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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

Safety & Efficacy Study of Smart Insulin Recommendation App (SIRA) for maintaining optimal glycemic control in Cardiac Surgery Patients with Diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090542
Enrollment
300
Registered
2025-07-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications Health Condition 2: E116- Type 2 diabetes mellitus with other specified complications Health Condition 3: E138- Other specified diabetes mellituswith unspecified complications Health Condition 4: Z488- Encounter for other specified postprocedural aftercare Health Condition 5: R739- Hyperglycemia, unspecified

Interventions

Intervention1: 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 insu

Sponsors

CareOps Solutions Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 1. Diagnosed with type 1 diabetes mellitus or other forms of diabetes requiring specialized insulin regimens 2. Unable or unwilling to give informed consent

Design outcomes

Primary

MeasureTime frame
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. Timepoint: NA—

Secondary

MeasureTime frame
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. Timepoint: NA—

Countries

India

Contacts

Public ContactDr Yatin Mehta

Medanta- The Medicity

Yatin.Mehta@Medanta.org9971698149

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026