En insulinpumpe fra Medtronic Corp i dette filbildet tatt 10. oktober 2014 i Meridian, Idaho Reuters/Brian Losness
DESTIN, Florida: Da Polly Varnados 9 år gamle datter ble diagnostisert med diabetes type 1, tok det ikke lang tid før familien hørte om insulinpumper.
I september 2012 valgte jenta en lilla - hennes favorittfarge.
I løpet av de neste syv månedene ble hun innlagt fire ganger på et medisinsk senter i McComb, Mississippi, med høyt blodsukker. Men da Varnado spurte om alle datterens problemer, sa hun at legen hennes skyldte på brukerfeil.
"De sa at det ikke var insulinpumpen, det var datteren min," sa Varnado, som ble registrert sykepleier slik at hun bedre kunne ta vare på jenta.
Når det gjelder medisinsk utstyr, har ingen hatt flere rapporterte problemer det siste tiåret enn insulinpumper, et produkt som brukes av hundretusenvis av diabetikere rundt om i verden, mange av dem barn.
Samlet sett er insulinpumper og deres komponenter ansvarlige for det høyeste totale antallet feil-, skade- og dødsrapporter i U.S. Food and Drug Administrations database for medisinsk utstyr, ifølge en Associated Press-analyse av rapporter siden 2008.
Når det gjelder skader alene, var insulinpumper nest etter metallhofteproteser, hvis problemer med metallspon i kroppen som forårsaker skade på bein og vev og andre problemer, har vært godt dokumentert og mye rapportert.
Derimot har problemer med insulinpumper stort sett fløyet under radaren.
Medisinske utstyrsselskaper og mange eksperter sier insulinpumper er trygge enheter som kan hjelpe diabetikere til å leve mer normale liv. De gir brukerfeil skylden for de fleste rapporterte problemene, og bemerker at pumpene er kompliserte enheter som krever spesiell opplæring for pasienter.
FDA bemerker at "diabetes er en farlig sykdom, og personer med diabetes som er avhengige av insulin har høyere risiko." Byrået sa at det "har spilt en kritisk rolle i å identifisere og adressere sikkerhetsproblemer for enheter ... inkludert å presse produsenter til å forbedre sikkerheten til designene deres."
I løpet av det siste tiåret har insulinpumper og pumpedeler laget av Medtronic Inc. vært gjenstand for 20 tilbakekallinger fra produsenten og rundt 100 søksmål med påstand om pumpefeil, ifølge en felles undersøkelse fra AP og International Consortium of Investigative Journalists.
I en uttalelse sa Medtronic at de overvåker sikkerheten til produktene sine gjennom kliniske studier og observasjonsstudier, og at "data støtter både sikkerheten og effektiviteten til insulinpumpene våre, som har hjulpet hundretusenvis av pasienter med å håndtere sin diabetes."
Selskapet nektet å svare på mer spesifikke spørsmål.
Varnado sa at hun ikke var klar over problemer med insulinpumper før hun mottok en melding i juli 2013 om at Medtronic tilbakekalte noen partier med deler til modellen datteren hennes hadde brukt.
Hun inngikk et konfidensielt forlik med selskapet i mars 2017 etter å ha anlagt et føderalt søksmål som hevdet at enheten ikke klarte å levere nok insulin. Hun er fortsatt overbevist om at enheten skadet barnet hennes.
"Når hun gikk av pumpen, dro hun aldri tilbake til sykehuset," sa Varnado.
Dr. Ben Wheeler, en ledende pediatrisk diabetesforsker i Australia, sa til AP at bruken av insulinpumper "ser ut til å være trygg" og er "potensielt tryggere" enn insulininjeksjoner, den tradisjonelle behandlingsmetoden.
Likevel fant en studie fra 2015 han var medforfatter at 40 prosent av insulinpumpebrukere opplevde problemer, "med et mindretall, spesielt hos barn, som krever sykehusledelse."
Studien sa også "det er bemerkelsesverdig at den totale pumpefeilraten ikke ser ut til å bli bedre med teknologiske fremskritt."
Diabetes oppstår når bukspyttkjertelen ikke klarer å lage nok insulin eller kroppen ikke kan reagere normalt på insulinet som produseres. Insulin er avgjørende for å regulere blodsukkeret, som produseres av mat og er hovedkilden til energi for kroppens celler.
Insulinpumper er små, datastyrte enheter som etterligner en normal bukspyttkjertel, og har to hovedkomponenter - pumpen og infusjonssettet. I tillegg til å vedlikeholde enheten, må brukere også overvåke diettene sine og manuelt legge inn informasjon, for eksempel hastigheten på insulintilførselen.
Selskaper markedsfører enheten aggressivt til voksne og barn. For eksempel har Medtronic - som lager de fleste pumpene som er i bruk i dag - en firmamaskot, "Lenny the Lion," for sine anslagsvis 250 000 barnebrukere.
Men eksperter sier at ikke alle er gode kandidater for enheten, og at potensielle brukere bør kontrolleres nøye for å sikre at de er egnet.
"Det er en skarp læringskurve," sa Dr. Desmond Schatz, medisinsk direktør ved University of Floridas Diabetes Institute. "Du må forstå pumpen. Du må forstå hvordan den fungerer... Du må forstå hvordan du endrer den. Du må forstå innstillingene."
FDAs data gir ingen forklaring på hvorfor enhetene har så mange uønskede hendelser. Mange av rapportene fra leger, produsenter og pasienter mangler kritisk informasjon - en rapporteringsfeil FDA erkjenner på tvers av alle enheter.
For eksempel skal medisinsk utstyrsselskaper og helsepersonell sende inn en bivirkningsrapport når en enhet mistenkes for å fungere feil eller bidra til en skade eller død. Rapporten bør inneholde en enhetsproblemkode og beskrive hva som skjedde, noe som kan hjelpe med å finne problemer med en bestemt enhet. Men en AP-analyse av FDA-dataene fant at Medtronic ikke inkluderte en enhetsproblemkode i praktisk talt noen av sine mer enn 150 000 rapporter av dødsfall eller skader relatert til insulinpumper siden 2008. FDA sa at enhetsprodusenter bør inkludere en problemkode, men ikke trenger det hvis informasjonen er ukjent.
Selskapet siterte et spesifikt problem i bare 2 prosent av tilfellene - oftest "Enheten viser feil melding."
I tillegg fant AP at Medtronic tilbød «ingen konklusjon kan trekkes på dette tidspunktet» som årsak i mer enn 80 prosent av rapportene. Den nest vanligste setningen: "Foreløpig er det ukjent om enheten kan ha forårsaket eller bidratt til hendelsen, siden intet produkt har blitt returnert."
Matt Harman, en Atlanta-basert advokat som har anlagt en rekke søksmål som involverer medisinsk utstyr, inkludert insulinpumper, sa at brukere heller ikke blir fortalt at data kan gå tapt hvis batterier fjernes fra enkelte pumpemodeller.
"Jeg kan ikke fortelle deg hvor mange ganger vi har blitt oppringt fra et fortvilet, ødelagt familiemedlem som hadde en kjær som døde under mistenkelige omstendigheter," sa han. "Men når vi prøver å finne ut hva som har skjedd, kan vi ikke hvis vi ikke har dataene."
FDA sa at de var klar over dette problemet i eldre insulinpumper og har oppfordret produsenter til å utvikle enheter med minner som ikke vil bli slettet når strømmen går eller har mulighet til å sende data til en sikker server for lagring.
FDA bemerker at antallet tilbakekallinger av pumper har gått ned i løpet av de siste fem årene - fra omtrent åtte årlig i løpet av de foregående 10 årene til et gjennomsnitt på tre per år - som den krediterer et initiativ fra 2010 med sikte på å øke kravene til produsenter og øke brukerbevissthet.
Men tilbakekallingene fra 2013 inkluderte en på det mest alvorlige nivået angående Medtronic MiniMed Paradigm insulininfusjonssett, med FDA som bemerket at "under visse forhold kan infusjonssettet fungere feil og levere et feilvolum insulin."
Rettssaker knyttet til insulinpumper gir ofte skylden for funksjonsfeil for å forårsake skader eller dødsfall.
En sak som ble anlagt i februar for føderal domstol i Mississippi hevder at Debbie Davis, en 56 år gammel banklåneansvarlig, døde to måneder etter at en insulinpumpe «leverte opp til en ukes verdi av insulin på en gang».
Mannen hennes, Mike Davis, fortalte AP at kona hans hadde vært diabetiker i omtrent 10 år og lett klarte sykdommen med injeksjoner, men bestemte seg for å prøve en pumpe i 2016 etter å ha hørt hvordan det kunne hjelpe.
En morgen i januar 2017, sa David, kunne han ikke vekke kona etter at hun hadde fylt insulinpumpen og lagt seg. Hun lå i koma i to måneder.
Syv måneder senere sa Davis at han mottok en tilbakekallingsmelding fra Medtronic som advarte om "potensiell overlevering av insulin." "Jeg visste akkurat da at det var det som gjorde det," sa han.
I rettsprotokollene i den pågående rettssaken benektet Medtronic at "enhetene fungerte feil, eller at de var defekte på noen måte."
FAQs
What is the FDA classification of insulin pumps? ›
Insulin pumps to date have either been cleared by the FDA as stand-alone devices (class II, moderate risk devices) or approved by the FDA as part of a single, predefined diabetes management system (class III, highest-risk devices).
Who is eligible for insulin pump? ›A pump may be a good choice for:
People who have frequent low blood sugar reactions. Anyone who has delays in absorption of food from the stomach (gastroparesis). Women planning pregnancy. People who want to use the pump's bolus calculator functions to determine insulin doses.
Automated insulin delivery (AID) is a way of delivering insulin through an insulin pump that communicates with a continuous glucose monitor (CGM). This is also known as a hybrid closed loop (HCL) system or an artificial pancreas device system.
How does a diabetes pump work? ›The pump sends insulin through a narrow plastic tube (a catheter) that ends in a tiny needle. The needle goes into your skin. The tube and needle are called an infusion set. With most infusion sets, the needle pulls out, leaving a tiny flexible tube called a cannula under your skin.
Are insulin pumps FDA approved? ›Agency Continues to Support Innovation of Next-Generation Technology in Diabetes Management. Today, the U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes.
Is an insulin pump a Class 3 device? ›In the US, the Food and Drug Administration (FDA) classifies insulin pumps as Class II (moderate risk) devices. However, those that are part of an integrated system with a CGM are classified as Class III (higher risk) devices.
Can insurance deny insulin? ›Insulin Issues
It's important to know that insurance plans don't always cover every available insulin, and yours may not be covered. You will need to check the formulary to see whether your insulin is covered and, if so, on which tier.
To disconnect: Pinch connector arms to open. Lift off of site. When you use an insulin pump, there is only short acting insulin infused in the pump. Once you're disconnected from the pump, you need to be extra careful and monitor your blood sugars many times during that period of time.
How much does an insulin pump cost without insurance? ›Insulin pump: An insulin pump is a wearable insulin delivery device. There are multiple pumps to choose from, and they range in cost from $4,500 and $6,500 without insurance. Supplies for the pump may cost an additional $1,500 a year for infusion sets and reservoirs.
Are insulin pumps covered by health insurance? ›Many insurance companies cover the cost of insulin pumps, but they have strict guidelines that you will have to follow before they will pay.
What is an alternative to an insulin pump? ›
- Injections. Many manage T1D it with multiple daily injections (MDI). ...
- Inhaler. Afrezza, a quick acting inhaled insulin, can be an alternative to injectable pre-meal insulin. ...
- Pumps.
It should last 4 to 8 years.
How long can a diabetic go without a pump? ›Remember: More than 2 hours without insulin delivery can lead to Diabetic Ketoacidosis (DKA).
What is the most serious disadvantage of insulin pump use? ›The main disadvantages of pump therapy are:
Risk of diabetic ketoacidosis (DKA) from pump or site malfunction.
What are the benefits? People who use pumps have fewer big swings in their blood sugar levels. People who use pumps have fewer problems with very low blood sugar. For some people, pumps improve hemoglobin A1c levels.
What insulin companies are being sued? ›The lawsuit alleges manufacturers Eli Lilly, Novo Nordisk, and Sanofi, and pharmacy benefit managers CVS Caremark, Express Scripts, and OptumRx, have leveraged their market power to overcharge patients. A 2021 report found that insulin costs roughly ten times more within the United States than outside it.
What is the insulin pump controversy? ›Sept 20 (Reuters) - The U.S. Food and Drug Administration on Tuesday warned that certain types of insulin pump systems manufactured by Medtronic (MDT. N) were vulnerable to cyberattacks and that hackers could potentially hamper insulin delivery by accessing the device.
What is the new FDA approved treatment for diabetes? ›The US Food and Drug Administration (FDA) has approved bexagliflozin (Brenzavvy, TheracosBio) for the treatment of adults with type 2 diabetes.
How often do insulin pumps fail? ›medwireNews: Insulin pump infusion set failures that result in prolonged hyperglycemia occur an average of four times per year per user and are more common in children and adolescents than adults, US study findings indicate.
What are the disadvantages of insulin pump therapy? ›- Insulin pumps can prove more expensive. ...
- You need to commit to testing your blood sugar 4-6 times daily or using a continuous glucose monitor.
- You need to count the carbohydrates in your food to work out the correct quantity of insulin to administer with meals and snacks.
What is the success rate of the insulin pump? ›
About 100% of the patients found the insulin pump therapy better than their previous treatment with insulin pens or syringes. In 81.1% of the patients, the insulin pump decreased the frequency of hypoglycemic episodes; in 5.4% there was no change in the frequency of hypoglycemic episodes.
Is being on insulin a disability? ›Yes. People with diabetes of all types are protected under the Americans with Disabilities Act as people with disabilities. This includes access to school, public places, the workplace and some benefits such as Social Security and disability insurance.
What is the best state to live in with diabetes? ›Hawaii is the top state for health care in the U.S. It has the best health outcomes in the country, with low preventable death (47 per 100,000 people), diabetes mortality and obesity rates.
Why are doctors reluctant to prescribe insulin? ›He proposed that some providers were reluctant to prescribe insulin to patients with type 2 diabetes because of both theoretical concerns (hypoglycaemia, weight gain and the belief that insulin has negative metabolic effects) and practical concerns (patient anxiety about insulin, patient cognitive abilities and the ...
What is an average A1C level? ›A normal A1C level is below 5.7%, a level of 5.7% to 6.4% indicates prediabetes, and a level of 6.5% or more indicates diabetes. Within the 5.7% to 6.4% prediabetes range, the higher your A1C, the greater your risk is for developing type 2 diabetes.
Can you ever get off insulin once you start? ›The short answer, as per experts, is yes, they can. Although people with type 1 diabetes cannot stop using insulin due to the nature of the ailment, those with type 2 diabetes can very well endeavour to discontinue using the hormone.
How long can you wear an insulin pump? ›Patients typically change the tubing that delivers insulin from their pumps every two to three days. The schedule reflects evidence that infusion set and injection site problems such as itching and bruising start to occur on the third day of use.
What do diabetics get free? ›If you take diabetes medicine, you're entitled to free prescriptions for all your medicines.
What is the average cost of insulin per month? ›According to the American Diabetes Association, people with type 1 diabetes need, on average, two to three vials per month. For the uninsured and those with poor coverage, a month's worth of insulin can cost, on average, $1,000 or more, Gaffney said.
What is the average cost of insulin after insurance? ›Nationally, the average out-of-pocket cost was $58 per insulin fill in 2019, typically for a 30-day supply. Patients with private insurance or Medicare paid about $63 per fill on average.
How much will insulin cost in 2023? ›
Effective January 1, 2023, out-of-pocket costs for insulin are capped at $35 per monthly prescription among Medicare Part D enrollees under the Inflation Reduction Act (IRA).
What is the insulin bill 2023? ›The Affordable Insulin Now Act of 2023 would: Require private group or individual plans to cover one of each insulin dosage form (i.e. vial, pen) and insulin type (i.e. rapid-acting, short-acting, intermediate-acting, and long-acting) for no more than $35 per month.
What insulin is $35 a month? ›Lilly's Insulin is $35 a Month with Insulin Affordability | Eli Lilly and Company. That's the most people living with diabetes who rely on Lilly insulin should have to pay. Updates now make it even easier for people to access the life-saving medicine they need. Get your $35 savings card here.
Which is better insulin pen or pump? ›Insulin pumps are more expensive, but also more accurate and precise. The pumps deliver a constant flow of insulin throughout the day, allowing for a more flexible lifestyle. There are fewer needle pricks with insulin pumps.
Are insulin pumps worth it? ›Advantages of an Insulin Pump
A pump is more accurate than shots, helping you better manage blood sugar levels. You'll have fewer blood sugar lows, which is important if you often have hypoglycemia. It may improve your A1c levels. Dosing for meals and snacks is easier.
OmniPod® Insulin Management System
The OmniPod and the Omnipod DASH may be the most popular pump for individuals with Type 1 and Type 2 diabetes on the market today.
The most urgent complications of insulin pump therapy are Diabetic Ketoacidosis (DKA) and Hypoglycemia.
How long is it safe to disconnect from an insulin pump? ›Check your blood glucose before you disconnect. Don't go longer than 1 to 2 hours without any insulin.
What happens if you don't change your insulin pump? ›Additional issues are that there may be reduced absorption at the catheter or needle infusion site and the risk of a local skin infection is higher the longer one keeps it in without changing. Some PWD are prone to abscess infections that need to be incised and drained by a local ED doctor as well.
Can your pancreas start working again type 1 diabetes? ›Beta Cell Reactivation May Be Viable Treatment for Patients With Type 1 Diabetes. Researchers achieved successful reactivation of pancreatic stem cells to become insulin expressing, suggesting future potential for replacing destroyed beta cells in patients with type 1 diabetes with newborn insulin-generating cells.
How long can a diabetic go without their insulin shot? ›
It lasts about 24 hours. If there is no glargine and you have not given rapid acting insulin (NovoRapid™ / Humalog™) within the past 3-4 hours, it is likely that your body will make ketones and is at risk of developing life threatening diabetic ketoacidosis (DKA).
What is the most common cause of death in type 1 diabetes? ›Heart and kidney disease are the main causes of death in people with type 1 diabetes. Dr. Francisco Prieto, National Advocacy Chair for the American Diabetes Association, pointed out that this population has "a risk of heart disease that is almost twice that of people without diabetes."
What happens if you pump too much insulin? ›When there is too much insulin in the blood, the cells absorb more sugar than they need to, leaving less sugar in the blood. Hypoglycemia, or low blood sugar, can occur as a result. When the blood sugar levels are too low, the body cannot function properly. The symptoms of an insulin overdose are those of hypoglycemia.
Is insulin bad for your heart? ›Insulin resistance and diabetes can cause many types of heart-related conditions. Heart disease happens when blocked arteries create problems with blood flow. That can lead to symptoms like chest pain, called angina. Insulin resistance can also lead to weight gain.
Do insulin pumps ever fail? ›Like any computers, insulin pumps can fail. Sometimes this occurs after office hours. It's important to have a plan in place. When your pump fails, you must inject insulin another way.
What is the best insulin to lower A1C? ›...
There are four DPP-4 inhibitors currently on the market in the U.S.:
- Alogliptin (Nesina)
- Linagliptin (Tradjenta)
- Saxagliptin (Onglyza)
- Sitagliptin (Januvia)
Insulin should be initiated when A1C is ≥7.0% after 2–3 months of dual oral therapy. The preferred regimen for insulin initiation in type 2 diabetes is once-daily basal insulin.
What should your A1C be for insulin? ›For most adults living with diabetes, an A1C level of less than 7% is a common treatment target. Lower or higher targets may be appropriate for some people. The target of less than 7% is associated with a lower risk of diabetes-related complications.
What is the FDA classification for Omnipod? ›Insulet Recalls Omnipod DASH Insulin Management System's Personal Diabetes Manager (PDM) for Risk of Battery Swelling, Leakage, or Extreme Overheating. The FDA has identified this as a Class I recall, the most serious type of recall.
What is the FDA classification for Dexcom G6? ›The Dexcom G6 System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes. FDA concludes that this device should be classified into Class II.
What is the classification and action of insulin? ›
There are three main groups of insulins: Fast-acting, Intermediate-acting and Long-acting insulin. Fast-acting insulin: Is absorbed quickly from your fat tissue (subcutaneous) into the bloodstream. Is used to control the blood sugar during meals and snacks and to correct high blood sugars.
What are the three main classifications of insulin medications? ›short-acting insulin. intermediate-acting insulin. mixed insulin. long-acting insulin.
Which automated insulin delivery systems are FDA approved? ›The FDA approved an advanced hybrid-closed loop insulin pump that provides automated real-time insulin corrections for the user, according to a press release. The Medtronic MiniMed 780G system was approved for use with the Guardian 4 sensor for children and adults aged 7 years and older with type 1 diabetes.
Is Omnipod considered an insulin pump? ›Omnipod provides non-stop insulin delivery through a tubeless, waterproof* insulin pump called a Pod—all with no multiple daily injections. Get up to 3 days (72 hours) of continuous insulin delivery and freedom with these innovative features: Wearable: Place the Pod almost anywhere you'd normally inject.
What FDA classification is glucose sensor? ›The Food and Drug Administration (FDA, Agency, or we) is classifying the integrated continuous glucose monitoring system into class II (special controls).
Does Dexcom track A1C? ›Dexcom CGM has been proven to lower A1C 7,8,9 and provides real-time glucose data up to every five minutes. This added information allows you to gain additional insights into your glucose levels and what may be impacting them, which can help you to proactively manage your diabetes.
What is FDA device classification? ›Class I includes devices with the lowest risk and Class III includes those with the greatest risk. As indicated above all classes of devices as subject to General Controls. General Controls are the baseline requirements of the Food, Drug and Cosmetic (FD&C) Act that apply to all medical devices, Class I, II, and III.
What is Dexcom FDA approved for? ›US FDA approves Dexcom G7 CGM for all types of diabetes.
What schedule classification is insulin? ›A drug or chemical can be treated as a Schedule 1 substance for criminal prosecution even if it is not a controlled substance. Controlled drugs that are considered to have virtually no risk for addiction, abuse or harm are not scheduled. Examples of those would be insulin, blood pressure and cholesterol medicines.
What category class is regular insulin? ›Regular insulin is a medication used in the management of diabetes mellitus and hyperglycemia of a variety of etiologies. It is in the short-acting insulin class of drugs.
What classification is insulin 70 30? ›
70/30 is an intermediate-acting insulin.
70/30 start working ½ hour after injection. The greatest blood sugar lowering effect is between 2 and 12 hours after the injection. This blood sugar lowering may last up to 24 hours.
Insulin glargine: Lantus, Basaglar, and Toujeo all contain insulin glargine and last for at least 24 hours. Toujeo lasts the longest (up to 36 hours). There are also several Lantus biosimilars that have been approved. These include Semglee (insulin glargine-yfgn) and Rezvoglar (insulin glargine-aglr).
What type of insulin do most diabetics use? ›There are different types of insulin depending on how quickly they work, when they peak and how long they last. Insulin is available in different strengths; the most common is U-100.
How long can a diabetic go without insulin? ›Rapid-acting insulin lasts for four hours, so if no other action has been taken to change the infusion site, then within approximately six hours, you can be at risk for a life-threatening condition called diabetic ketoacidosis (DKA).