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 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT04917692
Eligibility Criteria:
Inclusion Criteria:
* Age: 12-18 years
* Clinical diagnosis of type 1 diabetes
* Duration of diabetes \> 1 r
* Multiple daily injections or continuous subcutaneous insulin infusion.
* Home glucose testing 4 times per day or continuous glucose monitor.
* Hemoglobin A1c levels will be ≤ 10.5%
* History of adherence to insulin administration, carbohydrate counting.
Exclusion Criteria:
* Duration of type 1 diabetes for less than 1 year
* Medical conditions other than type 1 diabetes or treated hypothyroidism
* Medications other than insulin, levothyroxine or oral contraceptives for birth control
* Antihypertensive medications, lipid lowering medications, or anti-hyperglycemic agents other than insulin.
* Acute viral and bacterial illnesses are not exclusionary, but we will take a health history at baseline and at the time of any study visit and if a recent illness has occurred we will delay testing until the individual is symptom free for 1 week and off and treatment for the illness.
* Hospital admission for diabetic ketoacidosis in the last year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT04917692
Study Brief:
Protocol Section:
NCT04917692