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 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT05985135
Eligibility Criteria:
Inclusion Criteria - Type 1 Diabetes Group:
\- Able to provide written consent.
Exclusion Criteria - Type 1 Diabetes Group::
* BMI \< 20 or \> 32 kg/m\^2.
* Celiac disease.
* Pregnancy.
* Smoking.
* Reported history of illicit substance use.
* History of active cardiovascular, cerebrovascular, or peripheral vascular disease.
* Active renal disease evidenced by estimated glomerular filtration rate (GFR) \< 50 mL/min/1.73 m\^2.
* Severe peripheral or autonomic neuropathy.
* Dementia or any other neurologic disease.
* Uncontrolled psychiatric disease.
* Any learning disability.
* Anemia.
* Thyroid-stimulating hormone (TSH) ≥ 7 or TSH ≤ 7 and free T4 ≤ 0.9.
* Hemoglobin A1c \> 9.0%.
* Type 2 Diabetes Mellitus (T2DM), or impaired fasting glucose.
* Detectable C peptide.
Inclusion Criteria - Control Group:
* Able to provide written consent.
* T1DM treated with continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI) (not Degludec).
Exclusion Criteria - Control Group:
* BMI \< 20 or \> 32 kg/m\^2.
* Celiac disease.
* Pregnancy.
* Smoking.
* Reported history of illicit substance use.
* History of active cardiovascular, cerebrovascular, or peripheral vascular disease.
* Active renal disease evidenced by estimated GFR \< 50 mL/min/1.73 m\^2.
* Severe peripheral or autonomic neuropathy.
* Dementia or any other neurologic disease.
* Uncontrolled psychiatric disease.
* Any learning disability.
* Anemia.
* TSH ≥ 7 or TSH ≤ 7 and free T4 ≤ 0.9.
* T2DM, or impaired fasting glucose.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05985135
Study Brief:
Protocol Section:
NCT05985135