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:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT00493935
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year (The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
* Age 8.0 years to less than 18.0 years
* HbA1c \<10.0% (The DCA2000 will be used to assess eligibility.)
* Stable insulin regimen for at least 1 month and not anticipating a change prior to the subject's completion of the study (Stable is defined as no change in the overall insulin program, i.e., no change from SC injections to pump or Lantus therapy, or Lantus therapy to pump.)
* 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
* Subject is willing to have a bedtime snack each night and routinely has a snack at least 4 out of 7 nights as part of his/her normal diabetes management
* Subject has a home computer with internet access
* For females, subject not intending to become pregnant during the next month
* No expectation that subject will be moving out of the area of the clinical center during the next month
Exclusion Criteria:
* The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
* Known Celiac disease or other medical disorder (including lactose intolerance or food allergies such as peanuts) which would prevent the subject from consuming the bedtime snack
* The presence of any of the following diseases:
* Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
* Cystic fibrosis
* Other major illness that in the judgment of the investigator might interfere with the completion of the protocol (Adequately treated thyroid disease does not exclude subjects from enrollment)
* Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT00493935
Study Brief:
Protocol Section:
NCT00493935