Artificial Pancreas With Carbohydrate Suggestion for Patients With Type 1 Diabetes Prone to Hypoglycemia

Exclusion Criteria

• •Negative SARS-CoV-2 PCR test performed at arrival.
• •Subject willing to wear the SAFE-AP system continuously throughout the study.
• •Pregnancy and breastfeeding.
• •History of drug or alcohol abuse.
• •Progressive fatal disease.
• •Clinically relevant microvascular complications (macroalbuminuria, pre-proliferative and proliferative retinopathy), cardiovascular, hepatic, neurological, endocrine or other systematic, apart from T1D, which may hamper the implementation of the clinical study protocol or interpretation of results study.
• •Scheduled surgery during the study period.
• •Mental conditions that prevent the subject to understand the nature, purpose and possible consequences of the study.
• •Subjects who are unlikely to meet the clinical study protocol, eg. uncooperative attitude, inability to return for follow-up visits, or poor probability of completing the study.
• •Using an experimental drug or device during the past 30 days.