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See detailThe use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial
Battelino, T.; Conget, I.; Olsen, B. et al

in Diabetologia (2012), 55(12), 3155-3162

Aims/hypothesis The aim of this multicentre, randomised, controlled crossover study was to determine the efficacy of adding continuous glucose monitoring (CGM) to insulin pump therapy (CSII) in type 1 ... [more ▼]

Aims/hypothesis The aim of this multicentre, randomised, controlled crossover study was to determine the efficacy of adding continuous glucose monitoring (CGM) to insulin pump therapy (CSII) in type 1 diabetes. Methods Children and adults (n = 153) on CSII with HbA1c 7.5–9.5% (58.5–80.3 mmol/mol) were randomised to (CGM) a Sensor On or Sensor Off arm for 6 months. After 4 months’ washout, participants crossed over to the other arm for 6 months. Paediatric and adult participants were separately electronically randomised through the case report form according to a predefined randomisation sequence in eight secondary and tertiary centres. The primary outcome was the difference in HbA1c levels between arms after 6 months. Results Seventy-seven participants were randomised to the On/Off sequence and 76 to the Off/On sequence; all were included in the primary analysis. The mean difference in HbA1c was –0.43% (–4.74 mmol/mol) in favour of the Sensor On arm (8.04% [64.34 mmol/mol] vs 8.47% [69.08 mmol/mol]; 95% CI −0.32%, −0.55% [−3.50, −6.01 mmol/mol]; p < 0.001). Following cessation of glucose sensing, HbA1c reverted to baseline levels. Less time was spent with sensor glucose <3.9 mmol/l during the Sensor On arm than in the Sensor Off arm (19 vs 31 min/day; p = 0.009). The mean number of daily boluses increased in the Sensor On arm (6.8 ± 2.5 vs 5.8 ± 1.9, p < 0.0001), together with the frequency of use of the temporary basal rate (0.75 ± 1.11 vs 0.26 ± 0.47, p < 0.0001) and manual insulin suspend (0.91 ± 1.25 vs 0.70 ± 0.75, p < 0.018) functions. Four vs two events of severe hypoglycaemia occurred in the Sensor On and Sensor Off arm, respectively (p = 0.40). Conclusions/interpretation Continuous glucose monitoring was associated with decreased HbA1c levels and time spent in hypoglycaemia in individuals with type 1 diabetes using CSII. More frequent self-adjustments of insulin therapy may have contributed to these effects. [less ▲]

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See detailTrends in childhood type 1 diabetes incidence in Europe during 1989-2008: evidence of non-uniformity over time in rates of increase
Patterson, C.C.; Gyürüs, E.; Rosenbauer, J. et al

in Diabetologia (2012), 55(8), 2142-2147

Aims/hypothesis The aim of the study was to describe 20- year incidence trends for childhood type 1 diabetes in 23 EURODIAB centres and compare rates of increase in the first (1989–1998) and second ... [more ▼]

Aims/hypothesis The aim of the study was to describe 20- year incidence trends for childhood type 1 diabetes in 23 EURODIAB centres and compare rates of increase in the first (1989–1998) and second (1999–2008) halves of the period. Methods All registers operate in geographically defined regions and are based on a clinical diagnosis. Completeness of registration is assessed by capture–recapture methodology. Twenty-three centres in 19 countries registered 49,969 new cases of type 1 diabetes in individuals diagnosed before their 15th birthday during the period studied. Results Ascertainment exceeded 90% in most registers. During the 20-year period, all but one register showed statistically significant changes in incidence, with rates universally increasing. When estimated separately for the first and second halves of the period, the median rates of increase were similar: 3.4% per annum and 3.3% per annum, respectively. However, rates of increase differed significantly between the first half and the second half for nine of the 21 registers with adequate coverage of both periods; five registers showed significantly higher rates of increase in the first half, and four significantly higher rates in the second half. Conclusions/interpretation The incidence rate of childhood type 1 diabetes continues to rise across Europe by an average of approximately 3–4% per annum, but the increase is not necessarily uniform, showing periods of less rapid and more rapid increase in incidence in some registers. This pattern of change suggests that important risk exposures differ over time in different European countries. Further time trend analysis and comparison of the patterns in defined regions is warranted. [less ▲]

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See detailThe Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study: recruitment, intervention and follow-up.
Akerblom, H.K.; Krischer, J; Virtanen, SM et al

in Diabetologia (2011), 54(3), 627-633

AIMS/HYPOTHESIS: The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study was designed to establish whether weaning to a highly hydrolysed formula in infancy subsequently reduces the risk of type ... [more ▼]

AIMS/HYPOTHESIS: The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study was designed to establish whether weaning to a highly hydrolysed formula in infancy subsequently reduces the risk of type 1 diabetes. METHODS: The study population comprises newborn infants who have first-degree relatives with type 1 diabetes and meet the increased risk HLA inclusion, but not exclusion criteria. The study is being performed in 15 countries in three continents. First-degree relatives of patients with type 1 diabetes were identified from diabetes clinics, diabetes registries, and from other endocrinology or obstetrics offices and websites. HLA typing was performed at birth from cord or heel stick blood, and the results sent to the study's Data Management Unit within 2 weeks for communication of eligibility to the clinical study centre. All mothers recruited were encouraged to breastfeed. The intervention lasted for 6 to 8 months, and weaning formulas based on hydrolysed casein and standard cow's milk were compared. RESULTS: TRIGR recruited 5,606 infants, of whom 2,160 were enrolled as eligible participants, 6% more than the target of 2,032. Of those enrolled, 80% were exposed to the study formula. The overall retention rate over the first 5 years is 87%, with protocol compliance at 94%. The randomisation code will be opened when the last recruited child turns 10 years of age, i.e. in 2017. CONCLUSIONS/INTERPRETATION: The TRIGR experience demonstrates the feasibility and successful implementation of an international dietary intervention study. TRIGR is the first ever primary prevention trial for type 1 diabetes and, if completed successfully, will provide a definite answer to the research question. TRIAL REGISTRATION: ClinicalTrials.gov NCT00179777 FUNDING: The study was funded by the National Institute of Child Health and Development (NICHD) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH) (grant numbers HD040364, HD042444 and HD051997), Canadian Institutes of Health Research, the Juvenile Diabetes Research Foundation International and the Commission of the European Communities (specific RTD programme 'Quality of Life and Management of Living Resources', contract number QLK1-2002-00372 'Diabetes Prevention'. Other funding came from the EFSD/JDRF/Novo Nordisk Focused Research Grant, Academy of Finland, Dutch Diabetes Research Foundation and Finnish Diabetes Research Foundation). [less ▲]

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See detailCaesarean section is associated with an increased risk of childhood-onset type 1 diabetes mellitus: a meta-analysis of observational studies.
Cardwell, C. R.; Stene, L. C.; Joner, G. et al

in Diabetologia (2008), 51(5), 726-35

AIMS/HYPOTHESIS: The aim of this study was to investigate the evidence of an increased risk of childhood-onset type 1 diabetes in children born by Caesarean section by systematically reviewing the ... [more ▼]

AIMS/HYPOTHESIS: The aim of this study was to investigate the evidence of an increased risk of childhood-onset type 1 diabetes in children born by Caesarean section by systematically reviewing the published literature and performing a meta-analysis with adjustment for recognised confounders. METHODS: After MEDLINE, Web of Science and EMBASE searches, crude ORs and 95% CIs for type 1 diabetes in children born by Caesarean section were calculated from the data reported in each study. Authors were contacted to facilitate adjustments for potential confounders, either by supplying raw data or calculating adjusted estimates. Meta-analysis techniques were then used to derive combined ORs and to investigate heterogeneity between studies. RESULTS: Twenty studies were identified. Overall, there was a significant increase in the risk of type 1 diabetes in children born by Caesarean section (OR 1.23, 95% CI 1.15-1.32, p < 0.001). There was little evidence of heterogeneity between studies (p = 0.54). Seventeen authors provided raw data or adjusted estimates to facilitate adjustments for potential confounders. In these studies, there was evidence of an increase in diabetes risk with greater birthweight, shorter gestation and greater maternal age. The increased risk of type 1 diabetes after Caesarean section was little altered after adjustment for gestational age, birth weight, maternal age, birth order, breast-feeding and maternal diabetes (adjusted OR 1.19, 95% CI 1.04-1.36, p = 0.01). CONCLUSIONS/INTERPRETATION: This analysis demonstrates a 20% increase in the risk of childhood-onset type 1 diabetes after Caesarean section delivery that cannot be explained by known confounders. [less ▲]

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See detailImpact of IDDM2 on disease pathogenesis and progression in children with newly diagnosed type 1 diabetes: Reduced insulin antibody titres and preserved beta cell function
Nielsen, L. B.; Mortensen, H. B.; Chiarelli, F. et al

in Diabetologia (2006), 49(1), 71-74

Aims/hypothesis: The insulin-dependent diabetes mellitus 2 gene (IDDM2) is a type 1 diabetes susceptibility locus contributed to by the variable number of tandem repeats (VNTR) upstream of the insulin ... [more ▼]

Aims/hypothesis: The insulin-dependent diabetes mellitus 2 gene (IDDM2) is a type 1 diabetes susceptibility locus contributed to by the variable number of tandem repeats (VNTR) upstream of the insulin gene (INS). We investigated the association between INS VNTR class III alleles (-23HphIA/T) and both insulin antibody presentation and residual beta cell function during the first year after diagnosis in 257 children with type 1 diabetes. Materials and methods: To estimate C-peptide levels and autoantibody presentation, patients underwent a meal-stimulated C-peptide test 1, 6, and 12 months after diagnosis. The insulin -23HphIA/T variant was used as a marker of class III alleles and genotyped by PCR-RFLP. Results: The insulin antibody titres at 1 and 6 months were significantly lower in the class III/III and class I/III genotype groups than in the class I/I genotype group (p = 0.01). Class III alleles were also associated with residual beta cell function 12 months after diagnosis and independently of age, sex, BMI, insulin antibody titres, and HLA-risk genotype group (p = 0.03). The C-peptide level was twice as high among class III/III genotypes as in class I/I and class I/III genotypes (319 vs 131 and 166 pmol/l, p=0.01). Furthermore, the class III/III genotype had a 1.1% reduction in HbA1c after adjustment for insulin dose (p = 0.04). Conclusions/interpretation: These findings suggest a direct connection in vivo between INS VNTR class III alleles, a decreased humoral immune response to insulin, and preservation of beta cell function in recent-onset type 1 diabetes. © Springer-Verlag 2005. [less ▲]

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See detailSeasonality of birth in patients with childhood type 1 diabetes in nineteen European regions
McKinney, P.A.; De Beaufort, Carine UL

in Diabetologia (2001), 44(3), 67-74

AIMS/HYPOTHESIS: Differences in seasonality of birth patterns between the general population and the group who develop Type I (insulin-dependent) diabetes mellitus indicate that environmental factors ... [more ▼]

AIMS/HYPOTHESIS: Differences in seasonality of birth patterns between the general population and the group who develop Type I (insulin-dependent) diabetes mellitus indicate that environmental factors operating around the antenatal and perinatal period could be important. We investigated whether the same unsual patterns in seasonality of birth observed in children with Type I diabetes in Great Britain could also be found in other European populations. METHODS: Population-based incidence cohorts of children diagnosed with Type I diabetes under 15 years of age from 1989 onwards were analysed. Previously reported data sets from Great Britain were also included together with data on children diagnosed over an additional 5 year period (1988-1992). To assess the role of seasonality in diabetes, we used the method of Walter and Elwood to examine monthly birth figures for each country or region. RESULTS: Outside of Great Britain, no seasonality of birth was seen for any single or combination of European countries. Significant sinusoidal patterns were observed in Scotland, Yorkshire and Leicester, although the peak for Leicester appeared around autumn rather than spring. There was little evidence that sex or age at diagnosis played a part in differences in seasonal patterns, either overall or for any individual country. CONCLUSIONS/INTERPRETATION: We found no uniform seasonal pattern of birth in childhood diabetes patients across European populations, either overall or according to sex and age. This study provides no consistent evidence that environmental factors, which vary from season to season, have any influence on the fetal or neonatal life to determine the onset of Type I diabetes. However, a study of seasonality that takes into account possible changes both over time and over geographical areas could provide more insights. [less ▲]

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See detailCorrelations between the incidence of childhood onset type 1 diabetes in Europe and HLA genotypes
Ronningen, K.S.; Keiding, N.; Green, A. et al

in Diabetologia (2001), 44(3), 51-59

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See detailIs childhood onset type1 diabetes a wealth-related disease. An ecological analysis of European incidence rates
Patterson, C.C.; Dahlquist, G.; Soltesz, G. et al

in Diabetologia (2001), 44

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See detailTrends in the incidence of childhood onset diabetes in Europe. 1989-1998
Green, A.; Patterson, C.C.; De Beaufort, Carine UL

in Diabetologia (2001), 44(3), 3-8

AIMS/HYPOTHESIS: To study the epidemiology of childhood-onset (Type I) insulin-dependent diabetes mellitus in Europe, the EURODIAB collaborative group in 1988 established prospective, geographically ... [more ▼]

AIMS/HYPOTHESIS: To study the epidemiology of childhood-onset (Type I) insulin-dependent diabetes mellitus in Europe, the EURODIAB collaborative group in 1988 established prospective, geographically-defined registers of all children diagnosed with Type I diabetes under 15 years of age. This report is based on 24,423 children, registered by 36 centres, with complete participation during the period 1989-1998 and representing most European countries with a population coverage of approximately 20 million children. METHODS: Multiple sources of ascertainment were used to validate the level of ascertainment. Trends in Type I diabetes incidence during the period were analysed using Poisson regression with the results from the 36 centres pooled into nine regions. RESULTS: The standardised average annual incidence rate of Type I diabetes varied more than tenfold between centres. Overall, the annual increase in incidence was 3.2% (95%-CI: 2.7%, 3.7%), being highest for children in the 0-4-year age-group 4.8% (3.8%, 5.9%) and lowest for children in the 10-14-year age group 2.1 % (1.4%, 2.8%). However, the absolute increases in Type I diabetes were roughly similar in the three age-groups of 0-4, 5-9 and 10-14 years. Central Eastern Europe showed the highest increase whereas Sardinia and Northern Europe (except Finland) showed no evidence of an increase. For all age-groups relatively fewer cases had disease onset during the summer months, especially the 10-14-year age-group. CONCLUSION/INTERPRETATION: The extremely large range of incidence rates within Europe has been confirmed. The incidence rate is generally increasing but is more pronounced in some regions than in others. Seasonality at disease onset is apparent even in the youngest age-group. [less ▲]

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See detailGeographical variation of presentation at diagnosis of type 1 diabetes in children: the EURODIAB Study
Levy-Marchal, C.; Patterson, C.C.; Green, A. et al

in Diabetologia (2001), 44(3), 75-80

We aimed to describe the frequency and degree of diabetic ketoacidosis in children across Europe at the time of diagnosis of Type I (insulin-dependent) diabetes mellitus and to determine if factors such ... [more ▼]

We aimed to describe the frequency and degree of diabetic ketoacidosis in children across Europe at the time of diagnosis of Type I (insulin-dependent) diabetes mellitus and to determine if factors such as age and geographical region contribute to the risk of diabetic ketoacidosis. METHODS: The study was part of the EURODIAB project. A total of 24 centres, covering a population at risk of more than 15 million children below 15 years of age, recruited 1,260 children at the time of clinical diagnosis. RESULTS: Polyuria, by far the most frequent symptom, was observed in 96% of the children. In only 25% of the children was the duration of symptoms less than 2 weeks and this proportion was larger in the under 5 year age-group (37 vs 22%; p < 0. 001). Of the 11 centres that recorded diabetic ketoacidosis status, the overall proportion with diabetic ketoacidosis (pH < 7.3) was 40% (95%-CI: 36-44%) in at least 90 % of cases. After stratification by centre, the odds ratio for diabetic ketoacidosis in the under 5 age-group was 1.02 (95%-CI:0.69-1.49) relative to the older children. There was significant variation between the 11 centres in the frequency of diabetic ketoacidosis which ranged from 26 to 67% (p = 0.002). An inverse correlation between the frequency of diabetic ketoacidosis and the background incidence rate was found in these centres (Spearman's rank correlation, rs = -0.715;p = 0.012). CONCLUSION/INTERPRETATION: Rising standards of medical information and greater awareness concurrent with an overall increase in incidence could have resulted in changes in the clinical presentation at onset of Type I childhood diabetes in Europe. [less ▲]

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See detailThe Eurodiab Substudy 2 study group. Infections and vaccinations as risk factors for childhood type1(insulin dependent) diabetes mellitus: a multicentre case control investigation
De Beaufort, Carine UL

in Diabetologia (2000), 43

Aims/hypothesis. To determine if vaccinations and infections are associated with the subsequent risk of Type I (insulin-dependent) diabetes mellitus in childhood. Method. Seven centres in Europe with ... [more ▼]

Aims/hypothesis. To determine if vaccinations and infections are associated with the subsequent risk of Type I (insulin-dependent) diabetes mellitus in childhood. Method. Seven centres in Europe with access to population-based registers of children with Type I diabetes diagnosed under 15 years of age participated in a case-control study of environmental risk factors. Control children were chosen at random in each centre either from population registers or from schools and policlinics. Data on maternal and neonatal infections, common childhood infections and vaccinations were obtained for 900 cases and 2302 control children from hospital and clinic records and from parental responses to a questionnaire or interview. Results. Infections early in the child's life noted in the hospital record were found to be associated with an increased risk of diabetes, although the odds ratio of 1.61 (95% confidence limits 1.11, 2.33) was significant only after adjustment for confounding variables. None of the common childhood infectious diseases was found to be associated with diabetes and neither was there evidence that any common childhood vaccination modified the risk of diabetes. Pre-school day-care attendance, a proxy measure for total infectious disease exposure in early childhood, was found, however, to be inversely associated with diabetes, with a pooled odds ratio of 0.59 (95% confidence limits 0.46, 0.76) after adjustment for confounding variables. Conclusion/interpretation. It seems likely that the explanation for these contrasting findings of an increased risk associated with perinatal infections coupled with a protective effect of pre-school day care lies in the age-dependent modifying influence of infections on the developing immune system [less ▲]

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See detailThe EURODIAB Substudy 2 Study Group Vitamin D supplement in early childhood and risk for Type I (insulin-dependent) diabetes mellitus
De Beaufort, Carine UL

in Diabetologia (1999), 42(1), 51-55

The initiation of the immunopathogenetic process that can lead to Type I (insulin-dependent) diabetes mellitus in childhood probably occurs early in life. Studies in vitro have shown that vitamin D3 is ... [more ▼]

The initiation of the immunopathogenetic process that can lead to Type I (insulin-dependent) diabetes mellitus in childhood probably occurs early in life. Studies in vitro have shown that vitamin D3 is immunosuppressive or immunomodulating and studies in experimental models of autoimmunity, including one for autoimmune diabetes, have shown vitamin D to be protective. Seven centres in Europe with access to population-based and validated case registers of insulin-dependent diabetes patients participated in a case-control study focusing on early exposures and risk of Type I diabetes. Altogether data from 820 patients and 2335 control subjects corresponding to 85% of eligible patients and 76% of eligible control subjects were analysed. Questions focused on perinatal events and early eating habits including vitamin D supplementation. The frequency of vitamin D supplementation in different countries varied from 47 to 97% among control subjects. Vitamin D supplementation was associated with a decreased risk of Type I diabetes without indication of heterogeneity. The Mantel-Haenszel combined odds ratio was 0.67 (95% confidence limits: 0.53, 0.86). Adjustment for the possible confounders: a low birth weight, a short duration of breast feeding, old maternal age and study centre in logistic regression analysis did not affect the significant protective effect of vitamin D. In conclusion, this large multicentre trial covering many different European settings consistently showed a protective effect of vitamin D supplementation in infancy. The findings indicate that activated vitamin D might contribute to immune modulation and thereby protect or arrest an ongoing immune process initiated in susceptible people by early environmental exposures. [less ▲]

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See detailFamilial risk of type 1 diabetes in European children
De Beaufort, Carine UL

in Diabetologia (1998), 41

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See detailA review of the recent epidemiological data on the worldwide incidence of type 1 (insulin dependent) diabetes mellitus
Karvonen, M.; Tuomilehto, J.; Libman, J. et al

in Diabetologia (1993), 36

Nearly 70 registries from more than 40 countries have collected and published incidence data of childhood Type 1 (insulin-dependent) diabetes mellitus up to the end of the 1980s. The majority of incidence ... [more ▼]

Nearly 70 registries from more than 40 countries have collected and published incidence data of childhood Type 1 (insulin-dependent) diabetes mellitus up to the end of the 1980s. The majority of incidence data comes from regions of high incidence i.e. from Europe and North America. All these published data facilitate the descriptive comparison of incidence and variation of the occurrence of Type 1 diabetes roughly throughout the northern hemisphere. The aim of this paper is to review and compare the most recent epidemiology data on the incidence of Type 1 diabetes among children under the age of 15 years. A clear difference in incidence appeared between northern and southern hemisphere with no countries below the equator having an incidence greater than 15.0 per 100,000. In contrast above the equator the disease is common. Between continents the variation in incidence showed that the lowest incidences were found in Asia, followed by Oceania (Australia and New Zealand), South and North America, and the highest rates were in Europe. The incidence varied from 0.6 per 100,000 in Korea and Mexico to 35.3 per 100,000 in Finland showing prominent worldwide variation in incidence of Type 1 diabetes. The largest intracontinental variation in incidence appeared in Europe, varying from the highest in Finland to the lowest (4.6 per 100,000) in northern Greece. The highest incidence in the world was in northern Europe, but within the continent scale there were some striking exceptions from the overall level of incidence.(ABSTRACT TRUNCATED AT 250 WORDS) [less ▲]

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See detailIncidence of juvenile type 1 (insulin dependent) diabetes mellitus in France
Levy-Marchal, C.; Papoz, L.; De Beaufort, Carine UL et al

in Diabetologia (1990), 33

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See detailThe Fourth International Workshop on the Standardisation of Insulin Autoantibody Measurement
Kolb, H.; Arnaiz-Villena, A.; De Beaufort, Carine UL et al

in Diabetologia (1990), 33(10), 638-639

[No abstract available]

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See detailThe incidence of Type 1 (insulin-dependent) diabetes mellitus in subjects aged 0-19 years in Luxembourg: a retrospective study from 1977 to 1986
De Beaufort, Carine UL; Michel, G.; Glaesener, G.

in Diabetologia (1988), 31(10), 758-761

A decrease in the incidence of Type 1 (insulin-dependent) diabetes mellitus in the age group 0-14 years has been observed from north to south over north-western Europe. To evaluate whether this trend ... [more ▼]

A decrease in the incidence of Type 1 (insulin-dependent) diabetes mellitus in the age group 0-14 years has been observed from north to south over north-western Europe. To evaluate whether this trend could be found in Luxembourg (a small country between the Netherlands and France) we performed a retrospective study over a period of 10 years. Information concerning all Type 1 diabetic patients (aged 0-19 years at diagnosis), diagnosed between January 1, 1977 and December 31, 1986 was obtained through paediatricians, internists, general practitioners and the Luxembourg Diabetes Association (LDA). The LDA was used as the ascertainment group (to estimate the real number and incidence of Type 1 diabetes mellitus). During the study period 91 Type 1 diabetic patients aged between 0-19 years were diagnosed. An incidence of 11.2 was found in boys (0-19 years). Girls in the same age group showed a considerably lower incidence of 8.8. Standardised incidence (using as standard the world population) revealed an almost similar incidence in the Netherlands and Luxembourg (respectively 10.3 and 10.2) for the age group aged 0-14 years. In France a considerably lower incidence is found (3.6). To what extent different methodology contributes to the differences remains to be clarified. Further prospective studies are necessary to investigate the role of environmental and genetic factors. © 1988 Springer-Verlag. [less ▲]

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See detailHLA Dr3 is associated with a more slowly progressive form of IDDM
Ludvigsson, J.; Samuelson, U.; De Beaufort, Carine UL et al

in Diabetologia (1986), 29

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