Sensor-Augmented Insulin Pump with Predictive Low-Glucose Suspend (PLGS): Determining Optimal Settings of Pump and Sensor in a Multicenter Cohort of Patients with Type 1 Diabetes

Michael Joubert, Anaïs R Briant, Laurence Kessler, Fatéma Fall-Mostaine, Severine Dubois, Bruno Guerci, Laurène Schoumacker-Ley, Yves Reznik, Jean-Jacques Parienti, Michael Joubert, Anaïs R Briant, Laurence Kessler, Fatéma Fall-Mostaine, Severine Dubois, Bruno Guerci, Laurène Schoumacker-Ley, Yves Reznik, Jean-Jacques Parienti

Abstract

Introduction: The use of predictive low-glucose suspend (PLGS) sensor-augmented pumps has been shown to lead to a significant reduction in hypoglycemic episodes in patients with type 1 diabetes (T1D), but their effects on hyperglycemia exposure are heterogeneous. The aim of this study was to determine the settings of the Medtronic 640G system to obtain the optimal balance between occurrence of both hypoglycemia and hyperglycemia.

Methods: The hypo- and hyperglycemia area under the curve (AUC), as well as system settings [hypoglycemic threshold, mean insulin total daily dose (TDD), mean basal insulin percentage, and mean daily duration of PLGS] were collected between 2 and 12 times during 1 year in patients from four university hospital centers. Univariate/multivariate analyses and receiver operating characteristics (ROC) curves were performed to determine factors associated with hyper- and hypoglycemia AUC.

Results: A total of 864 observations were analyzed from 110 patients with T1D. Two preselected settings predictive of low hyperglycemia AUC were a basal insulin percentage < 52.0% [sensitivity (Se) = 0.66 and specificity (Sp) = 0.53] and a PLGS duration > 157.5 min/day (Se = 0.47 and Sp = 0.73). The preselected setting predictive of a low hypoglycemia AUC was a PLGS duration ≤ 174.4 min (Se = 0.83 and Sp = 0.51). Between-visit variation of PLGS and TDD was positively correlated (r = 0.61; p < 0.0001).

Conclusion: The most important Medtronic 640G setting was the mean daily PLGS duration, where a value between 157.5 and 174.4 min/day was associated with the best reduction in both hypo- and hyperglycemia AUC. In this study, we showed that PLGS duration could be indirectly modified through total daily insulin dose adaptation.

Trial registration: This study is registered in clinicaltrials.gov (NCT03047486).

Keywords: Hypo-minimizer; Predictive low-glucose suspend; Sensor-augmented pump; Type 1 diabetes.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Hyper- and hypoglycemia AUC centered and reduced in each participating center
Fig. 2
Fig. 2
ROC curves of setting parameters to protect from hyperglycemia (A) and hypoglycemia (B)
Fig. 3
Fig. 3
Plot of between-visit PLGS evolution (∆PLGS) (min) versus TDD evolution (∆TDD) (UI/kg). The computed regression equation between these two parameters is indicated on the graph

References

    1. American Diabetes A 9. Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes-2021. Diabetes Care. 2021;44(Suppl 1):S111–S124. doi: 10.2337/dc21-S009.
    1. American Diabetes A 7. Diabetes technology: standards of medical care in diabetes-2021. Diabetes Care. 2021;44(Suppl 1):S85–S99. doi: 10.2337/dc21-S007.
    1. Bekiari E, Kitsios K, Thabit H, et al. Artificial pancreas treatment for outpatients with type 1 diabetes: systematic review and meta-analysis. BMJ. 2018;361:k1310. doi: 10.1136/bmj.k1310.
    1. Karageorgiou V, Papaioannou TG, Bellos I, et al. Effectiveness of artificial pancreas in the non-adult population: a systematic review and network meta-analysis. Metabolism. 2019;90:20–30. doi: 10.1016/j.metabol.2018.10.002.
    1. Weisman A, Bai J-W, Cardinez M, Kramer CK, Perkins BA. Effect of artificial pancreas systems on glycaemic control in patients with type 1 diabetes: a systematic review and meta-analysis of outpatient randomised controlled trials. Lancet Diabetes Endocrinol. 2017;5(7):501–512. doi: 10.1016/S2213-8587(17)30167-5.
    1. Battelino T, Nimri R, Dovc K, Phillip M, Bratina N. Prevention of hypoglycemia with predictive low glucose insulin suspension in children with type 1 diabetes: a randomized controlled trial. Diabetes Care. 2017;40(6):764–770. doi: 10.2337/dc16-2584.
    1. Abraham MB, Nicholas JA, Smith GJ, et al. Reduction in hypoglycemia with the predictive low-glucose management system: a long-term randomized controlled trial in adolescents with type 1 diabetes. Diabetes Care. 2018;41(2):303–310. doi: 10.2337/dc17-1604.
    1. Bosi E, Choudhary P, de Valk HW, et al. Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial. Lancet Diabetes Endocrinol. 2019;7(6):462–472. doi: 10.1016/S2213-8587(19)30150-0.
    1. Forlenza GP, Li Z, Buckingham BA, et al. Predictive low-glucose suspend reduces hypoglycemia in adults, adolescents, and children with type 1 diabetes in an at-home randomized crossover study: results of the PROLOG trial. Diabetes Care. 2018;41(10):2155–2161. doi: 10.2337/dc18-0771.
    1. Choudhary P, de Portu S, Arrieta A, Castaneda J, Campbell FM. Use of sensor-integrated pump therapy to reduce hypoglycaemia in people with type 1 diabetes: a real-world study in the UK. Diabet Med. 2019;36(9):1100–1108. doi: 10.1111/dme.14043.
    1. Pinsker JE, Leas S, Müller L, Habif S. Real-world improvements in hypoglycemia in an insulin-dependent cohort with diabetes mellitus pre/post tandem basal-Iq technology remote software update. Endocr Pract. 2020;26(7):714–721. doi: 10.4158/EP-2019-0554.
    1. Tsunemi A, Sato J, Kurita M, et al. Effect of real-life insulin pump with predictive low-glucose management use for 3 months: analysis of the patients treated in a Japanese center. J Diabetes Investig. 2020;11(6):1564–1569. doi: 10.1111/jdi.13288.
    1. Beato-Vibora PI, Quiros-Lopez C, Lazaro-Martin L, et al. Impact of sensor-augmented pump therapy with predictive low-glucose suspend function on glycemic control and patient satisfaction in adults and children with type 1 diabetes. Diabetes Technol Ther. 2018;20(11):738–743. doi: 10.1089/dia.2018.0199.
    1. Katayama A, Tone A, Watanabe M, et al. The hypoglycemia-prevention effect of sensor-augmented pump therapy with predictive low glucose management in Japanese patients with type 1 diabetes mellitus: a short-term study. Diabetol Int. 2020;11(2):97–104. doi: 10.1007/s13340-019-00408-7.
    1. Muller L, Habif S, Leas S, Aronoff-Spencer E. Reducing hypoglycemia in the real world: a retrospective analysis of predictive low-glucose suspend technology in an ambulatory insulin-dependent cohort. Diabetes Technol Ther. 2019;21(9):478–484. doi: 10.1089/dia.2019.0190.
    1. Choudhary P, Olsen BS, Conget I, et al. Hypoglycemia prevention and user acceptance of an insulin pump system with predictive low glucose management. Diabetes Technol Ther. 2016;18(5):288–291. doi: 10.1089/dia.2015.0324.
    1. Keenan D, Mastrototaro J, Zisser H, et al. Accuracy of the Enlite 6-day glucose sensor with guardian and Veo calibration algorithms. Diabetes Technol Ther. 2012;14(3):225–231. doi: 10.1089/dia.2011.0199.
    1. Christiansen M, Garg S, Brazg R, et al. Accuracy of a fourth-generation subcutaneous continuous glucose sensor. Diabetes Technol Ther. 2017;19(8):446–456. doi: 10.1089/dia.2017.0087.

Source: PubMed

3
Sottoscrivi