Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-01 @ 12:51 PM
Study NCT ID:
NCT06848933
Status:
COMPLETED
Last Update Posted:
2025-02-27
First Post:
2024-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Could the Advanced Hybrid Closed-Loop System Algorithm Provide Postprandial Normoglycemia After a High-Fat, High-Protein Meal
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2024-11-28', 'studyFirstSubmitQcDate': '2025-02-26', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time spend in time in range (70-180 mg/dl) for postprandial 5 hours after the test meal', 'timeFrame': '1 month', 'description': 'Percentage of time when blood sugar is at 70-180 mg/dl for pst prandial 5 hours after the test meal'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['AHCLS', 'type 1 diabetes', 'high fat, high protein', 'adolescents'], 'conditions': ['Type 1 Diabetes Mellitus', 'Adolescents']}, 'descriptionModule': {'briefSummary': 'AHCL Systems Could Cover Postprandial Glycemic Response After High Fat and High Protein Meals', 'detailedDescription': "On the 1st, 2nd and 3rd day of the study, a pediatric endocrinologist from the research team will evaluate the continuous glucose measurement system data and optimize the carbohydrate/insulin ratios. On the 4th and 7th days of the study, participants with blood sugar levels between 70-140 mg/dl according to the continuous glucose measurement system, which is a component of the hybrid closed-loop insulin infusion pump system, will consume the test meal consisting of Dr Oetker Ristorante Pizza Mista (340 grams) (92 g carbohydrate, 33 g protein, 41 g fat) at lunch, under the supervision of a dietician from the research team, by switching the pump to manual mode and entering the carbohydrate amount of the meal into the pump. This application will be repeated on the 11th and 14th days of the study while the participant's pump is in automatic mode. Participants will not be allowed to consume food or beverages other than water or exercise for 5 hours after the meal. Blood sugar monitoring will be done with a continuous glucose measurement system. The participant will leave the hospital 5 hours after the start of the meal to return to their normal life. Dr Oetker Ristorante Pizza Mista, which was selected as the test meal, was chosen because it is a macronutrient content that is consumed by young people between the ages of 9-18 and that is similar to the test meals in the world literature and accepted research reports reporting the effect of high-fat and high-protein meals on glycemic response in individuals with diabetes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteering to participate in the study\n* Not having a disease accompanying type 1 diabetes (celiac, cystic fibrosis, etc.)\n\nExclusion Criteria:\n\n* \\- Not volunteering to participate in the study\n* Using psychiatric medication or any medication that may cause obesity at the time of trial\n* Having a disease accompanying type 1 diabetes (celiac, cystic fibrosis, etc.)'}, 'identificationModule': {'nctId': 'NCT06848933', 'acronym': 'AHCLS T1D nutr', 'briefTitle': 'Could the Advanced Hybrid Closed-Loop System Algorithm Provide Postprandial Normoglycemia After a High-Fat, High-Protein Meal', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Could the Advanced Hybrid Closed-Loop System Algorithm Provide Postprandial Normoglycemia After a High-Fat, High-Protein Meal', 'orgStudyIdInfo': {'id': 'AHCLS T1D high fat and protein'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adolescents with type 1 diabetes on Medtronic Minimed 780G', 'description': 'Each participant will consume the test meal in Medtronic Minimed 780Gmanual mode and Medtronic Minimed 780G in auto mode. Each participant will be in control of himself/herself', 'interventionNames': ['Other: Test meal', 'Device: Each participant will consume the test meal when on Medtronic Minimed 780G and will consume test meal on Medtronic Minimed 780G on manual mode', 'Device: Advanced hybrid closed loop system mode']}], 'interventions': [{'name': 'Test meal', 'type': 'OTHER', 'description': "On days 1, 2 and 3 of the study, a pediatric endocrinologist from the research team will evaluate the continuous glucose monitoring system data and optimize the carbohydrate/insulin ratios. On days 4 and 7 of the study, participants with blood sugar levels between 70-140 mg/dl according to the continuous glucose monitoring system, which is a component of the hybrid closed-loop insulin infusion pump system, will consume the test meal consisting of Dr Oetker Ristorante Pizza Mista (340 grams) (92 g carbohydrate, 33 g protein, 41 g fat) at lunch, under the supervision of a dietician from the research team, by switching the pump to manual mode and entering the carbohydrate amount of the meal into the pump. This application will be repeated on days 11 and 14 of the study, with the participant's pump in automatic mode. Participants will not be allowed to consume food or beverages other than water or exercise for 5 hours after the meal. Blood sugar monitoring will be done with the continuous", 'armGroupLabels': ['Adolescents with type 1 diabetes on Medtronic Minimed 780G']}, {'name': 'Each participant will consume the test meal when on Medtronic Minimed 780G and will consume test meal on Medtronic Minimed 780G on manual mode', 'type': 'DEVICE', 'description': 'After the intervention, blood glucose values will be documented from continued glucose measurement system for postprandial 5 hours,and compared in manual mode and auto mode', 'armGroupLabels': ['Adolescents with type 1 diabetes on Medtronic Minimed 780G']}, {'name': 'Advanced hybrid closed loop system mode', 'type': 'DEVICE', 'description': "On days 1, 2 and 3 of the study, a pediatric endocrinologist from the research team will evaluate the continuous glucose monitoring system data and optimize the carbohydrate/insulin ratios. On days 4 and 7 of the study, participants with blood sugar levels between 70-140 mg/dl according to the continuous glucose monitoring system, which is a component of the hybrid closed-loop insulin infusion pump system, will consume the test meal consisting of Dr Oetker Ristorante Pizza Mista (340 grams) (92 g carbohydrate, 33 g protein, 41 g fat) at lunch, under the supervision of a dietician from the research team, by switching the pump to manual mode and entering the carbohydrate amount of the meal into the pump. This application will be repeated on days 11 and 14 of the study, with the participant's pump in automatic mode. Participants will not be allowed to consume food or beverages other than water or exercise for 5 hours after the meal. Blood sugar monitoring will be done with the continuous", 'armGroupLabels': ['Adolescents with type 1 diabetes on Medtronic Minimed 780G']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35100', 'city': 'Izmir', 'state': 'Bornova', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University, Medical Faculty, Division of Pediatric Endocrinology', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'yasemin atik altınok, Assoc Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'İzmir Tınaztepe University'}, {'name': 'Damla Goksen, Prof Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ege University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Izmir Tinaztepe University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dietician, PhD, Assoc Prof', 'investigatorFullName': 'Yasemin Atik Altinok', 'investigatorAffiliation': 'Izmir Tinaztepe University'}}}}