670g Patient With Dexcom Upload Pump Data
Skillful Rev Med Devices. Author manuscript; available in PMC 2020 October 1.
Published in final edited form as:
PMCID: PMC6816287
NIHMSID: NIHMS1540684
MiniMed 670G Hybrid Airtight Loop Artificial Pancreas System for the handling of blazon 1 diabetes mellitus: overview of its rubber and efficacy
Aria Saunders
1University of Colorado Denver, Denver, CO
Laurel H. Messer
iiBarbara Davis Eye, University of Colorado Denver, Aurora, CO
Gregory P. Forlenza
2Barbara Davis Center, University of Colorado Denver, Aurora, CO
Abstract
Introduction
Automated insulin delivery for people with type 1 diabetes has been a major goal in the diabetes engineering field for many years. While a fully automatic arrangement has non yet been achieved, the MiniMed™ 670G artificial pancreas (AP) organization is the first commercially bachelor insulin pump that automates basal insulin delivery, while all the same requiring user input for insulin boluses. Determining the condom and efficacy of this organization is essential to the development of futurity devices striving for more automation.
Areas Covered
This review will provide an overview of how the MiniMed 670G system works including its safety and efficacy, how it compares to similar devices, and anticipated futurity advances in diabetes engineering science currently nether development.
Expert Opinion
The ultimate goal of advanced diabetes technologies is to reduce the brunt and amount of management required of patients with diabetes. In addition to reducing patient workload, achieving better glucose command and improving hemoglobin A1c (HbA1c) values are essential for reducing the threat of diabetes-related complications further down the route. Current devices come up close to reaching these goals, just agreement the unmet needs of patients with diabetes will let futurity technologies to achieve these goals more chop-chop.
Keywords: bogus pancreas (AP), automatic insulin delivery, continuous glucose monitor (CGM), hybrid closed loop, insulin pump, MiniMed 670G, Blazon 1 diabetes
1. INTRODUCTION
Type ane diabetes (T1D) is an autoimmune disorder characterized by the destruction of insulin-producing beta cells in the pancreas leading to insulin deficiency [1]. Insulin deficiency prevents glucose from entering into the cells to be metabolized for energy, and instead, glucose builds up in the blood. This accumulation leads to hyperglycemia, or elevated blood glucose. Every bit a result, patients with T1D require life-long, intensive insulin replacement to accomplish glucose levels equally close to normal as possible in gild to decrease the threat of long-term diabetic complications (e.m., neuropathy and retinopathy) [2].
The likelihood of developing long-term complications commonly related to diabetes can exist lessened past maintaining normal blood glucose levels. Nonetheless, less than 30% of patients with T1D are able to consistently reach normal glucose levels, despite the many advances in diabetes care [2]. T1D is i of the well-nigh mutual chronic diseases of children and adolescents, though information technology can arise at any historic period [3]. Both the incidence and prevalence of T1D has increased in recent years and are projected to continue to ascension [1, 3].
Treatment for T1D can be varied, but always requires continuous replacement of insulin. Multiple daily injections (MDI) is one mode that insulin is given. A long-acting insulin dose given once or twice per day provides the background insulin necessary for cellular metabolism of glucose, while rapid-acting insulin is given for each meal to cover carbohydrate intake and right elevated glucose values. Insulin pumps are another way to deliver exogenous insulin. Insulin pumps are minor, external devices that continuously evangelize pocket-sized amounts of rapid-acting insulin and, therefore, replace the need for multiple daily needle injections. The insulin is contained in a reservoir and infused through a cannula that is placed in the subcutaneous tissue and secured with adhesive-- creating what is referred to every bit an infusion site. Many insulin pumps contain tubing that connects the reservoir to the infusion site, while other pumps, chosen patch pumps, accept no tubing, and sits directly on the skin. The infusion site is not surgically placed, and it must exist removed and replaced every three days by the patient or a caregiver to prevent skin infection, lipohypertrophy, or scar tissue [half dozen].
Insulin pumps take many advantages over MDI for both basal (continuous insulin) and bolus (large dose) delivery. Offset, insulin pumps permit for the basal insulin supply to be tailored to the needs of the patient based on variance in activity level, time of day, and physiologic trends of hypoglycemia or hyperglycemia. Another advantage of insulin pumps over MDI is that insulin pumps can evangelize insulin to the nearest 0.01 units, whereas syringe injections tin can only evangelize insulin to the nearest 0.5 units. Insulin pumps besides provide the ability to administer multiple boluses a day without the additional discomfort of injections for the patient [seven].
In add-on to replacing insulin, individuals with T1D must also monitor their glucose levels. This can be done by blood glucose monitoring, or using a Continuous Glucose Monitor (CGM). CGMs are subcutaneous electrochemical sensors which measure the glucose levels of the interstitial fluid [8]. The sensor is connected to a transmitter that continuously transfers current claret glucose readings to a portable device or straight to the pump every v minutes, and will alert users if glucose levels exceed hyperglycemia or hypoglycemia thresholds [8]. Many types of CGM devices require multiple calibrations per solar day from a blood glucose meter value to improve accuracy [ix]. More advanced models of insulin pumps also allow for integration with continuous glucose monitor (CGM) sensors providing patients with a real-time value of their current blood glucose on the pump [eight]. CGM sensors are inserted under the peel by the patient and worn for seven–10 days before beingness replaced with a new sensor.
In hopes of minimizing the workload of managing T1D for individuals, research investigators are studying how to automate claret glucose control through the development of an bogus pancreas (AP) organisation, also referred to as a closed-loop organization. This means that instead of patients monitoring glucose levels and responding with insulin dose calculations, an algorithm will calculate insulin doses automatically. While futurity devices may be able to automate all aspects of glycemic control, delays in insulin absorption and deposition and transfer of glucose betwixt the intravenous and subcutaneous spaces mandate that early on systems operate as "hybrid closed-loop" devices, meaning that some insulin commitment (eastward.thousand., basal insulin) will be automated, but bolus insulin will still crave some amount of patient intervention (e.g., to bolus for meals, correct for hyperglycemia, or announce practise) in lodge to achieve the best control.
AP systems operate from 1 of three main control algorithms. The model predictive control (MPC) algorithm predicts future blood glucose readings and adjusts insulin delivery based on that prediction [9]. The 2d algorithm is proportional-integral-derivative (PID) command which responds to the real-time glucose values [ix] and adjusts basal insulin commitment to a target blood glucose (e.thousand., 120mg/dL) [xi]. Last is the fuzzy logic (FL) control which bases insulin doses on CGM information [9] and attempts to imitate the reasoning of diabetes clinicians [12]. The aggressiveness of the system'southward response to blood glucose deviations is adamant by the tuning of these control algorithms and unique features of each algorithm [10].
The Medtronic MiniMed™ 670G system (Medtronic, Northridge, CA) is the first commercially bachelor hybrid airtight-loop arrangement. It uses the MiniMed 670G insulin pump, the Guardian™ 3 CGM glucose sensor, and a modified PID algorithm called SmartGuard™ technology (Medtronic, Northridge, CA) [13]. The MiniMed 670G organization responds to the sensor glucose value and automatically adjusts basal insulin delivery every five minutes [13] past either increasing, decreasing, or suspending insulin delivery [14]. Auto Style, which is the proprietary name for the hybrid closed-loop functionality, targets a claret glucose of 120 mg/dL merely can modify this target to 150 mg/dL for exercise as post-exercise hypoglycemia is common. The other parameters determined by the system are based on previous total daily insulin doses and fasting glycemic control [15]. This organisation has been shown to meliorate hemoglobin A1c levels and increment time in range [16] which are two of the main focuses of diabetes management.
2. REVIEW
ii.1. OVERVIEW OF THE Market
The insulin pump market has evolved drastically over the years, with the MiniMed 670G system just existence 1 of many systems available to individuals with T1D. Many insulin pumps work as stand-alone pumps, meaning that they are not integrated with a CGM simply only evangelize insulin. There are also iii categories of insulin pump that work in conjunction with CGMs. With the kickoff type, the CGM sends sensor glucose values to be displayed on the insulin pump, only no decisions for dosing are fabricated from the CGM values. The second type involves the CGM sending sensor glucose values to the insulin pump which so tin make up one's mind to suspend insulin before and when the claret glucose value reaches the preset depression limit. This is called "suspend earlier low" and "suspend on low" [17]. The third type is the hybrid airtight-loop system where the CGM sends sensor glucose values to the insulin pump and the pump can then brand decisions on basal insulin delivery from those values.
At that place are currently three major companies that are producing insulin pumps in the Usa: Medtronic Diabetes, Insulet Corporation, and Tandem Diabetes Intendance [ix]. The near recent Medtronic insulin pump is the MiniMed 670G Hybrid Closed-loop, which can be integrated with the Guardian three CGM. The electric current Insulet insulin pump is the OmniPod Dash™ (Insulet Corporation, Acton, MA). The Dash is a patch pump that is ofttimes used in conjunction with the Dexcom G5® or G6® CGM (Dexcom, San Diego, CA) sensor just does non yet directly integrate with a CGM. It utilizes Bluetooth applied science to communicate betwixt the hand-held OmniPod Personal Diabetes Manager (PDM) and the insulin patch pump that is adhered to the pare [9]. Users can also access the insulin pump system information on a mobile device for remote monitoring. Finally, the Tandem insulin pump on the market at this fourth dimension is the T:slim X2™ insulin pump (Tandem Diabetes Care, San Diego, CA) which tin be integrated with the Dexcom G5 or G6 CGM systems. When integrated with the Dexcom G6, this pump uses Basal-IQ™ technology (Tandem Diabetes Intendance, San Diego, CA) to reduce occurrences of hypoglycemia through predictive depression glucose suspend (PLGS), which is the same concept as suspend before depression [17]. Another system comparable to the Tandem Basal-IQ organization is the Medtronic 640G system, which is available outside the United States. This system also has the PLGS feature which greatly reduces the number of glucose values less than 70 mg/dL [xviii]. While total discussion of different PLGS systems is beyond the telescopic of this manuscript, a side-by-side comparing of the features of the MiniMed 630G, MiniMed 640G/670G PLGS, and Tandem Basal-IQ functions was recently published by Messer and colleagues.[nineteen]
Many advances have been made with CGM devices likewise over the past few years, which directly affects how well a airtight-loop device will work. Currently, 4 different CGM systems are commercially available: the Medtronic Guardian 3 sensor, the Dexcom G6, the Senseonics Eversense® CGM (Senseonics, Inc., Germantown, MD) and the Abbott Freestyle® Libre (Abbott Laboratories, Chicago, IL). The Guardian Sensor 3 system is the only CGM that works in conjunction with the MiniMed 670G insulin pump to achieve hybrid closed-loop system functionality [ix]. This CGM sends its information direct to the MiniMed 670G pump and requires at least 2 calibrations per day with a recommendation of 3–4 calibrations [9] to achieve the greatest accurateness. Information technology is approved past the Food and Drug Administration (FDA) for apply in patients downward to age vii years.
While insulin pumps and CGMs accept many advantages, there are some limitations or concerns that patients have reported. For open loop pumps without automation, a big corporeality of user intervention is still required including careful monitoring of blood glucose and transmission alterations to basal commitment and other various parameters [9]. Also, with any pump there is a certain increase to the run a risk of diabetic ketoacidosis due to a bent cannula under the skin which occludes insulin delivery, or other infusion site failures that are not recognized quickly [nine]. CGM systems accept offered patients the ability to know their real-time claret glucose and take ultimately helped better the management of T1D [9]. All the same, the use of a CGM requires an additional insertion site on the body which may crusade an added element of discomfort for the user. Also, CGM readings tend to lag backside blood glucose values to a sure caste during times of rapid glucose level changes [9]. Possible factors attributing to this lag include departure in the diffusion of glucose from blood to interstitial fluid and delayed sensor reaction fourth dimension to glucose intake [xx]. CGM time lag is nigh commonly seen during exercise.
There are other reasons that insulin pumps and CGMs autumn short. Although the technological advancements and use of insulin pumps and CGMs have profoundly increased in recent years, overall glycemic control has non improved significantly and simply a minority of youth and adults with T1D see the HbA1c goals for platonic diabetes control [21–23]. Many individuals additionally discontinue use of insulin pumps and CGM for a diversity of reasons. In a survey of adults with T1D, the almost common barriers to pump use were non liking to wear a device and finding them uncomfortable. For CGMs, the cost of supplies was the major reason for discontinuation followed past the bother of alarms and not being able to trust the device for accurateness [24]. This mistrust in CGM accuracy poses an additional problem in that information technology could reduce the number of patients desiring the MiniMed 670G and hereafter AP systems, which rely on CGM information to make insulin dosing decisions. Properly addressing these psychosocial behaviors of T1D individuals tin can help to continue to increase the uptake of insulin pump and CGM use as well every bit ultimately better glycemic control beyond all age groups.
2.2. INTRODUCTION TO THE DEVICE
The MiniMed 670G insulin pump is the commencement hybrid airtight-loop system to exist approved by the FDA (see Figure one). The MiniMed 670G can operate in two modes: Manual Mode and Auto Mode. In Transmission Style, the MiniMed 670G acts equally a traditional pump working off insulin commitment settings programmed by the user. In this mode, the system may be integrated with the Guardian Sensor 3 to utilise the append before low feature which automatically suspends basal insulin delivery up to 30 minutes before the preset depression glucose value is reached to avoid hypoglycemia [9]. In Automobile Mode, the insulin pump is integrated with the Guardian Sensor iii to provide fully automated basal insulin delivery based off the calculated full daily dose of the previous 2–6 days and present blood glucose values [15, 25].
MiniMed 670G Insulin Pump and Guardian 3 CGM
The MiniMed 670G implements a modified PID algorithm [26]. This algorithm adjusts basal insulin delivery in response to the current glucose values, but it also takes into account insulin feedback which recognizes insulin delivery history [26]. Information technology aims to achieve a glucose target of 120 mg/dl. The modified PID algorithm has some unique functionality. Ane advantage of the arrangement is how it attempts to forbid postprandial hypoglycemia and hyperglycemia. The patient must initiate a properly calculated meal bolus prior to the repast; then the modified algorithm accounts for the insulin that is present at meal time and reduces the amount of insulin delivery afterwards the meal to forbid hypoglycemia due to insulin stacking [26].
The Guardian Sensor iii is a fourth-generation glucose sensor which is canonical to be worn for up to seven days [27]. The Guardian Sensor 3 is greatly improved from the previous Medtronic Enlite sensor in terms of sensor electrode design and enhanced algorithms that amend sensor accurateness and reliability [27]. The algorithm uses electrochemical impedance spectroscopy to detect sensor faults and glucose sensitivity changes that would require a new calibration [27]. A recent study analyzing the accurateness and precision of the Guardian Sensor 3 found that the mean absolute relative departure (MARD) between sensor glucose values and claret glucose meter values was smaller than with the Enlite sensor [28]. The MARD decreased an additional 1% when users calibrated three–4 times per twenty-four hours as opposed to the system-required 2 calibrations [28].
In addition to CGMs, infusion sets are another vital piece of equipment required for the apply of the MiniMed 670G. Infusion sets connect the insulin reservoir in the pump to the body (run across Effigy 2). An infusion ready includes a minor cannula that is inserted under the skin and tubing that is detachable from the infusion site connected to a reservoir of insulin. At that place are unlike types of infusion sets that provide a wide range of benefits for all types of patients. The differences in infusion sets include the ability to have a soft or steel cannula, various angles at which the cannula can exist inserted, and a variety of tubing lengths [29]
Insulin Pump Infusion Site
Training for the MiniMed 670G is a somewhat lengthy process if the individual has no prior experience with an insulin pump and CGM. For experienced pump and CGM users, training may be quicker, equally described past a big pediatric clinical center that published their grooming program which consisted of three steps [31]. The first step described past this group is a group or individual session where basic pump and CGM usage techniques are reviewed and instructions are given on how to use the Transmission Mode features including suspend earlier low. The second footstep is initiating Auto Mode, which can occur in person or via a video conference call ~1 week after starting Manual Mode. During the visit, the trainer explains what Auto Mode is, how to use it, as well as how to troubleshoot any Machine Fashion exits. After the MiniMed 670G user starts Auto Mode, follow-up telephone calls from a trainer could occur at weeks 1, ii, and iv after the start of Auto Mode to explain optimizing time in range and troubleshooting whatsoever problems or questions the patients may have [31]. In that location are likely many ways to train individuals on the MiniMed 670G, just all will demand to include Manual Manner preparation, Auto Mode grooming, and follow-up troubleshooting.
2.3. CLINICAL Contour AND POST-MARKET FINDINGS
The MiniMed 670G organization underwent phase 1, 2, and 3 clinical trials prior to its commercial approval by the FDA. This department will describe the clinical studies prior to commercial approval as well every bit various findings from post-market studies.
Stage I (Safety and Feasibility)
Prophylactic and feasibility information are available for the MiniMed 670G AP system and were nerveless on laptop-based systems within a hospital research unit with close-supervision by healthcare providers. A feasibility study conducted past Steil et al. researched whether a fully automatic closed-loop insulin delivery organization could help accomplish meliorate glycemic control using a PID system [32]. The study consisted of 10 T1D patients using an insulin pump and ii CGMs (1 used every bit a fill-in in case of sensor failure) that communicated with a laptop which ran the algorithms. The insulin delivery was based on the PID model. The P (proportion) factor delivered insulin in proportion to the departure between the sensor glucose value and the target glucose value of 120 mg/dL. The I (integral) factor delivered more insulin when there was a positive distance between the sensor glucose value and the target glucose value over fourth dimension and gave less insulin when that distance was negative, and the glucose was below target. The D (derivative) gene increased insulin delivery when the glucose was rising and decreased insulin delivery when the glucose was falling. This component adjusts insulin commitment in proportion to the rate of modify of glucose values. With the use of this arrangement, the average glucose was similar to that achieved with traditional pumps while the glucose variability was greatly reduced. The study resulted in no occurrences of astringent hypoglycemia, ~75% in target range, stable overnight glucose levels, and fasting glucose levels close to the target. Overall this study concluded that using an automated insulin delivery arrangement to improve glycemic control is doable.
Stage Two (Safety and Efficacy)
Ruiz et al. conducted a study on the consequence of the insulin feedback feature of AP systems on the glycemic control of airtight-loop users [26]. Insulin feedback was added to the original PID model explained by Steil et al. in their feasibility study [32]. This new study found that the overall blood glucose levels were significantly college when the insulin feedback was taken into account. Even so, the insulin feedback eliminated postprandial hypoglycemia, whereas 8 hypoglycemic events (6 direct after meal time) occurred in systems that did not employ insulin feedback. The balance of reduction in hypoglycemia versus reduction in hyperglycemia was a major focus of the early evolution of automatic systems, with the consensus of the field and regulators focusing on maximizing hypoglycemia reduction. The organization also returned the patient to normal glucose levels more quickly later on meals compared to the other organisation designs. The overall issue and benefit of incorporating insulin feedback into the algorithm for the MiniMed 670G system was that information technology enhanced the timing of insulin commitment at meals preventing postprandial hypoglycemia which is vital to maintaining adept glycemic command.
Phase III (Large Scale Condom and Efficacy)
2 multicenter pivotal studies published past Garg et al. and Forlenza et al. analyze the safety of the MiniMed 670G system for employ in T1D patients [14, 16]. Garg et al. reported on initial organization use in adolescents (ages 14–21 years) and adults (ages 22–75 years) with T1D. The report consisted of a ii-calendar week run-in phase in Manual Mode followed by a 3-month study phase in Auto Mode. The data collected during the two-week run-in phase was used as a ground for determining the Auto Style parameters. During this study, Automobile Mode was enabled 75.viii% of the time by adolescents and 88% of the time by adults. For both age groups, the percent of sensor glucose values within the target range increased during the day and dark. In that location were no episodes of severe hypoglycemia or diabetic ketoacidosis during the report.
Forlenza et al. reported on a similar multicenter report in children (ages vii–13 years) with T1D. This report consisted of a 2-week run-in phase in Manual Fashion followed by a 3-month report stage in Auto Mode, every bit well. During this report, Auto Mode was in use 81% of the time and the overall time in target range was 65%. The results of both studies showed increased fourth dimension in range, less fourth dimension in hypoglycemia and hyperglycemia, reduced glycemic variability, and lower HbA1c values. These outpatient clinical trial data are what led to the commercial approval of the MiniMed 670G organization past the FDA. Based on these ii studies, the MiniMed 670G system was determined to be safe for employ in patients ages 7 and older and to meliorate the overall direction of T1D.
Phase Four (Ongoing Surveillance)
Phase IV data on the MiniMed 670G organisation are being published now that the MiniMed 670G device has been commercially available for a few years. Stone et al. conducted a written report on the existent-world glucose outcomes afterward 3-months of MiniMed 670G use [xiii]. Data were extracted from the CareLink™ organisation (Medtronic, Northridge, CA) which is the database to which Medtronic users upload their pumps and/or CGMs to view their diabetes management history over a given time period. Afterward analyzing the CareLink data, the study showed increased fourth dimension in range from an average across all age groups of ~62.5% in Manual Manner to ~seventy.8% in Machine Mode. There was also a decrease in the percent of sensor glucose values in the hypoglycemia and hyperglycemia ranges.
Another study followed fifty-one youth through the first 6 months of MiniMed 670G hybrid closed-loop apply [33]. This written report institute a 37% discontinuation charge per unit and the patients who continued to use the system showed a subtract in the amount of fourth dimension spent in Auto Mode past ~10% besides every bit a decrease in sensor wear. As a result, these patients experienced an increment in HbA1c values and a decrease in the time in target glucose range. The proposed solution to this dilemma is to provide patients with additional support after the outset of Auto Fashion to ensure sensor clothing and help patients larn how to address Auto Style exits to increase the overall hybrid closed-loop use.
The studies demonstrating discontinuation of around a third of users starting the MiniMed 670G along with compunction in Automobile Mode use among those continuing to use the system display a concerning tendency in need of further research. Several large academic groups take begun longitudinal studies of these patients investigating predictors of discontinuation, behaviors around organization use, and glycemic control in continuers and discontinuers. These studies are currently ongoing without published conclusions at this time. While not specific to the MiniMed 670G, Tanenbaum investigated barriers to device uptake amid adults with T1D.[24] They found that hassle of wearing devices and dislike of having devices on one's trunk were often endorsed modifiable barriers. Other studies focused on CGM accept found that "alert fatigue" may play a major role in device discontinuation.[34] Information technology is likely that like on-trunk device burdens and issues with alarms take played part in discontinuation and attrition among users of the MiniMed 670G.
2.4. ALTERNATIVE DEVICES
While the MiniMed 670G is the only commercially available hybrid closed-loop insulin pump at this fourth dimension, other AP systems have been designed and are being tested in clinical trials for possible time to come commercialization. The Tandem Control-IQ AP organisation uses the Tandem t:slim X2 insulin pump with the Dexcom G6 CGM. This pump uses a hybrid airtight-loop algorithm which automates correction boluses, a hypoglycemia safety system which stops insulin commitment to avoid low blood glucose, and targets a tighter range of glucose levels overnight [35]. Early studies of the Control IQ organisation algorithm constitute an increase in the time in range (especially overnight), mean glycemic control much closer to target range without increasing hypoglycemia, and time in hyperglycemia was reduced [35–37]. The Control IQ device is currently in stage iii clinical trials.
The OmniPod Horizon™ Automated Glucose Control Organisation (Insulet Corporation, Acton, MA) is another hybrid closed-loop organization nether development. Information technology consists of an OmniPod patch pump, a personalized MPC algorithm, and a Dexcom CGM [38]. A handheld PDM device transmits commands, such every bit meal boluses or changes to settings to the OmniPod patch pump. The personalized MPC algorithm adjusts insulin dosing based on CGM values to reduce the difference between the predicted blood glucose over 60 minutes and the target blood glucose value [38]. The safety and feasibility studies of this device concluded that the system improved glycemic command, reduced exercise-related hypoglycemia with pre-exercise announcement, and improved postprandial glycemic command in the event of missed boluses or overestimated boluses [38–40].
Another series of approaches to automatic insulin delivery which must be considered are the so-called practise-it-yourself or DIY systems. [41, 42]. DIY systems are considered closed-loop systems as they automate insulin delivery and use CGM data to make future insulin dosing decisions. The users of these systems consist of those who have been frustrated with the time it has taken for newer, more automated systems to go commercially available. DIY systems consist of a controller such equally a cell phone or mini-computer which runs an open up-source algorithm and then communicates with an insulin pump and CGM using hacked device communication protocols. The control algorithm runs on an app that must be congenital by the patient which carries out the insulin delivery initiated past the user. Many patients take switched over to this form of diabetes management every bit they feel it removes much of the burden during twenty-four hour period-to-twenty-four hours life. However, the DIY systems have not undergone clinical trials, and the FDA has actively discouraged their apply in patients with TID due to safety concerns. Patients who choose to switch to the DIY system must take full responsibleness for their intendance and whatever technological or diabetes-related problems they experience equally a result.
A valuable resource for clinicians to empathise the many details of advanced diabetes technologies is the CARES paradigm, which helps clarify how systems Calculate insulin doses, how users can Suit system settings, when to REVERT to non-automatic functionality, how to EDUCATE patients on the system, and relevant SENSOR/SHARING characteristics [19, 43]. This concept was created with the goal of educating clinicians well-nigh the various diabetes technologies that are available in a manner that is applied and re-teachable to patients. It may also be beneficial to T1D patients who wish to compare their options for technologies and to find which choice would best conform their needs. An example of how the MiniMed 670G system would be explained using the CARES prototype is provided in Table i.
Table ane:
Explanation of MiniMed 670G Hybrid Closed Loop System Using a CARES Paradigm Example
| MiniMed 670G | |
|---|---|
| Calculation | HCL system --Uses TDI calculated from concluding 2–6 days --Automated basal calculated past system q v minutes --HCL ready point = 120 mg/dl --No automated correction doses. Transmission correction doses based on HCL algorithm and not on programmed sensitivity factors |
| ADJUSTMENT (for HCL manner) | Can modify: I:C ratios (for repast boluses), AIT (for subsequent correction doses), Temp target of 150 mg/dl (to change HCL set betoken) Cannot modify: |
| REVERT | -- Volition revert to OL if persistent hyperglycemia, maximum or minimum delivery thresholds, loss of CGM data, sensor integrity concerns --Must plough off HCL in guild to use temporary basal rates and/or combo boluses --Consider turning off for illness/ketones as system may append insulin. If insulin needs temporarily increase during illness, HCL may not exist able to respond quickly enough. Use temp basals in OL during illness if persistent hyperglycemia. --Consider turning off for dramatic change in insulin sensitivity (e.thousand. steroid utilise) due to system taking days to adjust TDI calculations |
| EDUCATION | --Consider treating hypoglycemia with less CHO (eastward.g. v–10g) if organization has not delivered insulin (been suspended) for menstruum of fourth dimension prior to low glucose --Important to pre-bolus for optimal mealtime direction (similar to traditional insulin pump) --Arrangement may brandish "BG required" for HCL operation, when user is required to enter a fingerstick BG value into the pump. This is different from a sensor scale. Users should understand difference between sensor calibration and BG required alerts. ----Follow system prompts for "BG required" --For dosing adjustments, change I:C ratios (10–25%) and active insulin time --Cannot utilise temp basals and/or combo boluses in HCL mode ('temp target' feature will permit for temporary reduction in basal insulin commitment in HCL mode) |
| SENSOR/SHARING | MiniMed Guardian 3 --Requires 2–4 calibrations for optimal use --6–7 mean solar day sensor life --Perform SMBG for diabetes direction decisions --Important to calibrate when glucose is stable ( i.e. before meals, bedtime, or when no sensor trend arrows) to prevent scale errors |
| AIT= Active Insulin Time, BG= Claret glucose, CGM= Continuous glucose monitor, CHO = carbohydrates, HCL= hybrid closed loop, I:C = Insulin to carbohydrate, ISF = Insulin sensitivity factor, OL= open loop, PLGS = Predictive Depression Glucose Append, SMBG = Self-Monitoring Blood Glucose, TDI= full daily insulin, TS= Threshold suspend |
2.5. HOW THE Engineering science FITS INTO THE FIELD
The MiniMed 670G system was starting time approved for use in the United states of america in the fall of 2016 [25]. It is FDA approved for use in patients ages 7 and older, but studies are underway to test the prophylactic and efficacy of the device downward to age ii years [44]. The MiniMed 670G later received CE (Conformité Européenne) mark approval in Europe in 2018 for ages vii years and older [45]. Other countries including Canada, South Africa, Australia, have also been approved for commercial use of 670G for ages 7 and older, with global expansion continuing to engagement [46].
3. Conclusion
T1D is a chronic autoimmune affliction that requires intense time and endeavour to maintain practiced blood glucose control. With the consistent and rapid growth of both the incidence and prevalence of T1D, the development of advanced technologies with the goal of reducing the burden for patients is essential. The MiniMed 670G hybrid closed-loop organisation has fabricated significant strides in improving automation for T1D management with its utilize of the modified PID control algorithm with insulin feedback. The automatic basal insulin delivery allows for more accurate and specialized basal insulin dosing and, therefore, more than consistent claret glucose trends from day to solar day.
Apply of the MiniMed 670G is shown to improve HbA1c values and to increment the amount of time spent in the target claret glucose range while not increasing occurrences of hypoglycemia which volition ultimately result in a decreased run a risk of developing diabetes-related complications. While the MiniMed 670G notwithstanding requires calibrations, meal boluses, and correction boluses, the overall user intervention is much less compared to other devices. Futurity advances in diabetes technology seek to remove these requirements leading to even less user involvement.
4. EXPERT Opinion
The idea of an artificial pancreas or airtight-loop arrangement for use in diabetes direction has been an exciting concept for many years. However, it is important to consider that there may be a big gap between a patient's expectation versus reality of the electric current applied science [47]. Many patients and even clinicians accept a concept of what an artificial pancreas should be and, while researchers are working difficult to brand those wishes get reality, a fully closed-loop artificial pancreas system has still not been fully attained. The MiniMed 670G system, along with other hybrid closed-loop systems that are currently undergoing clinical trials, all the same requires the user to input meal boluses, equally neither the sensor nor the insulin is able to react quickly enough to counteract the rapid rise in blood glucose caused by carbohydrate intake. Additionally, hybrid closed-loop systems volition not go on patients in the ideal blood glucose range 100% of the time. While this is the ideal, occurrences of both hypoglycemia and hyperglycemia are possible and somewhat inevitable, requiring users to arbitrate in social club to return to normal glucose levels.
However, even though the patients' expectations of the MiniMed 670G AP system may not e'er exist met, use of this arrangement will likely ultimately lead to better glucose control. It is currently the but hybrid closed-loop system commercially available, making information technology an appropriate pick for patients and clinicians who desire automated insulin delivery in conjunction with the CGM sensor.
Despite the shortcomings of the electric current MiniMed 670G AP system, the field of diabetes technology is rapidly changing, adding new techniques to lessen diabetes burden and management. Some means in which the electric current arrangement may exist improved in the futurity are listed. First, a major goal in the blueprint of hereafter devices is to remove nigh all exits from Auto Style every bit that is ane of the primary complaints of the electric current MiniMed 670G organisation. Automated correction boluses, in addition to the automated basal insulin delivery, are being researched, as well as a possible new blood glucose target of 110 mg/dL which will hopefully lower HbA1c values to an even greater extent. The next-generation enhanced-hybrid closed loop system volition incorporate changes to the current MiniMed 670G system to accomplish these improvements such every bit automated correction boluses and reduced alarms and closed loop exits. In a ane-week feasibility report completed past Lee et al. [48], use of the arrangement resulted in greater time in range, lower boilerplate sensor glucose, and a much higher corporeality of fourth dimension (99.98%) spent in closed loop mode. The participants did experience an increased time below seventy mg/dL; all the same, they all were satisfied overall with the arrangement and its steps toward optimizing glucose control in T1D patients.
Further goals include the addition of Bluetooth applied science which would allow for remote monitoring on smartphones and has been a notable request of both patients and caregivers of MiniMed 670G users. Other futurity improvements could include the ability for users to modify more of the parameters of the pump that are not currently able to be changed. The terminal comeback could include a improve sensor requiring less calibrations per day and achieving greater accuracy than past models. With a more authentic sensor, Auto Manner would be more precise in its delivery, too.
Another large step leading to decreased user intervention is the development of manufactory calibration for all CGM sensors. While this has been accomplished in the Dexcom G6 sensor, the Medtronic sensors necessary for the utilise of Auto Fashion do not provide this. Factory scale would allow for greater sensor accuracy leading to the greater overall accuracy of the hybrid airtight-loop system in addition to the removal of finger sticks.
Further advances with insulin pump technology may include the commercialization of a dual hormone pump. This type of pump would contain insulin to manage saccharide intake and right for hyperglycemia. Nevertheless, it would also incorporate glucagon, which is a hormone that increases the level of glucose in the blood to inhibit hypoglycemia from occurring [49]. Electric current pumps that contain only insulin must append insulin delivery to preclude the patient from having hypoglycemia, but the dual hormone pump would be able to both suspend insulin delivery and begin delivering glucagon to automatically bring the blood glucose level up into a safe range without the need to consume carbohydrate.
Another hope for future advancements is the ability of the AP system to automatically detect when the user is eating. Meal detection would remove ane of the largest areas of user error by incorrect carbohydrate counting and would potentially remove many occurrences of postprandial hyperglycemia without the need for carbohydrate counting. Some studies take already been completed testing current AP systems on how they react to unannounced meals and the results were promising; still, the studies did not effect in the claret glucose values that would be most desirable after a repast [50]. Meal announcement was all the same required for larger meals as the sensor reaction fourth dimension falls even farther backside with greater saccharide intake [51].
The achievement of these many advances in futurity diabetes technologies will ultimately lead to a fully closed-loop organization requiring very minimal to no user interaction. Researchers do not know exactly how close a fully closed-loop system is to evolution, simply bigger steps are beingness fabricated with each new device that make the dream of a fully closed-loop organization seem similar information technology could become reality someday.
Acknowledgments
FUNDING
This paper was funded by an NIH K12 accolade (NIDDK 2K12DK094712-06).
Declaration OF INTEREST
L.H. Messer has served as a consultant for Tandem Diabetes Intendance, Clinical Sensors, and Capillary Biomedical, and is a contracted trainer for Medtronic. G.P. Forlenza has received research funding from Medtronic, Dexcom, Abbott, Tandem, Insulet, Bigfoot, Beta Bionics, and TypeZero; he has served as a consultant/speaker for Medtronic, Dexcom, Abbott, Tandem, Insulet, DreaMed, and Lilly. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the discipline thing or materials discussed in the manuscript autonomously from those disclosed.
Footnotes
REVIEWER DISCLOSURES
Peer reviewers on this manuscript accept no relevant financial or other relationships to disclose.
Information RESOURCES
The Medtronic website, https://www.medtronicdiabetes.com/products/minimed-670g-insulin-pump-system, provides detailed explanations of what the MiniMed 670G organization is, how it works, and why people like using it.
Diabetes applied science resources can be establish at https://bdcpantherdiabetes.org/ which provides information for clinicians and patients with diabetes about the various advanced diabetes technologies that have been recently released.
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Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6816287/
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