Feasibility Study Using Zone-MPC Controller, HMS and Technosphere® Insulin Inhalation System From MannnKind Corp

Exclusion Criteria

• •Pregnancy (as determined by a positive blood pregnancy test performed in females of childbearing capacity during screening visit and urine test at time of admission for in-patient visit) or nursing mother.
• •Diabetic ketoacidosis in the past 6 months prior to enrollment requiring emergency room visit or hospitalization
• •Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
• •Current treatment for a seizure disorder;
• •o Subjects with a history of seizures may be included in the study if they receive written clearance from their neurologist
• •Cystic fibrosis
• •Active infection
• •A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as cognitive deficit.
• •Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write.
• •Coronary artery disease or heart failure. oSubjects with a history of coronary artery disease may be included in the study if they receive written clearance from their cardiologist
• •Presence of a known adrenal disorder
• •Active coronary artery disease or heart failure
• •Active gastroparesis
• •If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
• •Uncontrolled thyroid disease
• •o Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
• •Abuse of alcohol
• •A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
• •Current use of a beta blocker medication
• •Laboratory results:
• •* Hematocrit \< 30% or \>55%
• •* A1C \> 10%
• •* Abnormal liver or renal function (Transaminase \>2 times the upper limit of normal, Creatinine\> 1.5 mg/dL)
• •* Labs drawn at screening visit or within one month prior to screening (for other purposes) will suffice for enrollment purposes related to hematocrit
• •Subject has skin conditions that, in the determination of the investigator, would preclude wearing the study devices (infusion set and sensor), in the abdomen. Examples include but are not limited to: psoriasis, burns, scaring, eczema, tattoos, and significant hypertrophy at sites of device wear; any known allergy to medical adhesives.
• •Currently on long-term treatment using prednisone.
• •If subject had been on short term treatment of prednisone, defer enrollment until underlying condition and prednisone treatment have resolved.
• •Allergy to study drug, food or other study material
• •History of asthma, COPD (chronic obstructive pulmonary disease), or any other clinically relevant chronic lung disease
• •Respiratory track infection within 4 weeks before screening
• •Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality
• •Exposure to any investigational drug within 30 days.
• •History of malignancy within the 5 years before screening (other than basal cell carcinoma)
• •Inability, in the opinion of the investigator, to adequately inhale Technosphere® Inhalation powder
• •Abnormal spirometry
• •Currently smoking or discontinued smoking (including cigarettes, cigars, pipes) over the past 6 months.
• •Highly sensitive to insulin: insulin-to-carbohydrate ratio I:C \> 1:12.
• •Current participation in another investigational trial (unless participation to original protocol of IDE G110093) or has previously participated to this study.