Avari, P

Fernandez-Balsells, M

Fernandez-Real, J

Herrero, P

Jugnee, N

Leal, Y

Lopez, B

Martin, C

Massana, J

Nita, L

Oliver, N

Reddy, M

Thomas, M

Wos, M

Diabetes Technology & Therapeutics

English

Spiral - Imperial College Digital Repository

Parizad Avari1*, Yenny Leal2*, Marzena Wos2, Narvada Jugnee1, Maria Thomas1, Quim Massana3, Beatriz Lopez3, Lucian Nita4, Clare Martin5, Pau Herrero6, Nick Oliver1, José Manuel Fernández-Real2, Monika Reddy1, Mercè Fernández-Balsells2*Authors contributed equally 1Division of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College London, UK2Institut d’Investigació Biomèdica de Girona Dr Josep Trueta, Spain3Enginyeria Elèctrica, Electrònica i Automática, Universitat de Girona, Spain4 Department of Research & Development, Romsoft SRL, Romania5School of Engineering, Computing and Mathematics, Oxford Brookes University, Oxford, UK6Department of Electrical and Electronic Engineering, Imperial College London, London UKBackground and Aims• PEPPER (Patient Empowerment through Predictive PERsonaliseddecision support) is an EU-funded H2020 project that providespersonalised insulin bolus advice for people with Type 1 diabetes(T1D).• The PEPPER system includes an artificial intelligence (AI) poweredinsulin dose recommender and a safety system comprised ofpredictive glucose alarms, low-glucose suspend for insulin pump usersand personalised carbohydrate recommendations [1].• PEPPER offers a dual architecture to cater for both insulin injectionsand insulin pump treatments.• Users wear a real-time continuous glucose monitor and an activitymonitor that communicates to the handheld device.• Here, we evaluate the safety, feasibility and usability of the PEPPERsystem compared to a standard bolus calculator.Methods• Randomized controlled cross-over study.• After a 4-week run-in, participants were randomized toPEPPER/Control or Control/PEPPER in a 1:1 ratio for 12-weeks.• Participants then crossed over after a 3-week wash-out period.• The primary endpoint is percentage time in range (70 –180mg/dL)between the two groups.Efficacy and safety of the Patient Empowerment through Predictive Personalised Decision Support (PEPPER) system: an open-label randomised controlled trial Results• 58 participants were recruited at two clinical sites; ImperialCollege London in the UK and the Institut d'InvestigacióBiomèdica de Girona in Spain.• 44 participants were included in the final analysis.• Of 19 pump users (43%), the study had to be terminatedearly in 10 participants due to cessation of Cellnovo (pumpmanufacturer and study partner). Data has been includedfor analysis as these participants completed eitherintervention phase (Control or PEPPER) and was comparedto the baseline run-in period.Conclusion• The PEPPER Personalised Decision Support system is safeand feasible for use in people with Type 1 diabetes.• A trend suggesting improvement in time in range wasobserved between PEPPER and the control group.• These results are preliminary and further analysis is to beconducted on secondary outcomes, including glycaemicvariability, quality of life, and safety system outcomes.Acknowledgements• This project has received funding from the EuropeanUnion’s Horizon 2020 research and innovation programunder grant agreement 689810.References• Liu, C., Avari, P., Leal, Y., Wos, M., Sivasithamparam, K., Georgiou, P., et al. (2019). AModular Safety System for an Insulin Dose Recommender: A Feasibility Study. Journal ofdiabetes science and technologyInsulin pumpScreening Run-in period(4 weeks)Washout(3 weeks)Intervention groupPEPPER system (3 months)Control groupStandard bolus calculator (3 months)Intervention groupPEPPER system (3 months)Control groupStandard bolus calculator (3 months)Time in Glycaemic rangeBaseline (n=44)Control  (n=39)PEPPER (n=39) p-value%TIR (70-180mg/dL)55.3 (45.7 - 67.0)1.3 (-6.0 to 7.6)4.2 (-5.2 to 10.9) 0.44%TIR (70-140mg/dL)31.5 (25.0 - 43.4)-0.2(-7.0 to 6.2)2.1(-6.6 to 7.9)0.64%T <70mg/dL 3.0 (1.7 - 5.7)-0.3 (-1.7 to 0.9)-0.9 (-2.3 to 0.3)0.22%T <54mg/dL 1.1 (0.4- 2.0)-0.1 (-0.9 to 0.3)-0.2 (-1.1 to 0.1)0.35%T >180mg/dL 42.3(27.8 - 48.8)-1.6 (-7.6 to 6.9)-3.9 (-10.0 to 6.5) 0.66Demographics(n=44) Median (IQR) Gender (male:female) 23:21Pump:MDI 19:25Age (years) 42 (37 – 51)Duration of diabetes (years) 19 (11 – 26)HbA1c (mmol/mol) 60 (58 - 66) Table 1: Baseline DemographicsTable 2: Difference in percentage times in glycaemic ranges compared to baseline (run-In period)Figure 1: PEPPER Architecture and clinical platformFigure 2: PEPPER Phase 3 Clinical Study design

Efficacy and safety of the patient empowerment through predictive personalised decision support (pepper) system: an open-label randomised controlled trial

http://spiral.imperial.ac.uk/bitstream/10044/1/77578/2/ATTD2020_PEPPER_final.pdf

Efficacy and safety of the patient empowerment through predictive personalised decision support (pepper) system: an open-label randomised controlled trial

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