Dual-hormone Artificial Pancreas Versus Single-hormone Under Exercise and a Meal Challenge

Korábbi kezelés

• Scheduled surgery during the study period.
• Use of an experimental drug or device within the past 30 days.

Más betegség

• Presence of progressive, fatal disease.
• History of drug or alcohol abuse.
• History of being HIV positive, active hepatitis B or hepatitis C.
• Clinically significant microvascular complications (such as macroalbuminuria, pre-proliferative and proliferative retinopathy), cardiovascular, hepatic, neurological, endocrine, or other systemic conditions, apart from T1D, that may hinder the implementation of the clinical study protocol or the interpretation of study results.
• Mental conditions that affect the subject's ability to comprehend the nature, purpose, and potential consequences of the study.

Laborértékek

• Impaired liver function, as evidenced by serum glutamic-pyruvic transaminase (SGPT) or serum glutamic-oxaloacetic transaminase (SGOT) levels exceeding twice the upper limit of the reference normal range at Visit 1.

Egyéb

• Pregnancy or breastfeeding.
• Hypoglycemia unawareness (as indicated by a Clarke Test score greater than 3).
• Subjects deemed unlikely to adhere to the clinical study protocol, including those with an uncooperative attitude, inability to attend follow-up visits or low likelihood of completing the study.

• Age between 18 and 65 years.
• CSII treatment for a minimum of 6 months prior to Visit 1.
• Body mass index between 18 and 30 kg/m2.
• HbA1c level below 9.0% at Visit 1.
• Physical examination, laboratory data, and ECG (electrocardiogram) results are within normal limits. Clinically insignificant abnormalities, as determined by the investigator, will not be considered exclusion criteria.
• Postmenopausal women or women of childbearing age who have a negative urine pregnancy test during the screening visit.