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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT01501032
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months
* Age 12 to 65 years
* Hemoglobin A1c (HbA1c) between 5.0% and 10.5%, as measured with DCA2000 or equivalent device
* For females, not currently known to be pregnant
* Demonstration of proper mental status and cognition for the study
* An understanding of and willingness to follow the protocol and sign the informed consent or assent
Exclusion Criteria:
* Diabetic ketoacidosis in the past 6 months
* Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
* History of a seizure disorder (except hypoglycemic seizure).
* Coronary artery disease or heart failure.
* Cystic fibrosis
* Active infection
* A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
* A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, 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
* Current use of a beta blocker medication
* Hematocrit \<30%
* Use of pseudoephedrine 48 hours prior to Clinical Research Center (CRC) admission
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
65 Years
Study:
NCT01501032
Study Brief:
Protocol Section:
NCT01501032