Efficacy and Safety of HbA1c Prediction Model Based on Self-monitoring Blood Glucose in Patients With Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change in measured HbA1c from baseline to 24 weeks
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
HbA1c prediction model group
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.
Intervention: HbA1c prediction (Other)
Conventional treatment group
Study physicians adjusted patients' hypoglycemic therapy based on self-monitoring blood glucose records/glycated albumin, without predicted HbA1c.
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)
Investigators
Xianghai Zhou
Prof.
Peking University People's Hospital