Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT01519102
Status:
COMPLETED
Last Update Posted:
2012-12-10
First Post:
2012-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Closed-loop Operation After Morning Meal With and Without Carbohydrate Counting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-07', 'studyFirstSubmitDate': '2012-01-24', 'studyFirstSubmitQcDate': '2012-01-25', 'lastUpdatePostDateStruct': {'date': '2012-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incremental area under the curve of plasma glucose concentration as compared to pre-meal glucose value of the postprandial glucose excursions', 'timeFrame': '0-300min'}], 'secondaryOutcomes': [{'measure': 'Percentage of postprandial time of plasma glucose concentrations spent in the high range (above 10.0 mmol/l).', 'timeFrame': '0-300 min'}, {'measure': 'Mean plasma glucose concentration.'}, {'measure': 'Total insulin delivery'}, {'measure': 'Total glucagon delivery'}, {'measure': 'Plasma glucose concentration and incremental plasma glucose concentration at 2 hours postmeal'}, {'measure': 'Postprandial peak and incremental postprandial peak of plasma glucose concentration'}, {'measure': 'Percentage of time of plasma glucose concentrations spent in target range. Target range is defined to be between 4.0 and 10.0 mmol/l for 150 minutes postmeal and between 4.0 and 8.0 mmol/l afterwards'}, {'measure': 'Percentage of postprandial time of plasma glucose concentrations spent in the low range (below 4.0mmol/l)', 'timeFrame': '0-300min'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type-1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '24656963', 'type': 'DERIVED', 'citation': 'Haidar A, Farid D, St-Yves A, Messier V, Chen V, Xing D, Brazeau AS, Duval C, Boulet B, Legault L, Rabasa-Lhoret R. Post-breakfast closed-loop glucose control is improved when accompanied with carbohydrate-matching bolus compared to weight-dependent bolus. Diabetes Metab. 2014 Jun;40(3):211-4. doi: 10.1016/j.diabet.2013.12.001. Epub 2014 Mar 19.'}]}, 'descriptionModule': {'briefSummary': "Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosage based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.\n\nThe main goal of this project is to assess whether a dual-hormone closed-loop strategy would alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D) without a significant degradation in post-meal glucose control.\n\nEach patient will be admitted twice to a clinical research facility. In one visit, patients will eat a morning meal accompanied with a matching insulin bolus (depending on the carbohydrate content of the meal) and glucose levels will be subsequently regulated using dual-hormone closed-loop system. In the other visit, patients will eat the same meal but will inject only a partial insulin bolus (not depending on carbohydrate content of the meal) and the remaining needed insulin will be delivered based on glucose sensor excursions as part of closed-loop operation. If post-meal glucose levels were indifferent between the two visits, then this would suggest that carbohydrate counting may not be necessary during closed-loop operation as the closed-loop system will give any remaining insulin needed to cover the glucose absorbed from the meal. Twelve subjects will be enrolled in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females ≥ 18 and ≤ 65 years of old.\n* Clinical diagnosis of type 1 diabetes for at least one year. The diagnosis of type 1 diabetes is based on the investigator's judgment and medical history (e.g. history of acido-ketosis, etc.); C peptide level and antibody determinations are not needed.\n* The subject will have been on insulin pump therapy for at least 3 months.\n* Last (less than 3 months) HbA1c ≤ 12%.\n\nExclusion Criteria:\n\n* Clinically significant nephropathy, neuropathy (especially clinically significant gastroparesis) or retinopathy as judged by the investigator.\n* Recent (\\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.\n* Pregnancy.\n* Severe hypoglycemic episode within two weeks of screening.\n\n • Medication likely to affect with the interpretation of the results: Prandase, Victoza, Byetta and Symlin\n* Known or suspected allergy to the trial products or meal contents.\n* Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.\n* Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).\n* Unreliable carbohydrate counting\n* Problems with venous access"}, 'identificationModule': {'nctId': 'NCT01519102', 'acronym': 'CLASS02', 'briefTitle': 'Comparison of Closed-loop Operation After Morning Meal With and Without Carbohydrate Counting', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Recherches Cliniques de Montreal'}, 'officialTitle': 'An Open-label, Randomized Two-way, Cross-over Study to Compare Meal-and-carbohydrate-announcement Strategy Versus Meal-announcement Strategy During Closed-loop Regulation of Glucose Levels in a Morning Meal in Adults With Type-1 Diabetes.', 'orgStudyIdInfo': {'id': 'CLASS-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CHO-independent partial insulin bolus with closed-loop', 'interventionNames': ['Device: Dual Hormone closed-loop system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CHO-dependent full insulin bolus combined with closed-loop', 'interventionNames': ['Device: Dual Hormone closed-loop system']}], 'interventions': [{'name': 'Dual Hormone closed-loop system', 'type': 'DEVICE', 'description': 'The closed-loop system is composed of three components: continuous glucose system, insulin infusion pumps that infuses insulin and glucagon and a control algorithm that decides on the infusion rates based on sensor readings.', 'armGroupLabels': ['CHO-dependent full insulin bolus combined with closed-loop', 'CHO-independent partial insulin bolus with closed-loop']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2W 1R7', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut de Recherches Cliniques de Montréal (IRCM)', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Recherches Cliniques de Montreal', 'class': 'OTHER'}, 'collaborators': [{'name': 'McGill University', 'class': 'OTHER'}, {'name': "Montreal Children's Hospital of the MUHC", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Rémi Rabasa-Lhoret', 'investigatorAffiliation': 'Institut de Recherches Cliniques de Montreal'}}}}