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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT02750267
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of type 1 diabetes,
* The diagnosis of type 1 diabetes is based on the investigator's judgment
* C peptide levels and antibody determinations are not required
* Daily insulin therapy for ≥ 12 months
* Insulin pump therapy for ≥ 3 months
* Age ≥5 - ≤8 years old
* Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
* Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study
Exclusion Criteria:
The presence of any of the following is an exclusion for the study:
* Diabetic ketoacidosis in the past month
* Hypoglycemic seizure or loss of consciousness in the past 3 months
* History of seizure disorder (except for hypoglycemic seizure)
* History of any heart disease including coronary artery disease, heart failure, or arrhythmias
* Cystic fibrosis
* Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
* History of ongoing renal disease (other than microalbuminuria).
* Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine).
* Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
* Presence of a febrile illness within 24 hours of admission or acetaminophen use while wearing the CGM. The subject may be rescheduled for Research House/Hotel Admission if these criteria are not met. The study subject will not participate in the trial if these conditions are met.
* Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as:
* Inpatient psychiatric treatment in the past 6 months
* Uncontrolled adrenal insufficiency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
9 Years
Study:
NCT02750267
Study Brief:
Protocol Section:
NCT02750267