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IRCT20191026045251N3 IRCT 2023-03-04 Mashhad University of Medical Sciences Application carbohydrate counting application Application carbohydrate counting application on daily blood sugar control and glycosylated hemoglobin level in children with diabetes type 1 2022-12-21 anticipated 100 Complete https://irct.ir/trial/66243 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the participants are allocated to the intervention and control groups with Simple Blocked Randomization. The randomized unit is individual. First, blocks of four consisting of control group (2 people) and intervention group (2 people) will be formed. Based on this, 6 different sequences will be formed. After counting the blocks, the blocks will be randomly selected. The random selection continues forever until the sequence is determined for 100 people. The created sequence will be kept in a sealed envelope. 3 Type 1 diabetes mellitus. Intervention 1: Intervention group: Intervention group: In this group, an Android app will be installed for parents of children with type 1 diabetes. In this app, it is possible to determine the carbohydrate content of the child's food. Parents will record the food consumed by the child during the day in the app. The app automatically calculates the carbohydrates of the food consumed and the dose of insulin the child needs. The calculation formula will be based on the doctor's prescription. Also, the app has a notebook to record insulin and blood glucose fasting and two hours after a meal. In this group, before and three months after installing and using the app, fasting blood glucose levels, two-hour postprandial glucose, and Hg A1C will be measured. Intervention 2: Control group: In this group, parents of children with type 1 diabetes will be given a notebook. In this notebook, parents will record the amount of prescribed insulin, fasting blood glucose levels, two-hour postprandial glucose, and Hg A1C according to the table. The recording of the mentioned markers is based on the doctor's order. In this group, before and three months after receiving the booklet, fasting blood glucose levels, two-hour postprandial glucose, and Hg A1C will be measured. Yes - There is a plan to make this available What will be shared: Information about main outcome variables is shared. When: One year after the results are published To whom: Researchers of medical sciences of reputable scientific institutions Conditions: Analysis of the main variable - if there is a need to publish, permission must be obtained from the researchers of the present project. Where to obtain: Person responsible for general inquiries email How to obtain: A maximum of one month after the applicant's email Comments:
public Tahereh Sadeghi
School of Nursing and Midwifery, Ibn Sina Ave, doctora Crossroads, university Blve
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 SadeghiT@mums.ac.ir Mashhad University of Medical Sciences scientific Tahereh Sadeghi
School of Nursing and Midwifery, Ibn Sina Ave, doctora Crossroads, university Blve
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 SadeghiT@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Parents who have a child with type 1 diabetes Children with at least 3 months history of diabetes The age of a child with diabetes is 1 to 18 years Literacy for reading and writing Having a smart phone and internet access The age of mothers of children with diabetes is between 18 and 60 Consent to participate in the study 1 year 18 years Both Having other chronic underlying diseases in children with diabetes E10 Type 1 diabetes mellitus N/A N/A Intervention group: Intervention group: In this group, an Android app will be installed for parents of children with type 1 diabetes. In this app, it is possible to determine the carbohydrate content of the child's food. Parents will record the food consumed by the child during the day in the app. The app automatically calculates the carbohydrates of the food consumed and the dose of insulin the child needs. The calculation formula will be based on the doctor's prescription. Also, the app has a notebook to record insulin and blood glucose fasting and two hours after a meal. In this group, before and three months after installing and using the app, fasting blood glucose levels, two-hour postprandial glucose, and Hg A1C will be measured. Control group: In this group, parents of children with type 1 diabetes will be given a notebook. In this notebook, parents will record the amount of prescribed insulin, fasting blood glucose levels, two-hour postprandial glucose, and Hg A1C according to the table. The recording of the mentioned markers is based on the doctor's order. In this group, before and three months after receiving the booklet, fasting blood glucose levels, two-hour postprandial glucose, and Hg A1C will be measured.. Fasting blood Glucose. Timepoint: Before and three months after the intervention. Method of measurement: glucometer (Glucose meter). Two-Hour Postprandial Glucose. Timepoint: Before and three months after the intervention. Method of measurement: glucometer (Glucose meter). Glycated hemoglobin. Timepoint: Before and three months after the intervention. Method of measurement: blood test. Mashhad University of Medical Sciences Approved 2022-07-05 Research Ethics Committee of School of Nursing and Midwifery, Mashhad University of Medical Sciences School of Nursing and Midwifery, Gholestan Ave, Doctora Blvd, Mashhad Town Mashhad Razavi Khorasan Iran (Islamic Republic of)