Community-Based Personalised Lifestyle Intervention Guided by Intermittent Continuous Glucose Monitoring in Adults With Type 2 Diabetes: A Multicentre Randomised Controlled Trial.

AIMS: To evaluate whether a community-based personalised lifestyle intervention guided by intermittent continuous glucose monitoring (CGM) improves glycaemic and cardiometabolic outcomes in adults with type 2 diabetes.

MATERIALS AND

METHODS

In this multicentre, open-label randomised trial, 180 adults with type 2 diabetes and pre-randomisation HbA1c > 7.0% were assigned 1:1 to the CGM-guided intervention or usual community diabetes management and followed for 12 months. The intervention combined FreeStyle Libre 2 use at baseline, after the Month 3 assessment and at Month 6 with personalised lifestyle guidance and supervised exercise concentrated in the first 3 months. The primary outcome was HbA1c at Month 3, analysed using multiple-imputation ANCOVA adjusted for baseline HbA1c and community site.

RESULTS

The primary analysis set included 171 participants. The adjusted intervention-minus-control difference in Month 3 HbA1c was -0.09 percentage points (95% CI, -0.38 to 0.21; p = 0.573). Supportive complete-data ANCOVA in 125 participants yielded a similar estimate of -0.12 percentage points (95% CI, -0.44 to 0.20; p = 0.472). No significant between-group HbA1c differences were observed at Months 6 or 12, and secondary outcomes showed no consistent benefit. Two Month 3 responder outcomes nominally favoured the intervention, but neither remained significant after multiplicity adjustment (both q = 0.104). Exploratory analyses identified no baseline subgroup with greater Month 3 benefit.

CONCLUSIONS

The intervention did not significantly improve glycaemic or cardiometabolic outcomes beyond usual community care. Whether more sustained feedback and engagement can improve effectiveness requires evaluation before routine implementation.

TRIAL REGISTRATION: ChiCTR2400085258.