| CTRI Number |
CTRI/2025/07/090542 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to Assess the Safety and Effectiveness of the Smart Insulin Recommendation App (SIRA) in Managing Blood Sugar Levels in Heart Surgery Patients with Diabetes |
|
Scientific Title of Study
|
Safety & Efficacy Study of Smart Insulin Recommendation App (SIRA) for maintaining optimal glycemic control in Cardiac Surgery Patients with Diabetes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yatin Mehta |
| Designation |
Chairman - Institute of Critical Care & Anesthesia |
| Affiliation |
Medanta- The Medicity |
| Address |
1st Floor, Institute of Critical Care & Anesthesia
Medanta-The Medicity
Sector 38
Gurgaon
HARYANA
122001
India |
| Phone |
9971698149 |
| Fax |
|
| Email |
Yatin.Mehta@Medanta.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yatin Mehta |
| Designation |
Chairman - Institute of Critical Care & Anesthesia |
| Affiliation |
Medanta- The Medicity |
| Address |
1st Floor, Institute of Critical Care & Anesthesia
Medanta-The Medicity
Sector 38
Gurgaon
HARYANA
122001
India |
| Phone |
9971698149 |
| Fax |
|
| Email |
Yatin.Mehta@Medanta.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yatin Mehta |
| Designation |
Chairman - Institute of Critical Care & Anesthesia |
| Affiliation |
Medanta- The Medicity |
| Address |
1st floor, Institute of Critical Care & Anesthesia
Medanta-The Medicity
Sector 38
Gurgaon
HARYANA
122001
India |
| Phone |
9971698149 |
| Fax |
|
| Email |
Yatin.Mehta@Medanta.org |
|
|
Source of Monetary or Material Support
|
| CareOps Solutions Private Limited |
|
|
Primary Sponsor
|
| Name |
CareOps Solutions Private Limited |
| Address |
149, 1st Floor Vipul Trade Centre, Sector-48 Indid, Haryana, India, 122018 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Yatin Mehta |
Medanta-The Medicity |
1st Floor, Institute of Critical Care & Anesthesia, Medanta-The Medicity
Sector 38
Gurgaon
HARYANA |
9971698149
Yatin.Mehta@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, (2) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, (3) ICD-10 Condition: E138||Other specified diabetes mellituswith unspecified complications, (4) ICD-10 Condition: Z488||Encounter for other specified postprocedural aftercare, (5) ICD-10 Condition: R739||Hyperglycemia, unspecified, |
|
|
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. |
| 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 cardiac surgery and admitted to the post operative cardiac intensive care unit (ICU)
3. Diagnosed with: Pre existing diabetes mellitus (type2) 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 |
1. Diagnosed with type 1 diabetes mellitus or other forms of diabetes requiring specialized insulin regimens
2. Unable or unwilling to give informed consent |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Objectives:
1. To compare the efficacy of Smart Insulin Recommendation App (SIRA) in achieving optimal glycemic control (80 to 180mg/dl) as compared to standard operating procedures in hospitalized patients.
2. To compare the mean blood glucose between the two groups.
|
NA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes:
1. Incidence of mild & severe hypoglycemia between the two groups.
2. Incidence of mild & severe hyperglycemia between the two groups.
3. Postoperative glucose variability, measured as the coefficient of variation (CV), between the two groups.
4. Incidence of postoperative complications, including infections, acute kidney injury, stroke, cardiac events, & mortality, between the two groups.
5. Length of ICU stay & total hospital stay between the two groups.
Exploratory Outcome:
1. Nurse satisfaction scores as measured by using the unified theory of acceptance & use of technology (UTAUT) model.
|
NA |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
21/07/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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, controlled, open-label study to evaluate the safety and efficacy of SIRA (Smart Insulin Recommendation App), a decision support tool which recommends insulin doses based on real time glucose data captured from glucometer in hospitalized patients with diabetes undergoing cardiac surgery. The study will compare glycemic outcomes, safety parameters, and workflow efficiency between patients managed using SIRA-guided insulin recommendations and those managed with standard insulin therapy protocols. The primary objective is to assess whether SIRA can improve time-in-target glucose range and reduce glycemic variability without increasing the risk of hypoglycemia. |