Literature DB >> 25079676

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.

Sophie Borot1, Sylvia Franc2, Justine Cristante3, Alfred Penfornis1, Pierre-Yves Benhamou3, Bruno Guerci4, Hélène Hanaire5, Eric Renard6, Yves Reznik7, Chantal Simon8, Guillaume Charpentier9.   

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.
© 2014 Diabetes Technology Society.

Entities:  

Keywords:  catheter occlusion; continuous subcutaneous insulin infusion (CSII); insulin delivery accuracy; insulin pump; insulin therapy; microelectromechanical system (MEMS); patch pump; type 1 diabetes

Mesh:

Substances:

Year:  2014        PMID: 25079676      PMCID: PMC4455475          DOI: 10.1177/1932296814543946

Source DB:  PubMed          Journal:  J Diabetes Sci Technol        ISSN: 1932-2968


  20 in total

1.  Comparison of metabolic deterioration between insulin analog and regular insulin after a 5-hour interruption of a continuous subcutaneous insulin infusion in type 1 diabetic patients.

Authors:  B Guerci; L Meyer; A Sallé; A Charrié; B Dousset; O Ziegler; P Drouin
Journal:  J Clin Endocrinol Metab       Date:  1999-08       Impact factor: 5.958

2.  Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens using insulin lispro in type 1 diabetic patients on intensified treatment: a randomized study. The Study Group for the Development of Pump Therapy in Diabetes.

Authors:  H Hanaire-Broutin; V Melki; S Bessières-Lacombe; J P Tauber
Journal:  Diabetes Care       Date:  2000-09       Impact factor: 19.112

3.  Perceptions of psychosocial factors and the insulin pump.

Authors:  Marilyn D Ritholz; Arlene Smaldone; Jarim Lee; Astrid Castillo; Howard Wolpert; Katie Weinger
Journal:  Diabetes Care       Date:  2007-03       Impact factor: 19.112

4.  Changes in basal insulin infusion rates with subcutaneous insulin infusion: time until a change in metabolic effect is induced in patients with type 1 diabetes.

Authors:  Lutz Heinemann; Leszek Nosek; Christoph Kapitza; Matthias-Axel Schweitzer; Lars Krinelke
Journal:  Diabetes Care       Date:  2009-06-01       Impact factor: 19.112

Review 5.  Clinical review: Hypoglycemia with intensive insulin therapy: a systematic review and meta-analyses of randomized trials of continuous subcutaneous insulin infusion versus multiple daily injections.

Authors:  Mitra M Fatourechi; Yogish C Kudva; M Hassan Murad; Mohamed B Elamin; Claudia C Tabini; Victor M Montori
Journal:  J Clin Endocrinol Metab       Date:  2008-12-16       Impact factor: 5.958

Review 6.  Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus.

Authors:  Marie L Misso; Kristine J Egberts; Matthew Page; Denise O'Connor; Jonathan Shaw
Journal:  Cochrane Database Syst Rev       Date:  2010-01-20

Review 7.  Long-acting insulin analogs versus insulin pump therapy for the treatment of type 1 and type 2 diabetes.

Authors:  John C Pickup; Eric Renard
Journal:  Diabetes Care       Date:  2008-02       Impact factor: 19.112

8.  Quantifying the impact of a short-interval interruption of insulin-pump infusion sets on glycemic excursions.

Authors:  Howard Zisser
Journal:  Diabetes Care       Date:  2007-12-04       Impact factor: 19.112

9.  Continuous subcutaneous insulin infusion versus multiple daily insulin injections in type 2 diabetes: a meta-analysis.

Authors:  M Monami; C Lamanna; N Marchionni; E Mannucci
Journal:  Exp Clin Endocrinol Diabetes       Date:  2009-03-19       Impact factor: 2.949

10.  Safety of nighttime 2-hour suspension of Basal insulin in pump-treated type 1 diabetes even in the absence of low glucose.

Authors:  Jennifer L Sherr; Miladys Palau Collazo; Eda Cengiz; Camille Michaud; Lori Carria; Amy T Steffen; Kate Weyman; Melinda Zgorski; Eileen Tichy; William V Tamborlane; Stuart A Weinzimer
Journal:  Diabetes Care       Date:  2013-10-29       Impact factor: 19.112

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  10 in total

Review 1.  Boluses in Insulin Therapy.

Authors:  Ralph Ziegler; Guido Freckmann; Lutz Heinemann
Journal:  J Diabetes Sci Technol       Date:  2016-07-10

2.  Insulin Pump Occlusions: For Patients Who Have Been Around the (Infusion) Block.

Authors:  David C Klonoff; Guido Freckmann; Lutz Heinemann
Journal:  J Diabetes Sci Technol       Date:  2017-03-30

3.  Establishing Methods to Determine Clinically Relevant Bolus and Basal Rate Delivery Accuracy of Insulin Pumps.

Authors:  Ulrike Kamecke; Delia Waldenmaier; Cornelia Haug; Ralph Ziegler; Guido Freckmann
Journal:  J Diabetes Sci Technol       Date:  2018-07-13

4.  Patch Pumps: Are They All the Same?

Authors:  Lutz Heinemann; Delia Waldenmaier; Bernd Kulzer; Ralph Ziegler; Barry Ginsberg; Guido Freckmann
Journal:  J Diabetes Sci Technol       Date:  2018-08-22

5.  Reporting Insulin Pump Accuracy: Trumpet Curves According to IEC 60601-2-24 and Beyond.

Authors:  Stefan Pleus; Ulrike Kamecke; Delia Waldenmaier; Guido Freckmann
Journal:  J Diabetes Sci Technol       Date:  2018-10-12

6.  Occlusion Detection Time in Insulin Pumps at Two Different Basal Rates.

Authors:  Guido Freckmann; Ulrike Kamecke; Delia Waldenmaier; Cornelia Haug; Ralph Ziegler
Journal:  J Diabetes Sci Technol       Date:  2017-12-29

7.  10th Annual Symposium on Self-Monitoring of Blood Glucose, April 27-29, 2017, Warsaw, Poland.

Authors:  Christopher G Parkin; Anita Homberg; Rolf Hinzmann
Journal:  Diabetes Technol Ther       Date:  2017-11-14       Impact factor: 6.118

8.  Accuracy of Bolus and Basal Rate Delivery of Different Insulin Pump Systems.

Authors:  Guido Freckmann; Ulrike Kamecke; Delia Waldenmaier; Cornelia Haug; Ralph Ziegler
Journal:  Diabetes Technol Ther       Date:  2019-03-22       Impact factor: 6.118

Review 9.  Artificial Pancreas Device Systems for the Closed-Loop Control of Type 1 Diabetes: What Systems Are in Development?

Authors:  Sara Trevitt; Sue Simpson; Annette Wood
Journal:  J Diabetes Sci Technol       Date:  2016-05-03

10.  A Comparative Pulse Accuracy Study of Two Commercially Available Patch Insulin Infusion Pumps.

Authors:  Jenna L Bowen; Chris J Allender
Journal:  Eur Endocrinol       Date:  2016-08-28
  10 in total

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