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Koebrugge R.,Inreda Diabetic BV | Koops R.,Inreda Diabetic BV
Journal of Diabetes Science and Technology | Year: 2012

Background: The aim of this pilot study was to test the feasibility of a bihormonal (glucagon and insulin) closed-loop (CL) system by challenging the system with two meals and 30 min exercise. Methods: Ten patients with type 1 diabetes treated with continuous subcutaneous insulin infusion underwent a standardized protocol on three different occasions: 40 g carbohydrate breakfast followed 2 h later by 30 min of moderate-intensity exercise, followed 1.5 h later by a standardized 60 g carbohydrate lunch. An open-loop (OL) day served as control, the first CL day as tuning experiment, and the second CL day to compare with OL. Results: The overall mean venous glucose was similar: 9 (5.4-13.5) mmol/liter in OL versus 8.7 (6.4-11.0) mmol/liter in CL, p = .74. The p ostbreakfast glucose concentrations tended to be lower in OL than in CL [9.5 (4.3-13.3) versus 11.4 (7-16.2) mmol/liter; p = . 07] and higher in OL than in CL postlunch [9.4 (6.0-14.9) versus 7.7 (5.5-9.0) mmol/liter, p = .15]. The postexercise glucose concentrations were similar in OL and CL: 7.5 (4.6-13) versus 8.2 (5.5-13.1) mmol/liter; p = .45. In those patients coming in with baseline glucose above 7 mmol/liter, there was initial overinsulinization in CL. During OL, two hypoglycemic episodes occurred compared with four hypoglycemic episodes in three participants during CL. Glucagon seemed mostly effective in preventing hypoglycemia. Conclusions: Overall, CL glucose control was comparable to OL control, but there was overinsulinization in those patients with baseline glucose above 7 mmol/liter. © Diabetes Technology Society.


Van Bon A.C.,Rijnstate Hospital | Koebrugge R.,Inreda Diabetic B.V. | Koops R.,Inreda Diabetic B.V.
Diabetes Technology and Therapeutics | Year: 2014

Background: This study assessed the feasibility of a portable bihormonal closed-loop system at home. Subjects and Methods: Sixteen pump-treated patients with type 1 diabetes received 48 h of closed-loop therapy with a telemonitored insulin- and glucagon-delivering closed-loop system and 48 h of patient-managed open-loop therapy. Results: Owing to technical problems in five cases, only 11 patients could be analyzed. Whereas median (interquartile range) glucose levels were not significantly different during Day 1 of open-loop control (OL1) from closed-loop control (CL1) (8.27 [0.83] mmol/L vs. 8.84 [1.47] mmol/L; P=0.206), they were significantly lower during Day 2 of closed-loop control (CL2) versus open-loop control (OL2) (7.70 [2.29] mmol/L vs. 8.84 [0.87] mmol/L; P=0.027). Time spent in euglycemia (3.9-10 mmol/L) was comparable with 67.2% (38.5%) in OL1 versus 79.2% (16.9%) in CL1 (P=0.189) and 66.0% (29.8%) in OL2 versus 76.5% (23.9%) in CL2 (P=0.162). Time spent in hypoglycemia (<3.9 mmol/L) was comparable on Day 1 of control (OL1, 0.68% [8.68%]; CL1, 2.08% [7.61%]; P=0.593) but significantly higher during Day 2 of control (OL2, 0.00% [11.07%]; CL2, 2.8% [9.8%]; P=0.0172) (P=0.017). Conclusions: Bihormonal closed-loop control is feasible at home, with comparable time in euglycemia to open-loop control and significantly lower median glucose levels on Day 2 of control at the expense of more time in hypoglycemia, albeit still at a very low percentage of time. © Copyright 2014, Mary Ann Liebert, Inc. 2014.


LONDON--(BUSINESS WIRE)--The global artificial pancreas devices system (APDS) market is expected to grow at an impressive revenue of over USD 1 billion by 2020, according to Technavio’s latest research. In this research report, Technavio covers the market outlook and growth prospects of the global artificial pancreas devices system market for 2016-2020. The market is further segmented into four categories, which include threshold suspend device system (TSDS), non-threshold suspend device system (NTSDS), control to range system (CTRS) and control to target system (CTTS). “The APDS market has huge opportunities to grow as the existing devices lack efficiency in insulin delivery mechanism. The market is witnessing huge efforts toward R&D activities from vendors as well as research organizations. For instance, there have been 18 clinical trials conducted for the development of enhanced versions of APDS including second and third-generation devices,” says Sapna Jha, a lead cardiovascular and metabolic disorders research expert from Technavio. Technavio’s healthcare and life sciences research analysts segment the global APDS market into the following regions: In 2015, with a market share of over 64%, the Americas emerged as the leader in the global APDS market, followed by EMEA with over 24% and APAC with 11%. The APDS market in the Americas is expected to grow at a CAGR of more than 7% during the forecast period. The growing incidence of diabetes is expected to drive the adoption rates of APDS in the Americas, particularly North America. According to CDC 2012 statistics, 29.1 million Americans had diabetes in 2015. This scenario has driven vendors and research institutes to focus on developing novel devices for diabetes management. Such extensive R&D activities led to the timely approval of novel products, such as Medtronic’s MiniMed 530G (approved in 2013). The launch of this product is the first step toward the development of complete APDS in the market. Other vendors such as Johnson & Johnson and Insulet are also focusing on the development of complete APDS. Technavio’s sample reports are free of charge and contain multiple sections of the report including the market size and forecast, drivers, challenges, trends, and more. EMEA: extensive investment in R&D and launch of new products to fuel growth Growing awareness and the established healthcare infrastructure in Europe, have led to higher demand for APDS. Europe approved Medtronic’s MiniMed Veo in 2009. This product is the world’s first APDS with low glucose suspend feature, which works by automatically halting insulin delivery when sensor glucose levels reach to the pre-set low threshold. Moreover, new entrants in EMEA are expected to bring complete APDS during the forecast period. For instance, DreaMed Diabetes (Israel-based company), and Inreda Diabetic (Netherlands-based company) are extensively undertaking R&D activities to launch closed loop APDS in the market. These two companies are planning to bring APDS that finds application in remote monitoring. Such initiatives will substantially drive the adoption rates owing to the higher preference for treatment in a homecare environment. The APDS market in APAC is still in nascent stage owing to the lack of awareness among people, limited infrastructure, and financial constraints. “However, rising incidence of diabetes coupled with recent product approvals in key countries such as Japan and Australia are expected to improve the adoption rates in APAC,” says Sapna. The rising incidence of diabetes has fueled the need for novel devices and new product launches such as Medtronic’s MiniMed 620G which received the FDA approval in Japan. The MiniMed 620G is the first insulin pump that features built-in CGM design to deliver better clinical outcomes for individuals with diabetes. Also, Medtronic’s MiniMed 640G received approval in Australia in January 2015. In addition, vendors such as Medtronic are further looking to expand their presence in emerging markets such as China, which will further boost the growth of the market. The top vendors in the global APDS market as highlighted in this analysis are: Become a Technavio Insights member and access all three of these reports for a fraction of their original cost. As a Technavio Insights member, you will have immediate access to new reports as they’re published in addition to all 6,000+ existing reports covering segments like displays, embedded systems, and sensors. This subscription nets you thousands in savings, while staying connected to Technavio’s constant transforming research library, helping you make informed business decisions more efficiently. Technavio is a leading global technology research and advisory company. The company develops over 2000 pieces of research every year, covering more than 500 technologies across 80 countries. Technavio has about 300 analysts globally who specialize in customized consulting and business research assignments across the latest leading edge technologies. Technavio analysts employ primary as well as secondary research techniques to ascertain the size and vendor landscape in a range of markets. Analysts obtain information using a combination of bottom-up and top-down approaches, besides using in-house market modeling tools and proprietary databases. They corroborate this data with the data obtained from various market participants and stakeholders across the value chain, including vendors, service providers, distributors, re-sellers, and end-users. If you are interested in more information, please contact our media team at media@technavio.com.


Blauw H.,University of Amsterdam | Blauw H.,Inreda Diabetic BV | Keith-Hynes P.,Typezero Technologies, Llc | Keith-Hynes P.,University of Virginia | And 2 more authors.
Annals of Biomedical Engineering | Year: 2016

As clinical studies with artificial pancreas systems for automated blood glucose control in patients with type 1 diabetes move to unsupervised real-life settings, product development will be a focus of companies over the coming years. Directions or requirements regarding safety in the design of an artificial pancreas are, however, lacking. This review aims to provide an overview and discussion of safety and design requirements of the artificial pancreas. We performed a structured literature search based on three search components—type 1 diabetes, artificial pancreas, and safety or design—and extended the discussion with our own experiences in developing artificial pancreas systems. The main hazards of the artificial pancreas are over- and under-dosing of insulin and, in case of a bi-hormonal system, of glucagon or other hormones. For each component of an artificial pancreas and for the complete system we identified safety issues related to these hazards and proposed control measures. Prerequisites that enable the control algorithms to provide safe closed-loop control are accurate and reliable input of glucose values, assured hormone delivery and an efficient user interface. In addition, the system configuration has important implications for safety, as close cooperation and data exchange between the different components is essential. © 2016 The Author(s)


Grant
Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.2.4.3-1 | Award Amount: 5.49M | Year: 2012

The aim of PCDIAB is to build and evaluate a bihormonal (insulin and glucagon) artificial pancreas (AP) with automated closed loop glycaemic control for insulin treated patients with diabetes. This will be a breakthrough in diabetes management. We will miniaturize our current prototype consisting of well-established continuous glucose monitors, an insulin pump and a glucagonpump. The housing will be redesigned with dedicated miniature motors and the software will be embedded. The algorithm will be improved and a continuous glucose sensor (CGM) per-formance alert will be developed. In parallel, glucagon pharmacology will be investigated and a stable liquid glu-cagon analogue will be developed. Furthermore, administration of insulin and glucagon together with continuous glucose monitoring at the same subcutaneous site will be investigated, to enable even further miniaturization in the future. Deliverables include description of system integration of the bihormonal AP system and of an online detection of continuous glucose monitor performance. In a multinational controlled trial the bihormonal AP will be compared with standard intensive insulin therapy in daily life. Impact of the project includes simplified diabetes care, improved quality of life for patients with diabetes, dimin-ished occurrence of diabetes related complications and diminished health costs in the long run. Also, the project will strengthen competitiveness of European industry across a complete value chain involving large, mid-sized and small companies, enabling Europe to lead progress in AP systems. Finally, the project will put European research and clinical organizations in leading positions with an increased number of high-skilled jobs in the medical device industry. Dissemination and exploitation comprises a website, a conference, patents and scientific publications. The bihormonal closed loop system and the glucagon analogue can be developed into a product and brought to the market.


Blauw H.,Inreda Diabetic BV | Blauw H.,University of Amsterdam | Wendl I.,Profil Institute fur Stoffwechselforschung GmbH | Devries J.H.,University of Amsterdam | And 3 more authors.
Diabetes, Obesity and Metabolism | Year: 2016

Aims: To evaluate the pharmacokinetics and pharmacodynamics of different doses of glucagon administered subcutaneously (s.c.) at different blood glucose levels. Methods: This study was an open-label, randomized, three-period, cross-over experiment in 6 patients with type 1 diabetes. During each of the three periods, different blood glucose levels were established in four consecutive steps (8, 6, 4 and 2.8 mmol/l) and glucagon was given at each blood glucose level in doses from 0.11 to 0.44 mg and 0.33, 0.66 and 1 mg at the lowest glucose concentration. Results: Maximum glucagon concentration and area under the curve increased with increasing glucagon dose. Maximum glucagon concentration was reached after 10-20 min. Glucagon raised blood glucose in a dose-dependent manner at different baseline blood glucose levels. The median glucose excursion ranged from 2.6 to 6.2 mmol/l. Time to maximum glucose concentration was dose-dependent for the glucagon doses at 2.8 mmol/l, with median values from 40 to 80 min. Conclusions: Glucagon administered s.c. produces a stable pharmacokinetic and pharmacodynamic response at lower doses than the usual rescue dose and across a range of hypo- to hyperglycaemic blood glucose levels. This supports the use of small glucagon doses in the artificial pancreas to correct and prevent hypoglycaemia. © 2016 John Wiley & Sons Ltd.


PubMed | University of Amsterdam, Inreda Diabetic BV and Profil Institute fur Stoffwechselforschung GmbH
Type: Journal Article | Journal: Diabetes, obesity & metabolism | Year: 2016

To evaluate the pharmacokinetics and pharmacodynamics of different doses of glucagon administered subcutaneously (s.c.) at different blood glucose levels.This study was an open-label, randomized, three-period, cross-over experiment in 6 patients with type 1 diabetes. During each of the three periods, different blood glucose levels were established in four consecutive steps (8, 6, 4 and 2.8 mmol/l) and glucagon was given at each blood glucose level in doses from 0.11 to 0.44 mg and 0.33, 0.66 and 1 mg at the lowest glucose concentration.Maximum glucagon concentration and area under the curve increased with increasing glucagon dose. Maximum glucagon concentration was reached after 10-20 min. Glucagon raised blood glucose in a dose-dependent manner at different baseline blood glucose levels. The median glucose excursion ranged from 2.6 to 6.2 mmol/l. Time to maximum glucose concentration was dose-dependent for the glucagon doses at 2.8 mmol/l, with median values from 40 to 80 min.Glucagon administered s.c. produces a stable pharmacokinetic and pharmacodynamic response at lower doses than the usual rescue dose and across a range of hypo- to hyperglycaemic blood glucose levels. This supports the use of small glucagon doses in the artificial pancreas to correct and prevent hypoglycaemia.


PubMed | University of Amsterdam, Inreda Diabetic BV and Rijnstate Hospital
Type: Journal Article | Journal: Diabetes, obesity & metabolism | Year: 2016

To assess the performance and safety of an integrated bihormonal artificial pancreas system consisting of one wearable device and two wireless glucose sensor transmitters during short-term daily use at home.Adult patients with type 1 diabetes using an insulin pump were invited to enrol in this randomized crossover study. Treatment with the artificial pancreas started with a day and night in the clinical research centre, followed by 3days at home. The control period consisted of 4days of insulin pump therapy at home with blinded continuous glucose monitoring for data collection. Days 2-4 were predefined as the analysis period, with median glucose as the primary outcome.A total of 10 patients completed the study. The median [interquartile range (IQR)] glucose level was similar for the two treatments [7.3 (7.0-7.6)mmol/l for the artificial pancreas vs. 7.7 (7.0-9.0)mmol/l for the control; p=0.123]. The median (IQR) percentage of time spent in euglycaemia (3.9-10mmol/l) was longer during use of the artificial pancreas [84.7 (82.2-87.8)% for the artificial pancreas vs. 68.5 (57.9-83.6)% for the control; p=0.007]. Time in hypoglycaemia was 1.3 (0.2-3.2)% for the artificial pancreas and 2.4 (0.4-10.3)% for the control treatment (p=0.139). Separate analysis of daytime and night-time showed that the improvements were mainly achieved during the night.The results of this pilot study suggest that our integrated artificial pancreas provides better glucose control than insulin pump therapy in patients with type 1 diabetes at home and that the treatment is safe.

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