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Open-source automated insulin delivery systems (OS-AIDs) in a pediatric population with type 1 diabetes in a real-life setting: the AWeSoMe study group experience

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Abstract

Purpose

The use of open-source automated insulin delivery systems (OS-AIDs), for the management of type 1 diabetes (T1D), has increased over recent years in all age groups. Real-life data has demonstrated the safety and efficacy of these systems, however, studies in the pediatric population remain limited. In this study, we aimed to examine the effect of transition to an OS-AIDs on glycemic parameters, and on several aspects related to quality of life. In addition, we aimed to characterize the socioeconomic position of families who chose this treatment modality, assess their motivations to do so, and evaluate treatment satisfaction.

Methods

In this multi-center observational real-life study from the AWeSoMe Group, we compared glycemic parameters of 52 individuals with T1D (56% males, mean diabetes duration 4.2 ± 3.9 years), from the last clinic visit prior to OS-AIDs initiation to the most recent clinic visit while using the system. Socioeconomic position (SEP) index was retrieved from the Israel Central Bureau of Statistics. Caregivers completed questionnaires assessing reasons for system initiation and treatment satisfaction.

Results

Mean age at OS-AIDs initiation was 11.2 ± 4 years, range 3.3–20.7 years with a median usage duration of 11.1 months (range 3–45.7). Mean SEP Index was 1.033 ± 0.956 (value range: −2.797 to 2.590). Time in range (TIR) of 70 to 180 mg/dl increased from 69.0 ± 11.9 to 75.5 ± 11.7%, (P < 0.001), and HbA1c decreased from 6.9 ± 0.7 to 6.4 ± 0.6%, (P < 0.001). Time in tight range (TITR) of 70 to 140 mg/dl increased from 49.7 ± 12.9 to 58.8 ± 10.8% (P < 0.001). No episodes of severe hypoglycemia or DKA were reported. Reduction in diabetes burden and sleep quality improvement were the main reasons for OS-AID initiation.

Conclusions

In our cohort of youth with T1D, the transition to an OS-AID resulted in greater TIR and less severe hypoglycemia regardless of age, diabetes duration or SEP, which was found to be above average. The overall improvement in glycemic parameters in our study population with excellent baseline glycemic control, provides additional evidence of beneficence and efficacy of OS-AIDs in the pediatric population.

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Acknowledgements

An abstract of this manuscript was presented as a poster at the 60th Annual Meeting of the European Society for Pediatric Endocrinology (ESPE), Rome, Italy, September 17th 2022 and can be accessed at https://www.karger.com/Article/Pdf/525606. We would like to express our gratitude and appreciation to the participants and their families.

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Authors and Affiliations

  1. Pediatric Endocrinology and Diabetes Institute, Shamir (Assaf Harofeh) Medical Center, Zerifin, Israel

    Judith Nir & Marianna Rachmiel

  2. Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel

    Judith Nir, Marianna Rachmiel, Yael Lebenthal, Avivit Brener, Orit Pinhas-Hamiel, Eve Stern & Tal Ben-Ari

  3. Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK

    Abigail Fraser

  4. Pediatric Endocrinology and Diabetes Unit, Dana-Dwek Children’s Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

    Yael Lebenthal & Avivit Brener

  5. Pediatric Endocrine and Diabetes Unit, Edmond and Lily Safra Children’s Hospital, Sheba Medical Center, Ramat Gan, Israel

    Orit Pinhas-Hamiel & Eve Stern

  6. Juvenile Diabetes Center, Maccabi Healthcare Services, Raanana, Israel

    Orit Pinhas-Hamiel, Noa Levek & Zohar Landau

  7. Pediatric Endocrinology and Diabetes Unit, Soroka University Medical Center, Beer Sheva, Israel

    Alon Haim

  8. The Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel

    Alon Haim & Zohar Landau

  9. Pediatric Endocrinology Unit, Edith Wolfson Medical Center, Holon, Israel

    Tal Ben-Ari

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  1. Judith Nir
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Contributions

J.N., Z.L., M.R., Y.L., and O.P.-H. contributed to the study design. J.N., M.R., Y.L., A.B., O.P.-H., A.H., E.S., N.L., T.B., and Z.L. assisted with data collection. A.F. contributed to the manuscript writing and data interpretation, O.P.-H., A.B., and A.H. participated in data analysis and review of the manuscript. All contributing authors advised on analysis or interpretation of the data and all authors commented on and revised the manuscript and approved the submission. J.N. the corresponding author, had access to the study data and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Corresponding author

Correspondence to Judith Nir.

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The authors declare no competing interests.

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Written informed consent was obtained from all adult patients (18 years old or above) or by the parents or guardians of children (under 18 years of age).

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The study was conducted according to the principles of the Declaration of Helsinki. Each center obtained local ethics committee approval.

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Nir, J., Rachmiel, M., Fraser, A. et al. Open-source automated insulin delivery systems (OS-AIDs) in a pediatric population with type 1 diabetes in a real-life setting: the AWeSoMe study group experience. Endocrine 81, 262–269 (2023). https://doi.org/10.1007/s12020-023-03398-4

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