The study has not started, the device is not ready so the study will be delayed

The goal of this study is to perform a first-in-humans trial of a fully integrated, automated, closed-loop blood glucose control system designed for inpatient use. The GlucoSTAT was designed for use by patients with diabetes while they are in the hospital, and others who may develop high blood sugar as a result of their medical problems.

Our envisioned end product is an in-patient automated closed-loop control system for PG regulation in the ICU as well as on the general hospital wards. In order to qualify the system for the broad spectrum of challenges it will face in the inpatient setting, this study will test the ability of the new integrated configuration of the system (the GlucoSTAT) to control PG in subjects with extremes of insulin sensitivity. The first goal of this study is to test the safety and efficacy of the control system in insulin sensitive subjects with type 1 diabetes. The second goal of this study is to test the safety and efficacy of the control system in subjects with type 2 diabetes and substantial insulin resistance (TDD > 0.75 u/kg/day, with up to 3 subjects with a TDD > 2 u/kg/day).

Inclusion Criteria:

Type 1 diabetes:

1. Age 18 years or older with clinical type 1 diabetes for at least one year.
2. Diabetes currently managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (NovoLog or Fiasp), insulin lispro (Humalog), and insulin glulisine (Apidra).
3. Total daily dose (TDD) of insulin that is ≤ 1 U/kg
4. Prescription medication regimen stable for at least 1 month.
5. Informed consent obtained before any trial-related activities.

Type 2 diabetes:

1. Age 18 years or older with clinical type 2 diabetes for at least 1 year.

2. Diabetes currently managed using NPH as the basal insulin, which may be supplemented with regular or rapid-acting insulin and/or other anti-diabetic drugs.

3. Total daily dose (TDD) of insulin that is > 0.75 u/kg

   • Our goal is to have up to 3 T2D subjects with a TDD > 2 u/kg

4. Prescription medication regimen stable for at least 1 month.

5. Informed consent obtained before any trial-related activities.

Exclusion Criteria:

1. Unable to provide informed consent.

2. Unable to comply with study procedures.

3. Current participation in another diabetes-related clinical trial that, in the judgement of the principal investigator, will compromise the results of this study or the safety of the participant

4. Use of a long-acting insulin (in type 1 diabetes subjects) or a long-acting insulin other than NPH (in type 2 diabetes subjects), including insulin glargine (Lantus), insulin detemir (Levemir), insulin degludec (Tresiba), or ultra-lente.

5. Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception.

6. Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference.

7. Established history of latex, adhesive, or tape allergy that must be used in the study

8. Inadequate venous access as determined by study nurse or physician at time of screening.

9. Employed by, or having immediate family members employed by Beta Bionics, or being directly involved in conducting the clinical trial, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.

10. A condition that in the opinion of the investigator could interfere with the safe completion of the study. Conditions to be considered by the investigator may include the following:

    • Alcohol or drug abuse
    • Use of prescription drugs that may dull the sensorium, reduce sensitivity to symptoms of hypoglycemia, or hinder decision making during the period of participation in the study
    • Renal failure
    • Coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise (e.g. climbing a flight of stairs) despite medical management, or within the last 12 months before screening a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting
    • Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV
    • History of TIA or stroke in the last 12 months
    • Untreated or inadequately treated mental illness