Automated insulin management -
Participants were unrestricted in relation to their usual activity and dietary intake. The study did not interfere with or specify the medications prescribed by the local clinical team.
All participants were provided with a h telephone helpline to contact the local study team in the event of study-related issues. Fingerstick capillary glucose measurements were performed by participants as per usual clinical practice.
Glycemic management was performed by the clinical team according to local practice. A continuous glucose sensor, Dexcom G6 Dexcom , was inserted by the study team on the first day of the study arm.
The continuous glucose monitor receiver was modified to mask the sensor glucose concentration to the participant and investigators.
At the end of the standard insulin therapy period, the glucose sensor was removed. Participants were invited to complete the validated questionnaires at the end of each study period: the PAID questionnaire to assess diabetes distress, the Hypoglycaemia Confidence Survey to evaluate perceptions of ability to self-manage hypoglycemia and the Hypoglycaemia Fear Survey-II Worry Scale HFS-W to estimate hypoglycemia-related fear and anxiety Cambridge only 18 , 19 , Additionally, participants filled in a closed-loop experience questionnaire collecting feedback on satisfaction with closed-loop therapy, acceptance of wearing study devices and recommending closed-loop to others.
Because previous studies using closed-loop in an inpatient setting may not provide reliable information about the standard deviation of the primary endpoint in this particular population outpatients receiving maintenance dialysis , no formal power calculation was applied.
The sample size corresponds to the sample size of previous feasibility closed-loop randomized trials 9 , The primary endpoint was the percentage of time the sensor glucose measurement was in the target glucose range of 5.
This target glucose range was selected in line with recommendations for less stringent glucose control in this population due to their high risk for hypoglycemia and related adverse events 5 , 6 , 21 , 22 , Other key endpoints are the percentage of time spent with sensor glucose above Secondary efficacy endpoints included time spent with sensor glucose below 5.
Glucose variability was evaluated by the standard deviation and the coefficient of variation of sensor glucose utilizing data collected from the whole study period.
The between-day coefficient of variation of sensor glucose was calculated from daily mean glucose values — Variability of glucose and insulin requirements between dialysis and non-dialysis days was assessed using the coefficient of variation of sensor glucose and insulin requirements between dialysis days — and non-dialysis days — Mean inter-dialytic weight gain was calculated for each study period.
The statistical analysis plan was agreed by the investigators in advance. All analyses were carried out on an intention-to-treat basis. The respective values obtained during the day randomized interventions were compared. for normally distributed values or median interquartile range for non-normally distributed values.
A two-sample t -test on paired differences was used to compare normally distributed variables 24 and the Mann—Whitney—Wilcoxon rank-sum test for data that are not normally distributed.
No allowance was made for multiplicity. Outcomes were calculated using GStat software, version 2. All P values are two-tailed, and P values of less than 0.
Further information on research design is available in the Nature Research Reporting Summary linked to this Article. The data that support the findings of this study are available from the corresponding author for the purposes of advancing the management and treatment of diabetes.
All data shared will be de-identified. The study protocol is available with this paper. The control algorithm cannot be made publicly available because it is proprietary intellectual property. The control algorithm cannot be used in routine practice in the outpatient setting as regulatory approval has not yet been granted.
Abe, M. Haemodialysis-induced hypoglycaemia and glycaemic disarrays. Article CAS Google Scholar. Copur, S. et al. Serum glycated albumin predicts all-cause mortality in dialysis patients with diabetes mellitus: meta-analysis and systematic review of a predictive biomarker.
Acta Diabetol. Hill, C. Glycated hemoglobin and risk of death in diabetic patients treated with hemodialysis: a meta-analysis.
Kidney Dis. Galindo, R. Glycemic monitoring and management in advanced chronic kidney disease. Article Google Scholar. Hovorka, R. Closed-loop insulin delivery: from bench to clinical practice.
Thabit, H. Closed-loop insulin delivery in inpatients with type 2 diabetes: a randomised, parallel-group trial. Lancet Diabetes Endocrinol. Bally, L. Closed-loop insulin delivery for glycemic control in noncritical care.
Boughton, C. Fully closed-loop insulin delivery in inpatients receiving nutritional support: a two-centre, open-label, randomised controlled trial.
Fully closed-loop insulin delivery improves glucose control of inpatients with type 2 diabetes receiving hemodialysis. Kidney Int. Leelarathna, L.
Duration of hybrid closed-loop insulin therapy to achieve representative glycemic outcomes in adults with type 1 diabetes. Diabetes Care 43 , e38—e39 Herrero, P.
Robust determination of the optimal continuous glucose monitoring length of intervention to evaluate long-term glycaemic control. Diabetes Technol. Kazempour-Ardebili, S. Assessing glycemic control in maintenance hemodialysis patients with type 2 diabetes. Diabetes Care 32 , — Jung, H.
Analysis of hemodialysis-associated hypoglycemia in patients with type 2 diabetes using a continuous glucose monitoring system. Chu, Y. Epidemiology and outcomes of hypoglycemia in patients with advanced diabetic kidney disease on dialysis: a national cohort study.
PLoS ONE 12 , e Polonsky, W. Investigating hypoglycemic confidence in type 1 and type 2 diabetes. Cox, D. Fear of hypoglycemia: quantification, validation and utilization. Diabetes Care 10 , — Assessment of diabetes-related distress.
Diabetes Care 18 , — Battelino, T. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range.
Diabetes Care 42 , — American Diabetes Association. Glycemic targets. Standards of medical care in diabetes— Diabetes Care 44 , S73—S84 Frankel, A. Management of adults with diabetes on the haemodialysis unit: summary of guidance from the Joint British Diabetes Societies and the Renal Association.
Jones, B. Design and Analysis of Cross-Over Trials 3rd edn. CRC Press, Download references. Dexcom supplied discounted continuous glucose monitoring devices and sensors for the study. Company representatives had no role in the study conduct.
The study was supported by the National Institute for Health Research Cambridge Biomedical Research Centre. was supported by a grant from The Novo Nordisk UK Research Foundation and L. We are grateful to all study participants for their contribution, time and support. We acknowledge administrative support from N.
Ashcroft at the University of Cambridge. We thank D. Studer, C. Piazza and N. Truffer, who contributed to patient care and study logistics in Bern, and the Diabetes Center Bern for providing infrastructure for the study team in Bern.
The views expressed are those of the author s and not necessarily those of the NIHR, the Department of Health and Social Care or other funders. Charlotte K. Boughton, Aideen Daly, Malgorzata E. Cambridge University Hospitals NHS Foundation Trust, Wolfson Diabetes and Endocrine Clinic, Cambridge, UK.
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.
Department of Nephrology and Hypertension, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.
Department of Renal Medicine, Cambridge University Hospitals NHS Foundation Trust, University of Cambridge, Cambridge, UK. You can also search for this author in PubMed Google Scholar. and R.
co-designed the study. The specific benefits and limitations of each AID system help to define its individual utility. Much of this information provided below comes from our own clinical and personal experiences with these systems.
We also devised a question survey to poll local, national, and a few international endocrinologists, diabetologists, and experienced diabetes educators who care for PWD and train them on the use of insulin pumps and CGM systems to further validate our own experiences.
We received 60 responses to the survey. Figure 1 lists the survey questions with provider groups polled listed in the legend , and Table 1 includes a tally of key responses.
AID survey. In our survey, most respondents had experience with all three systems. Most respondents valued the ability to share CGM data using the Dexcom system in users with hypoglycemia unawareness. Those with hypoglycemia who have no compelling need to share CGM data also may do well with the MiniMed G system as long as they can tolerate the required calibrations and alerts Many respondents preferred the Tandem and DIY systems for PWD who want the most intensive control of their glucose and insulin delivery.
Those not able or willing to help set up a system were still willing to help adjust insulin settings in the algorithm based on glycemic trends. In a study involving 32 people with type 1 diabetes after 4—5 days of using the MiniMed G system, focus group analysis revealed that participants were willing to use the system, despite some hassles and limitations, if that use led to perceived health benefits In the near future, we believe there are several AID systems in the pipeline that will offer more choice, improved usability, and even more automation.
Some of these features, particularly those involving ease of use and insurance coverage, may be especially appealing for primary care providers PCPs and the PWD who depend on them for diabetes care.
More device interoperability may also emerge. The Omnipod patch pump differs from traditional tubed pumps in a few ways that already make the device more appealing for primary care. Unlike traditional pumps, which use tubing connected to an infusion set, the Omnipod sits directly on the body.
The disposable pod is filled with insulin before being placed on the body usually on the upper arm and is discarded after 3 days. In , Insulet launched a pay-as-you-go model for Omnipod, allowing users to effectively try the system at no extra cost.
This contrasts with traditional pumps, which require a large upfront investment and lock-in to a 4-year warranty. Additionally, the subscription-based Omnipod can be accessed through a pharmacy as opposed to a durable medical equipment supplier, as with other pumps , improving the experience for patients and providers.
Many find the one-piece, no-needle Omnipod pump to be easier to teach, learn, and use than traditional pumps, which have multiple components, including pump, reservoir, tubing, and infusion sets. These features have made Omnipod especially popular in pediatric settings and with pump-naive users and people with type 2 diabetes It will include automated basal rates and correction boluses.
Meals and exercise will still require manual bolus dosing and adjustments. For ease of use, Insulet plans to bring smartphone control to the Omnipod Horizon system, allowing users to deliver bolus doses or adjust insulin delivery using their personal smartphones, a feature long requested by many pump users Presumably, the smartphone connectivity will also mean that CGM and pump data can be uploaded to the Cloud wirelessly, another ease-of-use improvement for clinicians and PWD who use remote monitoring.
The system will also have fewer alarms and simpler operation than the G. The G will also add Bluetooth connectivity to the pump, allowing users to view pump data on their phones, upload pump data wirelessly, and update their pump wirelessly. These upgrades will make this system more attractive to providers by addressing many of the complaints noted previously regarding the G.
It will use the same Guardian CGM device as the G, which requires two fingersticks per day and has a 7-day wear time. The FDA is currently reviewing the Guardian CGM for nonadjunctive insulin dosing and, if approved, users will be able to deliver insulin bolus doses based on their CGM reading alone, without fingerstick BGM confirmation Since Tandem launched its Control-IQ AID system in January , the company has announced a series of iterative updates adding several features that may make the device more appealing for use in primary care.
A smartphone app for the t:slim X2 pump has recently launched and allows wireless data uploads of pump and CGM data for simplified remote patient monitoring in primary care.
Later, potentially in late or early , Tandem also plans to incorporate smartphone pump control e. Tandem also has plans to bring a fully closed-loop system with complete basal and bolus automation i. Such a system would certainly be useful in the primary care setting for patients who require bolus insulin doses in addition to basal insulin.
However, high upfront costs and perceived implementation difficulties remain a challenge for PCPs. Outside of the three big players Insulet, Tandem, and Medtronic , small start-up companies such as Beta Bionics and the nonprofit Tidepool Project have plans to bring their own AID systems to market.
Tidepool is a nonprofit group working on an AID algorithm-only closed-loop system. It plans to submit a variant of the DIY Loop app mentioned above to the FDA as an officially supported app available from the Apple App Store.
Tidepool has a month observational study of Loop users, which will likely be part of its FDA application submission Beta Bionics is another AID company that plans to develop a dual-hormone insulin and glucagon AID system. Users will not need to count carbohydrates; rather, they will only need to describe meals as containing more, less, or the same amount of carbohydrates as in a meal requiring a usual bolus dose.
Now is a great time for PCPs to become more familiar with AID technologies. PCPs may choose to play an active role implementing these systems within their own clinical practice or may choose to provide guidance to PWD who want to learn more and more effectively collaborate with local specialists.
We have already witnessed incredible improvements in not only quality of life, but also patient care and the efficiency of office visits related to the use of AID in clinical practice.
These improvements include AID-related A1C lowering, less difficulty managing labile blood glucose levels and their consequences, and simpler review of glycemic data. Most PCPs do not have direct access to certified pump trainers; however, those who want to pursue the use of these systems can seek assistance from representatives of the respective device companies to assist with insurance authorization and successful implementation.
Unfortunately, as evidenced by T1D Exchange registry data, most people with type 1 diabetes do not achieve goal A1C and TIR 5.
For this reason, many people with type 1 diabetes could greatly benefit from AID. It is also clear that fear of hypoglycemia is a barrier to achieving goal A1C 40 and TIR targets. AID could also potentially help alleviate this fear for all PWD on intensive insulin therapy.
However, with the Medtronic system, especially when the user can maintain auto mode, very few parameters can be adjusted by the provider. Although the DIY systems are fascinating and their use is becoming more widespread, they are unlikely to be recommended and used in primary care clinics without an endocrinology referral.
This situation may change when and if such systems receive FDA approval and become simpler to set up and use. Three AID systems are now on the U. market, and they have already made significant contributions to improving the lives of PWD.
Each AID system has its own features, subtleties in functionality, and limitations, making it important for clinicians and PWD to research and understand which one may be the best fit for their specific needs and characteristics. In our opinion, not all people with type 1 diabetes prefer or do better with AID.
As AID becomes more commonplace, we anticipate that the national median A1C will at last decrease, and TIR will improve, especially among people with type 1 diabetes. These technologies have already helped users to intensify glycemic control without increasing the risk of hypoglycemia, as indicated by improved TIR.
Exceptions to this opinion would include PCPs who care for PWD who are already successfully using AID and prefer to condense their medical care to their PCP office, as well as PCPs with a special interest in the care of patients with type 1 diabetes.
We hope that, one day soon, these systems will be commonplace and simple enough to initiate for any person with diabetes, even by clinicians who are inexperienced in their use. Future enhancements of the available devices and newer AID systems in the pipeline are heading in this direction.
It is also our hope that this article has not only helped to educate readers about AID technologies, but has also shared valuable resources to help navigate this topic more effectively with colleagues and patients. The authors thank Rayhan Lal, Dana Lewis, Steph Habif, Jim Hirsch, Christopher Snider, Christopher Angell, and Gary Scheiner for their help in preparing the manuscript.
The articles in this special-topic issue of Clinical Diabetes were supported by unrestricted educational grants to the American Diabetes Association from Abbott Diabetes Care and Dexcom.
and K. are employees of Close Concerns and diaTribe. Numerous industry entities are paid subscribers to the Close Concerns digital newsletter. Numerous industry entities are sponsors of diaTribe. No other potential conflicts of interest relevant to this article were reported.
researched, wrote, and revised the manuscript. and L. researched and revised the manuscript. wrote the section on the future of AID.
reviewed and revised the manuscript. is the guarantor of this work and, as such, had full access to all of the material presented and references cited and takes responsibility for the integrity and accuracy of this review.
The publication of this special-topic issue of Clinical Diabetes was supported by unrestricted educational grants to the American Diabetes Association from Abbott Diabetes Care and Dexcom.
Sign In or Create an Account. Search Dropdown Menu. header search search input Search input auto suggest. filter your search All Content All Journals Clinical Diabetes.
Advanced Search. User Tools Dropdown. Sign In. Skip Nav Destination Close navigation menu Article navigation. Volume 38, Issue 5.
Previous Article Next Article. Components of AID. User burden may be reduced with implanted sensors and combined insulin delivery glucose sensing platforms. And last but not least, AID affordability and reimbursement by health care systems will remain the gateway to system adoption.
Cloud databases will play an increasingly important role to support data sharing, virtual clinic visits, and remote access and will allow the deployment of data science tools, such as pattern recognition, neural networks, deep learning, and artificial intelligence.
In silico preclinical trials have been, and will continue to be, used for rapid and cost-effective testing of new ideas Merging large databases with in silico models will create a comprehensive virtual environment for experimenting with new system components prior to their deployment in clinical trials.
Preliminary work showing the potential of adaptation is already published , and a long-term vision for AID personalized medicine strategy has been presented AID key discreet data and the presented consensus report need to be directly integrated into the electronic health record EHR.
This integration is most important for ease of access by clinicians, ease of communication with PwD, and for population health management case management. Smart insulin pens connected with CGM will enable a kind of AID for people who prefer to use MDI therapy. Given the associated improvements in glycemic control and quality of life measures, clinicians should strongly consider use of AID systems in PwD who would benefit from this technological option.
We recommend that payers support usage of AID systems and other emerging technologies that reduce diabetes burden and improve patient-reported outcomes. Furthermore, studies have suggested long-term cost saving for health care systems using these systems. Failure to reimburse diabetes technologies such as AID systems will deprive many individuals with T1D who would benefit from this valuable technology and may result in increased disparities in diabetes outcomes due to racial and social inequities , The authors also wish to thank Christopher G Parkin, MS, CGParkin Communications, Inc.
ATTD congress supported the meeting and provided funding to Christopher G. Parkin, CGParkin Communications, Inc. Abbott Diabetes Care, Dexcom, Inc.
received Honoraria or consultation fees from Sanofi, Medtronic, Novo Nordisk, Eli Lilly, and Pfizer. participated in Medical Advisory Board of Sanofi, Medtronic, AstraZeneca, Eli Lilly, Insulet, Pfizer, and Dompe.
is a stock shareholder in NG Solutions Ltd. reports receiving grants from Helmsley Charitable Trust, Dexcom, Medtronic, Abbott Diabetes Care, and Insulet; personal fees and other from DreaMed Diabetes Ltd; personal fees from Novo Nordisk and Eli Lilly; R.
owns DreaMed Diabetes Ltd stock. received Research support from Dexcom, Novo Nordisk, and BD; speaker honoraria from Roche, Lifescan; is an ad board member for Sanofi, Roche.
has received research support, has acted as a consultant, or has been on the scientific advisory board for Abbott Diabetes Care, DexCom, Eli Lilly, Insulet, Medtronic, Novo Nordisk, and Sanofi.
served as a consultant for Ascensia, Bigfoot Biomedical, Inc. received research support and speaker honoraria from AstraZeneca, Boehringer, DexCom, Insulet, Lilly, Medtronic, Novo Nordisk, Roche, and Sanofi, and is a shareholder of DreaMed-Diabetes Ltd.
is a speaker for Eli Lilly, Dexcom, and Novo Nordisk; Advisory Board: Eli Lilly; License and consultancy honoraria: B. Braun and Abbott Diabetes Care; Patents related to closed-loop; Director: CamDiab; Research support: Dexcom, Abbott Diabetes Care, Medtronic. has received consulting fees from Abbott Diabetes Care, CeQur, Dexcom, Mannkind, and Provention.
declares that no conflict interest exists. is on the advisory board for Medtronic and Novo Nordisk, speaker at educational symposia sponsored by Novo Nordisk and Sanofi.
Co-investigator on EU IMI HypoRESOLVE program. received research support from Dexcom. reports no personal financial disclosures but reports that his institution has received funding on his behalf as follows: grant funding and study supplies from Tandem Diabetes Care, Beta Bionics, and Dexcom; study supplies from Medtronic, Ascencia, and Roche; consulting fees and study supplies from Eli Lilly and Novo Nordisk; and consulting fees from Insulet, Bigfoot Biomedical, vTv Therapeutics, and Diasome.
has served on Advisory Board Medtronic, Freelancer Diaexpert, Freelancer Medicolab. declares Advisory board for Cardinal Health and Provention Bio; Consultant for WellDoc, Inc; Independent Contractor pump trainer for Insulet and Tandem.
is a speaker and received advisory board fees from Abbott, AstraZeneca, Eli Lilly, Novartis, Roche, Sanofi; noneconomic support from Medtronic. declares Consultant for CamDiab. receives research support from Tandem Diabetes, Dexcom, Novo Nordisk, and Arecor paid to his institution.
serves as a consultant for Dexcom, Adocia, Air Liquide, and Roche. received speaker fees from Tandem and Arecor. reports institutional grants and material funding from Dexcom, Insulet, NIH, Roche Diagnostics, UVA Strategic Investment Fund, Tandem Diabetes Care, and Tolerion.
is a member of advisory board for Medtronic, Convatec, and Arecor. Received consulting fees from Insulet and Medtronic. Received grants support from Insulet, Medtronic, Beta Bionics, JDRF, and NIDDK.
is an employee for Biolinq Inc. has received research support, has acted as a consultant, or has been on the scientific advisory board for Abbott Diabetes Care, DexCom, Eli Lilly, Insulet, Medtronic, Novo Nordisk, Sanofi, Senseionics, and UnitedHealth.
holds stock in Pacific Diabetes Technologies, a company that may have a commercial interest in closed-loop technologies. has been on advisory boards for Novo Nordisk, Astra Zeneca, and Zealand.
received personal fees from Medtronic, Abbott, Dexcom, Insulet, Roche, Sanofi, Lilly, Novo Nordisk, and Astra Zeneca; research support from Novo Nordisk, Sanofi, Abbott, and Medtronic. received grant support diaTribe from Abbott, Ascencia, Bigfoot Biomedical, Dexcom, Insulet, LifeScan, Lilly, Medtronic, Novo Nordisk, One Drop, Roche, Sanofi, Senseonics, Xeris, and Zealand; news service subscription revenue Close Concerns from Abbott, Agamatrix, Air Liquide, Ascencia, BD, Beta Bionics, Bigfoot Biomedical, Biolinq, Capillary Biomedical, Cecilia Health, Cequr, DarioHealth, Dexcom, DreamED Diabetes, Glooko, Insulet, LifeScan, Lilly, MannKind, Medtronic, Metronom, Modular Medical, Novo Nordisk, Onduo, One Drop, Roche, Sanofi, Senseonics, Tandem, Xeris, Ypsomed, and Zealand; diaTribe.
has received research support from Abbott Diabetes Care, DexCom, Insulet, Medtronic, Sanofi, and has been on the scientific advisory board for Insulet. received speaker honoraria from Lilly paid to Institution. received research support from Medtronic, Dexcom, Novo Nordisk.
received research support from Insulet. is a consultant for Dexcom, Insulet. is a member of EU EXPAMED Panel for Medical products; received speaker honoraria from: Pfizer, Novo Nordisk, and Eli Lilly.
received consulting fee from Tandem Diabetes Care and Ypsomed. received research support from Medtronic, Dexcom, Abbott, Tandem, Insulet, Beta Bionics, and Lilly. Consultant, speaker, advisory board for Medtronic, Dexcom, Abbott, Tandem, Insulet, Beta Bionics and Lilly.
has received Advisory Boards Consulting fee through University of Colorado Denver from Medtronic, Zealand, and Eli Lilly. Research grants through University of Colorado Denver from Eli Lilly, Novo Nordisk, Medtronic, T1D Exchange, NIDDK, JDRF, Dexcom.
No stocks in any device or pharmaceutical company. participates in clinical research or has served as a consultant for: Abbott Diabetes Care, Dexcom, and Medtronic. is the head of HFS-Global LLC which licenses use of Fear of Hypoglycemia Surveys under a partnership with the University of Virginia.
is a member of Medtronic advisory board, a director of Ask Diabetes Ltd providing training and research support in health care settings and received training honoraria from Medtronic, Dexcom, and Sanofi and consulting fees for CamDiab.
is a consultant for a number of companies, one of the owners of Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany. is a speaker for Novo Nordisk, Advisory Boards for Eli Lilly, Novo Nordisk, Zealand, and Zucara.
Received research support from Dexcom. received Research grants from Medtronic Diabetes, Insulet, Beta Bionics; Consulting fee from Abbott Diabetes Care, Roche, Bigfoot, GWave. received consultant fees from Insulet, Cecelia Health, Lifescan Diabetes Institute.
declares Consultant to: Dexcom, Eli Lilly, Eoflow, Fractyl, Integrity, Lifecare, Roche Diagnostics, Thirdwayv. received research support and speaker honoraria from Amgen, B. Braun, Diamyd Medical, Medtronic, Novo Nordisk, Sanofi and is a shareholder of DreaMed Diabetes Ltd.
declares Consultant for Abbott Diabetes Care, BioLinq, Capillary Biomedical, Deep Valley Labs, Morgan Stanley, Provention Bio and Tidepool.
is on the advisory board for Abbott Diabetes Care, Dexcom, Insulet, Medtronic, Novo Nordisk, and Sanofi Diabetes Care. declares Speaker: Dexcom, Roche, and Novo Nordisk; Advisory Board: Medtronic. Research support: Dexcom, Abbott Diabetes Care, and Medtronic.
Advisory Board for Medtronic, Abbott Diabetes Care, and Novo Nordisk and research support via institution from Dexcom, Medtronic, Novo Nordisk, and Zealand Pharma. declares Advisory boards and received research support and honoraria from Medtronic, Merck, Novo Nordisk, Sanofi, and Abbott. declares Advisory boards for Dexcom, Cecelia Health, DiabetesWise.
and Tandem. Speaker: Sanofi, NovoNordisk, Eli -Lilly, and Insulet. Received research support: Beta Bionics, Novo Nordisk, Zealand. Patents and patents pending assigned to MGH and licensed to: Beta Bionics. Honoraria and travel support: Novo Nordisk, Roche, Senseonics. Scientific advisory board: Unomedical, Companion Medical.
Speaker: Dexcom, Insulet. Grants: Dexcom, Insulet, Eli Lilly, Novo Nordisk, and Sanofi. Advisory board member for Bigfoot Biomedical, Cecelia Health, Insulet, Medtronic, the T1D Fund, and Vertex. Research support from Dexcom, Insulet, and Medtronic.
Grants: Abbott. Speaker for Abbott, Dexcom, Insulet, Medtronic, and Tandem. Research support to Institution from Abbott. served on advisory boards of Novo Nordisk, Sanofi, Eli Lilly, Boehringer, Medtronic, Indigo, DreaMed Diabetes.
owns stocks of DreamMed Diabetes. Foster NC , Beck RW , Miller KM , et al. State of type 1 diabetes management and outcomes from the T1D Exchange in — Diabetes Technol Ther. Google Scholar.
Brown SA , Kovatchev BP , Raghinaru D , et al. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. N Engl J Med. Isganaitis E , Raghinaru D , Ambler-Osborn L , et al. Closed-loop insulin therapy improves glycemic control in adolescents and young adults: outcomes from the international diabetes closed-loop trial.
McAuley SA , Lee MH , Paldus B , et al. Six months of hybrid closed-loop versus manual insulin delivery with fingerprick blood glucose monitoring in adults with type 1 diabetes: a randomized, controlled trial.
Diabetes Care. Collyns OJ , Meier RA , Betts ZL , et al. Improved glycemic outcomes with Medtronic MiniMed advanced hybrid closed-loop delivery: results from a randomized crossover trial comparing automated insulin delivery with predictive low glucose suspend in people with type 1 diabetes.
Tauschmann M , Thabit H , Bally L , et al. Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, week randomised trial. Pease A , Zomer E , Liew D , et al.
Cost-effectiveness analysis of a hybrid closed-loop system versus multiple daily injections and capillary glucose testing for adults with type 1 diabetes.
Jendle J , Pöhlmann J , de Portu S , Smith-Palmer J , Roze S. Cost-effectiveness analysis of the MiniMed G hybrid closed-loop system versus continuous subcutaneous insulin infusion for treatment of type 1 diabetes.
Bott OJ , Hoffmann I , Bergmann J , et al. HIS modelling and simulation based cost-benefit analysis of a telemedical system for closed-loop diabetes therapy. Int J Med Inform. Serné EH , Roze S , Buompensiere MI , Valentine WJ , De Portu S , de Valk HW.
Cost-effectiveness of hybrid closed loop insulin pumps versus multiple daily injections plus intermittently scanned glucose monitoring in people with type 1 diabetes in The Netherlands.
Adv Ther. Boyne MS , Silver DM , Kaplan J , Saudek CD. Timing of changes in interstitial and venous blood glucose measured with a continuous subcutaneous glucose sensor. Slattery D , Amiel SA , Choudhary P. Optimal prandial timing of bolus insulin in diabetes management: a review.
Diabet Med. Castellanos LE , Balliro CA , Sherwood JS , et al. Performance of the insulin-only iLet bionic pancreas and the bihormonal iLet using dasiglucagon in adults with type 1 diabetes in a home-use setting. Haidar A , Tsoukas MA , Bernier-Twardy S , et al.
A novel dual-hormone insulin-and-pramlintide artificial pancreas for type 1 diabetes: a randomized controlled crossover trial. Youssef J E , Castle J , Ward WK.
A review of closed-loop algorithms for glycemic control in the treatment of type 1 diabetes. Forlenza GP , Cameron FM , Ly TT , et al. Fully closed-loop multiple model probabilistic predictive controller artificial pancreas performance in adolescents and adults in a supervised hotel setting.
Bergenstal RM , Garg S , Weinzimer SA , et al. Safety of a hybrid closed-loop insulin delivery system in patients with type 1 diabetes. Forlenza GP , Pinhas-Hamiel O , Liljenquist DR , et al.
Safety evaluation of the MiniMed g system in children years of age with type 1 diabetes. Brown SA , Beck RW , Raghinaru D , et al.
Glycemic outcomes of use of CLC versus PLGS in type 1 diabetes: a randomized controlled trial. Breton MD , Kanapka LG , Beck RW , et al. A randomized trial of closed-loop control in children with type 1 diabetes.
Brown SA , Forlenza GP , Bode BW , et al. Multicenter trial of a tubeless, on-body automated insulin delivery system with customizable glycemic targets in pediatric and adult participants with type 1 diabetes. Carlson AL , Sherr JL , Shulman DI , et al. Bergenstal RM , Nimri R , Beck RW , et al.
A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes FLAIR : a multicentre, randomised, crossover trial. Benhamou P-Y , Franc S , Reznik Y , et al. Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a week multicentre, open-label randomised controlled crossover trial.
Lancet Digital Health. Kariyawasam D , Morin C , Casteels K , et al. Hybrid closed-loop insulin delivery versus sensor-augmented pump therapy in children aged years: a randomised, controlled, cross-over, non-inferiority trial.
Lancet Digit Health. Blauw H , Onvlee AJ , Klaassen M , van Bon AC , DeVries JH. Fully closed loop glucose control with a bihormonal artificial pancreas in adults with type 1 diabetes: an outpatient, randomized, crossover trial.
Lum JW , Bailey RJ , Barnes-Lomen V , et al. A real-world prospective study of the safety and effectiveness of the loop open source automated insulin delivery system. Ware J , Allen JM , Boughton CK , et al. Randomized trial of closed-loop control in very young children with type 1 diabetes.
Boughton CK , Hartnell S , Thabit H , et al. Hybrid closed-loop glucose control with sensor augmented pump therapy in older adults with type 1 diabetes: an open-label multicentre, multinational, randomised, crossover study.
Lancet Healthy Longevity. Garg SK , Weinzimer SA , Tamborlane WV , et al. Glucose outcomes with the in-home use of a hybrid closed-loop insulin delivery system in adolescents and adults with type 1 diabetes.
Forlenza GP , Ekhlaspour L , DiMeglio LA , et al. Pediatr Diabetes. Sherr JL , Bode BW , Forlenza GP , et al. Safety and glycemic outcomes with a tubeless automated insulin delivery system in very young children with type 1 diabetes: a single-arm multicenter clinical trial.
Schoelwer MJ , Kanapka LG , et al. Ekhlaspour L , Town M , Raghinaru D , Lum JW , Brown SA , Buckingham BA. Glycemic outcomes in baseline hemoglobin A1C subgroups in the international diabetes closed-loop trial. Online ahead of print. Breton MDS , Kovatchev BP.
One year real-world use of the control-IQ advanced hybrid closed-loop technology. Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications of insulin-dependent diabetes mellitus.
Stone MP , Agrawal P , Chen X , et al. Retrospective analysis of 3-month real-world glucose data after the MiniMed G system commercial launch. Akturk HK , Giordano D , Champakanath A , et al. Long-term real-life glycaemic outcomes with a hybrid closed-loop system compared with sensor-augmented pump therapy in patients with type 1 diabetes.
Diabetes Obes Metab. Beato-Víbora PI , Gallego-Gamero F , Ambrojo-López A , Gil-Poch E , Martín-Romo I , Arroyo-Díez FJ. Rapid improvement in time in range after the implementation of an advanced hybrid closed-loop system in adolescents and adults with type 1 diabetes.
Da Silva J , Lepore G , Battelino T , et al. Real-world performance of the MiniMed G system: first Report of outcomes from Users. Messer LH , Berget C , Pyle L , et al.
Real-world use of a new hybrid closed loop improves glycemic control in youth with type 1 diabetes. Hood , KK , Garcia-Willingham N , Hanes S , et al.
Lived experience of CamAPS FX closed loop system in youth with type 1 diabetes and their parents. doi: doi: Cobry EC , Hamburger E , Jaser SS. Impact of the hybrid closed-loop system on sleep and quality of life in youth with type 1 diabetes and their parents. Abraham MB , de Bock M , Smith GJ , et al.
Effect of a hybrid closed-loop system on glycemic and psychosocial outcomes in children and adolescents with type 1 diabetes: a randomized clinical trial.
JAMA Pediatr. Messer LH , Berget C , Vigers T , et al. Real world hybrid closed-loop discontinuation: predictors and perceptions of youth discontinuing the G system in the first 6 months.
Berget C , Messer LH , Vigers T , et al. Six months of hybrid closed loop in the real-world: an evaluation of children and young adults using the G system.
Bergenstal RM , Gal RL , Connor CG , et al. Racial differences in the relationship of glucose concentrations and hemoglobin A1c levels. Ann Intern Med. Ziegler C , Liberman A , Nimri R , et al.
Reduced worries of hypoglycaemia, high satisfaction, and increased perceived ease of use after experiencing four nights of MD-logic artificial pancreas at home DREAM4. J Diabetes Res. Cobry EC , Kanapka LG , Cengiz E , et al. Health-related quality of life and treatment satisfaction in parents and children with type 1 diabetes using closed-loop control.
Bisio A , Brown SA , McFadden R , et al. Sleep and diabetes-specific psycho-behavioral outcomes of a new automated insulin delivery system in young children with type 1 diabetes and their parents.
Wheeler BJ , Collyns OJ , Meier RA , et al. Improved technology satisfaction and sleep quality with Medtronic MiniMed Advanced Hybrid Closed-Loop delivery compared to predictive low glucose suspend in people with type 1 diabetes in a randomized crossover trial. Acta Diabetol.
Kudva YC , Laffel LM , Brown SA , et al. Patient-reported outcomes in a randomized trial of closed-loop control: the pivotal international diabetes closed-loop trial. Cobry EC , Bisio A , Wadwa RP , Breton MD. Improvements in parental sleep, fear of hypoglycemia, and diabetes distress with use of an advanced hybrid closed loop system.
Barnard KD , Wysocki T , Ully V , et al. Closing the loop in adults, children and adolescents with sub-ptimally controlled type 1 diabetes under free living conditions: a psychosocial substudy. J Diabetes Sci Technol. Tauschmann M , Allen JM , Nagl K , et al. Home use of day-and-night hybrid closed-loop insulin delivery in very young children: a multicenter, 3-week, randomized trial.
Ekhlaspour L , Schoelwer MJ , Forlenza GP , et al. Safety and performance of the Tandem t:slim X2 with control-IQ automated insulin delivery system in toddlers and preschoolers.
Salehi P , Roberts AJ , Kim GJ. Efficacy and safety of real-life usage of MiniMed G automode in children with type 1 diabetes less than 7 years old. Stewart ZA , Wilinska ME , Hartnell S , et al. Closed-loop insulin delivery during pregnancy in women with type 1 diabetes.
Day-and-night closed-loop insulin delivery in a broad population of pregnant women with type 1 diabetes: a randomized controlled crossover trial. Kumareswaran K , Thabit H , Leelarathna L , et al. Feasibility of closed-loop insulin delivery in type 2 diabetes: a randomized controlled study.
Thabit H , Hartnell S , Allen JM , et al. Closed-loop insulin delivery in inpatients with type 2 diabetes: a randomised, parallel-group trial.
Lancet Diabetes Endocrinol. Akturk HK , Agarwal S , Hoffecker L , Shah VN. Inequity in racial-ethnic representation in randomized controlled trials of diabetes technologies in type 1 diabetes: critical need for new standards. Dovc K , Battelino T. Closed-loop insulin delivery systems in children and adolescents with type 1 diabetes.
Expert Opin Drug Deliv. Sherr JL , Buckingham BA , Forlenza GP , et al. Safety and performance of the Omnipod hybrid closed-loop system in adults, adolescents, and children with type 1 diabetes over 5 days under free-living conditions.
Lal RA , Basina M , Maahs DM , et al. One year clinical experience of the first commercial hybrid closed-loop system. Braune K , O'Donnell S , Cleal B , et al.
Real-world use of Do-It-Yourself artificial pancreas systems in children and adolescents with type 1 diabetes: online survey and analysis of self-reported clinical outcomes. JMIR Mhealth Uhealth. Varimo T , Pulkkinen MA , Hakonen E , et al.
First year on commercial hydrid closed-loop system - experience on children and adolescents with type 1 diabetes. Berget C , Akturk HK , Messer LH , et al. Real world performance of hybrid closed loop in youth, young adults, adults and older adults with type 1 diabetes: identifying a clinical target for hybrid closed loop use.
McAuley SA , Trawley S , Vogrin S , et al. Closed-loop insulin delivery versus sensor-augmented pump therapy in older adults with type 1 diabetes ORACL : a randomized, crossover trial. Fuchs J , Hovorka R.
Benefits and challenges of current closed-loop technologies in children and young people with type 1 diabetes. Front Pediatr. Fuchs J , Allen JM , Boughton CK , et al. Assessing the efficacy, safety and utility of closed-loop insulin delivery compared with sensor-augmented pump therapy in very young children with type 1 diabetes KidsAP02 study : an open-label, multicentre, multinational, randomised cross-over study protocol.
BMJ Open. Petruzelkova L , Jiranova P , Soupal J , et al. Pre-school and school-aged children benefit from the switch from a sensor-augmented pump to an AndroidAPS hybrid closed loop: a retrospective analysis.
Dovc K , Boughton C , Tauschmann M , et al. Young children have higher variability of insulin requirements: observations during hybrid closed-loop insulin delivery.
Anderson SM , Buckingham BA , Breton MD , et al. Hybrid closed-loop control is safe and effective for people with type 1 diabetes who are at moderate to high risk for hypoglycemia.
Abitbol A , Rabasa-Lhoret R , Messier V , et al. Overnight glucose control with dual- and single-hormone artificial pancreas in type 1 diabetes with hypoglycemia unawareness: a randomized controlled trial. Malone SK , Peleckis AJ , Grunin L , et al.
Characterizing glycemic control and sleep in adults with long-standing type 1 diabetes and hypoglycemia unawareness initiating hybrid closed loop insulin delivery. Burckhardt MA , Abraham MB , Dart J , et al.
Impact of hybrid closed loop therapy on hypoglycemia awareness in individuals with type 1 diabetes and impaired hypoglycemia awareness. Polsky S , Akturk HK. Case series of a hybrid closed-loop system used in pregnancies in clinical practice.
Diabetes Metab Res Rev. Farrington C , Stewart Z , Hovorka R , Murphy H. Farrington C , Stewart ZA , Barnard K , Hovorka R , Murphy HR. Experiences of closed-loop insulin delivery among pregnant women with Type 1 diabetes. Stewart ZA , Yamamoto JM , Wilinska ME , et al. Adaptability of closed loop during labor, delivery, and postpartum: a secondary analysis of data from two randomized crossover trials in type 1 diabetes pregnancy.
Bally L , Gubler P , Thabit H , et al. Fully closed-loop insulin delivery improves glucose control of inpatients with type 2 diabetes receiving hemodialysis. Kidney Int. Kaur H , Schneider N , Pyle L , et al. Efficacy of hybrid closed-loop system in adults with type 1 diabetes and gastroparesis.
Boughton CK , Tripyla A , Hartnell S , et al. Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial.
Nat Med. Sherwood JS , Jafri RZ , Balliro CA , et al. Automated glycemic control with the bionic pancreas in cystic fibrosis-related diabetes: A pilot study.
J Cyst Fibros. Scully KJ , Palani G , Zheng H , Moheet A , Putman MS. American Diabetes Association. Kovatchev BP , Kollar L , Anderson SM , et al. Carlson AL , Bode BW , Brazg RL , et al. June , ; Virtual. Thabit H , Tauschmann M , Allen JM , et al. Home use of an artificial beta cell in type 1 diabetes.
Bisio A , Gonder-Frederick L , McFadden R , et al. The impact of a recently approved automated insulin delivery system on glycemic, sleep, and psychosocial outcomes in older adults with type 1 diabetes: a pilot study.
Bally L , Thabit H , Hartnellet S , et al. Closed-loop insulin delivery for glycemic control in noncritical care. Mulinacci G , Alonso GT , Snell-Bergeon JK , Shah VN. Glycemic outcomes with early initiation of continuous glucose monitoring system in recently diagnosed patients with type 1 diabetes.
Kamrath C , Tittel SR , Kapellen TM , et al. Early versus delayed insulin pump therapy in children with newly diagnosed type 1 diabetes: results from the multicentre, prospective diabetes follow-up DPV registry. Lancet Child Adolesc Health.
Champakanath A , Akturk HK , Alonso GT , Snell-Bergeon JK , Shah VN. Continuous glucose monitoring initiation within first year of type 1 diabetes diagnosis is associated with improved glycemic outcomes: 7-year follow-up study.
Shah SC , Malone JI , Simpson NE. A randomized trial of intensive insulin therapy in newly diagnosed insulin-dependent diabetes mellitus. Buckingham B , Beck RW , Ruedy KJ , et al. Effectiveness of early intensive therapy on β-cell preservation in type 1 diabetes.
University of Cambridge. Closed Loop From Onset in Type 1 Diabetes CLOuD. Accessed September 22, Jaeb Center for Health Research. Hybrid Closed Loop.
Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes CLVer. Patton SR , Noser AE , Youngkin EM , Majidi S , Clements MA. Early initiation of diabetes devices relates to improved glycemic control in children with recent-onset type 1 diabetes mellitus.
Battelino T , Danne T , Bergenstal RM , et al. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range.
Kimbell B , Rankin D , Ashcroft NL , et al. What training, support, and resourcing do health professionals need to support people using a closed-loop system?
A qualitative interview study with health professionals involved in the closed loop from onset in type 1 diabetes CLOuD trial.
Messer LH. Why expectations will determine the future of artificial pancreas. Boughton CK , Hartnell S , Allen JM , Fuchs J , Hovorka R. Training and support for hybrid closed-loop therapy. Cescon M , DeSalvo DJ , Ly TT , et al. Early detection of infusion set failure during insulin pump therapy in type 1 diabetes.
Boughton CK , Hartnell S , Allen JM , Hovorka R. The importance of prandial insulin bolus timing with hybrid closed-loop systems. Pinsker JE , Harsimran Singh H , Molly McElwee Malloy MM , et al.
Vegan and organic food options HeileBetty HollsteggeLaura Automated insulin management insulim, Albert CaiKelly Close; Jnsulin Core strength exercises Manaegment Easy Enough to Use in Primary Care?. Clin Diabetes 1 December ; 38 5 : — There are three automated insulin delivery devices on the U. market, two of which are currently approved by the U. Food and Drug Administration. BMI for Overweight U. Mahagement and Drug Administration today authorized marketing of the Tandem Autommated Care Control-IQ Technology, an interoperable Autokated glycemic controller device that automatically adjusts insulin Automated insulin management to a person with Auotmated by connecting to an Automated insulin management controller-enabled manaagement pump ACE Automsted and integrated continuous glucose monitor iCGM. This is the first such controller that can be used with other diabetes devices that are also designed to be integrated into a customizable diabetes management system for automated insulin delivery. This FDA authorization paves the way for iCGMs and ACE pumps to be used with an interoperable automated glycemic controller as a complete automated insulin dosing AID system. AID systems typically consist of a pump, CGM and software to control the system of compatible devices.
Ich lehne ab.
Wacker, Sie haben sich nicht geirrt:)
Jetzt kann ich an der Diskussion nicht teilnehmen - es gibt keine freie Zeit. Ich werde frei sein - unbedingt werde ich schreiben dass ich denke.
Nach meiner Meinung irren Sie sich. Geben Sie wir werden es besprechen. Schreiben Sie mir in PM, wir werden reden.