Henry Feeser's Peritoneal Dialysis (PD) journey

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Single Injection for Diabetes in Development

July 13, 2023 / / 0 Comments

Emily Mullin wrote on July 10, 2023, Wired in an article titled “A One-Time Shot for Type 2 Diabetes? A Biotech Company Is On It.” The following is a summary of her article. As in the past, I am interested in all things diabetic because #1 I am a diabetic, and #2 47% of us on dialysis are also diabetic.

Fractyl Health, a biotech company based in Massachusetts, is in the early stages of developing a one-time gene therapy treatment for type 2 diabetes and weight control. This therapy could provide an alternative to drugs like Ozempic and Wegovy, which require weekly injections to control blood sugar and body weight.

Currently prescribed medications like Ozempic and Wegovy mimic a human hormone called GLP-1, released in response to eating, which cues the pancreas to produce insulin, regulating blood sugar. These drugs also interact with parts of the brain involved in appetite, signaling fullness and thereby assisting in weight loss. However, these medications can have unpleasant side effects, and their efficacy drops off if a patient misses a dose or discontinues usage after reaching weight-loss goals.

Fractyl’s innovation seeks to solve these problems by delivering a one-time treatment that could have lasting effects for years. The therapy involves introducing an artificial gene to the pancreas that continuously produces the GLP-1 hormone, removing the need for regular injections. The delivery method involves using inactivated viruses to transport the therapeutic gene to the pancreatic cells, leveraging the viruses’ innate ability to deliver genetic material to cells.

While this therapy is currently only in the experimental stage, with tests having been conducted on animals, the initial results show promise. Using mice bred to develop type 2 diabetes, the researchers found that a single infusion of the gene therapy could reduce fasting blood sugar by 70%, compared to a 64% reduction by semaglutide injections. Separate tests also indicated that the therapy reduced body weight in mice by 23%.

The delivery method for this therapy involves an endoscopic procedure with a thin needle attached to a catheter, which is threaded down the throat and into the GI tract. Initial safety tests have been performed on pigs, which have a pancreas anatomically similar to humans, and no adverse side effects were reported.

However, this therapy raises some concerns, particularly around the potential for inflammation in the pancreas and the high cost of gene therapies. Dr. Daniel Drucker, an endocrinologist, and professor of medicine at the University of Toronto, is skeptical about directly injecting therapy into the human pancreas due to its fragility and importance. In addition, existing gene therapies on the market are priced quite high, with treatments for conditions like beta-thalassemia and hemophilia B costing millions.

Maria Escobar Vasco, an endocrinologist and diabetes expert at UT Health San Antonio, acknowledges the potential of the therapy but insists on the need for extensive testing to ascertain its safety. The first human trials are slated for the end of 2024.

In the meantime, other alternatives to injection-based therapies are being explored, including semaglutide in pill form, which may offer more convenience. Whether Fractyl’s gene therapy will result in similar side effects as current drugs is yet to be determined, but if it proves to be effective and safe, it could revolutionize the management of diabetes and weight control.

Monthly Labs & Phosphorus

July 12, 2023 / / 0 Comments

Last week I had my adequacy test along with monthly labs. I noted that my A1c jumped from 5.3 to 6.3, and my phosphorus reading went slightly high rising from 4.8 in June to 5.7 in July.

Explaining my A1c is easy. I was starting to have hypoglycemic events during the night and coupled with higher temps here in North Texas and working outside resulting in lots of sweat I cut back on my insulin from 10 units to 7 at one point. I am gradually increasing my nightly insulin back toward 10 with success thus far. Keep in mind the goal for Type II diabetics is an A1c under 7.0 so I’m still within acceptable range.

My nephrologist and Diatetian were concerned about my Phosphorus increasing and suggested I start chewing a Velphoro, the big brown horse pill that absorbs phosphorus with any large meal, not just breakfast as I had been doing. So that’s what I’m doing now.

With this as a background, I turned to my AI assistant with the following prompt and result to provide us all more insight into just what this Phosphorus thing is all about. Read on ->

w=Write an interesting blog entry about the importance of controlling phosphorus in their diet for a person on peritoneal dialysis

ChatGPT

Title: Phosphorus in Check: The Crucial Role of Dietary Management for Peritoneal Dialysis Patients

While everyone needs a certain amount of phosphorus to maintain their body’s balance and function, those on peritoneal dialysis require a more precise, carefully controlled approach. Phosphorus, an essential mineral found abundantly in many foods, plays an integral part in building strong bones and teeth, aiding muscle function, and maintaining heart rhythm. However, the kidneys often struggle to filter this mineral in individuals with kidney disease, leading to high phosphorus levels in the blood—a condition known as hyperphosphatemia.

When it comes to dialysis, particularly peritoneal dialysis, excess phosphorus in the diet can cause several complications, ranging from calcification of organs and blood vessels to bone disease, heart disease, and even an increased risk of mortality. This makes dietary phosphorus control a key aspect of the healthcare strategy for individuals undergoing this treatment.

A Delicate Balance

The average person typically consumes more phosphorus than the body needs. However, in the case of peritoneal dialysis patients, the inability of their kidneys to remove excess phosphorus necessitates restrictions. While dialysis helps remove some phosphorus, it cannot remove as much as healthy kidneys would. This imbalance may lead to an overabundance of phosphorus in the blood, creating potential health hazards.

Effects of High Phosphorus Levels

One of the most significant health risks is the development of bone disease. Too much phosphorus can lead to lower calcium levels in the blood, stimulating the release of parathyroid hormone (PTH). High PTH levels can cause calcium to be drawn from the bones, weakening them over time—a condition known as renal osteodystrophy.

Additionally, excess phosphorus can bind with calcium in the blood, creating deposits that can stiffen and clog blood vessels—a process known as vascular calcification. This can lead to increased blood pressure and an elevated risk of heart disease, the leading cause of death in individuals with chronic kidney disease.

The Diet Factor

To minimize these risks, it’s essential to control dietary phosphorus. While it’s found in nearly all foods, it’s especially abundant in protein-rich foods like meats, poultry, fish, dairy products, beans, and nuts, as well as processed foods and drinks, which often contain added phosphates.

A dietitian can provide an individualized meal plan to keep phosphorus intake in check. The plan may involve consuming smaller portions of high-phosphorus foods, choosing foods with lower phosphorus-to-protein ratios, or opting for fresh, unprocessed foods. Some people may also need phosphorus binders, medications that help prevent phosphorus absorption.

Understanding the Adequacy Test for Peritoneal Dialysis: Essentials, Implications, and Caveats

July 11, 2023 / / 0 Comments

Every quarter (three months) I have to do a PD Adequacy Test. From my perspective, it involves collecting my urine for 24 hours, and collecting the Cycler drains into separate collection bags rather than draining them to the shower drain. The following morning I take both containers to my Fresenius lab appointment, where my dialysis nurse Cindy also draws blood, and often gives me an injection of this or that. I think I actually am getting more shots than I did in the military. The results of the adequacy test are central to my nephrologist’s input at our next dialysis team meeting, which is always scheduled shortly after this test.

With this as background, I thought readers might be interested in on what underlies the “adequacy test” so I obtained the following from my AI assistant. Read it and you’ll know all you need to know about this dialysis-specific test.

Title: Understanding the Adequacy Test for Peritoneal Dialysis: Essentials, Implications, and Caveats

Peritoneal dialysis (PD) is a life-sustaining treatment for patients suffering from end-stage renal disease (ESRD). PD uses the body’s own peritoneal membrane as a filter to remove waste products and excess fluid from the blood. To ensure the treatment’s effectiveness, an “adequacy” test is routinely performed, a vital assessment tool in managing PD patients. This blog will delve into the details of the PD adequacy test, discussing its significance, interpretation of results, and potential limitations.

What is the Adequacy Test for Peritoneal Dialysis?

Adequacy in the context of peritoneal dialysis refers to how effectively the treatment is cleaning the blood of toxins and maintaining proper fluid balance. The adequacy test measures key parameters like residual kidney function, total urea clearance, and ultrafiltration volume.

The primary focus of the adequacy test is measuring the clearance of a molecule called urea, a waste product produced by the body during protein metabolism. High urea levels indicate the body is not effectively removing waste, signifying suboptimal dialysis.

Why is the Adequacy Test Essential?

The adequacy test is crucial for several reasons:

  • Monitoring Treatment Effectiveness: The test gives healthcare providers a clear understanding of how effectively PD is functioning. It helps clinicians tweak the PD regimen, optimizing dialysis fluid volumes and dwell times to ensure maximum removal of toxins.
  • Preventing Overhydration: By measuring ultrafiltration volume, the test can help detect and prevent overhydration, a common complication in PD patients.
  • Preserving Residual Kidney Function: The adequacy test measures residual kidney function, which plays a critical role in the overall well-being of PD patients. The aim is to preserve this function as long as possible to improve the patient’s quality of life.

Interpreting Adequacy Test Results

The Kt/V is a commonly used index for assessing the adequacy of peritoneal dialysis. It measures the dialytic clearance of urea (K), adjusted for the patient’s total body water (V), and considers the time of dialysis (t).

The National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative (KDOQI) recommends a target weekly Kt/Vurea of ≥1.7 for adults on continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD). This signifies that the volume of blood cleaned of urea over a week should be at least 1.7 times the volume of the patient’s total body water.

Results lower than this threshold may necessitate adjustments in the dialysis prescription to improve urea clearance and maintain an optimal balance of electrolytes and fluids.

Caveats and Limitations

While the adequacy test provides crucial insights into the PD’s effectiveness, it also comes with certain limitations:

  • Urea as a Sole Marker: Urea clearance is an imperfect marker of dialysis adequacy as it doesn’t reflect the removal of larger, potentially more toxic solutes. New research is ongoing to identify additional biomarkers that could be used to assess PD adequacy more comprehensively.
  • Patient Variability: Factors such as age, gender, body size, and residual renal function can influence the required level of dialysis adequacy. Therefore, individualized patient assessment is crucial.
  • Quality of Life: Although dialysis adequacy is important for patient survival, it does not necessarily correlate with the quality of life. Factors such as dialysis-related symptoms, physical function, and mental health also need to be addressed.

Conclusion

The adequacy test for peritoneal dialysis is a critical tool for managing patients with ESRD. It helps gauge the effectiveness of the dialysis regimen and informs necessary adjustments to optimize the patient’s health. However, it is essential to remember that it is only one piece of the larger clinical picture.

Given the caveats and limitations of the PD adequacy test, it should not be used in isolation. Complementary assessments, such as those for nutritional status, inflammation, anemia management, bone-mineral disease, fluid status, and patient-reported outcomes, must also be considered to ensure comprehensive patient care.

Furthermore, communication between the healthcare provider and the patient is vital. The patients should understand the importance of the adequacy test, the implications of the results, and the potential adjustments in the dialysis prescription that may ensue based on the results.

Ongoing research might provide us with more precise markers of dialysis adequacy in the future, which can potentially enhance our ability to individualize and optimize PD therapy for each patient. However, until then, the urea clearance test continues to be a cornerstone of assessing and managing dialysis treatment for ESRD patients.

In conclusion, peritoneal dialysis adequacy testing is a significant part of the treatment plan for patients with end-stage renal disease. It is a tool that helps deliver personalized care and treatment, keeping patients’ unique needs and conditions in mind. However, it is just one aspect of a complex and multifaceted treatment landscape, and ongoing research and development promise to refine and enhance these critical treatment parameters.

New Type 2 Diabetic Shot in Trial

July 10, 2023 / / 0 Comments

Keep in mind that up to 47% of those on dialysis are also diabetics with hypertension coming in second. Thus anything pertaining to diabetes has almost a 50:50 chance of applying to those of us also on dialysis. I am one of this group thus my interest in all things diabetic. I have been treating diabetes for roughly 40 years and have been on dialysis less than one. Thus my sensitivity to advances in the treatment of diabetes.

In a June 24, 2023 article in The New England Journal of Medicine by Julio Rosenstock, MD et al titled “Weekly Codec Versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin,” research sponsored by Nova Nordisk was reported. Some clarification of terms first. “Week Codec” is a new weekly basal injection under development by Nova. This article reports on a phase of human testing under the rules and regulations of the USA’s FDA. Another definition: a basal injection for Type 2 diabetes is a long-lasting injection. An example of such an injection is Glargine U100 sold under the brand name “Lantus” by Lilly which I inject daily.

As is usual in these trials, the null hypothesis of no difference in paired groupings between those receiving the Weekly Codec and those receiving Lantus was made. The following conclusions are copied directly from the report’s end:

“the findings of the current trial highlight the totality of evidence for glycemic control with icodec. Among persons with long-standing diabetes taking noninsulin glucose-lowering agents including GLP-1 receptor agonists and SGLT-2 inhibitors, those who received icodec were more likely to reach a glycated hemoglobin level (That’s A1C) below 7% than those who received glargine U100, and they spent more time in the target glycemic range and were more likely to reach a glycated hemoglobin level below 7% without clinically significant or severe hypoglycemia (low blood sugar). In this phase 3a trial, we found that once-weekly insulin icodec offered better glycemic control than once-daily insulin glargine U100 in persons with type 2 diabetes who had not previously received insulin.”

While this is but one component of the march by Nova to gain full approval of Weekly icodec for treatment of Type 2 diabetics, it looks like its release in the future looks probably and perhaps we can move from daily injections of Lantus to weekly injections of icodec? I would be for that.

Fatty Liver, Diabetes & Dialysis: An Intersection

July 7, 2023 / / 0 Comments

Elaine Chen, penned an article in the June 25 2023 STATNews.com titled “ADA says all diabetes patients should be screened for nonalcoholic fatty liver disease.” As you might surmise, I have never heard of this malady. The article starts off with “The American Diabetes Association said Sunday that all adults with type 2 diabetes or prediabetes should be screened for nonalcoholic fatty liver disease, an increasingly prevalent condition that can lead to serious liver damage.” If you have been reading this blog, you know that I am a diabetic exacerbated by exposure to Agent Orange in Vietnam.

Fatty liver, also known as hepatic steatosis, is a condition where there is an accumulation of fat in the liver cells. The liver is responsible for processing fats, but when there is an excess of fat, it can build up in the liver, leading to fatty liver disease.

There are two types of fatty liver disease: alcoholic fatty liver disease and non-alcoholic fatty liver disease (NAFLD). As the name suggests, alcoholic fatty liver disease is caused by excessive alcohol consumption, while non-alcoholic fatty liver disease is caused by factors such as obesity, high cholesterol, and type 2 diabetes.

Fatty liver disease often has no symptoms, but it can lead to more serious liver damage, such as cirrhosis if left untreated. Treatment usually involves lifestyle changes such as losing weight, exercising regularly, and avoiding alcohol.

If you suspect you may have fatty liver disease or are a diabetic for certain, it’s important to see a doctor for proper diagnosis and treatment. I’m going to bring this concern up with my GP next visit. The reason this is so important to those of us on dialysis is that on the order of 47% of us are also diabetic. So it figures that we are also the heavy half of people with NAFLD. For the record, my BMI is less than 24 which rules out the obesity factor, and I do not have high cholesterol.

More About Abbott’s CGM and Dialysis: IMPORTANT

July 6, 2023 / / 1 Comment

I am using the Abbott Libre Freestyle 3 as I have often noted herein, and paying for the same out-of-pocket. Recently I had a bad sensor, called Abbott’s customer service, and they replaced it and requested I send the defunct one back which I immediately did. Today I received a formal letter from Abbott which stated they had not received the return and requested the same. The letter went on to state if it had already been returned to disregard their request. Before the letter went in the bin I read the small print.

On the back of the letter under Warnings/limitations, it states: ” The FreeStyle Libre Pro System does not provide real-time results and patients should adhere to their blood glucose monitoring routine while using the system….Patients with high levels of ascorbic acid (Vitamin C) or salicylic acid (used in Aspirin) or severe dehydration or excessive water loss may experience inaccurate results with this system. The FreeStyle Libre Pro System is not approved for pregnant women, persons on dialysis, or recommended for critically ill population….” All emphasis is mine.

The first sentence, “patients should adhere to their blood glucose monitoring routine while using the system” directly states to keep doing old fashion finger pricks while using the Libre system. Doesn’t this totally beg the issue of why even use it then?

The second group excludes Orange Juice which I am drinking for breakfast since my dialysis dietician took me off tomato juice because of potassium, and I have also been taking glasses of orange juice to stave off low glucose readings. I take a baby aspirin every day to appease my cardiologist. I have noted that I have been receiving lots of low glucose readings from my Libre 3 while at the same time having no physical presence of being low. Having been at this game for about 40 years I know what a low feels like.

The last statement precludes persons on dialysis from using their CGM in no uncertain terms, no ifs ands, or buts.

I turned to my ChatGPT AI with the following prompt and response in an attempt to dig deeper into this subject with the following results:

Prompt: I just received a letter from Abbott concerning the use of the Libre 3 CGM system. It states in Warnings/Limitations that the Freestyle Pro system is not approved for persons on dialysis or with high levels of ascorbic acid (Vitamin C). Why is this?

ChatGPT provided the following response:

The Freestyle Libre 3 Continuous Glucose Monitoring (CGM) system, like many glucose monitors, works by measuring the level of glucose in your interstitial fluid. This is the fluid that surrounds the cells of your tissues, and it generally mirrors the glucose levels in your blood.

For people on dialysis, there could be a few reasons why the device isn’t approved. The body’s fluid levels can fluctuate significantly during dialysis, and this might affect the accuracy of the CGM system. Additionally, dialysis patients often have other health complications that might affect the system’s performance. However, without more specific information from the manufacturer, it’s difficult to say for sure.

As for high levels of ascorbic acid (Vitamin C), this is likely due to the fact that ascorbic acid can interfere with glucose monitoring systems. Many glucose monitors, including the Freestyle Libre, use a method called glucose oxidase to measure glucose levels. However, ascorbic acid can react with glucose oxidase, leading to falsely high glucose readings. This is a known issue with many glucose monitors, and it’s likely the reason why the Freestyle Libre 3 isn’t approved for use in people with high ascorbic acid levels.

At this point, I am flummoxed and speechless. No MD I have interfaced with has brought this up. No RN I have interfaced with has brought this up. No medical professional of ANY ilk has brought this up. I am going to continue underway as before and keep gathering data, such as it is. Stand by for another itshay!

Back to basics: Just what is PD?

July 5, 2023 / / 0 Comments

I ran across a free new-to-me Ai site that purports to write essays for students. I plugged into the website, www.writeapp.co, and followed the bouncing ball to write the following blog on the basics of peritoneal dialysis (PD.) It did a creditable job. The graphic above is from Bing Illustrator.

Introduction

Peritoneal Dialysis (PD) is a treatment option for patients with end-stage renal disease that removes waste and excess fluids from the body. PD is an alternative to hemodialysis, which relies on the use of a machine to perform filtration. PD, on the other hand, utilizes the patient’s peritoneum as a natural filter. This essay will explain what Peritoneal Dialysis is, how it works, its types and their advantages and disadvantages, how it affects lifestyle changes, and conclude with recommendations for patients.

What is Peritoneal Dialysis (PD)?

Peritoneal dialysis is a treatment method used in place of hemodialysis for people who suffer from kidney failure or end-stage renal disease (ESRD). In PD treatment, the lining of your abdomen acts as a filter to remove harmful toxins and excess fluid from your blood. A catheter will be inserted into your abdomen through surgery; this will allow dialysate (a solution infused with minerals like sodium chloride) into your abdominal cavity where toxins present in your bloodstream enter it through capillaries in your peritoneum.

How does PD work?

Once dialysate enters the abdominal cavity via catheter tube implantation during surgery, wastes present in blood plasma pass across capillary walls into the peritoneum due to osmosis diffusion pressure gradients created by glucose present in the dialysate. The process occurs continuously over several hours while the patient goes about their daily routine.

Types of PD

There are two main types of Peritoneal Dialysis: Continuous Ambulatory Peritoneal Dialysis (CAPD), which requires no machine assistance; instead relies on manual exchanges five times or more every day by patients themselves without machines intervening; automated Peritoneal Dialysis also known as continuous cycling peritoneal dialysis 1(CCPD), allowing overnight treatments via an automated cycler at home providing 3-5 exchanges each night while the patient sleeps.

Advantages and Disadvantages of PD

PD has several benefits, one of which is that it allows patients more control over their treatment plans. The procedure can be carried out in the comfort of the patient’s home, allowing them to continue with their normal daily routine. This form of dialysis is also less invasive than hemodialysis since there are no needles involved. Some disadvantages include a high risk for infections due to catheter insertion and peritoneal membrane damage, requiring regular check-ups to prevent complications.

PD and Lifestyle Changes

Patients who undergo Peritoneal Dialysis must adjust their lifestyle accordingly. Patients should adopt healthy habits such as eating a healthy diet, reducing alcohol intake, taking medications regularly as prescribed by the physician, and avoiding strenuous activities that could interfere with catheter fluid movement within the abdomen whilst performing exchanges.

Conclusion

Peritoneal Dialysis (PD) is an effective mode of treating end-stage kidney disease compared to hemodialysis; however, it requires frequent monitoring and medical attention due to possible complications such as infection risks or peritonitis caused by incorrect techniques during exchanges or other factors discussed above. Physicians’ knowledge about this method plays an important role in whether they recommend it for patients over other treatment options; thus awareness campaigns should be created targeting clinicians on management protocols related to assessing suitability criteria for patients experiencing ESRD symptoms. More research needs to be conducted into examining how remote monitoring could improve patient care quality regarding long-term health outcomes after initial hospital discharge following PD commencement therapy. 

Independence Day Reflections: Freedom, Service, and a More Perfect Union

July 4, 2023 / / 1 Comment

As a Vietnam Veteran, I have a unique perspective on Independence Day, a holiday that celebrates our nation’s birth and its enduring promise of freedom. On July 4, we commemorate the passage of the Declaration of Independence in 1776, a momentous event where the Continental Congress voted in favor of independence from Great Britain​.

Independence Day is a day of patriotism, of pride in our nation and its foundational principles. Yet patriotism, as we understand it, is not about blind loyalty or uncritical support for a country or its elected officials. As veterans, we know the difference between true patriotism and hollow nationalism. True patriotism lies in the continued quest to find a more perfect union, a commitment to the ideals encapsulated in the Declaration of Independence and the Constitution of the United States​​.

The principles that bind us as a nation—freedom, equality, justice, and opportunity— are what we, as veterans, have been prepared to defend. It is about loving our country not for its power or wealth, but for its selflessness and idealism. This sense of devotion to country is not about misleading slogans and empty gestures but about ideals and the hope that this nation can serve as an example to the rest of the world​​.

Yet, as we celebrate, we must also remember the responsibility that comes with this freedom. Our forefathers knew that the union they were forming was not perfect, but they believed in the possibility of making it “more perfect” with each passing year. They envisioned a nation that belonged to “we the people” – not to the government or political parties​​.

Independence Day serves as a reminder of our duty to protect this vision and to correct our nation when it strays from its path. In the words of Martin Luther King Jr., “I criticize America because I love her. I want her to stand as a moral example to the world”​​. We acknowledge our nation’s imperfections, we admit our mistakes and strive to atone for them. This too, is a patriotic act.

As a Vietnam veteran, my experiences have taught me to value freedom, to understand the weight of service, and to appreciate the continual pursuit of a more perfect union. On this Independence Day, let us not just celebrate our freedom but also remember our responsibility to uphold the ideals of our nation and to continue striving for that perfect union our forefathers dreamed of so long ago​.

As we celebrate the Fourth of July this year, let us remember the courage, the sacrifice, and the vision that birthed this nation. Let’s continue to strive for a more perfect union, for ourselves, for our children, and for the generations yet to come. For we are not only celebrating a moment in history but a promise, a promise of freedom, equality, and the pursuit of happiness that has been the beating heart of our nation for nearly two and a half centuries.

Happy Independence Day to you all, and let freedom ring! But for individuals on dialysis reading this, NEVER RING THE BELL!

Oral Insulin from Lettuce

July 3, 2023 / / 1 Comment
Medicalpress, on June 14, 2023, reported on a new and novel approach to the manufacture of insulin for potential use involving lettuce, yes, lettuce. The article by Lauren Rebecca Thacker, University of Pennsylvania titled “A plant-based, oral delivery of insulin regulates blood sugar levels similar to natural insulin: Study.” A summary of the article follows:

A groundbreaking study led by Henry Daniell of Penn’s School of Dental Medicine has introduced a new, affordable insulin delivery method that could revolutionize diabetes treatment and dramatically lower the risk of hypoglycemia compared to current methods. Insulin, a lifesaving medication for the estimated 537 million adults living with diabetes worldwide, has traditionally been delivered via injection, which can cause hypoglycemia due to insulin reaching the bloodstream too quickly. Although automated insulin pumps can minimize this risk, they are expensive and only accessible to a small portion of diabetes patients globally​.

Daniell’s study, published in the journal Biomaterials, presents a plant-based, oral delivery of proinsulin that addresses these drawbacks. The new plant-based insulin contains all three peptides found in natural insulin, which clinical insulin lacks. The plant cell walls protect the insulin from stomach acids and enzymes until gut microbes break it down. The insulin is then delivered to the liver through the gut-liver axis. In trials with diabetic mice, this oral insulin-regulated blood sugar within 15 minutes of ingestion, similar to naturally secreted insulin, and without causing hypoglycemia, a common risk with traditional insulin injections​.

The production of this plant-based insulin, using lettuce in this case, involves blasting human insulin genes through plant cell walls using a “gene gun.” The insulin genes then integrate into the plant’s genome. The lettuce is freeze-dried, ground, and prepared for oral delivery following FDA guidelines. This method eliminates the need for expensive fermentation, purification, and cold storage/transportation, significantly reducing production costs. The final product is shelf-stable at room temperature, eliminating the need for cold storage and reducing post-production costs​​.

Daniell plans to test this plant-based insulin in canine and human subjects in the future. He has previously conducted canine studies and believes this method could significantly alter treatment for diabetes and other diseases. In addition to its advantages in efficacy and affordability, plant-based insulin aligns with Daniell’s commitment to making healthcare globally accessible and affordable. He emphasized that this new method could provide patients with a superior drug at a lower cost​.

For readers of this blog, we should take solace in that current research, while still in the animal-testing stage, appears to indicate that oral-based insulin may become available in some of our reader’s lifetimes!

STAT Health Introduces First In-Ear Wearable For OrthoStatics

June 30, 2023 / / 1 Comment

A month or so ago I suffered an Orthostatic Hypotension incident in front of our home while talking to a neighbor. I sensed it coming on and gently fainted onto the payment with his kind help. I recovered quickly and with input from my dialysis nurse Cindy, we altered my dialysis solution mix and it has not occurred since. This is the “why” I’m interested in this malady.

On June 13, 2023, CNBC ran an article announcing a startup, Stat Health was coming out with a wearable device that is placed in the ear per the above picture that gives a warning to the user well in advance of an event such as orthostatic fainting. The CNBC blurb states;

‘When users stand up, the earpiece automatically tracks changes in their heart rate, blood pressure trend and blood flow, which are useful insights for patients who commonly experience dizziness and fainting spells as a result of illnesses like long Covid and postural orthostatic tachycardia syndrome (POTS), among others. 

Users can track their metrics in an app on their cellphone and glean insights into how their lifestyle choices affect their symptoms. The STAT earpiece has also proven to predict fainting minutes before it happens, according to peer-reviewed findings published in Journal of the American College of Cardiology this year.”

I followed the bouncing ball and arrived at Stat Health’s website and signed up to be eligible for the device. They charged $1.00 to signup which puts me in the queue to receive the device and pay $50 a month to use the device and their software. More to follow as more is known. 

Here are the reference links for this article: CNBC’s initial reporting link, link to Stat Health, and press release. No artificial intelligence was used in writing this blog post.

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