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Clinical Trial
. 2024 Dec;26(12):5569-5579.
doi: 10.1111/dom.15906. Epub 2024 Sep 20.

Psychosocial outcomes with the Omnipod® 5 Automated Insulin Delivery System in caregivers of very young children with type 1 diabetes

Sarah A MacLeish  1 , Korey K Hood  2 , William H Polonsky  3   4 , Jamie R Wood  1 , Bruce W Bode  5 , Gregory P Forlenza  6 , Lori M Laffel  7 , Bruce A Buckingham  8 , Amy B Criego  9 , Melissa J Schoelwer  10 , Daniel J DeSalvo  11 , Jennifer L Sherr  12 , David W Hansen  13 , Lindsey R Conroy  14 , Lauren M Huyett  14 , Todd E Vienneau  14 , Trang T Ly  14 ; Omnipod 5 in Preschoolers Study Group
Affiliations
Clinical Trial

Psychosocial outcomes with the Omnipod® 5 Automated Insulin Delivery System in caregivers of very young children with type 1 diabetes

Sarah A MacLeish et al. Diabetes Obes Metab. 2024 Dec.

Abstract

Aim: Automated insulin delivery (AID) systems have demonstrated improved glycaemic outcomes in people with type 1 diabetes (T1D), yet limited data exist on these systems in very young children and their impact on caregivers. We evaluated psychosocial outcomes following use of the tubeless Omnipod® 5 AID System in caregivers of very young children.

Materials and methods: This 3-month single-arm, multicentre, pivotal clinical trial enrolled 80 children aged 2.0-5.9 years with T1D to use the Omnipod 5 AID System. Caregivers completed questionnaires assessing psychosocial outcomes-diabetes distress (Problem Areas in Diabetes), hypoglycaemia confidence (Hypoglycemia Confidence Scale), well-being (World Health Organization 5 Well-Being Index), sleep quality (Pittsburgh Sleep Quality Index), insulin delivery satisfaction (Insulin Delivery Satisfaction Survey) and system usability (System Usability Scale) at baseline with standard therapy and after 3 months of AID use.

Results: Following 3 months of Omnipod 5 use, caregivers experienced significant improvements across all measures, including diabetes-related psychosocial outcomes (Problem Areas in Diabetes; p < 0.0001, Hypoglycemia Confidence Scale; p < 0.01), well-being (World Health Organization 5 Well-Being Index; p < 0.0001) and perceived system usability (System Usability Scale; p < 0.0001). Significant improvements were seen in the Pittsburgh Sleep Quality Index total score and the overall sleep quality, sleep duration and efficiency subscales (all p < 0.05). Insulin Delivery Satisfaction Survey scores improved on all subscales (greater satisfaction, reduced burden and reduced inconvenience; all p < 0.0001).

Conclusions: Caregivers face unique challenges when managing T1D in very young children. While glycaemic metrics have unquestioned importance, these results evaluating psychosocial outcomes reveal additional meaningful benefits and suggest that the Omnipod 5 AID System alleviates some of the burdens caregivers face with diabetes management.

Keywords: clinical trial; insulin pump therapy; insulin therapy; patient‐reported outcomes.

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Conflict of interest statement

CONFLICT OF INTEREST STATEMENT

SAM reports personal fees from Insulet, during the conduct of the study. KKH reports consulting fees from Cecelia Health, Havas and Cercacor. WHP reports consulting fees from Dexcom, Abbott, and Insulet as well as grants from Dexcom and Abbott. JRW reports research support from Insulet, MannKind, Boehringer Ingelheim and Medtronic. BWB reports research support from Insulet, during the conduct of the study, as well as research support from Abbott, Advance, Diasome, DexCom, Janssen, Lilly, Medtronic, Novo Nordisk, Provention Bio, Sanofi, Sanvita, Senseonics, REMD Biotherapeutics, Xeris and vTv Therapeutics. BWB reports consultant and speaking fees from Boehringer Ingelheim, Insulet, Lilly, Mannkind, Medtronic, Novo Nordisk, Sanofi, Senseonics, Sanofi, Xeris and Zealand. GPF reports grants and personal fees from Insulet Corporation during the conduct of the study and grants and personal fees from Medtronic, grants and personal fees from Dexcom, grants from Abbott, grants and personal fees from Tandem, grants and personal fees from Lilly, and grants and personal fees from Beta Bionics, outside the submitted work. LML reports grants from Insulet, during the conduct of the study; personal fees from Eli Lilly, personal fees from Roche, personal fees from Insulet, personal fees from Boehringer Ingelheim, personal fees from Janssen, personal fees from Medtronic, personal fees from Provention, personal fees from Dompe, outside the submitted work. BAB reports grants and personal fees from Insulet, during the conduct of the study; grants and personal fees from Medtronic, non-financial support from Tandem, non-financial support from Dexcom, outside the submitted work; personal fees from Convatec, Lilly and Arecor. In addition, BAB has a patent 61197230 issued. ABC reports grants from Insulet, during the conduct of the study; grants from Dexcom, grants and other from Medtronic, grants from Abbott Diabetes, grants and other from Sanofi, grants and other from Eli Lilly, other from Medscape, outside the submitted work. MJS reports grants from Insulet, during the conduct of the study; grants and non-financial support from Tandem, non-financial support from Dexcom, and grants from Medtronic outside the submitted work. DJD reports research support from Insulet during the conduct of the study, as well as a grant from Lilly and personal honoraria from Dexcom and Insulet outside the submitted work. JLS reports research support from Insulet, during the conduct of the study, as well as research support from Medtronic and NIDDK. She has served on advisory boards for Bigfoot Biomedical, Cecelia Health, Insulet, Medtronic Diabetes, StartUp Health Diabetes Moonshot and Vertex. Consulting work has been done for Cecelia Health, Eli Lilly, Insulet, Medtronic and Zealand. DWH reports grants from Insulet, during the conduct of the study; grants from Medtronic grants from Lilly, and grants from Boehringer Ingelheim. TTL, TEV, LMH and LRC are full-time employees of and own stock in Insulet Corporation. No other conflicts of interest were reported.

References

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