Type 2 diabetes
Conditions
Interventions
control group :Continuous Subcutaneous Insulin Infusion
experimental group :Hybrid CloseLoop
Sponsors
Baoan Central Hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: ? Definite diagnosis of type 2 diabetes; ? Aged between 18 and 80; ? Duration of diabetes >= 5 years; ? Before admission, take 3 or more hypoglycemic drugs orally or (and) subcutaneous insulin therapy, regularly hypoglycemic treatment for at least 3 months; ? BMI: 18.5-28 kg/m2; ? HbA1c: 8%-13%, had hypoglycemia (fingertip blood glucose 11mmol/ L, or hypoglycemia (fingertip blood glucose <3.9 mmol/ L); ? The patients kept regular and constant food intake and exercise for 3 consecutive months.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes, special type diabetes, or hyperglycemia caused by drugs or stress; 2. Acute complications of diabetes: diabetic ketoacidosis, hyperosmolar coma, etc.; 3. Known proliferative diabetic retinopathy; 4. Serious infection: sepsis, sepsis, septic shock, etc.; 5. Patients with acute cerebrovascular events and cardiac insufficiency in acute stage and 3 months; 6. patients with obvious liver function damage (ALT increase of more than 3 times), renal function damage (eGFR = 30ml/min), severe lung disease, digestive hemorrhagic disease and acute pancreatitis, etc.; 7. Tumor, blood system diseases, rheumatic immune diseases using hormones or immunosuppressants; planned pregnancy or pregnancy, breast-feeding women; 9. Persons suffering from mental or mental diseases, dementia or inability to take care of themselves; 10. Patients who planned surgery during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time in range;TIR from the end of the experiment to the end of observation; | — |
Secondary
| Measure | Time frame |
|---|---|
| time above range;time below range;mean glucose;Standard deviation of glucose;coefficient of variation;mean amplitude of plasma glucose;Area under the hyperglycemic curve;Area under the hypoglycemic curve;Time (days) taken to meet TIR standards (more than 70%);Basal insulin dose and meal insulin dose for TIR compliance (more than 70%); | — |
Countries
China
Contacts
Public ContactYu Zhao
Outcome results
None listed