Comparing dual‐hormone and single‐hormone automated insulin delivery systems on nocturnal glucose management among children and adolescents with type 1 diabetes: A pooled analysis

Abstract

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

Performance of a dual-hormone closed-loop system versus insulin-only closed-loop system in adolescents with type 1 diabetes. A single-blind, randomized, controlled, crossover trial

“…Recently, a pooled analysis was performed for nocturnal control in children and adolescents using SH and DH. They found superiority in favor of the DH configuration for TIR, level 1 hypoglycemia and level 2 hyperglycemia ( 23 ).…”

Contributions to glucagon and pramlintide pharmacokinetics and pharmacodynamics modeling for multi-hormone artificial pancreas systems

“…Nevertheless, it reaches the same conclusions as the previous review. A recent review compared single and dual hormone AP (Wu et al, 2023). However, the authors (from the Montreal group) focused on nocturnal control in children and adolescents using three of their previous studies (Haidar et al, 2015b(Haidar et al, ,a, 2016.…”