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In this episode, hosts discuss the FDA clearance of the Omnipod 5 App for iPhones and a pair of studies examining use of automated insulin delivery systems.
Although those in the diabetes community has witnessed an avalanche of advances in management in recent decades, few have held the same promise, and captivated clinicians in the same fashion as automated insulin delivery systems.
In this special edition episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, discuss recent news in the world of automated insulin delivery. Hosts also spend time sharing perspective on the impact of the recent US Food and Drug Administration clearance of the Omnipod 5 App for iPhone.
See below for a brief overview of the studies discussed in this episode.
Presented at the 2023 European Association for the Study of Diabetes (EASD) Meeting and simultaneously published in the New England Journal of Medicine, the AiDapt study was an open-label, multicenter, randomized, controlled trial comparing automated hybrid closed-loop insulin delivery against continuing standard intensive insulin therapy, with both groups using continuous glucose monitoring, in pregnant women. The trial randomized 124 participants, with a mean age of 31.1 (Standard Deviation [SD], 5.3) years and a mean baseline HbA1c of 7.7% (SD, 1.2%).1
Upon analysis, results suggested the mean percentage of time in the target range of 63 to 140 mg/dL was 68.2% (SD, 10.5) in the closed-loop group and 55.6% (SD, 12.5) in the standard-care group (mean adjusted difference, 10.5 percentage points; 95% Confidence Interval [CI], 7.0 to 14.0; P < .001). Investigators noted no unanticipated safety problems occurred during pregnancy with use of closed-lop therapy and no differences were observed between groups with regard to number of preterm births, birth weight, neonatal complications, or admissions to the neonatal intensive care unit.1
The second study discussed by Isaacs and Bellini, which was also presented at EASD 2023, examined the effects of automated insulin delivery with the MiniMed 780G on ability to achieve time in tighter range using real-world data uploaded from August 2020 to December 2022 by de-identified users. In the study, time in tighter range was described as 70 to 140 mg/dL.2
Investigators used univariate and multivariable models to identify glycemic metrics, demographics and system characteristics associated with increased time in tighter range post-AHCL initiation, and associated with increased time in range post-AHCL initiation. Results of the study, which included 15,348 individuals, indicated users of the MiniMed 780G system on achieved a time in tighter range of 48.9%, with this figure growing to 56.1% when recommended settings were used.2
Relevant disclosures for Dr. Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Dr. Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.