Multinational Home Use of Closed-Loop Control Is Safe and Effective

Anderson, Stacey M.; Raghinaru, Dan; Pinsker, Jordan E.; Boscari, Federico; Renard, Éric; Buckingham, Bruce A.; Nimri, Revital; Doyle, Francis J.; Brown, Sue A.; Keith-Hynes, Patrick; Breton, Marc D.; Cherñavvsky, Daniel R.; Bevier, Wendy C.; Bradley, Paige K.; Bruttomesso, Daniela; Favero, Simone Del; Calore, Roberta; Cobelli, Claudio; Avogaro, Angelo; Farret, Anne; Place, Jérôme; Ly, Trang T.; Shanmugham, Satya; Phillip, Moshe; Dassau, Eyal; Dasanayake, Isuru; Kollman, Craig; Lum, John; Beck, Roy W.; Kovatchev, Boris

doi:10.2337/dc15-2468

Cited by 97 publications

(72 citation statements)

References 27 publications

(39 reference statements)

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“…These represent an intermediate step toward automated insulin delivery (AID) systems (38): rapid development has led to the recent market approval and launch of the first hybrid closed-loop system (MiniMed 670G; Medtronic) (39).…”

Section: Combination Of Cgm With Insulin Pumps: Automated Insulin Delmentioning

confidence: 99%

Improving the Clinical Value and Utility of CGM Systems: Issues and Recommendations

et al. 2017

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The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionize the use of intensive insulin therapy in diabetes; however, progress toward that vision has been gradual. Although increasing, the proportion of individuals using CGM rather than conventional systems for self-monitoring of blood glucose on a daily basis is still low in most parts of the world. Barriers to uptake include cost, measurement reliability (particularly with earlier-generation systems), human factors issues, lack of a standardized format for displaying results, and uncertainty on how best to use CGM data to make therapeutic decisions. This Scientific Statement makes recommendations for systemic improvements in clinical use and regulatory (pre-and postmarketing) handling of CGM devices. The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes.

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Section: Combination Of Cgm With Insulin Pumps: Automated Insulin Delmentioning

confidence: 99%

Improving the Clinical Value and Utility of CGM Systems: Issues and Recommendations

et al. 2017

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“…A future design aim is that the application can be employed concurrently with other applications run by the user. To this end, a smartphone-based AP platform (currently, for the development phase of the Diabetes Assistant (DiAS) platform, the smartphone is employed as a dedicated controller, and no other phone-related functions are permitted) (DiAS; University of Virginia, Charlottesville, VA, USA) has been developed [22] and evaluated in outpatient studies [10,[23][24][25][26]. Extended studies involving a two-month evening and night closed-loop control study have also been performed [27].…”

Section: Hardware Configurations Of the Ap Systemmentioning

confidence: 99%

Embedded Control in Wearable Medical Devices: Application to the Artificial Pancreas

et al. 2016

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Significant increases in processing power, coupled with the miniaturization of processing units operating at low power levels, has motivated the embedding of modern control systems into medical devices. The design of such embedded decision-making strategies for medical applications is driven by multiple crucial factors, such as: (i) guaranteed safety in the presence of exogenous disturbances and unexpected system failures; (ii) constraints on computing resources; (iii) portability and longevity in terms of size and power consumption; and (iv) constraints on manufacturing and maintenance costs. Embedded control systems are especially compelling in the context of modern artificial pancreas systems (AP) used in glucose regulation for patients with type 1 diabetes mellitus (T1DM). Herein, a review of potential embedded control strategies that can be leveraged in a fully-automated and portable AP is presented. Amongst competing controllers, emphasis is provided on model predictive control (MPC), since it has been established as a very promising control strategy for glucose regulation using the AP. Challenges involved in the design, implementation and validation of safety-critical embedded model predictive controllers for the AP application are discussed in detail. Additionally, the computational expenditure inherent to MPC strategies is investigated, and a comparative study of runtime performances and storage requirements among modern quadratic programming solvers is reported for a desktop environment and a prototype hardware platform.

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“…Adjusting the insulin dose on the basis of CGM glucose values therefore carries-at least a theoretical-risk of over-or underestimation with obvious attendant risks [41]. However, despite these concerns, interstitial glucose concentrations from CGM appear sufficiently robust for successful use with AID systems [38,39], and recent data suggest increased time in target when insulin dosing decisions are taken on the basis of CGM as opposed to SMBG [11]. Time trends in glucose concentrations may be more informative than infrequent single time point estimates using SMBG, even if the latter are more accurate from an analytical point of view.…”

Section: Glucose Measurement In Interstitial Fluidmentioning

confidence: 99%

“…Trends towards reductions in the occurrence of mild and severe hypoglycaemic events when using such combinations have been reported [35,36] but also challenged [37]. These represent an intermediate step towards automated insulin delivery (AID) systems [38]. Rapid development has led to the recent market approval and launch of the first hybrid closed-loop system (MiniMed 670G; Medtronic) [39].…”

Section: Combination Of Cgm With Insulin Pumps: Automated Insulin Delmentioning

confidence: 99%

Improving the clinical value and utility of CGM systems: issues and recommendations

et al. 2017

View full text Add to dashboard Cite

The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionise the use of intensive insulin therapy in diabetes; however, progress towards that vision has been gradual. Although increasing, the proportion of individuals using CGM rather than conventional systems for self-monitoring of blood glucose on a daily basis is still low in most parts of the world. Barriers to uptake include cost, measurement reliability (particularly with earlier-generation systems), human factors issues, lack of a standardised format for displaying results and uncertainty on how best to use CGM data to make therapeutic decisions. This scientific statement makes recommendations for systemic improvements in clinical use and regulatory (pre-and postmarketing) handling of CGM devices. The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes.

show abstract

Multinational Home Use of Closed-Loop Control Is Safe and Effective

Cited by 97 publications

References 27 publications

Improving the Clinical Value and Utility of CGM Systems: Issues and Recommendations

Improving the Clinical Value and Utility of CGM Systems: Issues and Recommendations

Embedded Control in Wearable Medical Devices: Application to the Artificial Pancreas

Improving the clinical value and utility of CGM systems: issues and recommendations

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