Minimed Paradigm

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The Medtronic Minimed Paradigm 515 pump (RF receiver), Silhouette infusion set, and UltraLink blood sugar meter (RF transmitter) Pump Silhouette and Meter.jpg
The Medtronic Minimed Paradigm 515 pump (RF receiver), Silhouette infusion set, and UltraLink blood sugar meter (RF transmitter)

MiniMed Paradigm is a series of insulin pumps 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 meters. 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. [1] [2]

Contents

In the United States, the device is regulated by a branch of the Food and Drug Administration. [3]

Description

Pump and infusion set (catheter) placement Minimed 515 and Silhouette Infusion set.jpg
Pump and infusion set (catheter) placement
Insulin basal bolus profile Insulin basal bolus.png
Insulin basal bolus profile

Insulin pumps are drug delivery devices used to treat patients with type 1 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 three 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. [4]

The Paradigm system consists of two basic parts: an insulin pump and an optional glucose sensor CGM worn for up to three days. The disposable sensor is subcutaneously-placed to make glucose measurements [5] in interstitial fluid every five 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. Any change in basal or bolus is patient-driven by programming the pump using the Bolus Wizard. 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. [6]

History

The development history of the Minimed pump goes back to the 1980s. [7]

FDA classification

The Food and Drug Administration has at least six classifications for the various parts of the Minimed Paradigm System.

Product codeGeneric part nameRegulation numberDevice classification codeDescription
MDSCGMnull Premarket approval [10] Invasive glucose sensor
FMFDrug reservoir21CFR888.5860 [11] standardsPiston syringe
NBWGlucose meter21CFR862.1345 [12] standardsGlucose test system
LZG/FRNInfusion/insulin pump21CFR888.5725 [13] standardsInfusion pump
FPAInfusion set21CFR888.5440 [14] standardsIntravascular administration set
KZHInfusion set insertion system21CFR880.6920 [15] standardsSyringer needle introducer

Competitive devices

Competitive devices include Deltec Cozmo, Animas Ping, Tandem Diabetes Care, Inc., Insulet OmniPod, Accu-chek Spirit Combo, and Sooil DiabecareIIS. [16]

Future devices

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). [9] The industry trend in portable devices has piggybacked on the success of wireless technology [17] 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. [18] While the slow-responding dynamics in the physiology of glucose regulation is not beyond the mathematics of PID controllers, 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.

Related Research Articles

<span class="mw-page-title-main">Insulin pump</span> Medical device to administer insulin

An insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin therapy. The device configuration may vary depending on design. A traditional pump includes:

Intensive insulin therapy or flexible insulin therapy is a therapeutic regimen for diabetes mellitus treatment. This newer approach contrasts with conventional insulin therapy. Rather than minimize the number of insulin injections per day, the intensive approach favors flexible meal times with variable carbohydrate as well as flexible physical activities. The trade-off is the increase from 2 or 3 injections per day to 4 or more injections per day, which was considered "intensive" relative to the older approach. In North America in 2004, many endocrinologists prefer the term "flexible insulin therapy" (FIT) to "intensive therapy" and use it to refer to any method of replacing insulin that attempts to mimic the pattern of small continuous basal insulin secretion of a working pancreas combined with larger insulin secretions at mealtimes. The semantic distinction reflects changing treatment.

<span class="mw-page-title-main">Blood glucose monitoring</span> Use of a glucose monitor for testing the concentration of glucose in the blood

Blood glucose monitoring is the use of a glucose meter for testing the concentration of glucose in the blood (glycemia). Particularly important in diabetes management, a blood glucose test is typically performed by piercing the skin to draw blood, then applying the blood to a chemically active disposable 'test-strip'. The other main option is continuous glucose monitoring (CGM). Different manufacturers use different technology, but most systems measure an electrical characteristic and use this to determine the glucose level in the blood. Skin-prick methods measure capillary blood glucose, whereas CGM correlates interstitial fluid glucose level to blood glucose level. Measurements may occur after fasting or at random nonfasting intervals, each of which informs diagnosis or monitoring in different ways.

<span class="mw-page-title-main">Hyperglycemia</span> Too much blood sugar, usually because of diabetes

Hyperglycemia or Hyperglycaemia is a condition in which an excessive amount of glucose (glucotoxicity) circulates in the blood plasma. This is generally a blood sugar level higher than 11.1 mmol/L (200 mg/dL), but symptoms may not start to become noticeable until even higher values such as 13.9–16.7 mmol/L (~250–300 mg/dL). A subject with a consistent fasting blood glucose range between ~5.6 and ~7 mmol/L is considered slightly hyperglycemic, and above 7 mmol/L is generally held to have diabetes. For diabetics, glucose levels that are considered to be too hyperglycemic can vary from person to person, mainly due to the person's renal threshold of glucose and overall glucose tolerance. On average, however, chronic levels above 10–12 mmol/L (180–216 mg/dL) can produce noticeable organ damage over time.

<span class="mw-page-title-main">Type 2 diabetes</span> Form of diabetes mellitus

Type 2 diabetes (T2D), formerly known as adult-onset diabetes, is a form of diabetes mellitus that is characterized by high blood sugar, insulin resistance, and relative lack of insulin. Common symptoms include increased thirst, frequent urination, fatigue and unexplained weight loss. Symptoms may also include increased hunger, having a sensation of pins and needles, and sores (wounds) that do not heal. Often, symptoms develop slowly. Long-term complications from high blood sugar include heart disease, stroke, diabetic retinopathy, which can result in blindness, kidney failure, and poor blood flow in the lower-limbs, which may lead to amputations. The sudden onset of hyperosmolar hyperglycemic state may occur; however, ketoacidosis is uncommon.

<span class="mw-page-title-main">Medtronic</span> Irish tax-registered medical device company

Medtronic plc is an American-Irish medical device company. The company's operational and executive headquarters are in Minneapolis, Minnesota, and its legal headquarters are in Ireland due to its acquisition of Irish-based Covidien in 2015. While it primarily operates in the United States, it operates in more than 150 countries and employs over 90,000 people. It develops and manufactures healthcare technologies and therapies.

Glycated hemoglobin, glycohemoglobin, glycosylated hemoglobin is a form of hemoglobin (Hb) that is chemically linked to a sugar. Several types of glycated hemoglobin measures exist, of which HbA1c, or simply A1c, is a standard single test. Most monosaccharides, including glucose, galactose, and fructose, spontaneously bond with hemoglobin when present in the bloodstream. However, glucose is only 21% as likely to do so as galactose and 13% as likely to do so as fructose, which may explain why glucose is used as the primary metabolic fuel in humans.

<span class="mw-page-title-main">Insulin glargine</span> Long-acting insulin

Insulin glargine sold under the brand name Lantus among others is a long-acting modified form of medical insulin, used in the management of type I and type II diabetes. It is injected just under the skin. Effects generally begin an hour after use.

<span class="mw-page-title-main">Type 1 diabetes</span> Form of diabetes mellitus

Type 1 diabetes (T1D), formerly known as juvenile diabetes, is an autoimmune disease that originates when cells that make insulin are destroyed by the immune system. Insulin is a hormone required for the cells to use blood sugar for energy and it helps regulate glucose levels in the bloodstream. It results in high blood sugar levels in the body prior to treatment. The common symptoms of this elevated blood sugar are frequent urination, increased thirst, increased hunger, weight loss, and other serious complications. Additional symptoms may include blurry vision, tiredness, and slow wound healing. Symptoms typically develop over a short period of time, often a matter of weeks if not months.

The term diabetes includes several different metabolic disorders that all, if left untreated, result in abnormally high concentrations of a sugar called glucose in the blood. Diabetes mellitus type 1 results when the pancreas no longer produces significant amounts of the hormone insulin, usually owing to the autoimmune destruction of the insulin-producing beta cells of the pancreas. Diabetes mellitus type 2, in contrast, is now thought to result from autoimmune attacks on the pancreas and/or insulin resistance. The pancreas of a person with type 2 diabetes may be producing normal or even abnormally large amounts of insulin. Other forms of diabetes mellitus, such as the various forms of maturity-onset diabetes of the young, may represent some combination of insufficient insulin production and insulin resistance. Some degree of insulin resistance may also be present in a person with type 1 diabetes.

<span class="mw-page-title-main">Automated insulin delivery system</span>

Automated insulin delivery systems are automated systems designed to assist people with insulin-requiring diabetes, by automatically adjusting insulin delivery in response to blood glucose levels. Currently available systems can only deliver a single hormone—insulin. Other systems currently in development aim to improve on current systems by adding one or more additional hormones that can be delivered as needed, providing something closer to the endocrine functionality of the pancreas.

<span class="mw-page-title-main">Prediabetes</span> Predisease state of hyperglycemia with high risk for diabetes

Prediabetes is a component of metabolic syndrome and is characterized by elevated blood sugar levels that fall below the threshold to diagnose diabetes mellitus. It usually does not cause symptoms but people with prediabetes often have obesity, dyslipidemia with high triglycerides and/or low HDL cholesterol, and hypertension. It is also associated with increased risk for cardiovascular disease (CVD). Prediabetes is more accurately considered an early stage of diabetes as health complications associated with type 2 diabetes often occur before the diagnosis of diabetes.

The dawn phenomenon, sometimes called the dawn effect, is an observed increase in blood sugar (glucose) levels that takes place in the early-morning, often between 2 a.m. and 8 a.m. First described by Schmidt in 1981 as an increase of blood glucose or insulin demand occurring at dawn, this naturally occurring phenomenon is frequently seen among the general population and is clinically relevant for patients with diabetes as it can affect their medical management. In contrast to Chronic Somogyi rebound, the dawn phenomenon is not associated with nocturnal hypoglycemia.

<span class="mw-page-title-main">Insulin (medication)</span> Use of insulin protein and analogs as medical treatment

As a medication, insulin is any pharmaceutical preparation of the protein hormone insulin that is used to treat high blood glucose. Such conditions include type 1 diabetes, type 2 diabetes, gestational diabetes, and complications of diabetes such as diabetic ketoacidosis and hyperosmolar hyperglycemic states. Insulin is also used along with glucose to treat hyperkalemia. Typically it is given by injection under the skin, but some forms may also be used by injection into a vein or muscle. There are various types of insulin, suitable for various time spans. The types are often all called insulin in the broad sense, although in a more precise sense, insulin is identical to the naturally occurring molecule whereas insulin analogues have slightly different molecules that allow for modified time of action. It is on the World Health Organization's List of Essential Medicines. In 2021, it was the 179th most commonly prescribed medication in the United States, with more than 2 million prescriptions.

Diabetic cheiroarthropathy, also known as diabetic stiff hand syndrome or limited joint mobility syndrome, is a cutaneous condition characterized by waxy, thickened skin and limited joint mobility of the hands and fingers, leading to flexion contractures, a condition associated with diabetes mellitus and it is observed in roughly 30% of diabetic patients with longstanding disease. It can be a predictor for other diabetes-related complications and was one of the earliest known complications of diabetes, first documented in 1974.

DexCom, Inc. is a company that develops, manufactures, produces, and distributes continuous glucose monitoring (CGM) systems for diabetes management. It operates internationally with headquarters in San Diego, California, and has manufacturing facilities in Mesa, Arizona and Batu Kawan, Malaysia.

Glucommander is a computer-directed method of inpatient glucose management.

International Diabetes Center at Park Nicollet (IDC) is a center for diabetes care, research and education located in Minneapolis, Minnesota, United States. The center provides clinical, motivational and educational services for people with diabetes. It is part of HealthPartners Institute.

The Open Artificial Pancreas System (OpenAPS) project is a free and open-source project that aims to make basic artificial pancreas system (APS) technology available to everyone. The OpenAPS project was designed with the idea of quickly getting the APS technology to more people using a direct approach, rather than waiting for clinical trials to be completed and regulatory approval to be granted.

<span class="mw-page-title-main">Continuous glucose monitor</span> Blood glucose monitoring device

A continuous glucose monitor (CGM) is a device used for monitoring blood glucose on a continual basis instead of monitoring glucose levels periodically by drawing a drop of blood from a finger. This is known as continuous glucose monitoring. CGMs are used by people who treat their diabetes with insulin, for example people with type 1 diabetes, type 2 diabetes, or other types of diabetes, such as gestational diabetes.

References

Notes

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  2. "Insulin Pumpers Minimed 511 Review". Insulin-pumpers.org.
  3. "Devices@FDA". Accessdata.fda.gov.
  4. "Medical and Drug Policies" (PDF).
  5. "Accuracy of Real-Time Continuous Glucose Monitoring in the MiniMed Paradigm System – DiabetesPro – American Diabetes Association". Archived from the original on 2007-10-18. Retrieved 2009-07-20.
  6. "Ingentaconnect Insulin Pump Therapy in Childhood Diabetes Mellitus: Guidelines F". Archived from the original on 2011-06-07. Retrieved 2009-07-19.
  7. "About Us | Medtronic Diabetes". Medtronicdiabetes.com. 14 December 2012.
  8. "Biotechnology Timeline 1977 - 1999". Archived from the original on 2009-04-25. Retrieved 2009-07-30.
  9. 1 2 "Overview | Medtronic". Newsroom.medtronic.com.
  10. Health, Center for Devices and Radiological (July 9, 2019). "Premarket Approval (PMA)". FDA.
  11. "CFR - Code of Federal Regulations Title 21". Accessdata.fda.gov.
  12. "CFR - Code of Federal Regulations Title 21". Accessdata.fda.gov.
  13. "CFR - Code of Federal Regulations Title 21". Accessdata.fda.gov.
  14. "CFR - Code of Federal Regulations Title 21". Accessdata.fda.gov.
  15. "CFR - Code of Federal Regulations Title 21". Accessdata.fda.gov.
  16. "Comparison of Current Insulin Pumps". Diabetesnet.com. November 22, 2010.
  17. "Metapress | A Fast Growing Resource for Young Entrepreneurs". December 14, 2017.
  18. "Patent US7029455 - Devices, systems and methods for patient infusion …". Archived from the original on 24 January 2013.