HbA1c Prediction Model in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05824286
• Other study ID #: RDL2022-30
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2023
• Source: Peking University People's Hospital
• Contact: Zhou Xianghai, Prof.
• Phone: 010-88324371
• Email: xianghai_zhou[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• HbA1c prediction
HbA1c prediction model was developed based on fasting capillary blood glucose and postprandial capillary blood glucose from self-monitoring blood glucose. Since HbA1c was measured once every 3 month, self-monitoring blood glucose records were transferred to predicted HbA1c by prediction model every month.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in measured HbA1c from baseline to 24 weeks		24 weeks
Secondary	Change in measured HbA1c from baseline to 12 weeks		12 weeks
Secondary	The percentages of participants with HbA1c less than 7.0% at 12 weeks		12 weeks
Secondary	The percentages of participants with HbA1c less than 7.0% at 24 weeks		24 weeks
Secondary	Change in weight from baseline to 24 weeks		24 weeks
Secondary	The rate of severe hypoglycemic events and confirmed hypoglycemic events during the 24 weeks of the study		24 weeks