Background:The comparative efficacy of automated insulin delivery (AID) systems and other treatment options for type 1 diabetes, accounting for the certainty of evidence (CoE), is unknown. Methods:We searched PubMed, EMBASE, the Cochrane Central Register of Controlled Trials and ClinicalTrials.gov and included outpatient randomised controlled trials (RCTs) published until January 8, 2025, in people with type 1 diabetes with a three-week or longer intervention of AID systems (PROSPERO registration number: CRD42023395492). We performed pairwise and network meta-analyses and used the Risk of Bias tool 2 and the Grading of Recommendations Assessment, Development and Evaluation methods to determine the CoE for each outcome. Findings:A total of 46 studies involving seven insulin treatment options and 4113 participants were included, of which 29 and 17 had low and moderate risks of bias, respectively. The intervention AID systems, including the hybrid closed-loop (HCL), advanced HCL (AHCL) and full closed-loop (FCL) systems, were evaluated in 20, 25 and 1 studies, respectively. The network meta-analysis did not indicate global inconsistencies but did indicate global publication bias for all glycaemic outcomes. The CoE varied between very low and high, depending on the treatment and outcome under consideration. Compared with pump therapy, the percentage of time in the range 70-180 mg/dl was greater with AID use (HCL: 19.7% [95% confidence interval 13.2%; 26.1%], moderate CoE; AHCL: 24.1% [18.2%; 29.9%], moderate CoE; FCL: 25.5% [11.1%; 39.9%], high CoE). Compared with pump therapy, the percentage of time above 180 mg/dl and 250 mg/dl was lower with AHCL, on average, by 19.6% (14.0%; 25.1%), moderate CoE, and 14.8% (8.8%; 20.8%), moderate CoE, respectively. The CoE was very uncertain regarding the overall effect of AID systems on the percentage of time below 70 mg/dl and 54 mg/dl and the HbA1c. Interpretation:AID systems improve glycaemic outcomes to varying degrees and with varying CoE. Funding:German Federal Ministry of Education and Research (BMBF; grant 01KG2203).
The type 1 diabetes incidence was analyzed in 0- to 14-year-old children in North Rhine-Westphalia, Germany, from 1996 to 2022. The data revealed an overall increasing trend, with variations by age and sex. The incidence increased in boys across age groups but peaked in girls in the 5-9-year age group.
Background The effect of closed-loop insulin delivery on the risk of acute diabetes complications in people with type 1 diabetes is unclear. We investigated whether the rates of severe hypoglycaemia and diabetic ketoacidosis are lower with hybrid closed-loop insulin therapy compared with sensor-augmented (open-loop) pump therapy in a large cohort of young people. Methods In this population-based cohort study, we evaluated young people with type 1 diabetes from 250 diabetes centres in Germany, Austria, Switzerland, and Luxembourg participating in the Diabetes Prospective Follow-up (DPV) initiative. Included participants were aged 2-20 years, with diabetes duration of more than 1 year, and were treated between Jan 1, 2021, and Dec 31, 2023. The primary outcomes were the rates of severe hypoglycaemia and ketoacidosis in people using closed-loop therapy versus open-loop therapy. Key secondary outcomes were differences in HbA1c levels, percentage of time in glucose range of 39-100 mmol/L, and glycaemic variability. To account for relevant confounders, we applied propensity score inverse probability of treatment weighting considering several baseline characteristics. Findings 13 922 young people (median age 132 years [IQR 100 to 160]; 51% male) in the DPV database met inclusion criteria and were included in the analysis. 7088 used closed-loop therapy and 6834 used open-loop therapy, with a median observation time of 16 years [IQR 11 to 24]. Individuals using closed-loop therapy had a higher rate of ketoacidosis (174 per 100 patient-years) than those using open-loop therapy (096 per 100 patient-years; incidence rate ratio 181 [137 to 240], p<00001) and there was no significant difference between groups in the rate of severe hypoglycaemia (559 per 100 patient-years vs 663 per 100 patient-years; incidence rate ratio 084 [95% CI 069 to 103], p=0089). Individuals using closed-loop therapy had a lower rate of hypoglycaemic coma (062 per 100 patient-years) compared with individuals using open-loop therapy (091 per 100 patient-years; incidence rate ratio 068 [95% CI 048 to 097], p=0034). Those in the closed-loop therapy group also had a lower HbA1c level (734% vs 750%; difference -016% [95% CI -020 to -013], p=00007), higher percentage of time in target glucose range of 39-100 mmol/L (64% vs 52%, difference 12% [10 to 14], p<00001), and less glycaemic variability (coefficient of variation 354% vs 383%; difference -29% [-33 to -25], p<00001) than those in the open-loop therapy group. The rate of ketoacidosis was particularly high in young people with HbA1c of 85% or higher in the closed-loop therapy group (525 per 100 patient- years) compared with the open-loop therapy group (153 per 100 patient-years; incidence rate ratio 343 [95% CI 169 to 697], p<00001). Interpretation Hybrid closed-loop insulin delivery has no significant effect on the rate of severe hypoglycaemia, and is associated with an increased risk of diabetic ketoacidosis, but is associated with a reduced risk of hypoglycaemic coma and improved glycaemia. These findings indicate the need for additional educational measures for the use of closed- loop insulin delivery.
Diabetes surveillance for children and adolescents in Germany is based on regionally collected register data and data from the Diabetes-Patienten-Verlaufsdokumentation (DPV). The largest regional incidence register in Germany is the North Rhine-Westphalian Diabetes Register maintained by the German Diabetes Center, Dusseldorf. Based on many years of continuous data collection, the incidence and prevalence trends of the last two decades are available. The incidence of type 1 diabetes in children and adolescents under the age of 18 has risen by an average of 2-3% annually to 33.0 per 100,000 person-years in 2022. The increase in type 2 diabetes was higher at around 7% per year. In 2022, the Germany-wide type 2 diabetes incidence in 11-17 year olds was 4.6 per 100,000 person-years. However, the trends in both incidence rates were not uniform over time. During the COVID-19 pandemic year 2021, more children and adolescents were newly diagnosed with diabetes than ever before: 5020 children and adolescents younger than 18 years with type 1 diabetes and 337 11 - 17 year olds with type 2 diabetes across Germany. In 2022 (as of 6/2024), more than 34,500 children and adolescents under the age of 18 years in Germany had type 1 diabetes (244.7 per 100,000 people) and almost 1000 children and adolescents with type 2 diabetes were registered (18.9 per 100,000 people). Even if the incidence rates fluctuate in the short term, it is to be expected that the incidence and prevalence will increase in the coming years and, thus, the overall need for care for children and adolescents with diabetes will continue to rise.
Die Diabetessurveillance für Kinder und Jugendliche in Deutschland beruht auf regional erhobenen Registerdaten sowie Daten aus der Diabetes-Patienten-Verlaufsdokumentation (DPV). Das deutschlandweit größte regionale Inzidenzregister ist das nordrhein-westfälische Diabetesregister am Deutschen Diabetes-Zentrum, Düsseldorf. Aufgrund der langjährigen und kontinuierlichen Datenerhebung lassen sich die Inzidenz- und Prävalenztrends der letzten zwei Jahrzehnte beschreiben. Die Typ-1-Diabetes-Inzidenz nahm bei Kindern und Jugendlichen unter 18 Jahren im Durchschnitt jährlich um 2–3
Aims: The objective of this study was to assess overall and segmented trends in the incidence of type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) in children and adolescents younger than 20 years, from 2002 to 2022. Methods: This study used registry data on physician-diagnosed T1DM or T2DM from primary and secondary sources, covering the German federal state of North Rhine-Westphalia with 18 million inhabitants. The ages at T1DM and T2DM onset ranged from 0 to 19 and 10-19 years, respectively. The main outcomes were direct ageand/or sex-standardized incidence rates per 100,000 person-years (PYs) and trends estimated as annual percentage changes (APCs), both with 95 % confidence intervals. The segmented trends for subperiods were based on joinpoint regression models. Results: From 2002-2022, 17,470 and 819 persons had incident T1DM and T2DM, respectively. The total number of PYs was 73,743,982 for T1DM and 39,210,453 for T2DM, with a mean coverage rate of 98 % for T1DM and 90 % for T2DM. The standardized T1DM incidence increased from 17.6 [16.3;18.9} in 2002 to 33.2 [31.3;35.1] in 2022, with an APC of 2.7 % [2.3 %;3.1 %]. The standardized T2DM incidence increased from 1.3 [0.8;1.7] in 2002 to 2.8 [2.0;3.6] in 2022, with an APC of 6.4 % [4.9 %;8.0 %]. There were four different segmented trends for T1DM and T2DM, with the incidence peaking in 2021 and subsequently declining. Conclusions: The incidence rates of T1DM and T2DM have increased over the past 20 years, with a wave-like pattern during the Covid-19 pandemic.
To analyze the ecological relationship between COVID-19 incidence in the total population and type 1 diabetes (T1D) incidence in children and adolescents, spatiotemporal models were applied considering time lags from 0 to 12 months. The results do not indicate a positive correlation between COVID-19 incidence and T1D incidence.
Purpose: To investigate the psychosocial burden during the COVID-19 pandemic in adolescents with type 1 diabetes and its association with metabolic control. Methods: Prospective multicenter observational cohort study based on data from the German Diabetes Prospective Follow-up Registry. Adolescents aged 12-20 years with type 1 diabetes were asked during routine follow-up visits to complete a questionnaire on psychosocial distress and daily use of electronic media during the COVID-19 pandemic from June 2021 to November 2022. Well-being, anxiety, and depression symptoms were assessed using World Health Organization Five Well-Being Index (WHO -5), General Anxiety Disorder scale 7 (GAD -7), and Patient Health Questionnaire-9 questionnaires. The impact of mental health symptoms on metabolic control was analyzed by using multivariable linear regression models adjusted for sex, diabetes duration, treatment, socioeconomic deprivation, and immigrant background. Results: Six hundred eighty eight adolescents (45.6% females) from 20 diabetes centers participated. Compared with a prepandemic cohort, WHO -5 scores were lower during the COVID-19 pandemic (estimated mean difference -9.6 [95% con fidence interval -11.6; -7.6], p < .001), but GAD -7 scores were not different (estimated mean difference 0.6 [95% con fidence interval -0.2; 1.5], p 1 / 4 .14). HbA 1c was signi ficantly positively associated with GAD -7 and Patient Health Questionnaire -9 and negatively associated with WHO -5 scores (all p < .001). Daily electronic media use was positively associated with adjusted mental health symptoms (all p < .01). Discussion: Although the overall well-being of adolescents with type 1 diabetes was reduced during the later phase of the COVID-19 pandemic, the additional psychological burden was relatively low. However, mental health symptoms were associated with poorer metabolic control and higher use of electronic media. (c) 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc.
Fragestellung: Wie ist die Wirksamkeit von automatisierten Insulindosierungssystemen (AID-Systemen) im Vergleich zu anderen aktuellen Optionen einer Insulintherapie bei Typ-1-Diabetes in Bezug auf die glykämische Kontrolle zu bewerten?
Fragestellung: Wie hat sich die Inzidenz des Typ-1-Diabetes (T1D) und Typ-2-Diabetes (T2D) bei Kindern und Jugendlichen unter 20 Jahren im Zeitraum von 2002 bis 2022 in Deutschland entwickelt?
ObjectiveStudies have shown an increased incidence of pediatric type 1 diabetes during the COVID-19 pandemic, but the detailed role of SARS-CoV-2 infection in the incidence increase in type 1 diabetes remains unclear. We investigated the spatiotemporal association of pediatric type 1 diabetes and COVID-19 incidence at the district level in Germany.MethodsFor the period from March 2020 to June 2022, nationwide data on incident type 1 diabetes among children and adolescents aged <20 years and daily documented COVID-19 infections in the total population were obtained from the German Diabetes Prospective Follow-up Registry and the Robert Koch Institute, respectively. Data were aggregated at district level and seven time periods related to COVID-19 pandemic waves. Spatiotemporal associations between indirectly standardized incidence rates of type 1 diabetes and COVID-19 were analyzed by Spearman correlation and Bayesian spatiotemporal conditional autoregressive Poisson models.ResultsStandardized incidence ratios of type 1 diabetes and COVID-19 in the pandemic period were not significantly correlated across districts and time periods. A doubling of the COVID-19 incidence rate was not associated with a significant increase in the incidence rate of type 1 diabetes (relative risk 1.006, 95% CI 0.987; 1.019).ConclusionOur findings based on data from the pandemic period indirectly indicate that a causal relationship between SARS-COV-2 infection and type 1 diabetes among children and adolescents is unlikely.
Background Diabetes distress is increasingly considered one of the most important psychosocial issues in the care of people with type 1 diabetes (T1D). We analyse whether diabetes distress and depression screening results of emerging adults are associated with the age at T1D onset. Methods Data were taken from two cohort studies conducted at the German Diabetes Center, Düsseldorf, Germany. The 18–30-year-old participants had an age at onset either before the age of 5 years (childhood-onset long-term T1D study group, N = 749) or during adulthood (adult-onset short-term T1D study group from the German Diabetes Study (GDS), N = 163). Diabetes distress and depression screening were analysed by means of the 20-item Problem Areas in Diabetes (PAID-20) scale and the nine-item depression module from the Patient Health Questionnaire (PHQ-9). The average causal effect of age at onset was estimated by a doubly robust causal inference method. Results The PAID-20 total scores were increased in the adult-onset study group [potential outcome mean (POM) 32.1 (95% confidence interval 28.0; 36.1) points] compared to the childhood-onset study group [POM 21.0 (19.6; 22.4) points, difference 11.1 (6.9; 15.3) points, p<0.001] adjusted for age, sex and haemoglobin A1c (HbA1c) levels. Moreover, more participants in the adult-onset group [POM 34.5 (24.9; 44.2) %] than in the childhood-onset group [POM 16.3 (13.3; 19.2) %] screened positive for diabetes distress [adjusted difference 18.3 (8.3; 28.2) %, p<0.001]. The PHQ-9 total score [difference 0.3 (-1.1; 1.7) points, p=0.660] and the proportion of participants with a positive screening result for depression [difference 0.0 (-12.7; 12.8) %, p=0.994] did not differ between the groups in the adjusted analyses. Conclusions Emerging adults with short-term type 1 diabetes screened positive for diabetes distress more often than adults with type 1 diabetes onset during early childhood when age, sex and HbA1c values were considered confounding factors. Accounting for age at onset or the duration of diabetes may help explain the heterogeneity in the data when psychological factors are examined.
Introduction Automated insulin delivery (AID), also known as artificial pancreas system or ‘closed-loop system’, represents a novel option for current treatments for type 1 diabetes (T1D). The objective of this systematic review and meta-analysis is to assess the efficacy of AID systems in comparison with current intensified insulin therapy for glycaemic control and patient-reported outcomes in individuals with T1D.Methods and analysis Studies will be eligible if they are randomised controlled trials (RCTs) in people with T1D of all ages, and if they compare an AID system for self-administration during the day and night period with any other type of insulin therapy for at least 3 weeks. The primary outcome will be time in the glucose target range of 70–180 mg/dL. A systematic review will be conducted in the MEDLINE, Embase, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov registries from their inception dates. Two authors will independently screen all references based on titles and abstracts against the eligibility criteria. For data extraction, standard forms will be developed and tested before extraction. All information will be assessed independently by at least two reviewers. The risk of bias of the included studies will be assessed using the Cochrane Risk of Bias 2 tool. The data synthesis will include a random-effects pairwise and network meta-analysis (NMA) in a frequentist framework. Where applicable and if sufficient RCTs are available, sensitivity analyses will be performed, and heterogeneity and publication bias will be assessed. The certainty of evidence from the NMA will be evaluated following the Grading of Recommendations Assessment, Development, and Evaluation working group guidance.Ethics and dissemination No ethical approval is needed. The results will be reported to the funder, presented in a peer-reviewed scientific journal and at conferences, and disseminated via press release, social media and public events.PROSPERO registration number CRD42023395492.
ObjectiveTo systematically summarise and evaluate the existing evidence on the effect of diet on the management of type 2 diabetes and prevention of complications.DesignUmbrella review of systematic reviews with meta-analyses of randomised controlled trials.Data sourcesPubMed, Embase, Epistemonikos, and Cochrane, from inception up to 5 June 2022.Eligibility criteria for selecting studiesSystematic reviews with meta-analyses of randomised controlled trials reporting summary effect estimates on the effect of diet on any health outcome in populations with type 2 diabetes were included in the review. Only meta-analyses with randomised controlled trials with the duration of at least 12 weeks were eligible for inclusion. Summary data were extracted by two investigators independently. Summary effect estimates with 95% confidence intervals were recalculated with a random effects model if the information provided was insufficient. Methodological quality was assessed with the A MeaSurement Tool to Assess systematic Reviews (AMSTAR) 2 tool and the certainty of evidence with the Grading of Recommendations Assessment, Development, and Evaluations (GRADE) approach.Results88 publications with 312 meta-analyses of randomised controlled trials were included. Methodological quality was high to moderate in 23% and low to very low in 77% of the included publications. A high certainty of evidence was found for the beneficial effects of liquid meal replacement on reducing body weight (mean difference −2.37 kg, 95% confidence interval −3.30 to −1.44; n=9 randomised controlled trials included in the meta-analysis) and body mass index (−0.87, −1.32 to −0.43; n=8 randomised controlled trials), and of a low carbohydrate diet (<26% of total energy) on levels of haemoglobin A1c(−0.47%, −0.60% to −0.34%; n=17 randomised controlled trials) and triglycerides (−0.30 mmol/L, −0.43 to −0.17; n=19 randomised controlled trials). A moderate certainty of evidence was found for the beneficial effects of liquid meal replacement, plant based, Mediterranean, high protein, low glycaemic index, and low carbohydrate diets (<26% total energy) on various cardiometabolic measures. The remaining results had low to very low certainty of evidence.ConclusionsThe evidence indicated that diet has a multifaceted role in the management of type 2 diabetes. An energy restricted diet can reduce body weight and improve cardiometabolic health. Beyond energy restriction, dietary approaches such as plant based, Mediterranean, low carbohydrate (<26% total energy), or high protein diets, and a higher intake of omega 3 fatty acids can be beneficial for cardiometabolic health in individuals with type 2 diabetes.Systematic review registrationPROSPERO CRD42021252309.
Introduction Family history of depression and childhood maltreatment are established risk factors for depression. However, how these factors are interrelated and jointly influence depression risk is not well understood. The present study investigated (i) if childhood maltreatment is associated with a family history of depression (ii) if family history and childhood maltreatment are associated with increased lifetime and current depression, and whether both factors interact beyond their main effects, and (iii) if family history affects lifetime and current depression via childhood maltreatment. Methods Analyses were based on a subgroup of the first 100,000 participants of the German National Cohort (NAKO), with complete information (58,703 participants, mean age = 51.2 years, 53% female). Parental family history of depression was assessed via self-report, childhood maltreatment with the Childhood Trauma Screener (CTS), lifetime depression with self-reported physician's diagnosis and the Mini-International Neuropsychiatric Interview (MINI), and current depressive symptoms with the depression scale of the Patient Health Questionnaire (PHQ-9). Generalized linear models were used to test main and interaction effects. Mediation was tested using causal mediation analyses. Results Higher frequencies of the childhood maltreatment measures were found in subjects reporting a positive family history of depression. Family history and childhood maltreatment were independently associated with increased depression. No statistical interactions of family history and childhood maltreatment were found for the lifetime depression measures. For current depressive symptoms (PHQ-9 sum score), an interaction was found, with stronger associations of childhood maltreatment and depression in subjects with a positive family history. Childhood maltreatment was estimated to mediate 7%–12% of the effect of family history on depression, with higher mediated proportions in subjects whose parents had a depression onset below 40 years. Abuse showed stronger associations with family history and depression, and higher mediated proportions of family history effects on depression than neglect. Discussion The present study confirms the association of childhood maltreatment and family history with depression in a large population-based cohort. While analyses provide little evidence for the joint effects of both risk factors on depression beyond their individual effects, results are consistent with family history affecting depression via childhood maltreatment to a small extent.