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Year:: 2023
Contributor:: Li, Melinda M. (Author); Feldman, Noah (Author); Tanzer, Joshua Ray (Author); Millington, Kate (Author); Brown University. Alpert Medical School. Scholarly Concentration Program. Non-Scholarly Concentrator (research program)
Subject:: Pediatrics; Diabetes; Insulin pumps

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Abstract:: Objectives: Clinical trials have demonstrated that patients with Type 1 diabetes mellitus (T1DM) on hybrid closed loop insulin pump therapy have improved glycemic control, but it is unknown if patients in a real world setting outside of clinical trials would see the same benefits. Diabetes technology has been shown to increase glycemic control although there are racial and other demographic disparities in access and uptake. The Omnipod 5 insulin pump is the only currently available tubeless hybrid closed loop insulin pump and was approved by the FDA in January 2022. We aimed to compare glycemic control as measured by time in range (TIR) and hemoglobin A1C (HbA1c) in patients with T1DM before and after starting hybrid closed loop insulin pump therapy, and investigate if glycemic control is influenced by demographic or diabetes characteristics. Methods: We obtained the electronic health records of patients seen at an academic medical center aged 2-26 with a diagnosis of diabetes mellitus who had been prescribed an Omnipod 5 between 07/01/2021 and 05/02/2023. These records were manually reviewed for suitability for inclusion and relevant data was collected and stored in a REDCap database. Data collected included demographic data (i.e. insurance, race, ethnicity, sex), diabetes data (i.e. age at diagnosis, date of pump initiation, episodes of diabetic ketoacidosis, prior use of other insulin pumps), HbA1c data at pump initiation visit and 3-month follow up visit, TIR data (the percent of time that patients were within target blood glucose range of 70-180 mg/dL) during three time intervals (i.e. 30, 60, and 90 days) before and after pump start. To identify patients of different backgrounds, we used cluster analysis methodology to identify clinically relevant groups based on personal demographics and medical history (using the KAMILA algorithm). Generalized mixed effects modeling compared identified groups empirically, to estimate and test the magnitudes of change. Results: 133 records were included in our analysis after eligibility screening. We reviewed cluster-identified patient characteristics and selected a four group solution, and their detailed demographic and diabetes characteristics are shown in Table 1. The salient characteristics for each group are as follows: Group 1 (n=42) was predominantly white (93%) and privately insured (93%), group 2 (n=26) had public insurance or was uninsured (100%) and was largely non-white (64%), group 3 (n=44) had the lowest prior pump usage (mean [95% CI], 0.52 [0, 1.52] months), group 4 (n=21) had the youngest average age at diagnosis (3.2 [2.6, 3.9] years ) and also the youngest age at pump initiation (5 [4.3, 5.8] years). Across all four groups, the TIR significantly increased after hybrid closed loop pump initiation as compared to baseline, from 46-47% to 60% (p<0.001 for all groups). Similarly, decreases in HbA1c values after pump initiation were observed across all four groups from 8.41-8.44 to 7.45-7.49 (p<0.05 for all groups). Conclusions: Improvements in glycemic control on hybrid closed loop insulin therapy were consistent across the groups despite the group differences in race, ethnicity, insurance status, prior insulin pump usage, age at diabetes diagnosis, and age at pump initiation. Importantly, these findings show that patients who are able to access hybrid closed loop insulin therapy do well despite demographic differences historically associated with poor glycemic control. These results are promising and support the increased role of hybrid closed loop insulin pumps in T1DM management.
Notes:: Scholarly concentration: Non-Scholarly Concentrator

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Li, Melinda M., Feldman, Noah, Tanzer, Joshua Ray, et al., "Real World Experience with the Omnipod 5 Hybrid Closed Loop Insulin Pump" (2023). Warren Alpert Medical School Academic Symposium. Brown Digital Repository. Brown University Library. https://repository.library.brown.edu/studio/item/bdr:fxexazyj/

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Warren Alpert Medical School Academic Symposium

The Warren Alpert Medical School Academic Symposium is an annual event at Warren Alpert Medical School of Brown University that provides Year II medical students a venue to present their summer research in a poster format. Participation in the Symposium …
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Real World Experience with the Omnipod 5 Hybrid Closed Loop Insulin Pump