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Ancient Romans tasted lethargic children's urine for diabetes mellitus. Today parents still obsess over color and smell of their children's urine. Although our society has made tremendous strides in point-in-time laboratory testing and in caring for patients with chronic conditions, we still rely on visual symptoms to prompt us to seek care.
We envision a future in which smart, low-cost everyday products watch our health unobtrusively. They will speak up only when they see signs of possible disease - making sure the right people are tested using traditionally-accepted clinical tests at the right time.
Our crowd-funding campaign for our investigational product - the Smart Diaper, phone app, and cloud service - will help us fund manufacturing, a data-gathering study at UCSF Benioff Children's Hospital, and another study meant to collect data for FDA registration. As a supporter, you can receive a pilot version of the investigational product and help us gather additional data we can use to refine our algorithms. Thank you for believing in a better future and please read on for more information.
1. Smart Diapers work with our app to keep track of your child's health
Once a day, when changing your child or when you simply notice that the diaper is wet, scan the front of the Smart Diaper with our mobile app. It takes less than ten seconds to take your phone out of your back pocket, scan, and put the phone back.
There is no need to wait for results - you canput the phone back in your pocket and change your child. Our algorithms will begin to analyze the data, looking for new trends.
2. Why should I be passionate about supporting Smart Diapers?
Smart Diapers are not a replacement for a mother's intuition, nor for medically accepted diagnostic testing. Instead, Smart Diapers are meant for alerting you of developing problems before visible symptoms appear, when you see symptoms and don't know what they mean, or when you see symptoms and are tempted to ignore them because you don't see their progress.
3. How do Smart Diapers work?
Kidneys filter specific solutes from blood into urine. By taking useful data on these solutes, as well as by picking up on signs of bacterial activity from a wet Smart Diaper, we make use of something that would normally be thrown directly into the trash. Smart Diapers alert you to certain conditions that require immediate attention and also track your child's health for months, automatically looking for emerging trends in multiple combinations of parameters. Some of the parameters that Smart Diapers track have no absolute "good range", and it is the changes in those parameters that are meaningful.
Smart Diapers are not meant to report a daily number, but, rather, only speak up in those rare cases when you should contact your physician for follow-up testing.
4. What can you tell me about my child
The data we track in the first version of Smart Diapers can reveal signs of
- urinary tract infection
- prolonged dehydration
- developing kidney problems.
Our goal is not to create another quantified self gadget, but to create a product that is unobtrusive in your daily life and only speaks up when there is reason to see a pediatrician or a specialist.
Why monitor for urinary tract infections
Any child can get a urinary tract infection, though girls get them more often than boys. 7-8% of girls have it by the age of 24 months. Most UTI's are not serious, but some can lead to chronic kidney infections which can cause permanent damage such as poor kidney function and high blood pressure later in life.
When symptoms are present, they can range from mild to severe, but, unfortunately, they are difficult to observe in children who wear diapers. UTI symptoms can include fever, pain or burning during urination with frequent discharge of a few drops of urine at a time, irritability, not eating and nausea.
Often, the symptoms may appear to pass, but because of structural deformities or simply because the body has found a temporary way to deal with the bacteria, the infection can recur - while the child will simply appear as having "just another fever."
Why monitor for prolonged dehydration
Every wonder if your child is drinking enough? Are you transitioning from breastfeeding to formula? Introducing a cup? Has your child had a sore throat for days?
We don't want to make you worry after a day, but if we see that your child's urine is overly concentrated for a prolonged period, we'll give you a heads up.
Why monitor for chronic kidney conditions
Kidney problems can develop for multiple reasons - due to premature birth, an infection, undiagnosed diabetes, etc. Typically, observable symptoms don't show up until several years later. Our goal is to look for early signs and to make sure that children who require diagnosis, monitoring, or care will receive it before the observable symptoms set in.
For children who have already been diagnosed with a chronic kidney condition, we hope Smart Diapers will obviate the need for parents to squeeze the diapers manually onto a urine analysis strip and keep track of results with a paper log sheet.
For researchers, we hope Smart Diapers and the data we collect become a useful tool. Are you a pediatric nephrologist? Interested in learning with us? Please get in touch by emailing firstname.lastname@example.org.
5. Designed with safety in mind
Smart Diapers were designed for both ergonomics and safety. Our dry reagent panel is separated from your child's skin by the diaper's absorbent core, and although we are sure the reagents do not produce even a rash when in direct contact, we've shown that no chemicals make it through the absorbent core to touch your child.
The reagents, diapers, and other components of Smart Diapers will be sourced from vendors in the U.S., Canada, Germany, and the UK, with the panel to be manufactured in our own facility in Brooklyn, NY under tight quality control.
5. Privacy - you can count on us
We will never share information that can be traced to your child. We do plan to collaborate with specific academic research partners to help us learn and improve Smart Diapers, but th eonly way we'll share any data with them is after anonymizing it.
All data is securely stored on Amazon's S3 and Amazon's databases. Communication between our phone app and Amazon and storage of data is secured by following the HIPAA Privacy and Security Rules.
6. Why we need you to back us:
- to start up automated manufacturing: with the help of two automation vendors, we've designed a manufacturing line for producing a reagent panel, and also negotiated agreements with two raw materials vendors; we estimate the time to our first production run at the end of November;
- to conduct our first study to monitor kids in a hospital: we have a signed agreement with University of California San Francisco Benioff Children's Hospital to study performance of Smart Diapers for monitoring children in pediatric intensive care; we will commence limited production for this and other research collaborations;
- to complete the FDA registration process: we and our clinical research organization (CRO) partner met with the FDA Office of In-Vitro Diagnostics on May 2nd to get their feedback on the registration requirements and we are now designing a study to produce data for registration; the CRO has taken multiple urine analysis products to marke and our safety testing partner is used by Colgate Palmolive and Johnson & Johnson.
7. The perks - help us improve our algorithms and be the coolest parent on the playground:
As our backer, you will receive Smart Diapers Pilot Edition and the Pilot Edition of the app prior to FDA approval. The Pilot Edition will allow our algorithms to improve while you begin collecting data - in the simplest and most unobtrusive way to your new workflow as a parent. You will also have first priority to order Smart Diapers upon FDA registration, while we are still ramping up production.
With your backing and help in improving our algorithms we will launch the best diapers you could possibly buy for your child! Please join us on our journey.
Thank you kindly for your support,
The Smart Diapers team
- Lisa Dixon, Ph.D. Physics, NYU
- Jennie Rubinshteyn BA Econ/Chemistry, Wellesley; MBA Wharton
- Morton Ehrenberg, Ph.D. & Post-doc Biomedical Engineering, U of Rochester; BS Biological Engineering, Cornell.
- Rick Shapiro, New School for Jazz & Contemporary Music
- Tarek Tantawy BS & MSc Biomedical Engineering, U of Connecticut
- Yaroslav Faybishenko BA Computer Science, UC Berkeley