The clinical value of CGM for diabetic patients undergoing insulin therapy has been widely recognized, but the evidence-based support for its use in non-insulin-treated type 2 diabetic patients remains insufficient. The primary objective of this study is to evaluate the effect of real-time continuous glucose monitoring (CGM) compared with self-monitoring of blood glucose on glycemic control in adults with non-insulin treated type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
160
Real-time Continuous glucose monitoring
Self-monitoring of blood glucose
Beijing Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Eighth Affiliated Hospital of Southern Medical University
Shunde, Guangdong, China
Renmin Hospital of Wuhan University (Hubei General Hospital)
Wuhan, Hubei, China
HbA1c
Between group differences (CGM and SMBG) for the change in HbA1c (from Central Lab) from baseline to week 24.
Time frame: From enrollment to the end of the 24-week intervention period.
HbA1c & CGM
1. Proportion of participants in each group achieving HbA1c \< 7.0% at Week 24. 2. Proportion of participants in each group achieving a reduction in HbA1c of ≥0.5% from baseline at Week 24. 3. Change from baseline in Time in Range (TIR, %) defined as blood glucose within 3.9-10 mmol/L at Week 24, between the two groups. 4. Change from baseline in Time in Target Range (TITR, %) defined as blood glucose within 3.9-7.8 mmol/L at Week 24, between the two groups. 5. Change from baseline in Time Above Range (TAR, %) defined as blood glucose \>10 mmol/L at Week 24, between the two groups. 6. Change from baseline in Time Below Range (TBR, %) defined as blood glucose \<3.9 mmol/L at Week 24, between the two groups. 7. Change from baseline in Mean Sensor Glucose (MSG, mmol/L) at Week 24, between the two groups. 8. Change from baseline in Coefficient of Variation (CV, %) at Week 24, between the two groups.
Time frame: From enrollment to the end of the 24-week intervention period.
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Qilu Hospital of Shandong University
Jinan, Shandong, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China