The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children

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