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
Open accessAbstract
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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Insulin pumps, particularly automated insulin delivery (AID) pumps which communicate with or incorporate continuous glucose monitoring systems (CGMs), are associated with a lower incidence of hospitalization for diabetic ketoacidosis (DKA) compared to those that rely on multiple daily injections.
“Insulin pumps, particularly automated insulin delivery (AID) pumps which communicate with or incorporate continuous glucose monitoring systems (CGMs), are associated with numerous benefits, including a lower incidence of hospitalization for diabetic ketoacidosis (DKA) compared to those that rely on multiple daily injections [3].”
From Performance of a Continuous Subcutaneous Insulin Infusion (CSII) Pump With Acoustic Volume and Flow Sensing in Simulated High-Consequence Situations (2024) · cites this paper as [3]
The Diabetic Ketoacidosis section reports lower DKA event rates with pump therapy than with injection therapy in children, adolescents, and young adults with type 1 diabetes. It reports DKA events rather than hospitalization rates, and the Discussion says continuous glucose monitoring was not analyzed; the study therefore does not establish the claimed benefit particularly for AID pumps. (LLM, conf=0.90)
Experimental — accuracy not yet measuredOccurrences of severe hypoglycemia and DKA (9.0 and 0.6 events per 100 person-years, respectively, in the safety cohort) observed during the study period are in line with other literature with estimates ranging from 7 to 130 and 4 to 8 events per 100 person-years, respectively, in insulin-requiring diabetes populations using MDI therapy.
“Occurrences of severe hypoglycemia and DKA (9.0 and 0.6 events per 100 person-years, respectively, in the safety cohort) observed during the study period are in line with other literature with estimates ranging from 7 to 130 and 4 to 8 events per 100 person-years, respectively, in insulin-requiring diabetes populations using MDI therapy (39-43).”
From Observed Glycemic and Psychosocial Benefits in the Prospective Bigfoot Unity Real World Study: A 6-Month Analysis (2025) · cites this paper as [40]
Evidence suggests insulin pump therapy may reduce diabetic ketoacidosis risk and diabetes complications, particularly retinopathy and peripheral neuropathy in youth, compared with multiple daily injections.
“There is also evidence that insulin pump therapy may reduce DKA risk (182,186) and diabetes complications, particularly retinopathy and peripheral neuropathy in youth, compared with MDI (169).”
From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [182]
With the combination of CGM and CSII, it is possible to shift HbA1c values and "time in range" (TIR) into the normal range without increasing the risk of hypoglycemia.
“With this combination, it is possible to shift HbA1c values and “time in range” (TIR) into the normal range without increasing the risk of hypoglycemia [ 62 ].”
From Hypoglycemia Unawareness—A Review on Pathophysiology and Clinical Implications (2024) · cites this paper as [62]
Continuous subcutaneous insulin infusion is associated with improved clinical outcomes in both type 1 diabetes and insulin-dependent type 2 diabetes.
“Continuous subcutaneous insulin infusion is associated with improved clinical outcomes in both type 1 diabetes (T1D)2 -4 and insulin-dependent type 2 diabetes (T2D).5,6”
From Bench-Side Dose Accuracy of an Open-Source Ultra-Low-Cost Insulin-Pump, With Testing Conducted to IEC 60601-2-24 (2024) · cites this paper as [3]
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- Authors
- Karges, B., Schwandt, A., Heidtmann, B., Kordonouri, O., Binder, E., Schierloh, U., Boettcher, C., Kapellen, T., Rosenbauer, J., & Holl, R. W.
- Affiliations
- RWTH Aachen University (DE)
- Universität Ulm (DE)
- Katholisches Kinderkrankenhaus Wilhelmstift (DE)
- Kinderkrankenhaus auf der Bult (DE)
- Innsbruck Medical University (AT)
- Centre Hospitalier de Luxembourg (LU)
- Justus-Liebig-Universität Gießen (DE)
- University Hospital Leipzig (DE)
- Deutsches Diabetes-Zentrum e.V. (DE)
- Corresponding author
- Karges, Beate
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2017-10-10
- Volume
- 318
- Issue
- 14
- Pages
- 1358
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC5818842
- OpenAlex
- W2764247723
- Cited by
- 452
- References
- 40
- Citations by year
- 2026: 32 · 2025: 31 · 2024: 48 · 2023: 56 · 2022: 59 · 2021: 74 · 2020: 57 · 2019: 59 · 2018: 28 · 2017: 5 · 2016: 1
- FWCI
- 32.23
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- RWTH Publications (RWTH Aachen) (submittedVersion)
- Funders
- European Foundation for the Study of Diabetes
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Keywords
- insulin pump therapy, insulin injection therapy, type 1 diabetes, severe hypoglycemia, diabetic ketoacidosis, HbA1c, glycemic control, children and adolescents, young adults, insulin dose, body mass index, diabetes complications, migration background, diabetes duration, health care utilization, health care costs
- MeSH terms
- Adolescent, Blood Glucose, Child, Child, Preschool, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Infant, Injections, Insulin, Insulin Infusion Systems, Male, Regression Analysis, Cohort Studies, Diabetic Ketoacidosis, Young Adult
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