<b><i>Objective:
</i></b>According to recent guidelines, individuals with type 1 diabetes should
spend less than 4.0% per day with glucose levels <3.9 mmol/L (<70 mg/dL)
and less than 1.0% per day <3.0 mmol/L (<54 mg/dL).
<p><b><i><br>
Research methods: </i></b>In the GOLD randomised cross-over trial,
161 individuals with type 1 diabetes treated with multiple daily insulin
injections (MDI) were randomised to Continuous Glucose Monitoring (CGM) or
conventional therapy with self-monitoring of blood glucose (SMBG) and evaluated
over 16 months. We estimated the association between time spent in
hypoglycaemia and various mean glucose and HbA1c levels.</p>
<p> </p>
<p><b><i>Results:
</i></b>Time spent in hypoglycaemia (<3.9 mmol/L and <3.0 mmol/L)
increased significantly with lower mean HbA1c and mean glucose levels during
both CGM and conventional therapy. During CGM, 24 (57.1%) individuals with
HbA1c <7.5 % (<58 mmol/mol) had <1.0% time spent in hypoglycaemia
<3.0 mmol/L and 23 (54.8%) had <4.0% time spent in hypoglycaemia <3.9 mmol/L.
During CGM, mean time spent in hypoglycaemia for individuals with mean HbA1c
7.0% (52 mmol/mol) was estimated to be 5.4% for <3.9 mmol/L and 1.5% for
<3.0 mmol/L. The corresponding values during SMBG were 9.2% and 3.5%,
respectively. Individuals with mean glucose levels of 8 mmol/L spent 4.9% more
time with glucose levels <3.9 mmol/L and 2.8% more time <3.0 mmol/L
during SMBG compared with CGM.</p>
<p> </p>
<p><b><i>Conclusions:
</i></b>Reaching current targets for time in hypoglycaemia and at the same time
HbA1c targets is challenging for type 1 diabetes patients treated with MDI both
with CGM and SMBG monitoring. However, CGM is associated with considerably less
time in hypoglycaemia than SMBG at a broad range of HbA1c levels and is crucial
for patients with MDI treatment to have a chance to approach hypoglycaemia
targets.</p>