FREQUENTLY ASKED QUESTIONS

Frequently Asked Questions

Revised November 15, 2016

What is Type 1 Diabetes?
Type 1 Diabetes (T1D), once known as Juvenile Diabetes, is an autoimmune disease, meaning that the body’s own immune system, for reasons unknown, attacks cells in the body that it shouldn’t. In the case of T1D, the immune system destroys cells in the pancreas that produce a hormone called insulin that is necessary to convert the food you eat into energy. People with T1D must take insulin for the rest of their lives, either through a pump or daily injections, in order to prevent their blood glucose levels from rising too high.

Though often diagnosed in childhood, T1D can be diagnosed at any age. It is an intensely managed condition, requiring hundreds of decisions a day about how much insulin to take, how to respond to blood glucose levels, how to make choices about the food you eat and the activities in which you participate, just to name a few. The roots of Bigfoot’s founders stem from their personal experience with T1D, and it is their personal and professional mission, as well as many of the people working at Bigfoot, to bring to market our automated insulin delivery system to make living with T1D easier and safer.

What is Type 2 Diabetes?
Type 2 Diabetes (T2D) is a metabolic condition in which the body is either unable to use the insulin made by the pancreas (known as insulin resistance) or in which the pancreas loses the ability to continue to produce insulin at the level that the body needs. A progressive disease, T2D often requires adjustments to therapy over time, which often includes the addition of insulin. According to recent statistics from the CDC, more than 30% of people with T2D in 2011 included insulin in their daily treatment regimen.

T2D may be diagnosed at any age and it is the most common type of diabetes, affecting roughly 95% of people with diabetes. The smartloop™ automated insulin delivery system we are developing at Bigfoot is intended to help those with T2D who are taking insulin to optimize their insulin dosing regimen in the simplest, smartest way possible.

What is hypoglycemia?
Hypoglycemia, or low blood sugar, occurs when there is not enough glucose in the bloodstream to fuel the cells of the body. Hypoglycemia is considered any glucose level below 70 mg/dL (3.9 mmol/L). It can be caused by too much insulin (or other diabetes medication) or by activity, such as exercise. Symptoms may include shakiness, sweatiness, headache, blurry vision, hunger, palpitations, and confusion.

Severe hypoglycemia may result in loss of consciousness, seizures, brain damage, and in rare cases, death. Severe hypoglycemia, such as a seizure that requires a hospital admission, results in a huge cost to the person with diabetes as well as the healthcare system. Bigfoot’s smartloop™ automated system intends to significantly reduce the risk of severe hypoglycemia, as well as the costs associated with it.

What is hyperglycemia?
Hyperglycemia, or high blood sugar, occurs when there is too much glucose in the bloodstream. A number of factors can cause hyperglycemia in people with diabetes, including but not limited to lack of insulin, food that has been eaten, stress, illness, and hormones. Symptoms may include thirst, frequent urination, hunger, or fatigue.

Severe hyperglycemia can result in a condition known as diabetic ketoacidosis (DKA), which may lead to coma, kidney failure, a problem with heart rhythm, heart attack, muscle breakdown (rhabdomyolysis), and in rare cases, death. Similar to severe hypoglycemia, severe hyperglycemia or DKA has significant costs to the person with diabetes and the healthcare system. By leveraging data and automation, the Bigfoot smartloop™ system intends to significantly reduce the instances of severe hypoglycemia and its related costs.

What is “time in range"?
“Time in range” refers to the percentage of time that a person’s blood glucose levels are in the recommended target range appropriate for that person. Different than HbA1c, which is a measurement that reflects an average glucose level over a period of time, time in range reflects the total amount of time that hypoglycemia and hyperglycemia are avoided. A primary goal of the Bigfoot smartloop™ automated insulin delivery system is to increase the amount of time a person with T1D or insulin-dependent T2D spends in his or her target glucose range: increasing their “time in range.”

What is “automated insulin delivery"?
“Automated insulin delivery” is the term we use at Bigfoot to describe how our system uses information about glucose (provided by a continuous glucose monitor, or CGM) to change the delivery of insulin by the insulin pump to assist in reducing hypoglycemia and hyperglycemia, and increasing time spent in a healthy, safe, target glucose range. Referred to in the media as an “artificial pancreas,” an automated insulin delivery system is not an implanted device and not a biological cure for diabetes.

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Is the Bigfoot smartloop™ system the same system that Bryan Mazlish created for his family?
The investigational system in development at Bigfoot Biomedical consists of a different dosing algorithm, different software, and different component hardware than the system that Bryan Mazlish created for his family. The Mazlish system was a proof-of-concept system that has inspired the work we do today, especially the real world experiences that Bryan’s wife and son have had while living with and wearing their system for over 50,000 hours.

Is the automated insulin delivery algorithm on the smartphone or on the pump?
The dosing algorithm lives on the pump in our investigational system. The smartphone is the window into the system; it is the primary way in which the status of the investigational system can be viewed or mealtime insulin doses may be announced.

What happens if my phone battery dies or I forget my phone at home?
If you cannot access your phone for whatever reason, automated insulin delivery in our investigational system will typically continue without interruption.

Does the Bigfoot smartloop™ system include glucagon?
We look forward to the day that the U.S. Food & Drug Administration (FDA) approves glucagon for use in an infusion pump and this option becomes available. Currently, there is no FDA-approved glucagon available for administration via an infusion pump, and there are many unanswered questions around the chronic administration of glucagon, as well as the use of glucagon in a closed loop system. In the meantime, we are maintaining a singular focus on developing a safe, simple, reliable, and accessible insulin-only system, that is available ASAP.

Can I order the Bigfoot smartloop™ system? When will it be available?
The Bigfoot investigational system is still in development at this time. It is our goal to submit our investigational system for Premarket Approval (PMA) to the U.S. FDA in early 2018. Approval of our PMA application would allow us to sell our product on the market.

I live outside the U.S. Will the Bigfoot smartloop™ system be available in my country?
While our initial launch is planned for the U.S., we have plans to bring the Bigfoot smartloop™ system to countries outside the United States. A timeline for these countries has not yet been announced.

Will my health insurance cover the Bigfoot smartloop™ system?
One of the founding goals of Bigfoot Biomedical was to design a comprehensive solution that would be cost-effective for patients, healthcare providers, and insurance payers. Until we have FDA approval to market a product, it is too early to predict which payers will support the Bigfoot smartloop™ system. You can rest assured, however, that we are striving for broad coverage for our solutions.

Can I participate in your clinical trials?
We have selected, and will continue to carefully select, some of the finest clinical trial investigators and research sites in the world. We leave participant recruitment and selection entirely in the hands of these outstanding investigators and research sites. If you would like to find out more about participating in a clinical trial, please visit clinicaltrials.gov to find trials for which you or your family member might be eligible.

Do you offer tours of Bigfoot’s lair?
At this time, we do not offer tours of Bigfoot Biomedical’s headquarters. While the work we do is exciting and life-changing, watching us do it is considerably less so.

Where can I buy those cool Bigfoot t-shirts?
Due to high demand for the Bigfoot t-shirts you’ve spotted on our social media channels, we've made them available to the community. Check out the Bigfoot Shop to outfit yourself in one of our comfy performance t-shirts.