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 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT06609356
Eligibility Criteria:
Inclusion Criteria:
Age: 18-60 years BMI: 18-28 kg/m² Weight: ≥ 50 kg
T1DM Participants:
Duration of T1DM: 1-30 years HbA1c: 5.7-7.5% Insulin Therapy: Using automated insulin delivery
GCK-MODY Participants:
HbA1c: 5.7-7.5% Genetic Confirmation: Positive GCK sequencing
Control Participants:
HbA1c: less than 5.5%
\*\* Exclusion Criteria: Severe Hypoglycemia: ≥1 episode in the past 3 months
Comorbidities:
* Any hospital admissions for diabetic ketoacidosis in the past 6 months
* SBP greater than 140 mmHg and DBP greater than 100 mmHg
* eGFR by MDRD equation of less than 60 mL/min/1.73 m²
* AST or ALT greater than 2.5 times ULN
* Hct less than 35%
Medications:
* Any antioxidant vitamin supplement within 2 weeks before the study
* Any systemic glucocorticoid
* Antipsychotics
* Atenolol, Metoprolol, Propranolol
* Niacin
* Any thiazide diuretic
* Any oral contraceptive pill with greater than 35 mcg ethinyl estradiol
* Growth hormone
* Any immunosuppressant
* Antihypertensive
* Any antihyperlipidemic
Other:
* Pregnancy
* Tanner stage less than 5
* Peri- or post-menopausal women
* Active smoker
T1DM Participants:
Medications: Any diabetes medication except insulin C-peptide: greater than 0.7 ng/mL (fasting)
GCK-MODY Participants:
None specific
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06609356
Study Brief:
Protocol Section:
NCT06609356