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Safety and Effectiveness of Smart Insulin Recommendation App (SIRA) in Kidney Transplant Participants with Diabetes.

Safety & Efficacy study in kidney transplant patients of Smart Insulin Recommendation App (SIRA), a mobile based insulin dosing application - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091344
Enrollment
34
Registered
2025-07-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: R739- Hyperglycemia, unspecified Health Condition 2: Z940- Kidney transplant status Health Condition 3: E138- Other specified diabetes mellituswith unspecified complications Health Condition 4: E116- Type 2 diabetes mellitus with other specified complications Health Condition 5: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

Sponsors

CareOps Solutions Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 Timepoint: 4 5 days of ICU stay.

Secondary

MeasureTime frame
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. Timepoint: 4 5 days of ICU stay

Countries

India

Contacts

Public ContactDr Shyam B Bansal

Medanta, the Medicity

shyam.bansal@medanta.org9810383522

Outcome results

None listed

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