medwireNews: Children and adolescents with type 1 diabetes using a predictive low-glucose management (PLGM) system have less hypoglycemia and fewer hypoglycemic events than those managed using sensor-augmented pump therapy (SAPT) alone, according to a 6-month trial.
The PLGM system enabled a “suspend before low” feature of the insulin pump, which caused the pump to suspend insulin infusion when sensor glucose was at or below 7.3 mmol/L (131 mg/dL; 70 mg/dL above the low limit) and predicted to be at or below 4.5 mmol/L (81 mg/dL; 20 mg/dL above the low limit) in 30 minutes.
“This study is the first randomized 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,” write Timothy Jones (The University of Western Australia, Perth) and colleagues in Diabetes Care.
Percentage time in hypoglycemia with sensor glucose below 3.5 mmol/L (63 mg/dL), the primary outcome, was significantly lower among patients managed with PLGM versus SAPT alone, at 1.4% versus 2.6%. This equated to 37.7 min/day in hypoglycemia with SAPT compared with 20 min/day with PLGM.
Both groups achieved a reduction in time in hypoglycemia relative to baseline, but the reduction was seen during both the day and night with PLGM use, compared with the daytime only with SAPT alone.
“This study highlights an almost twofold reduction in hypoglycemia exposure in children and adolescents with type 1 diabetes using PLGM during a 6-month, multicenter, randomized controlled home trial,” say the researchers, adding that it supports the findings of earlier in-clinic and short-term observational studies and trials.
The study recruited 154 children and young adults aged 8–20 years from five tertiary pediatric diabetes centers in Australia, and randomly assigned 74 individuals to SAPT alone and 80 to PLGM.
Concerns about an increase in the burden of the disease with use of the PLGM and SAPT systems were alleviated by a finding of no deterioration in the quality of life in either group during the study, as reported by participants and their parents. Furthermore, a similar proportion of ketosis in both groups adds to the evidence for the safety of the PLGM system.
The researchers conclude: “PLGM reduced hypoglycemia exposure without compromising glycemic 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.”
By Catherine Booth
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