Diabetes Mellitus
Conditions
Brief summary
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.
Interventions
DEVICESinocare iCan I3 CGM
Real-time Continuous glucose monitoring
DEVICESinocare jinzhi+Blood glucose meter
Self-monitoring of blood glucose
Sponsors
Sinocare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* (1)Subjects aged ≥18 years at screening (based on the day of signing the informed consent form) and of any gender * (2)Patients diagnosed with type 2 diabetes * (3)Prior to the screening, glycemic control was suboptimal with diet, exercise control, and oral medication or glucagon-like peptide-1RA (GLP-1RA) therapy maintained for more than 3 months, 7.5%≤HbA1c≤10% * (4)Subjects voluntarily sign an informed consent form
Exclusion criteria
* (1)Patients treated with insulin within 3 months prior to screening * (2)Currently or have used a CGM device within 3 months prior to enrollment * (3)Serious skin disease at the sensor placement site, allergy to tape or adhesives * (4)Pregnant females, those with a positive pregnancy test result at screening, or those who plan to become pregnant during the study * (5)Those who are participating or will participate in other clinical trials * (6)Those who, in the opinion of the investigator, should not participate in this clinical trial, such as: ①those who have a history of eye trauma or other diagnosed eye diseases resulting in visual impairment, etc.; ②those who are unwilling or unable to fully understand or cooperate due to speech disorders; ③those who suffer from mental disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | From enrollment to the end of the 24-week intervention period. | Between group differences (CGM and SMBG) for the change in HbA1c (from Central Lab) from baseline to week 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c & CGM | From enrollment to the end of the 24-week intervention period. | 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. |
Countries
China
Outcome results
None listed