Efficacy of unblinded and blinded intermittently scanned continuous glucose monitoring for glycemic control in adults with type 1 diabetes

ObjectiveIntermittently scanned continuous glucose monitoring (isCGM) is used for unblinded or blinded monitoring of interstitial glucose. We aimed to compare the efficacy of blinded and unblinded isCGM with the FreeStyle Libre system for glycemic control in adults with type 1 diabetes (T1D). Research design and methodsThis randomized clinical trial conducted between October 2018 and September 2019 across four endocrinology practices in China included 273 adults aged >= 18 years with T1D, who were randomly divided in a 2:1 ratio into the unblinded (n = 199) or blinded isCGM group (n = 78). In the blinded group, the clinician used FreeStyle Libre Pro system for monitoring, but self-monitoring was also performed by the patients. ResultsTwo hundred sixteen (78%) participants completed the study (152 [75%] in the unblinded and 64 [82%] in the blinded group). At 12 weeks, a significant increase in TIR (3.9-10.0 mmol/L) was only observed in the unblinded group, along with a significant decrease in hyperglycemia (>13.9 mmol/L), hypoglycemia (<3.0 mmol/L), glycemic variability. Further, the mean HbA1c reduction from baseline to 12 weeks was 0.5% in the unblinded isCGM group and 0.4% in the blinded isCGM group respectively (P < 0.001), but the significance did not remain after adjustment for between-group differences. Finally, 99.5% of the blinded isCGM values and 93.8% the of unblinded isCGM values were obtained at the final visit. ConclusionsThe unblinded isCGM system was associated with benefits for glucose management, but nearly 100% of the attempted profiles were obtained successfully with the blinded isCGM system. Thus, combining real-time and retrospective data with isCGM might be the most impactful way to utilize flash glycemic monitoring devices.

Automated summary

This study compared the efficacy of blinded and unblinded intermittent scanned continuous glucose monitoring (isCGM) for glycemic control in adults with type 1 diabetes. The results showed that unblinded isCGM led to a significant increase in time in range (3.9-10.0 mmol/L), and a decrease in hyperglycemia (>13.9 mmol/L), hypoglycemia (<3.0 mmol/L), and glycemic variability compared to blinded isCGM. However, the difference in mean HbA1c reduction between the two groups was not significant after adjustment. Combining real-time and retrospective data with isCGM might be the most impactful way to utilize flash glycemic monitoring devices.