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
| العنوان: | 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 |
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| المؤلفون: | 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 |
| المساهمون: | 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., James, L. |
| المصدر: | Lancet Diabetes and Endocrinology Lancet Diabetes and Endocrinology, Elsevier, 2019, 7 (6), pp.462-472. ⟨10.1016/S2213-8587(19)30150-0⟩ |
| بيانات النشر: | HAL CCSD, 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | 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 |
| الوصف: | 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 |
| اللغة: | English |
| تدمد: | 2213-8587 2213-8595 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4a1f07dcdfa77e081d8d7a2e4398f65bTest https://hal.archives-ouvertes.fr/hal-02328545Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....4a1f07dcdfa77e081d8d7a2e4398f65b |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 22138587 22138595 |
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