IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase

Exclusion Criteria

• •Pregnancy or planning pregnancy
• •eGFR ≤ 30 mL/min per 1.73 m2, if available from medical record
• •Completed any other research study within 6 months of screening date
• •Current or recent use within 3 months of an insulin delivery system that adjusts insulin in response to continuous glucose monitoring (CGM) data (such as an automated insulin delivery system like hybrid closed-loop insulin pump therapy)
• •Known dementia or mild cognitive impairment diagnosis
• •Diabetic ketoacidosis within the last 6 months
• •Use of non-insulin medications to treat diabetes
• •Those planning to change diet or exercise regimen during the study
• •History of trans-sphenoidal surgery or surgery to the upper part of the nasal cavity, chronic sinusitis, severe deviated septum, or difficulty with smell and/or taste
• •Severe psychiatric illness
• •Allergy to adhesives, insulin or any components of insulin product
• •Subject cannot adequately demonstrate ability to use and deploy the devices as determined by investigator
• •Evidence of suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
• •Subject has history of any of the following: moderate to severe pulmonary disease, poorly controlled congestive heart failure, significant cardiovascular and/or cerebrovascular events within previous 6 months, condition known to affect absorption, distribution, metabolism, or excretion of drugs such as any hepatic, renal or gastrointestinal disease or any other clinically relevant abnormality or illness that inclusion would pose a safety risk to the subject as determined by investigator.