Regimen Switch After Intensive Insulin Therapy
- Conditions
- Insulin
- Interventions
- Drug: Continuous intensive insulin therapy
- Registration Number
- NCT04833413
- Lead Sponsor
- Shanghai Zhongshan Hospital
- Brief Summary
Insulin intensive therapy have traditionally been considered a sequential therapy in type 2 diabetes last choice, a number of guidelines and consensus recommendations insulin intensive therapy can be as obvious hyperglycemia in patients with newly diagnosed T2DM part of a line, a subset of patients after insulin intensive treatment target often need to change to other treatments, especially for senile diabetes patients, due to its self management ability, simplify the insulin solution is more urgent. Current clinical guidelines do not provide specific clinical guidance, such as the timing and method of switch after initial insulin intensive therapy. The purpose of this study was to explore the timing, suitable population and conversion methods of insulin regimens after treatment.
- Detailed Description
Selecting initial insulin intensive therapy during the period of hospitalization in patients with type 2 diabetes, collect the basic information and biochemical information collection, including gender, age, duration of diabetes, intensive glucose-lowering treatment plan before treatment, diabetes complications, merger disease, smoking, drinking, height, weight, blood pressure, fasting glucose, glycosylated hemoglobin and glycosylated serum protein, insulin, c-peptide, liver and kidney function, blood lipid, blood routine, hypoglycemia is happening almost 1 month. Follow-up was conducted in January, March and June. Endocrinologists decide whether to continue the original hypoglycemic regimen or adjust it according to the glycemic control goals, islet β-cell function, diabetes complications, complications, hypoglycemia and other combination drugs, as well as patients' treatment willingness and compliance. To compare the timing of conversion of treatment regimens, the proportion of conversion to each regimen and the situation of reaching the standard, and to further analyze and compare the characteristics of people who switched to different regimens, in order to establish the basis for the selection of adjustment regimens after insulin treatment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Patients with type 2 diabetes;
- Patients who started intensive insulin therapy during hospitalization
- Age ≥18 years old
- Type 1 diabetes, special type diabetes
- Acute complications of diabetes (diabetic ketoacidosis, hyperglycemia and hyperosmolarity)
- Severe infection
- pregnancy or planned pregnancy
- Participating in other clinical studies or trials
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Continue intensive treatment group Continuous intensive insulin therapy Patients with type 2 diabetes who continued intensive treatment within 6 months after hospital discharge Premixed insulin treatment group Continuous intensive insulin therapy Patients with type 2 diabetes who changed to premixed insulin within 6 months after hospital discharge Basic insulin treatment group Continuous intensive insulin therapy Patients with type 2 diabetes who changed to basic insulin treatment within 6 months after hospital discharge
- Primary Outcome Measures
Name Time Method Change in HbA1c 1，3，6 months HbA1c in different conversion regimens
- Secondary Outcome Measures
Name Time Method Impact on body weight 1，3，6 months Impact on body weight in different conversion regimens
The average blood glucose 1，3，6 months The average blood glucose in different conversion regimens
Fasting blood glucose 1，3，6 months Fasting blood glucose in different conversion regimens
Incidence of hypoglycemia 1，3，6 months Incidence of hypoglycemia in different conversion regimens
Postprandial blood glucose 1，3，6 months Postprandial blood glucose in different conversion regimens
Trial Locations
- Locations (2)
Department of Endocrinoogy, Zhongshan Hospital Fudan University
🇨🇳Shanghai, China
Zhongshan hospital
🇨🇳Shanghai, Shanghai, China