BACKGROUNDAutomated insulin delivery (AID) systems combine insulin pump(s), continuous glucose monitoring (CGM) and a dosing algorithm automatically delivering insulin (single-hormone AID [SH-AID]) or insulin + glucagon (dual-hormone AID [DH-AID]). Compared with conventional insulin therapies, AIDs achieve superior glucose management for type 1 diabetes (T1D). [1][2][3] Limited evidence exists regarding the efficacy of DH-AID among the paediatric population. Studies from different research groups have suggested that DH-AID is superior to usual care (insulin pump +/À CGM) for time spent in the optimal glucose range both during 24-hour and during night-time in children with T1D. 4,5 In three studies conducted by our team, 6-8 the efficacy of DH-AID and SH-AID on nocturnal glucose management was also compared; however, the conclusions were different. Further, the reporting of CGM metrics in those studies was not yet standardized. 9 Here, we aim to draw a stronger conclusion by pooling data from multiple head-to-head trials on this topic and by using standardized CGM metrics to compare SH-AID and DH-AID.
| METHODSThis post hoc analysis used data from three open-label, randomized, controlled, crossover studies (CLASS 03, 7 04 8 and 08 6 ) comparing DH-AID, SH-AID and usual care interventions during the night-time period (Figure S1). In brief, CLASS 03 was a 24-hour study in a research facility including a 60-minute evening exercise session. CLASS 04 was a two-night home study with the first night involving a standardized dinner and the second night involving a 60-minute evening exercise session. CLASS 08 was a three-night study in a diabetes camp with unrestricted food intake and physical activity. For this pooled analysis, we included participants who were aged 8-17 years; had a clinical diagnosis of T1D for more than 12 months; used insulin pump therapy for more than three months and had HbA1c of 11% or less. Overnight
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