Type 2 diabetes
Conditions
Interventions
Digital Therapy Group:Following digital therapy system advice for short-term intensive insulin therapy
Conventional treatment group:Following healthcare professional guidance for short-term intensive insulin therapy
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
21 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 21-70; 2. Diagnosis of type 2 diabetes; 3. Disease duration = 8.5% or fasting glucose >= 11.1 mmol/L at screening; 5. No hypoglycemic therapy of the injectable type had been used at the time of enrollment.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of type 1 diabetes diabetes mellitus undifferentiated or specific types of diabetes mellitus; 2. Patients at high risk of hypoglycemia (previous hypoglycemic coma, previous cardiovascular disease other than hypertension, impaired liver function); 3. Combine any of the following scenarios: (1)Diabetes ketoacidosis; (2)Pregnancy; (3)Anemic; (4)Dystrophy; (5)Severe hepatic or renal insufficiency (AST/ALT more than 3 times the upper limit of normal and/or eGFR <30 mL/min/1.73 m^2); (6)Malignant tumor; (7)Postoperative organ transplant; (8)Severe infection; (9)Combination of any condition for which intensive glucose-lowering therapy with insulin is not appropriate in the opinion of the study physician; 4. Patients whose literacy or mental status does not allow them to cooperate with the study; 5. Coexisting medical conditions in the study that may hinder the interpretation of the validity and safety of the data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to achieve preset glycemic targets fasting glucose <6.1 mmol/L and 2-hour postprandial glucose <8 mmol/L;Change in fasting glucose from baseline to 2 weeks of treatment;Change in glycated albumin from baseline to 4 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of episodes of hypoglycemia (<3.9 mmol/L) and severe hypoglycemia;Percentage of time during which blood glucose was maintained at or above the preset target;Change in glycated albumin;Change in fasting plasma glucose; | — |
Countries
China
Contacts
Public ContactLuo Sihui
The First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed