TY - JOUR
T1 - How introduction of automated insulin delivery systems may influence psychosocial outcomes in adults with type 1 diabetes
T2 - Findings from the first investigation with the Omnipod® 5 System
AU - for the Omnipod 5 Research Group
AU - Polonsky, William H.
AU - Hood, Korey K.
AU - Levy, Carol J.
AU - MacLeish, Sarah A.
AU - Hirsch, Irl B.
AU - Brown, Sue A.
AU - Bode, Bruce W.
AU - Carlson, Anders L.
AU - Shah, Viral N.
AU - Weinstock, Ruth S.
AU - Bhargava, Anuj
AU - Jones, Thomas C.
AU - Aleppo, Grazia
AU - Mehta, Sanjeev N.
AU - Laffel, Lori M.
AU - Forlenza, Gregory P.
AU - Sherr, Jennifer L.
AU - Huyett, Lauren M.
AU - Vienneau, Todd E.
AU - Ly, Trang T.
N1 - Publisher Copyright:
© 2022 The Authors
PY - 2022/8
Y1 - 2022/8
N2 - Aims: To evaluate psychosocial outcomes for adults with type 1 diabetes (T1D) using the tubeless Omnipod® 5 Automated Insulin Delivery (AID) System. Methods: A single-arm, multicenter (across the United States), prospective safety and efficacy study of the tubeless AID system included 115 adults with T1D. Participants aged 18–70 years completed questionnaires assessing psychosocial outcomes – diabetes distress (T1-DDS), hypoglycemic confidence (HCS), well-being (WHO-5), sleep quality (PSQI), insulin delivery satisfaction (IDSS), diabetes treatment satisfaction (DTSQ), and system usability (SUS) – before and after 3 months of AID use. Associations among participant characteristics, psychosocial measures and glycemic outcomes were evaluated using linear regression analyses. Results: Adults using the tubeless AID system demonstrated improvements in diabetes-specific psychosocial measures, including diabetes distress, hypoglycemic confidence, insulin delivery satisfaction, diabetes treatment satisfaction, and system usability after 3 months (all P < 0.001). No changes in general well-being or sleep quality were observed. The psychosocial outcomes assessed were not consistently associated with baseline participant characteristics (i.e., age, sex, diabetes duration, glycemic outcomes including percent time in range 70–180 mg/dL, percent time below range < 70 mg/dL, hemoglobin A1c, or insulin regimen). Conclusions: Use of the Omnipod 5 AID system was associated with significant improvements in diabetes-related psychosocial outcomes for adults with T1D. Clinical Trials Registration Number: NCT04196140.
AB - Aims: To evaluate psychosocial outcomes for adults with type 1 diabetes (T1D) using the tubeless Omnipod® 5 Automated Insulin Delivery (AID) System. Methods: A single-arm, multicenter (across the United States), prospective safety and efficacy study of the tubeless AID system included 115 adults with T1D. Participants aged 18–70 years completed questionnaires assessing psychosocial outcomes – diabetes distress (T1-DDS), hypoglycemic confidence (HCS), well-being (WHO-5), sleep quality (PSQI), insulin delivery satisfaction (IDSS), diabetes treatment satisfaction (DTSQ), and system usability (SUS) – before and after 3 months of AID use. Associations among participant characteristics, psychosocial measures and glycemic outcomes were evaluated using linear regression analyses. Results: Adults using the tubeless AID system demonstrated improvements in diabetes-specific psychosocial measures, including diabetes distress, hypoglycemic confidence, insulin delivery satisfaction, diabetes treatment satisfaction, and system usability after 3 months (all P < 0.001). No changes in general well-being or sleep quality were observed. The psychosocial outcomes assessed were not consistently associated with baseline participant characteristics (i.e., age, sex, diabetes duration, glycemic outcomes including percent time in range 70–180 mg/dL, percent time below range < 70 mg/dL, hemoglobin A1c, or insulin regimen). Conclusions: Use of the Omnipod 5 AID system was associated with significant improvements in diabetes-related psychosocial outcomes for adults with T1D. Clinical Trials Registration Number: NCT04196140.
KW - Automated insulin delivery
KW - Closed-loop system
KW - Psychosocial outcomes
KW - Type 1 diabetes
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U2 - 10.1016/j.diabres.2022.109998
DO - 10.1016/j.diabres.2022.109998
M3 - Article
C2 - 35853530
AN - SCOPUS:85136338920
SN - 0168-8227
VL - 190
JO - Diabetes Research and Clinical Practice
JF - Diabetes Research and Clinical Practice
M1 - 109998
ER -
