Type 2 Diabetes
Conditions
Interventions
Closed-loop group:Perioperative glucose control in patients with Type 2 diabetes mellitus using a hybrid closed-loop insulin delivery system during the perioperative pe
Control group:Perioperative glucose control in patients with Type 2 diabetes mellitus using an insulin pump during the perioperative period.
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients with Type 2 Diabetes Mellitus (T2DM) scheduled to undergo elective surgery; 2.HbA1c >= 7.5% or random blood glucose >= 13.9 mmol/L; 3.Has been receiving combined therapy with two or more oral hypoglycemic agents and/or insulin for >=3 months; 4.Both genders, aged 18 to 75 years (as of the date of signing the informed consent form); 5.Individuals who are able to understand this study, comply with the study procedures, maintain a regular lifestyle, cooperate with blood glucose monitoring, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.The subject has experienced Diabetic Ketoacidosis (DKA) or Hyperglycemic Hyperosmolar Syndrome (HHS) within 6 months prior to screening; 2.The subject has experienced any of the following due to severe hypoglycemia within 6 months prior to screening: requiring medical assistance, coma, or seizure; 3.Patients with severe cardiac, hepatic, or renal dysfunction: cardiac function grade III or above; ALT or AST exceeding 3 times the upper limit of normal; eGFR <= 30 ml/min/1.73m^2; hemoglobin < 90 g/L; white blood cell count < 4.0×10^9/L or platelet count < 90×10^9/L; hemodynamically unstable; 4.Patients with endocrine disorders affecting glucose metabolism, such as hyperthyroidism, hypothyroidism, Cushing's syndrome, etc; 5.Patients with known allergies to any drugs or consumables involved in the clinical diagnosis and treatment protocol; 6.Individuals unsuitable for or presenting contraindications to conventional insulin pump therapy; 7.Patients with dermatological conditions such as rash or prurigo, or those with coagulation disorders; 8.Women who are pregnant, lactating, or planning a pregnancy during the clinical study period; 9.Patients with impaired consciousness or psychiatric disorders, lacking self-control or the ability to express themselves clearly; 10.Individuals with highly irregular eating habits, or those with a history of alcoholism or drug addiction; 11.Any other conditions deemed by the investigator as inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time in Range (TIR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of device deficiencies;Incidence of diabetic ketoacidosis (DKA);Time Above Range (TAR);Rate of severe hypoglycemia (Level 3);Time Below Range (TBR);Total Daily Dose (TDD);Coefficient of Variation (CV); | — |
Countries
China
Contacts
Public ContactJunqing zhang
Peking University First Hospital
Outcome results
None listed