Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT04878120
Status:
COMPLETED
Last Update Posted:
2024-05-30
First Post:
2021-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Hybrid Closed-Loop Control With Smart Prandial Insulin Dosing in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cf9qe@virginia.edu', 'phone': '4344220240', 'title': 'Dr. Chiara Fabris', 'organization': 'University of Virginia'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study was a 4-day randomized crossover camp, with participants crossing from 1st to 2nd intervention at the end of day 2. Protocol imposed meals in days 1-2 to be repeated in days 3-4. However, meal carbohydrate content used for insulin dosing was reduced in days 3-4 because of suspicion of inaccurate carb estimate from the kitchen and to limit hypoglycemia. This led to significant hypoglycemia reduction in days 3-4, independently of the intervention phase, which complicates data interpretation.'}}, 'adverseEventsModule': {'timeFrame': 'About six months', 'eventGroups': [{'id': 'EG000', 'title': 'Standard HCL Control', 'description': 'Use of standard HCL system', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'HCL Control With Smart Bolus Calculator', 'description': 'Use of HCL system with smart bolus calculator informed by insulin sensitivity', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Low Blood Glucose Index (LBGI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard HCL Control - HCL Control With Smart Bolus Calculator', 'description': 'Use of standard HCL system followed by use of HCL system with smart bolus calculator informed by insulin sensitivity'}, {'id': 'OG001', 'title': 'HCL Control With Smart Bolus Calculator - Standard HCL Control', 'description': 'Use of HCL system with smart bolus calculator informed by insulin sensitivity followed by use of standard HCL system'}], 'classes': [{'title': 'Camp days 1-2', 'categories': [{'measurements': [{'value': '2.87', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '3.19', 'spread': '1.73', 'groupId': 'OG001'}]}]}, {'title': 'Camp days 3-4', 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '0.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.733', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For interaction between study group and intervention', 'groupDescription': 'The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. To test the hypothesis that "HCL Control with Smart Bolus Calculator" reduces exposure to hypoglycemia with respect to "Standard HCL Control", a mixed ANOVA was performed with LBGI as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 hours (dinner postprandial period); the final metric for each intervention type is obtained as the average over two consecutive camp days (days 1-2 for the first intervention; days 3-4 for the second intervention)', 'description': 'LBGI computed from CGM collected in the four hours following the dinner meal.\n\nLBGI is a metric quantifying the risk for hypoglycemia (the higher the LBGI, the higher the exposure to/risk of hypoglycemia), calculated based on the following two steps:\n\n1. Transforming each CGM reading in the time-series of length N into a hypoglycemia risk score (rL(i), i=1,...,N) by applying the following transformation:\n\n rL(i) = 10 x (1.509 x (log(CGM(i))\\^1.084 - 5.381))\\^2, if CGM(i) \\<=112.5 mg/dL; rL(i) = 0, if CGM(i) \\>112.5 mg/dL\n2. Averaging the risk scores rL(i), i=1,...,N.\n\nThe hypoglycemia risk score ranges from 0 for CGM readings \\>112.5 mg/dL (no hypoglycemia risk) to 100 for CGM readings =20 mg/dL (maximum hypoglycemia risk); consequently, LBGI can theoretically assume values between 0 and 100 as well. Clinically relevant LBGI thresholds have been defined:\n\n1. LBGI \\<2.5: low hypoglycemia risk\n2. LBGI in 2.5-5: moderate hypoglycemia risk\n3. LBGI \\>5: high hypoglycemia risk.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Time Spent Below 70 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard HCL Control - HCL Control With Smart Bolus Calculator', 'description': 'Use of standard HCL system followed by use of HCL system with smart bolus calculator informed by insulin sensitivity'}, {'id': 'OG001', 'title': 'HCL Control With Smart Bolus Calculator - Standard HCL Control', 'description': 'Use of HCL system with smart bolus calculator informed by insulin sensitivity followed by use of standard HCL system'}], 'classes': [{'title': 'Camp days 1-2', 'categories': [{'measurements': [{'value': '10.33', 'spread': '14.55', 'groupId': 'OG000'}, {'value': '12.08', 'spread': '7.88', 'groupId': 'OG001'}]}]}, {'title': 'Camp days 3-4', 'categories': [{'measurements': [{'value': '2.31', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '3.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.824', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For interaction between study group and intervention', 'groupDescription': 'The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent below 70 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome', 'description': 'Percentage of CGM readings in hypoglycemia below 70 mg/dL', 'unitOfMeasure': 'percentage of time spent below 70 mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Time Spent in 70-180 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard HCL Control - HCL Control With Smart Bolus Calculator', 'description': 'Use of standard HCL system followed by use of HCL system with smart bolus calculator informed by insulin sensitivity'}, {'id': 'OG001', 'title': 'HCL Control With Smart Bolus Calculator - Standard HCL Control', 'description': 'Use of HCL system with smart bolus calculator informed by insulin sensitivity followed by use of standard HCL system'}], 'classes': [{'title': 'Camp days 1-2', 'categories': [{'measurements': [{'value': '83.16', 'spread': '14.40', 'groupId': 'OG000'}, {'value': '78.16', 'spread': '20.98', 'groupId': 'OG001'}]}]}, {'title': 'Camp days 3-4', 'categories': [{'measurements': [{'value': '81.47', 'spread': '15.30', 'groupId': 'OG000'}, {'value': '85.44', 'spread': '17.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.402', 'groupIds': ['OG000'], 'pValueComment': 'For interaction between study group and intervention', 'groupDescription': 'The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent in 70-180 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome', 'description': 'Percentage of CGM readings in normoglycemia between 70-180 mg/dL', 'unitOfMeasure': 'percentage of time spent in 70-180 mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Time Spent Above 180 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard HCL Control - HCL Control With Smart Bolus Calculator', 'description': 'Use of standard HCL system followed by use of HCL system with smart bolus calculator informed by insulin sensitivity'}, {'id': 'OG001', 'title': 'HCL Control With Smart Bolus Calculator - Standard HCL Control', 'description': 'Use of HCL system with smart bolus calculator informed by insulin sensitivity followed by use of standard HCL system'}], 'classes': [{'title': 'Camp days 1-2', 'categories': [{'measurements': [{'value': '6.51', 'spread': '9.69', 'groupId': 'OG000'}, {'value': '9.76', 'spread': '21.25', 'groupId': 'OG001'}]}]}, {'title': 'Camp days 3-4', 'categories': [{'measurements': [{'value': '16.22', 'spread': '16.37', 'groupId': 'OG000'}, {'value': '9.56', 'spread': '17.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.300', 'groupIds': ['OG000'], 'pValueComment': 'For interaction between study group and intervention', 'groupDescription': 'The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent above 180 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome', 'description': 'Percentage of CGM readings in hyperglycemia above 180 mg/dL', 'unitOfMeasure': 'percentage of time spent above 180 mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'High Blood Glucose Index (HBGI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard HCL Control - HCL Control With Smart Bolus Calculator', 'description': 'Use of standard HCL system followed by use of HCL system with smart bolus calculator informed by insulin sensitivity'}, {'id': 'OG001', 'title': 'HCL Control With Smart Bolus Calculator - Standard HCL Control', 'description': 'Use of HCL system with smart bolus calculator informed by insulin sensitivity followed by use of standard HCL system'}], 'classes': [{'title': 'Camp days 1-2', 'categories': [{'measurements': [{'value': '1.64', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '3.51', 'spread': '8.45', 'groupId': 'OG001'}]}]}, {'title': 'Camp days 3-4', 'categories': [{'measurements': [{'value': '4.10', 'spread': '4.74', 'groupId': 'OG000'}, {'value': '1.85', 'spread': '2.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.168', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For interaction between study arm and intervention', 'groupDescription': 'The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with HBGI as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome', 'description': 'HBGI computed from CGM collected in the four hours following the dinner meal.\n\nHBGI is a metric quantifying the risk for hyperglycemia (the higher the HBGI, the higher the exposure to/risk of hyperglycemia), calculated based on the following two steps:\n\n1. Transforming each CGM reading in the time-series of length N into a hyperglycemia risk score (rH(i), i=1,...,N) by applying the following transformation:\n\n rH(i) = 10 x (1.509 x (log(CGM(i))\\^1.084 - 5.381))\\^2, if CGM(i) \\>112.5 mg/dL; rH(i) = 0, if CGM(i) \\<=112.5 mg/dL\n2. Averaging the risk scores rH(i), i=1,...,N.\n\nThe hyperglycemia risk score ranges from 0 for CGM readings \\<=112.5 mg/dL (no hyperglycemia risk) to 100 for CGM readings =600 mg/dL (maximum hyperglycemia risk); consequently, HBGI can theoretically assume values between 0 and 100 as well. Clinically relevant HBGI thresholds have been defined:\n\n1. HBGI \\<4.5: low hyperglycemia risk\n2. HBGI in 4.5-9: moderate hyperglycemia risk\n3. HBGI \\>9: high hyperglycemia risk.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CGM Coefficient of Variation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard HCL Control - HCL Control With Smart Bolus Calculator', 'description': 'Use of standard HCL system followed by use of HCL system with smart bolus calculator informed by insulin sensitivity'}, {'id': 'OG001', 'title': 'HCL Control With Smart Bolus Calculator - Standard HCL Control', 'description': 'Use of HCL system with smart bolus calculator informed by insulin sensitivity followed by use of standard HCL system'}], 'classes': [{'title': 'Camp days 1-2', 'categories': [{'measurements': [{'value': '25.36', 'spread': '5.81', 'groupId': 'OG000'}, {'value': '25.74', 'spread': '8.69', 'groupId': 'OG001'}]}]}, {'title': 'Camp days 3-4', 'categories': [{'measurements': [{'value': '24.01', 'spread': '5.14', 'groupId': 'OG000'}, {'value': '21.74', 'spread': '5.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.476', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For interaction between study group and intervention', 'groupDescription': 'The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with CGM coefficient of variation as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome', 'description': 'CGM coefficient of variation as a measure of glucose variability', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Amount of Carbohydrate Administered as Rescue Treatments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard HCL Control - HCL Control With Smart Bolus Calculator', 'description': 'Use of standard HCL system followed by use of HCL system with smart bolus calculator informed by insulin sensitivity'}, {'id': 'OG001', 'title': 'HCL Control With Smart Bolus Calculator - Standard HCL Control', 'description': 'Use of HCL system with smart bolus calculator informed by insulin sensitivity followed by use of standard HCL system'}], 'classes': [{'title': 'Camp days 1-2', 'categories': [{'measurements': [{'value': '29.75', 'spread': '25.11', 'groupId': 'OG000'}, {'value': '37.45', 'spread': '23.51', 'groupId': 'OG001'}]}]}, {'title': 'Camp days 3-4', 'categories': [{'measurements': [{'value': '11.54', 'spread': '10.69', 'groupId': 'OG000'}, {'value': '20.41', 'spread': '14.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.914', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For interaction between study group and intervention', 'groupDescription': 'The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with total amount of carbohydrate administered as rescue treatments as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome', 'description': 'Total amount of carbohydrate administered as rescue treatments per study protocol', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard HCL System - HCL System With Smart Bolus Calculator', 'description': 'Use of standard HCL system followed by use of HCL system with smart bolus calculator informed by insulin sensitivity\n\nStandard HCL System: Standard HCL system (USS Virginia)\n\nHCL System with Smart Bolus Calculator: HCL system (USS Virginia) with smart bolus calculator informed by insulin sensitivity'}, {'id': 'FG001', 'title': 'HCL Control With Smart Bolus Calculator - Standard HCL Control', 'description': 'Use of HCL system with smart bolus calculator informed by insulin sensitivity followed by use of standard HCL system\n\nStandard HCL System: Standard HCL system (USS Virginia)\n\nHCL System with Smart Bolus Calculator: HCL system (USS Virginia) with smart bolus calculator informed by insulin sensitivity'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard HCL Control - HCL Control With Smart Bolus Calculator', 'description': 'Use of standard HCL system followed by use of HCL system with smart bolus calculator informed by insulin sensitivity'}, {'id': 'BG001', 'title': 'HCL Control With Smart Bolus Calculator - Standard HCL Control', 'description': 'Use of HCL system with smart bolus calculator informed by insulin sensitivity followed by use of standard HCL system'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '14.6', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '14.2', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hemoglobin A1c', 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '7.2', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '7.2', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-14', 'size': 7436967, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-15T17:15', 'hasProtocol': True}, {'date': '2022-04-14', 'size': 348961, 'label': 'Informed Consent Form: Minor Assent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-15T17:15', 'hasProtocol': False}, {'date': '2022-04-14', 'size': 244356, 'label': 'Informed Consent Form: Minor Assent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-15T17:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-02', 'studyFirstSubmitDate': '2021-05-04', 'resultsFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2021-05-06', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-02', 'studyFirstPostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Low Blood Glucose Index (LBGI)', 'timeFrame': '4 hours (dinner postprandial period); the final metric for each intervention type is obtained as the average over two consecutive camp days (days 1-2 for the first intervention; days 3-4 for the second intervention)', 'description': 'LBGI computed from CGM collected in the four hours following the dinner meal.\n\nLBGI is a metric quantifying the risk for hypoglycemia (the higher the LBGI, the higher the exposure to/risk of hypoglycemia), calculated based on the following two steps:\n\n1. Transforming each CGM reading in the time-series of length N into a hypoglycemia risk score (rL(i), i=1,...,N) by applying the following transformation:\n\n rL(i) = 10 x (1.509 x (log(CGM(i))\\^1.084 - 5.381))\\^2, if CGM(i) \\<=112.5 mg/dL; rL(i) = 0, if CGM(i) \\>112.5 mg/dL\n2. Averaging the risk scores rL(i), i=1,...,N.\n\nThe hypoglycemia risk score ranges from 0 for CGM readings \\>112.5 mg/dL (no hypoglycemia risk) to 100 for CGM readings =20 mg/dL (maximum hypoglycemia risk); consequently, LBGI can theoretically assume values between 0 and 100 as well. Clinically relevant LBGI thresholds have been defined:\n\n1. LBGI \\<2.5: low hypoglycemia risk\n2. LBGI in 2.5-5: moderate hypoglycemia risk\n3. LBGI \\>5: high hypoglycemia risk.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Time Spent Below 70 mg/dL', 'timeFrame': '4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome', 'description': 'Percentage of CGM readings in hypoglycemia below 70 mg/dL'}, {'measure': 'Percentage of Time Spent in 70-180 mg/dL', 'timeFrame': '4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome', 'description': 'Percentage of CGM readings in normoglycemia between 70-180 mg/dL'}, {'measure': 'Percentage of Time Spent Above 180 mg/dL', 'timeFrame': '4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome', 'description': 'Percentage of CGM readings in hyperglycemia above 180 mg/dL'}, {'measure': 'High Blood Glucose Index (HBGI)', 'timeFrame': '4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome', 'description': 'HBGI computed from CGM collected in the four hours following the dinner meal.\n\nHBGI is a metric quantifying the risk for hyperglycemia (the higher the HBGI, the higher the exposure to/risk of hyperglycemia), calculated based on the following two steps:\n\n1. Transforming each CGM reading in the time-series of length N into a hyperglycemia risk score (rH(i), i=1,...,N) by applying the following transformation:\n\n rH(i) = 10 x (1.509 x (log(CGM(i))\\^1.084 - 5.381))\\^2, if CGM(i) \\>112.5 mg/dL; rH(i) = 0, if CGM(i) \\<=112.5 mg/dL\n2. Averaging the risk scores rH(i), i=1,...,N.\n\nThe hyperglycemia risk score ranges from 0 for CGM readings \\<=112.5 mg/dL (no hyperglycemia risk) to 100 for CGM readings =600 mg/dL (maximum hyperglycemia risk); consequently, HBGI can theoretically assume values between 0 and 100 as well. Clinically relevant HBGI thresholds have been defined:\n\n1. HBGI \\<4.5: low hyperglycemia risk\n2. HBGI in 4.5-9: moderate hyperglycemia risk\n3. HBGI \\>9: high hyperglycemia risk.'}, {'measure': 'CGM Coefficient of Variation', 'timeFrame': '4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome', 'description': 'CGM coefficient of variation as a measure of glucose variability'}, {'measure': 'Total Amount of Carbohydrate Administered as Rescue Treatments', 'timeFrame': '4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome', 'description': 'Total amount of carbohydrate administered as rescue treatments per study protocol'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Insulin Sensitivity (SI)', 'Adolescent', 'Insulin Pump', 'Continuous Glucose Monitor (CGM)', 'Hybrid Closed Loop (HCL)', 'Diabetes Camp'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and feasibility of a smart bolus calculator that adjusts insulin dosing for meals according to real-time insulin sensitivity (SI) in adolescents with type 1 diabetes (T1D) using a hybrid closed loop (HCL) system during an active week of diabetes camp.', 'detailedDescription': 'This is a single center, double-blind, randomized, crossover trial. The study team will target enrollment of 30 adolescents (age 12 - \\<18 years) with T1D who currently manage their diabetes with an insulin pump and a continuous glucose monitoring (CGM) system. Participants will be randomized 1:1 to the use of the standard HCL system (USS Virginia) vs. the HCL system with the smart bolus calculator first. The trial will be held at a local camp facility and will consist of EITHER a weeklong (6 day/5 night) camp OR two long weekends (4 day/3 night) separated by a washout period of about one week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥12 and \\<18 years old at time of consent\n2. Clinical diagnosis, based on investigator assessment, of T1D for at least one year\n3. Currently using insulin for at least six months\n4. Currently using an insulin pump for at least three months\n5. Currently using a CGM system for at least three months\n6. Having at least 75% of CGM data over the previous four weeks\n7. Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections\n8. Access to internet and willingness to upload data during the study as needed\n9. For females, not currently known to be pregnant or breastfeeding\n10. A negative urine pregnancy test will be required for all females of childbearing potential\n11. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use\n12. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study\n13. Total daily insulin dose (TDD) of at least 10 U/day\n14. Willingness not to start any non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals)\n15. Willingness to eat at least 40 grams of carbohydrates per meal\n16. An understanding and willingness to follow the protocol and signed informed consent\n17. Participants and parent/legal guardians will be proficient in reading and writing in English\n18. Willingness to comply with COVID-19 precautions as defined by the study team\n19. Having completed a COVID-19 vaccination with an FDA-approved COVID-19 vaccine at least two weeks before the first study admission, and willing to provide a copy of the COVID-19 vaccination card\n\nExclusion Criteria:\n\n1. Hemoglobin A1c \\<5% or \\>10% if measured at screening or available from historical medical report performed within the last 6 months; in absence of a valid HbA1c measurement, average blood glucose estimated from CGM data to be approximately between 100 and 240 mg/dL\n2. History of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment\n3. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment\n4. Pregnancy or intent to become pregnant during the trial\n5. Currently breastfeeding or planning to breastfeed\n6. Currently being treated for a seizure disorder\n7. Planned surgery during study duration\n8. History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)\n9. Treatment with any non-insulin glucose-lowering agent (metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)\n10. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.\n11. Use of an insulin delivery mechanism that is not downloadable by the participant or study team\n12. Known contact with COVID-positive individual within 14 days of any study admission without negative follow-up COVID-19 Polymerase Chain Reaction (PCR) test performed 3-5 days after the date of exposure\n13. Symptoms of COVID-19 (e.g., fever, shortness of breath, unexpected loss of taste or smell) developed within 14 days of any study admission\n14. A positive COVID-19 test within 14 days of any study admission or during study admission participation\n15. Not being fully vaccinated at the time of the first camp admission (according to Center for Disease Control (CDC) guidelines a person is intended to be fully vaccinated after two weeks from either the second dose of the Pfizer or Moderna vaccine, or the single dose of the Johnson \\& Johnson vaccine)'}, 'identificationModule': {'nctId': 'NCT04878120', 'briefTitle': 'Hybrid Closed-Loop Control With Smart Prandial Insulin Dosing in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Hybrid Closed-Loop Control With Prandial Insulin Dosing Informed by Insulin Sensitivity in Adolescents With Type 1 Diabetes', 'orgStudyIdInfo': {'id': '210112'}, 'secondaryIdInfos': [{'id': '4-CDA-2020-948-A-N', 'type': 'OTHER_GRANT', 'domain': 'JDRF International (JDRF)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard HCL System - HCL System with Smart Bolus Calculator', 'description': 'Use of standard HCL system followed by use of HCL system with smart bolus calculator informed by insulin sensitivity', 'interventionNames': ['Device: Standard HCL System', 'Device: HCL System with Smart Bolus Calculator']}, {'type': 'OTHER', 'label': 'HCL System with Smart Bolus Calculator - Standard HCL System', 'description': 'Use of HCL system with smart bolus calculator informed by insulin sensitivity followed by use of standard HCL system', 'interventionNames': ['Device: Standard HCL System', 'Device: HCL System with Smart Bolus Calculator']}], 'interventions': [{'name': 'Standard HCL System', 'type': 'DEVICE', 'description': 'Standard HCL system (USS Virginia)', 'armGroupLabels': ['HCL System with Smart Bolus Calculator - Standard HCL System', 'Standard HCL System - HCL System with Smart Bolus Calculator']}, {'name': 'HCL System with Smart Bolus Calculator', 'type': 'DEVICE', 'description': 'HCL system (USS Virginia) with smart bolus calculator informed by insulin sensitivity', 'armGroupLabels': ['HCL System with Smart Bolus Calculator - Standard HCL System', 'Standard HCL System - HCL System with Smart Bolus Calculator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22902', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Center for Diabetes Technology', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Chiara Fabris, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia Center for Diabetes Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Juvenile Diabetes Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Chiara Fabris, PhD', 'investigatorAffiliation': 'University of Virginia'}}}}