Skip to content

Regimen Switch After Intensive Insulin Therapy

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04833413
Enrollment
1000
Registered
2021-04-06
Start date
2021-04-15
Completion date
2024-05-31
Last updated
2023-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin

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.

Interventions

DRUGContinuous intensive insulin therapy

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

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in HbA1c1,3,6 monthsHbA1c in different conversion regimens

Secondary

MeasureTime frameDescription
The average blood glucose1,3,6 monthsThe average blood glucose in different conversion regimens
Fasting blood glucose1,3,6 monthsFasting blood glucose in different conversion regimens
Postprandial blood glucose1,3,6 monthsPostprandial blood glucose in different conversion regimens
Incidence of hypoglycemia1,3,6 monthsIncidence of hypoglycemia in different conversion regimens
Impact on body weight1,3,6 monthsImpact on body weight in different conversion regimens

Countries

China

Contacts

Primary ContactXiao ying Li, MD
xiaoying_li@hotmail.com13651913857
Backup ContactYing Chen, MD
baiyuan9873@163.com15351890068

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026