Abstract
Background: The Clarke Questionnaire (CQ) determines the perception of hypoglycemia symptoms, and a score ?4 detects patients with Hypoglycemia unawareness (HU). Evidence regarding the association between Continuous Glucose Monitoring (CGM) metrics and the CQ score is limited.
Purpose: To describe the association between the CQ score and CGM metrics in patients diagnosed with diabetes treated with insulin at high risk of hypoglycemia.
Methodology: A cross-sectional study in adult patients with diabetes diagnostic, treated with insulin and a history of severe hypoglycemia or risk factors for hypoglycemia unawareness (HU). Firstly, Baseline demographic, clinical, and Clarke score data were recorded; secondly, a professional CGM was performed for six days. Finally, CGM metrics were compared for the groups with or without hypoglycemia unawareness, using different cut-off points (Clarke ? 4 and Clarke ? 3).
Results: 83 patients were included (median age 63 years old [IQR 53.5-70.5], DM2 63.9%, HbA1c 7.6±1.6%). The median of time in range (%TIR 70-180mg/dl) was 75% [RIC 63-92], time above range (%TAR>180mg/dl) was 15% [3-27], and the median time below range (%TBR< 70mg/dl) 3% (IQR 1-7). In patients with Clarke ?4 the %TIR was lower (Median 55[RIC 41-89] vs 77[RIC 68-92], p=0.05) at the expense of higher %TAR (Median 23[IQR 7-54] vs 15[IQR 3-16], p=0.15). No significant differences were found in %TBR<70mg/dl.
Conclusions: HU was associated with a lower %TIR between 70-180 mg/dL in a clinically and statistically significant way in patients using insulin with risk factors for hypoglycemia.
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