CGM-Assisted Community Management for Type 2 Diabetes

HbA1c was measured in venous blood at the central laboratory. The primary effect measure was the adjusted between-group mean difference in 24-week HbA1c, with adjustment for baseline HbA1c and prespecified baseline covariates. HbA1c is reported as a percentage, with lower values indicating better glycaemic control.

• Reach Proportion of registered adults with type 2 diabetes at the participating sites who received the CGM-assisted management strategy during the study implementation period.
• Adoption Proportion of invited community health institutions participating in the study and proportion of intervention providers completing the structured training programme.
• Implementation Fidelity Proportion of initiated CGM wear cycles yielding at least 7 valid days of sensor data, and proportion of intervention participants completing valid first, second, and third wear cycles.
• Incremental Delivery Cost Incremental per-participant cost of delivering the CGM-assisted management strategy from the health-care provider perspective, including sensors, transmitters, printed materials, provider time, and provider training.
• Maintenance Completion of the scheduled management pathway, stated willingness to continue CGM use at week 24, and continuation of CGM-related services after study completion.

Fasting plasma glucose was measured in venous blood at the central laboratory and compared between the two management groups with adjustment for baseline fasting plasma glucose and prespecified covariates.

Mean score on the five-point willingness-to-continue item among intervention-group participants completing the week-24 questionnaire; higher scores indicate greater willingness to continue CGM use.

Time in Range (TIR): percentage of time glucose levels are within target range (3.9-10.0 mmol/L).

Measurement method: Continuous glucose monitoring data analysis using CGM device (Anytime CT3A system).

Assessment period: Three 2-week CGM wearing periods at weeks 0, 8, and 16.

Measurement tool: EQ-5D-5L questionnaire, including:

EQ-5D-5L descriptive system (5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression); EQ VAS (visual analogue scale, 0-100 scale). Assessment timing: Baseline and 24-week endpoint.

Cost components:

Direct medical costs: CGM device costs, glucose monitoring supplies, outpatient visits, laboratory tests, medications; Healthcare resource utilization: frequency of hospital visits, emergency department visits, hypoglycemia-related healthcare contacts; Data collection: Patient self-report, medical records, and healthcare claims data; Assessment timing: Continuous throughout 24-week study period.

Mean total score on the 20-item CGM satisfaction scale among scoreable intervention-group respondents; scores range from 1 to 5, with higher scores indicating greater satisfaction.

Proportion of participants with a reduction in HbA1c of at least 0·5 percentage points and at least 1·0 percentage point from baseline to week 24.

Proportion of participants with week-24 HbA1c below 7·0%, 7·5%, and 8·0%.

Body-mass index at 24 weeks, calculated as weight in kilograms divided by height in metres squared.

Low-density lipoprotein cholesterol and triglyceride concentrations at 24 weeks, with total cholesterol and high-density lipoprotein cholesterol assessed as additional lipid outcomes.

Self-reported dietary and physical-activity changes between baseline and week 24.

Changes in glucose-lowering medication classes between baseline and week 24, including initiation, discontinuation, and change in the number of medication classes.