Comparison of two methods of carbohydrate counting and fixed-dose insulin in glycemic control in patients with type 1 diabetes
Design
This study is a randomized, clinical trial on 76 patients.
Settings and conduct
The current study is a randomized clinical trial and was conducted on a population of 6 to 18 years old with type 1 diabetes who referred to the diabetes clinic of Children's Medical Center. Patients will be randomly placed in the group under sugar control intervention with fixed-dose insulin method to determine mealtime insulin and will be completely unaware of the randomization process.
Participants/Inclusion and exclusion criteria
The research community includes; Population 6-18 years old with type 1 diabetes referring to the diabetes clinic of the Children's Medical Center, who have been diagnosed for at least six months and are undergoing insulin treatment and basic education in terms of diabetic diet and are not on their honeymoon period. Other underlying diseases, such as liver or kidney failure, history of feeding through a digestive tube, and lack of written consent to enter the study, are considered to exclude patients from the plan.
Intervention groups
Intervention group 1 - 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 2 - Patients are randomly assigned to the group under sugar control intervention with fixed-dose insulin method to determine mealtime insulin.
Main outcome variables
Glucose level, HbA1C level, The total amount of insulin received daily, Triglyceride, Cholesterol, LDL, HDL
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231016059738N1
Registration date:2023-11-05, 1402/08/14
Registration timing:prospective
Last update:2023-11-05, 1402/08/14
Update count:0
Registration date
2023-11-05, 1402/08/14
Registrant information
Name
shadi niliyeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 0024
Email address
shadi.niliyeh65@googlemail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-21, 1402/08/30
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of carbohydrate counting and fixed-dose insulin in glycemic control in children with type 1 diabetes
Public title
Glycemic control in children with type 1 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 6 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of children's Medical Center Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Sciences, Qods Street Intersection, Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-09-23, 1402/07/01
Ethics committee reference number
IR.TUMS.CHMC.REC.1402.112
Health conditions studied
1
Description of health condition studied
Type 1 diabetes
ICD-10 code
E10.9
ICD-10 code description
Type 1 diabetes mellitus without complications
Primary outcomes
1
Description
Glucose level
Timepoint
At the beginning of the study and after the intervention
Method of measurement
Paraclinic – Laboratory
2
Description
HbA1c
Timepoint
At the beginning of the study and after the intervention
Method of measurement
Paraclinic – Laboratory
3
Description
The Total Amount Of Insulin Received Daily
Timepoint
At the beginning of the study and after the intervention
Method of measurement
Questionnaire-Clinical File
4
Description
Cholesterol
Timepoint
At the beginning of the study and after the intervention
Method of measurement
Paraclinic – Laboratory
5
Description
Triglyceride
Timepoint
At the beginning of the study and after the intervention
Method of measurement
Paraclinic – Laboratory
6
Description
HDL
Timepoint
At the beginning of the study and after the intervention
Method of measurement
Paraclinic – Laboratory
7
Description
LDL
Timepoint
At the beginning of the study and after the intervention
Method of measurement
Paraclinic – Laboratory
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center Diabetes Clinic
Full name of responsible person
Fateme Siari Fard
Street address
Children's Medical Center, No. 62, next to Imam Khomeini Hospital, Dr. Mohammad Gharib St., at the end of Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9000
Email
cmcpr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nima Rezaei
Street address
Building No. 1, Faculty of Medicine, Porsina St. , Quds St. Enghelab St.,Tehran
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 6640 5357
Email
deanmed@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shadi Niliyeh
Position
Subspecialty Assistant
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Children's Medical Center, No. 62, next to Imam Khomeini Hospital, Dr. Mohammad Gharib St., at the end of Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
00982161479
Email
shadi.niliyeh65@googlemail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme Siari Fard
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Children's Medical Center, No. 62, next to Imam Khomeini Hospital, Dr. Mohammad Gharib St., at the end of Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9000
Email
masiesayarifard@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shadi Niliyeh
Position
Subspecialty Assistant
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Children's Medical Center, No. 62, next to Imam Khomeini Hospital, Dr. Mohammad Gharib St., at the end of Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
00982161479
Email
shadi.niliyeh65@googlemail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data can potentially be shared after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions and people working in industry