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BACKGROUND: The possible advantage of hybrid closed-loop therapy (i.e., artificial pancreas) over sensor-augmented pump therapy in very young children with type 1 diabetes is unclear. METHODS: In this multicenter, randomized, crossover trial, we recruited children 1 to 7 years of age with type 1 diabetes who were receiving insulin-pump therapy at seven centers across Austria, Germany, Luxembourg, and the United Kingdom. Participants received treatment in two 16-week periods, in random order, in which the closed-loop system was compared with sensor-augmented pump therapy (control). The primary end point was the between-treatment difference in the percentage of time that the sensor glucose measurement was in the target range (70 to 180 mg per deciliter) during each 16-week period. The analysis was conducted according to the intention-to-treat principle. Key secondary end points included the percentage of time spent in a hyperglycemic state (glucose level, >180 mg per deciliter), the glycated hemoglobin level, the mean sensor glucose level, and the percentage of time spent in a hypoglycemic state (glucose level

Objective: Many hybrid closed-loop (HCL) systems struggle to manage unusually high glucose levels as experienced with intercurrent illness or pre-menstrually. Manual correction boluses may be needed, increasing hypoglycemia risk with overcorrection. The Cambridge HCL system includes a user-initiated algorithm intensification mode (“Boost”), activation of which increases automated insulin delivery by approximately 35%, while remaining glucose-responsive. In this analysis, we assessed the safety of “Boost” mode. Methods: We retrospectively analyzed data from closed-loop studies involving young children (1-7 years, n = 24), children and adolescents (10-17 years, n = 19), adults (≥24 years, n = 13), and older adults (≥60 years, n = 20) with type 1 diabetes. Outcomes were calculated per participant for days with ≥30 minutes of “Boost” use versus days with no “Boost” use. Participants with Results: Eight weeks of data for 76 participants were analyzed. There was no difference in time spent 300 mg/dL was 1.39 percentage points (1.01 to 1.77; P < .001) higher on “Boost” days, with higher mean glucose and lower time in target range ( P < .001). Conclusions: Use of an algorithm intensification mode in HCL therapy is safe across all age groups with type 1 diabetes. The higher time in hyperglycemia observed on “Boost” days suggests that users are more likely to use algorithm intensification on days with extreme hyperglycemic excursions.

OBJECTIVE To evaluate the impact of CamAPS FX hybrid closed-loop (HCL) automated insulin delivery in very young children with type 1 diabetes (T1D) on caregivers’ well-being, fear of hypoglycemia, and sleepiness. RESEARCH DESIGN AND METHODS We conducted a multinational, open-label, randomized crossover study. Children (age 1–7 years) with T1D received treatment for two 4-month periods in random order, comparing HCL with sensor augmented pump (control). At baseline and after each treatment period, caregivers were invited to complete World Health Organization–Five Well-Being Index, Hypoglycemia Fear Survey, and Epworth Sleepiness Scale questionnaires. RESULTS Caregivers of 74 children (mean ± SD age 5 ± 2 years and baseline HbA1c 7.3 ± 0.7%; 42% female) participated. Results revealed significantly lower scores for hypoglycemia fear (P < 0.001) and higher scores for well-being (P < 0.001) after HCL treatment. A trend toward a reduction in sleepiness score was observed (P = 0.09). CONCLUSIONS Our results suggest better well-being and less hypoglycemia fear in caregivers of very young children with T1D on CamAPS FX HCL.

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.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.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.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.

Background CamAPS FX is a hybrid closed-loop smartphone app used to manage type one diabetes. The closed-loop algorithm has a default target glucose of 5.8 mmol/L (104.5 mg/dL), but users can select personal glucose targets (adjustable between 4.4 mmol/L and 11.0 mmol/L [79 mg/dL and 198 mg/dL, respectively]). Method In this post-hoc analysis, we evaluated the impact of personal glucose targets on glycemic control using data from participants in five randomized controlled trials. Results Personal glucose targets were widely used, with 20.3% of all days in the data set having a target outside the default target bin (5.5-6.0 mmol/L [99-108 mg/dL]). Personal glucose targets >6.5 mmol/L (117 mg/dL) were associated with significantly less time in target range (3.9-10.0 mmol/L [70-180 mg/dL]; 6.5-7.0 mmol/L [117-126 mg/dL]: mean difference = −3.2 percentage points [95% CI: −5.3 to −1.2; P < .001]; 7.0-7.5 mmol/L [126-135 mg/dL]: −10.8 percentage points [95% CI: −14.1 to −7.6; P < .001]). Personal targets >6.5 mmol/L (117 mg/dL) were associated with significantly lower time (Conclusions Discrete study populations showed differences in glucose control when applying similar personal targets.

Pediatric diabetes 23(3), 351-361 (2022). doi:10.1111/pedi.13319, Published by Wiley-Blackwell, Oxford [u.a.]

AimsTo explore parents’ experiences of using a hybrid closed-loop system (CamAPS FX) when caring for a very young child (aged 1–7 years) with type 1 diabetes.MethodsInterviews with n = 33 parents of 30 children who used the system during a randomised controlled trial. Data analysis used a descriptive thematic approach.ResultsWhile some parents were initially reticent about handing control to the system, all reported clinical benefits to using the technology, having to do less diabetes-related work and needing less clinical input over time. Parents welcomed opportunities to enhance the system’s efficacy (using Ease-off and Boost functions) as required. Parents described how the system’s automated glucose control facilitated more normality, including sleeping better, worrying less about their child, and feeling more confident and able to outsource care. Parents also described more normality for the child (alongside better sleep, mood and concentration, and lessened distress) and siblings. Parents liked being able to administer insulin using a smartphone, but suggested refinements to device size and functionality.ConclusionsUsing a hybrid closed-loop system in very young children can facilitate greater normality and may result in a lessened demand for health professionals’ input. Systems may need to be customised for very young children.

Increasing obesity and overweight has led to increased prevalence of type 2 diabetes mellitus (T2D) in adolescents and young adults all over the world. Overweight naturally reduces insulin sensitivity. The following permanent insulin resistance can be found even in younger obese children. Beta-cell insufficiency following high insulin production over years leads to impaired glucose tolerance and later type 2 diabetes mellitus. In children and adolescents, the diagnosis of T2D is often made by screening very obese patients with oral glucose tolerance test. Usually in these patients, few or no diabetes symptoms are found. As frequently found in pediatric pharmacotherapy, only a few of the modern substances used in adults are available for pediatric patients with type 2 diabetes mellitus. The essential change in lifestyle for weight reduction is difficult in this age group with often rather disappointing results.

Insulin treatment in children and adolescents with autoimmune type 1 diabetes has changed tremendously in the last 20 years with the knowledge of DCCT trial regarding near-normal glucose levels on the micro- and macrovascular outcome. Intensified insulin therapy is now standard of care. Carb counting however was introduced systematically only recently in several countries. In industrialized countries most patients in this age group are treated with continuous subcutaneous insulin injections. Nowadays this is combined with continuous subcutaneous glucose measurement commencing sensor-augmented pump therapy. Predictive low glucose suspend reduces the frequency of hypoglycemic events. Still not available for children is a commercially available closed loop system. However, treatment goals are still frequently not reached especially in the group of adolescents. Therefore several additive drugs are tested to improve treatment results. There are new insulins with faster and longer action profile in the pipeline to better mimic physiologic insulin profiles. Smart insulins may be able to mimic reaction on blood sugar levels. The broad facet of treatment modalities helps pediatric diabetes teams to individualize therapy and so improve patients' health-related quality of life.

Worsening metabolic control, weight changes and increasing insulin dose during puberty have emerged as a challenge in diabetes care. However, individual variation is large. Data from the German/Austrian/Luxembourgian diabetes registry DPV were used to identify distinct patterns of hemoglobin A1c (HbA1c), age/sex-standardized body mass index (BMI-SDS) and daily insulin dose from childhood to young adulthood. Longitudinal data from 9,239 participants with T1D aged 8 to 18 years with duration >=2 years and >=5 years of follow-up were analyzed. We applied group-based multitrajectory (GBMT) modeling, a generalization of the group-based trajectory approach, to identify latent groups of subjects following similar developmental curves over time across multiple variables (Nagin, 2018). The GBMT approach revealed five unique groups of heterogeneous HbA1c, BMI-SDS and insulin dose patterns over time (Fig1). Differences in age at onset, gender, migration background as well as height-SDS, insulin pump and CGM usage, frequency of SMBG and physical activity were found across all groups. The present study identified for the first time five distinct multitrajectories of HbA1c, BMI-SDS and insulin dose during puberty. This approach demonstrates that variability between individuals is obscured by statistics on central tendency. Disclosure A. Schwandt: None. O. Kuss: None. D.P. Dunstheimer: None. B. Karges: None. T.M. Kapellen: None. T. Meissner: None. M. Witsch: None. M. Flury: Other Relationship; Self; Pfizer Inc. S. Straubinger: None. R.W. Holl: None. Funding German Center for Diabetes Research; Robert Koch Institute; German Diabetes Association

Type 1 diabetes (T1D) is associated with additional autoimmune and endocrine disorders; however, their prevalences internationally are poorly understood. We analyzed 22,632 patients from the U.S. T1D Exchange (T1DX) registry (median age 18 years) and 38,470 patients from the German/Austrian DPV registry (median age 16 years) with T1D duration ≥1 year (median duration 10 and 6 years, respectively) with data between 01/2016 and 03/2018. Reported prevalences of thyroid disease, arthritis, Addison’s disease, and atrophic gastritis were compared using logistic regression models with registry, age group, and sex as covariates. Thyroid disease was more frequent in the T1DX, whereas arthritis was more frequent in the DPV. Prevalence increased with age in both registries. We found no significant differences between T1DX and DPV for Addison’s disease (Figure). Atrophic gastritis was rare in both registries (T1DX: n=3, DPV: n=21). After adjustment for age, thyroid disease was about twice as frequent in females compared with males (T1DX: 25 vs. 13%, DPV: 15 vs. 7%, both p Disclosure J. Hermann: None. K. Miller: None. G. Szinnai: None. N.C. Foster: None. T.M. Kapellen: None. L. DiMeglio: Research Support; Self; Amgen Inc., Caladrius Biosciences, Inc., Janssen Research & Development, Medtronic, Sanofi. Other Relationship; Self; Dexcom, Inc. E. Fröhlich-Reiterer: None. J.B. McGill: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Gilead Sciences, Inc., Novo Nordisk Inc., Sanofi US. Research Support; Self; Dexcom, Inc., Medtronic, Novartis AG, Sanofi US. Speaker's Bureau; Self; Aegerion Pharmaceuticals, Dexcom, Inc., Janssen Pharmaceuticals, Inc., MannKind Corporation. R.W. Holl: None. D.M. Maahs: Advisory Panel; Self; Novo Nordisk Inc. Consultant; Self; Abbott, Sanofi. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. Funding German Center for Diabetes Research; The Leona M. and Harry B. Helmsley Charitable Trust; German Center for Diabetes Research; German Diabetes Association; European Foundation for the Study of Diabetes; INNODIA

Die neue DDG-Leitlinie der hochsten Qualtitatsstufe richtet sich an alle Betreuer von Menschen mit Typ-1-Diabetes. Sie soll bewirken, dass Patienten mit grostmoglicher Eigenverantwortung ihre individuellen Therapieziele erreichen und akute Komplikationen sowie diabetesbedingte Folgeerkrankungen vermeiden konnen — und all dies bei hoher Lebensqualitat. Hierfur ist der HbA1c-Zielwert stets als ein Kompromiss zwischen dem Risiko fur Hypoglykamien und deren Folgen und der erwarteten Risikoreduktion anzusehen, wobei ein Wert von < 7,5% anzustreben ist.

Monogene Diabetesformen sind selten. Dennoch sollte bei schlanken Patienten, die als Jugendliche oder junge Erwachsenen an Diabetes erkranken, einen niedrigen Insulinbedarf und keine Betazellautoimmunitat haben, ein monogener Diabetes als Diagnose in Betracht gezogen werden. Die richtige Diagnose hat sowohl fur die Therapie (oft mit oralen Antidiabetika) als auch fur die Prognose und das Auftreten von Begleiterkrankungen Konsequenzen. Syndromale Diabeteserkrankungen sind noch seltener, haben jedoch zum Teil eine sehr schlechte Prognose. Bei Kombination eines Diabetes mit Taubheit, Optikusatrophie, Retinitis oder neurologischen Symptomen sind differenzialdiagnostische Uberlegungen erforderlich.

In der Behandlung von Jugendlichen mit Typ-2-Dia-betes ist eine Gewichtsreduktion und Verbesserung der Insulinsensitivitat durch Lebensstilanderungen anzustreben. Die medikamentose Behandlung ist derzeit noch durch die weitgehend fehlende Zulassung von oralen Antidiabetika auf Metformin und Insulin beschrankt. Wichtig ist ein Monitoring und die Therapie von moglichen Begleiterkrankungen.

Type 1 diabetes mellitus (T1DM) is characterized by an immunological reaction that is dominated by type-1 T helper (Th1) cells, whereas immunoglobulin E (IgE)-mediated allergies are associated with Th2 cell. According to the Th1/Th2-hypothesis, the immune system is said to either develop into the direction of Th1 or Th2 cells. This would mean that a child developing T1DM is unlikely to develop an IgE-mediated allergy and vice versa.The aim of the study was to investigate the association between the prevalence of T1DM and IgE-mediated allergies.We designed a prospective case control study with 94 children and adolescents with T1DM and 188 age- and sex-matched control children. The basis of our investigations was a questionnaire concerning the family and children's history as to the presence of IgE-mediated allergies. Moreover, the following blood investigations were done: total serum IgE, specific IgE antibodies to major inhalant allergens, and a multiplex cytokine analysis measuring levels of specific cytokines representing either Th1- or Th2- cytokines.Children with T1DM reported the presence of IgE-mediated allergies significantly more often than children of the control group. Children with T1DM had significantly higher tumor necrosis factor alpha (TNFα) levels than healthy controls. Levels of interleukin-2 (IL-2) and IL-6 were higher in the groups of children with the presence of a personal history of allergies, regardless of the presence of T1DM.Our results suggest that T1DM is associated with a higher risk of a self-reported presence of IgE-mediated allergies and that the Th1/Th2-hypothesis may be an oversimplification.

Zum Screening auf einen fruhen Typ-2-Diabetes wird bei Kindern und Jugendlichen der orale Glukosetoleranztest empfohlen. Eine grose Studie zeigt, dass sich der HbA1c-Wert besser eignet.