Hypoglycemia is under-reported by many patients; but the time in hypoglycemia among patients with type 2 diabetes (T2D) using pre-mixed (biphasic) insulin is not clear. This pilot study aimed to determine the amount of time in hypoglycemia in this patient cohort. The study included people with T2D, aged 18 or over, treated with pre-mixed (biphasic) insulin for at least 6 months with their most recent HbA1c <7.5% (58 mmol/mol) recorded in medical notes in the last 12 months. Pregnant patients were excluded, as were patients on dialysis. A total of 43 participants (65.1% male) from 12 primary and secondary care sites in the UK enrolled in the 2-week single arm study using the FreeStyle Libre Pro Flash Glucose Monitoring SystemTM. Mean HbA1c was 6.9±0.8% (52.1±8.3 mmol/mol), age was 68.8±8.3 years, BMI was 35.0±9.2 kg/m2, average duration of pre-mixed insulin was 6.8±4.8 years with a mean daily dose of 53.4±40.7 units (mean±SD). The number of blood glucose tests performed per day (self-reported) was 1.9±1.1. Time in hypoglycemia <70 mg/dL (3.9 mmol/L) was 1.35±1.56 hours per day, biological hypoglycemia was experienced by 34 patients. Approximately half of the time in hypoglycemia (<70 mg/dL [3.9 mmol/L]; 0.82±1.06 hours) was during night time hours (23:00 to 06:00). Time in hyperglycemia >180 mg/dL (10.0 mmol/L) was 3.55±3.07 hours per day, which mostly occurred was during daytime hours (06:00 to 23:00) (3.15±2.83 hours per day) (mean±SD). Five anticipated sensor insertion site symptoms were experienced by four participants: erythema (n=2 [1 slight pink, 1 well-defined redness]), pain (n=1), bruising (n=1) and bleeding (n=1), all were mild in severity. This population, with HbA1c in target range, have a greater amount of hypoglycemia than the International Consensus and ADA targets of <1 hour per day, excursions occurred both during the day and at night. Further improvements on this level of glycemic control is challenging for this type of insulin therapy due to further escalation of the risk of nocturnal hypoglycemia.
I.R. Idris: None. N. Annamalai: None. T. Aung: None. I. Binnian: None. F.W. Gibb: None. M.I. Malik: None.