UMIN-CTR Clinical Trial

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
Email	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
Email	goelmedha@gmail.com

Sponsor
Institute	Chacha nehru Bal Chikitsalaya Department of Pediatrics
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052180

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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