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CTRI Number  CTRI/2023/08/056945 [Registered on: 25/08/2023] Trial Registered Prospectively
Last Modified On: 23/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effectiveness and safety of early administration of subcutaneous long acting insulin in treatment of children with moderate and severe diabetic ketoacidosis: An open label randomized controlled trial 
Scientific Title of Study   Efficacy and safety of early administration of subcutaneous long acting insulin in management of children with moderate and severe diabetic ketoacidosis: An open label randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhakti Sarangi 
Designation  Professor 
Affiliation  Bharati Vidhyapeeth (deemed to be University) medical college 
Address  Department of Pediatrics, Bharati vidyapeeth medical college, Dhankawadi, Pune-Satara road, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9823746976  
Fax    
Email  dr.bhaktisarangi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhakti Sarangi 
Designation  Professor 
Affiliation  Bharati Vidhyapeeth (deemed to be University) medical college 
Address  Department of Pediatrics, Bharati vidyapeeth medical college, Dhankawadi, Pune-Satara road, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9823746976  
Fax    
Email  dr.bhaktisarangi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhakti Sarangi 
Designation  Professor 
Affiliation  Bharati Vidhyapeeth (deemed to be University) medical college 
Address  Department of Pediatrics, Bharati vidyapeeth medical college, Dhankawadi, Pune-Satara road, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9823746976  
Fax    
Email  dr.bhaktisarangi@gmail.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth medical college, Dhankawadi, Pune Satara road, Pune 411043 
 
Primary Sponsor  
Name  Bharati Vidyapeeth medical college 
Address  Bharati Vidyapeeth medical college, Dhankawadi, Pune Satara road, Pune 411043 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sai Charitha Naladala  Department of Pediatrics, Bharati Vidyapeeth medical college  Bharati Vidyapeeth medical college, Dhankawadi, Pune Satara road, Pune 411043
Pune
MAHARASHTRA 
7842776909

saicharitha97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth medical college institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: E101||Type 1 diabetes mellitus with ketoacidosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intravenous regular insulin infusion   The comparator group will receive intravenous regular insulin infusion ranging between 0.03-0.1 u/kg/hr depending on serial bedside blood glucose levels. 
Intervention  Subcutaneous Basalog along with intravenous regular insulin infusion  The intervention group will receive subcutaneous insulin glargine at a dose of 0.3units / kilogram within 2 hours of diagnosis of DKA followed by a same dose once every 24 hours until resolution of Diabetic ketoacidosis along with intravenous regular insulin infusion ranging between 0.03-0.1 u/kg/hr depending on serial bedside blood sugar levels. The brand of insulin glargine used will be Basalog (100 IU/ml) by Biocon limited. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children between 1 year and 18 years of age with type 1 DM who are admitted to the pediatric intensive care unit with moderate or severe diabetic ketoacidosis (DKA) as per the ISPAD 2022 guidelines.  
 
ExclusionCriteria 
Details  - Children with mild DKA.
- Children with moderate or severe DKA who have received a dose of glargine insulin within the last 24 hours.
- Children who’s parents refuse to participate in the study.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the time taken for resolution of acidosis in between two groups.
To calculate and compare the duration of insulin infusion and total IV insulin requirement in between the two groups.

 
From starting of DKA protocol to time of resolution of DKA (pH more than 7.3 and HCO3 more than 18). 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the occurrence of rebound hyperglycemia post transition to subcutaneous insulin in between the two groups.
To determine the incidence of complications including hypoglycemia and hypokalemia and compare outcomes in terms of length of PICU stay.
 
From starting of DKA protocol to 6 hours after time of resolution of DKA (pH more than 7.3 and HCO3 more than 18). 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Children with underlying T1DM or T2DM who present in Diabetic Ketoacidosis will form the study population. Once diagnosed, the children will be categorized into moderate and severe diabetic ketoacidosis based on ISPAD 2022. An informed and written consent will be obtained from the parents of the child while an assent will also be taken in cases where the child is more than 8 years old. The consent and assent will be administered by the primary investigator (myself) or the pediatric intensive care fellow on duty. The enrolled subjects will be randomized using block randomization with pre-formed blocks of 4 with parallel arms. The intervention group will receive subcutaneous insulin glargine at a dose of 0.3units / kilogram within 2 hours of diagnosis of DKA followed by a same dose once every 24 hours while the control group will receive the standard treatment protocol. The brand of insulin glargine used will be Basalog (100 IU/ml) by Biocon limited. Both sets of patients will otherwise be managed with replacement fluids and insulin infusion as per ISPAD 2022 recommendations and any complications will be managed as per standard therapy. The lab monitoring for both groups will consist of an hourly bedside blood glucose level, venous blood gas every 6 hours and serum electrolytes and anion gap every 12 hours. On resolution of DKA (pH > 7.3 and HCO3 > 15), children in both groups will be transitioned to subcutaneous regular insulin as per the sliding scale  with continued monitoring of blood sugars and blood gas parameters additionally as indicated. An increase in BSL beyond  >250mg/dl within 2 hours after stopping of insulin infusion will be considered as rebound hyperglycemia. Demographical data, clinical data and laboratory findings of patients are recorded. Criteria considered to transfer the patient out of PICU include normalized glucose levels without any rebound hyperglycemia or acidosis, after 6 hours of transition from IV insulin infusion to subcutaneous (SC) insulin injections. The outcome measures will include time taken for acidosis resolution, total insulin infusion requirement, rate in fall of blood sugar level, incidence of complications (hypoglycemia / hypokalemia), incidence of rebound hyperglycemia and length of PICU stay.

 

 

 

 

 

 

 
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