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Objective: To characterize patients with diabetes treated with a tubeless insulin pump (Omnipod® Insulin Management System; Insulet Corp., Acton, MA), and to evaluate the frequency of acute complications with long-term use of the system. Methods: This retrospective analysis of the German/Austrian Diabetes Patienten Verlaufsdokumentation (DPV) registry included data from 3657 patients with diabetes (n = 3582 type 1, n = 25 type 2, n = 50 latent autoimmune diabetes in adults/other) treated with a tubeless insulin pump. Hemoglobin A1c (HbA1c) levels and frequency of diabetic ketoacidosis (DKA) and severe hypoglycemia (SH) were compared between 1 year pre- and 1 year (n = 2911) or up to 3 years (n = 1311) post-tubeless insulin pump initiation and compared with a contemporary cohort on multiple daily injections (MDI) with 3-year data (n = 1874). Results: Patients using tubeless insulin pump therapy had a median age of 13.7 years [interquartile range 10.8, 17.3], diabetes duration 3.7 years [1.7, 8.0], and HbA1c 7.5% [6.9, 8.2]. In patients with 3 years of follow-up data (n = 1311), the percentage with ≥1 episode of DKA, SH (Level 3, requiring assistance), and SH (coma) event with prior treatment was 6.3%, 5.5%, and 1.7%, respectively. After 3 years of tubeless insulin pump therapy, the frequency of DKA, SH (Level 3), and SH (coma) decreased to 2.2%, 4.1%, and 0.5%, respectively. Both DKA and SH remained significantly lower compared with MDI after adjustment in multiple regression analysis. High treatment retention rates (>90%) were observed. Conclusion: Real-world registry data document that tubeless insulin pump therapy is associated with good glycemic control and a low frequency of DKA and SH in an age group prone to acute complications.

Background and Objective: Intermittent scanning continuous glucose monitoring (iscCGM) is increasingly used for glycemic monitoring in diabetes care. In this cross-sectional real-world analysis, is...

Summary Background Although continuous subcutaneous insulin infusion therapy (ie, insulin pump therapy) is associated with improved metabolic control compared with multiple daily insulin injections in children with type 1 diabetes, it is unclear when it is best to start it after diagnosis. In this study, we aimed to compare the outcomes between early and delayed start of insulin pump therapy in young patients with type 1 diabetes. Methods We based the current study on data from the multicentre, prospective diabetes follow-up registry (ie, Diabetes-Patienten-Verlaufsdokumentation [DPV]). The DPV registry comprises 501 diabetes centres from Germany, Austria, Switzerland, and Luxembourg. We included patients diagnosed with type 1 diabetes between 2004 and 2014, who were aged between 6 months and 15 years at the time of diagnosis, who had started insulin pump therapy either within the first 6 months (ie, the early treatment group) or in the second to third year (ie, the delayed treatment group) after diabetes diagnosis, and who were treated with insulin pump therapy for at least 1 year. The outcome parameters included the glycated haemoglobin (HbA1c) values, the cardiovascular risk profile, and rates of acute complications and diabetes-associated hospital admissions (ie, hospitalisation) during the most recent documented treatment year with insulin pump therapy. Statistical models were adjusted for age at diabetes diagnosis, year of diagnosis, sex, immigrant background, use of continuous glucose monitoring, centre size, and the German Index of Socioeconomic Deprivation 2012 terciles. Findings Our study sample comprised 8332 patients from 311 diabetes centres in Germany, Austria, Switzerland, and Luxembourg. The early treatment group consisted of 4004 (48·1%) of 8332 patients, and the delayed treatment group consisted of 4328 (51·9%). The median diabetes duration during follow-up was 6·7 years (IQR 5·1–8·7 in the early group; 5·0–8·7 in the delayed group) in both groups. Patients with early initiation of insulin pump therapy compared with those with delayed initiation of insulin pump therapy had significantly lower estimated mean HbA1c values (7·9% [95% CI 7·8–7·9] and 62·6 mmol/mol [95% CI 62·1–63·2] vs 8·0% [8·0–8·1] and 64·1 mmol/mol [63·6–64·6]; p=0·0006), and lower rates of hypoglycaemic coma (incidence risk ratio 0·44 [95% CI 0·24–0·79]; p=0·0064) and hospitalisation (0·86 [95% CI 0·78–0·94]; p=0·0016). A better cardiovascular risk profile was observed in patients with early initiation of insulin pump therapy than in those with delayed initiation: an estimated mean systolic blood pressure of 117·6 mm Hg (95% CI 117·2–117·9) versus 118·5 mm Hg (118·2–118·9), p=0·0007; and HDL cholesterol of 62·8 mg/dL (95% CI 62·2–63·5) versus 60·6 mg/dL (60·0–61·2), p Interpretation Our findings provide evidence for improved clinical outcomes associated with the early initiation of insulin pump therapy in children with type 1 diabetes. Funding The German Center for Diabetes Research (Deutsches Zentrum fur Diabetesforschung), German Robert Koch Institute, German Diabetes Association, and Diabetes Agenda 2010.

Aim To determine the prevalence of inflammatory bowel disease (IBD) in patients with type 1 diabetes (T1D) and to characterise patients with both diseases. Methods Data of 65.147 patients with T1D ≤18 years of 379 centres in Germany and Austria participating in the DPV initiative were analysed. A total of 63 children had comorbid IBD; IBD prevalence was 0.1%. Regression models were used to analyse differences in metabolic control, acute complications and steroid intake. Results Mean BMI‐SDS in patients with T1D and IBD was lower (−0.15 ± 0.11) compared to patients with T1D only (0.27 ± 0.00, p

ZusammenfassungZiel dieser Beobachtungsstudie ist die Beschreibung der aktuellen Nutzung von Diabetestechnologien bei Patienten/-innen mit Diabetes mellitus.Methode Auswertung von Daten des DPV-Registers zur Nutzung der Insulinpumpentherapie (CSII), kontinuierlicher Glukosemessung (CGM) und der Selbstmessung der Blutglukose (SMBG) aus 497 teilnehmenden Zentren in Deutschland, Österreich, Luxemburg und der Schweiz zwischen 1995 und 2019. Die Daten wurden bei Patienten/-innen mit Diabetes Typ 1 (Alter ≥ 0,5 Jahre) für 5 Altersgruppen ausgewertet. Zusätzlich wurden aktuelle (zwischen 2017 und 2019) Geschlechtsunterschiede in der Verwendung von Diabetestechnologie bei Typ-1-Patienten/-innen untersucht, ebenso wie die Nutzung von Insulinpumpen und CGM für Patienten/-innen mit Insulintherapie bei Typ-2-DM, bei zystischer Fibrose (CFRD), bei anderen Pankreaserkrankungen, neonatalem Diabetes und Maturity Onset Diabetes of the Young (MODY).Ergebnisse Es zeigte sich bei Patienten/-innen mit Diabetes Typ 1 ein Anstieg der CSII-Nutzung von 1995 bis 2019 von 1 % auf 55 % (2019: Zwischen 2017 und 2019 erfolgte eine Nutzung von Insulinpumpen und CGM bei neonatalem Diabetes (CSII 87 %; CGM 38 %), bei MODY (CSII 14 %; CGM 28 %) und bei CFRD (CSII 18 %; CGM 22 %). CGM und CSII wurden dagegen nur selten von Menschen mit Insulintherapie und Diabetes Typ 2 (CSII Schlussfolgerung Moderne Diabetestechnologien werden derzeit insbesondere von pädiatrischen Patienten/-innen mit Diabetes Typ 1, aber auch von Menschen mit neonatalem Diabetes breit genutzt, von Patienten/-innen mit MODY und CFRD sowie Erwachsenen mit Diabetes Typ 1 in etwas geringerem Maße mit ansteigendem Trend. Dagegen sind diese Technologien in der Therapie des Typ-2-Diabetes und bei anderen Pankreaserkrankungen zurzeit nur wenig verbreitet.

Use of continuous glucose monitoring (CGM) systems has become standard of care in type 1 diabetes (T1D) in many countries, particularly in children and adolescents (1,2). Results from clinical trials indicate that use of CGM leads to improved metabolic control and reduction in nonsevere hypoglycemia compared with self-monitoring of capillary blood glucose (3,4). Benefits are seen irrespective of insulin delivery method (pump or pen) (4,5) but are conditioned on near-daily sensor usage (4). Trial participants, however, are often biased toward higher education level, greater therapy adherence, and better self-management. Small sample size and short trial duration very often preclude appropriate assessment of CGM impact on rare events such as severe hypoglycemia (SH) or diabetic ketoacidosis (DKA). We therefore used real-world data from the German-Austrian-Swiss-Luxembourgian Diabetes Prospective Follow-up (DPV) registry to longitudinally assess HbA1c, SH, and DKA during the first year after initiation of CGM, including real-time CGM and intermittently scanned/viewed CGM. Anonymized patient registry records were analyzed. SH was defined as events requiring external assistance by another person and events resulting in coma/convulsion. DKA was defined by pH level

Zusammenfassung Fragestellung Assoziation zwischen Bildungsstand (BldS) der Eltern und diabetesbezogenen Outcomes bei Kindern mit Typ-1-Diabetes in Deutschland und Vergleich mit deren sozioökonomischem Status (SES). Material und Methode 1781 Kinder und Jugendliche mit Typ-1-Diabetes mellitus unter 18 Jahren aus 13 deutschen Diabeteszentren wurden von Juni 2013 bis Juni 2014 in die Studie eingeschlossen und Assoziationen des familiären BldS mit verschiedenen Diabetesoutcomes analysiert. Die Analyse wurde als Sekundäranalyse anhand des Datensatzes der DIAS-Studie durchgeführt. Diese hatte Assoziationen eines niedrigen SES (gemessen mit einem Index aus BldS, beruflicher Stellung und Haushaltseinkommen der Eltern) mit ungünstigen Diabetes- und Versorgungsoutcomes ermittelt. Die vorliegende Sekundäranalyse untersuchte Assoziationen derselben Outcomes mit dem BldS der Eltern, um zu prüfen, ob sich der BldS als vereinfachter Indikator für die Routinemessung des SES eignet.Die Daten wurden mittels der DPV-Software (Diabetes-Patienten-Verlaufsdokumentation) erfasst, die Analysen erfolgten je nach Verteilungscharakteristika der Outcomes mittels linearer, logistischer, negativ-binomialer oder Poisson-Modellen unter Adjustierung für Alter, Geschlecht, Diabetesdauer, jeweils mit und ohne zusätzliche Adjustierung für Migrationshintergrund. Ergebnisse Niedriger familiärer BldS war im Vergleich zu mittlerem/hohem BldS mit einer schlechteren glykämischen Einstellung (HbA1c) (8,1 % versus 7,8 %, p Zusammenfassung Der BldS der Eltern ist ein bedeutsamer Prädiktor für Gesundheits- und Versorgungsoutcomes bei Kindern mit Typ-1-Diabetes und sollte in der personalisierten Diabetestherapie von Kindern und Jugendlichen mehr Berücksichtigung erfahren. Als kurzer und leicht zu erhebender Indikator bildet er einen guten Näherungswert für die Routineerhebung der individuellen Stellung der Patientinnen und Patienten in der Sozialhierarchie in Diabetes-Standarddokumentationen.

Background: To apply and evaluate various equations for estimated glomerular filtration rates (eGFR) in a large paediatric type 1 diabetes population and compare the eGFR values with urinary creatinine clearances (UCC) in a subset of patients. Methods: Six eGFR formulae applicable for children and adolescents were used for calculation of eGFR values in 36,782 children/adolescents with type 1 diabetes. Via regression models, factors influencing eGFR values were identified. eGFR values were compared with measured UCC in 549 patients. Spearman correlation coefficients were given to assess the relation of eGFR and UCC values. Bland-Altman-Plots with corresponding linear regression were drawn to evaluate the agreement between eGFR and UCC. Results: eGFR values differed widely depending on the formula used, resulting in a percentage of pathological values

Niedrige Vitamin-D-Serum-Konzentrationen werden nicht nur mit der Rachitis, sondern vor allem aufgrund von Assoziationsstudien auch mit weiteren Erkrankungen in Zusammenhang gebracht. Da die Vitamin-D-Serum-Konzentrationen bei vielen deutschen Kindern und Jugendlichen jenseits des Sauglingsalters unter dem Zielwert liegen, wird bei Kindern auch eine Vitamin-D-Supplementierung diskutiert. Basierend auf einer Literaturrecherche randomisierter kontrollierter Studien (RCT) werden die Daten zu Wirkungen einer Vitamin-D-Supplementierung jenseits des zweiten Lebensjahres analysiert. Eine Vitamin-D-Supplementierung hat einen moglichen Nutzen fur die Risikosenkung von Influenzainfektionen und fur seltenere Exazerbationen bei Asthma bronchiale, beeinflusst hier jedoch nicht die Krankheitsschwere. Eine Vitamin-D-Supplementierung hat keinen relevanten Einfluss auf Aufmerksamkeitsdefizit- und Hyperaktivitatssyndrom, Herzinsuffizienz, arterielle Hypertonie, Auftreten eines Diabetes mellitus Typ 2 oder der Schubhaufigkeit bei multipler Sklerose, verringerte jedoch die Anzahl neu auftretender Herde im Magnetresonanztomogramm (MRT). Fur andere Endpunkte fehlen kontrollierte randomisierte Interventionsstudien. Aufgrund der vorliegenden Studienlage kann auch bei Vitamin-D-Serum-Konzentrationen unterhalb der Referenzwerte eine generelle Vitamin-D-Supplementierung fur Kinder im Alter >2 Lebensjahre ohne Risikofaktoren und ohne chronische Erkrankungen, die potenziell mit Storungen der Kalzium- oder Vitamin-D-Resorption einhergehen, nicht empfohlen werden.

Objective Continuous subcutaneous insulin infusion (CSII) is on the rise among pediatric patients with type 1 diabetes mellitus. Metabolic effects alone cannot explain this rising popularity. From the patient's perspective, the main benefits of CSII may be found in subjective psychosocial health outcomes (patient-reported outcomes [PRO]). Subjects and methods In a multicenter open randomized controlled trial, children and adolescents aged 6 to16 years currently treated with multiple daily injections (MDI) were randomized 1:1, stratified by center, to either starting with CSII immediately after the baseline interview or to continuing MDI while waiting 6 months for transmission to CSII. The primary outcomes were patient-reported diabetes-specific health-related quality of life (DHRQOL) and diabetes burden of the main caregiver. Secondary outcomes were caregiver stress, fear of hypoglycemia, satisfaction with treatment, and HbA1c. Results Two-hundred and eleven patients were randomized between February 2011 and October 2014, and 186 caregivers and 170 patients were analyzed using the intention-to-treat principle for primary outcomes. Children 8 to 11 years in the CSII group reported improved DHRQOL at follow-up compared to MDI (median difference [MD] 9.5, 95% confidence interval [CI] 3.6-16.7, P = 0.004). There were no treatment differences in the adolescent age-group 12 to 16 years (MD 2.7; 95% CI -3.2-9.5; P = 0.353). The main caregivers of the CSII group reported a significant decline of overall diabetes burden at follow-up compared to the MDI group (MD 0; 95% CI -1-0; P = 0.029). Secondary PROs also were in favor of CSII. Conclusions CSII has substantial psychosocial benefits. PROs demonstrate these benefits. Registered as NCT01338922 at clinicaltrials.gov.

Objective To evaluate the association between socioeconomic status (SES) and diabetes outcomes in German children and adolescents. Methods A total of 1829 subjects

Background Low vitamin D serum concentrations have been associated with rickets and other disorders in observational studies. Since vitamin D serum concentrations in children and adolescents are frequently below reference values, it is debated whether vitamin D should be supplemented after infancy. Methods The effects of vitamin D supplementation in children > 2 years of age are analyzed based on a literature review of randomized controlled trials (RCTs). Results Vitamin D supplementation can potentially reduce the risk for influenza infections and improve asthma bronchiale exacerbation; however, it has no impact on asthma bronchiale severity. Vitamin D supplementation has no relevant effect on attention-deficit/hyperactivity disorders, cardiac failure, hypertension, or incidence of type II diabetes mellitus. Vitamin D supplementation has no effect on the rate of multiple sclerosis relapses, but on the number of new lesions detected by MRI. For other endpoints, RCTs are lacking. Conclusion Based on currently available studies, routine vitamin D supplementation is not be recommended for children aged > 2 years, even when they have serum concentrations below reference values. Routine vitamin D supplementation is not recommended in children who do not have risk factors and chronic diseases which are associated with calcium or vitamin D resorption disorders.

Die kontinuierliche Glukosemessung (CGM) wird auch im Kindes-und Jugendalter immer haufiger eingesetzt. Der vor Kurzem veroffentlichte Beschluss des G‑BA wird den Zugang zu dieser Technologie als Kassenleistung weiter offnen. Voraussetzungen fur die erfolgreiche Langzeitnutzung von CGM sind realistische Erwartungen der Kinder und Jugendlichen mit Typ-1-Diabetes sowie ihrer Eltern, alltagsorientierte Schulung und die strukturierte Reflexion der taglichen Erfahrungen mit dem System. Mit SPECTRUM steht das erste herstellerunabhangige und produktneutrale CGM-Schulungs- und Behandlungsprogramm fur Eltern mit jungen Kindern, fur Jugendliche und fur Erwachsene mit Diabetes zur Verfugung. Seine Implementierung in der padiatrischen Diabetologie wird bundesweit durch Train-the-Trainer-Seminare fur interessierte Teammitglieder durch die Arbeitsgemeinschaft fur Padiatrische Diabetologie (AGPD e. V.) unterstutzt. In Planung sind die Evaluierung und Zertifizierung des Schulungsprogramms.

Little is known about the rates of acute complications when switching from MDI or traditional insulin pumps to tubeless insulin pump therapy. The German/Austrian Diabetes patients follow-up-registry (DPV) includes 2691 patients with type 1 (n=2640), type 2 (n=17) and LADA/other (n=34) diabetes types treated for 1.3±1.3 years with a tubeless insulin pump (Omnipod® Insulin Management System, Insulet Corp, Billerica, MA) since 2013. Patients with type 1 diabetes had a mean age of 12.3 year [IQR 9.6-15.0], diabetes duration 2.5 year [0.7-5.9], HbA1c 7.7% [6.8-8.3]. The prior treatment modality was 59.3% MDI, 37.5% other pump and 2.4% tubeless pump as initial therapy (0.3% unknown). Discontinuation of tubeless pump treatment in patients with type 1 diabetes was 7.3% and occurred after 0.7±0.9 mo. Despite the typical age-dependent increase in HbA1c in this primarily adolescent population, the rate of severe hypoglycemia (Level 3), hypoglycemic coma and DKA decreased between 29% to 76% with Omnipod System use compared to the year prior to treatment switch in the total cohort and type 1 patients with 3 year follow-up (n=835) (Table). In conclusion, analysis of the DPV registry shows that use of the Omnipod System has high treatment retention rates in type 1 diabetes and is associated with low rates of severe hypoglycemia and DKA in this age-group prone to acute complications.Three Year Outcomes with Omnipod System UseVariable (mean)Total CohortPatients with 3 yr Follow-upPost-OmnipodPost-OmnipodPre-Omnipod (prior year)1 yr (n=2167)2 yr (n=1351)3 yr (n=848)Pre-Omnipod (prior year)1 yr (n=835)2 yr (n=835)3 yr (n=835)Age, yr13.914.714.414.611.512.413.514.4BMI-SDS0.440.540.560.600.430.500.550.61Insulin dose, U/kg/d0.820.760.790.820.790.770.790.83HbA1c, %7.697.597.857.947.557.497.817.97Severe hypoglycemia (Level 3) patients affected per year, %5.25.54.33.75.77.24.73.6Severe hypoglycemia (coma) patients affected per year, %1.51.41.00.51.71.81.40.4DKA patients affected per year, %5.83.33.02.16.63.63.02.2 Disclosure T. Biester: Speaker's Bureau; Self; Medtronic, Ypsomed AG. T. Danne: Speaker's Bureau; Self; A. Menarini Diagnostics. Advisory Panel; Self; Abbott, AstraZeneca, Bayer AG, Boehringer Ingelheim GmbH. Speaker's Bureau; Self; Dexcom, Inc.. Research Support; Self; Eli Lilly and Company. Stock/Shareholder; Self; DreaMed Diabetes, Ltd.. Research Support; Self; Insulet Corporation. Speaker's Bureau; Self; Menarini Group. E. Bollow: None. A. Schwandt: None. B. Heidtmann: None. B. Rami-Merhar: Speaker's Bureau; Self; A. Menarini Diagnostics, Eli Lilly and Company, Medtronic MiniMed, Inc., Roche Diabetes Care Health and Digital Solutions. T. Haak: Speaker's Bureau; Self; Abbott. Advisory Panel; Self; Roche Diabetes Care Health and Digital Solutions, Sanofi, Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company, AstraZeneca. R.W. Holl: None.

OBJECTIVE To examine glycemic control in youth with type 1 diabetes (T1D) who switched from multiple daily injections (MDI) to a tubeless insulin pump (Omnipod Insulin Management System, Insulet Corporation, Billerica, Massachusetts) compared to patients who continued MDI therapy over a 3-year time period. RESEARCH DESIGN AND METHODS This retrospective analysis of the German/Austrian Diabetes Patienten Verlaufsdokumentation registry included data from 263 centers and 2529 patients

In den letzten 15 Jahren kam es in der Behandlung von Kindern und Jugendlichen mit Typ-1-Diabetes zu einer deutlichen Intensivierung der Insulintherapie. Vor allem der Einsatz der Insulinpumpen nahm stark zu. Die Mehrzahl der Kleinkinder unter 6 Jahren wird entweder sofort oder kurz nach der Manifestation des Diabetes mit CSII („continuous subcutaneous insulin infusion“) behandelt. Unter ihr kommt es – im Vergleich zur ICT („intensive conventional therapy“) – zu einer signifikanten Reduktion von Hypoglykamien, niedrigeren HbA1c-Werten (HbA1c: Glykohamoglobin) und einer Verbesserung der Lebensqualitat. Auch die kontinuierliche Glukosemessung wird im Kindes- und Jugendalter immer haufiger angewendet, entweder uber einige Tage zur Therapieoptimierung oder auch dauerhaft als sog. sensorunterstutzte Pumpen- oder Insulintherapie. Wird sie regelmasig und konsequent durchgefuhrt, kann die Stoffwechseleinstellung ohne vermehrtes Risiko fur Hypoglykamien weiter optimiert werden.

Bachran R, Beyer P, Klinkert C, Heidtmann B, Rosenbauer J, Holl RW; for the German/Austrian DPV Initiative, the German Pediatric CSII Working Group and the BMBF Competence Network Diabetes. Basal rates and circadian profiles in continuous subcutaneous insulin infusion (CSII) differ for preschool children, prepubertal children, adolescents and young adults. Objective: Initiation of continuous subcutaneous insulin therapy (CSII) requires an appropriate basal rate profile. Different approaches exist; however, there is a lack of evidence-based recommendations, especially in young children. Study design: In this large multicenter survey, 5941 CSII patients from the German/Austrian prospective documentation system (DPV) were analyzed. Patients were divided into four age groups

The aim of this study was to correlate the frequency of self-monitoring of blood glucose (SMBG) to the quality of metabolic control as measured by hemoglobin A1c (HbA1c), the frequency of hypoglycemia and ketoacidosis, and to see whether the associations between SMBG and these outcomes are influenced by the patient's age or treatment regime. We analyzed data from the DPV-Wiss-database of 26 723 children and adolescents aged 0-18 yr with type 1 diabetes recorded during 1995-2006. Variables evaluated were gender, age at visit, diabetes duration, therapy regime, insulin dose, body mass index-standard deviation scores (BMI-SDS), HbA1c, rate of hypoglycemia, and ketoacidosis. In the youngest age group of children under the age of 6 yr, the frequency of SMBG was the highest compared with that in children aged 6-12 yr or children aged12 yr: 6.0/d vs. 5.3/d vs. 4.4/d (p0.001). Frequency of SMBG differed significantly also in the different groups of treatment (p0.001), but only for the continuous subcutaneous insulin infusion (CSII) group the frequency was considerably higher: 5.3/d (CSII) vs. 4.7/d (multiple daily injections) vs. 4.6/d (conventional therapy). Adjusted for age, gender, diabetes duration, year of treatment, insulin regimen, insulin dose, BMI-SDS, and center difference, SMBG frequency was significantly associated with better metabolic control with a drop of HbA1c of 0.20% for one additional SMBG per day (p0.001). Increasing the SMBG frequency above 5/d did not result in further improvement of metabolic control. A higher frequency of SMBG measurements was related to better metabolic control. But only among adolescents aged12 yr, metabolic control (HbA1c) improved distinctively with two or more blood glucose measurements.

Aims To conduct a multicentre, matched-pair cohort analysis comparing glycaemic control and adverse events of continuous subcutaneous insulin infusion (CSII) with multiple daily injections (MDI) in paediatric patients. Methods Using standardized computer-based prospective documentation, HbA1c, insulin dose, body mass index–standard deviation score (BMI–SDS), rate of hypoglycaemia, rate of diabetic ketoacidosis (DKA) and intensity of care were analysed in 434 matched pairs during a follow-up period of 3 years after initiation of MDI or CSII. Results HbA1c was significantly lower in the CSII group during the first year of new regimen (CSII 7.5 ± 0.05 vs. MDI 7.7 ± 0.06; P

Objective: This study intends to analyse the basal insulin dosage for pediatric patients (0-18 years) with type 1 diabetes on insulin-pump therapy (CSII). Research design and methods: In a large German and Austrian prospectively documented data base (DPV) for children with diabetes, patients with CSII were identified. The documented basal rates from patients (0-18 years) were analysed and related to age, gender, duration of diabetes, body weight and type of insulin used in the pump. Data were evaluated for three age groups (0-6; >6-12; >12-18 years). Results: Complete data sets with documented hourly intervals of basal rate were available from 743 patients. Basal insulin dosage in the 3 age groups differed significantly (0-6 years 0.20IU/ kg body weight; >6-12 years 0.34IU/kg body weight; >12-18 years 0.41 IU/kg body weight p

Die CSII hat sich als intensivierte Insulintherapie in der Betreuung padiatrischer Patienten mit Diabetes mellitus in Deutschland fest etabliert. Die Option der Bolusabgabe zu den Mahlzeiten ohne schmerzhafte Injektion und die individuell programmierbare Basalrate erlauben eine nahezu physiologische Insulinsubstitution. Dies ermoglicht eine normnahe Blutzuckereinstellung ohne erhohtes Risiko fur Stoffwechselentgleisungen. Kleinkinder fuhren die CSII im Vergleich zu den anderen Altersgruppen prozentual am haufigsten durch. Aufgrund ihres geringen Insulinbedarfs bzw. der hohen Insulinempfindlichkeit profitieren sie ganz besonders von den Moglichkeiten der Insulinpumpentherapie, was sich u. a. in einer Reduktion der schweren Hypoglykamien zeigt. Eine klare Indikationsstellung, Akzeptanz der Insulinpumpe und entsprechende Schulung sind Voraussetzungen fur eine Umstellung auf die CSII.

Die Insulinpumpentherapie hat in den letzten Jahren zunehmendes Interesse in der padiatrischen Diabetologie gefunden. Ausgewertet wurden Daten von insgesamt 1346 Patienten unter 20 Jahren mit einer CSII von 104 Institutionen aus Deutschland und Wien. Das Durchschnittsalter lag bei 14,7±3,8, die durchschnittliche Diabetesdauer bei 7,0±3,9 Jahren; die CSII wurde im Mittel fur 1,0 Jahre durchgefuhrt. In der Gesamtgruppe betrug das durchschnittliche HbA1c 9,09±2,8%, die Rate schwerer Hypoglykamien lag bei 13,3/100 Patientenjahre. Die Korpergrose der Pumpenpatienten unterschied sich minimal von der Referenzgruppe, Gewicht und BMI waren signifikant erhoht gegenuber Kindern ohne Diabetes. Die Zahl der CSII-Patienten nimmt in Deutschland in allen Altersgruppen stetig zu. In der CSII-Gesamtgruppe ist die Rate schwerer Hypoglykamien gesenkt, die metabolische Kontrolle (HbA1c) jedoch noch nicht zufrieden stellend. Prospektive Interventionsstudien waren fur weitere Aussagen sinnvoll und wunschenswert.

Insulin pump therapy may improve metabolic control in young patients with type 1 diabetes, but the association with short-term diabetes complications is unclear.To determine whether rates of severe hypoglycemia and diabetic ketoacidosis are lower with insulin pump therapy compared with insulin injection therapy in children, adolescents, and young adults with type 1 diabetes.Population-based cohort study conducted between January 2011 and December 2015 in 446 diabetes centers participating in the Diabetes Prospective Follow-up Initiative in Germany, Austria, and Luxembourg. Patients with type 1 diabetes younger than 20 years and diabetes duration of more than 1 year were identified. Propensity score matching and inverse probability of treatment weighting analyses with age, sex, diabetes duration, migration background (defined as place of birth outside of Germany or Austria), body mass index, and glycated hemoglobin as covariates were used to account for relevant confounders.Type 1 diabetes treated with insulin pump therapy or with multiple (≥4) daily insulin injections.Primary outcomes were rates of severe hypoglycemia and diabetic ketoacidosis during the most recent treatment year. Secondary outcomes included glycated hemoglobin levels, insulin dose, and body mass index.Of 30 579 patients (mean age, 14.1 years [SD, 4.0]; 53% male), 14 119 used pump therapy (median duration, 3.7 years) and 16 460 used insulin injections (median duration, 3.6 years). Patients using pump therapy (n = 9814) were matched with 9814 patients using injection therapy. Pump therapy, compared with injection therapy, was associated with lower rates of severe hypoglycemia (9.55 vs 13.97 per 100 patient-years; difference, -4.42 [95% CI, -6.15 to -2.69]; P .001) and diabetic ketoacidosis (3.64 vs 4.26 per 100 patient-years; difference, -0.63 [95% CI, -1.24 to -0.02]; P = .04). Glycated hemoglobin levels were lower with pump therapy than with injection therapy (8.04% vs 8.22%; difference, -0.18 [95% CI, -0.22 to -0.13], P .001). Total daily insulin doses were lower for pump therapy compared with injection therapy (0.84 U/kg vs 0.98 U/kg; difference, -0.14 [-0.15 to -0.13], P .001). There was no significant difference in body mass index between both treatment regimens. Similar results were obtained after propensity score inverse probability of treatment weighting analyses in the entire cohort.Among young patients with type 1 diabetes, insulin pump therapy, compared with insulin injection therapy, was associated with lower risks of severe hypoglycemia and diabetic ketoacidosis and with better glycemic control during the most recent year of therapy. These findings provide evidence for improved clinical outcomes associated with insulin pump therapy compared with injection therapy in children, adolescents, and young adults with type 1 diabetes.

The following recommendations are directed to all professional and vocational groups which take care of and support children and adolescents with diabetes, as well as their families. It is also directed to higher level organisations, such as health insurers, which deal with diabetes. This guideline concentrates on the specifics for this age group which are not described in the DDG’s general guidelines for the therapy of type 1 diabetes, or are described there, but somewhat differently [1]. As stated in the specifications of the health ministries of Germany’s states and in keeping with the current practice of many clinics, this paediatric guideline applies to all diabetes patients who are not yet 18 years of age. In individual clinical cases this guideline can also be used for young adults.

The study aimed to compare participant characteristics, treatment modalities and clinical outcomes in registry participants less than 6 years old. Participant characteristics, treatment modalities and clinical outcomes (HbA1c, severe hypoglycaemia [SH] and diabetic ketoacidosis [DKA]) as well as frequencies of attaining HbA1c goals in line with the International Society for Pediatric and Adolescent Diabetes (

OBJECTIVE We aimed at developing and cross-validating a mathematical prediction model for an optimal basal insulin infusion pattern for children with type 1 diabetes on continuous subcutaneous insulin infusion therapy (CSII). RESEARCH DESIGN AND METHODS We used the German/Austrian DPV-Wiss database for quality control and scientific surveys in pediatric diabetology and retrieved all CSII patients RESULTS Of the 6,063 children, 5,903 clustered in one of four major circadian BR patterns, confirming our previous study. The oldest age-group (mean age 12.8 years) was represented by 2,490 patients (42.18%) with a biphasic dawn-dusk pattern (BC). A broad single insulin maximum at 9–10 p.m. (F) was unveiled by 853 patients (14.45%) (mean age 6.3 years). Logistic regression analysis revealed that age, to a lesser extent duration of diabetes, and partly sex predicted BR patterns. Cross-validation revealed almost identical probabilities for BR patterns BC and F in the two datasets but some variation in the remaining two BR patterns. CONCLUSIONS Reconfirmation of four key BR patterns in two very large independent cohorts supports that these patterns are realistic approximations of the circadian distribution of insulin needs in children with type 1 diabetes. Prediction of an optimal pattern a priori can improve initiation and clinical follow-up of CSII in children and adolescents. In addition, these BR patterns represent valuable information for insulin-infusion algorithms in closed-loop CSII.

Aim: This study investigated insulin pump therapy in pediatric patients with type 1 diabetes and Turkish origin compared with those without migration background in Germany. Subjects and Methods: Using a nationwide documentation program, we estimated the prevalence of insulin pump therapy in patients

The 65-kD isoform of glutamic acid decarboxylase (GAD65) is a major autoantigen in type 1 diabetes. We hypothesized that alum-formulated GAD65 (GAD-alum) can preserve beta-cell function in patients with recent-onset type 1 diabetes.We studied 334 patients, 10 to 20 years of age, with type 1 diabetes, fasting C-peptide levels of more than 0.3 ng per milliliter (0.1 nmol per liter), and detectable serum GAD65 autoantibodies. Within 3 months after diagnosis, patients were randomly assigned to receive one of three study treatments: four doses of GAD-alum, two doses of GAD-alum followed by two doses of placebo, or four doses of placebo. The primary outcome was the change in the stimulated serum C-peptide level (after a mixed-meal tolerance test) between the baseline visit and the 15-month visit. Secondary outcomes included the glycated hemoglobin level, mean daily insulin dose, rate of hypoglycemia, and fasting and maximum stimulated C-peptide levels.The stimulated C-peptide level declined to a similar degree in all study groups, and the primary outcome at 15 months did not differ significantly between the combined active-drug groups and the placebo group (P=0.10). The use of GAD-alum as compared with placebo did not affect the insulin dose, glycated hemoglobin level, or hypoglycemia rate. Adverse events were infrequent and mild in the three groups, with no significant differences.Treatment with GAD-alum did not significantly reduce the loss of stimulated C peptide or improve clinical outcomes over a 15-month period. (Funded by Diamyd Medical and the Swedish Child Diabetes Foundation; ClinicalTrials.gov number, NCT00723411.).

Ludwig-Seibold CU, Holder M, Rami B, Raile K, Heidtmann B, Holl RW; for the DPV Science Initiative, the German Working Group for insulin pump treatment in pediatric patients and the German BMBF Competence Network Diabetes. Continuous glucose monitoring in children, adolescents, and adults with type 1 diabetes mellitus: analysis from the prospective DPV diabetes documentation and quality management system from Germany and Austria. Objective: To determine frequency, duration, and relationship of continuous glucose monitoring (CGM) to glycemic control and rate of hypoglycemia in children and adults in Germany and Austria. Research design and methods: From 59 920 patients documented in the DPV (Diabetessoftware zur prospektiven Verlaufsdokumentation) database, 144 385 sensor days of 2874 patients using CGM between January 2008 and September 2010 were analyzed. Results: Overall, 4.8% of patients used CGM. In pediatric patients, study period (p = 0.0309), age (p = 0.0140), insulin dose (p 30 d) had significantly lower HbA1c (p < 0.0016). Severe hypoglycemia was not reduced in patients using CGM for

Hofer SE, Heidtmann B, Raile K, Frohlich-Reiterer E, Lilienthal E, Berghaeuser MA, Holl RW for the DPV-Science-Initiative and the German working group for insulin pump treatment in pediatric patients. Discontinuation of insulin pump treatment in children, adolescents, and young adults. A multicenter analysis based on the DPV database in Germany and Austria. Background: Insulin pump therapy is well established in the treatment of children and adolescents with type 1 diabetes. Most studies focus on outcome parameters like hemoglobin A1c (HbA1c), hypoglycemia, and quality of life, whereas few reports address patients who discontinue pump therapy. Objective: This survey focuses on the discontinuation rate of insulin pump treatment in the pediatric and young adult age group. Subjects and methods: The prospective multicenter Diabetes Patienten Verlausdokumentation (DPV) (electronic diabetes patient documentation system) database has been established since 1990 and is broadly used in Germany and Austria. All pump users among the participating centers documented since 1995 were included in this analysis. Results: In total, 11 710 patients with type 1 diabetes were recorded as treated with insulin pumps. In total, 463 patients (4%) switched from insulin pump treatment to multiple daily injections (MDI). In the group of patients who stopped with pump treatment, the mean duration of pump therapy was 1.7 yr (SE ± 0.06 yr), 60.5% of patients were female. Subdivided into age groups, the discontinuation rate was lowest in the age group < 5 yr (0.1%), followed by the groups aged 5–10 yr (0.3%) and 15–20 yr (0.8%). The group aged 10–15 yr showed the highest rate of discontinuation (2%). Conclusions: The discontinuation rate of insulin pump therapy is, in general, low (4%). The younger the patients at the time of initiating insulin pump treatment, the lower is the discontinuation rate. The highest rate was seen in adolescents aged 10–15 yr. Girls stopped insulin pump treatment more often than boys (60.5% vs. 39.5%).