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

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

Detailed Description
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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.

Official Title
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Comparison of Effectiveness of Glulisine and Lispro in Decreasing Post-Prandial Hyperglycemia in a Real-World Setting

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Apidra
* Drug: Humalog
* Drug: Novolog


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Humalog<br>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. | Drug: Humalog<br>* 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.<br>* Other names: Insulin lispro;|
| Active Comparator: Apidra<br>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. | Drug: Apidra<br>* 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.<br>* Other names: Insulin glulisine;|
| Active Comparator: Novolog<br>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.) | Drug: Novolog<br>* 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.)<br>* Other names: Insulin aspart;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | averaged over 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | averaged over 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-prandial hyperglycemia