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Carbohydrate Consumption as a Factor in Aspart Dosing

NCT01333514 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-05-01

Study results available
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Summary

Good sugar control in postoperative hospitalized patient has been shown to improve wound healing and infection rates. However, sugar control is difficult to achieve and suboptimal use of insulin is thought to be a contributory factor. Though it is known that generally the consumption of carbohydrates alone raises the blood sugar, the usual practice of dosing meal-time insulin is based on the fraction of the total meal-tray eaten which includes proteins, fats and carbohydrates. This leads to an overestimation of insulin required for a patient who consumes a portion of mainly proteins and fats on their trays or an underestimation for those eating mainly the carbohydrates on their tray. Low sugars or high blood sugars can follow respectively.

Hypothesis: The purpose of this study is to see if dosing meal-time insulin based on grams of carbohydrates consumed will result in better sugar control compared to the usual practice of dosing meal-time insulin based on percent of total meal consumed in hospitalized patients.

Conditions

Interventions

DRUG

aspart

Subjects will received aspart insulin subcutaneously based on the amount of carbohydrates consumed based on the formula 0.1 units/kg X (grams of carbohydrate eaten/75 grams carbohydrate)

DRUG

aspart- Insulin

0.1 units/kg of Aspart insulin will be given subcutaneously TID with meals if a subject eats 50% or more of their meal-tray

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Chung-Kay Koh, MD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01333514 on ClinicalTrials.gov