Regimen Switch After Intensive Insulin Therapy

June 5, 2023 updated by: Shanghai Zhongshan Hospital

Effectiveness of Regimen Switch After Intensive Insulin Therapy in Hospitalized Patients With Type 2 Diabetes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Department of Endocrinoogy, Zhongshan Hospital Fudan University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

2021.4 -- 2022.6 Adult patients with type 2 diabetes admitted to the endocrinology department of a level-2 or higher hospital and initiated intensive insulin therapy during hospitalization

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 therapy
  • Basic insulin therapy
  • Oral hypoglycemic drug therapy
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:
  • Premixed insulin therapy
  • Basic insulin therapy
  • Oral hypoglycemic drug therapy
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:
  • Premixed insulin therapy
  • Basic insulin therapy
  • Oral hypoglycemic drug therapy
Oral hypoglycemic drug treatment group
Patients with type 2 diabetes who changed to oral hypoglycemic drug treatment within 6 months after hospital discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: 1，3，6 months
HbA1c in different conversion regimens
1，3，6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The average blood glucose
Time Frame: 1，3，6 months
The average blood glucose in different conversion regimens
1，3，6 months
Fasting blood glucose
Time Frame: 1，3，6 months
Fasting blood glucose in different conversion regimens
1，3，6 months
Postprandial blood glucose
Time Frame: 1，3，6 months
Postprandial blood glucose in different conversion regimens
1，3，6 months
Incidence of hypoglycemia
Time Frame: 1，3，6 months
Incidence of hypoglycemia in different conversion regimens
1，3，6 months
Impact on body weight
Time Frame: 1，3，6 months
Impact on body weight in different conversion regimens
1，3，6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

April 3, 2021

First Submitted That Met QC Criteria

April 5, 2021

First Posted (Actual)

April 6, 2021

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSE-202104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Clinical study Report may be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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