Prediction of nocturnal hypoglycemia unawareness by fasting glucose levels or post-breakfast glucose fluctuations in patients with type 1 diabetes receiving insulin degludec: A pilot study

Abstract

ObjectiveTo evaluate whether nocturnal asymptomatic hypoglycemia (NAH) can be predicted by fasting glucose levels or post-breakfast glucose fluctuations in patients with type 1 diabetes (T1D) receiving insulin degludec.MethodsPatients with T1D receiving insulin degludec underwent at-home CGM assessments. Indices for glycemic variability before and after breakfast included fasting glucose levels and the range of post-breakfast glucose elevation. For comparison, the patients were classified into those with NAH and those without. The optimal cut-off values for the relevant parameters were determined to predict NAH using ROC analysis.ResultsThe study included a total of 31 patients (mean HbA1c values, 7.8 ± 0.7%), and 16 patients (52%) had NAH. Those with NAH had significantly lower fasting glucose levels than did those without (82 ± 48 mg/dL vs. 144 ± 69 mg/dL; P = 0.009). The change from pre- to post-breakfast glucose levels was significantly greater among those with NAH (postprandial 1-h, P = 0.028; postprandial 2-h, P = 0.028). The cut-off values for prediction of NAH were as follows: fasting glucose level <84 mg/dL (sensitivity 0.80/specificity 0.75/AUC 0.80; P = 0.004), 1-h postprandial elevation >69 mg/dL (0.75/0.67/0.73; P = 0.033), and 2-h postprandial elevation >99 mg/dL (0.69/0.67/0.71; P = 0.044).ConclusionsThe results suggest that fasting glucose level of < 84 mg/dL had approximately 80% probability of predicting the occurrence of NAH in T1D receiving insulin degludec. It was also shown that the occurrence of hypoglycemia led to greater post-breakfast glucose fluctuations and steeper post-breakfast glucose gradients.

Is it possible to predict the onset of nocturnal asymptomatic hypoglycemia in patients with type 1 diabetes receiving insulin degludec? Potential role of previous day and next morning glucose values

“…NH and NSH were found to have occurred in 16 (51.6%) and eight (25.8%) patients, respectively. There was no significant difference between those with NSH and those without regarding age, HbA1c, body mass index, duration of diabetes, total insulin dose or basal–bolus insulin ratio (results for NH as previously published) 7 ; there was also no difference between the groups regarding their bolus insulin dose before dinner and before breakfast (Table 1). None of the patients injected extra bolus insulin after meals.…”

“…We reported earlier that an acute post‐breakfast glucose elevation predicts the occurrence of nocturnal asymptomatic hypoglycemia (<70 mg/dL) in patients receiving insulin degludec whose fasting glucose levels are <84 mg/dL 7 . The American Diabetes Association and European Association for the Study of Diabetes proposed the criteria for hypoglycemia for use in clinical studies as “blood glucose levels of <54 mg/dL in non‐diabetes individuals which do not occur under physiological conditions” or “severe hypoglycemia associated with severe cognitive impairment requiring external assistance for recovery” in their 2016 joint consensus statement 8 .…”

Fear of hypoglycemia in adults with diabetes mellitus switching to treatment with IDegAsp co-formulation to examine real-world setting: an observational study (The HATICE study)

“…Hypoglycemia is a complication of diabetes mellitus, commonly recognized and feared, and prevents the intensification of treatment for certain patients and therefore, has a detrimental effect on quality of life and/or serious clinical outcomes [14]. Moreover, the unawareness of hypoglycemia, which is caused by the frequent severe hypoglycemia, can lead to permanent neurological damage [15]. In addition, fear of hypoglycemia leads to anxiety, behavior disorder, discontinuation of medications, loss of labor and economic decline in patients with diabetes [16,17].…”

GLU: a software package for analysing continuously measured glucose levels in epidemiology

“…Although fasting glucose levels have previously been approximated using CGM data, the methods used to derive this measure can be unclear. 47 , 48 In studies where meal times are known, fasting glucose levels may be inferred using CGM data recorded before breakfast or after at least 7 h fasting, 5 , 26 , 49 e.g. using the mean of the six consecutive values (with 5 min intervals) before breakfast.…”