Long-term Continuous Glucose Monitor Use in Very Young Children With Type 1 Diabetes: One-Year Results From the SENCE Study

Name, Michelle A. Van; Kanapka, Lauren; Kanapka, Lauren G.; Miller, Kellee M.; Albanese‐O’Neill, Anastasia; Commissariat, Persis; Corathers, Sarah; Harrington, Kara R.; Hilliard, Marisa E.; Anderson, Barbara J.; Kelley, Jennifer C.; Laffel, Lori; MacLeish, Sarah A.; Nathan, Brandon M.; Tamborlane, William V.; Wadwa, R. Paul; Willi, Steven M.; Williams, Kristen M.; Wintergerst, Kupper A.; Woerner, Stéphanie; Wong, Jenise C.; DeSalvo, Daniel J.

doi:10.1177/19322968221084667

Cited by 11 publications

(5 citation statements)

References 37 publications

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“…Previously published data indicated persistently high CGM use in all groups (all >88%), and no change in time‐in‐range or HbA1c with CGM use in any group 18 …”

Section: Resultsmentioning

confidence: 68%

“…All were required to have not used real‐time CGM in the 30 days prior to enrolment. Descriptions of participant recruitment and enrolment and characteristics of the study sample at baseline have been published 16–18 . A total of 143 children were randomized into the study, and 131 children remained in the study at 52 weeks.…”

Section: Methodsmentioning

confidence: 99%

“…Previously published data indicated persistently high CGM use in all groups (all >88%), and no change in timein-range or HbA1c with CGM use in any group. 18 F I G U R E 1 Psychosocial outcomes by treatment group and visit. The SENCE study developed and tested a structured family-focused education and intervention addressing behavioural and emotional challenges of new CGM use for parents of very young children with type 1 diabetes.…”

Section: Participantsmentioning

confidence: 99%

“…The original standard CGM and CGM + FBI groups were followed for the additional 26 weeks to observe intervention outcome maintenance. Effects on hypoglycaemia reduction were sustained at 12 months 18 . A flowchart of study completion can be found in Figure S1.…”

Section: Introductionmentioning

confidence: 99%

“…Effects on hypoglycaemia reduction were sustained at 12 months. 18 A flowchart of study completion can be found in Figure S1.…”

Section: Introductionmentioning

confidence: 99%

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Twelve‐month psychosocial outcomes of continuous glucose monitoring with behavioural support in parents of young children with type 1 diabetes

et al. 2023

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Aim: Managing type 1 diabetes in young children can cause significant stress for parents. Continuous glucose monitoring (CGM) may reduce parental burden. The Strategies to Enhance CGM Use in Early Childhood (SENCE) trial randomized parents of children (ages 2 to <8 years) with type 1 diabetes to CGM with family behavioural intervention (CGM + FBI), CGM alone (Standard-CGM) or blood glucose monitoring for 26 weeks before receiving CGM + FBI (BGM-Crossover). This report assesses changes in psychosocial outcomes for all groups over 52 weeks. Methods: CGM + FBI (n = 45), Standard-CGM (n = 42) and BGM-Crossover (n = 44) participants completed psychosocial assessments at baseline, 26 weeks and 52 weeks. Repeated measures linear regression models evaluated change within and between treatment groups. Results:The BGM-Crossover group reported improved diabetes burden (Δ −6.9, 95% CI [−11.3, −2.6], p = 0.003), fear of hypoglycaemia (Δ −6.4, CI [−10.1, −2.6], p = 0.002) and technology satisfaction (Δ 7.3, CI [2.4, 12.2], p = 0.005) from 26 to 52 weeks, similar to published findings in the CGM + FBI group over the first 26 weeks. The Standard-CGM group reported increased technology satisfaction (Δ 7.3, CI [0.6,14.0], p = 0.027) from baseline to 52 weeks. The CGM + FBI group reported less diabetes burden and fear of hypoglycaemia from baseline to 52 weeks, but changes were not statistically significant. Scores from 26 to 52 weeks did not deteriorate.Conclusions: Parents demonstrated psychosocial benefits following FBI that appeared to maintain without additional intervention. CGM-focused education with behavioural support likely helps parents of young children with type 1 diabetes reduce burden and worry in the short-and long-term. K E Y W O R D Sburden, CGM, fear of hypoglycaemia, randomized clinical trial, type 1 diabetes, young children

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“…Previously published data indicated persistently high CGM use in all groups (all >88%), and no change in time‐in‐range or HbA1c with CGM use in any group 18 …”

Section: Resultsmentioning

confidence: 68%

Section: Methodsmentioning

confidence: 99%

Section: Participantsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…Effects on hypoglycaemia reduction were sustained at 12 months. 18 A flowchart of study completion can be found in Figure S1.…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Twelve‐month psychosocial outcomes of continuous glucose monitoring with behavioural support in parents of young children with type 1 diabetes

et al. 2023

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Tecnología aplicada a la diabetes

Cebada,

Silva,

Escobar-Morreale

et al. 2024

Medicine - Programa de Formación Médica Continuada Acreditado

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Evidence from clinical trials on high-risk medical devices in children: a scoping review

Guerlich,

Patro-Golab,

Dworakowski

et al. 2023

Pediatr Res

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Background Meeting increased regulatory requirements for clinical evaluation of medical devices marketed in Europe in accordance with the Medical Device Regulation (EU 2017/745) is challenging, particularly for high-risk devices used in children. Methods Within the CORE-MD project, we performed a scoping review on evidence from clinical trials investigating high-risk paediatric medical devices used in paediatric cardiology, diabetology, orthopaedics and surgery, in patients aged 0–21 years. We searched Medline and Embase from 1st January 2017 to 9th November 2022. Results From 1692 records screened, 99 trials were included. Most were multicentre studies performed in North America and Europe that mainly had evaluated medical devices from the specialty of diabetology. Most had enrolled adolescents and 39% of trials included both children and adults. Randomized controlled trials accounted for 38% of the sample. Other frequently used designs were before-after studies (21%) and crossover trials (20%). Included trials were mainly small, with a sample size <100 participants in 64% of the studies. Most frequently assessed outcomes were efficacy and effectiveness as well as safety. Conclusion Within the assessed sample, clinical trials on high-risk medical devices in children were of various designs, often lacked a concurrent control group, and recruited few infants and young children. Impact In the assessed sample, clinical trials on high-risk medical devices in children were mainly small, with variable study designs (often without concurrent control), and they mostly enrolled adolescents. We provide a systematic summary of methodologies applied in clinical trials of medical devices in the paediatric population, reflecting obstacles in this research area that make it challenging to conduct adequately powered randomized controlled trials. In view of changing European regulations and related concerns about shortages of high-risk medical devices for children, our findings may assist competent authorities in setting realistic requirements for the evidence level to support device conformity certification.

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Long-term Continuous Glucose Monitor Use in Very Young Children With Type 1 Diabetes: One-Year Results From the SENCE Study

Cited by 11 publications

References 37 publications

Twelve‐month psychosocial outcomes of continuous glucose monitoring with behavioural support in parents of young children with type 1 diabetes

Twelve‐month psychosocial outcomes of continuous glucose monitoring with behavioural support in parents of young children with type 1 diabetes

Tecnología aplicada a la diabetes

Evidence from clinical trials on high-risk medical devices in children: a scoping review

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