Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2026-02-18 @ 1:44 AM
Study NCT ID:
NCT02199028
Status:
COMPLETED
Last Update Posted:
2019-10-11
First Post:
2014-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hyaluronidase Effect on Infusion Set Life
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': 'D006821', 'term': 'Hyaluronoglucosaminidase'}], 'ancestors': [{'id': 'D006026', 'term': 'Glycoside Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D011133', 'term': 'Polysaccharide-Lyases'}, {'id': 'D019757', 'term': 'Carbon-Oxygen Lyases'}, {'id': 'D008190', 'term': 'Lyases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'buckingham@stanford.edu', 'phone': '(408) 356-0911', 'title': 'Dr Bruce Buckingham', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was a proof on concept pilot study and included a small number of participants. There was no evidence that hyaluronidase prolonged infusion set wear.'}}, 'adverseEventsModule': {'timeFrame': "Adverse events were recorded during subject's participation in the study (screening to final visit). Adverse events were followed from onset to resolution.", 'description': 'Adverse events were recorded during weeks of infusion set wear. In the study a total of 117 weeks of infusion set wear were available for analysis including 58 hyaluronidase weeks and 59 control weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Hyaluronidase Week', 'description': 'Infuse 1mL Hyaluronidase at time of infusion set placement and again on Day 3\n\nHyaluronidase: If assigned to hyaluronidase week, subjects will inject 1 milliliter (ml) Hylenex (150 units/ml) into the catheter hub prior to connecting the insulin infusion set. They will then give a catheter fixed prime of 0.7 cc to clear the infusion set of hyaluronidase. On the morning of day 3 during a Hyaluronidase week, a second dose of 1ml Hylenex (150 units/1ml) will be injected through the catheter hub prior to breakfast using the Duo Infusion Set Tubing. They will then reconnect their pump catheter and give a fixed prime of 0.7 cc to clear the infusion set of hyaluronidase.', 'otherNumAtRisk': 30, 'otherNumAffected': 16, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Week', 'description': 'Subjects will not receive Hyaluronidase during this week', 'otherNumAtRisk': 30, 'otherNumAffected': 17, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Erythema >10 mm diameter', 'notes': 'Erythema at infusion set insertion site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Erythema'}, {'term': 'Infection at infusion set site', 'notes': 'abscess at insertion site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'abscess'}, {'term': 'Infection at sensor site', 'notes': 'abscess at Dexcom sensor insertion site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'abscess'}, {'term': 'Rash', 'notes': 'Tape allergy from Dexcom sensor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Rash'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of Insulin Infusion Set Wear as a Measure of the Effect of Hyaluronidase Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'week of infusion set wear', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase', 'description': 'Infuse 1mL Hyaluronidase at time of infusion set placement and again on Day 3\n\nHyaluronidase: If assigned to hyaluronidase week, subjects will inject 1 milliliter (ml) Hylenex (150 units/ml) into the catheter hub prior to connecting the insulin infusion set. They will then give a catheter fixed prime of 0.7 cc to clear the infusion set of hyaluronidase. On the morning of day 3 during a Hyaluronidase week, a second dose of 1ml Hylenex (150 units/1ml) will be injected through the catheter hub prior to breakfast using the Duo Infusion Set Tubing. They will then reconnect their pump catheter and give a fixed prime of 0.7 cc to clear the infusion set of hyaluronidase.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects will not receive Hyaluronidase during this week'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 weeks', 'description': 'Average (mean) days of wear are presented for each group. A longer period of wear was considered a better outcome.', 'unitOfMeasure': 'Days of wear', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'week of infusion set wear', 'denomUnitsSelected': 'week of infusion set wear', 'populationDescription': 'Thirty subjects were enrolled in this study; 28 completed all scheduled visits. Therefore, 117 total weeks of infusion set wear were available for analysis including 58 hyaluronidase weeks and 59 standard weeks.'}, {'type': 'SECONDARY', 'title': 'Maximum Glycemic Excursion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase', 'description': 'Infuse 1mL Hyaluronidase at time of infusion set placement and again on Day 3\n\nHyaluronidase: If assigned to hyaluronidase week, subjects will inject 1 milliliter (ml) Hylenex (150 units/ml) into the catheter hub prior to connecting the insulin infusion set. They will then give a catheter fixed prime of 0.7 cc to clear the infusion set of hyaluronidase. On the morning of day 3 during a Hyaluronidase week, a second dose of 1ml Hylenex (150 units/1ml) will be injected through the catheter hub prior to breakfast using the Duo Infusion Set Tubing. They will then reconnect their pump catheter and give a fixed prime of 0.7 cc to clear the infusion set of hyaluronidase.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects will not receive Hyaluronidase during this week'}], 'classes': [{'title': 'Day 1 0-1 hour of infusion set', 'categories': [{'measurements': [{'value': '43.5', 'spread': '44.5', 'groupId': 'OG000'}, {'value': '69.5', 'spread': '47.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 12-24 hours of infusion set', 'categories': [{'measurements': [{'value': '36.9', 'spread': '35.1', 'groupId': 'OG000'}, {'value': '72', 'spread': '48.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 2 24-48 hours of infusion set', 'categories': [{'measurements': [{'value': '56.4', 'spread': '25.9', 'groupId': 'OG000'}, {'value': '51.6', 'spread': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours post infusion', 'description': 'The effects of hyaluronidase on post-prandial glucodymamic parameters is presented as the estimated glycemic excursion, a composite value which was calculated based on peak glucose concentration (Cmax), time to Cmax (Tmax), time to early half-maximal glucose concentration (t50%), time to late t50%, and area under the curve (AUC) of glucose concentrations at time intervals of 120 and 240 minutes, with or without hyaluronidase. Estimated glycemic excursion for a patient with Type 1 diabetes that is less than 80 mg/dL is considered acceptable.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Tolerability of Hyaluronidase Injections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}, {'units': 'Diary Entries', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase Injections', 'description': 'Infuse 1mL Hyaluronidase at time of infusion set placement and again on Day 3\n\nHyaluronidase: If assigned to hyaluronidase week, subjects will inject 1 milliliter (ml) Hylenex (150 units/ml) into the catheter hub prior to connecting the insulin infusion set. They will then give a catheter fixed prime of 0.7 cc to clear the infusion set of hyaluronidase. On the morning of day 3 during a Hyaluronidase week, a second dose of 1ml Hylenex (150 units/1ml) will be injected through the catheter hub prior to breakfast using the Duo Infusion Set Tubing. They will then reconnect their pump catheter and give a fixed prime of 0.7 cc to clear the infusion set of hyaluronidase.'}], 'classes': [{'title': '"0" on 0-5 pain scale', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': '"1" on 0-5 pain scale', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': '"2" on 0-5 pain scale', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '"3" on 0-5 pain scale', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '"4" on 0-5 pain scale', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '"5" on 0-5 pain scale', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 weeks', 'description': 'Patients recorded pain experience at the infusion site (at time of injection and pain each day of wear) in subject diaries on a 0-5 pain scale (0 = no pain and 5 = worst pain imaginable).\n\nThe number of diary entries are presented by scale category.', 'unitOfMeasure': 'Diary entries', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Diary Entries', 'denomUnitsSelected': 'Diary Entries', 'populationDescription': 'Only participants in the Hyaluronidase injections group completed diary entries to track pain.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hylenex, Then Control', 'description': 'Participants assigned to active treatment arm (Hylenex) for weeks 1 and 3.\n\nOn weeks 1 and 3 (Hylenex weeks) subjects injected 1 milliliter (ml) Hylenex (150 units/ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear.\n\nOn weeks 2 and 4 (control weeks) no Hylenex was administered.'}, {'id': 'FG001', 'title': 'Control, Then Hylenex', 'description': 'Participants were first assigned to the control arm. They received active treatment (Hylenex) on weeks 2 and 4.\n\nOn weeks 1 and 3 (control weeks) no Hylenex was administered.\n\nOn weeks 2 and 4 (Hylenex weeks) subjects injected 1 milliliter (ml) Hylenex (150 units/ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear.'}], 'periods': [{'title': 'Week 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Week 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Week 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Week 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 30 subjects with Type 1 diabetes between 12-45 years were enrolled at 2 academic medical centers. 28 subjects completed the full 4 weeks of the study. 2 subjects discontinued for the study early. The last subject completed in March 2015.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hylenex, Then Control', 'description': 'Participants were first assigned to the control arm. They received active treatment (Hylenex) on weeks 2 and 4.\n\nOn weeks 1 and 3 (control weeks) no Hylenex was administered.\n\nOn weeks 2 and 4 (Hylenex weeks) subjects injected 1 milliliter (ml) Hylenex (150 units/ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear.'}, {'id': 'BG001', 'title': 'Control, Then Hylenex', 'description': 'Participants were first assigned to the control arm. They received active treatment (Hylenex) on weeks 2 and 4.\n\nOn weeks 1 and 3 (control weeks) no Hylenex was administered.\n\nOn weeks 2 and 4 (Hylenex weeks) subjects injected 1 milliliter (ml) Hylenex (150 units/ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', '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': '24.80552', 'spread': '8.22924', 'groupId': 'BG000'}, {'value': '30.06919', 'spread': '8.33594', 'groupId': 'BG001'}, {'value': '27.52718', 'spread': '8.57883', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Subjects between 12-45 years (inclusive) with clinical diagnosis of type 1 diabetes for at least one year, using an insulin pump for at least 3 months, and with an A1C less than 10%. 30 total subjects across two sites were enrolled and randomized the first week to either be in the control or experimental arm.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2014-01-28', 'resultsFirstSubmitDate': '2016-11-03', 'studyFirstSubmitQcDate': '2014-07-21', 'lastUpdatePostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-24', 'studyFirstPostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Insulin Infusion Set Wear as a Measure of the Effect of Hyaluronidase Treatment', 'timeFrame': 'Up to 4 weeks', 'description': 'Average (mean) days of wear are presented for each group. A longer period of wear was considered a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Maximum Glycemic Excursion', 'timeFrame': 'Up to 24 hours post infusion', 'description': 'The effects of hyaluronidase on post-prandial glucodymamic parameters is presented as the estimated glycemic excursion, a composite value which was calculated based on peak glucose concentration (Cmax), time to Cmax (Tmax), time to early half-maximal glucose concentration (t50%), time to late t50%, and area under the curve (AUC) of glucose concentrations at time intervals of 120 and 240 minutes, with or without hyaluronidase. Estimated glycemic excursion for a patient with Type 1 diabetes that is less than 80 mg/dL is considered acceptable.'}, {'measure': 'Pain Tolerability of Hyaluronidase Injections', 'timeFrame': 'Up to 4 weeks', 'description': 'Patients recorded pain experience at the infusion site (at time of injection and pain each day of wear) in subject diaries on a 0-5 pain scale (0 = no pain and 5 = worst pain imaginable).\n\nThe number of diary entries are presented by scale category.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hyaluronidase', 'infusion sets', 'insulin pump', 'Continuous glucose monitor'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '24090124', 'type': 'BACKGROUND', 'citation': 'Patel PJ, Benasi K, Ferrari G, Evans MG, Shanmugham S, Wilson DM, Buckingham BA. Randomized trial of infusion set function: steel versus teflon. Diabetes Technol Ther. 2014 Jan;16(1):15-9. doi: 10.1089/dia.2013.0119. Epub 2013 Oct 3.'}, {'pmid': '22920800', 'type': 'BACKGROUND', 'citation': 'Muchmore DB, Vaughn DE. Accelerating and improving the consistency of rapid-acting analog insulin absorption and action for both subcutaneous injection and continuous subcutaneous infusion using recombinant human hyaluronidase. J Diabetes Sci Technol. 2012 Jul 1;6(4):764-72. doi: 10.1177/193229681200600405.'}, {'pmid': '19764836', 'type': 'BACKGROUND', 'citation': 'Clausen TS, Kaastrup P, Stallknecht B. Effect of insulin catheter wear-time on subcutaneous adipose tissue blood flow and insulin absorption in humans. Diabetes Technol Ther. 2009 Sep;11(9):575-80. doi: 10.1089/dia.2009.0058.'}, {'pmid': '27222506', 'type': 'DERIVED', 'citation': 'DeSalvo DJ, Ly TT, Wadwa RP, Messer L, Westfall E, Gopisetty D, Hanes S, von Eyben R, Maahs DM, Buckingham BA. Continuous Glucose Sensor Survival and Accuracy Over 14 Consecutive Days. Diabetes Care. 2016 Aug;39(8):e112-3. doi: 10.2337/dc16-0796. Epub 2016 May 23. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This research study examines the effect of hyaluronidase on the length of time of insulin infusion set wear. The aim of the study is to improve the length of time that an infusion set can be worn by infusing hyaluronidase directly into the insulin infusion site.', 'detailedDescription': 'The investigators would like to see if the use of hyaluronidase will improve insulin infusion set survival and improve the onset of insulin action. The investigators will also assess the accuracy of the Dexcom G4P sensors with extended site use beyond the 7 day FDA approved time frame.\n\nThe use of sensor information combined with the knowledge of infused insulin from pump therapy could potentially help us detect when an infusion set is beginning to fail. Information from the sensor function to the point of failure, and sensor function in response to Tylenol may allow us to develop special formulas to determine when a sensor is not working well. This will be very important for creating an artificial pancreas.\n\nThirty subjects will be enrolled. Fifteen patients from each of the two sites: Stanford University and University of Colorado.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 3 months\n2. Total daily insulin dose of at least 0.4 units/kg/day\n3. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.\n4. Age 12 to 45 years\n5. Hemoglobin A1c level less than or equal to 10%\n6. Willingness to infuse 1 ml of hyaluronidase (Hylenex) into the insulin infusion set after insertion on day 1 and day 3 of the week they are assigned to use hyaluronidase\n7. Willingness to use a Silhouette or Comfort insulin infusion set throughout the study. The set includes the Duo Infusion Tubing for infusion of hyaluronidase (Hylenex).\n8. Willingness to eat the same breakfast each morning for the first two weeks of the study\n9. Willing to take two 500mg tablets of Tylenol Regular Strength and monitor glucose levels at ½, 1, 2, 4, 6, and 8 hours later.\n10. For females, not currently known to be pregnant\n11. An understanding of and willingness to follow the protocol and sign the informed consent\n12. Must be able to understand spoken or written English\n\nExclusion Criteria:\n\n1. Diabetic ketoacidosis in the past 6 months\n2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment\n3. Known tape allergies\n4. Current treatment for a seizure disorder\n5. Cystic fibrosis\n6. Active infection\n7. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:\n8. Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)\n9. Presence of a known adrenal disorder\n10. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study\n11. Abuse of alcohol\n12. Use of an OmniPod insulin infusion pump\n13. Pregnant or lactating females"}, 'identificationModule': {'nctId': 'NCT02199028', 'briefTitle': 'Hyaluronidase Effect on Infusion Set Life', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Evaluation of Glucose Sensor and Insulin Infusion Set Failures: Hyaluronidase Study', 'orgStudyIdInfo': {'id': '28949'}, 'secondaryIdInfos': [{'id': 'JDRF 17-2013/471', 'type': 'OTHER_GRANT', 'domain': 'JDRF'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyaluronidase, Then Control', 'description': 'Participants assigned to active treatment arm (Hylenex) for weeks 1 and 3.\n\nOn weeks 1 and 3 (Hyaluronidase weeks) subjects injected 1 milliliter (ml) Hyaluronidase (150 units/ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear.\n\nOn weeks 2 and 4 (control weeks) no Hyaluronidase was administered.', 'interventionNames': ['Drug: Hyaluronidase', 'Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Control, Then Hyaluronidase', 'description': 'Participants were first assigned to the control arm. They received active treatment (Hyaluronidase) on weeks 2 and 4.\n\nOn weeks 1 and 3 (control weeks) no Hyaluronidase was administered.\n\nOn weeks 2 and 4 (Hyaluronidase weeks) subjects injected 1 milliliter (ml) Hyluronidase (150 units/ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear.', 'interventionNames': ['Drug: Hyaluronidase', 'Other: Control']}], 'interventions': [{'name': 'Hyaluronidase', 'type': 'DRUG', 'otherNames': ['Hylenex'], 'description': '150 units/ml - subjects injected 1 milliliter (ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear.', 'armGroupLabels': ['Control, Then Hyaluronidase', 'Hyaluronidase, Then Control']}, {'name': 'Control', 'type': 'OTHER', 'description': 'No hyaluronidase administered into insulin infusion set.', 'armGroupLabels': ['Control, Then Hyaluronidase', 'Hyaluronidase, Then Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Bruce A Buckingham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Colorado, Denver', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Bruce A. Buckingham', 'investigatorAffiliation': 'Stanford University'}}}}