Impact of Overnight Home Closed Loop (CL) Insulin Delivery on Glycaemic Control and Counter-Regulatory Hormones Compared to Sensor Augmented Pump Therapy with Low Glucose Suspend (SAP-LGS) in Patients with Type 1 Diabetes (T1D) (#89)
Background: CL insulin delivery improves glycaemic control in patients with T1D although related changes in counter-regulatory hormones have not been studied.
Aim: To evaluate nocturnal glycaemic control, next day glycaemia, and associated changes in counter-regulatory hormones in T1D patients using an overnight CL system at home in comparison with current best available Open Loop (OL) technology represented by SAP-LGS.
Method: Fifteen type 1 diabetes participants (10 adults; 5 adolescents; HbA1c 7.60±0.59%) were assigned in random order to CL with a uni-hormonal artificial pancreas (proportional integral derivative with insulin feedback algorithm) and OL for 1 night in clinic followed by 4 nights at home. On night 4 at 3 AM an orange juice challenge was performed.
Results: The primary outcome, (sensor glucose time in target range overnight at home: 4.0-8.0 mmol/L) in CL vs. OL, was not statistically different (p=0.19). Sensor glucose time overnight (Mean[SD]) between 4.0 and 10.0 mmol/L was higher with CL vs. OL ( 83.9 [15.2] vs. 74.1[18.8]%; p=0.03). Sensor glucose time and area under the curve below target (< 4.0 mmol/L) were lower with CL: (0.21 [0.44] vs. 4.11 [6.03]%; p=0.02) and ( 0.01 [0.03] vs. 0.8 [1.11]mmol/min/ L; p=0.01) respectively. The number of symptomatic hypoglycaemic episodes overnight at home confirmed by capillary glucose readings (<4.0 mmol/L) was significantly lower with CL vs. control (8 vs. 21; p=0.015). There were no changes observed in counter-regulatory hormones.
Conclusions: Overnight CL use at home improved percentage time between 4.0-10.0mmol/L, and reduced nocturnal hypoglycaemia compared with OL implemented with SAP-LGS. The absence of changes observed in counter-regulatory hormones may relate to the small participant numbers and short study duration.