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 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT03591458
Eligibility Criteria:
Inclusion Criteria:
* Subjects with Type 1 Diabetes Mellitus for at least 5 years or more
* Age between 21 to 60 years old
* HbA1c less or equal to 9% with the latest measurement within the last 3 months
* Use of real time Continuous Glucose Monitoring (rtCGM) providing continuous glucose data points for at least 3 months, and at least 80% of CGM readings available over the last 2-week period
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
Exclusion Criteria:
* Ongoing or recent history of major depressive disorder, or other ongoing major psychiatric disorders
* History of anti-depressant use within the last three months
* Insulin pump linked to a CGM with programmed automatic insulin adjustment or suspension
* History of advanced cardiac, liver, kidney or neurological disease
* Active malignancy
* Uncontrolled Human Immunodeficiency Virus diseases
* Advanced diabetic retinopathy, neuropathy, or nephropathy
* Frequent acetaminophen use which can disrupt CGM accuracy
* Pregnancy or female of child-bearing potential unable to practice effective contraception during the study period
* Breastfeeding female, or female with prospective plan to initiate breastfeeding
* Ongoing history of alcohol abuse
* Contraindication to amitriptyline use, including hypersensitivity to amitriptyline or any component of the formulation, co-administration with or within 14 days of Monoamine Oxidase Inhibitors and co-administration with cisapride
* Inability to understand or cooperate with study procedures, including taking study drugs and recording hypoglycemic symptoms.
The participants meeting the above criteria will enter "Run-in Period". At the Visit 2, the following additional exclusion criteria will be applied before study drug randomization:
* \< 80% of CGM readings available over the last 2-week period
* Time spent in hypoglycemia (i.e., \< 70 mg/dL) for \< 5% over a 2-week period on based on CGM reading.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT03591458
Study Brief:
Protocol Section:
NCT03591458