Revisión detallada del MiniMed 670G de Medtronic

El MiniMed 670G de Medtronices una bomba de insulina junto con un sensor de glucosa. Utiliza un programa informático (llamado “algoritmo”) para automatizar ciertos aspectos de la administración de insulina. Decidí probar el 670G en parte por interés profesional (todos y su tía abuela me han estado pidiendo mi opinión sobre el sistema) y en parte por interés personal, ya que mi control de glucosa en sangre no ha sido el mejor en los últimos dos años. años.

Permítanme comenzar diciendo esto:

Desde que comencé a usar 670G, mi control general de la glucosa en sangre es mejor.

Tengo que seguir recordándome este hecho no intrascendente, porque todos los días encuentro cosas sobre este sistema que no me gustan especialmente.

En mi opinión, la bomba en sí deja mucho que desear. Hay tantas funciones, tantos menús y tantos pasos de seguridad/confirmación que el pulgar del botón está empezando a formar una ampolla. La pantalla a color es agradable, pero no lo suficientemente grande como para mostrar todo lo que necesita. Y el maldito clip está al revés. El conector del depósito me golpea en el estómago cada vez que me agacho y tengo que soltarlo para ver la pantalla y los menús de programación en la orientación adecuada.

La parte de “bucle cerrado híbrido” del sistema (lo que prefiero llamar la “función semiautomática”) es lo que hace que el 670G sea especial. Funciona haciendo ajustes a la insulina BASAL en función de los datos recibidos del sensor de glucosa vinculado. Dado que los sensores Medtronic de la generación anterior (Sof-Sensor, Enlite) eran, digamos, menos que óptimos, entré en esto con gran escepticismo. Después de todo, si el sensor no proporciona a la bomba un flujo constante de datos confiables, ¿qué sentido tiene?

Me ha sorprendido gratamente el rendimiento del nuevo sensor Guardian de Medtronic.

En mi experiencia, elsensor Guardiantiende a subestimar los valores de glucosa (a veces de manera significativa) y la precisión general aún no alcanza la DexcomG5. Y todavía requiere tres manos y cuatro formas diferentes de cinta para fijarlo a la piel, junto con cuatro a seis calibraciones por punción digital por día. Pero el proceso de inserción es rápido e indoloro y la señal del transmisor casi nunca pierde el ritmo. En general, Guardian representa una mejora importante con respecto a los sistemas CGM anteriores de Medtronic.

El algoritmo que determina las dosis de insulina basal realiza ajustes cada cinco minutos según las mediciones recientes de glucosa del sensor, la administración de insulina y las entradas de comidas (carbohidratos). El algoritmo se adapta diariamente en función de lo ocurrido durante los seis días anteriores. Por lo tanto, el algoritmo tiene componentes reactivos (basados ​​en lo que ya sucedió) y proactivos (que predicen lo que sucederá).

Sin embargo, el algoritmo es de naturaleza muy conservadora y hace todo lo que está a su alcance para mantener al usuario muy, muy lejos de cualquier cosa que se parezca a una hipoglucemia. El algoritmo basal tiene como objetivo un valor de glucosa de 120 mg/dl, y existen límites en cuanto a cuánto tiempo el sistema puede administrar cero insulina basal, así como la magnitud y duración de la administración basal máxima. La tasa máxima de administración basal se basa en una tasa que (el sistema cree) causaría que la glucosa cayera por debajo de 70 si funcionara durante aproximadamente 8 horas seguidas.

Piénselo de esta manera: El basal máximo en el modo automático es como no permitir que el capitán del barco gire el timón demasiado bruscamente por temor a que el barco se balancee. demasiado. Por supuesto, cuando tienes un barco grande y un timón pequeño, eso no es probable que suceda. Entonces, ¿por qué el enfoque ultraconservador? Probablemente porque a las autoridades reguladoras como la FDA les gusta así. Menos riesgo de hipoglucemia = menos posibilidades de comentarios negativos y problemas legales. Pero hace que el sistema responda menos de lo que podría ser.

Para aquellos que normalmente tienen una diferencia significativa entre su basal "pico" y su basal "valle", tal vez debido a un fenómeno de amanecer pronunciado, el basal máximo del algoritmo puede no ser suficiente para satisfacer las necesidades basales máximas.

Por cierto, las dosis en bolo NO están automatizadas. Los usuarios aún deben ingresar sus carbohidratos en la calculadora del asistente de bolo de la bomba, así como el valor de glucosa en sangre. Pero la sensibilidad original del usuario (factor de corrección) y la configuración objetivo NO se aplican. El sistema calcula las dosis de corrección basándose en un objetivo conservador de 150 mg/dl y un factor de sensibilidad/corrección que determina por sí solo.

A pesar de estas deficiencias, veo menos variabilidad general (más tiempo dentro del rango, menos altibajos extremos) y mis niveles de glucosa durante la noche son más estables que en años. Es raro que no me despierte dentro de un rango razonable por la mañana.

La parte de la noche a la mañana tiene mucho sentido. Debido a que el sistema ajusta la administración basal cada vez que los niveles de glucosa tienen una tendencia hacia arriba o hacia abajo, es capaz de alterar el patrón de glucosa en el transcurso de muchas horas y mantener todo dentro del rango... suponiendo que nada más interfiera.

Me recuerda a un gran crucero. Cuando el barco se mueve a gran velocidad, un timón pequeño no le permitirá cambiar de dirección lo suficientemente rápido como para evitar cosas como icebergs (esto es lo que le pasó al Titanic).

No es que el 670G vaya a provocar que alguien se estrelle y se hunda, pero existen similitudes en términos de lo que puede y no puede hacer para autorregular los niveles de glucosa en sangre. En tramos largos de aguas abiertas, un crucero grande con un timón pequeño puede llevarlo de un puerto a otro de manera muy efectiva. Durante el viaje, si el barco comienza a desviarse del rumbo, tiene suficiente espacio y tiempo para volver al rumbo.

670G hace lo mismo: en el transcurso de muchas horas, sin que nada afecte los niveles de glucosa más que la producción habitual de glucosa del hígado, la insulina basal se puede ajustar para compensar los sutiles flujos o reflujos en los niveles de glucosa. ¿Empiezas a subir un poco? La entrega basal aumenta para que, durante las próximas horas, vuelvas a la normalidad. ¿Empiezas a bajar un poco? Ocurre lo contrario. Como resultado, la mayoría de las mañanas te despiertas bastante cerca del punto de ajuste del sistema de 120 mg/dl.

Aquí vienen los icebergs

Todos los que viven con diabetes conocen los desafíos que debemos afrontar hora tras hora y minuto a minuto. Estos son los icebergs: las cosas alrededor de las cuales el sistema debe navegar para evitar altibajos extremos.

Básicamente, cualquier cosa que pueda provocar un aumento o una caída rápida y abrupta de los niveles de glucosa representa un iceberg. Recuerde, estamos ante un barco enorme, que se mueve rápidamente y con un timón pequeño.

El ajuste basal de la bomba simplemente no es lo suficientemente potente ni responde lo suficientemente como para prevenir niveles altos y bajos de glucosa cuando se enfrenta a icebergs.

Los icebergs incluyen:

• Alimentos (particularmente carbohidratos de rápida digestión)
• Actividad física (particularmente ejercicio intenso)
• Estrés (particularmente crisis repentinas e inesperadas)
• Cambios hormonales repentinos (resultantes de lesiones/traumatismos, rebotes de niveles bajos)
• Insulina en bolo “manual” (a partir de inyecciones o insulina inhalada)

También existen varias limitaciones en el sistema que dificultan su capacidad para mantener los niveles de glucosa dentro del rango de forma continua:

• Límites del ajuste basal automático. Como se describió anteriormente, los ajustes basales automáticos están limitados en términos de magnitud y duración. El “basal máximo” es relativamente conservador y sólo puede funcionar durante un máximo de 4 horas. El “basal mínimo” (entrega cero) sólo puede funcionar durante un máximo de 2,5 horas. A veces, realmente se necesitan ajustes más fuertes y prolongados para lograr y mantener niveles de glucosa dentro del rango; estos límites pueden ser... bueno... limitantes.

• Fiabilidad del sensor. Incluso cuando el sistema esté calibrado correctamente, habrá ocasiones en que el sensor informe información incorrecta o inexacta a la bomba. Y el algoritmo es tan bueno como los datos que se le introducen.

• Problemas de absorción. El hecho de que una dosis de insulina se administre debajo de la piel no significa que la insulina llegue al torrente sanguíneo como se esperaba y funcione como se esperaba. Esto se aplica tanto a la insulina basal como a la insulina en bolo. Los usuarios deben cambiar de sitio con frecuencia o regularidad, rotar correctamente y solucionar problemas de forma eficaz.

• Undetected pump problems. There is a long list of things that can go wrong! Air in the tubing, displaced infusion sets, partial occlusions, partially (or completely) spoiled insulin, leakage, and unintended disconnection just to name a few.

• Times out of auto mode. “Auto-mode” is what we call it when the system is automatically adjusting basal insulin based on data fed into it by the glucose sensor. There are several situations in which the system will phase out of auto-mode. There is a transition phase called “safe mode” that initiates under these conditions. Safe mode can run for up to 90 minutes, with a flat basal delivery and no automated adjustment. If the issues noted below are not resolved within 90 minutes, the pump returns to “manual mode”, which means that everything returns to the user’s default settings.

Auto mode is exited if:

• The sensor is in its warm-up phase
• The sensor is not communicating with the pump
• The sensor requires calibration
• There is a significant discrepancy between the sensor and the calibration value
• “Minimum” basal delivery has taken place for 2.5 hours
• “Maximum” basal delivery has taken place for 4 hours
• Glucose is above 300 for more than an hour
• Glucose is above 250 for more than 3 hours
• An occlusion is detected

Despite these “icebergs”, I have managed to achieve better glucose control with 670G than I could achieve on my own using a pump and non-integrated CGM.

Tying the Captain’s Hands

To compound some of the challenges, Medtronic took away certain tools that many consider essential to good self-management. This is like taking away resources that the captain of that big, fast-moving cruise ship would normally use to circumvent the icebergs.

Here are a few of the missing pieces:

1. Extended Bolus. When in “auto mode”, users no longer have the option of extending delivery of their boluses. Extending boluses is a useful tool when consuming large portions, slowly-digesting (low-glycemic-index) foods, or meals that take considerable time to consume. It is also essential for anyone with impaired digestion (gastroparesis). Under these conditions, “normal” boluses will peak too early, resulting in hypoglycemia soon after eating followed by a delayed rise. Medtronic may have assumed that the 670G’s basal adjustment would prevent this problem, but it doesn’t. It may reduce the severity of the fall-followed-by-rise pattern, but the pattern still exists. Users must think long and hard about timing their boluses properly to avoid this type of pattern.

1. Manual bolus adjustment.Auto mode does not allow users to adjust bolus doses once they have been calculated by the pump, and manual boluses are not an option. Planning to exercise? Tough cookies. Take what we say. Sensor shows a distinct rise or fall at the time of the bolus? Too bad. Take what we say. To alter the dose, users are forced to “lie” to the system by intentionally entering incorrect carb amounts or glucose values.

1. Correction dosesin “auto mode” are determined by the system, not the user. And the system does not target a glucose of 120 (as does the basal algorithm); it targets 150. Why? Most likely to appease the FDA and get the product to market as soon as possible. The system also does not base correction doses on the “sensitivity” or “correction factor” that the user (and their healthcare team) may know to work, but on a mystery-clad component of the system’s secret algorithm sauce. Despite all that, because the algorithm typically cranks up basal delivery prior to the need for a correction bolus (since the glucose is rising and elevated), the correction boluses sometimes overshoots and leads to lows.

1. The only allowable adjustment to the basal algorithm is a temporary target of 150 rather than 120. Presumably, this is for exercise. Trouble is, it takes a couple of hours for this adjustment to actually get the glucose up to 150 (so it has to be set a few hours in advance of exercise), and it isn’t sufficient to prevent hypoglycemia with longer and more intense forms of physical activity.

1. Temp Basal.User-set temporary basal adjustments are not an option in “auto mode” since the system adjusts the basal on its own. And there are limits to how much (and for how long) the system will raise/lower basal delivery. If the user knows that their basal needs are going to be significantly higher (or lower) for a period of time, it makes sense to be able to inform the system before glucose levels start trending out of range. For example, having a high-fat restaurant dinner always causes my glucose levels to rise throughout the night. I know that I can temporarily raise my basal rate to deal with this, but the 670G doesn’t allow for this kind of input. Instead, it waits until the glucose levels start rising (usually several hours after the meal), and then, after four hours of delivering what it considers my “maximal basal,” it alarms and shifts out of auto mode and into “safe mode” where the basal delivery is even lower than what it had been delivering.

A creative captain can figure out ways around daily challenges. Users have the option of switching in and out of auto-mode if they want to have access to things like temp basal settings, square/dual boluses, and self-adjustment of bolus doses. I often switch out of auto-mode during the daytime for this reason. One can adjust the timing and amount of boluses doses when delayed food absorption is anticipated. Delivery can be suspended temporarily and carbs can be consumed before/during exercise to keep from dropping low. Blog sobre ropa y moda Shein, Primark y Amazon

Trusting the 670G system, combined with some creative self-management techniques, has led to improved glucose management.

The Ideal Passenger

So who can benefit most from 670G? When functioning properly, it pushes the user towards glucose values in the 130-160 range, and A1c’s in the high 6s to low 7s. If this represents a nice improvement for you, then go for it. If it represents a step backwards, or is not consistent with your personal goals, then you might want to pass.

Trust me, passengers on this cruise ship don’t get to lie around on lounge chairs and be waited on hand foot. This is aworkingcruise! Expect to spend a fair amount of time in the kitchens and engine rooms. You’ll need to manage/maintain both the glucose sensor and the pump. Plan to perform fingersticks four to eight times a day for sensor calibrations and to keep the auto-mode feature running smoothly. Expect more alarms and alerts than usual. You’ll need to plan well-ahead to prevent lows (and highs, on occasion) when exercising. And you’ll still need to manage things the old-fashioned way when out of auto-mode (typically 10-20% of the time), and that means making sure your basal and bolus settings are properly fine-tuned.

It also takes a shrewd captain to navigate this ship. Using the 670G and its full array of automated delivery features requires a great deal of training, aptitude, and attention to detail. Compared to traditional pump therapy (with or without an independent continuous glucose monitor), 670G can be quite complex. Training typically requires three separate sessions: one to learn the pump, one to learn the sensor, and one to learn the automated basal delivery system (auto-mode). One must understand all of the conditions that are necessary for auto-mode to activate. There is even an “auto-mode readiness” status screen that is nine items long! You’ll need to know when/why the system may go out of auto-mode, and how to get back in. And then there’s “safe mode” – a sort of purgatory between auto-mode and manual mode in which the pump is delivering basal insulin but not self-adjusting it until an auto-mode problem is fixed. I’m still trying to wrap my brain around that one.

People who maintain a structured and predictable lifestyle also tend to succeed with 670G. There is much less chance of a cruise ship mishap in the Caribbean than in the Arctic Circle because of the lack of icebergs. Someone whose life includes frequent/inconsistent meals snacks, random physical activity, changing work shifts, varied sleep schedules or significant stress is going to struggle in auto-mode. By contrast, those who eat consistent/well-spaced meals (with minimal snacks), work out regularly (or not at all) and lead generally relaxed and predictable lives tend to stay in-range most of the time in auto-mode. And for that matter, those whose basal requirements include asignificantpeak valley (based on previous pump use basal fine-tuning) may struggle a bit due to the limited basal variations that can take place in auto-mode. Those with relatively stable basal requirements throughout the day night are more likely to experience success in auto-mode.

One other virtue that can’t be understated is PATIENCE. Don’t expect your diabetes worries to vanish the moment the box arrives from Medtronic. The company is struggling to meet sensor supply demand and furnish certified trainers, so you may have to wait a while to get started. Once you get started on the pump, you’ll likely need to wait for a second round of training to get set up on the sensor. And the system’s algorithm will require several days in “manual mode” before it has enough data for you to switch over to auto-mode (which requires yet another training session). Even then, the system continues to self-analyze data in order to improve its performance, so it might take several weeks before it reaches peak performance. Bottom line: patient people ultimately reap the benefits of the system.

To succeed in “auto mode” one must:

• Have conservative glucose management goals
• Put in a certain amount of work
• Possess some technical aptitude
• Lead a relatively structured life
• Be patient in terms of expectations

Tips for Insulin Pump Users

To get the most out of a cruise, it helps to know someone who knows cruises. They’ll guide you on things like avoiding “inside” cabins (unless youenjoyclaustrophobia), hitting restaurants during non-peak hours, and snagging poolside lounge chairs early. Here are a few insider tips to help you get the most from 670G:

• Change the sensors weekly. The Guardian sensors are designed for seven days of use, and you’ll do well by abiding to that. Unlike Dexcom sensors (which almostbegto be reused), Guardian sensors often start to deteriorate after the first week of use. And since the sensor is directing your basal insulin delivery, it just isn’t worth the risk.

• Call on your Medtronic trainers and clinical specialists for ongoing assistance. They have insight-a-plenty to help minimize the system’s downsides, shorten your learning curve, and ultimately extract the most possible benefit.

• Regular use of 670G has been shown to reduce the frequency and severity of hypoglycemia, but don’t count on the system to fix your lows once they have occurred. Cutting back (or turning off) basal insulin will help to raise the blood sugar, but it won’t do so quickly. It usually takes a few hours for this to occur. By that time, you could get into an accident, have a seizure, or worse. Use rapid-acting carbs to treat your lows. And when you treat your lows, do so conservatively. Since low blood sugars will usually coincide with a marked reduction in basal delivery by the pump, you won’t need as much carb as usual to bring your lows back up to normal.

• Pay attention to the timing of your boluses. Glucose levels are likely to spike just as much in auto-mode as they do in manual mode (or with any other system) if the boluses are given too late. For most meals and snacks, it is still necessary to bolus 15-20 minutes in advance. However, without an extended (dual/square) bolus option, bolusing for slowly-consumed, high-fat or low-glycemic-index foods, the user will need to delay or “split” their boluses in order prevent a post-meal drop and post-post-meal rise.

• Plan ahead when exercising. The only auto-mode feature that can help at all is the “temporary target” of 150. If you want to use this, it will need to be set at least 1-2 hours prior to the workout. Setting it at the onset of exercise will do no good since it takes a couple of hours for basal changes to influence glucose levels (remember: big ship, tiny rudder). And if you expect a delayed drop following your heavier workouts, keep the temporary target of 150 in place for several hours post-exercise.

• Download your data, and work with your healthcare team to analyze the results. Carelink Personal and Carelink Pro will let you see where improvements are taking place and where adjustments may needed. The two variables that you have control over in auto-mode are the carb ratios and active insulin time. Carelink reports will help you to optimize both of these settings. For people who did not fine-tune their basal settings through a series of fasting tests prior to using 670G, it is likely that your basal delivery will be reduced when in auto-mode. This, in turn, usually means that carb ratios will need to become more aggressive – something to watch for.

Issues With the Entire Fleet

Interestingly, I don’t believe the limitations inherent to 670G are limited to this particular system, although shortcomings to 670Gs algorithm and elimination of certain self-management tools may amplify the challenges. ANY hybrid closed-loop system that relies on basal adjustment alone is going to struggle to avoid the daily icebergs. My hope is that future iterations of the Medtronic hybrid closed-loop system and those developed by Medtronic’s competitors (Insulet, Tandem, Bigfoot and Beta-Bionics to name a few) will offer improvements such as:

• Ability for the user to customize how aggressive or conservative the algorithm functions
• Allowing the user to implement traditional advanced features such as extended bolus delivery, temporary basal rates, and the ability to override the pump’s bolus calculations
• Simplified and more logical pump programming, with fewer confirmation steps and overlapping menus
• Improved sensor accuracy with reduced calibration requirements
• Incorporation of faster-acting insulin, such as Novo Nordisk’s Fiasp. This will essentially increase the size of the ship’s rudder and allow it to do a better job of avoiding the icebergs

It would be nice to have a system that performs well in long stretches of open water AND navigates the icebergs deftly, and does so with minimal inconvenience to the user. Nevertheless, we have some very good options already. Unless you’re a subject under the United Healthcare dictatorship, you have CHOICES. You can pursue the 670G right away, deal with some of its shortcomings but enjoy the advantages of semi-automated delivery right away, and upgrade to its next-generation (new and improved, to some extent) system in a couple of years. Or you can go with another pump company, enjoy a pump that may have fewer drawbacks, utilize a separate CGM, and wait a couple of years for them to catch up to (or bypass) Medtronic on the hybrid closed-loop front.

The 670G represents an important step towards fully automating glucose control. However, it is important to put it in the proper context and set expectations at an appropriate level. Despite the system’s many limitations, it will improve the quality of life for many people affected by insulin-dependent diabetes.

And that’s saying something.

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Revisión detallada del MiniMed 670G de Medtronic

Aquí vienen los icebergsTying the Captain’s HandsThe Ideal PassengerTips for Insulin Pump UsersIssues With the Entire Fleet

salud

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2024-10-12

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