Unique ID issued by UMIN | UMIN000045712 |
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Receipt number | R000052180 |
Scientific Title | Efficacy and safety of low dose insulin against standard dose insulin infusion in children with diabetic ketoacidosis- an open label randomized controlled trial. |
Date of disclosure of the study information | 2021/10/10 |
Last modified on | 2021/10/10 18:31:01 |
Comparison of two doses of insulin for diabetic ketoacidosis in children
IDIC- Insulin doses in children
Efficacy and safety of low dose insulin against standard dose insulin infusion in children with diabetic ketoacidosis- an open label randomized controlled trial.
LDIC- Low dose insulin in children
Asia(except Japan) |
Diabetic ketoacidosis
Pediatrics |
Others
NO
To compare the time taken until resolution of acidosis in low-dose insulin infusion group and standard dose insulin infusion group.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
To compare the time taken until resolution of acidosis in both the groups while on treatment
To compare the time taken until decline in blood glucose till 250 mg/dL in both the groups
To compare the proportion of children developing hypoglycemia in both the groups
To compare the proportion of children developing hypokalemia in both the groups
To compare the incidences of treatment failures in both the groups
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
NO
NO
Institution is not considered as adjustment factor.
YES
Numbered container method
2
Treatment
Medicine |
low dose insulin infusion of regular insulin at rate of 0.05unit/kg/hour
standard dose insulin infusion of regular insulin at rate of unit/kg/hour
1 | years-old | <= |
12 | years-old | >= |
Male and Female
All consecutive children twelve years of age or younger, who presented with diabetic ketoacidosis defined as Hyperglycemia, Acidosis, Ketonemia or ketonuria will be enrolled
Symptomatic cerebral edema
30
1st name | Diganta |
Middle name | |
Last name | Saikia |
Chacha Nehru Bal Chikitsalaya
Government of Dehi
110031
Raja Ram Kohli Marg, Geeta Colony, Delhi
919899023635
drsaikiadiganta@gmail.com
1st name | Medha |
Middle name | |
Last name | Mittal |
Chacha nehru Bal Chikitsalaya
Government of Delhi
110031
Raja Ram Kohli Marg, Geeta Colony, Delhi
919599718219
goelmedha@gmail.com
Chacha nehru Bal Chikitsalaya
Department of Pediatrics
Chacha nehru Bal Chikitsalaya
Department of Pediatrics
Government of Delhi
Government offices of other countries
India
Chacha Nehru Bal Chikitsalaya, Government of Delhi
Geeta Colony
918595919301
mscnbc@gmail.com
NO
2021 | Year | 10 | Month | 10 | Day |
Unpublished
30
No longer recruiting
2017 | Year | 06 | Month | 30 | Day |
2017 | Year | 07 | Month | 04 | Day |
2017 | Year | 07 | Month | 05 | Day |
2021 | Year | 04 | Month | 04 | Day |
2021 | Year | 10 | Month | 10 | Day |
2021 | Year | 10 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052180
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