First year on commercial hybrid closed‐loop system—experience on 111 children and adolescents with type 1 diabetes

Abstract

Objective: The hybrid close-loop system (HCL) is a rapidly emerging treatment method for type 1 diabetes (T1D), but the long-term effectiveness of the system remains unclear. This study investigates the influence of the HCL on glycemic control in children and adolescents with T1D in a real-life setting during the first year on HCL. Research design and methods: This retrospective study included all the patients (n = 111) aged 3 to 16 years with T1D who initiated the HCL system between 1st of December 2018 and 1st of December 2019 in the Helsinki University Hospital. Time in range (TIR), HbA1c, mean sensor glucose (SG) value, time below range (TBR), and SG coefficient of variance (CV) were measured at 0, 1, 3, 6, and 12 month. The changes over time were analyzed with a repeated mixed model adjusted with baseline glycemic control.Results: After the initiation of HCL, all measures of glycemic control, except HbA1c, improved and the effect lasted throughout the study period. Between 0 and 12 month, TIR increased (β = À2.5 [95%CI: À3.6 À (À1.3)], p < 0.001), whereas mean SG values (β = À0.7 [95%CI: À0.9 À (À0.4)]), TBR (β = À2.5 [95%CI: À3.6 À (À1.3)]), and SG CV (β = À4.5 [95%CI: À6.3 À [À2.8]) decreased significantly (p < 0.001). Importantly, the changes occurred regardless of the age of the patient.Conclusions: Measurements of glycemic control, except HbA1c, improved significantly after the initiation of the HCL system and the favorable effect lasted throughout the follow-up. These results support the view that HCL is an efficacious treatment modality for children and adolescents with T1D of all ages.

Six-Month Effectiveness of Advanced vs. Standard Hybrid Closed-Loop System in Children and Adolescents With Type 1 Diabetes Mellitus

“…Contrarily to what was reported by Messer et al (28), in our cohort, the numbers of user-initiated meal insulin boluses significantly increased after using Auto mode, while CHO intake remained stable: children and adolescents using these HCL systems were more prone to bolus for every meal or snack, without increasing the CHO intake, and this an essential indicator of selfmanagement behavior, strongly associated with glycemic control (30,31). Moreover, no patients discontinued system use during the study period [as reported by Varimo et al (15)], compared to 4-30% of discontinuations reported in other cohorts (14,28). This can be explained by the high motivation of children, adolescents, and their families who started the HCL training in our Institute and their commitments by signing a therapeutic contract at the beginning (23).…”

“…Moreover, no patients discontinued system use during the study period [as reported by Varimo et al. ( 15 )], compared to 4-30% of discontinuations reported in other cohorts ( 14 , 28 ). This can be explained by the high motivation of children, adolescents, and their families who started the HCL training in our Institute and their commitments by signing a therapeutic contract at the beginning ( 23 ).…”

“…The pivotal trial showed a 5.5% increase in time in range (TIR, between 70 and 180 mg/dL) (7,8), and real-life data showed improved outcomes and the superiority of 670G compared to any other treatment modality (multi-daily injections [MDI], CSII or sensor-augmented pump [SAP]) (9)(10)(11)(12)(13). One real-life study on 92 individuals between 2-25 years of age found a decrease in HbA1c of -0.3% after six months of 670G use (14), while another study on 111 children and adolescents aged 3 to 16 years found an improvement in sensor-specific measures of glycemic control (but not HbA1c) that lasted throughout the first year of treatment (15).…”

Real‐world evidence on clinical outcomes of people with type 1 diabetes using open‐source and commercial automated insulin dosing systems: A systematic review

“…No episodes of DKA or severe hypoglycaemia were reported, yet six hyperglycaemic events occurred, attributed to infusion set blockages and influenza infections. 38 A 12-month study by Varimo et al 36 from Finland of 111 children and adolescents aged 3-17 reported increased TIR over 12 months of follow-up (55.7 ± 13.0% vs. 67.3 ± 8.6%; p < 0.001), yet the decreasing trend in HbA 1c failed to reach significance. TBR decreased significantly (5.9 ± 5.5% vs. 3.2 ± 2.6%; p < 0.001) only for those who previously used multiple daily injections.…”

“…34 A similar association between time in AM and HbA 1c reduction was observed by further studies of the 670G system. [35][36][37] However, Lal et al also reported high discontinuation of AM use (33%)-mainly related to sensor issues, dissatisfaction with the AID system and access to supplies-and a lack of evaluable data from another 29% of the participants, leading to a discontinuation rate of 46% of those who provided data. The study was limited by the inclusion of PwD with insurance coverage only.…”