Search

Your search keyword '"de Portu, Simona"' showing total 171 results
Start Over Author "de Portu, Simona"
171 results on '"de Portu, Simona"'

6. A European Cost–Utility Analysis of the MiniMed™ 780G Advanced Hybrid Closed-Loop System Versus Intermittently Scanned Continuous Glucose Monitoring with Multiple Daily Insulin Injections in People Living with Type 1 Diabetes

Author

Jendle, Johan, primary, Buompensiere, Maria Ida, additional, Ozdemir Saltik, Asli Zeynep, additional, de Portu, Simona, additional, Smith-Palmer, Jayne, additional, Pollock, Richard F., additional, and Cohen, Ohad, additional

Published
2023
Full Text
View/download PDF

7. 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

Author

Laurenzi, Andrea, Caretto, Amelia, Slatterly, David, Henderson-Wilson, Marcia, Weisnagel, S. John, Dubé, Marie-Christine, Julien, Valérie-Ève, Trevisan, Roberto, Lepore, Giuseppe, Bellante, Rosalia, Hramiak, Irene, Spaic, Tamara, Driscoll, Marsha, Borot, Sophie, Clergeot, Annie, Khiat, Lamia, Hammond, Peter, Ray, Sutapa, Dinning, Laura, Tonolo, Giancarlo, Manconi, Alberto, Ledda, Maura Serena, de Ranitz, Wendela, Silvius, Bianca, Wojtusciszyn, Anne, Farret, Anne, Vriesendorp, Titia, Immeker-de Jong, Folkje, van der Linden, Joke, Brink, Huguette S., Alkemade, Marije, Schaepelynck-Belicar, Pauline, Galie, Sébastien, Tréglia, Clémence, Benhamou, Pierre-Yves, Haddouche, Myriam, Hoogma, Roel, Leelarathna, Lalantha, Shaju, Angel, James, Linda, Bosi, Emanuele, Choudhary, Pratik, de Valk, Harold W, Lablanche, Sandrine, Castañeda, Javier, de Portu, Simona, Da Silva, Julien, Ré, Roseline, Vorrink-de Groot, Linda, Shin, John, Kaufman, Francine R, and Cohen, Ohad

Published
2019
Full Text
View/download PDF

10. Twelve‐month results of the ADAPT randomized controlled trial: Reproducibility and sustainability of advanced hybrid closed‐loop therapy outcomes versus conventional therapy in adults with type 1 diabetes.

Author

Edd, Shannon N., Castañeda, Javier, Choudhary, Pratik, Kolassa, Ralf, Keuthage, Winfried, Kroeger, Jens, Thivolet, Charles, Evans, Mark, Ré, Roseline, Cellot, Jessica, de Portu, Simona, Vorrink, Linda, Shin, John, van den Heuvel, Tim, Cohen, Ohad, Reznik, Yves, Catargi, Bogdan, Kessler, Laurence, Borot, Sophie, and Schaepelynck‐Belicar, Pauline

Subjects
TYPE 1 diabetes, INSULIN aspart, RANDOMIZED controlled trials, GLYCOSYLATED hemoglobin, HYPOGLYCEMIA, PATIENT reported outcome measures
Abstract

Aims: To reassess the 6‐month efficacy and to assess the 12‐month sustained efficacy of the MiniMed™ 780G advanced hybrid closed‐loop automated insulin delivery (AID) system compared to multiple daily injections plus intermittently scanned glucose monitoring (MDI+isCGM) in people with type 1 diabetes not meeting glucose targets. Methods: The ADAPT study was a prospective, multicentre, open‐label, randomized control trial in people with type 1 diabetes, with a glycated haemoglobin (HbA1c) concentration of at least 8.0% (64 mmol/mol), on MDI+isCGM therapy. After a 6‐month study phase, participants randomized at baseline to MDI+isCGM switched to AID (SWITCH) while the others continued AID therapy (SUSTAIN) for an additional 6 months. The primary endpoint of this continuation phase was the within‐group change in mean HbA1c between 6 and 12 months, with superiority in the SWITCH group and noninferiority in the SUSTAIN group (ClinicalTrials.gov: NCT04235504). Results: A total of 39 SWITCH and 36 SUSTAIN participants entered the continuation phase. In the SWITCH group, HbA1c was significantly decreased by −1.4% (95% confidence interval [CI] −1.7% to −1.1%; P < 0.001) from a mean ± SD of 8.9% ± 0.8% (73.9 ± 8.6 mmol/mol) at 6 months to 7.5% ± 0.6% (58.5 ± 6.9 mmol/mol) at 12 months. Mean HbA1c increased by 0.1% (95% CI −0.05% to +0.25%), from 7.3% ± 0.6% (56.5 ± 6.7 mmol/mol) to 7.4% ± 0.8% (57.7 ± 9.1 mmol/mol) in the SUSTAIN group, meeting noninferiority criteria. Three severe hypoglycaemia events occurred in two SWITCH participants during the continuation phase. Conclusion: ADAPT study phase glycaemic improvements were reproduced and sustained in the continuation phase, supporting the early adoption of AID therapy in people with type 1 diabetes not meeting glucose targets on MDI therapy. [ABSTRACT FROM AUTHOR]

Published
2023
Full Text
View/download PDF

11. Twelve-month results of the ADAPT randomized controlled trial: reproducibility and sustainability of advanced hybrid closed loop therapy outcomes versus conventional therapy in adults with type 1 diabetes

Author

Evans, Mark, Edd, Shannon, Castañeda, Javier, Choudhary, Pratik, Kolassa, Ralf, Keuthage, Winfried, Kroeger, Jens, Thivolet, Charles, Ré, Roseline, Cellot, Jessica, De Portu, Simona, Vorrink, Linda, Shin, John, Van Den Heuvel, Tim, Cohen, Ohad, Evans, Mark [0000-0001-8122-8987], and Apollo - University of Cambridge Repository

Abstract

In the care of type 1 diabetes, there is growing adoption of hybrid closed loop systems, as they have been shown in clinical trials and real-world use to safely provide favorable glycemic control compared to multiple daily injection and compared to sensor augmented pump therapies1-3. However, access to these technologies is often limited, as a stepwise approach to diabetes technologies is recommended. Hence, people with diabetes requiring intensive insulin therapy must start with multiple daily injection (MDI) therapy and self-monitoring blood glucose (SMBG) or intermittent scanning continuous glucose monitoring (CGM) before progressing to MDI therapy with real-time CGM, eventually moving on to automated insulin delivery (AID) system therapy if necessary4. This can be a lengthy process, exposing people with diabetes to prolonged periods of suboptimal blood glucose levels. Following this stepwise approach, there is evidence to support an improvement in glucose control with the MiniMedTM 780G Advanced Hybrid Closed Loop AID system compared to its predecessors (MiniMedTM 670G system)5 and to sensor-augmented pumps with predictive low glucose management6. However, to support a more direct approach to advanced diabetes management technology, it was of interest to compare the MiniMedTM 780G system to the most prevalent therapy, namely multiple daily injections (MDI) with intermittent scanning continuous glucose monitoring (isCGM)7.

Published
2023
Full Text
View/download PDF

12. Advanced Hybrid Closed Loop in Adult Population With Type 1 Diabetes: A Substudy From the ADAPT Randomized Controlled Trial in Users of Real-Time Continuous Glucose Monitoring

Author

van den Heuvel, Tim, primary, Kolassa, Ralf, additional, Keuthage, Winfried, additional, Kroeger, Jens, additional, Ré, Roseline, additional, de Portu, Simona, additional, Vorrink, Linda, additional, Shin, John, additional, Castañeda, Javier, additional, Vigersky, Robert, additional, and Cohen, Ohad, additional

Published
2023
Full Text
View/download PDF

13. A European Cost-Utility Analysis of the MiniMedTM 780G Advanced Hybrid Closed-Loop System versus Intermittently Scanned Continuous Glucose Monitoring with Multiple Daily Insulin Injections in People Living with Type 1 Diabetes

Author

Jendle, Johan, Buompensiere, Maria Ida, Ozdemir Saltik, Asli Zeynep, de Portu, Simona, Smith-Palmer, Jayne, Pollock, Richard, Cohen, Ohad, Jendle, Johan, Buompensiere, Maria Ida, Ozdemir Saltik, Asli Zeynep, de Portu, Simona, Smith-Palmer, Jayne, Pollock, Richard, and Cohen, Ohad

Abstract

Background: Advanced hybrid closed-loop (AHCL) automated insulin delivery systems are the most effective therapy in terms of assisting people with type 1 diabetes (T1D) to achieve glycemic targets; however, the cost can represent a barrier to uptake. Here, a cost-utility analysis of the MiniMedTM 780G AHCL system (MM780G) versus intermittently-scanned continuous glucose monitoring (is-CGM) plus multiple daily insulin injections (MDI) in people with T1D not achieving glycemic goals was performed across six European countries. Methods: Clinical input data were sourced from the ADAPT trial. Assuming a baseline HbA1c of 9.04%, HbA1c reductions of 1.54% for AHCL and 0.2% for is-CGM+MDI were assumed. The analyses were performed from a payer perspective over a time horizon of 40 years and an annual discount rate of 3% was applied. Results: Across all countries, the use of AHCL was projected to result in an incremental gain in quality-adjusted life expectancy of >2 quality-adjusted life years (QALYs) versus is-CGM+MDI. Lifetime direct costs were higher with AHCL resulting in incremental cost-utility ratios for AHCL versus is-CGM+MDI ranging from EUR 11,765 per QALY gained in Austria to EUR 43,963 per QALY gained in Italy. Conclusions: For people with T1D managed with is-CGM+MDI not achieving glycemic targets, initiation of the MM780G system was projected to improve long-term clinical outcomes; however, due to differences in healthcare costs between countries, the health economic outcomes differ. In the countries included here, AHCL is likely to be cost-effective relative to is-CGM+MDI for people not achieving glycemic goals with is-CGM+MDI. The ADAPT trial is registered with ClinicalTrials.gov, NCT04235504.

Published
2023
Full Text
View/download PDF

14. Response to: Letter to the Editor with Regard to the Cost-Effectiveness of Hybrid Closed-Loop Systems Versus Multiple Daily Injections Plus Intermittently Scanned Continuous Glucose Monitoring in Type 1 Diabetes in the Netherlands

Author

MS Interne Geneeskunde, Circulatory Health, Serné, Erik H., Roze, Stéphane, Buompensiere, Maria I., Valentine, William J., de Portu, Simona, de Valk, Harold W., MS Interne Geneeskunde, Circulatory Health, Serné, Erik H., Roze, Stéphane, Buompensiere, Maria I., Valentine, William J., de Portu, Simona, and de Valk, Harold W.

Published
2023

15. sj-docx-1-dst-10.1177_19322968231161320 – Supplemental material for Advanced Hybrid Closed Loop in Adult Population With Type 1 Diabetes: A Substudy From the ADAPT Randomized Controlled Trial in Users of Real-Time Continuous Glucose Monitoring

Author

van den Heuvel, Tim, Kolassa, Ralf, Keuthage, Winfried, Kroeger, Jens, Ré, Roseline, de Portu, Simona, Vorrink, Linda, Shin, John, Castañeda, Javier, Vigersky, Robert, and Cohen, Ohad

Subjects
111708 Health and Community Services, FOS: Clinical medicine, 111199 Nutrition and Dietetics not elsewhere classified, Medicine, FOS: Health sciences, 110306 Endocrinology
Abstract

Supplemental material, sj-docx-1-dst-10.1177_19322968231161320 for Advanced Hybrid Closed Loop in Adult Population With Type 1 Diabetes: A Substudy From the ADAPT Randomized Controlled Trial in Users of Real-Time Continuous Glucose Monitoring by Tim van den Heuvel, Ralf Kolassa, Winfried Keuthage, Jens Kroeger, Roseline Ré, Simona de Portu, Linda Vorrink, John Shin, Javier Castañeda, Robert Vigersky and Ohad Cohen in Journal of Diabetes Science and Technology

Published
2023
Full Text
View/download PDF

20. Cost-Effectiveness of Hybrid Closed Loop Insulin Pumps Versus Multiple Daily Injections Plus Intermittently Scanned Glucose Monitoring in People With Type 1 Diabetes in The Netherlands

Author

MS Interne Geneeskunde, Circulatory Health, Serné, Erik H., Roze, Stéphane, Buompensiere, Maria I., Valentine, William J., De Portu, Simona, de Valk, Harold W., MS Interne Geneeskunde, Circulatory Health, Serné, Erik H., Roze, Stéphane, Buompensiere, Maria I., Valentine, William J., De Portu, Simona, and de Valk, Harold W.

Published
2022

26. Predicting Factors Associated with Hypoglycemia Reduction with Automated Predictive Insulin Suspension in Patients at High Risk of Severe Hypoglycemia: An Analysis from the SMILE Randomized Trial

Author

MS Interne Geneeskunde, Circulatory Health, Habteab, Aklilu, Castañeda, Javier, De Valk, Harold, Choudhary, Pratik, Bosi, Emanuele, Lablanche, Sandrine, De Portu, Simona, Da Silva, Julien, Vorrink-De Groot, Linda, Shin, John, Cohen, Ohad, MS Interne Geneeskunde, Circulatory Health, Habteab, Aklilu, Castañeda, Javier, De Valk, Harold, Choudhary, Pratik, Bosi, Emanuele, Lablanche, Sandrine, De Portu, Simona, Da Silva, Julien, Vorrink-De Groot, Linda, Shin, John, and Cohen, Ohad

Published
2020

30. Predicting Factors Associated with Hypoglycemia Reduction with Automated Predictive Insulin Suspension in Patients at High Risk of Severe Hypoglycemia: An Analysis from the SMILE Randomized Trial

Author

Habteab, Aklilu, primary, Castañeda, Javier, additional, de Valk, Harold, additional, Choudhary, Pratik, additional, Bosi, Emanuele, additional, Lablanche, Sandrine, additional, de Portu, Simona, additional, Da Silva, Julien, additional, Vorrink-de Groot, Linda, additional, Shin, John, additional, and Cohen, Ohad, additional

Published
2020
Full Text
View/download PDF

36. 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

Author

Haddouche, Aini, Bellanne‐Chantelot, Christine, Rod, Anne, Fournier, Luc, Chiche, Laurence, Gautier, Jean‐Francois, Timsit, José, Laboureau, Sandrine, Chaillous, Lucy, Valero, Rene, Larger, Etienne, Jeandidier, Nathalie, Wilhelm, Jean‐Marie, Popelier, Marc, Guillausseau, Pierre‐Jean, Thivolet, Charles, Lecomte, Pierre, Benhamou, Pierre‐Yves, Reznik, Yves, Bosi, Emanuele, Choudhary, Pratik, De Valk, Harold, Lablanche, Sandrine, Castaneda, Javier, De Portu, Simona, Da Silva, Julien, Ré, Roseline, Vorrink-de Groot, Linda, Shin, John, Kaufman, Francine, Cohen, Ohad, Laurenzi, Andrea, Caretto, Amelia, Slatterly, David, Henderson-Wilson, Marcia, Weisnagel, S. John, Dubé, Marie-Christine, Julien, Valérie-Ève, Trevisan, Roberto, Lepore, Giuseppe, Bellante, Rosalia, Hramiak, Irene, Spaic, Tamara, Driscoll, Marsha, Borot, Sophie, Clergeot, Annie, Khiat, Lamia, Hammond, Peter, Ray, Sutapa, Dinning, Laura, Tonolo, Giancarlo, Manconi, Alberto, Ledda, Maura Serena, de Ranitz, Wendela, Silvius, Bianca, Wojtusciszyn, Anne, Farret, Anne, Vriesendorp, Titia, Immeker-de Jong, Folkje, van der Linden, Joke, Brink, Huguette, Alkemade, Marije, Schaepelynck-Belicar, Pauline, Galie, Sébastien, Tréglia, Clémence, Haddouche, Myriam, Hoogma, Roel, Leelarathna, Lalantha, Shaju, Angel, James, Linda, Institut National de l'Environnement Industriel et des Risques (INERIS), Service de Chirurgie digestive [Bordeaux], CHU Bordeaux [Bordeaux], Service de diabétologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition, Hôpital Laennec, Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Institut Cochin (IC UM3 (UMR 8104 / U1016)), Centre National de la Recherche Scientifique (CNRS)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Strasbourg, Pharmacologie Endocrinienne, Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Institut National de la Recherche Agronomique (INRA), Université de Liège, Centre Hospitalier Universitaire [Grenoble] (CHU), Laboratory of Fundamental and Applied Bioenergetics = Laboratoire de bioénergétique fondamentale et appliquée (LBFA), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Dipartimento di Biologia Evoluzionistica 'Leo Pardi', Università degli Studi di Firenze = University of Florence [Firenze] (UNIFI), King's College Hospital (KCH), University Medical Center [Utrecht], Medtronic Bakken Research Center BV, Medtronic Diabetes, International Trading Sàrl , Tolochenaz, Switzerland, Human Computer Technology Laboratory (HCTLab), Universidad Autonoma de Madrid (UAM), Service de Diabétologie - Endocrinologie [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institute of Child Health, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Endocrinologie, Hôpital Sainte-Marguerite [CHU - APHM] (Hôpitaux Sud )-CHU Marseille, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Cochin [AP-HP], Hôpital de la Conception [CHU - APHM] (LA CONCEPTION ), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hôpital Lariboisière, Institut National de la Recherche Agronomique (INRA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire de bioénergétique fondamentale et appliquée (LBFA), Université Grenoble Alpes (UGA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Joseph Fourier - Grenoble 1 (UJF), Università degli Studi di Firenze [Firenze], Service de diabétologie - endocrinologie, Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Hôpital Jean Minjoz, Service de diabétologie - endocrinologie [Besançon], Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Hôpital Jean Minjoz-Université de Franche-Comté (UFC), Bosi, E, Choudhary, P, de Valk, H, Lablanche, S, Castaneda, J, de Portu, S, Da Silva, J, Re, R, Vorrink-de Groot, L, Shin, J, Kaufman, F, Cohen, O, Laurenzi, A, Caretto, A, Slatterly, D, Henderson-Wilson, M, Weisnagel, S, Dube, M, Julien, V, Trevisan, R, Lepore, G, Bellante, R, Hramiak, I, Spaic, T, Driscoll, M, Borot, S, Clergeot, A, Khiat, L, Hammond, P, Ray, S, Dinning, L, Tonolo, G, Manconi, A, Ledda, M, de Ranitz, W, Silvius, B, Wojtusciszyn, A, Farret, A, Vriesendorp, T, Immeker-de Jong, F, van der Linden, J, Brink, H, Alkemade, M, Schaepelynck-Belicar, P, Galie, S, Treglia, C, Benhamou, P, Haddouche, M, Hoogma, R, Leelarathna, L, Shaju, A, James, L, Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hospices Civils de Lyon (HCL), Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), Bosi, E., Choudhary, P., de Valk, H. W., Lablanche, S., Castaneda, J., de Portu, S., Da Silva, J., Re, R., Vorrink-de Groot, L., Shin, J., Kaufman, F. R., Cohen, O., Laurenzi, A., Caretto, A., Slatterly, D., Henderson-Wilson, M., Weisnagel, S. J., Dube, M. -C., Julien, V. -E., Trevisan, R., Lepore, G., Bellante, R., Hramiak, I., Spaic, T., Driscoll, M., Borot, S., Clergeot, A., Khiat, L., Hammond, P., Ray, S., Dinning, L., Tonolo, G., Manconi, A., Ledda, M. S., de Ranitz, W., Silvius, B., Wojtusciszyn, A., Farret, A., Vriesendorp, T., Immeker-de Jong, F., van der Linden, J., Brink, H. S., Alkemade, M., Schaepelynck-Belicar, P., Galie, S., Treglia, C., Benhamou, P. -Y., Haddouche, M., Hoogma, R., Leelarathna, L., Shaju, A., and James, L.

Subjects
Adult, Male, Insulin pump, Pediatrics, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, [SDV]Life Sciences [q-bio], Population, glucose, hemoglobin A1c, insulin, antidiabetic agent, 030209 endocrinology & metabolism, Low insulin, law.invention, 03 medical and health sciences, Insulin Infusion Systems, 0302 clinical medicine, Endocrinology, Randomized controlled trial, law, Internal Medicine, medicine, Humans, Hypoglycemic Agents, Insulin, 030212 general & internal medicine, education, ComputingMilieux_MISCELLANEOUS, education.field_of_study, Type 1 diabetes, Continuous glucose monitoring, business.industry, Middle Aged, medicine.disease, Hypoglycemia, 3. Good health, Diabetes Mellitus, Type 1, Hypoglycaemia unawareness, Female, Open label, business
Abstract

Background: Hypoglycaemia unawareness and severe hypoglycaemia can increase fear of hypoglycaemia and the risk of subsequent hypoglycaemic events. We aimed to assess the safety and efficacy of insulin pump therapy with integrated continuous glucose monitoring (CGM) and a suspend-before-low feature (Medtronic MiniMed 640G with SmartGuard) in hypoglycaemia-prone adults with type 1 diabetes. Methods: SMILE was an open-label randomised controlled trial done in people aged 24–75 years with type 1 diabetes for 10 years or longer, HbA1c values of 5·8–10·0% (40–86 mmol/mol), and at high risk of hypoglycaemia (recent severe hypoglycaemia or hypoglycaemia unawareness defined by a Clarke or Gold score ≥4). Participants were enrolled from 16 centres (eg, clinics, hospitals, or university medical centres) in Canada, France, Italy, the Netherlands, and the UK. After baseline run-in phase (2 weeks), participants were randomly assigned to the MiniMed 640G pump (continuous subcutaneous insulin infusion) with self-monitoring of blood glucose (control group) or to the MiniMed 640G system with the suspend-before-low feature enabled (intervention group), for 6 months. The study statistician analysing the data was masked to group assignment until final database lock; because of the nature of the intervention, participants and treating clinicians could not be masked to group assignment. The primary outcome was the mean number of sensor hypoglycaemic events, defined as 55 mg/dL (3·1 mmol/L) or lower, and was analysed on an intention-to-treat basis in all randomly assigned participants. This trial is registered with ClinicalTrials.gov, number NCT02733991, and is completed. Findings: Between Dec 7, 2016, and March 27, 2018, 153 participants with a mean age 48·2 [12·4] years were randomly assigned: 77 to the control group (mean age 47·4 [12·5] years) and 76 to the intervention group (mean age 49·0 [12·2] years). After 6 months, the intervention group had significantly fewer hypoglycaemic events per participant per week (1·1 [SD 1·2] vs 4·1 [3·4] mean events, model-based treatment effect −2·9 [95% CI −3·5 to −2·3]; p

Published
2019

37. Cost-Effectiveness Analysis of the MiniMed 670G Hybrid Closed-Loop System Versus Continuous Subcutaneous Insulin Infusion for Treatment of Type 1 Diabetes

Author

Jendle, Johan, Pöhlmann, Johannes, de Portu, Simona, Smith-Palmer, Jayne, Roze, Stéphane, Jendle, Johan, Pöhlmann, Johannes, de Portu, Simona, Smith-Palmer, Jayne, and Roze, Stéphane

Abstract

BACKGROUND: Hybrid closed-loop (HCL) systems combine continuous glucose monitoring with continuous subcutaneous insulin infusion (CSII) to continuously self-adjust basal insulin delivery. Relative to CSII, HCL improves glycemic control and reduces the risk of hypoglycemia but has higher acquisition costs. The aim of this analysis was to assess the cost-effectiveness of the MiniMed™ 670G HCL system versus CSII in people with type 1 diabetes (T1D) in Sweden. METHODS: Cost-effectiveness analysis, from a societal perspective, was performed over patient lifetimes using the IQVIA CORE Diabetes Model. Clinical data were sourced from a study comparing the MiniMed 670G system with CSII in people with T1D. Cost data, expressed in 2018 Swedish krona (SEK), were obtained from Swedish reference prices and published literature. RESULTS: The MiniMed 670G system was associated with a quality-adjusted life-year (QALY) gain of 1.90 but higher overall costs versus CSII, leading to an incremental cost-effectiveness ratio (ICER) of SEK 164,236 per QALY gained. Use of the HCL system resulted in a lower cumulative incidence of diabetes-related complications. Higher HCL system acquisition costs were partially offset by reduced complication costs and productivity losses. In people with T1D poorly controlled at baseline, the MiniMed 670G system was associated with 2.25 incremental QALYs versus CSII, yielding an ICER of SEK 15,830 per QALY gained. CONCLUSIONS: The MiniMed 670G system was associated with clinical benefits and quality-of-life improvements in people with T1D relative to CSII. At a willingness-to-pay threshold of SEK 300,000 per QALY gained, this HCL system likely represents a cost-effective treatment option for people with T1D in Sweden., Funding Agency:Medtronic International Trading Sarl

Published
2019
Full Text
View/download PDF

38. 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

Author

Bosi, Emanuele, primary, Choudhary, Pratik, additional, de Valk, Harold W, additional, Lablanche, Sandrine, additional, Castañeda, Javier, additional, de Portu, Simona, additional, Da Silva, Julien, additional, Ré, Roseline, additional, Vorrink-de Groot, Linda, additional, Shin, John, additional, Kaufman, Francine R, additional, Cohen, Ohad, additional, Laurenzi, Andrea, additional, Caretto, Amelia, additional, Slatterly, David, additional, Henderson-Wilson, Marcia, additional, Weisnagel, S. John, additional, Dubé, Marie-Christine, additional, Julien, Valérie-Ève, additional, Trevisan, Roberto, additional, Lepore, Giuseppe, additional, Bellante, Rosalia, additional, Hramiak, Irene, additional, Spaic, Tamara, additional, Driscoll, Marsha, additional, Borot, Sophie, additional, Clergeot, Annie, additional, Khiat, Lamia, additional, Hammond, Peter, additional, Ray, Sutapa, additional, Dinning, Laura, additional, Tonolo, Giancarlo, additional, Manconi, Alberto, additional, Ledda, Maura Serena, additional, de Ranitz, Wendela, additional, Silvius, Bianca, additional, Wojtusciszyn, Anne, additional, Farret, Anne, additional, Vriesendorp, Titia, additional, Immeker-de Jong, Folkje, additional, van der Linden, Joke, additional, Brink, Huguette S., additional, Alkemade, Marije, additional, Schaepelynck-Belicar, Pauline, additional, Galie, Sébastien, additional, Tréglia, Clémence, additional, Benhamou, Pierre-Yves, additional, Haddouche, Myriam, additional, Hoogma, Roel, additional, Leelarathna, Lalantha, additional, Shaju, Angel, additional, and James, Linda, additional

Published
2019
Full Text
View/download PDF

40. Study of MiniMed 640G Insulin Pump with SmartGuard in Prevention of Low Glucose Events in Adults with Type 1 Diabetes (SMILE): Design of a Hypoglycemia Prevention Trial with Continuous Glucose Monitoring Data as Outcomes

Author

De Valk, Harold W., primary, Lablanche, Sandrine, additional, Bosi, Emanuele, additional, Choudhary, Pratik, additional, Silva, Julien Da, additional, Castaneda, Javier, additional, Vorrink, Linda, additional, De Portu, Simona, additional, and Cohen, Ohad, additional

Published
2018
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results