UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045712 |
|---|---|
| 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 |
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Basic information
Public title
Comparison of two doses of insulin for diabetic ketoacidosis in children
Acronym
IDIC- Insulin doses in children
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.
Scientific Title:Acronym
LDIC- Low dose insulin in children
Region
| Asia(except Japan) |
Condition
Condition
Diabetic ketoacidosis
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the time taken until resolution of acidosis in low-dose insulin infusion group and standard dose insulin infusion group.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare the time taken until resolution of acidosis in both the groups while on treatment
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
low dose insulin infusion of regular insulin at rate of 0.05unit/kg/hour
Interventions/Control_2
standard dose insulin infusion of regular insulin at rate of unit/kg/hour
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All consecutive children twelve years of age or younger, who presented with diabetic ketoacidosis defined as Hyperglycemia, Acidosis, Ketonemia or ketonuria will be enrolled
Key exclusion criteria
Symptomatic cerebral edema
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Diganta |
| Middle name | |
| Last name | Saikia |
Organization
Chacha Nehru Bal Chikitsalaya
Division name
Government of Dehi
Zip code
110031
Address
Raja Ram Kohli Marg, Geeta Colony, Delhi
TEL
919899023635
drsaikiadiganta@gmail.com
Public contact
Name of contact person
| 1st name | Medha |
| Middle name | |
| Last name | Mittal |
Organization
Chacha nehru Bal Chikitsalaya
Division name
Government of Delhi
Zip code
110031
Address
Raja Ram Kohli Marg, Geeta Colony, Delhi
TEL
919599718219
Homepage URL
goelmedha@gmail.com
Sponsor or person
Institute
Chacha nehru Bal Chikitsalaya
Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Chacha nehru Bal Chikitsalaya
Department of Pediatrics
Government of Delhi
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
India
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chacha Nehru Bal Chikitsalaya, Government of Delhi
Address
Geeta Colony
Tel
918595919301
mscnbc@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 10 | Day |
Last modified on
| 2021 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052180
