Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes
| Autor: | Amy Criego, Sarah A. Macleish, Jennifer L. Sherr, Jordan E. Pinsker, Ruth S. Weinstock, Anders L. Carlson, Anuj Bhargava, Richard M. Bergenstal, Thomas C. Jones, Daniel J. DeSalvo, Grazia Aleppo, Carol J. Levy, Bruce W. Bode, Sanjeev N. Mehta, Gregory P. Forlenza, Viral N. Shah, Bruce A. Buckingham, Irl B. Hirsch, David W Hansen, Sue A. Brown, Lori M. Laffel, Trang T. Ly |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
Blood Glucose medicine.medical_specialty Adolescent Diabetic ketoacidosis Endocrinology Diabetes and Metabolism 030209 endocrinology & metabolism Hypoglycemia Young Adult 03 medical and health sciences Insulin Infusion Systems 0302 clinical medicine Emerging Technologies: Data Systems and Devices Internal medicine Multicenter trial Diabetes mellitus Internal Medicine medicine Humans Hypoglycemic Agents Insulin Prospective Studies 030212 general & internal medicine Child Prospective cohort study Aged Glycemic Glycated Hemoglobin Advanced and Specialized Nursing Type 1 diabetes business.industry Incidence (epidemiology) Middle Aged medicine.disease Diabetes Mellitus Type 1 business |
| Zdroj: | Diabetes Care |
| ISSN: | 1935-5548 0149-5992 |
| DOI: | 10.2337/dc21-0172 |
| Popis: | OBJECTIVE Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of disease is significant. We report on a pivotal safety study of the first tubeless, on-body automated insulin delivery system with customizable glycemic targets. RESEARCH DESIGN AND METHODS This single-arm, multicenter, prospective study enrolled 112 children (age 6–13.9 years) and 129 adults (age 14–70 years). A 2-week standard therapy phase (usual insulin regimen) was followed by 3 months of automated insulin delivery. Primary safety outcomes were incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes were change in HbA1c and percent time in sensor glucose range 70–180 mg/dL (“time in range”). RESULTS A total of 235 participants (98% of enrolled, including 111 children and 124 adults) completed the study. HbA1c was significantly reduced in children by 0.71% (7.8 mmol/mol) (mean ± SD: 7.67 ± 0.95% to 6.99 ± 0.63% [60 ± 10.4 mmol/mol to 53 ± 6.9 mmol/mol], P < 0.0001) and in adults by 0.38% (4.2 mmol/mol) (7.16 ± 0.86% to 6.78 ± 0.68% [55 ± 9.4 mmol/mol to 51 ± 7.4 mmol/mol], P < 0.0001). Time in range was improved from standard therapy by 15.6 ± 11.5% or 3.7 h/day in children and 9.3 ± 11.8% or 2.2 h/day in adults (both P < 0.0001). This was accomplished with a reduction in time in hypoglycemia CONCLUSIONS This tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA1c levels and time in target glucose range with a very low occurrence of hypoglycemia. |
| Databáze: | OpenAIRE |
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