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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:
Other configurations are possible. More recent models may include disposable or semi-disposable designs for the pumping mechanism and may eliminate tubing from the infusion set.
An insulin pump is an alternative to multiple daily injections of insulin by insulin syringes or an insulin pen and allows for flexible insulin therapy when used in conjunction with blood glucose monitoring and carbohydrate counting.
Insulin pumps are used to deliver insulin on a continuous basis to a person with type I diabetes.
Insulin pumps, cartridges, and infusion sets may be far more expensive than syringes used for insulin injection with several insulin pumps costing more than $6,000; necessary supplies can cost over $300. [3] Another disadvantage of insulin pump use is a higher risk of developing diabetic ketoacidosis if the pump malfunctions. [3] This can happen if the pump battery is discharged, if the insulin is inactivated by heat exposure, if the insulin reservoir runs empty, the tubing becomes loose and insulin leaks rather than being injected, or if the cannula becomes bent or kinked in the body, preventing delivery. [3] Therefore, pump users typically monitor their blood sugars more frequently to evaluate the effectiveness of insulin delivery.
Use of insulin pumps is increasing because of:
In the early 1960s, Dr. Arnold Kadish, a physician working at Loma Linda University, developed a closed-loop device for blood glucose control using a double-lumen autoanalyzer to measure blood glucose linked to an intravenous insulin infusion pump. Although it worked, the prototype was considered so bulky, worn as a backpack, and complicated, that it was never commercialized. [10] In 1976, the first commercialized insulin pump was created and was named the Biostator. The pump was a 60 kg bedside device. [11] It also had the capability of monitoring blood glucose levels, so this also doubles as the first continuous glucose monitor. Between 1978 and 1988, Robert Channon, working with Guy's Hospital and the Bristol Royal Infirmary, developed a series of miniature insulin infusion pumps. [12] [13] Today, insulin pumps are so small that they can fit in a pocket or a purse.
In 1984, an Infusaid implantable infusion device was used to treat a 22-year-old patient successfully. [14]
The insulin pump was first endorsed in the United Kingdom in 2003 by the National Institute for Health and Care Excellence (NICE).
New insulin pumps are becoming "smart" as new features are added to their design. These simplify the tasks involved in delivering an insulin bolus.
MiniMed 670G is a type of insulin pump and sensor system created by Medtronic. It was approved by the US FDA in September 2016 and was the first approved hybrid closed loop system which senses a patient's basal insulin requirement and automatically adjusts its delivery to the body. [21] [22] [23]
Mylife YpsoPump, developed by Ypsomed, was launched in Europe in 2016. [24] Eli Lilly had planned to work with Ypsomed to introduce this to the United States, but that effort was terminated in 2022. [24]
Omnipod 5: On January 28, 2022, Insulet Corporation announced the FDA has approved the Omnipod 5, the first tubeless closed loop insulin pump with Smartphone control, working with the Dexcom G6 Continuous Glucose Monitor. The Omnipod 5 will have a feature named SmartAdjust technology that allows for the increase, decrease, or suspension of insulin based on the user's custom blood glucose targets. [25]
INSUL by AgVa: AgVa Healthcare announced that Insul by Agva is the world's most advanced and affordable Insulin pump. Features such as a built-in glucometer, Bluetooth connectivity, android and IOS app, as well as long-lasting and economical disposables. [26]
An insulin pump allows the replacement of slow-acting insulin for basal needs with a continuous infusion of rapid-acting insulin.
The insulin pump delivers a single type of rapid-acting insulin in two ways: [30]
An insulin pump user can influence the profile of the rapid-acting insulin by shaping the bolus. Users can experiment with bolus shapes to determine what is best for any given food, which means that they can improve control of blood sugar by adapting the bolus shape to their needs.
A standard bolus is an infusion of insulin pumped completely at the onset of the bolus. It's the most similar to an injection. By pumping with a "spike" shape, the expected action is the fastest possible bolus for that type of insulin. The standard bolus is most appropriate when eating high carb low protein low fat meals because it will return blood sugar to normal levels quickly.
An extended bolus is a slow infusion of insulin spread out over time. By pumping with a "square wave" shape, the bolus avoids a high initial dose of insulin that may enter the blood and cause low blood sugar before digestion can facilitate sugar entering the blood. The extended bolus also extends the action of insulin well beyond that of the insulin alone. The extended bolus is appropriate when covering high fat high protein meals such as steak, which will be raising blood sugar for many hours past the onset of the bolus. The extended bolus is also useful for those with slow digestion (such as with gastroparesis or coeliac disease).
A combination bolus/multiwave bolus is the combination of a standard bolus spike with an extended bolus square wave. This shape provides a large dose of insulin up front, and then also extends the tail of the insulin action. The combination bolus is appropriate for high carb high fat meals such as pizza, pasta with heavy cream sauce, and chocolate cake.
A super bolus is a method of increasing the spike of the standard bolus. Since the action of the bolus insulin in the blood stream will extend for several hours, the basal insulin could be stopped or reduced during this time. This facilitates the "borrowing" of the basal insulin and including it into the bolus spike to deliver the same total insulin with faster action than can be achieved with spike and basal rate together. The super bolus is useful for certain foods (like sugary breakfast cereals) which cause a large post-prandial peak of blood sugar. It attacks the blood sugar peak with the fastest delivery of insulin that can be practically achieved by pumping.
Since the pump user is responsible to manually start a bolus, this provides an opportunity for the user to pre-bolus to improve upon the insulin pump's capability to prevent post-prandial hyperglycemia. A pre-bolus is simply a bolus of insulin given before it is actually needed to cover carbohydrates eaten.
There are two situations where a pre-bolus is helpful:
Similarly, a low blood sugar level or a low glycemic food might be best treated with a bolus after a meal is begun. The blood sugar level, the type of food eaten, and a person's individual response to food and insulin affect the ideal time to bolus with the pump.
The pattern for delivering basal insulin throughout the day can also be customized with a pattern to suit the pump user.
Basal insulin requirements will vary between individuals and periods of the day. The basal rate for a particular time period is determined by fasting while periodically evaluating the blood sugar level. Neither food nor bolus insulin must be taken for 4 hours before or during the evaluation period. If the blood sugar level changes dramatically during evaluation, then the basal rate can be adjusted to increase or decrease insulin delivery to keep the blood sugar level approximately steady.
For instance, to determine an individual's morning basal requirement, they must skip breakfast. On waking, they would test their blood glucose level periodically until lunch. Changes in blood glucose level are compensated with adjustments in the morning basal rate. The process is repeated over several days, varying the fasting period, until a 24-hour basal profile has been built up which keeps fasting blood sugar levels relatively steady. Once the basal rate is matched to the fasting basal insulin need, the pump user will then gain the flexibility to skip or postpone meals such as sleeping late on the weekends or working overtime on a weekday.
Many factors can change insulin requirements and require an adjustment to the basal rate:
A pump user should be educated by their diabetes care professional about basal rate determination before beginning pump therapy.
Since the basal insulin is provided as a rapid-acting insulin, the basal insulin can be immediately increased or decreased as needed with a temporary basal rate. Examples when this is helpful include:
In August 2011, an IBM researcher, Jay Radcliffe, demonstrated a security flaw in insulin pumps. Radcliffe was able to hack the wireless interface used to control the pump remotely. [31] Pump manufacturer Medtronic later said security research by McAfee uncovered a flaw in its pumps that could be exploited. [32]
Hypoglycemia, also spelled hypoglycaemia or hypoglycæmia, sometimes called low blood sugar, is a fall in blood sugar to levels below normal, typically below 70 mg/dL (3.9 mmol/L). Whipple's triad is used to properly identify hypoglycemic episodes. It is defined as blood glucose below 70 mg/dL (3.9 mmol/L), symptoms associated with hypoglycemia, and resolution of symptoms when blood sugar returns to normal. Hypoglycemia may result in headache, tiredness, clumsiness, trouble talking, confusion, fast heart rate, sweating, shakiness, nervousness, hunger, loss of consciousness, seizures, or death. Symptoms typically come on quickly.
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.
The following is a glossary of diabetes which explains terms connected with diabetes.
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.
Basal rate, in biology, 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.
A glucose meter, also referred to as a "glucometer", is a medical device for determining the approximate concentration of glucose in the blood. It can also be a strip of glucose paper dipped into a substance and measured to the glucose chart. It is a key element of glucose testing, including home blood glucose monitoring (HBGM) performed by people with diabetes mellitus or hypoglycemia. A small drop of blood, obtained from slightly piercing a fingertip with a lancet, is placed on a disposable test strip that the meter reads and uses to calculate the blood glucose level. The meter then displays the level in units of mg/dL or mmol/L.
The main goal of diabetes management is to keep blood glucose (BG) levels as normal as possible. If diabetes is not well controlled, further challenges to health may occur. People with diabetes can measure blood sugar by various methods, such as with a BG meter or a continuous glucose monitor, which monitors over several days. Glucose can also be measured by analysis of a routine blood sample. Usually, people are recommended to control diet, exercise, and maintain a healthy weight, although some people may need medications to control their blood sugar levels. Other goals of diabetes management are to prevent or treat complications that can result from the disease itself and from its treatment.
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.
The untethered regimen is a technique combining the use of an insulin pump with a slow-acting insulin analog such as Lantus or Levemir. This allows an insulin dependent person to disconnect the pump when desired while maintaining the flexible benefits that the insulin pump can provide.
Diabetes 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:
Chronic Somogyi rebound is a contested explanation of phenomena of elevated blood sugars experienced by diabetics in the morning. Also called the Somogyi effect and posthypoglycemic hyperglycemia, it is a rebounding high blood sugar that is a response to low blood sugar. When managing the blood glucose level with insulin injections, this effect is counter-intuitive to people who experience high blood sugar in the morning as a result of an overabundance of insulin at night.
Noninvasive glucose monitoring (NIGM), called Noninvasive continuous glucose monitoring when used as a CGM technique, is the measurement of blood glucose levels, required by people with diabetes to prevent both chronic and acute complications from the disease, without drawing blood, puncturing the skin, or causing pain or trauma. The search for a successful technique began about 1975 and has continued to the present without a clinically or commercially viable product.
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 2022, it was the 192nd most commonly prescribed medication in the United States, with more than 2 million prescriptions.
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 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.
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, Batu Kawan, Malaysia and Athenry, Ireland.
Tandem Diabetes Care, Inc. is an American medical device manufacturer based in San Diego, California. The company develops medical technologies for the treatment of diabetes and specifically insulin infusion therapy.
Nightscout is a free and open-source project, and associated social movement, that enables accessing and working with continuous glucose monitor (CGM) data. Nightscout software aims to give users access to their real time blood sugar data by putting this data in the cloud. In addition to browser-based data visualization, Nightscout can also be used to review data from a phone or smartwatch, or to remotely monitor CGM data for individuals with type 1 diabetes. Associated with Nightscout software is a broader "CGM in the Cloud" social movement, supporting individuals seeking to access and use realtime CGM data through commercial and DIY approaches.
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.
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.
Donislecel, sold under the brand name Lantidra, is a cellular therapy medication used for the treatment of type 1 diabetes. Donislecel is an allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells. Donislecel is administered as a single infusion into the hepatic (liver) portal vein.