Background: Hypoglycemia is a common side effect of insulin replacement therapy in patients with type 1 diabetes mellitus (T1DM). With the advancement of diabetes technology, sensor-augmented pump therapy (SAP) with predictive low glucose suspend feature offers a potential solution for hypoglycemia in patients with T1DM. However, evidence from randomized trials about the efficacy and safety of PLGS is limited.
Method: We did a systematic search and included randomized trials evaluating the effect of SAP with PLGS feature compared with SAP or insulin pump therapy in decreasing hypoglycemia in children and adolescents with type 1 diabetes mellitus, with at least two weeks of follow-up. Two review authors independently selected studies, extracted data and evaluated the risk of bias using the Cochrane 'Risk of bias' tool.
Results: We included five RCT with a total sample size of 493 patients and studies duration ranged between two weeks and 6 months. All the included studies have at least one domain with a high risk of bias except one study with a low risk of bias. There is low quality evidence that PLGS is superior to SAP in decreasing % of hypoglycemia <3.9 mmol/l/24 hrs with absolute mean difference of 17 minutes/day (19 min lower-15.3 min lower) and moderate quality of evidence that PLGS is superior to SAP in decreasing % of nocturnal hypoglycemia <3.9 mmol/l/ with absolute mean difference of 31.9 minutes/day (44 min lower-19.7 min lower) without increasing percentage of hyperglycemia or events of diabetic ketoacidosis. However, there was no statistically significant reduction of severe hypoglycemia< 2.8 mmol/l and no enough evidence regarding the long-term effects of PLGS.
Limitations: Most of the studies were open-label studies with risk of cointervention and ascertainment bias. Four out of five studies had a short duration with no evaluation of long term effects of PLGS.
Conclusions and Implications of key findings: In children and adolescents with T1DM, PLGS is superior to SAP in decreasing hypoglycemia<3.9 mmol/l and nocturnal hypoglycemia <3.9 mmol/l without increasing the risk of DKA or hyperglycemia. There is no difference between SAP and PLGS in decreasing severe hypoglycemia and no enough evidence to test the long-term effect of PLGS.
19 - 21 Sep 2019
European Society for Paediatric Endocrinology