Claim: Problems spur FDA caution on insulin pump
Verdict: SUPPORTS

Retrieved passages:
title: Insulin detemir
text: Drug Administration (FDA) issued a public health advisory for Levemir insulin after learning that 129,000 stolen vials reappeared and were being sold in the U.S. market. The FDA warned that the stolen vials "may not have been stored and handled properly and may be dangerous for patients to use." The stolen vials were identified as lots XZF0036, XZF0037, and XZF0038. 1. http://content.nejm.org/cgi/content/full/NEJMoa075392, Addition of Biphasic, Prandial, or Basal Insulin to Oral Therapy in Type 2 Diabetes; (2006) Rury R. Holman, M.B., Ch.B., F.R.C.P., Kerensa I. Thorne, M.Sc., Andrew J. Farmer, D.M., F.R.C.G.P., Melanie J. Davies, M.D., F.R.C.P., Joanne F. Keenan,

title: Insulin pump
text: Radcliffe, demonstrated a security flaw in insulin pumps. Radcliffe was able to hack the wireless interface used to control the pump remotely. Pump manufacturer Medtronic later said security research by McAfee uncovered a flaw in its pumps that could be exploited. Insulin pump 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

title: Minimed Paradigm
text: 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. 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 3 days while the pump is clip-belt worn. There is a quick-disconnect feature for

title: Tandem Diabetes Care
text: with the Dexcom G4 Platinum CGM System. This device was approved by the FDA in September 2015. The FDA approved a tool to update the software on Tandem's pumps in July, 2016. The Tandem Product Updater is designed to deliver software updates to Tandem's pumps to provide new features and interface improvements. In announcing the approval, Tandem stated that the first use of the new tool will be to update t:slim pumps which were shipped prior to April, 2015 with a new version of the firmware which speeds the loading process and offers other enhancements. In late October 2016, Tandem

title: Insulin pump
text: 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. Another disadvantage of insulin pump use is a higher risk of developing diabetic ketoacidosis if the pump malfunctions. 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

title: Animas Corporation
text: up to 500 rules set by the user on how to act on different occasions (such as when eating a certain food type). In April 2013, the Food and Drug Administration issued a Class I Recall for the Animas 2020. The recall specifies an issue with the pump initiating a false alarm or warning sound, which may prompt pump users to inadvertently administer more insulin and can result in a serious health risk. The Animas Ping is an insulin pump which communicates wirelessly with a meter/display device. Animas Corporation teamed up with Dexcom Inc. and developed the first insulin pump

title: Novo Nordisk
text: – had an increased risk of side effects in the pancreas such as pancreatitis and pancreatic cancer. It was concluded that data currently available did not confirm these concerns. In October 2013, batches of NovoMix 30 FlexPen and Penfill insulin were recalled in some European countries as their analysis had shown that a small percentage of the products in these batches did not meet the specifications for insulin strength. In September 2017, Novo Nordisk agreed to pay $58.7 million to end a United States Department of Justice probe into the lack of FDA disclosure to doctors about the cancer risk

title: Liraglutide
text: inhibitors (such as sitagliptin). In response, the United States FDA and the European Medicines Agency conducted a review of all available data regarding the possible connection between incretin mimetics and pancreatitis or pancreatic cancer. In a joint 2014 letter to the New England Journal of Medicine, the agencies concluded that "A pooled analysis of data from 14,611 patients with type 2 diabetes from 25 clinical trials in the sitagliptin database provided no compelling evidence of an increased risk of pancreatitis or pancreatic cancer" and "Both agencies agree that assertions concerning a causal association between incretin-based drugs and pancreatitis or pancreatic

title: Diabetes management
text: undergoing for an oral product. Also oral combination products of insulin and a GLP-1 agonist are being developed. Insulin therapy creates risk because of the inability to continuously know a person's blood glucose level and adjust insulin infusion appropriately. New advances in technology have overcome much of this problem. Small, portable insulin infusion pumps are available from several manufacturers. They allow a continuous infusion of small amounts of insulin to be delivered through the skin around the clock, plus the ability to give bolus doses when a person eats or has elevated blood glucose levels. This is very similar to

title: Diabetes management
text: how the pancreas works, but these pumps lack a continuous "feed-back" mechanism. Thus, the user is still at risk of giving too much or too little insulin unless blood glucose measurements are made. A further danger of insulin treatment is that while diabetic microangiopathy is usually explained as the result of hyperglycemia, studies in rats indicate that the higher than normal level of insulin diabetics inject to control their hyperglycemia may itself promote small blood vessel disease. While there is no clear evidence that controlling hyperglycemia reduces diabetic macrovascular and cardiovascular disease, there are indications that intensive efforts to normalize

title: Insulin pump
text: 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 diabetic person's basal insulin requirement and automatically adjusts its delivery to the body. An insulin pump allows the replacement of slow-acting insulin for basal needs with a continuous infusion of rapid-acting

title: Untethered regimen
text: the pump. Sometimes, an insulin pump will require repair. Pump manufacturers offer fast turn-around times, and replacement pumps are sent quickly. This may be a time when an insulin-dependent person has to be pump-free for a few days. It is good to be familiar with this technique. All insulin-dependent persons will become very ill with diabetic ketoacidosis if denied insulin for a sustained period. The period varies with each person and their situation. An insulin pump problem at night (such as running out of insulin, a dead battery, or leaky infusion set tubing) that goes undetected can lead to ketoacidosis

title: Abdominal obesity
text: insulin resistance and/or breast cancer risk). The risk increases considering the fact that they are located in the proximity or in between organs in the abdominal cavity. For example, fat next to the liver drains into it, causing a fatty liver, which is a risk factor for insulin resistance, setting the stage for Type 2 diabetes. In the presence of diabetes mellitus type 2, the physician might instead prescribe metformin and thiazolidinediones (rosiglitazone or pioglitazone) as antidiabetic drugs rather than sulfonylurea derivatives. Thiazolidinediones may cause slight weight gain but decrease "pathologic" abdominal fat (visceral fat), and therefore may be prescribed

title: Insulin (medication)
text: attempt to mimic real beta cell insulin (as with insulin lispro, insulin aspart, and insulin glulisine), or steadily absorbed after injection instead of having a 'peak' followed by a more or less rapid decline in insulin action (as with insulin detemir and insulin glargine), all while retaining insulin's glucose-lowering action in the human body. However, a number of meta-analyses, including those done by the Cochrane Collaboration in 2005, Germany's Institute for Quality and Cost Effectiveness in the Health Care Sector [IQWiG] released in 2007, and the Canadian Agency for Drugs and Technology in Health (CADTH) also released in 2007 have

title: Dipeptidyl peptidase-4 inhibitor
text: no favorable effect of DPP-4 inhibitors on all-cause mortality, cardiovascular mortality, myocardial infarction or stroke. Drugs belonging to this class are: Other chemicals which may inhibit DPP-4 include: In those taking sulphonylureas, there is an increased risk of low blood sugar. Adverse effects, including nasopharyngitis, headache, nausea, heart failure, hypersensitivity and skin reactions. The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines like sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling. FDA has added a new Warning and Precaution about this risk to the labels of all

title: Insulin aspart
text: be used with external insulin pumps. The insulin in reservoirs of insulin pumps and infusion sets should be changed every 48 hours to avoid insulin degradation and loss of preservative. The following insulin pumps have been used in Novolog® clinical or in vitro studies conducted by Novo Nordisk: Medtronic Paradigm® 512 and 712, Minimed 508, Disetronic® D-TRON® and H-TRON®. NovoLog Mix 70/30 is a product marketed by Novo Nordisk which contains 30% insulin aspart and 70% insulin aspart protamine. The insulin aspart protamine portion is a crystalline form of insulin aspart, which delays the action of the insulin, giving it

title: Rosiglitazone
text: of rosiglitazone. Published studies did not provide evidence that patient-oriented outcomes like mortality, morbidity, adverse effects, costs and health-related quality of life are positively influenced by rosiglitazone. One of the safety concerns identified before approval was fluid retention. Moreover, the combination of rosiglitazone with insulin resulted in a higher rate of congestive heart failure. In Europe there were contraindications for use in heart failure and combination with insulin. A meta analysis of all trials from 2010 confirmed a higher risk of heart failure and a double risk when rosiglitazone was administered as add-on therapy to insulin. Two meta-analyses of real

title: Insulin lispro
text: for postprandial glucose control. It has a shortened delay of onset, allowing slightly more flexibility than regular insulin, which requires a longer waiting period before starting a meal after injection. Both preparations should be coupled with a longer acting insulin (e.g. NPH insulin) or an insulin infusion pump for good glycemic control. Insulin lispro is an FDA approved drug used to treat people living with Type 1 diabetes or Type 2 diabetes. Insulin lispro has non-FDA labeled uses for diabetic neuropathy prevention and cardiovascular disease prevention. Common side effects include skin irritation at the site of injection, hypoglycemia, hypokalemia, and

title: Medical device
text: Jay Radcliff, a security researcher interested in the security of medical devices, raised fears about the safety of these devices. He shared his concerns at the Black Hat security conference. Radcliff fears that the devices are vulnerable and has found that a lethal attack is possible against those with insulin pumps and glucose monitors. Some medical device makers downplay the threat from such attacks and argue that the demonstrated attacks have been performed by skilled security researchers and are unlikely to occur in the real world. At the same time, other makers have asked software security experts to investigate the

title: Insulin analog
text: the yeast genome, and the yeast expressed the insulin analogue, which was then harvested from a bioreactor. This analogue also prevents the formation of hexamers, to create a faster acting insulin. It is approved for use in CSII pumps and Flexpen, Novopen delivery devices for subcutaneous injection. Glulisine is rapid acting insulin analog from Sanofi-Aventis, approved for use with a regular syringe, in an insulin pump. Standard syringe delivery is also an option. It is sold under the name Apidra. The FDA-approved label states that it differs from regular human insulin by its "rapid onset and shorter duration of action".