Type 2 Diabetes
Conditions
Interventions
Standard Care Group:Standard diabetes management
Intelligent Decision-Support Group:Diabetes management supported by an intelligent decision-support system
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Meets the 1999 World Health Organization diagnostic criteria for type 2 diabetes mellitus. 2.Aged 18 to 75 years. 3.HbA1c level of 7.5% to 10.5%, measured within 30 days prior to enrollment. 4.Provides written informed consent.
Exclusion criteria
Exclusion criteria: 1.Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period. 2.Participants who plan to undergo major surgery during the trial, or who plan to undergo MRI examination while wearing the CGM device. 3.Currently participating in another clinical trial. 4.Serum ALT or AST levels >= 3 times the upper limit of normal. 5.Chronic kidney disease stage 4–5 (estimated glomerular filtration rate <30 mL/min/1.73 m^2, calculated using the CKD-EPI equation), or currently receiving dialysis, or with a history of kidney transplantation. 6.New York Heart Association (NYHA) functional class III or IV heart failure. 7.Hospitalization required within 3 months prior to enrollment or currently due to diabetic ketoacidosis, hyperosmolar hyperglycemic state, severe hypoglycemic events, acute coronary syndrome, ischemic stroke, severe infection, or major trauma. 8.Currently receiving systemic glucocorticoid therapy or expected to require such treatment during the study period. 9.Presence of other inadequately controlled endocrine disorders, such as hypothyroidism, hyperthyroidism, adrenal insufficiency, Cushing’s syndrome, acromegaly, or hypopituitarism. 10.Patients with malignant tumors who are receiving systemic antineoplastic therapy, or those judged by the investigator to have a life expectancy of less than 1 year. 11.Any condition that may affect the reliability of HbA1c measurement, such as anemia (hemoglobin <90 g/L), hemoglobinopathy, recent red blood cell transfusion or use of erythropoietin, or chronic gastrointestinal blood loss. 12.Any medical, psychological, or social factor that, in the investigator’s judgment, makes the participant unsuitable for this study, such as intellectual disability or other disabilities affecting compliance; a history of severe psychiatric illness or disorder that interferes with study participation (e.g., bipolar disorder, schizophrenia, history of suicide attempt, current suicidal ideation, or substance abuse); obvious lack of understanding of the trial; or inability to cooperate due to physical or cognitive impairment. 13.Known allergy to medical-grade skin adhesives or disinfectants used for the study; severe skin lesions at the intended CGM insertion site that may interfere with device attachment or the accuracy of interstitial glucose monitoring, such as psoriasis, recent burns or severe sunburn, eczema, scars, or dermatitis herpetiformis; or the presence of another implanted medical device (e.g., a cardiac pacemaker).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Standard Deviation of Glucose (SD, mmol/L);Time Above Range (TAR, >13.9 mmol/L, %);Proportion of participants achieving HbA1c 10.0 mmol/L, %);Dietary behavior metrics;Triglyceride (TG);Total Cholesterol (TC);Serum Uric Acid (SUA);Mean Glucose (mmol/L);Time in Range (TIR, 3.9–10.0 mmol/L,);Time Below Range (TBR, <3.9 mmol/L, %);Time Below Range (TBR, <3.0 mmol/L, %); | — |
Countries
China
Contacts
Public ContactXianghai Zhou
Peking University People's Hospital
Outcome results
None listed