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
|
|
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
|
|
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. |