Background: Automated insulin delivery with predictive low glucose suspend (PLGS) feature has the potential to reduce risk of hypoglycemia in patients with type 1 diabetes mellitus (T1DM). We aim to systematically synthesize the evidence on the efficacy and safety of PLGS in children and adolescents with T1DM.
Methods: We performed a systematic search through Ovid/MEDLINE, Ovid/Embase, and other search engines. We included randomized controlled trials (RCTs) evaluating the effect of sensor augmented pump (SAP) with PLGS feature compared to SAP or insulin pump therapy without SAP in decreasing hypoglycemia in children and adolescents aged 2 to 18 years with T1DM, with at least 2 weeks of follow-up. Two reviewers independently selected studies, extracted data, and evaluated the risk of bias (ROB).
Results: Five RCTs with total sample size of 493 children aged 6 to 18 years met the inclusion criteria. The overall ROB of included studies was low. There is high quality evidence that PLGS is superior to SAP in decreasing time spent in hypoglycemia (sensor glucose [SG] <3.9 mmol/L [<70 mg/dL]/24 h) and nocturnal hypoglycemia (SG <3.9 mmol [<70 mg/dL]/L/night) with an absolute mean difference of 17.4 min/d (95% CI: -19.2, -15.5) and 26.3 min/night (95% CI: -35.5, -16.7), respectively, without increasing percentage of time spent in hyperglycemia or episodes of diabetic ketoacidosis (DKA). There was insufficient evidence for the impact of PLGS on health related quality of life (HRQL).
Conclusions: PLGS is superior to SAP in decreasing daytime and nocturnal hypoglycemia without increasing the risk of DKA or hyperglycemia. Future studies should address the impact of PLGS on children younger than 6-years-old and HRQL.
Keywords: adolescent; blood glucose self-monitoring; child, type 1 diabetes mellitus; continuous glucose monitoring system; insulin infusion system.
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