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CTRI Number  CTRI/2025/07/091344 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 15/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Safety and Effectiveness of Smart Insulin Recommendation App (SIRA) in Kidney Transplant Participants with Diabetes. 
Scientific Title of Study   Safety & Efficacy study in kidney transplant patients of Smart Insulin Recommendation App (SIRA), a mobile based insulin dosing application  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shyam B Bansal 
Designation  Vice Chairman of Medanta Institute of Nephrology and Kidney Transplant 
Affiliation  Medanta, the Medicity 
Address  12th Floor, Institute of Nephrology and Kidney Transplant, Medanta- The Medicity

Gurgaon
HARYANA
122001
India 
Phone  9810383522  
Fax    
Email  shyam.bansal@medanta.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Shyam B Bansal 
Designation  Vice Chairman of Medanta Institute of Nephrology and Kidney Transplant 
Affiliation  Medanta, the Medicity 
Address  12th Floor, Institute of Nephrology and Kidney Transplant, Medanta- The Medicity

Gurgaon
HARYANA
122001
India 
Phone  9810383522  
Fax    
Email  shyam.bansal@medanta.org  
 
Details of Contact Person
Public Query  
Name  Dr Shyam B Bansal 
Designation  Vice Chairman of Medanta Institute of Nephrology and Kidney Transplant 
Affiliation  Medanta, the Medicity 
Address  12th Floor, Institute of Nephrology and Kidney Transplant, Medanta- The Medicity

Gurgaon
HARYANA
122001
India 
Phone  9810383522  
Fax    
Email  shyam.bansal@medanta.org  
 
Source of Monetary or Material Support  
CareOps Solutions Private Limited 149, 1st Floor Vipul Trade Centre, Sector-48 Indi, Haryana, India, 122018 
 
Primary Sponsor  
Name  CareOps Solutions Private Limited 
Address  149, Vipul Trade Center, Sector 48, Gurugram-122018 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Shyam B Bansal  Medanta-The Medicity  12th Floor, Institute of Nephrology and Kidney Transplant, Sector 38
Gurgaon
HARYANA 		 9810383522

shyam.bansal@medanta.org  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medanta Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R739||Hyperglycemia, unspecified, (2) ICD-10 Condition: Z940||Kidney transplant status, (3) ICD-10 Condition: E138||Other specified diabetes mellituswith unspecified complications, (4) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, (5) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Smart insulin recommendation app (SIRA)  The Smart Insulin Recommendation App (SIRA) is a mobile-based clinical decision support tool designed to assist nursing staff in optimizing insulin administration at bedtime. The application leverages real-time patient glucose data—captured either from point-of-care devices or manually entered readings—to generate personalized insulin dose recommendations. By integrating clinical algorithms and standardized protocols, SIRA aims to reduce variability in insulin dosing, minimize the risk of hypo- and hyperglycemia, and support timely, data-driven decision-making at the bedside. Participants will use the app-guided insulin dosing for a period of 3 months. 
Comparator Agent  Standard of care paper based insulin recommendation  The current standard of care for hospital-based insulin administration typically involves clinicians manually prescribing insulin doses once daily using paper-based charts or order sheets. These dosing decisions are usually made during morning rounds, based on the patients blood glucose trends, dietary intake, and clinical status. Once documented, the insulin orders are then transcribed and administered by nursing staff according to the written instructions. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Adults aged 18 years or older.
2. Undergoing kidney transplant and admitted to the postoperative intensive care unit (ICU).
3. Diagnosed with: Pre-existing diabetes mellitus (type 2), or New-onset hyperglycemia during their ICU stay (defined as blood glucose levels greater that 180 mg dl on two or more occasions).
4. Expected to remain in the ICU for at least 4–5 days postoperatively.
5. Able to provide informed consent or have a legally authorized representative provide consent on their behalf.
 
 
ExclusionCriteria 
Details  Participants will be excluded from the study if they meet any of the following criteria:
Diagnosed with type 1 diabetes mellitus or other forms of diabetes requiring specialized insulin regimens.
Unable/ unwilling to give informed consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Improvement in glycemic control, measured as the percentage of blood glucose readings within the target range (e.g., 70–180 mg/dL).
2. Mean blood glucose
 		 4–5 days of ICU stay. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Reduction in hypoglycemic episodes (blood glucose less than 70 mg/dL).
2. Reduction in severe hyperglycemia (blood glucose greater than 250 mg/dL).
3. Impact on length of hospital stay and overall patient outcomes.
4. Reduction in insulin-related dosing errors.
5. Clinician and nursing staff satisfaction with the use of INSULIN-Rx.
 		 4–5 days of ICU stay 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   31/07/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a prospective, open-label study evaluating the safety and efficacy of InsulinRx, a precision insulin titration system, in managing postoperative hyperglycemia in kidney transplant patients with type 2 diabetes or new-onset hyperglycemia. The study includes 34 adult patients (17 per group) during their 4–5 day stay in the ICU. The primary endpoints are mean blood glucose levels and the percentage of readings within the target range (80–180 mg/dL), while secondary outcomes include incidence of hypoglycemia, hyperglycemia, glucose variability, postoperative complications, and ICU/hospital stay duration. With prior pilot data showing no hypoglycemia and 70% of glucose readings within range, the study aims to validate InsulinRx as a safe and effective tool to optimize glycemic control, reduce complications, and support clinical decision-making in a high-risk transplant population.

 
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