Using person reported outcomes: Psychometric properties of the German diabetes treatment satisfaction questionnaire (DTSQ) for teens and parents.

Aims: To examine psychometric properties including the factor structure of the German versions of the Diabetes Treatment Satisfaction Questionnaire for teens and parents (DTSQ-T/-P). Methods: Linguistically validated questionnaires were completed by 363 adolescents with type 1 diabetes and 655 parent-caregivers in a multicenter study. Confirmatory factor analysis (CFA), reliability, and correlations were examined. Results: CFA confirmed the 2-factor model of treatment satisfaction (TS) & perceived diabetes control (PDC) with an adjustment of removing the "medical support" item from the TS and examining it as a single item in this study. Cronbach's α of TS for DTSQ-T/-P was 0.82 & 0.83, respectively, and α of the two-item PDC factor was 0.70 & 0.60, respectively. The DTSQ scale scores positively correlated with time in range and inversely correlated with HbA1c. Scale scores of DTSQ-T/-P showed significantly positive relations to the KIDSCREEN-10 Index and negative associations with the Problem Areas in Diabetes (PAID). The TS of the parents was correlated with depressive symptoms measured in the Patient Health Questionnaire-9. Conclusions: The DTSQ-T/-P produced psychometrically sound scores in measuring diabetes treatment satisfaction in German teens with type 1 diabetes and their parents. German DTSQ versions for teens and parents are recommended in research and clinical practice.

Health-related quality of life among adolescents with type 1 diabetes since the second wave of the COVID-19 pandemic in Germany.

OBJECTIVE: The COVID-19 pandemic had an impact on everyday life and in general, reduced the health-related quality of life (HRQoL) of adolescents. In this study, we assess the HRQoL of adolescents with type 1 diabetes (T1D) in Germany since the second wave of the COVID-19 pandemic by using self-report and parent-proxy reports, to identify risk factors, to compare to peers and to examine the agreement of HRQoL between parents and their children. METHODS: A total of 445 adolescents (12-18 years) and 413 parents participated in an anonymous cross-sectional survey conducted at three German diabetes centres from January 2021 to June 2022. Inclusion criteria were diabetes duration ≥1 year and German-speaking. Teen HRQoL was assessed by using self-report and parent-proxy report versions of the KIDSCREEN-10 index. RESULTS: The majority of adolescents reported average (75.5%) HRQoL. Approximately 11.3% of teens reported high and 13.2% low HRQoL. Teen's female gender, older age, higher diabetes burden and parental depression symptoms contributed to lower self-reported HRQoL among teens. For parent-proxy reports, increasing diabetes burdens, parental depression symptoms, non-migrant status, high education and ketoacidosis contributed to lower scores on teen HRQoL. The mean scores of the KIDSCREEN-10 index for adolescents did not differ from the German norm. In comparison to healthy peers during the first wave of the pandemic, adolescents in the current study reported higher HRQoL. The overall teen-parent agreement was fair although parents reported significantly lower teen HRQoL than adolescents did. CONCLUSIONS: HRQoL of most adolescents with T1D during the COVID-19 pandemic was average with parents reporting significantly lower scores. Self-reported and parent-proxy-reported HRQoL and the level of agreement due to different perspectives can provide important information for clinical care and intervention planning.

Expected Basal Insulin Requirement During Continuous Subcutaneous Insulin Infusion Therapy by Age Group, Sex, and Body Mass Index, Based on 25,718 Young People with Type 1 Diabetes in the DPV Registry.

Background: Since the introduction of insulin pumps into the therapy of pediatric subjects, different approaches have been taken to find optimal basal rates. Previously, the DPV registry provided circadian basal rate patterns for different age groups. As the number of pump users has increased recently and short-acting insulin analogues are now predominant, we performed a new analysis with a larger data pool. Methods: We included all recent basal profiles from type 1 diabetes (T1D) patients between 1 and 25 years from the DPV 2021 data pool. We excluded night-time-only pump users, human regular insulin users, and daily basal rates <0.05 and >1.0 U/(kgBW·d). Results: In the analysis of profiles from 25,718 young persons with T1D, differences in the daily pattern of basal rates were found between age groups. In addition, we saw significant (P < 0.001) differences in total daily basal dose between genders in all age groups except adults. In addition, the shape of the expected basal-rate pattern differed by body mass index, HbA1c, and use of continuous glucose monitoring. Discussion: This analysis demonstrates multiple factors influencing basal patterns and insulin requirement, including age group, gender, overweight, HbA1c, bolus frequency, and sensor use. As circadian basal rates are still mandatory for initiating insulin pump therapy with or without automation, a multimodal approach is necessary to estimate optimal basal rates.

Psychometric properties of the German teen and parent versions of the Problem Areas in Diabetes Scale (PAID).

The negative impact of psychosocial burden in connection with the treatment of Type 1 diabetes (T1D) indicates the need for regular screening of diabetes distress in adolescents with T1D and their parents. Psychometric properties of the German versions of Problem Areas in Diabetes scale-Teen (PAID-T) and Parent (P-PAID-T) are examined in order to provide a clinical screening tool. Linguistically translated questionnaires were used in a multicenter study with 459 families. Confirmatory factor analysis, validity, and reliability were examined. Teens (42.8% female) had a mean age of 14.7 years. Most parent-caregivers were mothers (74.4%) and were born in Germany (83.1%). Results corroborate the three-factor model for the PAID-T with acceptable model fit, and convergent and discriminant validity was observed. The four-factor model for parents was also supported but had inadequate discriminant validity in this study. Teen and parent scores showed excellent Cronbach's α = 0.91 and 0.93, respectively. The PAID-T and P-PAID-T scores were positively correlated with HbA1c (rs = .343 and .252, respectively, p < .001) and negatively correlated with treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire) and KIDSCREEN-10 index (teens: rs = -.545 and -.575; parents: rs = -.563 and -.489, respectively, all p < .001). The P-PAID-T correlated positively with depressive symptoms measured in Patient Health Questionnaire -9 (rs = .537, p < .001). The German versions of PAID-T and P-PAID-T produced scores that demonstrated good reliability and validity. Like the original English versions, the German versions are useful to detect diabetes-specific distress in families and to tailor interventions for affected teenagers and their parents. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Understanding Daily, Emotional, and Physical Burdens and Needs of Parents Caring for Children with Type 1 Diabetes.

Aims: To investigate (1) daily, emotional, and physical caregiving burdens in parents of children with type 1 diabetes, (2) the sociodemographic and clinical predictors of three burdens, and (3) support measures that parents wish to receive. Methods: The study was a multicenter cross-sectional survey conducted in nine German pediatric diabetes centers. A questionnaire assessing three types of burdens and wishes for support was distributed to parents with a child with type 1 diabetes visiting one of the pediatric centers for a routine check-up. Results: Data from 1,107 parents (83% mothers) were analyzed. Parents reported significantly higher emotional burdens compared to daily and physical burdens (p < 0.0001). Mothers felt more burdened than fathers did. Parents of younger children reported higher daily and physical burdens compared to the parents of older children, and similarly, parents of technology users reported higher daily and physical burdens compared to the parents of nontechnology users. However, emotional burdens did not differ in both comparisons. Other demographic factors (i.e., parent's age, migration status, and single-parent family status) predicted high levels of daily or physical burdens, but only HbA1c level and the parent's gender (mother) predicted a high emotional burden. Independent of the level of burden, 78% of parents wanted additional diabetes training. Conclusion: Despite parents reporting high emotional burdens in connection with diabetes care, HbA1c and the gender of the reporting parent were the only risk factors. As the child gets older, parents' daily and physical distress decrease but not the emotional burden. Diabetes training including regularly offered booster sessions as well as low-threshold interventions for mental health issues and practical self-care skills is recommended to provide continuous support for parents.

Long-term Occupational Consequences for Families of Children With Type 1 Diabetes: The Mothers Take the Burden.

OBJECTIVE: To investigate the occupational and financial consequences for parents following the onset of type 1 diabetes in their child. RESEARCH DESIGN AND METHODS: A questionnaire assessing occupational and financial situations before and in the first year after the onset of diabetes was distributed to all families with a child ≤14 years of age at diagnosis with a diabetes duration of at least 12 months in nine German pediatric diabetes centers. RESULTS: Data of 1,144 children (mean age at diagnosis 6.7 [3.6] years; 46.5% female) and their families were obtained. Mothers' occupational status reflected in paid working hours was significantly reduced in the first year after their child's diabetes diagnosis (P < 0.001). Overall, 15.1% of mothers stopped working, and 11.5% reduced working hours. Mothers of preschool children were particularly affected. Fathers' working status hardly changed (P = 0.75). Nearly half of the families (46.4%) reported moderate to severe financial losses. Compared with an earlier similar study in 2003, significant negative occupational consequences for mothers and financial burden on families remained unchanged in 2018 (P = 0.59 and 0.31, respectively). CONCLUSIONS: Mothers of young children with newly diagnosed diabetes experienced negative consequences in their occupational situation. This inequality for mothers can have long-term negative consequences for their mental health and future economic situation. There is an urgent need for action to reduce the burden on families and to provide professional, social, and regulatory support, especially for mothers of young children with diabetes.

Declining Frequency of Acute Complications Associated with Tubeless Insulin Pump Use: Data from 2,911 Patients in the German/Austrian Diabetes Patienten Verlaufsdokumentation Registry.

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.

Intermittently Scanned Glucose Values for Continuous Monitoring: Cross-Sectional Analysis of Glycemic Control and Hypoglycemia in 1809 Children and Adolescents with Type 1 Diabetes.

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, iscCGM data were compared to traditional parameters of glycemic control in young people with type 1 diabetes. Methods: Using the DPV registry, most recent data from children and adolescents aged <18 years with uploaded iscCGM sensor profiles with at least 14 days of data and a > 50% completeness were evaluated using recommended parameters of sensor metrics. Analysis was performed stratified by age group, glycemic control, and type of therapy; data were taken from DPV data pool in February 2020. Results: Glucose sensor profiles and clinical data from 1809 individuals (mean age 13.4 years, 53% male, and mean diabetes duration 5.02 years) were evaluated in this study. More than 50% of this population (n = 965) reached the current German treatment target of hemoglobin A1c (HbA1c) <7.5%. In this target, the mean scanning frequency was higher than in groups with HbA1c >7.5 or >8.0% (12.0 vs. 10.2 vs 7.6 times per day). The group of preschool children had the highest frequency of scanning (16.6 vs. 13.3 times per day in school kids and 7.9 in adolescents), the lowest HbA1c level, and the lowest risk for hypoglycemia (low blood glucose index 0.8 vs. 1.0 vs 1.2). Conclusion: Real-world data will help to determine the value of iscCGM to improve clinical and patient-related outcomes in pediatric diabetology. Not only the use of a device but also the intensity of use seems to have a high and direct impact on glycemic control.

Comorbidity of inflammatory bowel disease in children and adolescents with type 1 diabetes.

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 < .001). Patients with T1D and IBD had a significantly higher use of steroids (22% ± 0.05% vs. 1% ± 0.00, p < .001) and a significantly higher rate of severe hypoglycaemic events per patient year (0.33 ± 0.07 vs. 0.16 ± 0.00, p = .001). No differences were found in HbA1c levels, insulin dose and occurrence of DKA. CONCLUSION: Although children and adolescents with T1D and IBD take steroids more often, they suffer from severe hypoglycaemia more frequently and have a lower BMI-SDS. These findings might be explained by chronic intestinal inflammation leading to malabsorption, malnutrition and increased severe hypoglycaemia.

Early versus delayed insulin pump therapy in children with newly diagnosed type 1 diabetes: results from the multicentre, prospective diabetes follow-up DPV registry.

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<0·0001; however, diastolic blood pressure; concentrations of LDL cholesterol, non-HDL cholesterol, and triglycerides; and estimated body-mass index standard deviation scores during follow-up did not differ significantly between both groups. 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 für Diabetesforschung), German Robert Koch Institute, German Diabetes Association, and Diabetes Agenda 2010.

Estimated Glomerular Filtration Rates Calculated by New and Old Equations in Children and Adolescents With Type 1 Diabetes-What to Do With the Results?

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 <60 mL/min/1.73 m2 up to 8%. Regression models showed age, sex, and duration of diabetes as influencing factors. Microalbuminuria was associated with significantly higher eGFR values for all formulae. In comparison of eGFR with UCC, the highest correlation coefficient was 0.33, the lowest 0.01. Bland-Altman-Plots demonstrated graphically a poor agreement between eGFR and UCC, regardless of the formula used. Conclusions: The broad range of eGFR values indicate that an ideal eGFR formula for children and adolescence with T1D is yet missing. The minimal agreement between measured UCC and eGFR values urges us to be careful in application and interpretation of eGFR values regardless of the formula used.

Vitamin D supplementation after the second year of life: joint position of the Committee on Nutrition, German Society for Pediatric and Adolescent Medicine (DGKJ e.V.), and the German Society for Pediatric Endocrinology and Diabetology (DGKED e.V.).

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.

The association between socio-economic status and diabetes care and outcome in children with diabetes type 1 in Germany: The DIAS study (diabetes and social disparities).

OBJECTIVE: To evaluate the association between socioeconomic status (SES) and diabetes outcomes in German children and adolescents. METHODS: A total of 1829 subjects <18 years old with type 1 diabetes mellitus from 13 German diabetes centers were included from June 2013 until June 2014. Data were collected within the multicenter DPV (Diabetes Prospective Follow-up) registry. SES was measured with a composite index. Multivariable regression models were applied to analyze the association of SES and outcomes adjusted for age, sex, diabetes duration, and migration status. RESULTS: Low SES was significantly associated with worse diabetes outcomes: higher hemoglobin A1C (HbA1c) (64.3 mmol/mol), lower proportion of insulin pump therapy (43.6%), fewer daily self-monitored blood glucose (SMBG) measurements (5.7), more inpatient days per patient-year (5.8) compared to patients with medium/high SES (HbA1c: 61.3 mmol/mol, P < 0.001/59.8 mmol/mol, P < 0.0001; proportion of pump therapy: 54.5%, P < 0.01/ 54.9%, P < 0.01; SMBG: 6.0, P < 0.01/ 6.1, P < 0.01; inpatient days: 4.5, P < 0.0001/3.4, P < 0.0001). The inclusion of migration status in the models resulted in only minor changes in the outcomes. CONCLUSION: Despite free health care, low SES is associated with unfavorable diabetes outcomes in Germany. The poorer diabetes outcomes of children with diabetes have been attributed to their migration status and may be partly explained by low SES. Both factors must become part of targeted diabetes care in children and adolescents with type 1 diabetes.

Psychosocial benefits of insulin pump therapy in children with diabetes type 1 and their families: The pumpkin multicenter randomized controlled trial.

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.

Long-term study of tubeless insulin pump therapy compared to multiple daily injections in youth with type 1 diabetes: Data from the German/Austrian DPV registry.

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 <20 years (n = 660 tubeless insulin pump; n = 1869 MDI) who initiated treatment on a tubeless insulin pump as of January 1, 2013 and had 1 year of data preswitch from MDI and 3 years of data postswitch to a tubeless pump. Outcomes included the change in glycated hemoglobin (HbA1c), insulin dose, and body mass index (BMI) SD score (SDS). RESULTS: Youth with T1D who switched from MDI therapy to a tubeless insulin pump showed better glycemic control at 1 year compared to patients who continued MDI treatment, adjusted mean ± SE: 7.5% ± 0.03% (58 mmol/mol) vs 7.7% ± 0.02% (61 mmol/mol); P < .001, with no between-group difference at 2 and 3 years. Total daily insulin dose was lower (P < .001) in the tubeless insulin pump group, 0.80 ± 0.01, 0.81 ± 0.01, and 0.85 ± 0.01 U/kg, vs the MDI group, 0.89 ± 0.01, 0.94 ± 0.01, and 0.97 ± 0.01 U/kg, at 1, 2, and 3 years, respectively (all P < .001). BMI SDS increased in both groups and was not different over time. CONCLUSIONS: Treatment with a tubeless insulin pump in youth with T1D was associated with improvements in glycemic control compared to MDI after 1 year and appears to be an effective alternative to MDI.

Association of Insulin Pump Therapy vs Insulin Injection Therapy With Severe Hypoglycemia, Ketoacidosis, and Glycemic Control Among Children, Adolescents, and Young Adults With Type 1 Diabetes.

Importance: Insulin pump therapy may improve metabolic control in young patients with type 1 diabetes, but the association with short-term diabetes complications is unclear. Objective: 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. Design, Setting, and Participants: 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. Exposures: Type 1 diabetes treated with insulin pump therapy or with multiple (≥4) daily insulin injections. Main Outcomes and Measures: 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. Results: 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. Conclusions and Relevance: 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.

Continuous Subcutaneous Insulin Infusion in Neonates and Infants Below 1 Year: Analysis of Initial Bolus and Basal Rate Based on the Experiences from the German Working Group for Pediatric Pump Treatment.

BACKGROUND: Diabetes mellitus is rare in young infants and neonates. Continuous subcutaneous insulin infusion (CSII) is used most frequently for insulin treatment in this age group. However, the individual doctor's experience is scarce because of the low prevalence of diabetes in this age. For this study patients treated with CSII with an age below 1 year were selected from the German/Austrian DPV (Diabetes-Patienten-Verlaufsdokumentation) database, and basal rate and bolus calculation were described. MATERIALS AND METHODS: For all patients less than 1 year of age, basal rate and mealtime boluses were compared among infants with type 1 diabetes mellitus (T1DM), infants with neonatal diabetes mellitus (NDM), and infants with antibody status unknown diabetes mellitus (AUDM). RESULTS: Fifty-eight patients with T1DM, 67 neonates with NDM, and 43 infants with early diabetes development after 6 months and negative ß-cell antibodies (AUDM) could be analyzed. T1DM patients at onset required a median total insulin amount of 0.83 IU/kg of body weight, whereas NDM patients required 0.74 IU/kg of body weight (P = 0.63). Basal insulin requirement however, was different between the two groups (0.56 IU/kg of body weight in NDM vs. 0.43 IU/kg in T1DM) (P = 0.036). The percentage basal profile of NDM and T1DM patients was quite similar to children at the age of 1-5 years. The proportion of prandial insulin at onset was significantly different (32% in NDM vs. 53% in T1DM) (P < 0.00001). AUDM patients showed almost similar data to T1DM patients. The pattern of mealtime bolus insulin was not different among the groups. CONCLUSIONS: The presented data can be used as an initial guide value to start CSII treatment in neonates and infants. To be on the safe side we recommend the lower quartile for the dosage as the starting value in nonketotic patients.

Contrasting the clinical care and outcomes of 2,622 children with type 1 diabetes less than 6 years of age in the United States T1D Exchange and German/Austrian DPV registries.

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 (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 (<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 HbA1c 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 HbA1c 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 HbA1c goals, compared with children from T1DX (HbA1c <7.5%: 56% vs 22%, p < 0.001; HbA1c <8.5%: 90% vs 66%, p < 0.001). The adjusted odds of having an HbA1c 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 HbA1c, whereas the frequency of DKA was higher for the T1DX and greater in those with higher HbA1c levels. CONCLUSIONS/INTERPRETATION: DPV data indicate that an HbA1c 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 HbA1c targets that are recommended for this age group in the USA.

Predicting the optimal basal insulin infusion pattern in children and adolescents on insulin pumps.

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 <20 years of age (November 2009). A total of 1,248 individuals from our previous study were excluded (dataset 1), resulting in 6,063 CSII patients (dataset 2) (mean age 10.6 ± 4.3 years). Only the most recent basal insulin infusion rates (BRs) were considered. BR patterns were identified and corresponding patients sorted by unsupervised clustering. Logistic regression analysis was applied to calculate the probabilities for each BR pattern. Equations were based on both independent datasets separately, and probabilities for BR patterns were cross-validated using typical test 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.