Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-02-24 @ 3:17 PM
Study NCT ID:
NCT02307968
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2014-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Insulin Therapy Between Inner and Outer Upper Thigh
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-03', 'studyFirstSubmitDate': '2014-11-25', 'studyFirstSubmitQcDate': '2014-12-02', 'lastUpdatePostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain', 'timeFrame': 'immediately after injection, 1-5minutes', 'description': 'the pain degree the patient feel while insulin injected using Visual Analog scale'}, {'measure': 'bleeding', 'timeFrame': 'immediately after injection, 1-5minutes', 'description': 'if bleeding occurs after insulin injected just by using Yes or No'}, {'measure': 'leaking', 'timeFrame': 'immediately after injection, 1-5minutes', 'description': 'if there is leaking after insulin injected just by using Yes or No'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '27090917', 'type': 'DERIVED', 'citation': 'Yuan J, Chen Y, Xuan Y, Cao L, Zhu J, Wang F, Zhou X, Ye Q, Liao L, Zheng Y, Zhou Q, Chen X, Chen M, Zhou W. Can the upper inner side of the thigh become a new option for insulin injection? Curr Med Res Opin. 2016 Jul;32(7):1319-24. doi: 10.1185/03007995.2016.1174107. Epub 2016 May 17.'}]}, 'descriptionModule': {'briefSummary': "To observe the patient's preference, pain perception, and usability between inner and outer upper thigh for insulin therapy. To add another injection site for insulin therapy.", 'detailedDescription': 'The most common injection site is the abdomen (or stomach). The back of the upper arms, the upper buttocks or hips, and the outer side of the thighs are also used. These sites are the best to inject into for two reasons: They have a layer of fat just below the skin to absorb the insulin, but not many nerves - which means that injecting there will be more comfortable than injecting in other parts of your body. But while the needle for insulin therapy is becoming shorter, it is possible to inject insulin at the inner thigh site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'diabetes population', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All adult patients more than 18 years age old with diabetes that need insulin therapy\n\nExclusion Criteria:\n\n* Those diabetes with psychologic diseases and those patients won't be injected at thigh"}, 'identificationModule': {'nctId': 'NCT02307968', 'acronym': 'CUSTIOT', 'briefTitle': 'Comparative Study of Insulin Therapy Between Inner and Outer Upper Thigh', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Zhejiang University'}, 'officialTitle': "Comparison of Patient's Preference, Pain Perception, and Usability Between Inner and Outer Upper Thigh for Insulin Therapy", 'orgStudyIdInfo': {'id': 'ChiCTR-OPN-14005516'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'inner thigh insulin injection', 'description': 'inject insulin at inner thigh site is the intervention arm. So we inject insulin at this site to see if this site is suitable for insulin injection.', 'interventionNames': ['Other: insulin injection site']}, {'label': 'outer thigh insulin injection', 'description': 'outer thigh site for insulin therapy is the usual site'}], 'interventions': [{'name': 'insulin injection site', 'type': 'OTHER', 'description': 'insulin injected site between inner thigh and out thigh', 'armGroupLabels': ['inner thigh insulin injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Department of Endocrinology, the First Affiliated Hospital to Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Jingyun Yuan, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Endocrinology, the First Affiliated Hospital to Zhejiang University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Zhou Weibin', 'investigatorAffiliation': 'First Affiliated Hospital of Zhejiang University'}}}}