
    slow subject enrollment, unable to complete trial in a timely manner
  
['type1 diabetes mellitus', 'hypoglycemia unawareness']
['amitriptyline', 'placebo']

        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.
      