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16-01-2024 | Type 1 Diabetes | Original Article

A comparison of the usage of an open-source automated insulin delivery system and the MiniMed™ 780 G system in children and adolescents with type 1 diabetes in real-world settings: the AWeSoMe study group

Authors: Zohar Landau, Yael Lebenthal, Kineret Mazor-Aronovitch, Avivit Brener, Noah Levek, Talia Jacobi-Polishook, Tal Ben Ari, Shirly Abiri, Alon Haim, Judith Nir, Marianna Rachmiel, Orit Pinhas-Hamiel

Published in: Endocrine | Issue 3/2024

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Abstract

Purpose

In recent years there has been a noticeable increase in the use of advanced hybrid closed-loop systems (AHCLs) for managing type 1 diabetes (T1D) among youth. However, there is a lack of comparison between the open-source automated insulin delivery (AID) system and the MiniMed™ 780 G system (780 G).

Methods

In this multi-center study, we retrospectively compared selected glycemic ranges of 26 individuals who used open-source AID and 20 individuals who used 780 G (age 11.3 years [IQR 9.3, 12.9] and 13.4 years [IQR 10.9, 16.5], respectively, p = 0.069) from system initiation to the most recent visit.

Results

At baseline, the median HbA1c was significantly lower and the time below range (TBR)<54mg/dL was significantly higher in the open-source AID group compared to the 780 G group (6.8% [IQR 6.4, 7.1] vs. 7.4% [IQR 6.9, 8.6], p = 0.006 and (1.0% [IQR 0.5, 2.8] vs. 0.0% [0.0, 1.0], p = 0.014), respectively; the median time in range (TIR70–180mg/dL) was similar (p = 0.068). After a median duration of 10.9 months on AHCLs the reduction of HbA1c was similar ( ~ 0.3%). The time spent in the hypoglycemic ranges was longer among users of the open-source AID compared to 780 G (TBR54–70mg/dL 4.2% [IQR 2.6, 7.3] vs. 2.0% [1.0, 4.0], p = 0.005) and TBR<54mg/dL 1.1% [IQR 0.4, 2.3] vs. 0.0 [0.0, 1.0], p = 0.001).

Conclusions

Both AHCLs similarly improved HbA1c and TIR70–180mg/dL. The open-source AID youth had better glycemic control but spent longer time in the hypoglycemic range. These findings must be considered when choosing the use of AHCL technologies.
Literature
1.
go back to reference R.A. Lal, L. Ekhlaspour, K. Hood, B. Buckingham, Realizing a closed-loop (Artificial Pancreas) system for the treatment of Type 1 diabetes. Endocr. Rev. 40, 1521–1546 (2019)CrossRefPubMedPubMedCentral R.A. Lal, L. Ekhlaspour, K. Hood, B. Buckingham, Realizing a closed-loop (Artificial Pancreas) system for the treatment of Type 1 diabetes. Endocr. Rev. 40, 1521–1546 (2019)CrossRefPubMedPubMedCentral
2.
go back to reference K. Braune, R.A. Lal, L. Petruželková, G. Scheiner, P. Winterdijk, S. Schmidt, L. Raimond, K.K. Hood, M.C. Riddell, T.C. Skinner, K. Raile, S. Hussain, Open-source automated insulin delivery: international consensus statement and practical guidance for health-care professionals. Lancet Diabetes Endocrinol. 10, 58–74 (2022)CrossRefPubMed K. Braune, R.A. Lal, L. Petruželková, G. Scheiner, P. Winterdijk, S. Schmidt, L. Raimond, K.K. Hood, M.C. Riddell, T.C. Skinner, K. Raile, S. Hussain, Open-source automated insulin delivery: international consensus statement and practical guidance for health-care professionals. Lancet Diabetes Endocrinol. 10, 58–74 (2022)CrossRefPubMed
3.
go back to reference J.L. Sherr, L. Heinemann, G.A. Fleming, R.M. Bergenstal, D. Bruttomesso, H. Hanaire, R.W. Holl, J.R. Petrie, A.L. Peters, M. Evans, Automated insulin delivery: benefits, challenges, and recommendations. A consensus report of the joint diabetes technology working group of the european association for the study of diabetes and the American Diabetes Association. Diabetologia 66, 3–22 (2023)CrossRefPubMed J.L. Sherr, L. Heinemann, G.A. Fleming, R.M. Bergenstal, D. Bruttomesso, H. Hanaire, R.W. Holl, J.R. Petrie, A.L. Peters, M. Evans, Automated insulin delivery: benefits, challenges, and recommendations. A consensus report of the joint diabetes technology working group of the european association for the study of diabetes and the American Diabetes Association. Diabetologia 66, 3–22 (2023)CrossRefPubMed
4.
go back to reference L. Petruzelkova, P. Jiranova, J. Soupal, M. Kozak, L. Plachy, V. Neuman, S. Pruhova, B. Obermannova, S. Kolouskova, Z. Sumnik, Pre-school and school-aged children benefit from the switch from a sensor-augmented pump to an AndroidAPS hybrid closed loop: A retrospective analysis. Pediatr. Diabetes 22, 594–604 (2021)CrossRefPubMed L. Petruzelkova, P. Jiranova, J. Soupal, M. Kozak, L. Plachy, V. Neuman, S. Pruhova, B. Obermannova, S. Kolouskova, Z. Sumnik, Pre-school and school-aged children benefit from the switch from a sensor-augmented pump to an AndroidAPS hybrid closed loop: A retrospective analysis. Pediatr. Diabetes 22, 594–604 (2021)CrossRefPubMed
5.
go back to reference M.J. Burnside, D.M. Lewis, H.R. Crocket, R.A. Meier, J.A. Williman, O.J. Sanders, C.A. Jefferies, A.M. Faherty, R.G. Paul, C.S. Lever, S.K.J. Price, C.M. Frewen, S.D. Jones, T.C. Gunn, C. Lampey, B.J. Wheeler, M.I. de Bock, Open-source automated insulin delivery in Type 1 diabetes. N. Engl. J. Med. 387, 869–881 (2022). https://doi.org/10.1056/NEJMoa2203913CrossRefPubMed M.J. Burnside, D.M. Lewis, H.R. Crocket, R.A. Meier, J.A. Williman, O.J. Sanders, C.A. Jefferies, A.M. Faherty, R.G. Paul, C.S. Lever, S.K.J. Price, C.M. Frewen, S.D. Jones, T.C. Gunn, C. Lampey, B.J. Wheeler, M.I. de Bock, Open-source automated insulin delivery in Type 1 diabetes. N. Engl. J. Med. 387, 869–881 (2022). https://​doi.​org/​10.​1056/​NEJMoa2203913CrossRefPubMed
6.
go back to reference J. Da Silva, G. Lepore, T. Battelino, A. Arrieta, J. Castañeda, B. Grossman, J. Shin, O. Cohen, Real-world performance of the MiniMed™ 780G system: first report of outcomes from 4120 users. Diabetes Technol. Ther. 24, 113–119 (2022)CrossRefPubMedPubMedCentral J. Da Silva, G. Lepore, T. Battelino, A. Arrieta, J. Castañeda, B. Grossman, J. Shin, O. Cohen, Real-world performance of the MiniMed™ 780G system: first report of outcomes from 4120 users. Diabetes Technol. Ther. 24, 113–119 (2022)CrossRefPubMedPubMedCentral
7.
go back to reference M. Bassi, M. Teliti, M. Lezzi, A. Iosca, M.F. Strati, L. Carmisciano, G. d’Annunzio, N. Minuto, D. Maggi, A Comparison of Two Hybrid Closed-Loop Systems in Italian Children and Adults With Type 1 Diabetes. Front Endocrinol. (Lausanne) 12, 802419 (2022)CrossRefPubMed M. Bassi, M. Teliti, M. Lezzi, A. Iosca, M.F. Strati, L. Carmisciano, G. d’Annunzio, N. Minuto, D. Maggi, A Comparison of Two Hybrid Closed-Loop Systems in Italian Children and Adults With Type 1 Diabetes. Front Endocrinol. (Lausanne) 12, 802419 (2022)CrossRefPubMed
8.
go back to reference Characterization and Classification of Statistical Areas Within Municipalities and Local Councils by the Socio-Economic Level of the Population 2015. 2019 Characterization and Classification of Statistical Areas Within Municipalities and Local Councils by the Socio-Economic Level of the Population 2015. 2019
9.
go back to reference T. Battelino, T. Danne, R.M. Bergenstal, S.A. Amiel, R. Beck, T. Biester, E. Bosi, B.A. Buckingham, W.T. Cefalu, K.L. Close, C. Cobelli, E. Dassau, J.H. DeVries, K.C. Donaghue, K. Dovc, F.J. Doyle, S. Garg, G. Grunberger, S. Heller, L. Heinemann, I.B. Hirsch, R. Hovorka, W. Jia, O. Kordonouri, B. Kovatchev, A. Kowalski, L. Laffel, B. Levine, A. Mayorov, C. Mathieu, H.R. Murphy, R. Nimri, K. Nørgaard, C.G. Parkin, E. Renard, D. Rodbard, B. Saboo, D. Schatz, K. Stoner, T. Urakami, S.A. Weinzimer, M. Phillip, Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range. Diabetes Care 42, 1593–1603 (2019)CrossRefPubMedPubMedCentral T. Battelino, T. Danne, R.M. Bergenstal, S.A. Amiel, R. Beck, T. Biester, E. Bosi, B.A. Buckingham, W.T. Cefalu, K.L. Close, C. Cobelli, E. Dassau, J.H. DeVries, K.C. Donaghue, K. Dovc, F.J. Doyle, S. Garg, G. Grunberger, S. Heller, L. Heinemann, I.B. Hirsch, R. Hovorka, W. Jia, O. Kordonouri, B. Kovatchev, A. Kowalski, L. Laffel, B. Levine, A. Mayorov, C. Mathieu, H.R. Murphy, R. Nimri, K. Nørgaard, C.G. Parkin, E. Renard, D. Rodbard, B. Saboo, D. Schatz, K. Stoner, T. Urakami, S.A. Weinzimer, M. Phillip, Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range. Diabetes Care 42, 1593–1603 (2019)CrossRefPubMedPubMedCentral
10.
go back to reference R.M. Bergenstal, R.W. Beck, K.L. Close, G. Grunberger, D.B. Sacks, A. Kowalski, A.S. Brown, L. Heinemann, G. Aleppo, D.B. Ryan, T.D. Riddlesworth, W.T. Cefalu, Glucose management indicator (GMI): a new term for estimating a1c from continuous glucose monitoring. Diabetes Care 41, 2275–2280 (2018)CrossRefPubMedPubMedCentral R.M. Bergenstal, R.W. Beck, K.L. Close, G. Grunberger, D.B. Sacks, A. Kowalski, A.S. Brown, L. Heinemann, G. Aleppo, D.B. Ryan, T.D. Riddlesworth, W.T. Cefalu, Glucose management indicator (GMI): a new term for estimating a1c from continuous glucose monitoring. Diabetes Care 41, 2275–2280 (2018)CrossRefPubMedPubMedCentral
11.
go back to reference K. Braune, S. O’Donnell, B. Cleal, D. Lewis, A. Tappe, I. Willaing, B. Hauck, K. Raile, Real-world use of do-it-yourself artificial pancreas systems in children and adolescents With Type 1 diabetes: online survey and analysis of self-reported clinical outcomes. JMIR Mhealth Uhealth 7, 14087 (2019)CrossRef K. Braune, S. O’Donnell, B. Cleal, D. Lewis, A. Tappe, I. Willaing, B. Hauck, K. Raile, Real-world use of do-it-yourself artificial pancreas systems in children and adolescents With Type 1 diabetes: online survey and analysis of self-reported clinical outcomes. JMIR Mhealth Uhealth 7, 14087 (2019)CrossRef
12.
go back to reference K. Braune, K.A. Gajewska, A. Thieffry, D.M. Lewis, T. Froment, S. O’Donnell, J. Speight, C. Hendrieckx, J. Schipp, T. Skinner, H. Langstrup, A. Tappe, K. Raile, and B. Cleal, Why #WeAreNotWaiting-Motivations and Self-Reported Outcomes Among Users of Open-source Automated Insulin Delivery Systems: Multinational Survey. J Med Internet Res 23, https://doi.org/10.2196/25409 (2021) K. Braune, K.A. Gajewska, A. Thieffry, D.M. Lewis, T. Froment, S. O’Donnell, J. Speight, C. Hendrieckx, J. Schipp, T. Skinner, H. Langstrup, A. Tappe, K. Raile, and B. Cleal, Why #WeAreNotWaiting-Motivations and Self-Reported Outcomes Among Users of Open-source Automated Insulin Delivery Systems: Multinational Survey. J Med Internet Res 23, https://​doi.​org/​10.​2196/​25409 (2021)
13.
go back to reference A. Arrieta, T. Battelino, A.E. Scaramuzza, J. Da Silva, J. Castañeda, T.L. Cordero, J. Shin, O. Cohen, Comparison of MiniMed 780G system performance in users aged younger and older than 15 years: evidence from 12 870 real-world users. Diabetes Obes. Metab. 24, 1370–1379 (2022)CrossRefPubMedPubMedCentral A. Arrieta, T. Battelino, A.E. Scaramuzza, J. Da Silva, J. Castañeda, T.L. Cordero, J. Shin, O. Cohen, Comparison of MiniMed 780G system performance in users aged younger and older than 15 years: evidence from 12 870 real-world users. Diabetes Obes. Metab. 24, 1370–1379 (2022)CrossRefPubMedPubMedCentral
15.
go back to reference T. Urakami, Severe hypoglycemia: is it still a threat for children and adolescents with Type 1 diabetes? Front Endocrinol. (Lausanne) 11, 609 (2020)CrossRefPubMed T. Urakami, Severe hypoglycemia: is it still a threat for children and adolescents with Type 1 diabetes? Front Endocrinol. (Lausanne) 11, 609 (2020)CrossRefPubMed
16.
go back to reference L. Zhang, L. Yang, Z. Zhou, Data-based modeling for hypoglycemia prediction: Importance, trends, and implications for clinical practice. Front Public Health 11, (2023) L. Zhang, L. Yang, Z. Zhou, Data-based modeling for hypoglycemia prediction: Importance, trends, and implications for clinical practice. Front Public Health 11, (2023)
Metadata
Title
A comparison of the usage of an open-source automated insulin delivery system and the MiniMed™ 780 G system in children and adolescents with type 1 diabetes in real-world settings: the AWeSoMe study group
Authors
Zohar Landau
Yael Lebenthal
Kineret Mazor-Aronovitch
Avivit Brener
Noah Levek
Talia Jacobi-Polishook
Tal Ben Ari
Shirly Abiri
Alon Haim
Judith Nir
Marianna Rachmiel
Orit Pinhas-Hamiel
Publication date
16-01-2024
Publisher
Springer US
Published in
Endocrine / Issue 3/2024
Print ISSN: 1355-008X
Electronic ISSN: 1559-0100
DOI
https://doi.org/10.1007/s12020-024-03683-w

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