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Temporal Trends and Contemporary Use of Insulin Pump Therapy And 2050 Diabetes Care Volume 42, November 2019 Louisa van den Boom,1 Beate Karges,2 Temporal Trends and Marie Auzanneau,3,4 Birgit Rami-Merhar,5 Eggert Lilienthal,6 Simone von Sengbusch,7 Contemporary Use of Insulin Nicolin Datz,8 Carmen Schroder,¨ 9 Thomas Kapellen,10 Markus Laimer,11 Pump Therapy and Glucose Sebastian M. Schmid,4,12 Heiko Muller,¨ 13 Monitoring Among Children, Johannes Wolf,14 and Reinhard W. Holl3,4 Adolescents, and Adults With Type 1 Diabetes Between 1995 and 2017 1Division of Pediatric Diabetes, Clementine Chil- dren’s Hospital, Frankfurt, Germany CLIN CARE/EDUCATION/NUTRITION/PSYCHOSOCIAL – Diabetes Care 2019;42:2050 2056 | https://doi.org/10.2337/dc19-0345 2Division of Endocrinology and Diabetes, Medical Faculty, RWTH Aachen University, Aachen, Germany 3Institute of Epidemiology and Medical Biometry, ZIBMT, University of Ulm, Ulm, Germany 4German Center for Diabetes Research (DZD), Neuherberg, Germany 5Department of Pediatric and Adolescent Med- icine, Medical University of Vienna, Vienna, Austria 6Department of Pediatrics, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany 7Department of Pediatrics and Adolescent Med- icine, Division of Pediatric Endocrinology and OBJECTIVE Diabetes, University of Lubeck,¨ Lubeck,¨ Germany 8 To investigate temporal trends and contemporary use of insulin pump therapy Diabetes Center for Children and Adolescents, Children’s Hospital Auf Der Bult, Hannover, and glucose monitoring in type 1 diabetes. Germany 9Department of Pediatrics, Division of Endocri- RESEARCH DESIGN AND METHODS nology and Diabetes, University of Greifswald, In a population-based study, we analyzed the use of insulin pump therapy, Greifswald, Germany 10 continuous glucose monitoring (CGM), and self-monitoring of blood glucose (SMBG) Department of Women and Child Health, Hos- fi pital for Children and Adolescents, University of from 1995 to 2017 in patients with type 1 diabetes identi ed from the Diabetes Leipzig, Leipzig, Germany Prospective Follow-up (DPV) database in Germany and Austria. Patients were 11Department of Diabetes, Endocrinology, Clin- stratified by age, sex, migration background, and country. ical Nutrition and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, RESULTS Switzerland 12Department of Internal Medicine I, University Among 96,547 patients with type 1 diabetes (median age 17.9 years, 53% males), the Hospital Lubeck,¨ Lubeck,¨ Germany percentage using insulin pump therapy increased from 1% in 1995 to 53% in 2017, 13Department of Pediatrics, DKD Helios Klinik with the highest rates in the youngest patients (92% in preschoolers, 74% in children, Wiesbaden, Wiesbaden, Germany 14 56% in adolescents aged <15 years, 46% in adolescents aged ‡15 years, 37% in Department of Pediatric and Adolescent Med- icine, St. Vincenz Hospital, Paderborn, Germany adults). The percentage of patients using CGM increased from 3% in 2006 to 38% in Corresponding author: Beate Karges, bkarges@ 2017, with the highest rates in the youngest patients (58%, 52%, 45%, 33%, and 15% ukaachen.de of respective age-groups). Daily SMBG frequencies increased from 1995 to 2016 and Received 19 February 2019 and accepted 13 decreased afterward, most prominently in the youngest patients. Between August 2019 2015 and 2017, pump therapy was more frequently used in female versus male This article contains Supplementary Data online adolescents and adults (all P < 0.001), while no sex differences were observed for at http://care.diabetesjournals.org/lookup/suppl/ pump use in children <10 years (all P 5 1.0) and for CGM use in all age-groups (all doi:10.2337/dc19-0345/-/DC1. P 5 1.0). L.v.d.B. and B.K. share first authorship. © 2019 by the American Diabetes Association. CONCLUSIONS Readers may use this article as long as the work is properly cited, the use is educational and not Since 1995, insulin pump use has continuously increased, and insulin pump therapy fi < for pro t, and the work is not altered. More infor- is now standard in patients aged 15 years. CGM use sharply rose in recent years, mation is available at http://www.diabetesjournals particularly in young children. .org/content/license. care.diabetesjournals.org van den Boom and Associates 2051 Insulin pump therapy offers the potential compared by sex, migration background, seizures according to the ISPAD classifi- to improve glycemic control (1,2) and and country. Patients included in the cation (13). may help to reduce long-term diabetes study were identified from the Diabetes complications (3,4) as well as the risk of Prospective Follow-up (DPV) database at Statistical Analyses acute complications, such as severe hy- Ulm University. As of 31 December 2017, HbA1c values were mathematically stan- poglycemia and diabetic ketoacidosis (2) 470 diabetes centers have documented dardized to the Diabetes Control and in patients with type 1 diabetes. Young diabetes treatment and outcomes using Complications Trial (DCCT) reference patients using pump therapy experi- the DPV Diabetes Documentation Sys- range (4.05–6.05%) using the multiple- ence a benefit in health-related quality tem. The analysis of anonymized data of-the-mean transformation method. BMI of life (1,5). In recent years, continuous was approved by the ethics committee valuesweretransformedtoSDscoreson glucose monitoring (CGM) measuring of Ulm University. the basis of German reference values by interstitial glucose concentrations to applying the LMS method (14). The navigate insulin therapy has gained pop- Study Population Wilcoxon test was used to compare contin- ularity among patients with type 1 di- Patients were eligible for inclusion in the uous variables. The x2 test was used to abetes (1,6). study if they had a clinical diagnosis of compare variables with binomial distri- The use of insulin pumps (7) and CGM type 1 diabetes and were treated with bution. Adjustment for multiple compar- (8) in type 1 diabetes treatment has been insulin in Germany or Austria. Exclusion isons was performed according to the fostered by rapid technological evolu- criteria were age ,6 months at diagnosis Holm-Bonferroni stepdown procedure. tion (6,9), efficacy as demonstrated and diabetes duration ,12 months. For P , 0.05 (two-sided) was considered by clinical trials and scientific reports each patient, clinical data including age, statisticallysignificant. All analyses were (1,2,6,8,10), cost-effectiveness encour- duration of diabetes, HbA1c level, and performed using SAS version 9.4 for aging reimbursement by health care BMI (calculated as weight in kilograms di- Windows software (SAS Institute). systems (6,10,11), and acceptance by vided by the square of height in meters) patients in their daily lives and by were aggregated as medians of the most RESULTS health care providers (8,12). The impact recent treatment year. Insulin treatment Study Population of these technologies on routine diabetes regimen was categorized as pump ther- A total of 96,547 patients with type 1 care during the past 20 years is, however, apy or injection therapy. Migration back- diabetes treated in 432 diabetes centers not well defined, particularly among pa- ground was defined as place of birth was included in this study. To investigate tients of different age-groups. The aim of outside Germany or Austria for the pa- temporal trends, data from 1,513,196 this study was to investigate temporal tient or for one or both parents. visits between 1995 and 2017, represent- trends in the use of insulin pump therapy, ing 414,503 patient-years, were ana- CGM, and self-monitoring of blood glucose Outcomes lyzed. The median age of the study (SMBG) from 1995 to 2017 in children, The percentage of patients using insulin population was 17.9 years, 53% of pa- adolescents, and adults with type 1 di- pump therapy and CGM and the mean tients were males, 33,341 patients were abetes and to compare the contemporary daily SMBG frequency were investigated. treated with insulin pump therapy, and use of insulin pumps, CGM, and SMBG by Pump therapy was defined as continuous 63,206 patients were treated with in- sex, migration background, and country subcutaneous insulin infusion docu- jection therapy (Table 1). CGM was used using a large population-based registry mented at least once per year. CGM by 14,419 individuals $1 day/year, by from Germany and Austria. was defined as the use of either inter- 10,745 patients $30 days/year, and by mittent scanning or real-time glucose 8,201 $100 days/year (Table 1). SAP was RESEARCH DESIGN AND METHODS monitoring. CGM was analyzed for any used by 7,070 patients, including 609 Study Design use ($1 day/year), for use $30 days/ using LGS or PLGS systems. This population-based cohort study an- year, and for use $100 days/year. Sensor- To compare the contemporary use of alyzed the use of insulin pump therapy augmented pump therapy (SAP) was diabetes technologies by sex, migration and glucose monitoring among patients defined as simultaneous use of insulin background, and country, 41,597 pa- with type 1 diabetes between 1 January pump therapy and CGM $30 days/year. tients (53% males) were included 1995 and 31 December 2017 in Germany As a subgroup of SAP, low-glucose sus- between 2015 and 2017, of whom and Austria. The percentage of patients pend (LGS) and predictive low-glucose 38,324 were treated in Germany and using pump therapy, the percentage suspend (PLGS) systems were docu- 3,273 were treated in Austria. Of these using CGM, and their mean daily mented. Frequency of SMBG per day patients, 7,931 (19%) had a migration SMBG frequency were longitudinally in- was aggregated as the mean from all background. Median age was 16.4 vestigated by calendar year in patients visits per year. Severe hypoglycemia was years (quartiles 12.4; 20.7). Median di- aged 1.5–4.9 years (preschoolers), 5–9.9 defined as requiring assistance from an- abetes duration was 6.8 years (3.5; 12.1).
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