Regimen Switch After Intensive Insulin Therapy

NCT ID: NCT04833413

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2024-05-31

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.

Conditions

Insulin

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Continue intensive treatment group

Patients with type 2 diabetes who continued intensive treatment within 6 months after hospital discharge

Continuous intensive insulin therapy

Intervention Type: DRUG

After initial intensive insulin therapy in hospital, patients were grouped according to different treatment regimens within 6 months of discharge

Premixed insulin treatment group

Patients with type 2 diabetes who changed to premixed insulin within 6 months after hospital discharge

Continuous intensive insulin therapy

Intervention Type: DRUG

After initial intensive insulin therapy in hospital, patients were grouped according to different treatment regimens within 6 months of discharge

Basic insulin treatment group

Patients with type 2 diabetes who changed to basic insulin treatment within 6 months after hospital discharge

Continuous intensive insulin therapy

Intervention Type: DRUG

After initial intensive insulin therapy in hospital, patients were grouped according to different treatment regimens within 6 months of discharge

Oral hypoglycemic drug treatment group

Patients with type 2 diabetes who changed to oral hypoglycemic drug treatment within 6 months after hospital discharge

No interventions assigned to this group

Interventions

Continuous intensive insulin therapy

After initial intensive insulin therapy in hospital, patients were grouped according to different treatment regimens within 6 months of discharge

Intervention Type: DRUG

Other Intervention Names

Premixed insulin therapy; Basic insulin therapy; Oral hypoglycemic drug therapy

Eligibility Criteria

Inclusion Criteria

• Patients with type 2 diabetes;
• Patients who started intensive insulin therapy during hospitalization
• Age ≥18 years old

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan hospital

Shanghai, Shanghai Municipality, China

Site Status: NOT_YET_RECRUITING

Department of Endocrinoogy, Zhongshan Hospital Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiao ying Li, MD

Role: CONTACT

xiaoying_li@hotmail.com

13651913857

Ying Chen, MD

Role: CONTACT

baiyuan9873@163.com

15351890068

Facility Contacts

Xiao ying Li, MD

Role: primary

xiaoying_li@hotmail.com

13651913857

Juan yu Fan, MD

Role: backup

fanyujuan22@sohu.com

18101947845

Yujuan Fan

Role: primary

fanyujuan22@sohu.com

18101947845

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Other Identifiers

ZSE-202104

Identifier Type: -

Identifier Source: org_study_id