In‐home use of a hybrid closed loop achieves time‐in‐range targets in preschoolers and school children: Results from a randomized, controlled, crossover trial

Abstract

Aim To obtain additional information on the incremental differences between using a sensor‐augmented pump (SAP) without automated insulin delivery (AID), using it with predictive low‐glucose management (PLGM) or as hybrid closed loop (HCL), in preschool and school children. Methods We conducted a monocentric, randomized, controlled, two‐phase crossover study in 38 children aged 2‐6 and 7‐14 years. The primary endpoint was the percentage of time in range (TIR) of 70‐180 mg/dl. Other continuous glucose sensor metrics, HbA1c, patient‐related outcomes (DISABKIDS questionnaire, Fear of Hypoglycaemia Survey) and safety events were also assessed. Results from 2 weeks of SAP, 8 weeks of PLGM and 8 weeks of HCL were compared using a paired t‐test or Wilcoxon signed‐rank test. Results Overall, we found a high rate of TIR target (>70%) achievement with HCL in preschool (88%) and school children (50%), with average times in Auto Mode of 93% and 87%, respectively. Preschool children achieved a mean TIR of 73% ± 6% (+8% vs. SAP, +6% vs. PLGM) and school children 69% ± 8% (+15% vs. SAP and + 14% vs. PLGM). Overall, HbA1c improved from 7.4% ± 0.9% to 6.9% ± 0.5% (P = .0002). Diabetes burden and worries and fear of hypoglycaemia remained at low levels, without significant changes versus PLGM. No events of severe hypoglycaemia or diabetic ketoacidosis occurred. Conclusions Preschool children profit from AID at least as much as those aged 7 years and older. To ensure safe use and prescribing modalities, regulatory approval is also required for young children.

ISPAD Clinical Practice Consensus Guidelines 2022: Diabetes technologies: Insulin delivery

“…[188][189][190][191][192][193][194] The RCTs have demonstrated the efficacy of both HCL and AHCL to achieve $10%-15% increase TIR (3.9-10 mmol/L, 70-180 mg/dl) when compared to conventional pump therapy, SAP, PLGS, or HCL to ACHL. [179][180][181][182][183][184][185][186][187] Similar findings in change in TIR from baseline data collection periods have been noted in the single-arm trials. [188][189][190][191][192][193][194] (Table 3).…”

“…In addition to the increased TIR, longer outpatient studies have also demonstrated that AID use has led to a concomitant reduction in HbA1c by 0.3%-0.7%. 179,[181][182][183][184][185][187][188][189][190][191][192][193][194] A post-hoc analysis conducted on data from the Diabetes Control and Complications Trial (DCCT), demonstrated that a 10% lower TIR was strongly associated with risk of retinopathy progression and development of microalbuminuria (hazard rates of 64% and 40%, respectively). 30 Importantly, this data was derived from 7-point fingerstick testing conducted during daytime hours in the DCCT, and so it may underestimate the true TIR.…”

“…Some outpatient trials of these devices have been conducted using an RCT design, [179][180][181][182][183][184][185][186][187] while others have been single arm trials. [188][189][190][191][192][193][194] The RCTs have demonstrated the efficacy of both HCL and AHCL to achieve $10%-15% increase TIR (3.9-10 mmol/L, 70-180 mg/dl) when compared to conventional pump therapy, SAP, PLGS, or HCL to ACHL.…”

Empfehlungen zur Diabetes-Behandlung mit automatischen Insulin-Dosierungssystemen

“…1 ). Für Patienten unter 6 Jahren liegt in Europa gegenwärtig nur eine Zulassung für CamAPS FX vor 31 , 32 , 33 , obwohl außerhalb Europas auch die 770G-Pumpe für Kinder < 7 Jahre zugelassen ist 34 und auch für das Tandem-Control-IQ-System Daten in dieser Altersgruppe vorliegen 35 . Darüber hinaus sind für besondere Populationen wie schwangere Frauen mit Typ-1-Diabetes 36 , 37 oder Menschen mit Typ-2-Diabetes positive Studienergebnisse vorgelegt worden 38 , 39 .…”

Proceedings of 21st ISPAD science school for physicians 2022

“…Several trials demonstrated that the use of these systems allows to improve glycemic control and the quality of life of children with T1D and their caregivers. [19][20][21][22][23] Most parents spent less time managing their child's diabetes with a closed-loop system, being worried about their child's glucose control and had less trouble sleeping whilst their child was using the system. The use of artificial pancreas systems also facilitates normality for both parents and children who experience injections or insulin pumps or any other modality.…”