Diabetes Mellitus, Type 2
Conditions
Keywords
Blood Glucose Self-Monitoring, HbA1c Prediction Model, Ridge Regression
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.
Interventions
OTHERHbA1c 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.
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in measured HbA1c from baseline to 24 weeks | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| The percentages of participants with HbA1c less than 7.0% at 24 weeks | 24 weeks |
| Change in weight from baseline to 24 weeks | 24 weeks |
| The rate of severe hypoglycemic events and confirmed hypoglycemic events during the 24 weeks of the study | 24 weeks |
Countries
China
Contacts
Primary ContactZhou Xianghai, Prof.
Outcome results
None listed