Patients with type 1 diabetes (T1D) who used the Omnipod 5 Automated Insulin Delivery (AID) System saw significant improvements in psychosocial outcomes, including diabetes distress and hypoglycemic confidence over a 3-month period.
Use of an automated insulin delivery (AID) system was associated with significant improvements in diabetes-related psychosocial outcomes for adults with type 1 diabetes (T1D), according to study findings published recently in Diabetes Research and Clinical Practice.
As the first study indicated to report on psychosocial outcomes with a tubeless AID system, researchers followed participants using the Omnipod 5 AID system. The device is an on-body system consisting of a tubeless insulin pump with a built-in algorithm that communicates continuous glucose monitor data directly with the Omnipod 5 App via smartphone to inform automated insulin dosing.
A single-arm, multicenter, prospective safety and efficacy study was conducted to evaluate the psychosocial outcomes for adults with T1D using the Omnipod system.
A total of 115 adults between 18 and 70 years of age with T1D in the United States were assessed. The authors noted that these adults with T1D were already experiencing positive outcomes with their prior therapy, with relatively low glycated hemoglobin A1C (HbA1c)and favorable psychosocial outcomes at the start of the study.
Participants completed questionnaires examining psychosocial outcomes, including the T1D Distress Scale (T1-DDS), the Hypoglycemia Confidence Scale (HCS), the World Health Organization 5 Well-Being Index (WHO-5), the Pittsburgh Sleep Quality Index (PSQI), the Insulin Delivery Satisfaction Survey (IDSS), the Diabetes Treatment Satisfaction Questionnaire (DTSQ), and the System Usability Scale (SUS). Questionnaires were completed before and after 3 months of Omnipod use.
Researchers evaluated associations among participant characteristics, psychosocial measures, and glycemic outcomes using linear regression analyses.
Findings showed that adults using Omnipod demonstrated improvements in diabetes-specific psychosocial measures. Significant improvements were measured for diabetes distress and hypoglycemic confidence after 3 months (all, P < .001). Of the 7 T1-DDS subscales for diabetes distress, participants reported significant improvements in reductions in powerlessness, management distress, hypoglycemia distress, eating distress, and physician distress.
Significant improvements in treatment satisfaction and usability were also observed with the Omnipod system compared with prior treatment across insulin delivery satisfaction, diabetes treatment satisfaction, and system usability after 3 months (all, P < .001).
Participants reported significant reductions in the burden and inconvenience of the insulin delivery device, with no reduction in system effectiveness observed. No changes were observed in general well-being or sleep quality. Additional benefits beyond those attained with prior therapy were cited regarding the use of the Omnipod 5 System.
Conversely, researchers found that the psychosocial outcomes assessed were not consistently associated with baseline participant characteristics, including age, sex, diabetes duration, and glycemic outcomes of percent time in range 70-180mg/dL, percenttime below range less than 70mg/dL, HbA1c, or insulin regimen. Changes in psychosocial outcomes did not differ between groups according to prior therapy type or baseline HbA1c.
Several study limitations were cited, including the lack of a randomized control group for comparison. The 3-month period of the study was limited, and it did not measure impact on psychosocial measures over time in a real-world environment.
A majority of participants in the study were non-Hispanic White (85.2%) and many of these patients were already close to achieving their HbA1c goal at enrollment. These factors may limit the generalizability of the study in relation to racial and ethnic groups and broader ranges of glycemic control.
Despite these limitations, the authors assert that the Omnipod 5 AID System was associated with substantial improvement in diabetes distress, usability, and satisfaction in this sample population. They further noted that a post market study is planned to evaluate the Omnipod system in a larger sample that is more representative of the T1D population.
“These results indicate that the Omnipod 5 AID System evaluated in this study could offer a valuable option to potentially relieve some of the emotionally and cognitively taxing aspects of diabetes management for adults with T1D,” concluded researchers.
Polonsky WH, Hood KK, Levy CJ, et al. How introduction of automated insulin delivery systems may influence psychosocial outcomes in adults with type 1 diabetes: Findings from the first investigation with the Omnipod® 5 System. Diabetes Res Clin Pract. Published online July 16, 2022. doi:10.1016/j.diabres.2022.109998