HbA1c Prediction Model in Patients With Type 2 Diabetes
Not Applicable
Recruiting
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Other: HbA1c prediction
- Registration Number
- NCT05824286
- Lead Sponsor
- Peking University People's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HbA1c prediction model group HbA1c prediction 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.
- Primary Outcome Measures
Name Time Method Change in measured HbA1c from baseline to 24 weeks 24 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Peking University People's Hospital
🇨🇳Beijing, Chongqing, China