Automated insulin delivery in older adults with type 1 diabetes
Open accessAbstract
BACKGROUND: Older adults with type 1 diabetes are at risk for serious hypoglycemia. Automated insulin delivery can reduce risk but has not been sufficiently evaluated in this population. METHODS: We conducted a multicenter, randomized crossover trial in adults older than or equal to 65 years of age with type 1 diabetes. Participants completed three 12-week periods of using hybrid closed loop, predictive low-glucose suspend, and sensor-augmented pump insulin delivery in a randomized order. The primary outcome was the percentage of time with continuous glucose monitoring glucose values less than 70 mg/dl. RESULTS: Eighty-two participants between 65 and 86 years of age were randomly assigned: 45% were female; the baseline mean (±SD) glycated hemoglobin level was 7.2±0.9%; and the baseline percentage of time with glucose values less than 70 mg/dl was 2.49±1.78%. In the sensor-augmented pump, hybrid closed-loop, and predictive low-glucose suspend periods, percentages of time with glucose less than 70 mg/dl were 2.57±1.54%, 1.58±0.95%, and 1.67±0.96%, respectively. Compared with the sensor-augmented pump results, the mean difference with the hybrid closed-loop system was -1.05 percentage points (95% confidence interval [CI], -1.48 to -0.73 percentage points; P<0.001) and with the predictive low-glucose suspend system it was -0.93 percentage points (95% CI, -1.27 to -0.66 percentage points; P<0.001). Comparing a hybrid closed-loop system with a sensor-augmented pump, time in the range 70 to 180 mg/dl changed by 8.9 percentage points (95% CI, 7.4 to 10.4 percentage points) and the glycated hemoglobin level changed by 0.2 percentage points (95% CI, -0.3 to -0.1 percentage points). Serious adverse events were uncommon. Severe hypoglycemia occurred in 4% or less of participants; there were two hospitalizations for diabetic ketoacidosis. CONCLUSIONS: In older adults with type 1 diabetes, automated insulin delivery decreased hypoglycemia compared with sensor-augmented pump delivery. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number: NCT04016662.).
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Real-world data also aligned with clinical trial outcomes showing HbA1c reductions of 0.3-0.7% across diverse age groups.
“Realworld data also aligned with clinical trial outcomes showing HbA₁ c reductions of 0•3-0•7% across diverse age groups.95,101,102”
From The future of type 1 diabetes therapy (2025) · cites this paper as [101]
The Results (Abstract; page not available in our copy) report an HbA1c reduction with hybrid closed-loop delivery, but the mean difference was 0.2%, not 0.3–0.7%. The trial enrolled only adults aged 65–86 and does not establish an outcome across diverse age groups or compare its findings with real-world data. (LLM, conf=0.88)
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References 29 · Cited by 45
- Authors
- Kudva, Y. C., Henderson, R. J., Kanapka, L. G., Weinstock, R. S., Rickels, M. R., Pratley, R. E., Chaytor, N., Janess, K., Desjardins, D., Pattan, V., Peleckis, A. J., Casu, A., Rizvi, S. R., Bzdick, S., Whitaker, K. J., Jo Kamimoto, J. L., Miller, K., Kollman, C., & Beck, R. W.
- Affiliations
- Mayo Clinic (US)
- Jaeb Center for Health Research (US)
- SUNY Upstate Medical University (US)
- University of Pennsylvania (US)
- AdventHealth Orlando (US)
- Washington State University Spokane (US)
- Elkhart Clinic (US)
- Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, and Institute for Diabetes, Obesity and Metabolism, University of Pennsylvania Perelman School of Medicine, Philadelphia
- T1D Exchange (US)
- ORCID
- Venue
- NEJM Evidence
- Publisher
- Massachusetts Medical Society
- Published
- 2025-01
- Volume
- 4
- Issue
- 1
- Pages
- EVIDoa2400200-EVIDoa2400200
- ISSN
- 2766-5526 (ISSN-L)
- PMC
- PMC11840810
- OpenAlex
- W4405720417
- Cited by
- 45
- References
- 29
- Citations by year
- 2026: 24 · 2025: 20 · 2024: 1
- FWCI
- 14.82
- Type
- journal article
- Language
- en
- Open access
- green
- pmc.ncbi.nlm.nih.gov
- Locations
- NEJM Evidence (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- Funders
- University of Pennsylvania (UL1 TR001878)
- Dexcom
- Tandem Diabetes Care
- National Institutes of Health (UL1TR001878)
- National Institute of Diabetes and Digestive and Kidney Diseases (R01DK122603, U01DK144420)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- type 1 diabetes, older adults, artificial pancreas, hybrid closed-loop system, predictive low glucose suspend, sensor-augmented pump, hypoglycemia, glycemic control, HbA1c, continuous glucose monitoring, diabetic ketoacidosis, time in range, insulin pump therapy, hospitalization risk, adverse events, crossover trial, glycemic variability
- MeSH terms
- Aged, Aged, 80 and over, Blood Glucose, Diabetes Mellitus, Type 1, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Male, Blood Glucose Self-Monitoring, Cross-Over Studies
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