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.
The Childhood Diabetes Registry of Saxony has been existing since 1999. The aim of this study was to investigate the incidence rates, cohort and point prevalence, and the trends of type 1 diabetes ...among children and adolescents based on the registry data over the past 21 years.
A completeness check of the Childhood Diabetes Registry of Saxony for the observation period 2012-2019 was performed using the capture-recapture method. The age-standardized incidence rates per 100,000 person years (PY) were estimated for the observation period 1999-2019. Prevalence was estimated per 100,000 children and adolescents as the point prevalence of five consecutive years, and as a cohort prevalence for the birth cohorts, which result from the difference of age and year at diagnosis. Trend analyses were executed using join point regression.
A completeness of 98% (95% CI 89-100) was determined for the period from 2012 to 2019. The standardized incidence rate of type 1 diabetes among children and adolescents increased from 17.1 per 100,000 PY in 1999 to 24.7 per 100,000 PY in 2019. If this trend continues, the incidence rate will increase to 34.8 (95% CI 24.4-49.6) per 100,000 PY in 2030. The point prevalence of 5 consecutive years did not show a continuous trend over time. According to this method, the prevalence reached a plateau in the last segment (2013-2019). The calculation of cohort prevalence indicated a continuous increase from 2013 to 2019 with no significant statistical difference in terms of sex.
The point prevalence and the last incidence rates indicate that type 1 diabetes of children and adolescents is slowing down or has reached a plateau in Saxony. Nevertheless, the cohort prevalence predicts a steady increase. Future studies should continue investigating these trends in a longer observation period and consider including possible correlating environmental factors.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
We aimed to assess the feasibility and safety of hybrid closed-loop insulin delivery in children with type 1 diabetes aged 1-7 years as well as evaluate the role of diluted insulin on glucose ...control.
In an open-label, multicenter, multinational, randomized crossover study, 24 children with type 1 diabetes on insulin pump therapy (median age 5 years interquartile range 3-6 and mean ± SD HbA
7.4 ± 0.7% 57 ± 8 mmol/mol and total insulin 13.2 ± 4.8 units/day) underwent two 21-day periods of unrestricted living and we compared hybrid closed-loop with diluted insulin (U20) and hybrid closed-loop with standard strength insulin (U100) in random order. During both interventions, the Cambridge model predictive control algorithm was used.
The proportion of time that sensor glucose was in the target range between 3.9 and 10 mmol/L (primary end point) was not different between interventions (mean ± SD 72 ± 8% vs. 70 ± 7% for closed-loop with diluted insulin vs. closed-loop with standard insulin, respectively;
= 0.16). There was no difference in mean glucose levels (8.0 ± 0.8 vs. 8.2 ± 0.6 mmol/L;
= 0.14), glucose variability (SD of sensor glucose 3.1 ± 0.5 vs. 3.2 ± 0.4 mmol/L;
= 0.16), or the proportion of time spent with sensor glucose <3.9 mmol/L (4.5 ± 1.7% vs. 4.7 ± 1.4%;
= 0.47) or <2.8 mmol/L (0.6 ± 0.5% vs. 0.6 ± 0.4%;
> 0.99). Total daily insulin delivery did not differ (17.3 ± 5.6 vs. 18.9 ± 6.9 units/day;
= 0.07). No closed-loop-related severe hypoglycemia or ketoacidosis occurred.
Unrestricted home use of day-and-night closed-loop in very young children with type 1 diabetes is feasible and safe. The use of diluted insulin during closed-loop does not provide additional benefits compared with standard strength insulin.
Aims/hypothesis
While the use of insulin pumps in paediatrics has expanded dramatically, there is still considerable variability among countries in the use of pump technology. The present study ...sought to describe differences in metabolic control and pump use in young people with type 1 diabetes using data collected in three multicentre registries.
Methods
Data for the years 2011 and 2012 from 54,410 children and adolescents were collected from the Prospective Diabetes Follow-up Registry (DPV;
n
= 26,198), T1D Exchange (T1DX;
n
= 13,755) and the National Paediatric Diabetes Audit (NPDA;
n
= 14,457). The modality of insulin delivery, based on age, sex and ethnic minority status, and the impact of pump use on HbA
1c
levels were compared.
Results
The overall mean HbA
1c
level was higher in the NPDA (8.9 ± 1.6% 74 ± 17.5 mmol/mol) than in the DPV (8.0 ± 1.6% 64 ± 17.0 mmol/mol,
p <
0.001) and T1DX (8.3 ± 1.4% 68 ± 15.4 mmol/mol,
p <
0.001). Conversely, pump use was much lower in the NPDA (14%) than in the DPV (41%,
p <
0.001) and T1DX (47%,
p <
0.001). In a pooled analysis, pump use was associated with a lower mean HbA
1c
(pump: 8.0 ± 1.2% 64 ± 13.3 mmol/mol vs injection: 8.5 ± 1.7% 69 ± 18.7 mmol/mol,
p <
0.001). In all three registries, those with an ethnic minority status were less likely to be treated with a pump (
p <
0.001) and boys were treated with a pump less often compared with girls (
p <
0.001).
Conclusions/interpretation
Despite similar clinical characteristics and proportion of minority participants, substantial differences in metabolic control exist across the three large transatlantic registries of paediatric patients with type 1 diabetes, which appears to be due in part to the frequency of insulin pump therapy.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Diabetic ketoacidosis (DKA) in children and adolescents with established type 1 diabetes is a major problem with considerable morbidity, mortality, and associated costs to patients, families, and ...health care systems. We analyzed data from three multinational type 1 diabetes registries/audits with similarly advanced, yet differing, health care systems with an aim to identify factors associated with DKA admissions.
Data from 49,859 individuals <18 years with type 1 diabetes duration ≥1 year from the Prospective Diabetes Follow-up Registry (DPV) initiative (n = 22,397, Austria and Germany), the National Paediatric Diabetes Audit (NPDA; n = 16,314, England and Wales), and the T1D Exchange (T1DX; n = 11,148, U.S.) were included. DKA was defined as ≥1 hospitalization for hyperglycemia with a pH <7.3 during the prior year. Data were analyzed using multivariable logistic regression models.
The frequency of DKA was 5.0% in DPV, 6.4% in NPDA, and 7.1% in T1DX, with differences persisting after demographic adjustment (P < 0.0001). In multivariable analyses, higher odds of DKA were found in females (odds ratio OR 1.23, 99% CI 1.10-1.37), ethnic minorities (OR 1.27, 99% CI 1.11-1.44), and HbA1c ≥7.5% (≥58 mmol/mol) (OR 2.54, 99% CI 2.09-3.09 for HbA1c from 7.5 to <9% 58 to <75 mmol/mol and OR 8.74, 99% CI 7.18-10.63 for HbA1c ≥9.0% ≥75 mmol/mol).
These multinational data demonstrate high rates of DKA in childhood type 1 diabetes across three registries/audits and five nations. Females, ethnic minorities, and HbA1c above target were all associated with an increased risk of DKA. Targeted DKA prevention programs could result in substantial health care cost reduction and reduced patient morbidity and mortality.
To estimate the national incidence rate and trend of type 1 diabetes (T1DM) in Germany from 1999 to 2008 and the national prevalence in 2008 in the age group 0-14 years.
Data were taken from a ...nationwide registry for incident cases of T1DM in the ages 0-4 years and 3 regional registries (North-Rhine-Westphalia, Baden-Wuerttemberg and Saxony) for incident cases of T1DM in the ages 0-14 years covering 41% of the child population in Germany. The degree of ascertainment was ≥ 97% in all registries. Incident and prevalent cases were grouped by region, sex, age (0-4, 5-9, 10-14 years), and, for incident data, additionally by two 5-year periods (1999-2003, 2004-2008). Poisson regression models were fitted to the data to derive national estimates of incidence rate trends and prevalence in the age groups 5-9, 10-14 and 0-14 years. We used direct age-standardization.
The estimated national incidence rate in 0-14-year-olds increased significantly by 18.1% (95%CI: 11.6-25.0%, p<0.001) from 1999-2003 to 2004-2008, independent of sex, corresponding to an average annual increase of 3.4% (95%-CI: 2.2-4.6%). The overall incidence rate was estimated at 22.9 per 100,000 person-years and we identified a within-country west-east-gradient previously unknown. The national prevalence in the ages 0-14 years on 31/12/2008 was estimated to be 148.1 per 100,000 persons.
The national incidence rate of childhood T1DM in Germany is higher than in many other countries around the world. Importantly, the estimated trend of the incidence rate confirms the international data of a global increase of T1DM incidences.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
The aim of this study was to analyze the incidence rates of type 1 diabetes in Saxony before and after the German reunification.
The study examined two registries: one until 1990 and one since 1999. ...Only patients under 15 years of age with type 1 diabetes and living in Saxony were included in the study. Standardized incidence rates were described based on direct age standardization procedures using the Standard European Population for each calendar year between the observation periods 1982-1989 and 1999-2014. Age was grouped into three classes: 0-4, 5-9 and 10-14 years of age. Incidence data were presented as age-standardized incidence rates per 100,000 person-years (PY) with 95% confidence intervals CI. Joinpoint regression was used for trend analyses and Poisson regression was used to adjust for the effects of age and sex on the incidence.
A total number of 2,092 incident cases of type 1 diabetes (1,109 males; 983 females) were included. The age-standardized incidence rates of type 1 diabetes per 100,000 PY was 7.9 95%CI 6.8; 8.9 in the period from 1982-1989 and 20.1 95%CI 14.0; 26.1 in the period from 1999-2014. The yearly increase in incidence over the entire time period (1982-2014) was 4.3% according to the average annual percent change (AAPC) method, and estimated to be 4.4% 95% CI 4.0; 4.8% using a Poisson regression model adjusting for sex and age group.
In this study, a significantly increasing incidence of type 1 diabetes was observed after reunification. In future studies it would be interesting to follow up on the question of which environmental and lifestyle factors could be causing the increasing type 1 diabetes incidence.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Aims/hypothesis
The study aimed to compare participant characteristics, treatment modalities and clinical outcomes in registry participants less than 6 years old.
Methods
Participant characteristics, ...treatment modalities and clinical outcomes (HbA
1c
, severe hypoglycaemia SH and diabetic ketoacidosis DKA) as well as frequencies of attaining HbA
1c
goals in line with the International Society for Pediatric and Adolescent Diabetes (<7.5% <58 mmol/mol) and ADA (<8.5% <69 mmol/mol) were compared.
Results
Insulin pump use was more frequent (74% vs 50%,
p
< 0.001) and HbA
1c
levels lower in the Prospective Diabetes Follow-up Registry (DPV) than in the T1D Exchange (T1DX) (mean 7.4% vs 8.2%,
p
< 0.001). A lower HbA
1c
level was seen in the DPV compared with the T1DX for both pump users (
p
< 0.001) and injection users (
p
< 0.001). More children from DPV were meeting the recommended HbA
1c
goals, compared with children from T1DX (HbA
1c
<7.5%: 56% vs 22%,
p
< 0.001; HbA
1c
<8.5%: 90% vs 66%,
p
< 0.001). The adjusted odds of having an HbA
1c
level <7.5% or <8.5% were 4.2 (
p
< 0.001) and 3.6 (
p
< 0.001) higher for the DPV than the T1DX, respectively. The frequency of SH did not differ between registries or by HbA
1c
, whereas the frequency of DKA was higher for the T1DX and greater in those with higher HbA
1c
levels.
Conclusions/interpretation
DPV data indicate that an HbA
1c
of <7.5% can frequently be achieved in children with type 1 diabetes who are under 6 years old. An improved metabolic control of type 1 diabetes in young patients appears to decrease the risk of DKA without increasing SH. The greater frequency of suboptimal control in young patients in the T1DX compared with the DPV is not fully explained by a less frequent use of insulin pumps and may relate to the higher HbA
1c
targets that are recommended for this age group in the USA.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ