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IRCT20181106041574N1 IRCT 2019-01-16 Tehran University of Medical Sciences Comparison of Once- Versus Twice-Daily Administration of long-acting insulin Detemir in children with type 1 diabetes Comparison of Once- Versus Twice-Daily Administration of long-acting insulin Detemir in children with type 1 diabetes 2019-01-21 anticipated 50 Complete https://irct.ir/trial/35110 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocks randomization method. Block randomization method with random selection of blocks size (4 and 8) will be used, Blocked Randomization with Randomly Selected Block Sizes will be performed.The number of samples assigned to each group in each block is equal. After the random sequences of groups A and B are listed in the blocks, they are numbered. In order to Allocation concealment, to the sample size, the sealed opaque envelopes is provided. To keep the contents hidden from the outside of the envelope, Each of the sequences created on the card is recorded and the cards are inserted into the envelopes respectively. The outer surface of the envelopes is also numbered in the same way. At the time of the sampling, one of the envelopes is opened according to the order of entry of qualified participants, and the designated group of the participant is determined, Blinding description: laboratory personel and data analizor are blind. 3 Diabetes mellitus type 1. Intervention 1: Intervention group: The insulin used is (Levemir®; NovoNordisk A / S, Bagsvaerd, Denmark, 100 U / ml). For patients, the schedule is once a day for insulin Detemir plus a short-acting insulin for food.The whole study period is 4 months. The first month will be spent teaching the patient and adjusting the dose of insulin.Before starting the study and at the end of the fourth month, the patient's HbA1c is measured.The height and weight at the beginning and the end of the study and the insulin dose required at the end of the study will be recorded. HbA1c measurements are carried out at the Laboratory of the children medical center and by staff who are unaware of the research, and the rest are done at Endocrine clinic of medical center. In the course of the study, patients are monitored for events such as hypoglycemia or need for hospitalization due to the lack of proper control of the disease. Intervention 2: Intervention group: The insulin used is (Levemir®; NovoNordisk A / S, Bagsvaerd, Denmark, 100 U / ml). For patients, the schedule is twice a day for insulin Detemir plus a short-acting insulin for food.The whole study period is 4 months. The first month will be spent teaching the patient and adjusting the dose of insulin.Before starting the study and at the end of the fourth month, the patient's HbA1c is measured.The height and weight at the beginning and the end of the study and the insulin dose required at the end of the study will be recorded.HbA1c measurements are carried out at the Laboratory of the children medical center and by staff who are unaware of the research, and the rest are done at Endocrine clinic of medical center.At the end, the results of the two groups will be compared. In the course of the study, patients are monitored for events such as hypoglycemia or need for hospitalization due to the lack of proper control of the disease. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is im not sure, due to ethic issue
public Reza Tavakolizadeh
Ziaeian hospital, No.2781, Abouzar Street, District 17, Tehran, Iran
Tehran Iran (Islamic Republic of) 1366736511 +98 21 5517 6814 rtavakolizadeh@sina.tums.ac.ir Tehran University of Medical Sciences scientific Reza Tavakolizadeh
Ziaeian hospital, No.2781, Abouzar Street, District 17, Tehran, Iran
Tehran Iran (Islamic Republic of) 1366736511 +98 21 5517 6814 rtavakolizadeh@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Diabetes mellitus type 1 (according to ISPAD 2014 criteria) Age at diagnosis: 2-6 years old Lasting at least 1 year since diagnosis Desire to use insulin Detemir 24 months no limit Both The use of drugs that are effective on controlling diabetes E10.9 Type 1 diabetes mellitus without complications Treatment - Drugs Treatment - Drugs Intervention group: The insulin used is (Levemir®; NovoNordisk A / S, Bagsvaerd, Denmark, 100 U / ml). For patients, the schedule is once a day for insulin Detemir plus a short-acting insulin for food.The whole study period is 4 months. The first month will be spent teaching the patient and adjusting the dose of insulin.Before starting the study and at the end of the fourth month, the patient's HbA1c is measured.The height and weight at the beginning and the end of the study and the insulin dose required at the end of the study will be recorded. HbA1c measurements are carried out at the Laboratory of the children medical center and by staff who are unaware of the research, and the rest are done at Endocrine clinic of medical center. In the course of the study, patients are monitored for events such as hypoglycemia or need for hospitalization due to the lack of proper control of the disease. Intervention group: The insulin used is (Levemir®; NovoNordisk A / S, Bagsvaerd, Denmark, 100 U / ml). For patients, the schedule is twice a day for insulin Detemir plus a short-acting insulin for food.The whole study period is 4 months. The first month will be spent teaching the patient and adjusting the dose of insulin.Before starting the study and at the end of the fourth month, the patient's HbA1c is measured.The height and weight at the beginning and the end of the study and the insulin dose required at the end of the study will be recorded.HbA1c measurements are carried out at the Laboratory of the children medical center and by staff who are unaware of the research, and the rest are done at Endocrine clinic of medical center.At the end, the results of the two groups will be compared. In the course of the study, patients are monitored for events such as hypoglycemia or need for hospitalization due to the lack of proper control of the disease. HbA1c. Timepoint: 3 Months. Method of measurement: lab. Tehran University of Medical Sciences Approved 2018-07-14 Research Ethics Committee of Children’s Medical Center, Tehran University of Medical Sciences No 62, Dr. Gharib St., Keshavarz Blvd., Tehran Tehran Tehran Iran (Islamic Republic of)