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!
Every morning I have to read my glucose level off of my Libre 3 Continuous Glucose Monitor and enter the reading into the Cycler’s “fitals” screen. Other than of interest to me, it was 99 this morning, no one from my team ever comments on this or how in general my diabetic control is doing. I would like to think this is because we are on track and doing an OK job with diabetic control. At the present time, my A1C is in the 6.2 range where it more or less stays. It has been as low as 5.4 and as high as 6.7. I don’t remember how long it has been, years since it has ever been over 7. That did get me thinking about how important, especially to those who are on dialysis, it is to maintain tight diabetic control. Thus this blog with the help of my AI assistant offer the following treatise on diabetic control and dialysis.
Introduction
Diabetes mellitus is a chronic metabolic disorder characterized by elevated blood glucose levels, resulting from defects in insulin secretion, insulin action, or both. In 2021, the International Diabetes Federation estimated that over 537 million adults worldwide had diabetes, and this number is projected to rise to 643 million by 2030 (IDF Diabetes Atlas, 2021). Poorly managed diabetes can lead to numerous long-term complications, including diabetic kidney disease (DKD), which is the leading cause of the end-stage renal disease (ESRD) requiring dialysis (Afkarian et al., 2016).
Dialysis is a life-sustaining treatment for patients with ESRD that serves to remove waste products and excess fluid from the body when the kidneys can no longer perform this function effectively. However, managing diabetes and dialysis simultaneously presents a unique set of challenges. This blog will discuss the importance of optimal diabetic control for patients on dialysis, focusing on the effects on patient outcomes, cardiovascular risks, and quality of life, as well as exploring potential strategies for achieving optimal control.
Effects on Patient Outcomes
Optimal diabetes control is crucial for patients on dialysis, as it has been shown to improve patient outcomes. A study by Williams et al. (2012) found that among diabetic patients on hemodialysis, those with poor glycemic control (HbA1c ≥ 8%) had significantly higher mortality rates compared to those with good glycemic control (HbA1c < 7%). Furthermore, Ricks et al. (2012) reported that in a cohort of 24,875 diabetic patients undergoing dialysis, each 1% increase in HbA1c was associated with a 14% increase in the risk of all-cause mortality. These findings suggest that appropriate diabetic control is essential for improving survival rates among patients undergoing dialysis.
Cardiovascular Risks
Patients with diabetes and ESRD are at an increased risk of cardiovascular complications. According to the United States Renal Data System (USRDS, 2020), cardiovascular disease accounts for approximately 50% of deaths in ESRD patients, with diabetes being a major contributing factor. Optimizing diabetic control can help reduce cardiovascular risk in patients on dialysis. For example, a study by Shurraw et al. (2011) found that a 1% reduction in HbA1c was associated with a 15% decrease in the risk of myocardial infarction and a 17% decrease in the risk of stroke among diabetic patients on hemodialysis.
Moreover, patients with diabetes and ESRD often have other cardiovascular risk factors, such as hypertension and dyslipidemia, which can be exacerbated by poor glycemic control (Charytan et al., 2020). Thus, optimal management of diabetes in conjunction with other risk factors is essential to minimize cardiovascular morbidity and mortality in patients on dialysis.
Quality of Life
Diabetes and dialysis can both negatively impact the quality of life (QOL) of patients. However, studies have shown that improved glycemic control is associated with better QOL scores. A study by Kalantar-Zadeh et al. (2012) found that among diabetic patients on hemodialysis, those with better glycemic control (HbA1c < 7%) had significantly higher QOL scores compared to those with poor glycemic control (HbA1c ≥ 8%). Additionally, optimal diabetes management can help prevent or slow the progression of other diabetes-related complications, such as neuropathy and retinopathy, which can further enhance patients’ QOL (ADA, 2021).
Strategies for Achieving Optimal Diabetic Control
Achieving optimal diabetic control in patients on dialysis requires a comprehensive approach, encompassing medical management, lifestyle modifications, and patient education.
4.1. Medical Management
Medical management of diabetes in patients on dialysis requires close monitoring of blood glucose levels and appropriate adjustments to the patient’s diabetes medication regimen. Insulin therapy is the most commonly used treatment for patients with diabetes on dialysis, as oral antidiabetic medications are often contraindicated or require dose adjustments due to impaired renal function (Molitch, 2019). In addition, continuous glucose monitoring (CGM) systems can be a valuable tool for patients on dialysis, as they provide real-time information on glucose levels, allowing for more accurate adjustments of insulin doses (Buse et al., 2020).
4.2. Lifestyle Modifications
Lifestyle modifications, including diet and exercise, are essential components of diabetes management for patients on dialysis. A tailored meal plan, developed in consultation with a registered dietitian, can help patients manage their blood glucose levels while also adhering to their dialysis-specific dietary restrictions (Kovesdy & Kalantar-Zadeh, 2016). Regular physical activity, as recommended by the American Diabetes Association (ADA, 2021), can also help improve glycemic control, cardiovascular health, and overall well-being.
4.3. Patient Education
Patient education is a critical component of diabetes management for patients on dialysis. It is essential for patients to understand the importance of regular blood glucose monitoring, medication adherence, and lifestyle modifications to achieve optimal glycemic control. Collaborative, patient-centered educational programs, such as the Chronic Kidney Disease Self-Management Program (CKD-SMP), have been shown to improve diabetes knowledge and self-care behaviors in patients with ESRD (Chen et al., 2018).
While the importance of optimal diabetic control in dialysis patients is well-established, there are several challenges that healthcare professionals and patients may encounter in achieving this goal. This section will discuss some of these challenges, as well as potential future directions for improving diabetic management in this population.
Challenges and Future Directions in Diabetic Control for Dialysis Patients
5.1. Challenges in Diabetic Control
One challenge in managing diabetes for patients on dialysis is the complexity of their medical regimen. In addition to managing their diabetes medications and insulin therapy, patients must also adhere to dialysis-specific dietary restrictions and fluid intake limitations, which can make maintaining optimal glycemic control more difficult (Kovesdy & Kalantar-Zadeh, 2016).
Another challenge is the increased risk of hypoglycemia in patients undergoing dialysis. Dialysis can cause fluctuations in blood glucose levels, and insulin requirements may change due to the removal of glucose and insulin during the dialysis process (Molitch, 2019). As a result, patients on dialysis are at a higher risk of hypoglycemia, which can be life-threatening if not promptly recognized and treated (ADA, 2021).
5.2. Future Directions
To address these challenges and improve diabetes management in patients on dialysis, research is ongoing to develop new therapeutic options and strategies. For example, novel glucose-lowering medications, such as sodium-glucose cotransporter-2 (SGLT2) inhibitors, are being investigated for their potential use in patients with ESRD (Molitch, 2019). SGLT2 inhibitors have been shown to reduce the risk of cardiovascular events and slow the progression of kidney disease in patients with type 2 diabetes (Zinman et al., 2015), and ongoing studies are evaluating their safety and efficacy in patients on dialysis (ClinicalTrials.gov, NCT03819153).
Additionally, advances in technology may help improve diabetes management for dialysis patients. For instance, the development of closed-loop insulin delivery systems, also known as artificial pancreas devices, may offer an effective solution for managing blood glucose levels in this population (Bally et al., 2017). These systems combine continuous glucose monitoring with automated insulin delivery, allowing for precise adjustments of insulin doses based on real-time glucose levels, which may help reduce the risk of hypoglycemia and improve overall glycemic control.
Conclusion
In conclusion, optimal diabetic control is of utmost importance for patients on dialysis, as it can significantly improve patient outcomes, reduce cardiovascular risks, and enhance the quality of life. Achieving optimal glycemic control requires a comprehensive approach, including medical management, lifestyle modifications, and patient education. Healthcare professionals and patients must work collaboratively to develop individualized treatment plans that address the unique challenges of managing diabetes and dialysis concurrently.
References
ADA. (2021). Standards of Medical Care in Diabetes—2021. Diabetes Care, 44(Supplement 1), S1-S232.
Afkarian, M., Sachs, M. C., Kestenbaum, B., Hirsch, I. B., Tuttle, K. R., Himmelfarb, J., & de Boer, I. H. (2016). Kidney disease and increased mortality risk in type 2 diabetes. Journal of the American Society of Nephrology, 27(2), 486-495.
Buse, J. B., Wexler, D. J., Tsapas, A., Rossing, P., Mingrone, G., Mathieu, C., … & Consoli, A. (2020). 2019 Update to: Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care, 43(2), 487-493.
Charytan, D., Solomon, S. D., Ivanovich, P., Remuzzi, G., Cooper, M. E., McGill, J. B., … & Parving, H. H. (2020). Efficacy and safety of losartan in diabetic patients with or without chronic kidney disease: a post hoc analysis of the
Reduction of Endpoints in Non-Insulin-Dependent Diabetes Mellitus with the Angiotensin II Antagonist Losartan trial. Nephrology Dialysis Transplantation, 35(11), 1935-1944.
Chen, S. H., Tsai, Y. F., Sun, C. Y., Wu, I. W., Lee, C. C., & Wu, M. S. (2018). The impact of self-management support on the progression of chronic kidney disease—a prospective randomized controlled trial. Nephrology Dialysis Transplantation, 33(11), 1976-1982.
Kalantar-Zadeh, K., Kopple, J. D., Regidor, D. L., Jing, J., Shinaberger, C. S., Aronovitz, J., … & Kovesdy, C. P. (2012). A1C and survival in maintenance hemodialysis patients. Diabetes Care, 35(5), 1043-1051.
Kovesdy, C. P., & Kalantar-Zadeh, K. (2016). Why is protein-energy wasting associated with mortality in chronic kidney disease? Seminars in Nephrology, 36(1), 3-16.
Molitch, M. E. (2019). Management of diabetes in patients with chronic kidney disease. Diabetes Spectrum, 32(3), 211-216.
Ricks, J., Molnar, M. Z., Kovesdy, C. P., Shah, A., Nissenson, A. R., Williams, M., & Kalantar-Zadeh, K. (2012). Glycemic control and cardiovascular mortality in hemodialysis patients with diabetes: a 6-year cohort study. Diabetes, 61(3), 708-715.
Shurraw, S., Majumdar, S. R., Thadhani, R., Wiebe, N., & Tonelli, M. (2011). Glycemic control and the risk of death in 1,484 patients receiving maintenance hemodialysis. American Journal of Kidney Diseases, 57(4), 549-556.
USRDS. (2020). United States Renal Data System 2020 Annual Data Report: Epidemiology of kidney disease in the United States. American Journal of Kidney Diseases, 77(1), A7-A8.
Williams, M. E., Lacson, E., Teng, M., Ofsthun, N., & Lazarus, J. M. (2012). Hemodialyzed type I and type II diabetic patients in the US: Characteristics, glycemic control, and survival. Kidney International, 72(5), 629-637.
A strong case has been made in a preponderance of reviewed medical journals that diabetes is the primary and number one predictor of a future requirement to go on dialysis. See stats in the table below from CDC here: The extreme need for close diabetic control does not end once a person goes on dialysis; if anything, because PD at a minimum requires dumping a sugar solution into one’s stomach, it becomes even more critical.
For adults with diagnosed diabetes:
69% had high blood pressure, and 44% had high cholesterol.
39% had chronic kidney disease, and 12% reported having vision impairment or blindness.
Diabetes was highest among Black and Hispanic/Latino adults, in both men and women.
This blog is not about the how-to of diabetic control, but about one of the new tools just hitting the market to ascertain the degree of control, that is, how is my “blood sugar/glucose doing?”
Coming out of China is a new class of wearable devices in the form of a wristwatch at a very reasonable price called smart watches, or bio watches. They are generally available from Temu.com/App, Aliexpress.com, etc. for about $40.00. I have purchased two from Temu.com via their App for $39.62. See the Graphic below for all they are purported to be able to measure from here: The watches are based on the GR5515 chip and are Model E400 from Vanssa in China. Scroll down this link for more info on all the watch purports to do:
E400 Functions
I have been using the watch’s many functions in parallel with my go-to standard blood pressure, O2, temperature, and glucose (I use the Libre 3 CGM) as comparisons. I find some of the readings to be right on, and others to be somewhat consistent. It should be pointed out that the documentation that comes with the device explicitly states they are NOT to be used for medical purposes – yet I might add. As the video describes below, they are great for trends. I have found the E400 watch to be a great addition to a bag of tools for the diabetic/person on dialysis used in conjunction with the associated H Band App. Please watch the video embedded below for an independent review of the E400.
My next blog will discuss using the Libre 3 CGM for diabetic control while on dialysis.
Diabetes is a serious health condition that affects millions of people worldwide. For those with diabetes, managing the disease can be a complex and challenging task. For those with diabetes and end-stage renal disease (ESRD), dialysis can be an essential part of their care. In this blog, we’ll discuss the connection between diabetes and dialysis, and what patients need to know to stay safe and healthy.
Diabetes can cause a number of complications that can lead to the need for dialysis, including hypertension, heart disease, and nephropathy. (I have all three, having gone through a triple bypass in 2015.) Nephropathy, or kidney disease, is a major complication of diabetes and can cause ESRD. When ESRD occurs, dialysis is necessary to keep the patient alive.
I was first diagnosed as a diabetic in the early nineties via a glucose tolerance test while on active duty in the Navy. I was first diagnosed with the real possibility of Chronic Kidney Failure in the early 2000 timeframe. My diabetic condition progressed from control with diet and exercise to oral meds to insulin plus oral meds until the present day. Same with ESRD only doctors just stated “we’ll watch it.” What they meant was it was going to happen and we’ll just watch it happen. For me, diabetes and dialysis have been a fact of life, that is sooner or later…….
There are two types of dialysis that may be used for those with diabetes: hemodialysis and peritoneal dialysis. The general populace is often confused by this distinction, thinking only that one goes to a dialysis center three times a week for a couple of hours. Hemodialysis involves using a dialysis machine to filter the blood outside of the body. I underwent hemo as it is called for about six weeks while I was getting set up and moving through the queue for peritoneal dialysis aka PD. It is miserable and time-consuming, and a cold experience wipes you out, and I wouldn’t wish it on anybody including my worse enemies (if I had any which I don’t.)
“Although the ancient Egyptians were the first to describe the peritoneal cavity in approximately 3000 BC, the concept of peritoneal dialysis is relatively new. In the late 19th century, Wegner, a German investigator, was the first to use peritoneal solutions in animals.” From here: The solution used is called dextrose dialysate, or dextrose, or more formally dialysate.
What I use is a 1.5% or 2.5% Dextrose solution of Hydrous Dextrose, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride, and water. 8000 mL or 8 liters of this fluid is pumped into my Peritoneal cavity via a catheter in my stomach 2 liters at a time. When filled it remains there for two hours (dwell) and then is pumped back out (drain.) This takes place four times every night, seven days a week. This is all controlled by the Liberty Cycler apparatus.
Ideally, the drain takes place at 100ml per minute, or 20 minutes for the entire individual drain process. If you add up four dwell periods of two hours each, and four drains at a minimum of 20 minutes each (this rarely happens in this short a timeframe), you end up with eight hours of dwell, and 80 minutes or one hour and 20 minutes of the drain, for a total time on dialysis ideally of nine hours and 20 minutes. This NEVER NEVER happens. With me, it is more like 10 hours and thirty minutes every night. Add to this setup and tear-down times and you can see that PD requires lots of time to accomplish.
Dialysis is not a walk in the park, but short of a kidney transplant, there are no other solutions currently available. I did read that research into using printed kidneys is currently underway. Sign me up. In a follow-up blog, I intend to discuss in more depth the diabetic side of the diabetic dialysis balance.
