Understanding Insulin Pen Prior Approval Requirements For Blindness

what constitutes blindness for prior approval of insulin pens

Insulin pens are widely used by both blind and sighted people. However, insulin pen manufacturers include a disclaimer in the instructions warning against use by visually impaired people. This has prompted studies to be carried out to compare the accuracy of dosing with insulin pens between visually impaired and sighted people. These studies have provided preliminary evidence of the safety of insulin pens for blind people, but further research is needed. This introduction will explore the topic of blindness and prior approval of insulin pens, including the accessibility and usability of insulin pens for blind people.

Characteristics Values
Number of people with diagnosed diabetes in the United States 18 million
Percentage of people with diagnosed diabetes in the United States with visual impairment or blindness 18% (3.3 million)
Percentage of Americans with diabetes requiring insulin injections 28.7%
Types of insulin pens "Smart" or connected insulin pens, disposable insulin pens, reusable insulin pens, insulin pumps
Insulin pen manufacturers Novo Nordisk, Eli Lilly, Sanofi-Aventis, Owen Mumford
Insulin pen products InDuo, Innovo, Novolin InnoLet, Novolog FlexPen, Novopen 3, Novopen Junior
Devices to allow blind people to draw up a measured insulin dose Prodigy Count-A-Dose, manufactured by Diagnostic Devices, Inc.

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Insulin pen accessibility for blind people

In the United States, about 18% of people with diagnosed diabetes have visual impairment or blindness. Insulin pens are widely used by both blind and sighted people. However, insulin pen manufacturers include a disclaimer in the instructions warning against use by visually impaired people, without giving a rationale.

A study was conducted to compare the accuracy of dosing with insulin pens between visually impaired and sighted people. The study provided preliminary evidence of the safety of insulin pens for use by visually impaired people and raised questions about the validity of the disclaimer. The study also highlighted the need for further research on the safety of insulin pens for blind people.

Another study evaluated the accessibility and usability of the eight insulin pens available in the US market for people who are blind or have low vision. The study found that while insulin pens are relatively easy to use, they have serious accessibility barriers for blind or visually impaired people. Inspecting the remaining insulin level, priming the pen, and setting the dose all require the use of vision. The study also found that people who are blind or have low vision have to rely on sighted assistance to use an insulin pen safely, which is not ideal for diabetes self-care.

To improve the accessibility of insulin pens for blind or visually impaired people, manufacturers could consider adding speech-output functionality to monitor insulin levels and speak dosage information. Enhancing display contrast and the size of the displayed information would also improve accessibility for visually impaired users.

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Safety of insulin pens for blind users

In the United States, 18% of people with diagnosed diabetes have visual impairment. Insulin pens are widely used by both blind and sighted people. However, insulin pen manufacturers include a disclaimer in the instructions warning against use by visually impaired people, without giving a rationale.

A study conducted by Case Western Reserve University compared the accuracy of dosing with insulin pens between visually impaired and sighted people. The study found that blind participants may make fewer clinically significant errors in dosing overall than sighted people. However, the difference was small enough to not be statistically significant. The study provided preliminary evidence of the safety of insulin pens for visually impaired people and raised questions about the validity of the disclaimer.

The American Foundation for the Blind has also evaluated the accessibility and usability of insulin pens. They found three main barriers that can affect the ability of a blind person to use insulin pens independently:

  • The need to inspect the gauge on the insulin cartridge visually to ensure that enough insulin is remaining.
  • The difficulty, when priming the pen, of determining whether any insulin was ejected from the needle.
  • Concerns about accurately setting a dose when relying only on tactile and click feedback, especially in a noisy situation or when setting a large dose.

While the evidence suggests that insulin pens can be safe for blind users, further research is needed to validate these findings and ensure the inclusion of people with disabilities in technology research.

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Insulin pen instructions for blind people

In the United States, 18% of people with diagnosed diabetes have visual impairment. Insulin pens are widely used by both blind and sighted people. However, insulin pen manufacturers include a disclaimer in the instructions warning against use by visually impaired people without giving a rationale.

A study conducted with 40 blind participants and 41 sighted participants showed that insulin pens can be used safely by visually impaired people. The study also raised questions about the validity of the disclaimer. However, further research is needed to confirm the safety of insulin pens for blind people.

The study used the HumaPen® Luxura™, which has more complex procedures for use than a disposable pen. It requires the insertion of a 300-unit insulin cartridge and has ½-unit increments for dosing. The researchers chose this pen because they reasoned that if participants could use it accurately, they would be able to use a simpler pen accurately.

Before the full study, a pilot study was conducted with 12 blind staff members of the NFB as participants. All participants received a copy of the informed consent form in a format of their choice: print, email (legible to screen-reading programs), or as an audio recording. After signing, blind participants were offered a copy so they could request verification of the contents from a trusted sighted person.

The study provided evidence that insulin pens can be used safely by visually impaired people. However, it is important to consult a physician or certified diabetes educator before using an insulin pen.

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Diabetes self-management tools for blind people

Diabetes is the leading cause of new blindness in American adults aged 20 to 74. An estimated 12,000 to 24,000 people in the United States lose their vision to diabetic retinopathy each year. In addition, diabetes increases the risk of developing cataracts, glaucoma, and other eye conditions that can cause severe visual impairment.

About 18% of people with diagnosed diabetes in the United States have visual impairment or blindness. These people have the same diabetes self-management (DSM) needs as people without visual impairment, but they also require accessible information, tools, and techniques.

There are several devices and creative ways of using ordinary household items that can help blind people with diabetes self-management. Here are some examples:

  • Talking blood glucose meters, such as the Prodigy Voice, which is the only meter to receive an Access Award from the American Foundation for the Blind.
  • Bathroom scales, blood pressure monitors, thermometers, and prescription bottle holders.
  • Devices that emit audible clicks or beeps.
  • Insulin pens: Insulin pens are widely used by both blind and sighted people. However, manufacturers include a disclaimer warning against use by visually impaired people without providing a rationale. A study provided preliminary evidence of the safety of insulin pens for visually impaired people, but further research is needed.
  • Insulin pumps: A case report presented at the 2016 American Diabetes Association meeting described the successful use of the OmniPod insulin pump by a legally blind type 2 diabetes patient. The patient used a phone application that translated text instructions from the personal diabetes manager (PDM) into speech.
  • Inhaled insulin: Afrezza, an inhaled form of insulin, is available but requires further investigation for use in visually impaired patients.

In addition to these tools, it is important for blind people with diabetes to work with a certified diabetes educator or low-vision rehabilitation specialist to learn diabetes self-management. The lighting in the home should also be evaluated to meet the individual's needs.

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Studies on insulin pens for blind people

In the United States, about 18% of people with diagnosed diabetes have visual impairment or blindness, which equates to around 3.3 million people. These people have the same diabetes self-management (DSM) needs as people without visual impairment, but they also require accessible information, tools, and techniques. Insulin pens are widely used by both blind and sighted people, but major manufacturers include a disclaimer in the instructions warning against use by visually impaired people without giving a rationale.

A study conducted by Case Western Reserve University compared the accuracy of dosing with insulin pens between visually impaired and sighted people. Forty blind participants and 41 sighted participants were enrolled in the study. Each participant received standardized instructions for insulin pen use, either in recorded (visually impaired group) or printed (sighted group) format, and delivered 10 systematically varied doses into an injection ball. This study provided preliminary evidence of the safety of insulin pens for visually impaired people and raised questions about the validity of the manufacturer's disclaimer.

Another study by the American Foundation for the Blind evaluated the accessibility and usability of insulin pens for blind people. They listed the tasks involved in using an insulin pen and evaluated each pen to determine if it could be performed by touch alone or if vision would be required. They also investigated the accessibility of the print and electronic manuals from the perspectives of blind and low-vision people.

A 2002 study conducted at the University of Pittsburgh found that 87% of participants described the insulin pen as easier to use than a syringe, and 85% found it more discreet. A similar 1998 study in the UK found that insulin pens deliver more accurate doses than syringes.

While these studies suggest that insulin pens may be a viable option for blind people, further research is needed to confirm the safety and effectiveness of their use by visually impaired individuals.

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Frequently asked questions

Blindness is a condition where a person has a visual impairment that affects their ability to perform tasks that require sight. For the purpose of insulin pen use, blindness can range from partial vision loss to complete lack of sight.

The main challenge of using insulin pens for people with blindness is accurately measuring the insulin dose. Reading the dosage window, which displays the number of units of insulin selected, may be difficult for individuals with visual impairments.

Yes, there are alternatives to insulin pens for people with blindness. One option is to use an insulin pump, a small device worn on the body that continuously injects microscopic amounts of insulin. Another alternative is the Prodigy Count-A-Dose, which helps measure insulin doses and can be used with audio instructions.

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