Status:
COMPLETED
The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children
Lead Sponsor:
Corewell Health West
Collaborating Sponsors:
Helen DeVos Children's Hospital
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
4-11 years
Phase:
PHASE4
Brief Summary
To determine whether insulin glulisine decreases the breakfast post prandial glycemic excursion in comparison to insulin aspart.
Detailed Description
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 sub...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00913497
Start Date
June 1 2009
End Date
January 1 2012
Last Update
September 18 2023
Active Locations (1)
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1
Helen DeVos Childrens Hospital
Grand Rapids, Michigan, United States, 49503