Minimed Paradigm
Encyclopedia
MiniMed Paradigm is a series of insulin pump
s manufactured by Medtronic
for patients with diabetes mellitus
. The pump operates with a single AAA battery
and uses a piston-plunger pump
to infuse
a programmed amount of insulin
into the patient through a length of tubing. The Paradigm uses a one-way wireless radio frequency
link to receive blood sugar
measurements from select glucose meter
s. The Paradigm RT (Real Time) series adds the ability to receive data from a mated continuous blood-glucose monitor. Although the pump can use these measurements to assist in calculating a dose of insulin, no actual change in insulin delivery occurs without manual user-intervention.
In the United States
, the device is regulated by a branch
of the Food and Drug Administration
.
and type 2
diabetes. The Minimed Paradigm REAL-Time and Continuous Glucose Monitoring (CGM) system, which received FDA clearance in 2006, uses tubing and a reservoir with rapid-acting insulin. This "infusion set" is patient-connected via a catheter to the abdomen region. The infusion set can remain in the place for 3 days while the pump is clip-belt worn. There is a quick-disconnect feature for the tubing. The pump delivers insulin in two modes. In Basal rate
mode, the delivery is continuous in small doses similar to a pancreas
, for example 0.15 units per hour throughout the day. Basal rates are set to meet individual metabolic rates. In Bolus
mode, the delivery is programmed to be a one-time delivery prior to eating or after an unexpected high, for example 18 units spread out to several hours. This type of continuous treatment is in contrast to traditional multiple daily injections
(MDI) that use slower-acting insulin. Continuous treatment reduces glucose variability.
The Paradigm system consists of two basic parts: an insulin pump and an optional glucose sensor CGM worn for up to 3 days. The disposable sensor is subcutaneously-placed to make glucose measurements in interstitial fluid
every 5 minutes and transmit the reading via low power radio frequency (ISM band
) to the pump for realtime display. However, insulin therapy may be conducted without CGM and although there is not yet an automated insulin-regulation feedback mechanism between measure and infusion to control the amount and timing of insulin, this is clearly a future objective. So any change in basal or bolus is patient-driven by programming the pump using the Bolus WizardTM. The latest model pumps are the MiniMed Paradigm 522 and 722 which differ in reservoir size, 176 versus 300 units, respectively. In 2007 the FDA approved a pediatric model for patients 7 to 17 years old.
The Minimed Paradigm System is composed of the following parts:
In addition to system parts, there are other necessary parts associated with overall diabetes therapy
including a glucose meter for finger stick calibration
s and treatment verification, traditional injectors and supplies, ketones test supplies, test strip vials, skin preparation, glucagon
supplements, etc. If using OneTouch UltraLink meter, readings are sent wirelessly to the pump.
The development history of the Minimed pump goes back to the 1980s.
The Food and Drug Administration
has at least six classifications for the various parts of the Minimed Paradigm System.
, to multiple daily injections (MDI) 4-5 per day, to continuous subcutaneous insulin infusion
(CSII) having basal doses of as little as 15 minutes and few bolus doses. The objective of CSII is to reduce the long-term variability of blood glucose by increasing the frequency of infusion. In 1995 the ADA issued the statement, "CSII is an acceptable alternative to multiple injection therapy in the management of Insulin Dependent Diabetes Mellitus".
The Diabetes Control and Complications Trial
(DCCT) study showed that CSII patients achieved an A1c of 7.3% (much better than the 9.1% achieved for conventional treatment). This large and controlled study also showed that improvement in glycemic control could reduce the incidence of microvascular complications for type 1 diabetes by 60%. The United Kingdom Prospective Diabetes Study
(UKPDS) achieved similar conclusions when it studied glycemic control in patients with Type 2 diabetes. The UKPDS results proved that control of glucose levels to near-normal levels delays the onset and slow the progression of microvascular complications for Type 2 diabetes.
The DCCT study did, however, find that there was an increase occurrence in episodes of hypoglycemia
related to CSII as compared to conventional therapy. But at the time there were few studies on the use of combined CSII and blood glucose monitoring
. Also, no rapid-acting insulin or pumps were in practice. Wainstein in 2005 reported on the efficacy
of insulin therapy with CSII versus MDI in the treatment of 40 poorly controlled obese Type 2 diabetic patients. The results showed treatment with CSII significantly reduced HbAlc levels compared with treatment with MDI.
One other study, the Epidemiology of Diabetes Interventions and Complications (EDIC) study, showed that treatment is durable. It was the first study to show that, in a 17 year span, controlling A1c with CSII can reduce risk of cardiovascular events by 42%. But still little was published related to benefits of clinical use of combined CSII and blood glucose monitoring devices, especially CGM. Up until 2006 there were no clinical trials that reported outcomes comparing the use of insulin pumps in conjunction with glucose monitoring devices. It was not until 2007 that clinical trials began: 1) Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy; 2) Feasibility Study of Effective Methods for Training Pump Naive Subjects To Use The Paradigm System And Evaluate Effectiveness. and 3) Use of Real-Time Continuous Glucose Monitoring System in Patients With Type 1 Diabetes Mellitus.
The Minimed Paradigm pump or CGM should not be operated without training and consultation from a health care provider and manufacturer representative.
, while others are a matter of convenience. These include high/low alarms for continuous nighttime monitoring and temporary basal rates. Others include immediate intervention capability to reduce glycemic variability; provides more frequent information that helps to understand cause and effect of life style; a better pancreas simulator compared to MDI; and more flexibility eating. Furthermore, it has been shown that CGM reduces long-term A1c, provides better control, and without increasing risk of hypoglycemia.
, Animas Ping, Insulet OmniPod, Accu-chek
Spirit Combo, and Sooil DiabecareIIS.
s awarded in medicine, chemistry, and physics, and after more than 23 million people in the United States alone were diagnosed with diabetes in 2007, the industry continues to have the same basic description of a pump system in the marketplace, "a glucose sensor, a processor, and a pump" instead of "sensors, processors, and pumps".
The ultimate long-term goal of future technology for a portable device for treating diabetes is to: a) eliminate all dependent peripheral devices, for example, calibration meter, injection syringes/pens, glucagon, etc.; b) manage very complex life situations with fully automated protocols, for example, respond to DKA, sickness, extreme exercise/eating; and c) single on-off button control. This is absolutely not an impossible goal.
There are vast more complex and faster-responding systems that have sought solutions for control and whereby the engineering and mathematics of dynamical system
s have provided such solutions. For starter, in control theory
a true closed-loop feedback pump will have to infuse not just rapid-acting insulin for positive errors, but also infuse glucagon
for negative errors. For managing complex life situations, the pump will need several MEMS
-based sensors to monitor more than just glucose, for example heart rate
, breathing, ECG, temperature, CO2
, blood pH
, dissolved O2
, etc.
Currently, Medtronic has the following research and development
projects in its pipeline: Next Generation REAL-Time Continuous Glucose Monitoring System; Next Generation Insulin Pump; Pre-filled Insulin Reservoirs; Implantable Insulin Pump; and Artificial pancreas
(Semi-Automated System & Closed-Loop System). The industry trend in portable devices has piggybacked on the success of wireless technology but not on the success of other disciplines, such as dynamical system
, Cybernetics
and adaptive systems, for root-cause
solutions to close the "true" loop. While the slow-responding dynamics in the physiology of glucose regulation is not beyond the mathematics of PID controller
s, 50 years of patient-perspective "advancement" says it is beyond the corporate, congressional
, and lobbying
leaders. Also, the accuracy of existing continuous glucose monitoring systems poses a problem for an artificial pancreas.
Insulin pump
The insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion therapy.The device includes:...
s manufactured by Medtronic
Medtronic
Medtronic, Inc. , based in suburban Minneapolis, Minnesota, is the world's largest medical technology company and is a Fortune 500 company.- History :...
for patients with diabetes mellitus
Diabetes mellitus
Diabetes mellitus, often simply referred to as diabetes, is a group of metabolic diseases in which a person has high blood sugar, either because the body does not produce enough insulin, or because cells do not respond to the insulin that is produced...
. The pump operates with a single AAA battery
AAA battery
A triple A or AAA battery is a standard size of dry cell battery commonly used in portable electronic devices. A carbon-zinc battery in this size is designated by IEC as "R03", by ANSI C18.1 as "24", by old JIS standard as "UM 4", and by other manufacturer and national standard designations that...
and uses a piston-plunger pump
Pump
A pump is a device used to move fluids, such as liquids, gases or slurries.A pump displaces a volume by physical or mechanical action. Pumps fall into three major groups: direct lift, displacement, and gravity pumps...
to infuse
Route of administration
A route of administration in pharmacology and toxicology is the path by which a drug, fluid, poison, or other substance is taken into the body.-Classification:Routes of administration are usually classified by application location...
a programmed amount of insulin
Insulin
Insulin is a hormone central to regulating carbohydrate and fat metabolism in the body. Insulin causes cells in the liver, muscle, and fat tissue to take up glucose from the blood, storing it as glycogen in the liver and muscle....
into the patient through a length of tubing. The Paradigm uses a one-way wireless radio frequency
Radio frequency
Radio frequency is a rate of oscillation in the range of about 3 kHz to 300 GHz, which corresponds to the frequency of radio waves, and the alternating currents which carry radio signals...
link to receive blood sugar
Blood sugar
The blood sugar concentration or blood glucose level is the amount of glucose present in the blood of a human or animal. Normally in mammals, the body maintains the blood glucose level at a reference range between about 3.6 and 5.8 mM , or 64.8 and 104.4 mg/dL...
measurements from select glucose meter
Glucose meter
A glucose meter is a medical device for determining the approximate concentration of glucose in the blood. It is a key element of home blood glucose monitoring by people with diabetes mellitus or hypoglycemia...
s. The Paradigm RT (Real Time) series adds the ability to receive data from a mated continuous blood-glucose monitor. Although the pump can use these measurements to assist in calculating a dose of insulin, no actual change in insulin delivery occurs without manual user-intervention.
In the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, the device is regulated by a branch
Center for Devices and Radiological Health
The Center for Devices and Radiological Health is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices...
of the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
.
Description
Insulin pumps are drug delivery devices used to treat patients with type 1Diabetes mellitus type 1
Diabetes mellitus type 1 is a form of diabetes mellitus that results from autoimmune destruction of insulin-producing beta cells of the pancreas. The subsequent lack of insulin leads to increased blood and urine glucose...
and type 2
Diabetes mellitus type 2
Diabetes mellitus type 2formerly non-insulin-dependent diabetes mellitus or adult-onset diabetesis a metabolic disorder that is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency. Diabetes is often initially managed by increasing exercise and...
diabetes. The Minimed Paradigm REAL-Time and Continuous Glucose Monitoring (CGM) system, which received FDA clearance in 2006, uses tubing and a reservoir with rapid-acting insulin. This "infusion set" is patient-connected via a catheter to the abdomen region. The infusion set can remain in the place for 3 days while the pump is clip-belt worn. There is a quick-disconnect feature for the tubing. The pump delivers insulin in two modes. In Basal rate
Basal rate
In biology, basal rate is the rate of continuous supply of some chemical or process. In the case of diabetes mellitus, it is a low rate of continuous insulin supply needed for such purposes as controlling cellular glucose and amino acid uptake....
mode, the delivery is continuous in small doses similar to a pancreas
Pancreas
The pancreas is a gland organ in the digestive and endocrine system of vertebrates. It is both an endocrine gland producing several important hormones, including insulin, glucagon, and somatostatin, as well as a digestive organ, secreting pancreatic juice containing digestive enzymes that assist...
, for example 0.15 units per hour throughout the day. Basal rates are set to meet individual metabolic rates. In Bolus
Bolus
-Medicine:* Bolus , the administration of a drug, medication or other substance in the form of a single, large dose* Bolus , a tissue equivalent substance used in radiation therapy...
mode, the delivery is programmed to be a one-time delivery prior to eating or after an unexpected high, for example 18 units spread out to several hours. This type of continuous treatment is in contrast to traditional multiple daily injections
Conventional insulinotherapy
Conventional insulinotherapy is a therapeutic regimen for treatment of diabetes mellitus which contrasts with the newer intensive insulinotherapy....
(MDI) that use slower-acting insulin. Continuous treatment reduces glucose variability.
The Paradigm system consists of two basic parts: an insulin pump and an optional glucose sensor CGM worn for up to 3 days. The disposable sensor is subcutaneously-placed to make glucose measurements in interstitial fluid
Interstitial fluid
Interstitial fluid is a solution that bathes and surrounds the cells of multicellular animals. It is the main component of the extracellular fluid, which also includes plasma and transcellular fluid...
every 5 minutes and transmit the reading via low power radio frequency (ISM band
ISM band
The industrial, scientific and medical radio bands are radio bands reserved internationally for the use of radio frequency energy for industrial, scientific and medical purposes other than communications....
) to the pump for realtime display. However, insulin therapy may be conducted without CGM and although there is not yet an automated insulin-regulation feedback mechanism between measure and infusion to control the amount and timing of insulin, this is clearly a future objective. So any change in basal or bolus is patient-driven by programming the pump using the Bolus WizardTM. The latest model pumps are the MiniMed Paradigm 522 and 722 which differ in reservoir size, 176 versus 300 units, respectively. In 2007 the FDA approved a pediatric model for patients 7 to 17 years old.
The Minimed Paradigm System is composed of the following parts:
- Insulin pump models 522/722
- Glucose sensor kit (CGM)
- Minilink RFRadio frequencyRadio frequency is a rate of oscillation in the range of about 3 kHz to 300 GHz, which corresponds to the frequency of radio waves, and the alternating currents which carry radio signals...
transmitter - Infusion set and reservoirs
- CareLink USB upload device
- CareLink therapy management softwareDiabetes management softwareDiabetes Management Software refers to software tools that run on personal computers and personal digital assistants to help persons with Type 1 and Type 2 diabetes manage the data associated with:*test results from a glucose meter*diabetes logbooks...
In addition to system parts, there are other necessary parts associated with overall diabetes therapy
Diabetes management
Diabetes is a chronic disease with no proven cures but a lot of research is underway. It is associated with an impaired glucose cycle that alters the patient's metabolism. Management of this disease may include carefully managing diet, exercising, taking oral diabetes medication, using some form...
including a glucose meter for finger stick calibration
Calibration
Calibration is a comparison between measurements – one of known magnitude or correctness made or set with one device and another measurement made in as similar a way as possible with a second device....
s and treatment verification, traditional injectors and supplies, ketones test supplies, test strip vials, skin preparation, glucagon
Glucagon
Glucagon, a hormone secreted by the pancreas, raises blood glucose levels. Its effect is opposite that of insulin, which lowers blood glucose levels. The pancreas releases glucagon when blood sugar levels fall too low. Glucagon causes the liver to convert stored glycogen into glucose, which is...
supplements, etc. If using OneTouch UltraLink meter, readings are sent wirelessly to the pump.
The development history of the Minimed pump goes back to the 1980s.
- 1983 – 1st Pump MiniMed 502 (Eli Lilly makes synthetic insulin)
- 1985 – MiniMed 504 Insulin Pump
- 1992 – Launch Of MiniMed 506 Insulin Pump
- 1996 – Introduction of MiniMed 507 Pump
- 1999 – Launch of the Model 507C
- 1999 – Introduction of MiniMed 508 Insulin Pump
- 2002 – Inauguration of the MiniMed Paradigm 511
- 2003 – 1st Wireless MiniMed Paradigm 512/712 (followed by 515/715)
- 2006 – MiniMed Paradigm REAL-Time 522/722
- 2010 – MiniMed Paradigm REAL-Time Revel 523/723
The Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
has at least six classifications for the various parts of the Minimed Paradigm System.
| Product code | Generic part name | Regulation number | Device classification code | Description |
|---|---|---|---|---|
| MDS | CGM | null | Premarket approval Premarket approval Premarket approval is the U.S. Food and Drug Administration process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices and is significantly different from the Premarket Notification process known as 510... |
Invasive glucose sensor |
| FMF | Drug reservoir | 21CFR888.5860 | standards | Piston syringe |
| NBW | Glucose meter | 21CFR862.1345 | standards | Glucose test system |
| LZG/FRN | Infusion/insulin pump | 21CFR888.5725 | standards | Infusion pump |
| FPA | Infusion set | 21CFR888.5440 | standards | Intravascular administration set |
| KZH | Infusion set insertion system | 21CFR880.6920 | standards | Syringer needle introducer |
Basis for CSII vs. MDI
Present day treatment has evolved from conventional 2 injections per dayConventional insulinotherapy
Conventional insulinotherapy is a therapeutic regimen for treatment of diabetes mellitus which contrasts with the newer intensive insulinotherapy....
, to multiple daily injections (MDI) 4-5 per day, to continuous subcutaneous insulin infusion
Intensive insulinotherapy
Intensive insulinotherapy is a therapeutic regimen for diabetes mellitus treatment. This newer approach contrasts with conventional insulinotherapy...
(CSII) having basal doses of as little as 15 minutes and few bolus doses. The objective of CSII is to reduce the long-term variability of blood glucose by increasing the frequency of infusion. In 1995 the ADA issued the statement, "CSII is an acceptable alternative to multiple injection therapy in the management of Insulin Dependent Diabetes Mellitus".
The Diabetes Control and Complications Trial
Diabetes control and complications trial
The Diabetes Control and Complications Trial , was a landmark medical study conducted by the United States National Institute of Diabetes and Digestive and Kidney Diseases . It significantly changed the management principles of Diabetes mellitus from the 1990s onwards...
(DCCT) study showed that CSII patients achieved an A1c of 7.3% (much better than the 9.1% achieved for conventional treatment). This large and controlled study also showed that improvement in glycemic control could reduce the incidence of microvascular complications for type 1 diabetes by 60%. The United Kingdom Prospective Diabetes Study
United Kingdom Prospective Diabetes Study
The United Kingdom Prospective Diabetes Study was the largest clinical research study into diabetes ever conducted at the time. The study was conceived by Professor Robert Turner at Oxford University in 1976, conducted in the UK in 1977-1997, and published main results in 1998.-External links:* *...
(UKPDS) achieved similar conclusions when it studied glycemic control in patients with Type 2 diabetes. The UKPDS results proved that control of glucose levels to near-normal levels delays the onset and slow the progression of microvascular complications for Type 2 diabetes.
The DCCT study did, however, find that there was an increase occurrence in episodes of hypoglycemia
Hypoglycemia
Hypoglycemia or hypoglycæmia is the medical term for a state produced by a lower than normal level of blood glucose. The term literally means "under-sweet blood"...
related to CSII as compared to conventional therapy. But at the time there were few studies on the use of combined CSII and blood glucose monitoring
Blood glucose monitoring
Blood glucose monitoring is a way of testing the concentration of glucose in the blood . Particularly important in the care of diabetes mellitus, a blood glucose test is performed by piercing the skin to draw blood, then applying the blood to a chemically active disposable 'test-strip'...
. Also, no rapid-acting insulin or pumps were in practice. Wainstein in 2005 reported on the efficacy
Efficacy
Efficacy is the capacity to produce an effect. It has different specific meanings in different fields. In medicine, it is the ability of an intervention or drug to reproduce a desired effect in expert hands and under ideal circumstances.- Healthcare :...
of insulin therapy with CSII versus MDI in the treatment of 40 poorly controlled obese Type 2 diabetic patients. The results showed treatment with CSII significantly reduced HbAlc levels compared with treatment with MDI.
One other study, the Epidemiology of Diabetes Interventions and Complications (EDIC) study, showed that treatment is durable. It was the first study to show that, in a 17 year span, controlling A1c with CSII can reduce risk of cardiovascular events by 42%. But still little was published related to benefits of clinical use of combined CSII and blood glucose monitoring devices, especially CGM. Up until 2006 there were no clinical trials that reported outcomes comparing the use of insulin pumps in conjunction with glucose monitoring devices. It was not until 2007 that clinical trials began: 1) Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy; 2) Feasibility Study of Effective Methods for Training Pump Naive Subjects To Use The Paradigm System And Evaluate Effectiveness. and 3) Use of Real-Time Continuous Glucose Monitoring System in Patients With Type 1 Diabetes Mellitus.
Using the Paradigm
Using the Minimed Paradigm pump or CGM requires training. There is a self-study provided by the manufacturer composed of the following basic steps:- Step 1: Open the box and remove the insulin pump.
- Step 2: Read the Insulin Pump Therapy Workbook. Answer all questions in each section.
- Step 3: Review chapters 1, 3, 4 in the Paradigm User Guide. Insert the battery. Practice pushing buttons as you follow the self-study materials. The pump is shipped in a mode that allows practicing without reservoir.
- Step 4: Log onto "Pump School Online". Review all sections of the tutorial and practice using the insulin pump. Do the same for the CGM portion. Print the Certificate of Completion and bring to your training along with the physician prescription containing programmable pump data.
The Minimed Paradigm pump or CGM should not be operated without training and consultation from a health care provider and manufacturer representative.
Benefits
The benefits of the Minimed Paradigm and CGM system are many, some highly significant in terms of reducing the probability of dangerous events, including overnight death or coma from extended period of untreated extreme hypoglycemiaHypoglycemia
Hypoglycemia or hypoglycæmia is the medical term for a state produced by a lower than normal level of blood glucose. The term literally means "under-sweet blood"...
, while others are a matter of convenience. These include high/low alarms for continuous nighttime monitoring and temporary basal rates. Others include immediate intervention capability to reduce glycemic variability; provides more frequent information that helps to understand cause and effect of life style; a better pancreas simulator compared to MDI; and more flexibility eating. Furthermore, it has been shown that CGM reduces long-term A1c, provides better control, and without increasing risk of hypoglycemia.
Insurance coverage
The MiniMed Paradigm 522 and 722 Insulin Pumps have a list price of $6,195 while the optional starter kit for the CGM components list for US $999. Insurance coverage for the CGM system is possible under pharmacy benefits (vs. durable medical benefits which have typically a 20% co-pay). Approximately 30% of American patients with typical "commercial" coverage can process their CGM under pharmacy, while 90% of American patients are actually eligible for coverage if they meet plan requirements. The estimated out-of-pocket cost is US $0.86 per day for pharmacy benefit or US $2.33 per day for durable medical benefit.Competitive devices
Competitive devices includes Deltec CozmoDeltec Cozmo
The Deltec Cozmo and CozMore are a series of insulin pumps made by Smiths Medical used to treat diabetes. The company has announced that it intends to stop selling the Cozmo The pump is used to deliver basal insulin continuously, and bolus insulin at meal times by pressing the buttons...
, Animas Ping, Insulet OmniPod, Accu-chek
Accu-chek
Accu-Chek is the brand of blood sugar-testing devices and Insulin Pumps manufactured by Roche Diagnostics, largely for the diabetic market.Accu-Chek Blood Glucose Monitor Kits contain:...
Spirit Combo, and Sooil DiabecareIIS.
Future devices
It was 1996 when three Russian biomedical engineers (Bobylev, Gromova, Toloknov) wrote, "To date, the feedback principle of insulin therapy is not fully implemented because the number of monitored physiological parameters is insufficient ... In the early 1960's, Kadish used a system consisting of a glucose sensor, a processor, and a pump to control glycemia in patients with diabetes." Later, this system was developed by Albisser. Today, nearly 50 years after Dr. Arnold Kadish's system, and after advancements as measured by Nobel prizeNobel Prize
The Nobel Prizes are annual international awards bestowed by Scandinavian committees in recognition of cultural and scientific advances. The will of the Swedish chemist Alfred Nobel, the inventor of dynamite, established the prizes in 1895...
s awarded in medicine, chemistry, and physics, and after more than 23 million people in the United States alone were diagnosed with diabetes in 2007, the industry continues to have the same basic description of a pump system in the marketplace, "a glucose sensor, a processor, and a pump" instead of "sensors, processors, and pumps".
The ultimate long-term goal of future technology for a portable device for treating diabetes is to: a) eliminate all dependent peripheral devices, for example, calibration meter, injection syringes/pens, glucagon, etc.; b) manage very complex life situations with fully automated protocols, for example, respond to DKA, sickness, extreme exercise/eating; and c) single on-off button control. This is absolutely not an impossible goal.
There are vast more complex and faster-responding systems that have sought solutions for control and whereby the engineering and mathematics of dynamical system
Dynamical system
A dynamical system is a concept in mathematics where a fixed rule describes the time dependence of a point in a geometrical space. Examples include the mathematical models that describe the swinging of a clock pendulum, the flow of water in a pipe, and the number of fish each springtime in a...
s have provided such solutions. For starter, in control theory
Control theory
Control theory is an interdisciplinary branch of engineering and mathematics that deals with the behavior of dynamical systems. The desired output of a system is called the reference...
a true closed-loop feedback pump will have to infuse not just rapid-acting insulin for positive errors, but also infuse glucagon
Glucagon
Glucagon, a hormone secreted by the pancreas, raises blood glucose levels. Its effect is opposite that of insulin, which lowers blood glucose levels. The pancreas releases glucagon when blood sugar levels fall too low. Glucagon causes the liver to convert stored glycogen into glucose, which is...
for negative errors. For managing complex life situations, the pump will need several MEMS
Microelectromechanical systems
Microelectromechanical systems is the technology of very small mechanical devices driven by electricity; it merges at the nano-scale into nanoelectromechanical systems and nanotechnology...
-based sensors to monitor more than just glucose, for example heart rate
Heart rate
Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute . Heart rate can vary as the body's need to absorb oxygen and excrete carbon dioxide changes, such as during exercise or sleep....
, breathing, ECG, temperature, CO2
Carbon dioxide
Carbon dioxide is a naturally occurring chemical compound composed of two oxygen atoms covalently bonded to a single carbon atom...
, blood pH
Acidosis
Acidosis is an increased acidity in the blood and other body tissue . If not further qualified, it usually refers to acidity of the blood plasma....
, dissolved O2
Oxygen
Oxygen is the element with atomic number 8 and represented by the symbol O. Its name derives from the Greek roots ὀξύς and -γενής , because at the time of naming, it was mistakenly thought that all acids required oxygen in their composition...
, etc.
Currently, Medtronic has the following research and development
Research and development
The phrase research and development , according to the Organization for Economic Co-operation and Development, refers to "creative work undertaken on a systematic basis in order to increase the stock of knowledge, including knowledge of man, culture and society, and the use of this stock of...
projects in its pipeline: Next Generation REAL-Time Continuous Glucose Monitoring System; Next Generation Insulin Pump; Pre-filled Insulin Reservoirs; Implantable Insulin Pump; and Artificial pancreas
Artificial pancreas
The artificial pancreas is a technology in development to help people with diabetes automatically control their blood glucose level by providing the substitute endocrine functionality of a healthy pancreas....
(Semi-Automated System & Closed-Loop System). The industry trend in portable devices has piggybacked on the success of wireless technology but not on the success of other disciplines, such as dynamical system
Dynamical system
A dynamical system is a concept in mathematics where a fixed rule describes the time dependence of a point in a geometrical space. Examples include the mathematical models that describe the swinging of a clock pendulum, the flow of water in a pipe, and the number of fish each springtime in a...
, Cybernetics
Cybernetics
Cybernetics is the interdisciplinary study of the structure of regulatory systems. Cybernetics is closely related to information theory, control theory and systems theory, at least in its first-order form...
and adaptive systems, for root-cause
Root cause
A root cause is rarely an initiating cause of a causal chain which leads to an outcome or effect of interest. Commonly, root cause is misused to describe the depth in the causal chain where an intervention could reasonably be implemented to change performance and prevent an undesirable outcome.In...
solutions to close the "true" loop. While the slow-responding dynamics in the physiology of glucose regulation is not beyond the mathematics of PID controller
PID controller
A proportional–integral–derivative controller is a generic control loop feedback mechanism widely used in industrial control systems – a PID is the most commonly used feedback controller. A PID controller calculates an "error" value as the difference between a measured process variable and a...
s, 50 years of patient-perspective "advancement" says it is beyond the corporate, congressional
United States Congress
The United States Congress is the bicameral legislature of the federal government of the United States, consisting of the Senate and the House of Representatives. The Congress meets in the United States Capitol in Washington, D.C....
, and lobbying
Lobbying
Lobbying is the act of attempting to influence decisions made by officials in the government, most often legislators or members of regulatory agencies. Lobbying is done by various people or groups, from private-sector individuals or corporations, fellow legislators or government officials, or...
leaders. Also, the accuracy of existing continuous glucose monitoring systems poses a problem for an artificial pancreas.