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 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT03353792
Eligibility Criteria:
Inclusion Criteria:
* Provide signed and dated informed consent form
* Male or female
* Age 50-75 years (at least 50% over the age of 65)
* T1DM (\>20 years duration)
* C-peptide undetectable
* HbA1c of \< 8%
* Insulin pump therapy
* History of frequent hypoglycemia with unawareness (defined as 2 or more episodes of severe hypoglycemia within one year requiring assistance) and 2 or more glucose values \< 54 mg/dL during the week of Continuous Glucose Monitoring (CGM) (iPRO monitor, Medtronic) prior to enrollment
* BMI \<27 kg/m2
* Good general health as evidenced by medical history and blood screening
* Willing to comply with all study procedures and be available for the duration of the study
* Willing to fast for a limited time period on the morning of a clamp study
Exclusion Criteria:
* Significant diabetic complications (untreated proliferative retinopathy, creatinine ≥1.5 mg/dl, urinary albumin levels 300 mg/day, autonomic neuropathy, painful peripheral neuropathy)
* Significant alcohol intake and vegetarian diet since both are known to have an impact on counterregulation and brain metabolism
* Any contraindications for MRI scanning, including presence of metallic implants or claustrophobia.
* Heavy exercise on a regular basis (i.e. marathon runners)
* Known allergic reactions to components of the study product(s)
* Treatment with another investigational drug or other intervention
* Active infection including hepatitis C, hepatitis B, HIV
* Any past or current history of alcohol or substance abuse
* Psychiatric or neurological disorders under active treatment
* Baseline hemoglobin \< 10.5 g/dL in females, or \< 12.5 g/dL in males. Blood donation within 30 days of the study
* History of coagulopathy or medical condition requiring long-term anticoagulant therapy (low-dose aspirin treatment is allowed)
* Co-existing cardiac, liver, and kidney disease
* Abnormal liver function tests
* Women that are on oral contraceptives, post-menopausal, pregnant (as assessed by pregnancy test that will be performed on female participants at reproductive age), or lactating.
* Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT03353792
Study Brief:
Protocol Section:
NCT03353792