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 @ 2:30 PM
Ignite Modification Date:
2025-12-24 @ 2:30 PM
NCT ID:
NCT01390259
Eligibility Criteria:
Inclusion Criteria:
* 12 years of age and up to and including 18 years of age.
* Have type 1 diabetes mellitus as defined by American Diabetes Association criteria or judgment of physician for at least 1 year (including those who may also be treated with metformin).
* Use of an insulin pump
* If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have stability on the medication for at least 2 months prior to enrollment in the study
* Willingness to use lispro (Humalog) insulin for the duration of the inpatient study
* Demonstration of proper mental status and cognition for the study
* Willingness to stop using any dietary supplements for two weeks prior to admission and for the duration of their participation
* HemoglobinA1c \< 10.0
* A score of 2 or greater on the hypoglycemia unawareness scale, see Attachment A
* Tanner Stage II or greater (not pre-pubertal) on screening physical exam
* Body weight of 30 kg or more at screening
* BMI must be under 95th percentile for age based on published BMI reference standards
Exclusion Criteria:
* Age \<12 or \>18
* Pregnancy
* Hematocrit \<37% (females); \<36% (males)
* HemoglobinA1c ≥ 10.0
* Any symptomatic coronary artery disease, or a history of congenital heart abnormalities.
* Score of less than 2 on the hypoglycemia unawareness scale
* Tanner Stage I on screening physical exam
* Use of a medication that significantly lowers heart rate (beta blockers, reserpine, guanethidine, methyldopa, clonidine, cimetidine, digitalis, calcium channel blockers, amiodarone, antiarrythmic drugs, or lithium)
* Congestive heart failure
* History of a cerebrovascular event
* Use of a medication that significantly impacts glucose metabolism (oral steroids)
* Atrial fibrillation
* Uncontrolled hypertension (resting blood pressure \>140/90)
* History of a systemic or deep tissue infection with methicillin-resistant staph aureus or Candida albicans
* Use of a device that may pose electromagnetic compatibility issues and/or radiofrequency interference with the FreeStyle NavigatorTM CGM or DexCom Seven® (implantable cardioverter-defibrillator, electronic pacemaker, neurostimulator, intrathecal pump, and cochlear implants)
* Active enrollment in another clinical trial
* Allergy or adverse reaction to lispro insulin
* Known adrenal gland problem, pancreatic tumor, or insulinoma
* Current alcohol abuse by patient history, substance abuse by patient history, or severe mental illness
* Retinopathy and renal failure
* Uncontrolled anxiety or panic disorder
* Known bleeding diathesis or dyscrasia
* Renal insufficiency (creatinine \>1.5)
* Any comorbid condition affecting glucose metabolism
* Body weight of less than 30 kg at screening
* BMI equal to or greater than 95th percentile for age based on published BMI reference standards. See Appendix B.
* Asthma or exercise -induced asthma
* Any mobility-restrictive condition
* Children who are wards of state or at high risk for becoming wards of state
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT01390259
Study Brief:
Protocol Section:
NCT01390259