Abstract
Introduction: Despite recent advances in diabetes technology, most people living with type 1 diabetes mellitus (T1D) are unable to meet glycemic targets. Real-world evidence can provide insight into outcomes achieved with specific treatment devices when used in clinical practice. The aim of this study was to analyze real-world outcomes collected from a large cohort of people living with T1D and initiating treatment with the Omnipod DASH System. Methods: In this retrospective observational study, real-world outcomes were analyzed from a database of information collected from people with T1D initiating the Omnipod DASH System. Information in the database was either taken directly from the patient’s medical record or self-reported if medical records were unavailable. The primary outcome was change in glycated hemoglobin (HbA1c) from baseline (before initiation) to 3 months after initiation. Secondary outcomes were changes in total daily dose of insulin (TDD) and self-reported frequency of hypoglycemic events (< 70 mg/dL). Results are separated for the adult (≥ 18 years, N = 3341) and pediatric (< 18 years, N = 1397) cohorts. Results: The change in HbA1c from baseline was − 0.9 ± 1.6% (− 10 ± 18 mmol/mol; p < 0.0001) in adults and − 0.9 ± 2.0% (− 10 ± 22 mmol/mol; p < 0.0001) in the pediatric cohort. For those previously using multiple daily injections, HbA1c decreased by − 1.0 ± 1.7% (− 11 ± 19 mmol/mol) in adults and − 1.0 ± 2.1% (− 11 ± 23 mmol/mol) in the pediatric cohort (both p < 0.0001). Hypoglycemic events decreased in adults from 2.9 to 1.3 episodes per week (− 1.6 ± 3.2 events/week; p < 0.0001), and in the pediatric cohort from 2.8 to 1.5 episodes per week (− 1.3 ± 2.7 events/week; p < 0.0001). In adults, TDD decreased by 19.9% (p < 0.0001), and it remained stable in the pediatric cohort (p > 0.05). Conclusions: Real-world outcomes from this large cohort of people initiating therapy with the Omnipod DASH System showed significant improvement in HbA1c and a substantial reduction in hypoglycemic events after 3 months of use.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 593-610 |
| Number of pages | 18 |
| Journal | Diabetes Therapy |
| Volume | 14 |
| Issue number | 3 |
| DOIs | |
| State | Published - Mar 2023 |
Funding
Funding for this work and the journal’s Rapid Service Fee was provided by Insulet Corporation. The authors thank the Omnipod DASH users whose data were included in this study. The authors appreciate the efforts of Steve Lowen, PhD, of Insulet Corporation for providing advice on the data analysis, and Irene Hadjiyianni, PhD, for the critical review of the manuscript. Funding for this work and the journal’s Rapid Service Fee was provided by Insulet Corporation. Andreas Festa, MD, provided writing and administrative support throughout the publication process and received payment from Insulet Corporation for this support. Editorial support of the manuscript was provided by Jodi Bernstein, PhD MPH RD, of Jodi Bernstein Medical Writing (Toronto, Canada), who received payment from Insulet Corporation. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. TV and TTL contributed to the conception of the work. LMH, TV, and TTL contributed to the design of the work, and FL and LMH contributed to the acquisition of data for the work. AC, FL, LMH, and TTL contributed to the analysis of the data, and GA, DJD, FL, LMH, TV, and TTL contributed to the interpretation of data. FL and LMH drafted the manuscript, and all authors critically reviewed the manuscript for important intellectual content. All authors approved of the final manuscript. The primary results were presented in part at the 14th International Conference on Advanced Technologies and Treatments for Diabetes in June 2021, the 57th Annual Meeting of the European Association for the Study of Diabetes in September 2021, and the 47th Annual Conference of the International Society for Pediatric and Adolescent Diabetes in October 2021 (all virtual meetings). Additionally, the results were encored at the American Pharmacists Association 2022 Annual Meeting in San Antonio, Texas in March 2022. GA has served as independent consultant for Bayer, Dexcom, and Insulet, and her institution has received research support from Dexcom, Eli Lilly, Fractyl, EMMES, Insulet, Tandem Diabetes, and Welldoc separate from this work. DJD has served as an independent consultant for Dexcom and Insulet, and his institution has received research support from Insulet separate from this work. FL was a full-time employee of Insulet Corporation at the time the study was conducted and is currently a full-time employee of Sanofi. LMH, AC, TV, and TTL are full-time employees of Insulet Corporation and are shareholders of stock in Insulet Corporation. The study protocol was submitted to the Western Institutional Review Board (submission number 2623242–44579044), which granted a waiver of authorization for use and disclosure of protected health information and granted human subjects research exemption under 45CFR§46.104(d)(4). The study protocol was in agreement with the Helsinki Declaration of 1964 and its later amendments. The datasets generated during and/or analyzed during the current study are not publicly available.
Keywords
- CSII
- HbA1c
- Insulin pumps
- Insulin therapy
- Real-world outcomes
- Type 1 diabetes
ASJC Scopus subject areas
- Internal Medicine
- Endocrinology, Diabetes and Metabolism
