Comparing the efficacy and safety of diffrent insulin regimes in managing diabetes in patients receiving pulse steroids

Comparative Efficacy and Safety of Glargine With Short-Acting Analog Versus NPH With Short-Acting Analog in Pulse Steroid Therapy-Induced Hyperglycemia - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085669

Enrollment

Registered

2025-04-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Interventions

Intervention1: INSULIN GALRGINE WITH SHORT ACTING ANALOG INSULIN: The total daily insulin dose will be calculated using a previously derived regression model based on data from 100 patients treated wi

Eligibility

Inclusion criteria

Inclusion criteria: Type 2 diabetes patients older than 18 years of age receiving pulse steroids will be included

Exclusion criteria

Exclusion criteria: Patients with Type 1 diabetes Stage 4 ckd or greater Active infection Cld will be excluded

Design outcomes

Primary

Measure	Time frame
Comparison of the total number of blood glucose readings within the target range between the two insulin regimens. Target blood glucose levels: Fasting blood glucose less than 140 milligrams per deciliter Postprandial blood glucose less than 200 milligrams per deciliter Expressed as the percentage of total blood glucose readings within the target range. Incidence of Hypoglycemia: Mild Hypoglycemia: Blood glucose less than 70 milligrams per deciliter Severe Hypoglycemia: Blood glucose less than 40 milligrams per deciliter Comparison of total hypoglycemic events per patient and the percentage of patients experiencing hypoglycemia.Timepoint: Blood glucose levels will be monitored at fasting, pre-meal, postprandial, and bedtime. Daily monitoring throughout the hospital stay. Incidence of Hypoglycemia: Recorded daily during hospitalization. Any episode of blood glucose less than 70 milligrams per deciliter will be noted immediately.	—

Measure

Time frame

Comparison of the total number of blood glucose readings within the target range between the two insulin regimens. Target blood glucose levels: Fasting blood glucose less than 140 milligrams per deciliter Postprandial blood glucose less than 200 milligrams per deciliter Expressed as the percentage of total blood glucose readings within the target range. Incidence of Hypoglycemia: Mild Hypoglycemia: Blood glucose less than 70 milligrams per deciliter Severe Hypoglycemia: Blood glucose less than 40 milligrams per deciliter Comparison of total hypoglycemic events per patient and the percentage of patients experiencing hypoglycemia.Timepoint: Blood glucose levels will be monitored at fasting, pre-meal, postprandial, and bedtime. Daily monitoring throughout the hospital stay. Incidence of Hypoglycemia: Recorded daily during hospitalization. Any episode of blood glucose less than 70 milligrams per deciliter will be noted immediately.

—

Secondary

Measure	Time frame
To evaluate the effectiveness of a previously derived regression model for predicting the starting insulin dose in patients receiving pulse steroids. The model was developed based on data from 100 patients previously treated with pulse steroids in our hospital. Timepoint: At the time of initiation of insulin therapy on Day Zero & end of pulse steroids either day 3 or day 5	—

Countries

India

Contacts

Public ContactDr Krish Panikar

Amrita institue of medical sciences

pravvp@gmail.com9495247676

Outcome results

None listed

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