An insulin pump can halve children’s exposure to hypoglycaemia if it includes an automated system to suspend basal insulin when hypoglycaemia is predicted, endocrinologists in WA have shown in a “real world” trial.
The benefits seen with six months of home use of a Predictive Low Glucose Management System (PLGM) confirm the positive results seen in clinic-based studies of the technology, according to Professor Tim Jones and colleagues from the Children’s Diabetes Centre at the WA Telethon Kids Institute and the Department of Endocrinology and Diabetes at the Princess Margaret Hospital for Children, Perth.
In a randomised controlled trial they assessed the impact of a Medtronic MiniMed 640G pump with a ‘Suspend Before Low’ function, against a regular sensor-augmented pump therapy system with the suspend functions not enabled. The PLGM pump was set to suspend basal insulin if an algorithm predicted a serum glucose of less than 4.5 mmol/L within in 30 minutes.
The study was conducted in 154 children with type 1 diabetes, aged eight to 18 in a home setting for six months.
Over the study period, the PLGM group had a significant reduction (1.5% vs 2.6%) in time spent in hypoglycaemia (SG <3 mmol/L ) compared with SAPT. A similar reduction was seen in percentage time with SG <3 mmol/L both during day and night.
Hypoglycaemic events (SG <3.5 mmol/L for >20 minutes) also declined with PLGM compared to SAPT (139 vs 227 events/patient-years).
There was an increase in time spent with blood glucose in the range 10–15 mmol/L in both groups, and no difference between the two groups (SAPT 27% to 31% vs. PLGM 29% to 31%).
After six months, there was no difference in HbA1c levels between the two groups, and no change in quality of life or fear of hypoglycaeamia. There was also a non-significant trend towards reduced impaired awareness of hypoglycaemia among the users of the PLGM system.
Writing in Diabetes Care, the researchers said the findings were a positive result for the only commercially available insulin pump with a predictive glucose technology suspend system in Australia. The positive findings in a long term home trial were notable given that children often faced technology problems with pumps and concerns with sensor alerts and skin irritation.
“This study is the first randomised controlled home trial and provides high quality evidence of the efficacy and safety of the PLGM system in the prevention of hypoglycemia in real-life situations,” they said.
“PLGM reduced hypoglycemia exposure without compromising glycaemic control or quality of life in children and adolescents with type 1 diabetes and thereby is an important technological device to reduce hypoglycemia in their day-to-day lives.”
The study was funded through the Clinical Research Network (CRN) by the Department of Health and Ageing (DoHA). The second phase in both adults and children with type 1 diabetes will trial a hybrid closed loop system with a more complex algorithm to automate basal insulin through the day and night when linked to a continuous glucose monitor.