Type 2 Diabetes Mellitus
Conditions
Interventions
Observation group (type 2 diabetes mellitus insulin pump therapy cohort):None
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age: >=18 years old; (2) Diagnosis: the patient was diagnosed with type 2 diabetes mellitus in accordance with the diagnostic criteria of "Guidelines for the Prevention and Treatment of Diabetes in China" (2024 edition) issued by the Diabetes Society of the Chinese Medical Association. (3) Timing of treatment: doctors decided to start insulin pump therapy for the first time during hospitalization. (4) Dietary status: those who were able to eat diabetic meals normally (receiving standard medical nutrition treatment) and regularly ate three meals a day; (5) Observation window: the duration of CSII treatment was expected to be >=24 hours, and it was expected to complete at least one complete blood glucose monitoring cycle of "after dinner, before bed, and fasting the next morning". (6) Data integrity: baseline data were complete, including all input variables needed for the model (demographic characteristics, anthropometric indicators, medical history, laboratory test results, etc.). (7) Informed consent: subjects or their legal representatives voluntarily signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Special diseases and physiological states: (1) Type of diabetes: type 1 diabetes mellitus, gestational diabetes mellitus or other special type of diabetes mellitus; (2) Acute stress state: Patients were admitted to the hospital in diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), severe infection with systemic inflammatory response syndrome (SIRS) (e.g., diabetic foot with Wagner grades 3-5, such as sepsis and necrotizing fasciitis), trauma, or perioperative period of major surgery. Patients who need intravenous insulin therapy and have not transitioned to stable subcutaneous CSII; (3) special feeding mode: patients who cannot eat by mouth, rely on nasal feeding (gastric tube), parenteral nutrition (intravenous nutrition), or need fasting state; (4) Severe liver and kidney failure: patients with kidney disease in the dialysis stage or patients diagnosed with liver failure. (5) Run-in intervention: patients who were admitted to the hospital in the morning and received insulin pump therapy should be excluded if hypoglycemia (<3.9 mmol/l) had occurred before T0 (before dinner), which forced the doctor to significantly modify the original basal rate plan. 2. Interfering medications and treatment history: (1) Glucocorticoid use: patients receiving systemic glucocorticoids (such as prednisone, dexamethasone, etc.) within 4 weeks before enrollment or currently; (2) long-acting insulin residue: patients who had been injected with ultra-long-acting insulin (e.g., insulin icoides) within 4 weeks before enrollment. Note: Use of GLP-1RA weekly preparations was not excluded. (3) Non-initial insulin pump therapy: patients with continuous use of their own insulin pump before admission. 3. Compliance and Ethics: (1) Unable to cooperate with routine fingertip blood glucose monitoring, or unable to wear insulin pump stably due to skin or mental problems; (2) patients with severe mental disorders, obvious cognitive impairment, or other conditions that may affect the compliance and safety of the study according to the attending doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Predictive Accuracy of Glucose Trend Engine;Sensitivity of Safety Guardrails for Hypoglycemia Detection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Simulated Reduction in Hypoglycemia Risk (Counterfactual);Simulated Time in Range / TIR (Counterfactual); | — |
Countries
China
Contacts
Public ContactXi Rong
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed