Dataset Information

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.

SUBMITTER: Ekhlaspour L

PROVIDER: S-EPMC8080923 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature

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

Ekhlaspour Laya L Schoelwer Melissa J MJ Forlenza Gregory P GP DeBoer Mark D MD Norlander Lisa L Hsu Liana L Kingman Ryan R Boranian Emily E Berget Cari C Emory Emma E Buckingham Bruce A BA Breton Marc D MD Wadwa R Paul RP

Diabetes technology & therapeutics 20201208 5

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 ...[more]

PMID: 33226837

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Project description:Optimizing glycemic control without risking hypoglycemia is crucial in toddlers and preschoolers with type 1 diabetes (T1D) to avoid cognitive impairment later in life. Hence, this study aims to compare glycemic parameters among toddlers and preschoolers with T1D in relation to different basal insulins. Sixty toddlers and preschoolers with T1D with mean age of 3.53 ± 1.17 years (range, 2-6) and mean diabetes duration of 9.37 ± 1.85 months were randomly assigned into three equal groups; group A received insulin degludec, group B received insulin glargine, and group C were on NPH. At baseline, the three groups were matched regarding clinical and laboratory parameters (p > 0.05). They were followed up at 3 and 6 months for insulin daily dose (IDD), hypoglycemia and severe-hypoglycemia frequency, and glycated hemoglobin (HbA1c). At the study endpoint, continuous glucose monitoring (CGM) was assessed in a random sample of 10 patients from each group. The mean time in range (TIR) of the studied cohort was 55.07 ± 24.05%, and their mean coefficient of variation (CV) was 42.82 ± 11.69%. The TIR was significantly higher in the degludec group (69.36 ± 18.54) and the glargine group (55.43 ± 26.51) than the NPH group (32.56 ± 9.11), p < 0.001. Meanwhile, the CV was significantly lower in the degludec group (35.12 ± 6.47) than the gargine (44.1 ± 13.13) and the NPH (53.8 ± 7.54) groups, p < 0.001. The insulin degludec and glargine groups had significantly lower HbA1c (p = 0.002), hypoglycemia (p = 0.006), severe hypoglycemia (p = 0.029), and IDD (p = 0.015) than the NPH group.ConclusionInsulin degludec and glargine resulted in better HbA1c and TIR with reduced hypoglycemia and IDD than NPH among toddlers and preschoolers with T1D. Moreover, CV was lowest in the insulin degludec group.What is known• Insulin therapy is the mainstay of T1D management. • Optimal insulin therapy for young children with T1D should provide effective glycemic.What is new• Insulin degludec and insulin glargine have better efficacy than NPH insulin among toddlers and preschoolers with T1D in the term of significantly lower coefficient of variation, HbA1c and IDD and significantly higher time in range. • Insulin degludec and insulin glargine have better safety in the term of less hypoglycemia and severe hypoglycemia episodes than NPH insulin among toddlers and preschoolers with T1D.

Project description:Objective: Pivotal trials of automated insulin delivery (AID) closed-loop systems have demonstrated a consistent picture of glycemic benefit, supporting approval of multiple systems by the Food and Drug Administration or Conformité Européenne mark receipt. To assess how pivotal trial findings translate to commercial AID use, a systematic review of retrospective real-world studies was conducted. Methods: PubMed and EMBASE were searched for articles published after 2018 with more than five nonpregnant individuals with type 1 diabetes (T1D). Data were screened/extracted in duplicate for sample size, AID system, glycemic outcomes, and time in automation. Results: Of 80 studies identified, 20 met inclusion criteria representing 171,209 individuals. Time in target range 70-180 mg/dL (3.9-10.0 mmol/L) was the primary outcome in 65% of studies, with the majority of reports (71%) demonstrating a >10% change with AID use. Change in hemoglobin A1c (HbA1c) was reported in nine studies (range 0.1%-0.9%), whereas four reported changes in glucose management indicator (GMI) with a 0.1%-0.4% reduction noted. A decrease in HbA1c or GMI of >0.2% was achieved in two-thirds of the studies describing change in HbA1c and 80% of articles where GMI was described. Time below range <70 mg/dL (<3.9 mmol/L) was reported in 16 studies, with all but 1 study showing stable or reduced levels. Most systems had >90% time in automation. Conclusion: With larger and more diverse populations, and follow-up periods of longer duration (∼9 months vs. 3-6 months for pivotal trials), real-world retrospective analyses confirm pivotal trial findings. Given the glycemic benefits demonstrated, AID is rapidly becoming the standard of care for all people living with T1D. Individuals should be informed of these systems and differences between them, have access to and coverage for these technologies, and receive support as they integrate this mode of insulin delivery into their lives.

Dataset Information

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

Publications

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

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