Comparison of the efficacy of Once- Versus Twice-Daily Administration of insulin Detemir in children with type 1 diabetes.
Design
For patients, the schedule is once or twice a day for insulin Detemir plus a short-acting insulin for food.
Blocks randomization method and 4 blocks were used including 2 participants in intervention group 1 and 2 participants in intervention group 2.
sample size : 25 for each group
Settings and conduct
The first month : teaching the patient and adjusting the dose of insulin.
Before starting the study and at the end of the fourth month,: HbA1c is measured at the Laboratory of the children medical center and by staff who are unaware of the research
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.
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.
It will be available 24 hours a day through a dedicated telephone number for patients and an awareness of their sugar control status, measured in the home and recorded in the sugar chart and sent via the Telegram.
Participants/Inclusion and exclusion criteria
Inclusion
Diabetes mellitus type 1 (according to ISPAD 2014 criteria).
Age at diagnosis :2-6 years old
Lasting 1 year since diagnosis
Desire to use Detemir
Exclusion:
The use of drugs that are effective on controlling diabetes at any time during the duration of the study.
Intervention groups
For patients, the schedule is once or twice a day for insulin Detemir plus a short-acting insulin for food.
Main outcome variables
HbA1c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181106041574N1
Registration date:2019-01-16, 1397/10/26
Registration timing:prospective
Last update:2019-01-16, 1397/10/26
Update count:0
Registration date
2019-01-16, 1397/10/26
Registrant information
Name
Reza Tavakolizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5517 6814
Email address
rtavakolizadeh@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Once- Versus Twice-Daily Administration of long-acting insulin Detemir in children with type 1 diabetes
Public title
Comparison of Once- Versus Twice-Daily Administration of long-acting insulin Detemir in children with type 1 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
The use of drugs that are effective on controlling diabetes
Age
From 24 months old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
Blinding description
laboratory personel and data analizor are blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Children’s Medical Center, Tehran University of Medical Sciences
Street address
No 62, Dr. Gharib St., Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱٩٧٣٣۱۵۱
Approval date
2018-07-14, 1397/04/23
Ethics committee reference number
IR.TUMS.CHMC.REC.1397.014
Health conditions studied
1
Description of health condition studied
Diabetes mellitus type 1
ICD-10 code
E10.9
ICD-10 code description
Type 1 diabetes mellitus without complications
Primary outcomes
1
Description
HbA1c
Timepoint
3 Months
Method of measurement
lab
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical center
Full name of responsible person
Reza Tavakolizadeh
Street address
Children's Medical Center, 62 Qarib St. , Keshavarz Blvd., Tehran 14194, Iran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2917
Fax
+98 21 6693 0024
Email
cmc.tums@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Floor 6, Central building of Tehran University, Qods street, Keshavarz Blv., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Email
rmo@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
100
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
Reza Tavakolizadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ziaeian hospital, No.2781, Abouzar Street, District 17, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6814
Fax
Email
rtavakolizadeh@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Tavakolizadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ziaeian hospital, No.2781, Abouzar Street, District 17, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6814
Fax
Email
rtavakolizadeh@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Tavakolizadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ziaeian hospital, No.2781, Abouzar Street, District 17, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6814
Fax
Email
rtavakolizadeh@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The study protocol and informed consent form will be shared.
When the data will become available and for how long
Up to one year after printing results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Use in similar studies or for meta-analysis studies
From where data/document is obtainable
Corresponding author of article
What processes are involved for a request to access data/document
Via an academic email, study must be registered and have a valid ethics code.