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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000045712 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Diabetic ketoacidosis | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |