<b>Objective: </b>This study evaluated the effects of continuous glucose
monitoring (CGM) combined with family behavioral intervention (CGM+FBI) and CGM
alone (Standard-CGM) on glycemic outcomes and parental quality of life compared
with blood glucose monitoring (BGM) in children ages 2 to <8 years with type
1 diabetes
<p><b>Research Design and Methods: </b>A
multicenter (N=14), 6-month, randomized controlled trial including 143 youth 2
to <8 years of age with type 1 diabetes. Primary analysis included treatment
group comparisons of percent time in range (TIR, 70-180 mg/dL) across follow-up
visits.</p>
<p><b>Results: </b>About 90% of participants in the CGM groups used CGM ≥ 6
days/week at 6-months. Between-group TIR comparisons showed no significant
changes: CGM+FBI vs BGM = 3.2% [95% CI -0.5%, 7.0%], Standard-CGM vs BGM = 0.5%
[-2.6% to 3.6%], CGM+FBI vs Standard-CGM = 2.7% [-0.6%, 6.1%]. Mean time <70
mg/dL was reduced from baseline to follow-up in the CGM+FBI (from 5.2% to 2.6%)
and Standard-CGM (5.8% to 2.5%) groups , compared with 5.4% to 5.8% with BGM
(CGM+FBI vs. BGM, p<0.001, Standard-CGM vs BGM p<0.001). No severe hypoglycemic events occurred in the
CGM+FBI group, 1 in the Standard-CGM, and 5 in the BGM. CGM+FBI parents
reported greater reductions in diabetes burden and fear of hypoglycemia
compared with Standard-CGM (p=0.008 and 0.04) and BGM (p=0.02 and 0.002). </p>
<b>Conclusions:
</b>CGM used consistently over a 6-month period in young
children with type 1 diabetes did not improve TIR but did significantly reduce
time in hypoglycemia. The FBI benefited parental well-being.
Extended 6-Month Follow-Up of A Randomized Clinical Trial to Assess the Efficacy and Safety of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes in Young Children Aged 4 to <10 Years
