]>
IRCT20231016059738N1 IRCT 2023-11-05 Tehran University of Medical Sciences Glycemic control in children with type 1 diabetes Comparison of two methods of carbohydrate counting and fixed-dose insulin in glycemic control in children with type 1 diabetes 2023-11-21 anticipated 76 Complete https://irct.ir/trial/73251 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: They will be allocated to two intervention groups A and B using the block randomization method and using the https://www.sealedenvelope.com/ system with blocks of 4 and with a ratio of 1:1. 2 Type 1 diabetes. Intervention 1: Intervention group: Patients are randomly assigned to the group under sugar control intervention with carbohydrate counting method to determine mealtime insulin. Finally, the changes of each of the measured parameters in two groups before and after the intervention will be reviewed. Intervention 2: Intervention group: Patients are randomly assigned to the group under sugar control intervention with fixed-dose insulin method to determine mealtime insulin. Finally, the changes of each of the measured parameters in two groups before and after the intervention will be reviewed. Yes - There is a plan to make this available What will be shared: Data can potentially be shared after de-identifying individuals When: The access period starts 6 months after the results are published To whom: The data will be available to researchers working in academic and scientific institutions and people working in industry Conditions: Unlimited Where to obtain: Shadi Niliyeh . 09131841595 . shadi.niliyeh65@googlemail.com How to obtain: Unlimited Comments:
public Shadi Niliyeh
Children's Medical Center, No. 62, next to Imam Khomeini Hospital, Dr. Mohammad Gharib St., at the end of Keshavarz Blvd., Tehran
Tehran Iran (Islamic Republic of) 1419733151 00982161479 shadi.niliyeh65@googlemail.com Tehran University of Medical Sciences scientific Fateme Siari Fard
Children's Medical Center, No. 62, next to Imam Khomeini Hospital, Dr. Mohammad Gharib St., at the end of Keshavarz Blvd., Tehran
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6147 9000 masiesayarifard@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Type 1 diabetes patients 6 to 18 years old, who have been diagnosed for at least six months Treated with insulin They are not in the honeymoon period Have been subjected to basic training in terms of diabetic diet 6 years 18 years Both Underlying diseases such as liver or kidney failure A history of feeding through a digestive tube Failure to provide written consent to enter the study E10.9 Type 1 diabetes mellitus without complications Treatment - Drugs Treatment - Drugs Intervention group: Patients are randomly assigned to the group under sugar control intervention with carbohydrate counting method to determine mealtime insulin. Finally, the changes of each of the measured parameters in two groups before and after the intervention will be reviewed Intervention group: Patients are randomly assigned to the group under sugar control intervention with fixed-dose insulin method to determine mealtime insulin. Finally, the changes of each of the measured parameters in two groups before and after the intervention will be reviewed Glucose level. Timepoint: At the beginning of the study and after the intervention. Method of measurement: Paraclinic – Laboratory. HbA1c. Timepoint: At the beginning of the study and after the intervention. Method of measurement: Paraclinic – Laboratory. The Total Amount Of Insulin Received Daily. Timepoint: At the beginning of the study and after the intervention. Method of measurement: Questionnaire-Clinical File. Cholesterol. Timepoint: At the beginning of the study and after the intervention. Method of measurement: Paraclinic – Laboratory. Triglyceride. Timepoint: At the beginning of the study and after the intervention. Method of measurement: Paraclinic – Laboratory. HDL. Timepoint: At the beginning of the study and after the intervention. Method of measurement: Paraclinic – Laboratory. LDL. Timepoint: At the beginning of the study and after the intervention. Method of measurement: Paraclinic – Laboratory. Tehran University of Medical Sciences Approved 2023-09-23 Research Ethics Committees of children's Medical Center Tehran University of Medical Sciences Central building of Tehran University of Medical Sciences, Qods Street Intersection, Keshavarz Blvd., Tehran Tehran Tehran Iran (Islamic Republic of)