Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT00891995
Status:
TERMINATED
Last Update Posted:
2016-12-30
First Post:
2009-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015190', 'term': 'Blood Glucose Self-Monitoring'}, {'id': 'D007332', 'term': 'Insulin Infusion Systems'}], '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': 'D000085263', 'term': 'Self-Testing'}, {'id': 'D012648', 'term': 'Self Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D016503', 'term': 'Drug Delivery Systems'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D007260', 'term': 'Infusion Pumps'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D001187', 'term': 'Artificial Organs'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kruedy@jaeb.org', 'phone': '8139758690', 'title': 'Katrina Ruedy', 'organization': 'Jaeb Center for Health Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Intensive Treatment', 'description': 'The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.', 'otherNumAtRisk': 48, 'otherNumAffected': 6, 'seriousNumAtRisk': 48, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Standard Treatment', 'description': 'The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.', 'otherNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'severe hypoglycemia', 'notes': 'Severe hypoglycemia occurred in one participant (two events, at 6 months while CGM was being used and 12 months after CGM had been discontinued) in the intensive group and in no participants in the usual care group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'venous thrombosis', 'notes': 'There were two cases of venous thrombosis related to the intravenous line that resolved without consequence.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'faint', 'notes': 'During follow up, in the intensive group, one participant fainted following the 3-month MMTT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'skin infection', 'notes': 'During follow up, in the intensive group, one participant had a skin infection related to the CGM sensor insertion.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'depression and anxiety', 'notes': 'In the usual care group, two participants developed depression and anxiety.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Needle stick/puncture', 'notes': "On admission, during insertion of sensor into abdomen of patient, the skin was pinched up due to minimal body fat. The sensor entered subject's skin then exited other side and punctured nurse's thumb which resulted in cross contamination.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'gastroenteritis', 'notes': 'In the usual care group, one participant was hospitalized for gastroenteritis.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaphylactic reaction', 'notes': 'During inpatient hybrid closed-loop control (HCLC) therapy, one subject had an anaphylactic reaction following his first dinner, presumably resulting from a peanut allergy, and received intravenous steroids.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation', 'notes': 'During follow up, in the intensive group, one participant with a prior history of depression developed suicidal ideation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Treatment', 'description': 'The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.43', 'groupId': 'OG000', 'lowerLimit': '0.34', 'upperLimit': '0.52'}, {'value': '0.52', 'groupId': 'OG001', 'lowerLimit': '0.32', 'upperLimit': '0.75'}]}]}], 'analyses': [{'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'One-sided p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline C-peptide AUC, age, gender and diabetic ketoacidosis.', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At baseline, MMTT data were collected at 0 and 90 min; at 12 months, MMTT data were collected at 0 to 240 min post meal', 'description': 'In the primary analysis of the 12-month Mixed-Meal Tolerance Test (MMTT) results, the geometric mean (95% C.I.) of C-peptide average AUC (=AUC/time) was 0.43 (0.34, 0.52) pmol/ml in the intensive treatment group and 0.52 (0.32, 0.75) pmol/ml in the usual care group (P=0.49).', 'unitOfMeasure': 'pmol/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the 68 participants who completed 1 year visit and with positive autoantibody, 1 participant in the intensive treatment group did not complete MMTT test, thus was excluded from all C-peptide analyses.'}, {'type': 'SECONDARY', 'title': 'Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Treatment', 'description': 'The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.53', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '0.65'}, {'value': '0.65', 'groupId': 'OG001', 'lowerLimit': '0.40', 'upperLimit': '0.95'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 to 240 min post meal at 1 year MMTT', 'unitOfMeasure': 'pmol/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the 68 participants who completed 1 year visit and with positive autoantibody, 1 participant in the intensive treatment group did not complete MMTT test, thus was excluded from all C-peptide analyses.'}, {'type': 'SECONDARY', 'title': 'Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Treatment', 'description': 'The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 240 min post meal at 1 year MMTT', 'description': 'Outcome measure in the table is the incidence of 2 hour peak C-peptide\\>=0.2 pmol/ml. Since the formal clinical trial stopped at 12 months due to lack of efficiency (later follow-up were used to collect data for secondary analyses by pooling the two groups), only the outcome at 12 months are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the 68 participants who completed 1 year visit and with positive autoantibody, 1 participant in the intensive treatment group did not complete MMTT test, thus was excluded from all C-peptide analyses.'}, {'type': 'SECONDARY', 'title': 'HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Treatment', 'description': 'The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.40', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'One-sided p-value', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline A1c, age, gender and Diabetic ketoacidosis', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events (Severe Hypoglycemia)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Treatment', 'description': 'The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CGM Mean Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Treatment', 'description': 'The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000', 'lowerLimit': '117', 'upperLimit': '186'}, {'value': '152', 'groupId': 'OG001', 'lowerLimit': '145', 'upperLimit': '171'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 year', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who used CGM (either blinded or unblinded CGM) for at least 24 hours at 12 months.'}, {'type': 'SECONDARY', 'title': 'CGM Measured Glucose Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Treatment', 'description': 'The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.'}], 'classes': [{'title': '%Glucose 71-180 mg/dL', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '47', 'upperLimit': '83'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '57', 'upperLimit': '79'}]}]}, {'title': '%Glucose <=70 mg/dL', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '7.7'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '5.0'}]}]}, {'title': '%Glucose >180 mg/dL', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '49'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '41'}]}]}, {'title': '%Coefficient of variation', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '39'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '38'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 year', 'description': 'Include a series of glucose indices created from CGM measured glucose data, such as % time with glucose values \\<=70 mg/dl, % time with glucose values within target range of 71-180 mg/dl, % time with glucose values \\>180 mg/dl, and glucose variability as measured by coefficient of variation. These indices were calculated by giving equal weight to each of the 24 h of the day. At least 24 h of CGM data were required for calculating these indices.', 'unitOfMeasure': 'percent', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who used CGM (either blinded or unblinded CGM) for at least 24 hours at 12 months.'}, {'type': 'SECONDARY', 'title': 'Daily Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Treatment', 'description': 'The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'unitOfMeasure': 'u/day/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'BMI Percentile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Treatment', 'description': 'The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '39', 'upperLimit': '81'}, {'value': '62', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 year', 'unitOfMeasure': 'percent', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intensive Treatment', 'description': 'The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and continuous glucose monitoring (CGM) in addition to standard monitoring with a home glucose meter for 2 years.'}, {'id': 'FG001', 'title': 'Standard Treatment', 'description': 'The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intensive Treatment', 'description': 'The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.'}, {'id': 'BG001', 'title': 'Standard Treatment', 'description': 'The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', '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': '12.7', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '14.7', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '13.3', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Only 48 participants in the intensive treatment group and 20 participants in the standard treatment group who show any positive autoantibody in the first year were included in the analyses.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'whyStopped': 'Primary outcome evaluation determined lack of treatment group difference', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-09', 'studyFirstSubmitDate': '2009-04-30', 'resultsFirstSubmitDate': '2016-01-11', 'studyFirstSubmitQcDate': '2009-04-30', 'lastUpdatePostDateStruct': {'date': '2016-12-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-09-02', 'studyFirstPostDateStruct': {'date': '2009-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment.', 'timeFrame': 'At baseline, MMTT data were collected at 0 and 90 min; at 12 months, MMTT data were collected at 0 to 240 min post meal', 'description': 'In the primary analysis of the 12-month Mixed-Meal Tolerance Test (MMTT) results, the geometric mean (95% C.I.) of C-peptide average AUC (=AUC/time) was 0.43 (0.34, 0.52) pmol/ml in the intensive treatment group and 0.52 (0.32, 0.75) pmol/ml in the usual care group (P=0.49).'}], 'secondaryOutcomes': [{'measure': 'Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment', 'timeFrame': '0 to 240 min post meal at 1 year MMTT'}, {'measure': 'Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT', 'timeFrame': '0 to 240 min post meal at 1 year MMTT', 'description': 'Outcome measure in the table is the incidence of 2 hour peak C-peptide\\>=0.2 pmol/ml. Since the formal clinical trial stopped at 12 months due to lack of efficiency (later follow-up were used to collect data for secondary analyses by pooling the two groups), only the outcome at 12 months are reported.'}, {'measure': 'HbA1c', 'timeFrame': '1 year'}, {'measure': 'Adverse Events (Severe Hypoglycemia)', 'timeFrame': '1 year'}, {'measure': 'CGM Mean Glucose', 'timeFrame': '1 year'}, {'measure': 'CGM Measured Glucose Outcomes', 'timeFrame': '1 year', 'description': 'Include a series of glucose indices created from CGM measured glucose data, such as % time with glucose values \\<=70 mg/dl, % time with glucose values within target range of 71-180 mg/dl, % time with glucose values \\>180 mg/dl, and glucose variability as measured by coefficient of variation. These indices were calculated by giving equal weight to each of the 24 h of the day. At least 24 h of CGM data were required for calculating these indices.'}, {'measure': 'Daily Insulin Dose', 'timeFrame': '1 year'}, {'measure': 'BMI Percentile', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 1 Diabetes', 'Closed Loop Therapy', 'Continuous Glucose Monitor'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '24130350', 'type': 'BACKGROUND', 'citation': 'Buckingham B, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Tamborlane WV; Diabetes Research in Children Network (DirecNet) Study Group; Type 1 Diabetes TrialNet Study Group. Effectiveness of early intensive therapy on beta-cell preservation in type 1 diabetes. Diabetes Care. 2013 Dec;36(12):4030-5. doi: 10.2337/dc13-1074. Epub 2013 Oct 15.'}, {'pmid': '23570538', 'type': 'RESULT', 'citation': 'Diabetes Research in Children Network (DirecNet) Study Group; Type 1 Diabetes TrialNet Study Group; Buckingham BA, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Cantwell M. The effects of inpatient hybrid closed-loop therapy initiated within 1 week of type 1 diabetes diagnosis. Diabetes Technol Ther. 2013 May;15(5):401-8. doi: 10.1089/dia.2013.0002. Epub 2013 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if very tight blood glucose control from the onset of Type 1 Diabetes can preserve beta cell function. Study subjects will be randomly assigned to receive either standard diabetes management or intensive diabetes management, which involves several days of closed loop therapy followed by home use of a continuous glucose monitor and insulin pump.', 'detailedDescription': 'The specific aim of this study is to determine if early restoration of metabolic control will improve C-peptide production compared to children receiving routine diabetes management and the secondary aim is to determine if allowing the islet cells to be less metabolically active will have an impact on the underlying autoimmune process.\n\nFollowing completion of the baseline procedures (Mixed Meal Tolerance Test and blood sample collection), participants are randomized to either the Standard Treatment Group or the Intensive Treatment Group which includes 4-6 days of inpatient closed loop therapy followed by outpatient use of an insulin pump and continuous glucose monitor for diabetes management.\n\nAll subjects will be seen 7 times in the first year and 4 times in the second year for follow-up testing. Subjects who are still producing insulin after 2 years may be asked to return every 6 months for an additional 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 6.0 to \\<46.0 years\n* Diagnosis of type 1 diabetes with initiation of insulin therapy within past 7 days (day 1 being the first day of insulin therapy)\n* If participant is female with reproductive potential, willing to avoid pregnancy and pregnancy test negative.\n* Willing to accept randomization to either the intensive diabetes management group or the standard care group.\n* Willing to complete the planned 2 years of follow-up.\n* Able to electronically transmit data monthly.\n* Investigator believes that the participant (and parent/guardian for children) understands and agrees to comply with the study protocol and is capable of undertaking all necessary testing.\n\nExclusion Criteria:\n\n* Currently pregnant or lactating, or anticipate getting pregnant in the next one year.\n* Currently anemic (hematocrit level will be obtained at the screening visit).\n* Chronic use of systemic steroids or other noninsulin pharmaceuticals that might affect glycemic control or the presence of a disease that is likely to be treated with such medications during the first two years of the study.\n* Complicating medical issues that might interfere with study conduct.\n* Inpatient psychiatric treatment in the past 6 months (if the participant is a minor, for either the participant or the participant's primary care giver).\n* Currently participating in another type 1 diabetes treatment study, including an intervention trial for treatment of diabetic ketoacidosis."}, 'identificationModule': {'nctId': 'NCT00891995', 'briefTitle': 'Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes', 'nctIdAliases': ['NCT00505206'], 'organization': {'class': 'OTHER', 'fullName': 'Jaeb Center for Health Research'}, 'officialTitle': 'Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'DirecNet 012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive Treatment', 'description': 'closed loop therapy (4-6 days), insulin pump (2 years), continuous glucose monitoring (2 years), home glucose monitoring (2 years)', 'interventionNames': ['Device: Closed loop', 'Device: Home glucose monitoring', 'Device: Insulin pump', 'Device: Continuous glucose monitor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Treatment', 'description': 'home glucose monitoring (2 years)', 'interventionNames': ['Device: Home glucose monitoring']}], 'interventions': [{'name': 'Closed loop', 'type': 'DEVICE', 'description': 'Closed loop therapy for up to 4 to 6 days', 'armGroupLabels': ['Intensive Treatment']}, {'name': 'Home glucose monitoring', 'type': 'DEVICE', 'description': 'Standard diabetes management using a home glucose meter.', 'armGroupLabels': ['Intensive Treatment', 'Standard Treatment']}, {'name': 'Insulin pump', 'type': 'DEVICE', 'description': 'Insulin pump use for 2 years', 'armGroupLabels': ['Intensive Treatment']}, {'name': 'Continuous glucose monitor', 'type': 'DEVICE', 'description': 'Continuous glucose monitor use for 2 years', 'armGroupLabels': ['Intensive Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80010', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center for Childhood Diabetes', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Roy W Beck, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jaeb Center for Health Research'}, {'name': 'Jay S. Skyler, M.D., M.A.C.P.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jaeb Center for Health Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}