Diabetes
Conditions
Interventions
Test group:A hybrid closed-loop insulin pump system
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male and female, aged >=18 years (on the day of signing the informed consent); 2. Clinical diagnosis of diabetes, including type 1 diabetes, type 2 diabetes, etc.; 3. Type 1 subjects were screened for diabetic patients who had received insulin therapy for more than 6 months; 4. Glycated hemoglobin (HbA1c) was higher than 7.5% and lower than 10% in type 2 diabetic subjects at screening visit; 5. If patients with type 2 diabetes are being treated with oral metformin hydrochloride, a stable dose should be maintained after screening and enrollment. Other oral hypoglycemic drugs should be stopped during screening; 6. Subjects received fingertip blood glucose measurement at least 4 times a day; 7. Subjects' thyroid stimulating hormone (TSH) was normal. If thyroid stimulating hormone (TSH) is outside the normal reference range, serum free triiodothyronine (FT3) needs to be below or within the normal laboratory value and serum free thyroxine (FT4) within the normal reference range. (Reports within 6 months before the signing of the informed consent form are valid, not limited to reports of the hospital); 8. If the subject has celiac disease, the investigator must determine that the subject has been adequately treated; 9. Those who can comply with diabetic diet, self-monitor blood glucose and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The subject has diabetic ketoacidosis and the treatment time is less than 48 hours; 2. The subject's sensor implantation area has uncured adverse skin conditions (e.g., diffuse subcutaneous nodules, psoriasis, scars, stretch marks, etc.); 3. Abnormal coagulation function (the report within 7 days before the signing of the informed consent is valid, not limited to the report of the hospital), abnormal judgment criteria: APTT (activated partial thromboplastin time) or PT (prothrombin time) test result is greater than 1.5 times the upper limit of normal value; 4. Patients with any of the following cardiac conditions within 8 weeks before screening: (1) Decompensated cardiac insufficiency (New York College of Cardiology [NYHA] class III or IV) within 8 weeks before screening; (2) Diagnosis of unstable angina pectoris; (3) History of myocardial infarction, coronary artery bypass grafting or coronary stent implantation; (4) Uncontrolled or severe arrhythmias; 5. The subjects have concomitant diseases of hyperthyroidism; 6. The subject has adrenal insufficiency; 7. Patients who had used glucocorticoid drugs (excluding topical or inhaled preparations) for more than 7 days within 8 weeks before screening; 8. Subjects were using a DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonist), metformin, cangazolline (Invokana or other SGLT2 inhibitor) 120 hours before screening; 9. The subject has a known retinal proliferative lesion or a history of other visual impairment; 10. The subject has mental disease, no self-control, and cannot express clearly; 11. Major surgery is expected during the study period, which will directly affect insulin pump therapy; 12. Hematocrit (Hct) was below the normal laboratory reference range. (Reports within 6 months before the signing of the informed consent form are valid, not limited to reports of the hospital); 13. Skin diseases affecting subcutaneous injection or serious bleeding factors affecting venous blood collection; 14. Glomerular filtration rate (eGFR) < 30; 15. Pregnant or lactating women; Fertile subjects (male or female) who intend to have children or are unable to guarantee one or more contraceptive methods from before the first dose until 3 months after the end of the trial; 16. Participated in other clinical trials within 3 months before the screening visit; 17. There were other conditions judged by the researcher as not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood sugar; | — |
Countries
China
Contacts
Public ContactWu Xiaohong
Zhejiang Provincial People's Hospital
Outcome results
None listed