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IRCT20180213038720N1 IRCT 2018-09-03 Rasht University of Medical Sciences Comparison of 32-Gauge with 4-mm Pen Needle and 8-mm Pen Needle efficiency on Glycemic Control, leakage, and pain in Type 2 Diabetes Patients Comparison of 32-Gauge with 4-mm Pen Needle and 8-mm Pen Needle efficiency on Glycemic Control, leakage, and pain in Type 2 diabetes Patients Referred to Razi Therapeutic and Educational Hospital, Rasht-2017 2018-04-02 anticipated 207 Complete https://irct.ir/trial/29860 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: This is a cross-sectional randomized clinical trial study. The study population was type 2 diabetic patients referring to the Razi Educational Center Endocrine Center of Rasht. The method is easy to select and is randomly assigned to two groups according to the random allocation rule. N/A Type 2 diabetes. Considering the crossover nature of this clinical trial in the first intervention group (A): At first, during 3 days of first hospitalization week, the insulin injection is done by the researcher with 90 degree angle and by means of Gauge 32 needle with 4 mm length and at second intervention group (B): During the last 3 days of the first week of hospitalization, insulin injection with 90 degree angle and by means of Gauge 32 needle with 8 mm length is done by the researcher. Then for post cycle therapy for both groups, there is no intervention for one day and instead the routine treatment is followed. Then the groups are substituted with each other and in the second intervention (B): In 3 last days of first week hospitalization, the insulin injection with 90 degree angle and by means of Gauge-32 with 4 mm length is done by the researcher and in the first intervention group (A): In 3 last days of the first week hospitalization, the insulin injection with 90 degree angle and by means of Gauge-32 needle and 8 mm length is done by the researcher.. Yes - There is a plan to make this available What will be shared: Collected data will be given to the individuals or organizations -a raw information- that will be provided with the consent of the participants without any name, address or telephone number, and other items When: after we have finished the study if data crashed or disposed it will be reachable in a raw information To whom: just those have a Written request from authoritative research organizations Conditions: if there was need to be called in analysis field you can call 09116470641 Where to obtain: mostafa sodmand phone number: 09116470641 How to obtain: after confirmation the requeste, only raw and unidentifiable information from the mail will be delivered within one week. Comments: if you have any question about this study call these numbers 09116470641 09155328439 09113312939
public Hossein Rafiei
Ashkan Aparteman, Molaii Ave, Shohada Blvd, Rasht
Rasht Iran (Islamic Republic of) 4176763977 +98 13 3382 0978 hrk.vairon@gmail.com Rasht University of Medical Sciences scientific Mostafa Soodmand
Student Street, Shahid Beheshti Highway, Rasht
Rasht Iran (Islamic Republic of) 4146939841 +98 13 3355 5056 msudmand@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patient must be between 18 to 75 years old patient must have type 2 diabetes patient must have used injecting insulin at least for 2 years patient BMI must be over 18/5 Patient should not be mentally retired or have any psychological disease patient must use insulin pen 18 years 75 years Both Patient does not want to participate in the study. Patient has skin problems in the injection site. patient does not have diabetes. E11 Type 2 diabetes mellitus Treatment - Devices Considering the crossover nature of this clinical trial in the first intervention group (A): At first, during 3 days of first hospitalization week, the insulin injection is done by the researcher with 90 degree angle and by means of Gauge 32 needle with 4 mm length and at second intervention group (B): During the last 3 days of the first week of hospitalization, insulin injection with 90 degree angle and by means of Gauge 32 needle with 8 mm length is done by the researcher. Then for post cycle therapy for both groups, there is no intervention for one day and instead the routine treatment is followed. Then the groups are substituted with each other and in the second intervention (B): In 3 last days of first week hospitalization, the insulin injection with 90 degree angle and by means of Gauge-32 with 4 mm length is done by the researcher and in the first intervention group (A): In 3 last days of the first week hospitalization, the insulin injection with 90 degree angle and by means of Gauge-32 needle and 8 mm length is done by the researcher. Comparison of 2 Pen Needles efficiency on patient Glycemic Control. Timepoint: Comparison of 2 Pen Needle gauges efficiency on patient Glycemic Control that patient blood sugar will be distinct in first ,third and 6th day. Method of measurement: patient blood sugar will be distinct by blood sampling and laboratory instruments. Comparison of 2 pen needle Gauges efficiency on needle leakage. Timepoint: Comparison of 2 Pen Needle gauges efficiency on needle leakage that will be evaliated in first ,third and 6th day. Method of measurement: leakage will be approved by the researcher. Comparison of 2 Pen Needles efficiency on patient pain while injection. Timepoint: Comparison of 2 Pen Needle gauges efficiency on needle pain that will be evaliated in first ,third and 6th day. Method of measurement: pain will be evaluated by the Visual Analogue Scale. None. Timepoint: None. Method of measurement: None. Rasht University of Medical Sciences Approved 2018-02-03 Ethics committee of Guilan University of Medical Sciences Research and technology of Guilan University of Medical Sciences, Old Building, School of Health, In Front of the 17th Shahrivar Hospital, Shahid Siadati St, Namjoo Ave, Rasht, Iran Rasht Guilan Iran (Islamic Republic of)