Comparison of the effect of of preprandial and postprandial injection of Insulin Aspart on glycemic control of children with diabetes mellitus type 1
Design
Two arm crossover group on 60 patients
Settings and conduct
The target population is patients aged 6 to 17 years with type 1 diabetes who are treated with basal insulin and insulin Aspart as short-acting insulin, but are poor controlled. Sixty 6-17 year old patients with mentioned conditions who are admitted in the pediatric endocrinology clinic of Hazrat Rasoul centre are selected and divided into two groups by convenient sampling. FBS, 2hpp BS and HGA1C of all patients will be checked.
Lantus insulin is given to both groups as the basal insulin. The first group will inject insulin Aspart 15 minutes before and the second group will inject the insulin Aspart 15 minutes after each meal subcutaneously.
Patients will be visited every 2 weeks by a pediatric endocrinologist and an assistant. if needed, the patient's insulin dose will be changed. After 3 months, the patients' glucose profiles are checked and compared.Then, the 2 groups are replaced. after 3 months, BS profiles of the two groups will be evaluated and compared again.
Participants/Inclusion and exclusion criteria
6-17 year old children with poor controlled insulin dependent diabetes
Intervention groups
First of all patients' FBS, 2hpp BS and HGA1C will be check. Lantus insulin will be adminstered to both groups as the basal insulin. The first group will be recommended to inject insulin Aspart 15 minutes before and the second group 15 minutes after each meal subcutaneously.
After 3 months, the patients' glucose profiles will be checked and compared.Then, the 2 groups are replaced and after 3 months, the BS profiles of the 2 groups are checked and compared again.
Main outcome variables
FBS,2hpp BS,HGA1c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210221050444N1
Registration date:2022-05-28, 1401/03/07
Registration timing:registered_while_recruiting
Last update:2022-05-28, 1401/03/07
Update count:0
Registration date
2022-05-28, 1401/03/07
Registrant information
Name
Payam Samei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 1833
Email address
samei.p@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of preprandial and postprandial injection of Insulin Aspart on glycemic control of type 1 diabetic children
Public title
Effect of Insulin Aspart in diabetic children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
6-17 year old children suffering from diabetic type 1
Under treatment by insulin
poor controlled
Exclusion criteria:
Dissatisfaction of parents to participate in the project
Age
From 6 years old to 17 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Science, Rahmatieh st., Shahrekord, Iran.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۳۸۳۳۴۳۵
Approval date
2022-02-08, 1400/11/19
Ethics committee reference number
IR.SKUMS.REC.1400.231
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus type 1
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Time of the injection of Insulin
Timepoint
at the beginning and 3 months of beginning of the study
Method of measurement
Before and after meal
Secondary outcomes
1
Description
FBS
Timepoint
3 months and six months after the beginning of study
Method of measurement
blood sample
2
Description
2hpp BS
Timepoint
3 months and six months after the beginning of study
Method of measurement
blood sample
3
Description
HGA1C
Timepoint
3 months and six months after the beginning of study
Method of measurement
blood sample
4
Description
hypoglycemic episodes
Timepoint
Every time signs and symptoms of hypoglycemia occure
Method of measurement
Test by glucometere
Intervention groups
1
Description
Intervention group: subcutaneous injection of Insulin Aspart 15 minutes before taking of each meal for six months
Category
Treatment - Other
2
Description
Intervention group: subcutaneous injection of Insulin Aspart 15 minutes after taking of each meal for six months