Efficacy and Safety of HbA1c Prediction Model Based on Self-monitoring Blood Glucose in Patients With Type 2 Diabetes

Peking University People's Hospital1 site in 1 country150 target enrollmentJanuary 4, 2023

ConditionsDiabetes Mellitus, Type 2

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 2
Sponsor: Peking University People's Hospital
Enrollment: 150
Locations: 1
Primary Endpoint: Change in measured HbA1c from baseline to 24 weeks
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Patients with type 2 diabetes who have poor blood glucose control are enrolled to evaluate the efficacy and safety of the HbA1c prediction model for adjust the hypoglycemic treatment regimen, compared with the conventional treatment using self-monitoring blood glucose or glycated albumin.

Registry

clinicaltrials.gov

Start Date

January 4, 2023

End Date

December 30, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peking University People's Hospital

Responsible Party

Principal Investigator

Xianghai Zhou

Prof.

Peking University People's Hospital

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years old;
•Diagnosed with type 2 diabetes mellitus, and the hypoglycemic treatment was not limited; The study physicians judged that the hypoglycemic treatment regimen was stable in nearly 8 weeks;
•Have HbA1c results within 4 weeks, and the range was 7.5-11%;
•Willing and able to conduct self-glucose monitoring;
•Have not participated in any other research program in the past 4 weeks.

Exclusion Criteria

•Type 1 diabetes mellitus;
•Severe hypoglycemia ≥1 time or fasting C-peptide ≤0.80 ng/mL in the past 6 months;
•Diabetic ketosis in the last 1 week;
•Oral or inhaled corticosteroids for more than 14 days within the last 8 weeks;
•Anemia, recent blood transfusion, hemoglobinopathy (hemoglobinosis and thalassemia), use of erythropoietic drugs, undergoing dialysis;
•Pregnancy or breastfeeding;
•Receiving chemotherapy or radiation therapy;
•Have a severe mental illness and cannot complete the trial.

Outcomes

Primary Outcomes

Change in measured HbA1c from baseline to 24 weeks

Time Frame: 24 weeks

Secondary Outcomes

Change in measured HbA1c from baseline to 12 weeks(12 weeks)
The percentages of participants with HbA1c less than 7.0% at 12 weeks(12 weeks)
Change in weight from baseline to 24 weeks(24 weeks)
The percentages of participants with HbA1c less than 7.0% at 24 weeks(24 weeks)
The rate of severe hypoglycemic events and confirmed hypoglycemic events during the 24 weeks of the study(24 weeks)