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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults ≥18 years

Admitted to non-ICU units

Require scheduled prandial insulin as part of basal-bolus insulin therapy with CC.

Disqualifiers

History of type 1 DM

History of total pancreatectomy

Use of pre-admission CC for prandial insulin administration

Critical illness requiring ICU admission at time of recruitment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carbohydrate-counting-based prandial rapid-acting insulin dosing

    Other intervention

    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.

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

    Other intervention

    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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Carbohydrate-Counting-Based Prandial Insulin DosingActive comparator 1 intervention
Group B: Flexible Fixed Mealtime Insulin DosingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Time With Glucose in Target Range of 100 to 180 mg/dL

Patient-level percentage of time that glucose is within the target range of 100 to 180 mg/dL. This measure will be calculated using all glucose values obtained from randomization to discharge. For each patient, the time within range will be calculated using linear interpolation between consecutive measurements. For the percentage calculation, the numerator will be the calculated time within range, and the denominator will be the total time from the first glucose measurement after randomization to the last glucose measurement before discharge.

Time frame
From randomization to hospital discharge, up to 30 days

Secondary outcomes

1

Number of Hyperglycemia Events Greater Than 300 mg/dL

Number of glucose values greater than 300 mg/dL from randomization to hospital discharge.

Time frame
From randomization to hospital discharge, up to 30 days
2

Rate of Hyperglycemia Events Greater Than 300 mg/dL Per Patient-Day

Rate of glucose values greater than 300 mg/dL, calculated as the number of hyperglycemia events divided by the number of patient-days from randomization to hospital discharge.

Time frame
From randomization to hospital discharge, up to 30 days
3

Percentage of Time With Glucose Greater Than 300 mg/dL

Patient-level percentage of time that glucose is greater than 300 mg/dL, calculated using available glucose measurements from randomization to hospital discharge with linear interpolation between consecutive measurements.

Time frame
From randomization to hospital discharge, up to 30 days
4

Number of Hypoglycemia Events Less Than 70 mg/dL

Number of glucose values less than 70 mg/dL from randomization to hospital discharge.

Time frame
From randomization to hospital discharge, up to 30 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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