title: Accuracy of a new patch pump based on a microelectromechanical system (MEMS) compared to other commercially available insulin pumps: results of the first in vitro and in vivo studies.
abstract: The JewelPUMP™ (JP) is a new patch pump based on a microelectromechanical system that operates without any plunger. The study aimed to evaluate the infusion accuracy of the JP in vitro and in vivo. For the in vitro studies, commercially available pumps meeting the ISO standard were compared to the JP: the MiniMed® Paradigm® 712 (MP), Accu-Chek® Combo (AC), OmniPod® (OP), Animas® Vibe™ (AN). Pump accuracy was measured over 24 hours using a continuous microweighing method, at 0.1 and 1 IU/h basal rates. The occlusion alarm threshold was measured after a catheter occlusion. The JP, filled with physiological serum, was then tested in 13 patients with type 1 diabetes simultaneously with their own pump for 2 days. The weight difference was used to calculate the infused insulin volume. The JP showed reduced absolute median error rate in vitro over a 15-minute observation window compared to other pumps (1 IU/h): ±1.02% (JP) vs ±1.60% (AN), ±1.66% (AC), ±2.22% (MP), and ±4.63% (OP), P < .0001. But there was no difference over 24 hours. At 0.5 IU/h, the JP was able to detect an occlusion earlier than other pumps: 21 (19; 25) minutes vs 90 (85; 95), 58 (42; 74), and 143 (132; 218) minutes (AN, AC, MP), P < .05 vs AN and MP. In patients, the 24-hour flow error was not significantly different between the JP and usual pumps (-2.2 ± 5.6% vs -0.37 ± 4.0%, P = .25). The JP was found to be easier to wear than conventional pumps. The JP is more precise over a short time period, more sensitive to catheter occlusion, well accepted by patients, and consequently, of potential interest for a closed-loop insulin delivery system.
authors: Department of Endocrinology-Metabolism and Diabetology-Nutrition, University Hospital of Besançon and University of Franche-Comte, Besançon, France.
authors: Sophie
authors: S
authors: Borot
authors: Centre Hospitalier Sud-Francilien, Department of Diabetes and Endocrinology, Corbeil-Essonne, France Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète, Corbeil-Essonnes, France.
authors: Sylvia
authors: S
authors: Franc
authors: Department of Endocrinology, Pôle DigiDune, Grenoble University Hospital, Joseph-Fourier University, Grenoble, France.
authors: Justine
authors: J
authors: Cristante
authors: Department of Endocrinology-Metabolism and Diabetology-Nutrition, University Hospital of Besançon and University of Franche-Comte, Besançon, France.
authors: Alfred
authors: A
authors: Penfornis
authors: Department of Endocrinology, Pôle DigiDune, Grenoble University Hospital, Joseph-Fourier University, Grenoble, France.
authors: Pierre-Yves
authors: PY
authors: Benhamou
authors: University of Lorraine and the Department of Diabetology, Metabolic Diseases and Nutrition, Brabois Adult Hospital, Vandoeuvre les Nancy, France.
authors: Bruno
authors: B
authors: Guerci
authors: Cardiovascular and Metabolic Unit, Department of Diabetology, University Hospital of Toulouse, Toulouse, France.
authors: Hélène
authors: H
authors: Hanaire
authors: Department of Endocrinology, Diabetes, and Nutrition and Clinical Investigation Centre, Montpellier University Hospital, Montpellier, France.
authors: Eric
authors: E
authors: Renard
authors: Endocrinology and Diabetes Department, Côte de Nacre, Caen, France.
authors: Yves
authors: Y
authors: Reznik
authors: Hospices Civils de Lyon, University of Lyon, Lyon, France.
authors: Chantal
authors: C
authors: Simon
authors: Centre Hospitalier Sud-Francilien, Department of Diabetes and Endocrinology, Corbeil-Essonne, France Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète, Corbeil-Essonnes, France kerbonac@free.fr.
authors: Guillaume
authors: G
authors: Charpentier
mesh_terms: D000328:Adult; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D066298:In Vitro Techniques; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems; D008297:Male; D055617:Micro-Electrical-Mechanical Systems / Q000295:instrumentation / Q000379:methods; D008875:Middle Aged; D017060:Patient Satisfaction; D010865:Pilot Projects; D057968:Transdermal Patch
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin
keywords: catheter occlusion; continuous subcutaneous insulin infusion (CSII); insulin delivery accuracy; insulin pump; insulin therapy; microelectromechanical system (MEMS); patch pump; type 1 diabetes