posted on 2020-08-28, 16:04authored byAneta Hásková, Lucie Radovnická, Lenka Petruželková, Christopher G. Parkin, George Grunberger, Eva Horová, Vendula Navrátilová, Ondřej Kádě, Martin Matoulek, Martin Prázný, Jan Šoupal
Background: The aim of this trial was
to compare the efficacy of real-time and <a>intermittently-scanned
</a>continuous glucose monitoring (rtCGM and isCGM, respectively) in
maintaining optimal glycemic control.
<p>Methods: <a>In
this randomized study, adults with T1D and normal hypoglycemia</a><b> </b>awareness (GOLD score <4) used rtCGM (Guardian Connect Mobile) or
isCGM (Freestyle Libre) during 4 days of physical activity (exercise phase) and in subsequent 4 weeks at home (home
phase). Primary endpoints were time in hypoglycemia (<3.9 mmol/l [<70
mg/dl]) and time in range (3.9-10.0 mmol/l [70-180 mg/dl]). The isCGM group wore an additional
masked Enlite sensor (iPro2) for 6 days to check for bias between the different
sensors used by the rtCGM and isCGM systems.<b></b></p>
<p>Results: Sixty adults with T1D (mean age 38±13 years, A1C
62±12 mmol/mol [7.8±1.1%]) were randomized to rtCGM (n=30) or isCGM (n=30). All participants
completed the study. Percentage of time in hypoglycemia (<3.9 mmol/l [<70
mg/dl)) was lower among rtCGM vs. isCGM participants in the exercise phase (6.8±5.5% vs. 11.4±8.6%, respectively; p=0.018) and during the home phase (5.3±2.5% vs. 7.3±4.4%, respectively; p=0.035).
Hypoglycemia differences were significant and most notable during the night.
rtCGM participants spent more time in range (3.9-10 mmol/l [70-180 mg/dl]) than isCGM participants throughout
both the exercise (78.5±10.2% vs. 69.7±16%, respectively; p=0.0149) and home (75.6±9.7% vs. 67.4±17.8%, respectively; p=0.0339)
phases. The results were robust to the insignificant bias between rtCGM and
isCGM sensors that masked CGM found in the isCGM arm.<a></a></p>
<p>Conclusion: rtCGM was superior to
isCGM in reducing hypoglycemia
and improving time in range in T1D adults with normal hypoglycemia awareness,
demonstrating the value of rtCGM alarms during exercise and in daily diabetes
self-management.</p>
<br>
Funding
This study was initiated, designed, and performed by the investigators and supported by the Grant 15-26705A (program RVO-VFN00064165) of the Agency for Healthcare Research (AZV) of the Czech Republic.