Safety and Performance of the Tandem t:slim X2 with Control-IQ Automated Insulin Delivery System in Toddlers and Preschoolers

Abstract

Background: Glycemic control is particularly challenging for toddlers and preschoolers with type 1 diabetes (T1D), and data on the use of closed-loop systems in this age range are limited. Materials and Methods: We studied use of a modified investigational version of the Tandem t:slim X2 Control-IQ system in children aged 2 to 5 years during 48 h in an outpatient supervised hotel (SH) setting followed by 3 days of home use to examine the safety of this system in young children. Meals and snacks were not restricted and boluses were estimated per parents' usual routine. At least 30 min of daily exercise was required during the SH phase. All participants were remotely monitored by study staff while on closed-loop in addition to monitoring by at least one parent throughout the study. Results: Twelve participants diagnosed with T1D for at least 3 months with mean age 4.7 ± 1.0 years (range 2.0–5.8 years) and hemoglobin A1c of 7.3% ± 0.8% were enrolled at three sites. With use of Control-IQ, the percentage of participants meeting our prespecified goals of less than 6% time below 70 mg/dL and less than 40% time above 180 mg/dL increased from 33% to 83%. Control-IQ use significantly improved percent time in range (70–180 mg/dL) compared to baseline (71.3 ± 12.5 vs. 63.7 ± 15.1, P = 0.016). All participants completed the study with no adverse events. Conclusions: In this brief pilot study, use of the modified Control-IQ system was safe in 2–5-year-old children with T1D and improved glycemic control.

Glycemic outcomes of children 2–6 years of age with type 1 diabetes during the pediatric MiniMed ™ 670G system trial

“…Pilot safety and effectiveness studies in young children have been performed on the t:slim X2™ with Control-IQ (Tandem, Diabetes Care, San Diego, CA) 17 and Omnipod™ Horizon (Insulet Corporation, Acton, MA) systems. 22 The former studied 12 children (4.7 Cordero, PhD).…”

The Impact of Hypo- and Hyperglycemia on Cognition and Brain Development in Young Children with Type 1 Diabetes

“…A recent short pilot study evaluated a modified investigational version of the Tandem t:slim X 2 Control-IQ system in very young children (2–5 years old) in both a supervised and home setting with unrestricted meals and snacks. The system significantly improved TIR compared to baseline, with <6% hypoglycemia and <40% hyperglycemia in 83% of participants compared to 33% prior to system use [63].…”

Hybrid closed-loop insulin delivery versus sensor-augmented pump therapy in children aged 6–12 years: a randomised, controlled, cross-over, non-inferiority trial

“…[14][15][16] In adolescents with poor glycaemic control, a closed-loop system has been shown to increase the TIR without increasing hypoglycaemia or ketoacidosis events. 17,18 An increasing number of studies have assessed hybrid closed-loop systems in children younger than 14 years; 17,[19][20][21][22][23][24][25][26][27][28][29][30] however, only a few studies have assessed hybrid closedloop systems under conditions resembling everyday life in the long-term, during day and night, in participants exclusively younger than 14 years in a parallel-group, randomised trial showing an improvement in the TIR without increasing hypoglycaemia. 22,25 The first-generation Diabeloop device (DBLG1; Diabeloop, Grenoble, France) is, to date, the only hybrid closed-loop system that allows customisation of several parameters according to the patient's physiology.…”