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

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 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

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

Value
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