Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-30 @ 9:04 PM
Study NCT ID:
NCT07121504
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2025-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hybrid Closed-Loop for Perioperative Glycemic Control in T2DM With Parenteral Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006963', 'term': 'Hyperphagia'}], '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': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-06-20', 'size': 399937, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-22T05:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2025-05-22', 'studyFirstSubmitQcDate': '2025-08-06', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety outcomes', 'timeFrame': 'Up to 28 days', 'description': 'Safety outcomes will include the difference in the incidence rates of: (1) perioperative infections, (2) hypoglycemia (Level 1: \\<3.9 mmol/L; Level 2: \\<3.0 mmol/L; severe: requiring assistance), (3) diabetic ketoacidosis/ketosis, (4) adverse events and device-related adverse events, and (5) all serious adverse events (SAEs), between groups.'}], 'primaryOutcomes': [{'measure': 'CGM-measured Time in Range (TIR 5.6-10.0 mmol/L)', 'timeFrame': 'Up to 28 days', 'description': 'The difference in percentage of time spent within target glucose range (5.6-10.0 mmol/L) between groups, as continuously monitored by a CGM device, to evaluate the effectiveness of hybrid closed-loop insulin delivery versus control in improving glycemic control for perioperative T2DM patients receiving parenteral nutrition.'}], 'secondaryOutcomes': [{'measure': 'Time above range (TAR) >10.0 mmol/L', 'timeFrame': 'Up to 28 days', 'description': 'The difference in the CGM-measured percentage of time with sensor glucose values \\> 10.0 mmol/L between group'}, {'measure': 'Time above range (TAR) >20.0 mmol/L', 'timeFrame': 'Up to 28 days', 'description': 'The difference in the CGM-measured percentage of time with sensor glucose values \\> 20.0 mmol/L between group'}, {'measure': 'Time below range (TBR) <5.6 mmol/L', 'timeFrame': 'Up to 28 days', 'description': 'The difference in the CGM-measured percentage of time with sensor glucose values \\<5.6 mmol/L between groups'}, {'measure': 'Time below range (TBR) < 3.9 mmol/L', 'timeFrame': 'Up to 28 days', 'description': 'The difference in the CGM-measured percentage of time with sensor glucose values \\<3.9 mmol/L between groups'}, {'measure': 'Time below range (TBR) < 3.0 mmol/L', 'timeFrame': 'Up to 28 days', 'description': 'The difference in the CGM-measured percentage of time with sensor glucose values \\<3.0 mmol/L between groups'}, {'measure': 'Time below range (TBR) < 2.8 mmol/L', 'timeFrame': 'Up to 28 days', 'description': 'The difference in the CGM-measured percentage of time with sensor glucose values \\<2.8 mmol/L between groups'}, {'measure': 'CGM-measured Mean Glucose Level', 'timeFrame': 'Up to 28 days', 'description': 'CGM-measured mean glucose level between groups'}, {'measure': 'CGM-measured Glucose Standard Deviation (SD)', 'timeFrame': 'Up to 28 days', 'description': 'The difference in the CGM-measured glucose standard deviation between groups. Standard Deviation represents how much glucose levels fluctuate over time from a given average.'}, {'measure': 'CGM-Measured Glucose Coefficient of Variation (CV)', 'timeFrame': 'Up to 28 days', 'description': 'The difference in the CGM-measured glucose coefficient of variation (CV) between groups. The CV is calculated as the ratio of the standard deviation to the mean glucose values for each participant, derived from CGM data.'}, {'measure': 'CGM-Measured Glucose Risk Index (GRI)', 'timeFrame': 'Up to 28 days', 'description': 'The CGM-measured glucose risk index (GRI) between groups. GRI is a comprehensive metric derived from CGM data, designed to quantify the overall risk associated with blood glucose variability. It integrates multiple aspects of glucose levels, including the frequency and severity of both hypo- and hyperglycemic events, as well as the duration of time spent outside the target glucose range.'}, {'measure': 'Insulin dose', 'timeFrame': 'Up to 28 days', 'description': 'The difference in the insulin dose between groups'}, {'measure': 'Preoperative optimization duration (days)', 'timeFrame': 'Up to 28 days', 'description': 'The difference in the preoperative optimization duration between groups'}, {'measure': 'Time in range (TIR) 4.4-10.0 mmol/L', 'timeFrame': 'Up to 28 days', 'description': 'The difference in percentage of time spent within target glucose range (4.4-10.0 mmol/L) between groups, as continuously monitored by a CGM device, to evaluate the effectiveness of hybrid closed-loop insulin delivery versus control in improving glycemic control for perioperative T2DM patients receiving parenteral nutrition.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hybrid closed-loop', 'perioperative', 'parenteral nutrition'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Glycemic control in surgical patients with type 2 diabetes mellitus (T2DM) receiving parenteral nutrition represents a major clinical challenge. This randomized controlled trial evaluates the comparative effectiveness and safety of hybrid closed-loop (HCL) insulin delivery versus conventional insulin pumps combined with continuous glucose monitoring (CGM) in perioperative T2DM patients requiring short-term parenteral nutrition.', 'detailedDescription': 'This study is a single-center, open-label, 1:1 randomized controlled exploratory trial. Participants were randomly allocated via complete randomization into two groups: the experimental group (hybrid closed-loop insulin delivery system) and the control group (using identical hardware devices, with the experimental group operating in closed-loop mode while the control group in open-loop mode). The intervention duration ranged from 5 to 7 days, adjusted based on glycemic control status, aiming to compare the efficacy and clinical benefits of hybrid closed-loop insulin delivery versus insulin pumps combined with CGM for glycemic management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Diagnosis of T2DM requiring surgical procedures (duration ≥2 hours) with anticipated short-term total parenteral nutrition (TPN) during the perioperative period (expected hospitalization \\>72 hours).\n3. Glycemic control criteria (meeting any of the following):\n\n ①HbA1c ≥7.5% or random plasma glucose ≥13.9 mmol/L\n * Established T2DM with poor glycemic control (HbA1c ≥7.5%) despite combination therapy (≥2 oral antidiabetic drugs) ③Insulin-treated patients with suboptimal control (HbA1c ≥7.0%) after adequate dose adjustment.\n4. Willing to sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with acute diabetic complications, including: diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), etc.\n2. Patients with type 1 diabetes or other specific types of diabetes.\n3. Patients with severe organ dysfunction, defined as:\n\n * Cardiac function ≥Class III (NYHA classification)\n\n * ALT/AST \\>3× upper limit of normal (ULN) ③ eGFR ≤30 mL/min/1.73 m²\n\n * Hemoglobin \\<90 g/L ⑤ WBC count \\<4.0×10⁹/L or platelets \\<90×10⁹/L ⑥ Hemodynamic instability\n4. Patients with endocrine disorders affecting glucose metabolism, such as: hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.\n5. Patients with known hypersensitivity to any drugs or materials used in the study protocol.\n6. Patients who have contraindications to conventional insulin pump therapy.\n7. Patients with dermatological conditions (e.g., skin rash, prurigo) or coagulation disorders.\n8. Patients with impaired consciousness or psychiatric disorders affecting decision-making capacity or communication ability.\n9. Patients who have other conditions deemed unsuitable for trial participation by investigators.\n10. Patients who suffer severe surgical complications."}, 'identificationModule': {'nctId': 'NCT07121504', 'briefTitle': 'Hybrid Closed-Loop for Perioperative Glycemic Control in T2DM With Parenteral Nutrition', 'organization': {'class': 'OTHER', 'fullName': 'Second Xiangya Hospital of Central South University'}, 'officialTitle': 'Effect of Hybrid Closed-Loop Insulin Delivery System on Glycemic Management in Perioperative Patients With Type 2 Diabetes Receiving Parenteral Nutrition: An Open-Label, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HCL-T2D 2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hybrid closed-loop insulin delivery system', 'description': 'T2DM patients in the experimental group will receive the hybrid closed-loop insulin delivery system.', 'interventionNames': ['Device: Hybrid closed-loop insulin delivery system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional insulin pump with CGM', 'description': 'T2DM patients in the control group will receive conventional insulin pump therapy with CGM.', 'interventionNames': ['Device: conventional insulin pumps combined with CGM']}], 'interventions': [{'name': 'Hybrid closed-loop insulin delivery system', 'type': 'DEVICE', 'description': 'Perioperative patients with T2D receiving parenteral nutrition will receive hybrid closed-loop insulin delivery system for glycemic management.', 'armGroupLabels': ['Hybrid closed-loop insulin delivery system']}, {'name': 'conventional insulin pumps combined with CGM', 'type': 'DEVICE', 'description': 'Perioperative patients with T2D receiving parenteral nutrition will receive conventional insulin pumps combined with CGM for glycemic management.', 'armGroupLabels': ['Conventional insulin pump with CGM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xia Li', 'role': 'CONTACT', 'email': 'lixia2014@vip.163.com', 'phone': '+86 13974885753'}], 'facility': 'Department of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University, Changsha, Hunan 410011', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Xia Li, MD, PhD', 'role': 'CONTACT', 'email': 'lixia2014@vip.163.com', 'phone': '+86 13974885753'}], 'overallOfficials': [{'name': 'Xia Li, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Xiangya Hospial of Central South University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xia Li', 'investigatorAffiliation': 'Second Xiangya Hospital of Central South University'}}}}