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In a multicenter, randomized, crossover trial involving children 1 to 7 years of age with type 1 diabetes, a closed-loop system was compared with sensor-augmented pump therapy in random order. The closed-loop system improved glycemic control in very young children with type 1 diabetes, without increasing the time spent in a hypoglycemic state.

Zusammenfassung Mit der Kommerzialisierung und klinischen Verfügbarkeit der automatischen Insulindosierung (AID) brach ein neues Zeitalter in der Behandlung des Typ-1-Diabetes an. Robuste Forschungsergebnisse randomisierter Langzeitstudien ergaben: Die AID-Therapie verbessert die Stoffwechsellage in allen pädiatrischen Altersgruppen, ohne dass höhere akute Komplikationen oder Hypoglykämieraten auftreten. Daten des realen Lebens aus prospektiven Beobachtungsstudien und retrospektive Clouddaten der Hersteller bestätigen diese Behandlungserfolge. Auch bei Manifestation sind AID-Systeme sicher einsetzbar und bringen gegenüber Standardtherapien langfristig Vorteile für Kinder und Jugendliche mit neu diagnostiziertem Typ-1-Diabetes. Langzeitstudien mit Daten des realen Lebens gibt es noch nicht. In Zukunft sollten Registerdaten diesbezüglich ausgewertet werden, um systemübergreifend die Beständigkeit der glykämischen Outcomes zu erschließen. Ein vollautomatisches AID-System, bei dem die Notwendigkeit der manuellen Abgabe von Insulinboli zu den Mahlzeiten entfällt, bleibt das ultimative Ziel der AID-Forschung, ist aber bislang nicht erhältlich und bei Kindern und Jugendlichen wenig erforscht.

Mit der Kommerzialisierung und klinischen Verfügbarkeit der automatischen Insulindosierung (AID) brach ein neues Zeitalter in der Behandlung des Typ-1-Diabetes an. Robuste Forschungsergebnisse randomisierter Langzeitstudien ergaben: Die AID-Therapie verbessert die Stoffwechsellage in allen pädiatrischen Altersgruppen, ohne dass höhere akute Komplikationen oder Hypoglykämieraten auftreten. Daten des realen Lebens aus prospektiven Beobachtungsstudien und retrospektive Clouddaten der Hersteller bestätigen diese Behandlungserfolge. Auch bei Manifestation sind AID-Systeme sicher einsetzbar und bringen gegenüber Standardtherapien langfristig Vorteile für Kinder und Jugendliche mit neu diagnostiziertem Typ-1-Diabetes. Langzeitstudien mit Daten des realen Lebens gibt es noch nicht. In Zukunft sollten Registerdaten diesbezüglich ausgewertet werden, um systemübergreifend die Beständigkeit der glykämischen Outcomes zu erschließen. Ein vollautomatisches AID-System, bei dem die Notwendigkeit der manuellen Abgabe von Insulinboli zu den Mahlzeiten entfällt, bleibt das ultimative Ziel der AID-Forschung, ist aber bislang nicht erhältlich und bei Kindern und Jugendlichen wenig erforscht.

In a trial involving youths with new-onset type 1 diabetes, intensive glucose control with hybrid closed-loop therapy for 24 months did not preserve C-peptide secretion as compared with standard insulin therapy.

To the Editor: Ware et al. (Jan. 20 issue) 1 found that a closed-loop insulin-delivery system was superior to glucose sensor–augmented insulin-pump therapy for glycemic control in children 1 to 7 years age with type 1 diabetes. The closed-loop device has been investigated to provide patients with a stable glycemic status and a trouble-free environment, without frequent adjustment of insulin infusions. 2,3 However, unscheduled contacts with trial staff were more frequent during the closed-loop period than during the sensor-augmented pump therapy period (178 vs. 119 contacts) (Tables S7 and S8 in the Supplementary Appendix, available with the full text of their article . . .

Objectives We explored parents' views about healthcare professionals having remote access to their young child's insulin and glucose data during a clinical trial to inform use of data sharing in routine pediatric diabetes care. Research Design and Methods Interviews with 33 parents of 30 children (aged 1–7 years) with type 1 diabetes participating in a randomized trial (KidsAP02) comparing hybrid closed‐loop system use with sensor‐augmented pump therapy. Data were analyzed using a qualitative descriptive approach. Results Parents reported multiple benefits to healthcare professionals being able to remotely access their child's glucose and insulin data during the trial, despite some initial concerns regarding the insights offered into everyday family life. Key benefits included: less work uploading/sharing data; improved consultations; and, better clinical input and support from healthcare professionals between consultations. Parents noted how healthcare professionals' real‐time data access facilitated remote delivery of consultations during the COVID‐19 pandemic, and how these were more suitable for young children than face‐to‐face appointments. Parents endorsed use of real‐time data sharing in routine clinical care, subject to caveats regarding data access, security, and privacy. They also proposed that, if data sharing were used, consultations for closed‐loop system users in routine clinical care could be replaced with needs‐driven, ad‐hoc contact. Conclusions Real‐time data sharing can offer clinical, logistical, and quality‐of‐life benefits and enhance opportunities for remote consultations, which may be more appropriate for young children. Wider rollout would require consideration of ethical and cybersecurity issues and, given the heightened intrusion on families' privacy, a non‐judgmental, collaborative approach by healthcare professionals.

The management of type 1 diabetes in infancy presents significant challenges. Hybrid closed loop systems have been shown to be effective in a research setting and are now available for clinical use. There are relatively little reported data regarding their safety and efficacy in a real world clinical setting. We report two cases of very young children diagnosed with type 1 diabetes at ages 18 (Case 1) and 7 months (Case 2), who were commenced on hybrid closed‐loop insulin delivery using the CamAPS FX™ system from diagnosis. At diagnosis, total daily dose (TDD) was 6 and 3.3 units for Case 1 and 2, respectively. Closed loop was started during the inpatient stay and weekly follow up was provided via video call on discharge. Seven months from diagnosis, Case 1 has an HbA1C of 49 mmol/mol, 61% time in range (TIR, 3.9–10 mmol/L) with 2% time in hypoglycemia (<3.9 mmol/L) with no incidents of very low blood glucose (BG; <3 mmol/L, 54 mg/dL) over 6 months. Given the extremely small TDD of insulin in Case 2, we elected to use diluted insulin (insulin aspart injection, NovoLog, Novo Nordisk Inc., Plainsboro, NJ, Diluting Medium for NovoLog®). Six months from diagnosis, the estimated HbA1c is 50 mmol/mol, TIR 76% with 1% hypoglycemia and no incidents of very low BG (<3 mmol/L, 54 mg/dL) over 6 months. We conclude that the use hybrid closed‐loop can be safe and effective from diagnosis in children under 2 years of age with type 1 diabetes.

Introduction. Parents of children living with type 1 diabetes (T1D) often report short and/or poor quality sleep. The development of closed-loop systems promises to transform the management of T1D. This study compared sleep quality and quantity in caregivers of children using a closed-loop system (CL) or sensor-augmented pump (SAP) therapy. Method. Data from sleep diaries, accelerometers, and questionnaires were provided by forty parents (classified as caregiver 1 (main analyses) or 2 (supplementary analyses) based on their contribution towards treatment management) of 21 very young children aged 1 to 7 years living with T1D (mean age: 4.7 (SD = 1.7)). Assessments were made at a single post-randomisation time point when the child was completing either the 16-week CL arm (n = 10) or the 16-week SAP arm (n = 11) of the main study. Results. Overall, there was a mixed pattern of results and group differences were not statistically significant at the p<0.05 level. However, when we consider the direction of results and results from caregiver 1, sleep diary data showed that parents of the CL (as compared to the SAP) group reported a shorter sleep duration but better sleep quality, fewer awakenings, and less wake after sleep onset (WASO). Actiwatch data showed that caregiver 1 of the CL (as compared to the SAP) group had a shorter sleep latency; greater sleep efficiency; and less wake after sleep onset. Results from the Pittsburgh Sleep Quality Index also showed better sleep quality for caregiver 1 of the CL group as compared to the SAP group. Conclusions. Results from this study suggest that sleep quality and quantity in parents of children using CL were not significantly different to those using SAP. Considering effect sizes and the direction of the non-significant results, CL treatment could be associated with better sleep quality in the primary caregiver. However, further research is needed to confirm these findings. This trial is registered with NCT05158816.