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STEADY SHOT: Reduce Lipodystrophy

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The Steady Shot campaign is sponsored by the Clinton Global Initiative University, in which about 1,000  student entrepreneurs worldwide are invited to meet in Chicago in October of 2018 to solve global challenges. Of those students, some were selected to compete in the GoFundMe commitments challenge; all striving to raise the most funds for their commitments before CGIU kicks off. As a type 1 diabetic, my commitment is to reduce lipodystrophy (lipo) caused from subQ injections. 

It's not pretty, but it's reality for some people. Lipo causes erratic absorption of medicine (putting the injector at risk), makes injections more painful, and in extreme cases, makes people skip injections. Lipo's caused by injecting in the same spot too many times and it's a menace to the injector community.

As a type 1 diabetic injecting insulin for seven years, I suffered a minor case of lipo from injecting my abdomen and thighs for too long. My doctor suggested I inject in the back of my arms, lower back, and buttocks. However, injecting into these areas was uncomfortable and awkward. I also couldn't inject with my left hand, further limiting the spots I could reach. In the United States alone, there are 8.3 million people injecting insulin to treat diabetes, 8.9 million injecting prescription weight loss, 4 million injecting human growth hormone. The majority of people who inject medicine daily only inject in their abdomen and thighs. Up to 1/3 of all subQ injectors are estimated to have lipo.


Determined to find a solution, I engineered the Steady Shot. A simple, plastic attachment for pen needles and syringes.




The Steady Shot lets people easily inject with either hand and lifts the skin towards the needle when pressed into the fat. Allowing for easy insertion into the subQ or fatty layer. People who only injected in their abdomen and thighs can now reach their arms, lower back, and buttocks; a 75% increase in area to inject. These people can now rest their usual injection sites, and let them heal. After a month of rotating with the Steady Shot, the light bruising on my thighs started disappearing.  Excited to share my idea, I pitched to a startup accelerator in Madison, WI (D2P). They felt for the large number of people with injection-related problems and wanted to help Steady Shot execute. As of April 2016, we started working diligently towards commercialization.








While in D2P, we met with healthcare professionals and patients to validate the idea's feasibility, FDA consultants to determine and pursue regulatory pathways, IP consultants to ensure the devices protectability, CAD design and 3D printing companies to prototype Steady Shots. We also connected with a small team of marketing students and gathered a group of 20 SubQ injectors to test the Steady Shot and perform analysis on their feedback.  

Feedback from the group was very positive. In their feedback people said things like "I'm pregnant and this is especially great for me as shots in my abdomen are harder," and "it was nice having extra support to help keep the pen needle from moving around while I was injecting," and "it was very easy to reach new places that were difficult before” and “it definitely makes it easier to inject using a pen, I don’t need to worry about staying still when injecting.” I valued every piece of feedback, and worked to improve Steady Shot’s design as I continued working with D2P.

I've been using and updating the Steady Shot for over two years. I recently graduated from UW-Madison and am now working a full-time job to fund my passion for Steady Shot. I can personally attest to how the Steady Shot has impacted my life. After the first few months of rotating with the Steady Shot, the light bruising on my thighs was gone. Today, after 2 years of use, the lipo in my abdomen tissue is gone. I believe Steady Shot can help more people like me who deal with lipo.

Now I need you to help make Steady Shot available to all subQ injectors who need it. Even those without lipodystrophy can benefit.

Steady Shot can also:
- Help injectors overcome needle phobia by hiding the needle
- Make it easier for kids and caregivers to inject
- Make it easier for elderly with dexterity/vision issues to inject
- Guard against accidental needle sticks
- Make learning injections easier
- Aid emergency injections in a moving vehicle

But Steady Shot is intended to reduce lipo, because if medicine is injected into lipo; the medicine is erratically absorbed. Putting the injector at risk.

The next steps for Steady Shot include purchasing injection molds, pursuing further FDA and patent compliance, producing and packaging an initial order of inventory, and marketing to raise awareness of lipo and how it can heal when rotating with Steady Shot. All of this is very expensive, and every bit of your help is a brick to build a world without lipodystrophy.  Anything you can spare is greatly appreciated. Thanks for reading and please share!


Read more about the story:
https://news.wisc.edu/invention-could-help-diabetics-with-safer-surer-insulin-injections/

Teams competing in the CGIU Commitments Challenge:
https://gfmnorma.wpengine.com/CGIU2018?utm_source=CGI+U+Master+List+-+DO+NOT+DELETE&utm_campaign=60d30495f2-20170629_CGIUAlumni_COPY_01&utm_medium=email&utm_term=0_a9011412ad-60d30495f2-254912205


Statistics relating to challenges Steady Shot aims to fix:


Rotation Issues:
-       NCBI: Only 5 percent of the patients who correctly rotated injection sites had LH, whereas 98 percent of the patients with LH either did not rotate the sites or did so incorrectly.
-       NCBI: Lipo can slow the absorption of insulin at the site by as much as 25 percent.
-       US National Library of Medicine: up to 42.5 percent of participants did not adhere to an adequate site rotation plan and up to 47 percent of participants showed grade 1 lipohypertrophy (LH).
-       BD Patent: People do not rotate injection sites due to a lack of ergonomic ease with which a patient can reach different body areas to self-inject.
-       PubMed: 70 percent of patients were not rotating properly. There was a strong relationship between the presence of lipo and improper or lack of rotation of sites.
-       Clinical Impact: Of 401 adult patients, lipo prevalence was 53 percent.

Needle Phobia:
-       NCBI: 22 percent of participants reported a fear of needles.
-       DPU: 13 percent of male participants and 15 percent of female participants avoided dental treatment for fear of needles.
-       Research Gate: 37 percent of participants between ages 14-25 years reported fear of needles.

Dexterity Issues:
-       NCBI: There is a need to simplify insulin regimens and dosing in the elderly population.
-       NCBI: There is an importance of considering dexterity and manual skill when designing medical devices.

Needlestick injuries:
-       ISRN Nursing: 37 percent of nurses reported they have sustained a needle-stick injury.
-       Hamadan University of Medical Sciences: Operating room personnel are at a high risk of needlestick injuries.

Prevent Bending of the Needle:
-       Journal of Diabetes Nursing: There is a significant problem with needles breaking due to the pressure applied to puncture the skin and angle of injection.

Organizer

Shawn Michels
Organizer
Milwaukee, WI

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