Effect of Apidra Compared to Humalog in Decreasing Post-Prandial Hyperglycemia

University of Florida107 enrolled

Overview

This study aims to compare the post-meal blood glucose values of two drugs in a "real-world" setting.

This is a randomized, open-label trial that aims to compare the glycemic excursion following food intake following post-meal injection of Glulisine (Apidra) insulin and Lispro (Humalog) insulin in a real-world setting. Children participating in the Florida Camp for Children and Youth with Diabetes will be randomized to receive either Glulisine or Apidra to cover carbohydrates after meals. The difference in blood glucose values will be analyzed before and 2 hours after meals to see if there is a difference in post-prandial hyperglycemia between groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

107

Conditions

Type 1 Diabetes

Interventions

ApidraDRUG

Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.

HumalogDRUG

Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.

NovologDRUG

Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)

Eligibility

Sex: ALLMin age: 9 YearsMax age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of type 1 Diabetes * Children and Youth attending Florida Diabetes Camp in DeLand, FL Exclusion Criteria: * only campers participating in sessions I and II are eligible to participate

Locations (1)

Camp Winona

DeLeon Springs, Florida, United States

Outcomes

Primary Outcomes

The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch.

Blood glucose concentrations were measured prior to and 90 minutes following lunch. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model. The number of participants for analysis was based upon a convenience sample of individuals attending Florida Camp for Children and Youth with Diabetes at Camp Winona.

Time frame: averaged over 5 days

Secondary Outcomes

Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner

Blood glucose concentrations were measured prior to and 120 minutes following dinner. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.

Time frame: averaged over 5 days

Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast

Blood glucose concentrations were measured prior to and 120 minutes following breakfast. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.

Time frame: averaged over 5 days

Data from ClinicalTrials.gov

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