HbA1c Prediction Model in Patients With Type 2 Diabetes

Peking University

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: HbA1c prediction

Study type: Interventional

Funder types: Other

Identifiers

NCT05824286

RDL2022-30

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

HbA1c prediction model group

Experimental group

Description:

HbA1c was predicted every month based on self-monitoring blood glucose for patients in HbA1c prediction model group. Study physicians adjusted patients' hypoglycemic therapy based on self-monitoring blood glucose records/glycated albumin and predicted HbA1c every month.

Treatment:

Other: HbA1c prediction

Conventional treatment group

No Intervention group

Description:

Study physicians adjusted patients' hypoglycemic therapy based on self-monitoring blood glucose records/glycated albumin, without predicted HbA1c.