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Original Investigation
October 10, 2017

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

Author Affiliations
  • 1Division of Endocrinology and Diabetes, Medical Faculty, RWTH Aachen University, Aachen, Germany
  • 2Institute of Epidemiology and Medical Biometry, ZIBMT, University of Ulm, Ulm, Germany
  • 3German Center for Diabetes Research (DZD), Neuherberg
  • 4Children’s Hospital Wilhelmstift, Hamburg, Germany
  • 5Diabetes Center for Children and Adolescents, Children’s Hospital Auf Der Bult, Hannover, Germany
  • 6Department of Pediatrics, Medical University of Innsbruck, Innsbruck, Austria
  • 7Department of Pediatrics, Centre Hospitalier de Luxembourg, Luxembourg City, Luxembourg
  • 8Division of Paediatric Endocrinology and Diabetology, Center of Child and Adolescent Medicine, Justus Liebig University Giessen, Giessen, Germany
  • 9Hospital for Children and Adolescents, University of Leipzig, Leipzig, Germany
  • 10Institute for Biometrics and Epidemiology, German Diabetes Center, Leibniz Center at the University of Düsseldorf, Düsseldorf, Germany
JAMA. 2017;318(14):1358-1366. doi:10.1001/jama.2017.13994
Key Points

Question  Are the rates of severe hypoglycemia and diabetic ketoacidosis lower with insulin pump therapy than with insulin injection therapy in young patients with type 1 diabetes?

Findings  In this population-based observational study including 30 579 young patients with type 1 diabetes, pump therapy, compared with injection therapy, was associated with significantly lower rates of severe hypoglycemia (9.55 vs 13.97 per 100 patient-years) and ketoacidosis (3.64 vs 4.26 per 100 patient-years), and with lower hemoglobin A1c levels (8.04% vs 8.22%) in a propensity score–matched cohort.

Meaning  Insulin pump therapy was associated with reduced risks of short-term diabetes complications and with better glycemic control compared with injection therapy.

Abstract

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.

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