Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-27 @ 9:28 AM
Study NCT ID:
NCT00928057
Status:
COMPLETED
Last Update Posted:
2010-10-20
First Post:
2009-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Glycemic Control Among Diabetics Using Three Different Pen Needles
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kenneth_kassler-taub@bd.com', 'phone': '201 847 6729', 'title': 'Kenneth Kassler-Taub, MD', 'organization': 'BD Medical, Medical Affairs'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'upon enrollment to study completion', 'description': 'Adverse events collection began once subjects were enrolled and continued throughout the 6 week randomized intervention period.\n\nThe Investigator considered all Serious Adverse Events as unlikely to be related to, or not related to, the study devices or procedures.', 'eventGroups': [{'id': 'EG000', 'title': '8mm PN', 'description': 'All randomized subjects that used the 8 mm pen needle.', 'otherNumAtRisk': 84, 'otherNumAffected': 24, 'seriousNumAtRisk': 84, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': '5mm PN', 'description': 'All randomized subjects that used the 5 mm pen needle.', 'otherNumAtRisk': 89, 'otherNumAffected': 23, 'seriousNumAtRisk': 89, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '4mm PN', 'description': 'All randomized subjects that used the 4mm pen needle.', 'otherNumAtRisk': 173, 'otherNumAffected': 40, 'seriousNumAtRisk': 173, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'hypoglycemia', 'notes': 'all nonserious events including severe unexplained events as defined by the protocol', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 36}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperglycemia', 'notes': 'all nonserious events including severe unexplained events as defined by the protocol', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain at injection site', 'notes': 'The investigator was not required to report mild, self-limited injection site pain as an adverse event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 173, 'numAffected': 27}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-Hodgkins lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent (%) Absolute Change in Fructosamine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '4 mm / 8 mm PN', 'description': 'use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN'}, {'id': 'OG001', 'title': '4 mm / 5 mm PN', 'description': 'use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '6.4'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '6.0'}]}]}], 'analyses': [{'pValue': '0.506', 'groupIds': ['OG000'], 'pValueComment': 'The threshold for statistical significance, or alpha, is 0.05.', 'groupDescription': 'The effects of pen needle type on glycemic control were tested for statistical significance using analysis of variance (ANOVA). The ANOVA model was used to calculate the absolute percent (%)change in fructosamine (% \\|∆ Fru\\|), with 95 % confidence intervals.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANOVA model has effects for subject, insulin dose group, investigator site and order of pen needle use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To conclude equivalence for glycemic control, the average absolute percent change in fructosamine and 95% confidence interval had to be within 20%.\n\n80 subjects were required to be in each insulin dose group (40 per PN arm) to provide 90% power for an equivalence with alpha=0.05.'}, {'pValue': '0.878', 'groupIds': ['OG001'], 'pValueComment': 'The threshold for significance, or alpha, is 0.05.', 'groupDescription': 'The effects of pen needle type on glycemic control were tested for statistical significance using ANOVA. The ANOVA model was used to calculate the % \\|∆ Fru\\|, with 95% confidence intervals.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANOVA model has effects for subject, insulin dose group, investigator site and order of pen needle use.', 'testedNonInferiority': True, 'nonInferiorityComment': 'To conclude equivalence for glycemic control, the average absolute percent change in fructosamine and 95% confidence interval had to be within 20%.\n\n80 subjects were required to be in each insulin dose group (40 per PN arm) to provide 90% power for an equivalence with alpha=0.05.'}], 'paramType': 'MEAN', 'timeFrame': '3 weeks per pen needle, from visit 2-3 and visit 3-4.', 'description': 'Within each study arm (4mm / 5mm PN, or 4mm / 8mm PN) subjects used one pen needle (PN) for 3 weeks then switched to the alternate PN for the next three weeks, for a total of 6 weeks. The principal endpoint measure of glycemic control is the percent absolute change in serum fructosamine concentration, based on the fructosamine (FRU) concentration measured in micromoles per liter (umol/L) at the end of each three week period. The change was calculated according to the following formula:\n\nPercent absolute change in FRU, or %\\|∆ FRU\\|= 100\\*\\[FRU(4mm)-FRU(5 or 8mm)\\]/\\[FRU(5 or 8mm)\\].', 'unitOfMeasure': 'Percent absolute change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '167 subjects completed the study. 163 of the 167 completed subjects were included in this analysis. Four (4) of 167 were excluded due to out of window fructosamine samples (3), or laboratory error with fructosamine sample (1).'}, {'type': 'SECONDARY', 'title': 'Percent Absolute Change in Fructosamine, by Dose Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '4 mm / 8 mm PN', 'description': 'use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN'}, {'id': 'OG001', 'title': '4 mm / 5 mm PN', 'description': 'use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN'}], 'classes': [{'title': 'Low Insulin Dose Group', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '6.7'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '7.2'}]}]}, {'title': 'Regular Insulin Dose Group', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '7.0'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '5.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks per pen needle, from visit 2-3 and visit 3-4.', 'description': 'Glycemic control was determined separately for each insulin dose group in the same manner as described for the primary outcome measure, according to the following formula:\n\n%\\|∆ FRU\\|= 100\\*\\[FRU(4mm)-FRU(5 or 8mm)\\]/\\[FRU(5 or 8mm)\\].', 'unitOfMeasure': 'Percent absolute change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '4 of the 167 completed subjects were excluded for out of window fructosamine samples (3), or lab error with a sample (1).\n\nFor 4 mm/8 mm: this includes 45 subjects in the Low Dose insulin group and 35 in the Regular Dose group. For 4 mm/5 mm: this includes 47 subjects in the Low Dose insulin group and 36 in the Regular Dose group.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Severe Unexplained Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '4 mm PN', 'description': 'All randomized subjects that used the 4mm PN, either during the first or second 3 weeks of the study.'}, {'id': 'OG001', 'title': '5 mm PN', 'description': 'All randomized subjects that used the 5mm PN, either during the first or second 3 weeks of the study.'}, {'id': 'OG002', 'title': '8 mm PN', 'description': 'All randomized subjects that used the 8mm PN, either during the first or second 3 weeks of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During 3 weeks using each pen needle', 'description': "Severe Unexplained Hypoglycemia is defined as an event in which the subject's blood glucose is below 50 milligrams per deciliter (mg/dL) and/or they required assistance from another person for treatment and there is no identified cause (for example, the subject skipped a meal). These events were also reported as Adverse Events.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects that were randomized and used at least one of the study pen needles are included. The number of subjects with one or more events while using each PN is presented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Severe Unexplained Hyperglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '4 mm PN', 'description': 'All randomized subjects that used the 4mm PN, either during the first or second 3 weeks of the study.'}, {'id': 'OG001', 'title': '5 mm PN', 'description': 'All randomized subjects that used the 5mm PN, either during the first or second 3 weeks of the study.'}, {'id': 'OG002', 'title': '8 mm PN', 'description': 'All randomized subjects that used the 8mm PN, either during the first or second 3 weeks of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During 3 weeks using each pen needle', 'description': 'Severe Unexplained Hyperglycemia is defined as requiring a visit to the emergency room or hospitalization and/or having a blood glucose value above 450mg/dL without an identified cause (for example, the subject missed an insulin dose). These events were also reported as Adverse Events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects that were randomized and used at least one of the study pen needles are included. The number of subjects with one or more events while using each PN is presented.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Subjects With at Least One Leakage Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '4 mm PN', 'description': 'All randomized subjects that used the 4mm PN'}, {'id': 'OG001', 'title': '5 mm PN', 'description': 'All randomized subjects that used the 5mm PN'}, {'id': 'OG002', 'title': '8 mm PN', 'description': 'All randomized subjects that used the 8mm PN'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'each PN was used for 3 weeks', 'description': 'After each insulin injection with a study pen needle, subjects recorded in their study diary if they observed insulin leakage from the injection site. Subjects were not required to make a diary entry if there was no leakage.', 'unitOfMeasure': 'percent of subjects', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relative Injection Pain Score Assessed by Subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '4 mm / 8 mm PN', 'description': 'use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN'}, {'id': 'OG001', 'title': '4 mm / 5 mm PN', 'description': 'use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.26', 'spread': '4.24', 'groupId': 'OG000'}, {'value': '-11.91', 'spread': '5.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG001'], 'pValueComment': 'The threshold for statistical significance, or alpha, is 0.05.', 'groupDescription': 'The null hypothesis is that the pain from the 4mm is the same or greater than the pain for the reference. The alternative hypothesis is that the pain from the 4mm is less than the pain for the reference.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'As described for the 4 vs. 5mm statistical analysis.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Visit 4: 18-24 days after starting 2nd pen needle', 'description': 'After using the second assigned pen needle (PN) for 3 weeks, subjects used a 150mm Visual Analog Scale (VAS) to rate the pain of the second PN relative to the first PN. The VAS was anchored at the center (0mm) with "as painful", and at the extreme ends with "much less painful" (-75mm) and "much more painful" (+75mm). VAS scores were adjusted for the order of PN use, such that a positive score means that the 4mm PN was scored as more painful than the reference PN (5mm or 8mm), and a negative score indicates that the 4mm PN was less painful than the reference.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 167 subjects that completed the study, 137 subjects had within-window VAS pain scores for Visit 4 and were included in this analysis. Per the protocol, the allowable visit window was 18-24 days from Visit 3, when the subject switched from the 1st to 2nd assigned pen needle.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Reported Injection Site Leakage Events, by Pen Needle Type and Droplet Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '4 mm PN', 'description': 'Use of 4 mm PN for insulin injections for 3 weeks.'}, {'id': 'OG001', 'title': '5 mm PN', 'description': 'Use of 5 mm PN for insulin injections for 3 weeks.'}, {'id': 'OG002', 'title': '8 mm PN', 'description': 'Use of 8 mm PN for insulin injections for 3 weeks.'}], 'classes': [{'title': '1+, or 1 ul', 'categories': [{'measurements': [{'value': '372', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}]}, {'title': '2+, or 10 ul', 'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}]}, {'title': '3+, or 20 ul', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': '4+, or 50 ul', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '5+, or > 50 ul', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'each PN was used for 3 weeks', 'description': 'If insulin leakage from the injection site was observed, subjects rated the size of the leakage droplet based on a visual scale provided in their diaries. Scores of 1+, 2+, 3+, and 4+ correspond to droplet sizes of 1, 10, 20 and 50 ul, respectively. Droplets larger than those shown on the scale were scored as 5+. Subjects were not required to make a diary entry if there was no leakage.', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants shown is the number of subjects that reported at least one event of leakage (see previous data table). The number of reported leakage events is presented for each droplet size category. No data were collected if there was no leakage.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '4 mm / 8 mm PN', 'description': "This group represents all subjects that were randomized to compare the 4mm and 8mm pen needle (PN) during the study. Each PN was used for 3 consecutive weeks; which PN was used first was based on the subject's randomization assignment."}, {'id': 'FG001', 'title': '4 mm / 5 mm PN', 'description': "This group represents all subjects that were randomized to compare the 4mm and 5mm pen needle (PN) during the study. Each PN was used for 3 consecutive weeks; which PN was used first was based on the subject's randomization assignment."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were recruited at four independent research centers/diabetes clinics from June 2009 - October 2009', 'preAssignmentDetails': 'A total of 205 subjects were screened at four sites. Of those, 32 subjects did not satisfy eligibility criteria or withdrew consent prior to using the test products, and the remaining 173 subjects were enrolled and randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '4 mm / 8 mm PN', 'description': 'This group represents all subjects that were randomized to the study arm comparing the 4 mm and 8 mm pen needles, regardless of whether they completed the study.'}, {'id': 'BG001', 'title': '4 mm / 5 mm PN', 'description': 'This group represents all subjects that were randomized to the study arm comparing the 4 mm and 5 mm pen needles, regardless of whether they completed the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'groupId': 'BG000', 'lowerLimit': '18.1', 'upperLimit': '76.0'}, {'value': '53.8', 'groupId': 'BG001', 'lowerLimit': '22.3', 'upperLimit': '76.2'}, {'value': '52.6', 'groupId': 'BG002', 'lowerLimit': '18.1', 'upperLimit': '76.2'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes Type', 'classes': [{'title': 'Type 1 diabetes', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': 'Type 2 diabetes', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '30.1', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '49'}, {'value': '30.9', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '48'}, {'value': '30.5', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '49'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'FULL_RANGE'}, {'title': 'Hemoglobin A1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '7.6', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '7.5', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'A blood sample for HbA1c was collected at screening', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insulin Dose Group', 'classes': [{'title': 'Low Dose', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}, {'title': 'Regular Dose', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Subjects were assigned to an insulin dosing group (Low or Regular) based on their baseline regimen to help ensure balance among treatment arms. Low Dose: largest single dose of insulin a day, with a pen device, was \\<=20 units. Regular Dose: largest single dose of insulin a day, with a pen device, 21-40 units.', 'unitOfMeasure': 'participants'}, {'title': 'Single Largest Daily Insulin Dose', 'classes': [{'categories': [{'measurements': [{'value': '19.6', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '40'}, {'value': '21.3', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '40'}, {'value': '20.5', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '40'}]}]}], 'paramType': 'MEAN', 'description': 'At baseline, subjects described their current insulin regimen, including the largest single daily insulin dose self-administered with a pen needle.', 'unitOfMeasure': 'Units', 'dispersionType': 'FULL_RANGE'}, {'title': 'Serum Fructosamine Concentration', 'classes': [{'categories': [{'measurements': [{'value': '298.3', 'spread': '48.4', 'groupId': 'BG000'}, {'value': '301.5', 'spread': '61.0', 'groupId': 'BG001'}, {'value': '299.9', 'spread': '55.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'A blood sample was collected at baseline (Visit 2).', 'unitOfMeasure': 'umol/L', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-24', 'studyFirstSubmitDate': '2009-06-24', 'resultsFirstSubmitDate': '2010-08-12', 'studyFirstSubmitQcDate': '2009-06-24', 'lastUpdatePostDateStruct': {'date': '2010-10-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-09-24', 'studyFirstPostDateStruct': {'date': '2009-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Subjects With at Least One Leakage Event', 'timeFrame': 'each PN was used for 3 weeks', 'description': 'After each insulin injection with a study pen needle, subjects recorded in their study diary if they observed insulin leakage from the injection site. Subjects were not required to make a diary entry if there was no leakage.'}, {'measure': 'Reported Injection Site Leakage Events, by Pen Needle Type and Droplet Size', 'timeFrame': 'each PN was used for 3 weeks', 'description': 'If insulin leakage from the injection site was observed, subjects rated the size of the leakage droplet based on a visual scale provided in their diaries. Scores of 1+, 2+, 3+, and 4+ correspond to droplet sizes of 1, 10, 20 and 50 ul, respectively. Droplets larger than those shown on the scale were scored as 5+. Subjects were not required to make a diary entry if there was no leakage.'}], 'primaryOutcomes': [{'measure': 'Percent (%) Absolute Change in Fructosamine', 'timeFrame': '3 weeks per pen needle, from visit 2-3 and visit 3-4.', 'description': 'Within each study arm (4mm / 5mm PN, or 4mm / 8mm PN) subjects used one pen needle (PN) for 3 weeks then switched to the alternate PN for the next three weeks, for a total of 6 weeks. The principal endpoint measure of glycemic control is the percent absolute change in serum fructosamine concentration, based on the fructosamine (FRU) concentration measured in micromoles per liter (umol/L) at the end of each three week period. The change was calculated according to the following formula:\n\nPercent absolute change in FRU, or %\\|∆ FRU\\|= 100\\*\\[FRU(4mm)-FRU(5 or 8mm)\\]/\\[FRU(5 or 8mm)\\].'}], 'secondaryOutcomes': [{'measure': 'Percent Absolute Change in Fructosamine, by Dose Group', 'timeFrame': '3 weeks per pen needle, from visit 2-3 and visit 3-4.', 'description': 'Glycemic control was determined separately for each insulin dose group in the same manner as described for the primary outcome measure, according to the following formula:\n\n%\\|∆ FRU\\|= 100\\*\\[FRU(4mm)-FRU(5 or 8mm)\\]/\\[FRU(5 or 8mm)\\].'}, {'measure': 'Number of Subjects With Severe Unexplained Hypoglycemic Events', 'timeFrame': 'During 3 weeks using each pen needle', 'description': "Severe Unexplained Hypoglycemia is defined as an event in which the subject's blood glucose is below 50 milligrams per deciliter (mg/dL) and/or they required assistance from another person for treatment and there is no identified cause (for example, the subject skipped a meal). These events were also reported as Adverse Events."}, {'measure': 'Number of Subjects With Severe Unexplained Hyperglycemic Events', 'timeFrame': 'During 3 weeks using each pen needle', 'description': 'Severe Unexplained Hyperglycemia is defined as requiring a visit to the emergency room or hospitalization and/or having a blood glucose value above 450mg/dL without an identified cause (for example, the subject missed an insulin dose). These events were also reported as Adverse Events.'}, {'measure': 'Relative Injection Pain Score Assessed by Subject', 'timeFrame': 'Visit 4: 18-24 days after starting 2nd pen needle', 'description': 'After using the second assigned pen needle (PN) for 3 weeks, subjects used a 150mm Visual Analog Scale (VAS) to rate the pain of the second PN relative to the first PN. The VAS was anchored at the center (0mm) with "as painful", and at the extreme ends with "much less painful" (-75mm) and "much more painful" (+75mm). VAS scores were adjusted for the order of PN use, such that a positive score means that the 4mm PN was scored as more painful than the reference PN (5mm or 8mm), and a negative score indicates that the 4mm PN was less painful than the reference.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pen Needle', 'Diabetes', 'Insulin', 'Glycemic', 'Pain', 'Fructosamine', 'Leakage', 'Hypoglycemia', 'Hyperglycemia'], 'conditions': ['Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '20429832', 'type': 'RESULT', 'citation': 'Hirsch LJ, Gibney MA, Albanese J, Qu S, Kassler-Taub K, Klaff LJ, Bailey TS. Comparative glycemic control, safety and patient ratings for a new 4 mm x 32G insulin pen needle in adults with diabetes. Curr Med Res Opin. 2010 Jun;26(6):1531-41. doi: 10.1185/03007995.2010.482499.'}, {'pmid': '22762347', 'type': 'DERIVED', 'citation': 'Hirsch LJ, Gibney MA, Li L, Berube J. Glycemic control, reported pain and leakage with a 4 mm x 32 G pen needle in obese and non-obese adults with diabetes: a post hoc analysis. Curr Med Res Opin. 2012 Aug;28(8):1305-11. doi: 10.1185/03007995.2012.709181. Epub 2012 Jul 18.'}]}, 'descriptionModule': {'briefSummary': 'Anxiety about needles is a commonly expressed concern by diabetics about beginning insulin therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy profile of currently marketed pen needles may appeal to many diabetic patients as the new needle may be perceived as less intimidating and more comfortable. Currently marketed pen needles range in length from 5 to 12.7 millimeters (mm).\n\nThe primary purpose of this study was to evaluate whether the investigational 4mm x 32 Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent glucose control (as measured by fructosamine levels) as the currently marketed BD 5mm x 31 G and BD 8mm x 31 G pen needles (PN)in diabetic subjects with varying insulin dosage regimens.', 'detailedDescription': 'Within each dose group, subjects were randomly assigned at baseline to one of two study arms. One study arm (4/5 mm PN) compared the BD 4mm PN to the 5mm PN, and the other arm (4/8 mm PN) compared the BD 4mm PN to the 8mm PN, in a crossover fashion. Based on the randomization, subjects used either the 4mm or the other assigned PN (5mm or 8mm) for the first 3 weeks, then switched to the alternate PN for the next 3 weeks. Glycemic control was assessed by serum fructosamine (FRU) levels at the end of each 3 week period.\n\nBased on their baseline insulin regimen, subjects were also assigned to an insulin dosing group (Low or Regular) to help ensure balance among treatment arms. Requirements for each group were as follows: Low Dose: largest single dose of insulin each day with a pen device must be less than or equal to 20 units. Regular Dose: largest single dose of insulin each day, with a pen device, must be 21-40 units.\n\nExplanation of Visits and Timing of Assessments:\n\nVisit 1:\n\n* Screening\n* Informed Consent\n* Demographics\n* Inclusion /Exclusion\n* Hemoglobin A1c measurement (HbA1c)\n\nVisit 2 (Baseline:)\n\n* Insulin dose group assignment (Low dose or Regular dose)\n* Randomization\n* Fructosamine blood sample collected\n* Dispense pen needle (PN) assigned first\n\nVisit 3 (approximately 3 weeks after starting first PN)\n\n* Pain rated by subject relative to baseline PN\n* Review Adverse Events (AEs) and reported events of injection site leakage\n* Fructosamine blood sample collected\n* Dispense second assigned PN\n\nVisit 4 (approximately 3 weeks after starting second PN):\n\n* Review AEs and reported events of injection site leakage\n* Fructosamine blood sample collected\n* Pain rated relative to previously used PN\n* Study Completion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Insulin requiring diabetics (type 1 or type 2)\n* Using a pen device for injections at least once per day, for at least two months prior to baseline (Study Visit Two).\n* 18 to 75 years of age, inclusive.\n* Body Mass Index from 18 to 50 kg/m², inclusive.\n* Hemoglobin A1c from 5.5 to 9.5 percent (%), inclusive.\n* Largest single dose of insulin a day less than or equal to 40 units\n\nExclusion Criteria:\n\n* Current status or history of a medical condition that would contraindicate treatment with the study product or other conditions which, in the opinion of the Investigator, would place the subject at risk or have the potential to confound interpretation of the study results (i.e. recent history of ketoacidosis, hypoglycemic unawareness, etc.).\n* Hemophilia or any other disorder which causes excessive bleeding or requires frequent transfusions.\n* History of intravenous drug abuse (self-reported).\n* Bleeding disorder, hemophilia or subject is currently taking anti-coagulant medications (e.g., heparin, Coumadin®, warfarin).\n* Self-reported blood borne infection.\n* Pregnant (from medical history only).'}, 'identificationModule': {'nctId': 'NCT00928057', 'briefTitle': 'Comparison of Glycemic Control Among Diabetics Using Three Different Pen Needles', 'organization': {'class': 'INDUSTRY', 'fullName': 'Becton, Dickinson and Company'}, 'officialTitle': 'Comparison of Glycemic Control Among Diabetics Using the 4mm x 32G BD Pen Needle Versus the 8mm x 31G BD Pen Needle and the 5mm x 31G BD Pen Needle', 'orgStudyIdInfo': {'id': 'BDDC-08-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4 mm / 8 mm PN', 'description': 'Subjects randomized to this study arm used either the 4mm PN or the 8mm PN for 3 weeks, then switched to the alternate PN for another 3 weeks. Order of PN use was randomly determined.', 'interventionNames': ['Device: 4mm x 32G pen needle', 'Device: 8mm x 31G pen needle']}, {'type': 'EXPERIMENTAL', 'label': '4 mm / 5 mm PN', 'description': 'Subjects randomized to this study arm used either the 4mm PN or the 5mm PN for 3 weeks, then switched to the alternate PN for another 3 weeks. Order of PN use was randomly determined.', 'interventionNames': ['Device: 4mm x 32G pen needle', 'Device: 5mm x 31G pen needle']}], 'interventions': [{'name': '4mm x 32G pen needle', 'type': 'DEVICE', 'otherNames': ['BD Ultra-Fine™ Nano pen needle, Catalog number 320122'], 'description': 'For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were advised to inject straight in when using the 4mm PN, with no pinch up.', 'armGroupLabels': ['4 mm / 5 mm PN', '4 mm / 8 mm PN']}, {'name': '8mm x 31G pen needle', 'type': 'DEVICE', 'otherNames': ['BD Ultra-Fine™ Short pen needle, Catalog number 320109'], 'description': 'For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were directed to use pinch-up when injecting in the abdomen or thigh with the 8mm PN, and no pinch-up at other injection sites.', 'armGroupLabels': ['4 mm / 8 mm PN']}, {'name': '5mm x 31G pen needle', 'type': 'DEVICE', 'otherNames': ['BD Ultra-Fine™ Mini pen needle, Catalog Number 320119'], 'description': 'For 3 weeks, subjects used this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects followed their usual insulin regimen and there was no upper limit on total daily insulin dosage or number of injections. Subjects were advised to inject straight in when using the 5mm PN, with no pinch up.', 'armGroupLabels': ['4 mm / 5 mm PN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92026', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'AMCR Institute, Inc.', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Diabetes Associates', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Rainier Clinical Research Center, Inc.', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}], 'overallOfficials': [{'name': 'Kenneth Kassler-Taub, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Becton, Dickinson and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Becton, Dickinson and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Kenneth Kassler-Taub / WW Vice President / Medical Affairs', 'oldOrganization': 'BD Medical'}}}}