Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Dec 14:25:e44002.
doi: 10.2196/44002.

Psychosocial Outcomes Among Users and Nonusers of Open-Source Automated Insulin Delivery Systems: Multinational Survey of Adults With Type 1 Diabetes

Jasmine Schipp  1   2 , Christel Hendrieckx  1   3 , Katarina Braune  4   5   6   7 , Christine Knoll  4   6 , Shane O'Donnell  8 , Hanne Ballhausen  4   6   7 , Bryan Cleal  9 , Mandy Wäldchen  8 , Dana M Lewis  10 , Katarzyna A Gajewska  11   12 , Timothy C Skinner  1 , Jane Speight  1   3
Affiliations

Psychosocial Outcomes Among Users and Nonusers of Open-Source Automated Insulin Delivery Systems: Multinational Survey of Adults With Type 1 Diabetes

Jasmine Schipp et al. J Med Internet Res. .

Abstract

Background: Emerging research suggests that open-source automated insulin delivery (AID) may reduce diabetes burden and improve sleep quality and quality of life (QoL). However, the evidence is mostly qualitative or uses unvalidated, study-specific, single items. Validated person-reported outcome measures (PROMs) have demonstrated the benefits of other diabetes technologies. The relative lack of research investigating open-source AID using PROMs has been considered a missed opportunity.

Objective: This study aimed to examine the psychosocial outcomes of adults with type 1 diabetes using and not using open-source AID systems using a comprehensive set of validated PROMs in a real-world, multinational, cross-sectional study.

Methods: Adults with type 1 diabetes completed 8 validated measures of general emotional well-being (5-item World Health Organization Well-Being Index), sleep quality (Pittsburgh Sleep Quality Index), diabetes-specific QoL (modified DAWN Impact of Diabetes Profile), diabetes-specific positive well-being (4-item subscale of the 28-item Well-Being Questionnaire), diabetes treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire), diabetes distress (20-item Problem Areas in Diabetes scale), fear of hypoglycemia (short form of the Hypoglycemia Fear Survey II), and a measure of the impact of COVID-19 on QoL. Independent groups 2-tailed t tests and Mann-Whitney U tests compared PROM scores between adults with type 1 diabetes using and not using open-source AID. An analysis of covariance was used to adjust for potentially confounding variables, including all sociodemographic and clinical characteristics that differed by use of open-source AID.

Results: In total, 592 participants were eligible (attempting at least 1 questionnaire), including 451 using open-source AID (mean age 43, SD 13 years; n=189, 41.9% women) and 141 nonusers (mean age 40, SD 13 years; n=90, 63.8% women). Adults using open-source AID reported significantly better general emotional well-being and subjective sleep quality, as well as better diabetes-specific QoL, positive well-being, and treatment satisfaction. They also reported significantly less diabetes distress, fear of hypoglycemia, and perceived less impact of the COVID-19 pandemic on their QoL. All were medium-to-large effects (Cohen d=0.5-1.5). The differences between groups remained significant after adjusting for sociodemographic and clinical characteristics.

Conclusions: Adults with type 1 diabetes using open-source AID report significantly better psychosocial outcomes than those not using these systems, after adjusting for sociodemographic and clinical characteristics. Using validated, quantitative measures, this real-world study corroborates the beneficial psychosocial outcomes described previously in qualitative studies or using unvalidated study-specific items.

Keywords: artificial; diabetes mellitus; hypoglycaemia; pancreas; patient-reported outcome measures, surveys, and questionnaires; quality of life; sleep quality; type 1.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Timeline depicting the development of type 1 diabetes management and technology. This timeline is based on publications on insulin administration [3-5], glucose monitoring [6,7], intermittently scanned continuous glucose monitors (CGMs) [8], and open-source automated insulin delivery (AID) systems [9].
Figure 2
Figure 2
Diagram of participant inclusion and attrition. Adults with other types of diabetes (6 with type 2 diabetes, 21 with latent autoimmune diabetes, 6 with maturity-onset diabetes of the young, 1 with type 3c diabetes, and 1 participant with partial loss of pancreas) were excluded. AID: automated insulin delivery.
See this image and copyright information in PMC

References

    1. Dennick K, Sturt J, Speight J. What is diabetes distress and how can we measure it? A narrative review and conceptual model. J Diabetes Complications. 2017;31(5):898–911. doi: 10.1016/j.jdiacomp.2016.12.018. https://www.sciencedirect.com/science/article/abs/pii/S1056872716306638?... S1056-8727(16)30663-8 - DOI - PubMed
    1. Speight J, Holmes-Truscott E, Hendrieckx C, Skovlund S, Cooke D. Assessing the impact of diabetes on quality of life: what have the past 25 years taught us? Diabet Med. 2020;37(3):483–492. doi: 10.1111/dme.14196. https://onlinelibrary.wiley.com/doi/10.1111/dme.14196 - DOI - DOI - PubMed
    1. Kesavadev J, Saboo B, Krishna MB, Krishnan G. Evolution of insulin delivery devices: from syringes, pens, and pumps to DIY artificial pancreas. Diabetes Ther. 2020;11(6):1251–1269. doi: 10.1007/s13300-020-00831-z. https://link.springer.com/article/10.1007/s13300-020-00831-z 10.1007/s13300-020-00831-z - DOI - DOI - PMC - PubMed
    1. Mathieu C, Martens PJ, Vangoitsenhoven R. One hundred years of insulin therapy. Nat Rev Endocrinol. 2021;17(12):715–725. doi: 10.1038/s41574-021-00542-w.10.1038/s41574-021-00542-w - DOI - PubMed
    1. Sims EK, Carr ALJ, Oram RA, DiMeglio LA, Evans-Molina C. 100 years of insulin: celebrating the past, present and future of diabetes therapy. Nat Med. 2021;27(7):1154–1164. doi: 10.1038/s41591-021-01418-2. https://europepmc.org/abstract/MED/34267380 10.1038/s41591-021-01418-2 - DOI - PMC - PubMed

Publication types