Regimen Switch After Intensive Insulin Therapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Continue intensive treatment group Patients with type 2 diabetes who continued intensive treatment within 6 months after hospital discharge |
Drug: Continuous intensive insulin therapy
After initial intensive insulin therapy in hospital, patients were grouped according to different treatment regimens within 6 months of discharge
Other Names:
|
| Premixed insulin treatment group Patients with type 2 diabetes who changed to premixed insulin within 6 months after hospital discharge |
Drug: Continuous intensive insulin therapy
After initial intensive insulin therapy in hospital, patients were grouped according to different treatment regimens within 6 months of discharge
Other Names:
|
| Basic insulin treatment group Patients with type 2 diabetes who changed to basic insulin treatment within 6 months after hospital discharge |
Drug: Continuous intensive insulin therapy
After initial intensive insulin therapy in hospital, patients were grouped according to different treatment regimens within 6 months of discharge
Other Names:
|
| Oral hypoglycemic drug treatment group Patients with type 2 diabetes who changed to oral hypoglycemic drug treatment within 6 months after hospital discharge |
Outcome Measures
Primary Outcome Measures
- Change in HbA1c [1，3，6 months]
HbA1c in different conversion regimens
Secondary Outcome Measures
- 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
- Postprandial blood glucose [1，3，6 months]
Postprandial blood glucose in different conversion regimens
- Incidence of hypoglycemia [1，3，6 months]
Incidence of hypoglycemia in different conversion regimens
- Impact on body weight [1，3，6 months]
Impact on body weight in different conversion regimens
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with type 2 diabetes;
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Patients who started intensive insulin therapy during hospitalization
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Age ≥18 years old
Exclusion Criteria:
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Type 1 diabetes, special type diabetes
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Acute complications of diabetes (diabetic ketoacidosis, hyperglycemia and hyperosmolarity)
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Severe infection
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pregnancy or planned pregnancy
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Participating in other clinical studies or trials
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan hospital | Shanghai | Shanghai | China | 200032 |
| 2 | Department of Endocrinoogy, Zhongshan Hospital Fudan University | Shanghai | China |
Sponsors and Collaborators
- Shanghai Zhongshan Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZSE-202104