The SENCE study in children < 8 yrs with T1D compared the efficacy of CGM combined with a family behavioral intervention (CGM + FBI) and CGM alone (Standard-CGM) with blood glucose monitoring (BGM) alone. Time in hypoglycemia fell in both CGM groups but was unaffected in the BGM group during the 26-week trial. After trial completion, both CGM groups extended their time on CGM for 26 weeks without additional education/behavioral intervention. This analysis assessed whether prolonged CGM use maintained durable reductions in time in hypoglycemia throughout the entire 52-week period. The extended study was completed by 45 of 50 in the CGM + FBI group and 42 of 44 in Standard-CGM. In these 87 kids, median age was 5.6 years and 31% were on insulin pumps. Differences in the two CGM groups were compared to masked baseline CGM data from run-in. Median time <70 mg/dL was reduced from baseline to 52 weeks in CGM+FBI group (3.4%,50 minutes/day to 2.0%, 29 minutes/day, p<0.001, see Figure) and with Standard-CGM (4.1%, 59 minutes/day, to 2.1%, 30 minutes/day, p<0.001). Importantly, time in hypoglycemia remained lower after conclusion of the interventions through 52 weeks in both groups. We observed similar reductions for time <54 mg/dL (data not shown).
Conclusion: Sustained CGM use results in less hypoglycemia in young children with T1D.
M.A. Van Name: None. K. Miller: None. L. Kanapka: None. W.V. Tamborlane: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Sanofi US. Other Relationship; Self; Eisai Inc., MannKind Corporation. L. DiMeglio: None.
The Leona M. and Harry B. Helmsley Charitable Trust