Evaluating an Insulin Pump for Time in Range (TIR) in Patients with Type 1 Diabetes

Prior treatment

• A history of 2 or more episodes of severe hypoglycemia leading to medical assistance, coma or seizure in the 6 months prior to screening;
• The presence of at least 4 hypoglycemic symptoms, occurrence or detection of hypoglycemic events within 1 month before screening;
• Patients who developed the following cardiac conditions in the 6 months prior to screening: a) decompensated cardiac insufficiency (New York College of Cardiology (NYHA) Class III or IV); b) unstable angina; c) History of myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; d) Uncontrolled or severe arrhythmia;
• Patients with the following cerebrovascular diseases in the 6 months before screening: a) transient ischemic attack; b) stroke;
• Subjects who have received, or plan to receive, red blood cell transfusions or erythropoietin (EPO) therapy within the 3 months prior to screening;
• Used immunosuppressants, cytotoxic drugs, systemic steroid drugs (excluding topical or inhaled preparations) for more than 7 days in the 3 months prior to screening or planned to be used during the study period;
• Screening subjects who have used hormone therapy for 3 or more consecutive days in the preceding 3 months, are currently using, or plan to use systemic hormone therapy during the study period;
• Major surgery is planned during the study period and will directly affect subjects treated with insulin pumps;
• Subjects and their families lacked relevant knowledge and were unable to correctly master the user after receiving training (excluding subjects who were hospitalized or admitted to the hospital during the study period for insulin pump operation by a doctor/nurse);
• Participated in other clinical trials within 3 months prior to screening;

Other illness

• Hyperglycemia with severe circulatory disorders and shock;
• Acute complications of diabetes (such as diabetic ketoacidosis, diabetic hyperosmolar non-ketotic coma);
• Any serious systemic disease determined by the investigator or any other disease that the investigator believes may interfere with the results of this study, including but not limited to mental illness, immune system disease, malignancy, etc.;
• Present with known proliferative retinal lesions or other history of visual impairment;
• History of hearing loss;
• Other conditions deemed unsuitable for inclusion by the researcher.

Lab values

• Impaired liver and kidney function (total bilirubin \> 1.5 times the upper limit of normal, alanine aminotransferase (ALT) \> 2.5 times the upper limit of normal; Glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2);
• Subjects with erythrocyte specific volume lower than the lower limit of normal laboratory values;
• Patients with abnormal coagulation function (activated partial thromboplastin time (APTT) or prothrombin time (PT) test results \>1.5 times the upper limit of normal value);
• Participants who plan to use drugs containing acetaminophen, vitamin C, etc. that affect blood glucose measurement during the study period;
• Subjects who do not have self-glucose monitoring conditions or do not accept home self-glucose monitoring;
• People who are allergic to glucose sensors, subcutaneous infusion sets, and medical tape;
• There are adverse skin conditions (such as diffuse subcutaneous nodules, psoriasis, rash, staphylococcal infection, psoriasis, scars, stretch marks, etc.) at the site where the glucose sensor and insulin pump subcutaneous infusion device are planned to be placed;

Other

• Subjects are excluded if they meet any of the following criteria:
• Patients with hyperthyroidism;
• Subjects with sickle cell anaemia, thalassaemia or hemoglobinopathy;
• Subjects who are unwilling to bury the infusion tube subcutaneously or wear the pump for a long time, and psychologically do not accept insulin pump treatment;
• Subjects with poor compliance, unable to cooperate with intensive treatment or irregular exercise;
• Young or elderly subjects who are unable to take care of themselves and have no guardian;
• Subjects who are not able to use effective contraception during pregnancy, lactation or during the study;

• Subjects must meet all of the following criteria to be enrolled:
• Age between 8 and 75 years old, regardless of gender;
• Subjects with T1DM (including adult occult autoimmune diabetes mellitus (LADA)) who have been judged by investigators to require insulin pump therapy;
• Subjects who are able to cooperate with insulin pump therapy and derive weekly data from insulin pump during study treatment;
• During the study period, the subject's total daily insulin should be ≥8 units;
• Subjects who are able to follow a diabetic diet;
• Those who can voluntarily sign informed consent.