple options (non-ordinal))'}, {'measure': 'Patients who stop using the DBLG-1 system', 'timeFrame': 'from 4,8,12 and 24 months after start', 'description': 'Number of patients who stop using the DBLG-1 system'}], 'primaryOutcomes': [{'measure': 'Time in range', 'timeFrame': '12 months after start', 'description': 'Change in the percentage of time spent in range (sensor glucose 70-180 mg/dL) from before start to 12 months after start of the DBLG1 system'}], 'secondaryOutcomes': [{'measure': 'Time in range [exc. primary outcome]', 'timeFrame': 'from before start to 4,8,12 and 24 months after start, with the exclusion of the primary outcome', 'description': 'Change in the percentage of time spent in range (sensor glucose 70-180 mg/dL) after start of the DBLG1 system, with exclusion of the primary endpoint'}, {'measure': 'Time in tigh range', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Change in the percentage of time spent in tigh range (sensor glucose 70-140 mg/dL) after start of the DBLG1 system.'}, {'measure': 'Time in level 2 hypoglycemia', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Change in the percentage of time spent in level 2 hypoglycemia (sensor glucose below 54 mg/dL) after start of the DBLG1 system.'}, {'measure': 'Time in level 1 hypoglycemia', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Change in the percentage of time spent in level 1 hypoglycemia (sensor glucose \\< 70 mg/dL and \\>=54 mg/dl) after start of the DBLG1 system.'}, {'measure': 'Time below range', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Change in the percentage of time spent below range (sensor glucose \\< 70 mg/dL) after start of the DBLG1 system.'}, {'measure': 'Time above range', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Change in the percentage of time spent above range (sensor glucose \\>180 mg/dL) after start of the DBLG1 system.'}, {'measure': 'Time in level 2 hyperglycemia', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Change in the percentage of time spent in level 2 hyperglycemia (sensor glucose \\>250 mg/dL) after start of the DBLG1 system.'}, {'measure': 'Time in level 1 hyperglycemia', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Change in the percentage of time spent in level 1 hyperglycemia (sensor glucose \\>180 mg/dL and \\<= 250 mg/dl)) after start of the DBLG1 system.'}, {'measure': 'Glycemic variability', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Change in Coefficient of variation (CV) and standard deviation (SD) after start of the DBLG1 system.'}, {'measure': 'Mean glucose concentration', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Change in mean glucose concentration after start of the DBLG1 system.'}, {'measure': 'HbA1c', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Change in HbA1c (%) after start of the DBLG1 system.'}, {'measure': 'Correlation between clinical characteristics and HbA1c changes', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Correlation between recorded clinical characteristics and HbA1c changes after start of the DBLG1 system.'}, {'measure': 'Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': "Change in Patient's Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life))"}, {'measure': 'Clarke hypoglycemia awareness survey', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Change in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey (scale: unaware (≥4 times "R" or once "U") or aware (\\<4 times "R"))'}, {'measure': 'Gold scale', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Change in hypoglycemia awareness measured by the Gold-scale (scale: 1 (aware) - 7 (unaware))'}, {'measure': 'Hypoglycemia Fear Survey (HFS-II)', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Change in fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))'}, {'measure': 'PAID-SF questionnaire', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Change in distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))'}, {'measure': 'Diabetes Impact and Device Satisfaction Scale (DIDSS)', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Impact of diabetes and device satisfaction by the Diabetes Impact and Device Satisfaction Scale (scale: device satisfaction = 7 (not satisfied) - 70 (very satisfied); diabetes impact = 4 (low impact) - 40 (high impact))'}, {'measure': 'Diabetes Treatment Satisfaction Questionnaire, Status (DTSQs)', 'timeFrame': 'from before start to 4,8,12 and 24 months after start', 'description': 'Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs. Scale: 0 (low satisfaction) - 36 (high satisfaction))'}, {'measure': 'Reasons to stop using the DBLG-1 device', 'timeFrame': 'when the patient stops using the DBLG-1 system', 'description': 'Self-developed questionnaire about the reasons the patient stopped using the DBLG-1 device (multiple choice)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'To evaluate the impact of the DBLG1 hybrid closed-loop system on glycemic control and patient-reported outcomes in adults living with type 1 diabetes under real-life conditions.', 'detailedDescription': 'This is a multicenter real-world observational study analyzing data on the use of the DBLG1 system in patients with T1D treated in the participating centers in Belgium. Data from patients with T1D who start(ed) with the DBLG1 between may-01 2022 up to and including August-01 2023 will be analyzed. Data will be collected during clinical routine follow-up from electronic medical records, questionnaires, standard of care laboratory tests and CGM-data. Baseline data from before start (up to -12 months) of the DBLG1 system and follow-up data at 4, 8, 12, 16, 20 and 24 months will be analyzed. There are no medical interventions, nor extra visits or laboratory tests planned outside normal clinical routine. Glycemic control and patient-reported outcomes during follow-up will be compared with glycemic control and patient-reported outcome data at baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with T1D, aged 18 years and older, who start with the DBLG1 system in Belgium', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with type 1 diabetes\n* aged 18 years and older\n* starting with the DBLG1 system in the participating centers\n* who signed the informed consent\n\nExclusion Criteria:\n\n* patients who do not have type 1 diabetes\n* younger than 18 years\n* who do not start with the DBLG1 system\n* who are not able to sign the informed consent\n* who do not want to sign the informed consent'}, 'identificationModule': {'nctId': 'NCT06154135', 'acronym': 'INLOOP', 'briefTitle': 'Insulin Delivery Using the DBLG1 Closed-loop on Glycemic Control and PROMs in Adults Living With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Erasme University Hospital'}, 'officialTitle': 'Insulin Delivery Using the DBLG1 Closed-loop Algorithm on Glycemic Control and Patient-reported Outcomes in Adults Living With Type 1 Diabetes: a Multicenter Real-world Observational Study in Belgium', 'orgStudyIdInfo': {'id': 'SRB2022123'}}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'Department of Endocrinology, OLVZ Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '2820', 'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Department of Endocrinology, Imeldaziekenhuis', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Department of Endocrinology, ULB-Hôpital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Department of Endocrinology and Nutrition, Cliniques Universitaires St. Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Department of Endocrinology, UZ Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Department of Endocrinology and metabolic diseases, UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '6060', 'city': 'Gilly', 'country': 'Belgium', 'facility': 'Department of Endocrino-Diabetology, Grand Hôpital de Charleroi - site Saint-Joseph', 'geoPoint': {'lat': 50.42449, 'lon': 4.4789}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Department of Endocrinology, UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Department of Diabetes, Nutrition and Metabolic disorders, CHU de Liège - site du Sart Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Department of Endocrinology, CHR de la Citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '6042', 'city': 'Lodelinsart', 'country': 'Belgium', 'facility': 'Department of internal Medicine, CHU de Charleroi - Hôpital Civil Marie Curie', 'geoPoint': {'lat': 50.43138, 'lon': 4.44886}}, {'zip': '7000', 'city': 'Mons', 'country': 'Belgium', 'facility': 'Department of Endocrinology, CHR Mons-Hainaut (Warquignies)', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}], 'overallOfficials': [{'name': 'Laurent Crenier, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CUB - Hôpital Erasme'}]}, 'ipdSharingStatementModule': {'url': 'https://www.inami.fgov.be/SiteCollectionDocuments/fiche_approuvement_tao_diabete_2.pdf', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Available since May,1 2022', 'ipdSharing': 'YES', 'description': 'The protocol is published online', 'accessCriteria': 'open access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasme University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}