Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT00109434
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of type 1 diabetes for at least 18 months
* HbA1c \<10.0% as measured by the DCA2000.
* Age 10.0 to \<18.0 years
* Weight \>36.0 kg
* BMI (body mass index) \>5th and \<95th percentiles for age/gender
* Stable insulin regimen for at least 1 month and not anticipating a change prior to the subject's completion of the study
* Insulin regimen involves either use of an insulin pump or Lantus (with short-acting insulin)
* NPH or Lente, if part of the insulin regimen, is given only in the morning before breakfast
* Normal hematocrit (within normal limits of local laboratory)
* Normal thyroid function (measured within the previous year)
* Parent/guardian and subject understand the study protocol and agree to comply with it
* Informed Consent Form signed by the parent/guardian and Child Assent Form signed
Exclusion Criteria:
* Insulin regimen includes Ultralente/Lente or NPH at times other than the morning before breakfast
* A recent injury to body or limb, Addison's disease, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
* Asthma which has been medically treated within the last year
* Current use of glucocorticoid medication (by any route of administration)
* Current use of a beta blocker medication
* Use of pseudoephedrine 48 hours prior to CRC admission (if used in the 48 hours prior to the scheduled second admission, the admission will be deferred)
* Severe hypoglycemia resulting in seizure or loss of consciousness in the 2 weeks prior to CRC admission (if a severe episode occurs within 2 weeks prior to the scheduled second admission, the admission will be deferred)
* Active infection (if at the time of the planned second admission an infection is present, the admission will be deferred)
* Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
17 Years
Study:
NCT00109434
Study Brief:
Protocol Section:
NCT00109434