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NOT YET RECRUITING
NCT07808398
NA

Comparing Glycemic Outcomes of Carbohydrate Counting vs. Fixed Mealtime Insulin Dosing in Hospitalized Patients With Hyperglycemia

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

Summary

The study compares two current practices for calculating insulin dose for admitted patients: flexible fixed mealtime dosing based on percent of meal eaten and carbohydrate counting based on amount of carbohydrates eaten.

Official title: Comparing Glycemic Outcomes of Carbohydrate Counting vs. Fixed Mealtime Insulin Dosing in Hospitalized Patients With Hyperglycemia: an EHR-embedded Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2026-10

Completion Date

2027-05

Last Updated

2026-09-08

Healthy Volunteers

No

Interventions

OTHER

Carbohydrate-counting-based prandial rapid-acting insulin dosing

For each meal, the provider enters an insulin-to-carbohydrate ratio in the EHR. After the meal, nursing staff document the grams of carbohydrates consumed. The EHR calculates the rapid-acting insulin dose using the ordered insulin-to-carbohydrate ratio, along with any correctional insulin dose based on the pre-meal glucose value. The calculated insulin dose is then administered as soon as possible after meal completion.

OTHER

Flexible fixed mealtime rapid-acting insulin dosing based on percentage of meal consumed

For each meal, the EHR calculates a full fixed prandial rapid-acting insulin dose from the provider-entered insulin-to-carbohydrate ratio, assuming a full meal contains 75 grams of carbohydrates and rounding to the nearest whole-unit dose according to the protocol. After the meal, nursing staff document whether the participant consumed 0%, 25%, 50%, 75%, or 100% of the meal. The EHR then instructs nursing staff to administer the corresponding proportion of the fixed dose as soon as possible after meal completion.