Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-03-02 @ 4:02 PM
Study NCT ID:
NCT00574405
Status:
COMPLETED
Last Update Posted:
2017-09-13
First Post:
2007-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'D061267', 'term': 'Insulin Aspart'}, {'id': 'D061268', 'term': 'Insulin Lispro'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061266', 'term': 'Insulin, Short-Acting'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thrailkillkathrynm@uams.edu', 'phone': '501-364-1430', 'title': 'Kathryn Thrailkill, MD', 'organization': "Arkansas Children's Hospital Research Institute"}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Post hoc analysis demonstrated that the study design was weakened by an underestimation of the sample size per group needed to determine a statistically significant result for our primary outcome measure.'}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Multiple Daily Injection Therapy', 'description': 'Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.', 'otherNumAtRisk': 12, 'otherNumAffected': 10, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Insulin Pump Therapy, Started at Diagnosis.', 'description': 'Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.', 'otherNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain/constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}, {'term': 'Pump malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other'}, {'term': 'Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other'}, {'term': 'pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other'}, {'term': 'Vision change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other'}, {'term': 'myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other'}], 'seriousEvents': [{'term': 'Hospitilized for treatment of Urinary tract infection', 'notes': 'Subject was hospitilized in a local hospital for initial treatment of symptoms of a urinary tract infection; discharged home on oral antibiotics, in good condition. Patient had a history of recurrent UTIs, prior to study enrollment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multiple Daily Injection Therapy', 'description': 'Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.'}, {'id': 'OG001', 'title': 'Insulin Pump Therapy, Started at Diagnosis.', 'description': 'Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Changes in Glycemic Control, as Assessed by the Change in Hemoglobin A1c and Variations in Daily Blood Glucose Measurements (Fasting BG and CGMS) From Day 1 of Treatment to Month 12 of Treatment.', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Changes in Daily Insulin Requirements Over Time', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis.', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Multiple Daily Injection Therapy', 'description': 'Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.'}, {'id': 'FG001', 'title': 'Insulin Pump Therapy, Started at Diagnosis.', 'description': 'Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '104 children with T1D were screened between 04/05-02/09; 64 declined to participate; 16 did not meet inclusion/exclusion criteria. 24 subjects (12 per group) were enrolled. 1 subject in each group withdrew after initial randomization. Of the remaining 22, 1 completed the 9-mo visit, 1 completed the 6-mo visit, and 1 completed the 1-mo visit.', 'preAssignmentDetails': 'One subject in each group withdrew from further participation after initial randomization, possibly because of dissatisfaction with the assigned mode of treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Multiple Daily Injection Therapy', 'description': 'Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.'}, {'id': 'BG001', 'title': 'Insulin Pump Therapy, Started at Diagnosis.', 'description': 'Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.'}, {'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': '12', 'groupId': 'BG001'}, {'value': '24', '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': '12.1', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '12.1', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '12.1', 'spread': '2.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-11', 'studyFirstSubmitDate': '2007-12-12', 'resultsFirstSubmitDate': '2011-07-14', 'studyFirstSubmitQcDate': '2007-12-14', 'lastUpdatePostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-07-14', 'studyFirstPostDateStruct': {'date': '2007-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Changes in Glycemic Control, as Assessed by the Change in Hemoglobin A1c and Variations in Daily Blood Glucose Measurements (Fasting BG and CGMS) From Day 1 of Treatment to Month 12 of Treatment.', 'timeFrame': '12 months'}, {'measure': 'Changes in Daily Insulin Requirements Over Time', 'timeFrame': '12 months'}, {'measure': 'Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis.', 'timeFrame': '12 months'}, {'measure': 'Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Insulin pump', 'Beta cell'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Type I diabetes (T1DM) is the second most common chronic illness effecting children in the USA. Worldwide, Type I diabetes is increasing in incidence, and its underlying etiology remains elusive. Nevertheless, recent data supports the notion that early and intensive management of Type I diabetes can 1) decrease long-term complications of diabetes; and 2) may significantly improve beta cell function and insulin secretion over ensuing years. To this end, we propose using insulin pump therapy to preserve and/or enhance residual endogenous B-cell secretory capacity among patients with newly diagnosed Type 1 DM. Furthermore, we anticipate that early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple daily injection (MDI) therapy, and will be well-tolerated by the patient. These data will provide important pilot information to explore the potential role of intensive insulin pump therapy in the treatment of children newly diagnosed with Type I diabetes. The specific aim of this study is to test the following hypothesis: Early use of insulin pump therapy is effective in preserving or enhancing residual endogenous pancreatic B-cell secretory capacity among patients with newly diagnosed T1DM: Moreover, early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple injection therapy, and will be well-tolerated by the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical history and clinical presentation consistent with the diagnosis of Type 1 DM.\n* Age: 8-18 years\n\nExclusion Criteria:\n\n* Clinical presentation consistent with Type 2 DM.\n* History of other chronic systemic inflammatory or autoimmune disease or other severe medical conditions.\n* Concurrent pregnancy.\n* Participation in other research protocols or use of other investigational agents within 30 days of enrollment.'}, 'identificationModule': {'nctId': 'NCT00574405', 'acronym': 'ktpump', 'briefTitle': 'Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy', 'organization': {'class': 'OTHER', 'fullName': "Arkansas Children's Hospital Research Institute"}, 'officialTitle': 'Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy', 'orgStudyIdInfo': {'id': '29256'}, 'secondaryIdInfos': [{'id': 'CUMG - 090104KT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'MDI = 3-4+ insulin injections/day, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®).', 'interventionNames': ['Drug: MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®])']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.', 'interventionNames': ['Device: CSII (Animas Corporation insulin pump, model IR 1200)']}], 'interventions': [{'name': 'MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®])', 'type': 'DRUG', 'otherNames': ['Novolog® or Humalog®'], 'description': 'MDI = 3-4+ insulin injections/day, using NPH + regular insulin or Lantus + insulin lispro; 12 month treatment duration.', 'armGroupLabels': ['1']}, {'name': 'CSII (Animas Corporation insulin pump, model IR 1200)', 'type': 'DEVICE', 'otherNames': ['Animas Corporation insulin pump, model IR 1200'], 'description': 'CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital/Research Institute", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Kathryn M Thrailkill, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Arkansas Children's Hospital Research Institute"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}