Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-31 @ 2:34 PM
Study NCT ID:
NCT02189694
Status:
COMPLETED
Last Update Posted:
2014-09-03
First Post:
2014-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-01', 'studyFirstSubmitDate': '2014-07-03', 'studyFirstSubmitQcDate': '2014-07-10', 'lastUpdatePostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of time of glucose levels spent below 4.0 mmol/L.', 'timeFrame': 'Up to 8 hours'}], 'secondaryOutcomes': [{'measure': 'Percentage of time of glucose levels spent between 4.0 and 8.0 mmol/L', 'timeFrame': 'Up to 8 hours'}, {'measure': 'Percentage of time of glucose levels spent below 3.5 mmol/L', 'timeFrame': 'Up to 8 hours'}, {'measure': 'Percentage of time of glucose levels spent below 3.3 mmol/L', 'timeFrame': 'Up to 8 hours'}, {'measure': 'Percentage of time of glucose levels spent above 8 mmol/L', 'timeFrame': 'Up to 8 hours'}, {'measure': 'Percentage of time of glucose levels spent above 10 mmol/L.', 'timeFrame': 'Up to 8 hours'}, {'measure': 'Area under the curve of glucose levels below 4.0 mmol/L', 'timeFrame': 'Up to 8 hours'}, {'measure': 'Area under the curve of glucose levels below 3.5 mmol/L', 'timeFrame': 'Up to 8 hours'}, {'measure': 'Area under the curve of glucose levels below 3.3 mmol/L', 'timeFrame': 'Up to 8 hours'}, {'measure': 'Area under the curve of glucose levels above 8.0 mmol/L', 'timeFrame': 'Up to 8 hours'}, {'measure': 'Area under the curve of glucose levels above 10.0 mmol/L.', 'timeFrame': 'Up to 8 hours'}, {'measure': 'Mean glucose levels.', 'timeFrame': 'Up to 8 hours'}, {'measure': 'Standard deviation of glucose levels', 'timeFrame': 'Up to 8 hours', 'description': 'Measure of glucose variability.'}, {'measure': 'Total insulin delivery', 'timeFrame': 'Up to 8 hours'}, {'measure': 'Hypoglycemic risk assessed by the total number of hypoglycemic event (> 15 minutes) below 3.1 mmol/L', 'timeFrame': 'Up to 8 hours'}, {'measure': 'Hypoglycemic risk assessed by the number of patients experiencing at least one hypoglycemic event (> 15 minutes) below 3.1 mmol/L', 'timeFrame': 'Up to 8 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 1 diabetes', 'Hypoglycemia', 'Insulin', 'Glucagon', 'Closed-loop system', 'Artificial pancreas'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '26066705', 'type': 'DERIVED', 'citation': 'Haidar A, Legault L, Matteau-Pelletier L, Messier V, Dallaire M, Ladouceur M, Rabasa-Lhoret R. Outpatient overnight glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or conventional insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2015 Aug;3(8):595-604. doi: 10.1016/S2213-8587(15)00141-2. Epub 2015 Jun 8.'}]}, '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 dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.\n\nThe main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in children with type 1 diabetes in a diabetes camp.\n\nThe investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent in hypoglycemia in children with type 1 diabetes (T1D) compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy to reduce time spent in hypoglycemia", 'detailedDescription': "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 dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.\n\nThe investigators aim to conduct a randomized three-way cross-over trial comparing single hormone closed-loop strategy, dual-hormone closed-loop strategy and the conventional pump therapy. The investigators aim to compare the three interventions for 3 consecutive nights in children with type 1 diabetes in a diabetes camp."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males or females between the 8 and 17 years of old.\n* Clinical diagnosis of type 1 diabetes for at least one year. The subject will have been on insulin pump therapy for at least 3 months.\n* HbA1c ≤ 11.0%.\n\nExclusion Criteria:\n\n* Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.\n* Severe hypoglycemic episode within two weeks of inclusion in the study. A severe hypoglycemic episode is defined as loss of conscience, seizure or a hospital emergency visit.\n* Current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). Stable doses of inhaled steroids are acceptable.\n* Known or suspected allergy to the trial products.\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 use trial pump, etc)."}, 'identificationModule': {'nctId': 'NCT02189694', 'briefTitle': 'Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Recherches Cliniques de Montreal'}, 'officialTitle': 'An Open-label, Randomized, Three-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Pump Therapy in Regulating Overnight Glucose Levels in Children With Type 1 Diabetes in a Diabetes Camp', 'orgStudyIdInfo': {'id': 'CLASS-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin pump therapy', 'description': 'Glucose levels will be controlled for 3 consecutive nights using insulin pump therapy. Subjects will carry on with their normal conventional insulin pump therapy and will be allowed to freely implement therapeutic adjustments..', 'interventionNames': ['Device: Insulin pump therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single-hormone closed-loop strategy', 'description': "Glucose levels will be controlled by single-hormone closed-loop strategy for 3 consecutive nights. A member of the research team will be present at the diabetic camp to ensure protocol implementation and patient's safety. Glucose levels will be controlled by single-hormone closed-loop strategy between 22:00 until 7:00 next morning. Glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pump's parameters will then be changed manually to implement the computer generated recommendations.", 'interventionNames': ['Device: Single-hormone closed-loop strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dual-hormone closed-loop strategy', 'description': "Glucose levels will be controlled by dual-hormone closed-loop strategy for 3 consecutive nights. A member of the research team will be present at the diabetic camp to ensure protocol implementation and patient's safety. Glucose levels will be controlled by dual-hormone closed-loop strategy between 22:00 until 7:00 next morning. Glucose sensor readings will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery and glucagon mini-boluses. Pumps' parameters will then be changed manually to implement the computer generated recommendations.", 'interventionNames': ['Device: Dual-hormone closed-loop strategy']}], 'interventions': [{'name': 'Single-hormone closed-loop strategy', 'type': 'DEVICE', 'description': 'Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.', 'armGroupLabels': ['Single-hormone closed-loop strategy']}, {'name': 'Dual-hormone closed-loop strategy', 'type': 'DEVICE', 'description': 'Variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) and Glucagon (Eli Lilly and Company) will be used.', 'armGroupLabels': ['Dual-hormone closed-loop strategy']}, {'name': 'Insulin pump therapy', 'type': 'DEVICE', 'description': 'Subjects will use conventional pump therapy to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.', 'armGroupLabels': ['Insulin pump therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2W 1R7', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut de recherches cliniques de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Rémi Rabasa-Lhoret, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de recherches cliniques de Montréal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Recherches Cliniques de Montreal', 'class': 'OTHER'}, 'collaborators': [{'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'}}}}