Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-02-25 @ 9:47 PM
Study NCT ID:
NCT04460092
Status:
UNKNOWN
Last Update Posted:
2020-07-07
First Post:
2020-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D010146', 'term': 'Pain'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-09-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-05', 'studyFirstSubmitDate': '2020-05-10', 'studyFirstSubmitQcDate': '2020-07-05', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma glucose', 'timeFrame': 'Up to 7 days', 'description': 'Laboratory check the Plasma glucose according to the routine of the hospital units'}, {'measure': 'Insulin leakage', 'timeFrame': 'Up to 7 days', 'description': 'The rate of insulin leakage after injection is observational'}, {'measure': 'Pain when insulin injection', 'timeFrame': 'Up to 7 days', 'description': 'Survey severity pain when insulin injection by Visual Analogue Scale (VAS). This is a numerical scale that tells the patient the severity of their pain from one to ten. The larger the number, the more pain there is.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus, Type 2', 'Blood Glucose', 'Pain', 'leakage', 'insulin injections'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This is a Clinical crossover trial study. In this study, 100 patients with type II diabetes will be selected based on entry and exit criteria, then randomly divided into two equal groups (group "A" and group "B").In the first three days of the first week of hospitalization, in group "A" insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 5 mm, and in the other group insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 8 mm will be done. After a one-day break, in another three days, the types of needles used in the two groups are moved together. After a one-day break, in another three days, the types of needles used in the two groups are replaced together. Then the VAS scale will be used to assess post-injection pain; the amount of leakage after the injection will be measured in two ways Yes/No, according to the researcher\'s observation. And to check the effect of Needles on controlling patients\' blood sugar, their blood sugar levels will be measured based on the routine of hospital units.', 'detailedDescription': 'This is a Clinical crossover trial study. In this study, 100 patients with type II diabetes will be selected based on entry and exit criteria, then randomly divided into two equal groups (group "A" and group "B").In the first three days of the first week of hospitalization, in group "A" insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 5 mm, and in the other group insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 8 mm will be done. After a one-day break, in another three days, the types of needles used in the two groups are moved together. After a one-day break, in another three days, the types of needles used in the two groups are replaced together. Then the VAS scale will be used to assess post-injection pain; the amount of leakage after the injection will be measured in two ways Yes/No, according to the researcher\'s observation. And to check the effect of Needles on controlling patients\' blood sugar, their blood sugar levels will be measured based on the routine of hospital units.\n\nAfter entering the data in SPSS20 software, the collected data will be analyzed using descriptive statistics (frequency, percentage, mean, standard deviation) and statistical tests (t-test, chi-square).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having type II diabetes\n* Use injectable insulin for at least two years\n* BMI \\>18\n* Lack of mental illness and mental retardation\n* Use insulin pen\n\nExclusion Criteria:\n\n* Lack of desire to participate in the study\n* Having a skin problem in the injection site'}, 'identificationModule': {'nctId': 'NCT04460092', 'briefTitle': 'Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose', 'organization': {'class': 'OTHER', 'fullName': 'Baqiyatallah Medical Sciences University'}, 'officialTitle': 'The Effect of Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose Control in Type - II Diabetic Patients in Baqiyatollah Hospital and Clinic, Tehran, 2019 -2020', 'orgStudyIdInfo': {'id': 'IR.BMSU.BAQ.REC.1398.059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group "A"', 'description': 'In the first three days, participants in group "A" will inject 90-degree insulin injections using 5-mm 32-gauge needles. Then, with an interval of one day, in the second three days, they will use 32-gauge needles with a length of 8 mm to inject insulin.', 'interventionNames': ['Device: 5-mm 32-gauge Insulin needles in the first three days of Intervention', 'Device: 8-mm 32-gauge Insulin needles in the last three days of Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Group"B"', 'description': 'In the first three days, participants in group "B" will inject 90-degree insulin injections using 8-mm 32-gauge needles. Then, with an interval of one day, in the second three days, they will use 32-gauge needles with a length of 5mm to inject insulin.', 'interventionNames': ['Device: 8-mm 32-gauge Insulin needles in the first three days of Intervention', 'Device: 5-mm 32-gauge Insulin needles in the last three days of Intervention']}], 'interventions': [{'name': '5-mm 32-gauge Insulin needles in the first three days of Intervention', 'type': 'DEVICE', 'description': '32-gauge needles with a length of 5mm to inject insulin in first three days', 'armGroupLabels': ['Group "A"']}, {'name': '8-mm 32-gauge Insulin needles in the first three days of Intervention', 'type': 'DEVICE', 'description': '32-gauge needles with a length of 8mm to inject insulin in first three days', 'armGroupLabels': ['Group"B"']}, {'name': '5-mm 32-gauge Insulin needles in the last three days of Intervention', 'type': 'DEVICE', 'description': '32-gauge needles with a length of 5mm to inject insulin in second three days', 'armGroupLabels': ['Group"B"']}, {'name': '8-mm 32-gauge Insulin needles in the last three days of Intervention', 'type': 'DEVICE', 'description': '32-gauge needles with a length of 8mm to inject insulin in second three days', 'armGroupLabels': ['Group "A"']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0', 'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Mohammad Sadegh Bagheri Baghdasht', 'role': 'CONTACT'}], 'facility': 'Mohammad Sadegh Bagheri Baghdasht', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Mohammad Sadegh Bagheri Baghdasht', 'role': 'CONTACT', 'email': 'hiasdasd0@gmail.com', 'phone': '0098 936 8214509'}], 'overallOfficials': [{'name': 'Esmail Heidaranlu', 'role': 'STUDY_CHAIR', 'affiliation': 'Baqiyatallah Medical Sciences University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baqiyatallah Medical Sciences University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohammad Sadegh Bagheri Baghdasht', 'investigatorAffiliation': 'Baqiyatallah Medical Sciences University'}}}}