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

data gathered over 20 days of treatment. Participants alternated between study interventions for 10 days on each intervention.

Adverse events were not specifically reported in the published work for this study. Patients in this study were members of both arms on alternating days.

This study was completed over 10 years ago, raw data is no longer available, the results reported in this entry are based on the published document for the trial that was published in 2013. This is the only information that is available for reporting. Per the published works, the target enrollment was met and data analyzed.