How Are Home Tests and Devices Revolutionizing Healthcare?

The FDA announced on March 5, 2024 that it approved “…the first over-the-counter (OTC) continuous glucose monitor (CGM).” Many people with type 2 diabetes already use such devices, but they require a doctor’s prescription. Now the FDA states that even “…those without diabetes who want to better understand how diet and exercise may impact blood sugar levels…” will be able to buy the Dexcom Stelo Glucose Biosensor System. That day arrived on August 26, 2024!

CGMs Not Just For People with Diabetes!

People with diabetes are often encouraged to wear a continuous glucose monitor to keep tabs on their blood sugar levels. Up until now, such devices have been available only by prescription.

Dexcom has been making one of the more popular prescription products for years. Now, Dexcom just launched its over-the-counter continuous glucose monitor called Stelo by Dexcom.

It is designed for people who do not use insulin and who don’t have problems with low sugar complications. It is intended to be used for those with type 2 diabetes or prediabetes.

In addition, people without blood sugar problems can use it to better understand how their diet and exercise regimens impact blood glucose levels. The cost is around $100 for two CGMs. Each lasts for about two weeks. That is less expensive than prescription continuous glucose monitors.

The Old Medical Model Was Secretive and Condescending:

There was a time, not that long ago, when patients were completely excluded from medical information. Medical libraries were sacrosanct. Only health care professionals were allowed access to this privileged information.

The same was true of diagnostic tests. Patients had to visit a doctor’s office to have their blood pressure measured. Other tests, such as blood glucose or oxygen, were also out of reach. About the only health tools in most homes were a bathroom scale and a thermometer.

Doctors might or might not tell their patients the results from various tests or procedures. Sometimes they just prescribed a drug based on what they had observed during an office visit or learned through a laboratory test. Patients were expected to swallow their pills without question.

Shifting Control Through Access to Information, New Home Tests and Devices!

Times have changed! The Internet has made vast quantities of medical information available to everyone. Not all of it is accurate, but much of it comes from highly reliable sources such as the National Library of Medicine (PubMed) that provides abstracts and sometimes full texts of the world’s medical literature. Anyone can read articles in JAMA, the New England Journal of Medicine, British Medical Journal, PLOS Medicine, and many more.

Blood pressure monitors are now widely available and highly accurate. Almost anyone can measure their own blood pressure at home. The costs can range from around $40 to $120 depending upon options.

Smart watches can measure heart rate and detect abnormal heart rhythms such as atrial fibrillation. There are even sophisticated electrocardiogram devices that are the size of a credit card. The cost is around $100. For someone with arrhythmias, such a device can be incredibly helpful.

Measuring Blood Sugar Is Not Just for People With Diabetes!

People with diabetes have long been able to measure their blood sugar at home instead of having to go in to the doctor’s office. However, until recently this required sticking the fingers with a sharp lancet, squeezing out a drop of blood, getting it properly positioned on the testing strip and maneuvering the strip into the monitoring device. This was not something everyone undertook lightly.

Now, there are continuous glucose monitors (CGMs). These devices are a little bigger than a quarter and attach to the upper arm with minimal pain or trouble. Once in place, the CGM communicates its data to a smartphone to let the person know where their blood sugar stands as well as where it has been. This allows an individual to monitor how diet and exercise affect blood glucose and make appropriate changes to improve control.

Up till now, people with type 1 or type 2 diabetes needed a doctor’s prescription to access any CGM. Insurance companies did not pay for these sophisticated tools without a diabetes diagnosis.

The Dexcom Stelo Glucose Biosensor:

The FDA has specifically stated that the Stelo integrated system can be used by people without diabetes who want to know how activity and diet alter blood sugar. That way people get quick feedback on the effects of an afternoon Mocha Cookie Crumble Frappuccino or a glass of sweet iced tea.

Such an instant report card can help people modify their behavior. One study found that people using a CGM were better able to control their type 2 diabetes and to lose weight (JMIR Diabetes, May 3, 2023).

People with type 1 diabetes also use CGM technology, with or without a connection to an insulin pump. A study of 550 volunteers with type 1 diabetes found that use of a CGM reduced their risk for retinopathy (JAMA Network Open, March 6, 2024). Diabetic retinopathy is a serious complication that can lead to vision loss. During the eight years of the trial, people using a CGM were only about half as likely to develop diabetic retinopathy as those not using the technology.

Of course, it is not the monitor that makes all the difference. Having quick access to data allows people to change their behavior in a healthier direction.

Are We Overusing Home Tests and Devices?

Some physicians are uncomfortable with the idea that patients are using a wide variety of home tests and devices. What was once a medical mystery has become demystified.

When patients can diagnose their own low oxygen levels with a fingertip pulse oximeter, some health professionals feel intimidated. A cardiologist confided to me that he thought that the Apple Watch with its heart rate and ECG (electrocardiogram) monitor was turning the country into hypochondriacs.

On the other hand, people cannot easily determine if they are experiencing atrial fibrillation on their own. This abnormal heart rhythm can increase the risk for strokes. Identifying such an arrhythmia can lead to prompt action.

A Story About Atrial Fibrillation:

Q. You wrote recently about people using devices to track their own health. My husband upgraded his Fitbit to a model with more bells and whistles.

Within days, it was notifying him he had an irregular heart rhythm called Afib. This was mostly detected at night during sleep, and he had never noticed any symptoms.

We thought it was probably a fluke, but he went to the cardiologist out of caution. After testing, we learned he does indeed have Afib. As a result, he was put on a blood thinner to prevent a stroke.

I think self-monitoring devices are great as long as the person involves a medical practitioner in interpreting the results and taking needed action.

A. We are so glad your husband was able to detect atrial fibrillation (Afib) with his activity tracker. Many smart watches and other devices can detect this arrhythmia. An anticoagulant can help prevent blood clots from forming that might lead to a stroke. We agree that self-monitoring helps in collaborating with a health care professional.

Why Use a Blood Glucose Monitor If You Do Not Have Diabetes?

We live in a world that is full of temptations. Snacking is a national pastime. So is binge watching shows on TV or a small screen. Once you are hooked, it’s hard to stop.

We all know that exercising and eating healthy foods is sensible, but we often have trouble motivating ourselves to follow through. That’s why monitors and feedback can be useful tools for some people.

Continuous Blood Glucose Readings:

We recently heard from someone who is about 10 pounds overweight and is prediabetic. His blood glucose levels fluctuate between 105 to 120 mg/dL.

He told us that his primary care physician prescribed a continuous blood glucose monitor. This device is about the size of a half dollar and attaches to the back of his arm. He uses his smart phone to periodically check what the monitor has measured.

Our reader shared what happened after getting the monitor:

“I used to cheat on my diet every afternoon. I would reward myself for working hard by indulging in a bowl of ice cream or a couple of cookies. Sometimes I would have a Frappuccino. I never worried about calories or sugar.

“After getting the monitor, though, I could see the impact these sweet snacks had on my blood sugar. It was a bit like getting an instant report card. I cut back on the sugar and my blood glucose levels have improved substantially. I also have lost a few pounds.”

Old-Fashioned Home Tests and Devices:

Not everyone responds in the same way to feedback. Take the original monitoring device, a bathroom scale. Some people do best when they weigh themselves every day. If they make progress, they are encouraged and if they slip up, they try harder the next day.

Others beat themselves up if they gain a pound or two from one day to the next. That can lead to frustration and giving up.

Activity Monitors:

There are lots of devices these days to provide motivated individuals accountability. Step counters can tell you whether you have been sitting for too long or if you have met your exercise goals.

Watches or monitors that you wear on your wrist can monitor your progress if you are swimming, walking, biking, running or using an elliptical machine. When you meet your goals, you get an electronic pat on the back. Doctors and health coaches can receive data from such devices if the patient is willing to share it.

Blood Pressure: A Critical Component of Home Tests and Devices!

One of our favorite monitoring devices is the electronic blood pressure device. When I was writing the original People’s Pharmacy book (St. Martin’s Press) 50 years ago, I was concerned.

That’s why I noted that

“as many as 20 percent of all adults in North America suffer from blood pressure above the normal range.”

Today, it is more than 50 percent! Everyone has probably heard that hypertension is the “silent killer.”

I also wrote back in the early 1970s:

“The very first thing that you have to learn is how to take your own blood pressure.”

That was a heretical concept in the 1970s. I quoted two doctors with different perspectives (Modern Medicine, “Symposium on Hypertension,” 40(6):75-113, 1972).

One physician (Dr. Dustan) responded to the question:

“Roughly how many people among your practice do you think are capable of taking their own pressures?

“Dr. Dustan: All of them, and all of them do.”

A different physician, Dr. Wilkins responds:

“I do not agree. Only a minority of my patients take their own blood pressure. Why? Maybe this is philosophical, but I believe the emotional burden of disease should not be borne by the patient but by the physician, the family, or other supporting elements. In some patients, the emotional stimulus of taking one’s own blood pressure may have adverse influences. He becomes anxious about the reading, about the procedure…”

I went on to state:

“In order to measure your blood pressure properly, you will need a stethoscope and a sphygmomanometer. Don’t let this complicated-sounding word put you off. It is merely a simple medical instrument consisting of an inflatable arm cuff and a pressure gauge.”

I lied…or over-simplified. The old blood pressure devices were not simple. They required listening with a stethoscope for special “Korotkoff” sounds as blood began pulsing through the brachial artery. I went into great detail about how to determine both systolic and diastolic blood pressure using this time-tested strategy.

Modern BP devices are much easier to use. The arm band can be applied with one hand. Most inflate automatically. The monitor “listens” for the Korotkoff sounds electronically and provides a digital readout of your blood pressure.

We are especially fond of the Omron brand product line. Consumer Reports has consistently rated their various BP monitors as highly accurate and easy to use. At the time of this writing, highly rated products range from $35 to $110 depending upon how many bells and whistles you want.

I tested a wristwatch-type Omron BP monitor called HeartGuide. The company promotes it for “Blood Pressure Anytime, Anywhere.”

It literally sits on your wrist like a watch. At $500, it is super pricey, though. I found that the plastic inflatable wristband was irritating to my skin and returned it to Omron. I did like the convenience, though. CR was not impressed with it, however. The testers gave the Heart Guide BP8000-M Blood Pressure Monitor low grades for accuracy.

Why Are BP Monitors So Important?

Blood pressure readings can be especially valuable since many people have white coat hypertension. That is a condition in which blood pressure readings are elevated primarily in the doctor’s office.

Research demonstrates that for motivated individuals, BP readings and activity monitors can provide helpful feedback.

A study published in the Journal of Medical Internet Research (Jan. 25, 2023) found this:

“The results showed that simply receiving accurate step count feedback led to improvements in participants’ AAMs [activity adequacy mindset], helping them realize that they were engaging in more health-promoting physical activity than they had previously believed…Participants also experienced improvements in mental health (ie, symptoms of anxiety, depression, sleep disturbance, and fatigue), self-esteem, and aerobic capacity and began eating more healthily (consuming fewer high-fat foods and more healthy produce).”

Heart Health: Home Tests and Devices Save Lives!

We interviewed Dr. Eric Topol more than a decade ago on our nationally syndicated public radio show. He is an eminent cardiologist and had been chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic.  He was talking about his book, The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care.

During our conversation, Dr. Topol shared his experience using sensors and an iPhone on a plane at 35,000 feet.

He also shared this emergency medical diagnosis with The Atlantic (March 12, 2012):

“The emergency announcement on the transcontinental flight was terse and urgent: ‘Is there a doctor on board?’ A passenger in distress was feeling intense pressure in his chest.”

Dr. Topol had a prototype electrocardiogram device with him on that fateful plane ride:

“‘It’s a case that fits over your iPhone with two built-in sensors connected to an app,’ says Topol, showing me the device, made by Oklahoma City-based AliveCor. ‘You put your fingers on the sensors, or put them up to your chest, and it works like an ECG that you read in real-time on your phone.’

“‘So I put the sensors right on the man’s chest,’ he continues, ‘and I could tell he was having a heart attack. I said to the pilot: ‘Get this guy off the plane, this is the real deal.’ And they made an emergency landing. My understanding is he did very well.’”

Dr. Topol used a similar device on two other occasions. He Tweeted:

“Diagnosed atrial fib, rapid VR [ventricular response] for a woman in distress today on at plane 30K ft, … no emergency landing req’d.”

ECG on your Smart Phone:

There are now various devices that provide electrocardiogram-like recordings on a smart phone. They are all careful to state that they cannot diagnose a heart attack. They do help people determine if they are experiencing atrial fibrillation, which is a serious arrhythmia.

The one that I like to use is KardiaMobile 6L. It states on the box that it is:

“The only FDA-cleared 6 lead personal EKG. In just 30 seconds, know if your heart rhythm is normal of if Atrial Fibrillation is detected.”

You can send the electrocardiogram to your physician or speak with “a board-certified cardiologist” for an extra fee of $69. You can also download a pdf version of your EKG (also known as an ECG). The KardiaMobile is 3.5 inches long by about 1.2 inches wide and is about 1/8 inch thick. In other words, it is incredibly small and is easily transported. The company now has a credit card-sized device that is even more handy.

Other Home Tests and Devices:

COVID-19

There are so many other monitoring devices it is hard to know where to start or stop. One of the most intriguing new developments in home testing involves infectious disease detection. By now, most people are very much aware of do-it-yourself COVID-19 tests.

Prior to these kits, people had to go to special testing places and wait a couple of days to get results. The home tests provide an answer within 10 to 15 minutes. These are “antigen” tests. They are not quite as accurate as the PCR (polymerase chain reaction) tests, but for most people they a very good first step in identifying COVID-19. There is more information at this link.

Influenza A and B:

Did you know that the FDA issued an emergency use authorization (EUA) for:

“…the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19.”

I have long wondered why the FDA allows doctors access to a rapid influenza test, but not consumers. Imagine that we are in the middle of flu season, say around mid-January. News broadcasts warn that flu is widespread.

Soon thereafter you start developing a sore throat, nasal congestion and a cough. Is it a cold or the flu and does it matter? I think it matters a lot because the treatment for influenza is different than symptomatic treatment for a cold. Flu drugs actually have antiviral activity. You can read about using Tamiflu (oseltamivir) at this link.

Although Tamiflu and other antiviral drugs such as Xofluza (baloxavir), Relenza (zanamivir) and Rapivab (peramir) are controversial, they only work if given early during an infection.

Trying to make a doctor’s appointment when you are sick with influenza is challenging. Chances of getting a quick appointment will be slim. By the time you can get a prescription for an antiviral drug, the window of opportunity is likely to be lost.

Having a home test of influenza A and B would be extremely helpful. In theory you could buy a Lucira COVID-19 & Flu Home Test.

According to the FDA, it:

“…correctly identified 99.3% of negative and 90% of positive Influenza A samples, 100% of negative and 88.3% of positive COVID-19 samples and 99.9% of negative Influenza B samples.”

As I write this, though, the test is “not available.” A representative tells me that it should be back in stock in a few months. We hope it can be purchased before the coming flu season. We are predicting a particularly nasty influenza outbreak this year based on the Australian experience. You can read more about that at this link.

Lots More Home Tests and Devices:

I could go on indefinitely, but by now you are getting bored, so I will wrap this up. There are home tests for blood in the stool. They are a crude but helpful way to detect early colon cancer.

Another test is called FIT (fecal immunochemical test). According to a study published in the Annals of Internal Medicine (Feb. 26, 2019), it can detect up to 80 percent of cancers.  There is also Cologuard, which bases its test results on detecting DNA from polyps. You can read about all these tests and colonoscopies at this link.

Pregnancy kits are quick and reliable. You can also test urine for the presence of nitrite. It is a marker for bladder infections. There are also home tests for kidney damage and hepatitis C. Home thyroid testing is also possible. Healthline provides an overview at this link.

Final Words:

We have just scratched the surface of home tests and devices. The thrust of most home testing options is to empower patients and make them partners in their own health care.

There was a time when physicians controlled access to health data. Now that monitoring devices are small, relatively affordable and convenient, it is up to people to learn the best ways to utilize these technologies to get feedback for better health.

Of course, some people may carry this to extremes. One patient got so obsessed with his blood pressure that he started measuring it every hour on the hour. When it went up 10 or 15 points, he got quite anxious and that only made things worse. Finally, his physician discouraged such obsessive monitoring.

This demonstrates why even with sophisticated testing devices, people need to work with their health care providers to interpret the findings and select optimal therapies. Such a partnership is the new paradigm for better health.

What do you think? Please share your thoughts about home tests and devices in the comment section below. Have you ever measured your own blood pressure or blood glucose? How did the process work for you? What other home tests have you used?

If you find this topic of interest you will want to listen to our podcast with Dr. Alan Greene. It is Show 1352: Home Tests, Tech and Tools to Improve Your Health.

The image for this post was provided by Dexcom.