Physiologic Insulin Resensitization (PIR) Treatment in Patients With a Diagnosis of Type 2 Diabetes Mellitus (T2DM)

Prior treatment

• Has in the past two (2) years received treatment for a malignancy.
• Has in the past one (1) year used non-prescription opioids or non- prescriptive psychoactive drugs.

Other illness

• Has - in the opinion of the Investigator - psychiatric, behavioral, cognitive and/or clinical dysfunction (whether or not related to known medical illness or drug / alcohol use) that would affect the subject's safety and/or compliance.

Lab values

• Has in the past six (6) months had a hypoglycemic event requiring urgent care and/or administration of glucagon, osteocalcin, or parenteral glucose, unless approved for enrollment by the Medical Monitor.
• Has within the past one (1) month participated in a clinical study involving either of the following:
  • An investigational drug or procedure for any clinical indication
  • An investigation method for glucose control using approved agents.

Other

• Current pregnancy or intends to become pregnant during the study
• Is nursing or is planning to nurse during the study.
• Is on active dialysis at time of screening
• Weighs more than 450 lbs or has a waist circumference that exceeds the size of the MR bore when the coil is placed
• Has had recent iodine or barium-based contrast imaging
• Has an implanted device with metal incompatible with MR scanning, or the presence of any other metal in the body (such as shrapnel)
• Is unable to remain still for extended periods of time or to hold breath for 10 seconds
• Is claustrophobic.

• Is 18 or older (male or female)
• Have a documented diagnosis of T2DM of 6 months or greater prior to screening and an HbA1c \>7.5. Patients may have treatment regimens associated with T2DM that include diabetic oral and/or injectable medications including insulin and/or GLP-1 receptor agonists.
• In the opinion of the Investigator, has been on an appropriate, stable regimen for management of any complications present for the past six (6) months.
• In the opinion of the Investigator, is able to do all of the following:
  • Provide valid informed consent.
  • Understand and comply with study procedures as presented in the consent process.
  • Has the capacity or support to attend all required visits.
• If female, the subject must meet either of the following sets of conditions:
  • Is of non-childbearing potential, defined as meeting either of the following criteria:
  • Age ≥50 years and post-menopausal for at least one (1) year
  • Surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy
  • Is of childbearing potential and meets both of the following criteria:
  • Has a negative serum pregnancy test (beta-human chorionic gonadotropin) at screening.
  • Agrees to practice an acceptable method of birth control (contraception) from screening until at least 30 days after last study treatment