The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children
The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children
To determine whether insulin glulisine decreases the breakfast post prandial glycemic
 excursion in comparison to insulin aspart.
This is a treatment, open label, crossover study comparing two and four hour breakfast post
 prandial blood glucose levels after receiving a dose of insulin glulisine or insulin aspart
 administered subcutaneously and consuming the breakfast meal from a prescribed menu
 containing 45, 60 or 75 grams of carbohydrate. Each subject will receive insulin glulisine
 for ten days and insulin aspart for ten days.
Inclusion Criteria:

 -  current patient in the Helen DeVos Children's Hospital Diabetes Clinic;

 -  ages 4-11 years;

 -  prepubertal (Tanner Stage I);

 -  diagnosed with type 1 diabetes mellitus with positive islet cell antibodies or
 presenting at time of diagnosis with positive serum or urine ketones and requiring
 insulin since diagnosis;

 -  at least six months from date of diagnosis of type 1 diabetes mellitus;

 -  TSH within reference range and negative transglutaminase IgA antibodies within nine
 months of study start;

 -  HbA1C between 6.9 and 10% within 30 days of study start; parent or guardian able and
 willing to provide written informed consent prior to enrollment;

 -  at time of study start, current insulin regimen includes multiple daily injections
 with insulin glargine as the basal insulin and insulin aspart or insulin lispro as the
 pre-meal rapid acting insulin

 Exclusion Criteria:

 -  pubertal (Tanner stage 2 or greater);

 -  concurrent Addison's disease, celiac disease or untreated hypothyroidism; - receiving
 oral, injectable or inhaled steroids or immunosuppressant medications;

 -  receiving stimulants for treatment of attention deficit disorder or attention deficit
 hyperactivity disorder;

 -  intercurrent illnesses such as a fever > 101 degrees F, infection, or gastroenteritis;

 -  use of any medication to treat diabetes other than those listed under in inclusion
 criteria;

 -  potential for lack of compliance or any other issue which, in the opinion of the
 investigator, would compromise the subject's safety or successful participation in the
 study