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Why ‘Controlling’ Blood Sugar Shouldn’t Be the Goal

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No person with diabetes, no matter how many years they’ve had it, has achieved absolute control of their blood sugar. In fact, I would argue that “control” is not possible at all.

It has to do with the word control itself, but more on that later.

Even people who use the latest technologies – including insulin pumps, continuous glucose monitors (CGM), smart insulin pens, and hybrid closed loops – won’t have perfect levels every day. Most will see an improvement in their time in range, but not control.

I saw this firsthand at the 2023 EASD conference in Hamburg, Germany, where many of my fellow diabetes advocates wearing hybrid systems had their alarms go off frequently.

It may feel disheartening, but understanding that “full control” over blood sugar levels is not possible can be liberating and empowering. If you think of it as a process of managing with the goal of improvement, it can free you from chasing the impossible goal of perfection, easing the stress, frustration, disappointment, guilt, and self-blame that can come from feeling like you failed.

I’ll explain below how to better work with the constant fluctuations of blood sugar and share some of my practices for navigating (as opposed to controlling) it.

The complex science behind blood sugar management

Our heartbeat, blood pressure, gut and brain signaling, digestion, liver processes, nervous system, and more all interact and influence blood sugar levels. So does living in an unpredictable world.

Personally, every morning I deal with the “dawn effect.” I need to take 1 unit of rapid-acting insulin immediately or I’ll go up 30 points in minutes. The stress of presenting at a conference, even though I feel relaxed, releases hormones that raise my blood sugar.

Adam Brown’s 42 Factors that Affect Blood Glucose is always worth sharing to remind us how many factors, biological and environmental, impact blood sugar.

Instead of using the verb “control,” I prefer “manage.” To manage comes from the Italian maneggiare, meaning to handle and train horses. It suggests a mutual adapting to, respecting, and evolving between two complex entities: the horse and rider. Or, in this case, the complex dance between humans, the environment, and blood sugars.

Even after living with type 1 diabetes for 51 years, I cannot, for example, see 142 mg/dL on my CGM, decide I want to be 102 mg/dL, and make it happen. Yes, I’ll take some insulin or go on a walk, but I cannot guarantee exactly where my blood sugar will settle.

This was much to the chagrin of my husband who early in our marriage thought there must be a few root causes I could manipulate and the effect would be absolute control. But one evening, 15 minutes after I’d ordered my meal in a restaurant and pre-bolused, the waiter came back to say, “There’s been an accident in the kitchen, your meal will take another 20 minutes.”

That’s when the husband saw that managing blood sugar is not a cause-and-effect task but a complex one that relies on constant sensemaking. Sensemaking is the act of trying something and seeing what happens. We do it all the time but we don’t recognize it.

You may think what I’m saying is obvious, but the word “control” is used so often in the language of diabetes that on some level we have absorbed it as true and possible. We hold ourselves responsible for our numbers thinking we should be judged on them. This causes a lot of unnecessary suffering.

Why do we believe we can ‘control’ blood sugar?

During the industrial and scientific revolutions, the idea of machine efficiency was brought into medicine. The human body was widely viewed as a machine. This can be useful for acute care but fails miserably for chronic care, as is the case for managing diabetes.

But machine thinking seeped into diabetes care with control-like, statistical formulas: insulin-to-carb ratio, insulin-on-board, pump algorithms, and carb-counting. Don’t get me wrong: these are enormously helpful, but they don’t turn us into machines.

Improving time in range

Success in managing blood sugar and spending more time in range is knowing how to influence your numbers and sensing what to do with any blood sugar number you see.

This requires you to have a general knowledge of how things affect your blood sugar and a familiarity with your patterns. That said, because so many variables are involved, any action may take some trial and error.

Here are steps that help me spend, on average, 90% time in range.

Influencing your blood sugar

  1. Wear a CGM: I recommend wearing a CGM to anyone with diabetes, particularly if you use insulin. You need to be able to see your numbers to know where you are and where you’re going. A CGM is also an easy way to see your patterns: check your blood sugar before and two hours after a meal or physical activity to see its impact on your blood sugar. If you don’t use a CGM, you can check for patterns using a meter. While the 2-hour check is a mechanical rule, it will give you a sense.
  2. Routine: I eat the same breakfast of plain Greek yogurt, a spoonful of tahini and almond butter, and a slice of a flaxseed muffin every morning when I’m home. My lunches and dinners are similar day to day in quantity and carbs, and I follow a low-carb diet. Eating and exercising consistently also helps my numbers be more similar day to day.

Nudging: small pushes back into range

I follow Dr. Richard Bernstein’s “law of small numbers.” If I’m too high, I take a small amount of insulin to nudge my numbers down, wait, watch, and repeat if necessary.

When I need to raise my blood sugar, if it’s not dangerously low, I’ve learned to take one or two glucose tablets and watch what happens rather than eat everything in the refrigerator like I used to.

Practicing patience and forgiveness

Managing blood sugar takes vigilance. You’ll have more energy to do it when you flow with your numbers, rather than fight them. That means staying calm and seeing the big picture. It means knowing that many variables, not just your decisions, affect blood sugar.

That said, I’m far from perfect. I certainly have times I feel overwhelmed or frustrated by my numbers and my mind shouts, “How could I let that happen again? Why didn’t I wait before I took that extra shot?”

But the temptation to think why didn’t I do this instead of that is useless since I can only know which decision was better in hindsight.

To help my nervous system stay calm, I practice this simple exercise – sometimes during the day or when I’m tempted to rage bolus.

I stand with my knees unlocked, feel my feet on the floor, let my arms rest by my side or hold them over my chest, and slow my breathing. I acknowledge this number is not my fault. My actions alone didn’t cause it. Then I reflect as best I can on what might have created it so I might do better in the future. I think, what do I do now, and do it; I don’t dwell on the number.

In closing

It’s important to mention that managing diabetes is not easy. If it was, more than 50-60% of people with diabetes would reach the time in range recommendation, which is 70% of the time (the equivalent of 17 hours a day).

This past summer at Camp Nejeda I presented this myth of “control” to adults who have been living with type 1 diabetes for decades. They all knew it instinctively, but hearing someone say it caused one woman to sob, releasing years of blame she had been carrying.

It’s time we realize that it’s more accurate and helpful to tell people to “manage” their blood sugar instead of “control” it. Our numbers emerge from dozens of factors, some within our sphere of influence, many not. As such, we’re responsible for our efforts but not our outcome.

Rest in this understanding and see if giving up the idea of perfect numbers helps you spend more time in range with less stress.

Could AID Transform Type 2 Diabetes Care?

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While AID has traditionally been used in type 1 diabetes, new data suggests this technology has many of the same benefits in type 2 – namely, improving time in range and A1C while reducing hypoglycemia. Plus, AID dramatically simplifies blood sugar management. 

From continuous glucose monitoring (CGM) to automated insulin delivery (AID) systems, diabetes technologies that began as innovations for people with type 1 diabetes are slowly beginning to reach people with type 2.

For instance, many insurance companies now cover CGMs for people with type 2 diabetes who take insulin as well as those who are not on insulin but have a history of hypoglycemia. And earlier this week, the FDA approved Stelo by Dexcom, a CGM designed specifically for people with type 2 diabetes who are not taking insulin.

However, less progress has been made with reimbursement by insurance companies for AID. Off-label use of AID drew significant attention at the ATTD 2024 conference, with presenters highlighting the benefits for many people with diabetes across a range of settings and systems.

AID improves time in range across different systems and settings

Research shows that AID leads to many of the same benefits in type 2 diabetes as in type 1 diabetes: improved time in range, reduced hypoglycemia, and reduced A1C. Importantly, these benefits were consistent across different study settings and regardless of which AID system was used.

A study of 30 Tandem Control-IQ users with type 2 diabetes found that time in range increased by about 15% from 56% at baseline to 71% at six weeks. This translates to an increase of 3.6 hours per day spent in range.

Dr. Anders Carlson, diabetes medical director at the International Diabetes Center in Minnesota, said this finding is in line with studies in type 1 diabetes as well as the time in target range guidelines for type 1 diabetes.

Outside of clinical trials, research suggests that the benefits of AID extend to people with type 2 diabetes in the “real world.”

In a study presented at ATTD, MiniMed 780G users were able to achieve 71-75% time in range outside of a clinical trial, again meeting the targets for diabetes. “This is really compelling evidence that in a real-world setting, this AID system can work for people with type 2 diabetes,” Forlenza said.

Participants who used the recommended MiniMed 780G settings (i.e. the lowest glucose target) achieved a time in range of 80%.

For Carlson, this finding raises an important question – what are the optimal settings for AID in type 2 diabetes? For instance, since low blood sugar (hypoglycemia) is less of a concern, it may be beneficial to have more aggressive targets from the get-go.

Another study investigated the Omnipod 5 AID system in 24 participants with type 2 diabetes, finding strong improvements in time in range with minimal hypoglycemia. Among those on MDI, time in range increased from 43% at baseline to 58% at six months. Participants on basal insulin only saw even larger improvements in time in range, from 31% at baseline to 65% at six months.

Dr. Anne Peters, professor of medicine at USC, also highlighted reductions in total daily insulin dose among participants on MDI – yet another way in which AID could simplify type 2 diabetes management.

How might combining AID with GLP-1s and SGLT-2s affect glucose levels?

Growing use of GLP-1 receptor agonists, SGLT-2 inhibitors, and diabetes technology poses new questions for the future of diabetes care. That is, how might the combination of technology and medications optimize outcomes for people with type 2 diabetes?

In the Omnipod 5 study, half of the patients were also taking a GLP-1 or SGLT-2. Overall, Omnipod users taking a GLP-1 or SGLT-2 saw greater improvements in time in range compared to those who were only taking insulin. Participants in the GLP-1 or SGLT-2 group saw a 24% increase in time in range from 28% at the start of the study to 62% at eight weeks. Meanwhile, participants not using a GLP-1 or SGLT-2 improved their time in range by 18%, from 35% at baseline to 53% at eight weeks.

Carlson said this finding suggests that combining GLP-1s or SGLT-2s with AID could potentially lead to even better glycemic control than AID alone – though formal studies will be needed to test this hypothesis.

Similarly, Dr. Gregory Forlenza, associate professor of pediatric endocrinology at the University of Colorado, noted the ability of GLP-1s to reduce insulin needs. Combining these powerful medications with AID may help people with type 2 diabetes improve glycemic control and lose weight. It’s possible these improvements could even help people work toward diabetes remission.

What about AID for older adults with type 2 diabetes?

Starting insulin can be challenging for people of all ages, but it can be especially complex for older adults or disabled people with type 2 diabetes who receive home care.

Elderly people have a higher risk of severe hypoglycemia and hypoglycemia or ketoacidosis. Diabetes management for older adults can also be complicated by impaired cognition or dementia, reduced mobility, and difficulty accessing care.

In this context, the CLOSE AP+ study investigated AID assisted by nurses in people with type 2 diabetes unable to manage their own multiple daily injections (MDI) at home. CLOSE AP+ tested Control-IQ technology in 25 participants who had an average age of 70 years.

At 12 weeks, time in range improved significantly, from 37% to 63%. Time below range was less than 1%, while time above range was under 10%. Overall, Reznik highlighted that a majority of participants reached the American Diabetes Association guidelines for older people with diabetes. These guidelines recommend:

  • At least 50% time in range (70-180 mg/dL)
  • Less than 1% time below range (<70 mg/dL)
  • Less than 10% time above range (>250 mg/dL)

It’s also worth noting that participants using Control-IQ technology saw a significant 1.3% reduction in A1C. Over 90% of participants reached an A1C of less than 8% by the end of the trial, without any increase in severe hypoglycemia. Dr. Yves Renzik, professor of endocrinology at CHU Caen Normandy in France, also highlighted high patient confidence and high nurse satisfaction with the AID system in this study.

Ultimately, the CLOSE AP+ study showed that AID can be used safely in people with type 2 diabetes who require home nursing care. This confirms the benefits of AID extend beyond the “standard” person with type 2 diabetes to older adults and people with disabilities.

The bottom line

Numerous presentations at ATTD 2024 demonstrated that AID is safe and effective for people with type 2 diabetes. Both clinical trials and real-world data show that this technology increases time in range and improves A1C while minimizing hypoglycemia.

“I want to emphasize that across a wide variety of real world and clinical trial evidence sets, and across very different AID systems, everyone is either doing a great job hitting a goal for time in range or achieving a massive improvement in glucose control,” Forlenza said. He noted that AID leads to time in range increases of 15% to 24% in people with type 2 diabetes, nearly double the improvements typically seen in type 1 diabetes.

However, several questions remain to be answered regarding optimal settings, bolusing, and the potential of AID when combined with GLP-1s and SGLT-2s. Carlson highlighted the following areas for further research:

  • Are people on MDI the only candidates for AID? Or could AID be used in all people with type 2, regardless of their insulin needs and whether or not they’re meeting glycemic goals?
  • Is previous experience with technology necessary for successful use of AID in people with type 2 diabetes?
  • Does AID help with diabetes self-management (such as carb awareness)?
  • What role will primary care providers provide in supporting AID in this population?

Beyond glycemic data, it’s also important to consider user experience with AID. Overall, the data suggests that people with type 2 diabetes had good satisfaction and confidence in using these systems. Even people who hadn’t previously used diabetes devices reported a positive experience with AID, Peters noted.

“I honestly wasn’t sure my patients would like AID – many were technology-naive people,” Peters said. “But they loved it and they wanted to stay on it because they felt it improved their glycemic control.”

Hair Loss and Diabetes

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Hair loss is a common condition affecting millions of people each year. Hair loss occurs for a variety reasons. Diabetes is one of them.

One of the lesser-known effects of fluctuating blood sugar levels is losing hair all over the body. Understanding and acknowledging the relationship between diabetes and hair can help you handle the issue effectively. This article will explore the connections between hair loss and diabetes.

When Should You Worry About Hair Loss?

According to the American Academy of Dermatology (AAD), adults lose about 50 to 100 strands of hair a day, which is to be expected. AAD calls this hair shedding, which is different from hair loss. 

Hair loss occurs when there is excessive hair shedding. Here are some signs that may tell you that you could be losing hair. 

  • Visibly receding hairline
  • The appearance of bald patches
  • Widening center or side partitions
  • Unusually increased hair fall
  • Hair falling out in clumps
  • A noticeable reduction in hair thickness or density

While hair loss is a natural part of aging (for both men and women), you’ll probably know when your hair loss has accelerated to an unexpected level.

How Diabetes Causes Hair Loss

Diabetes mellitus can affect every part of the body, including the hair follicles. The relationship between diabetes and hair loss is complex and multifaceted.

Unfortunately, there’s not much data on the prevalence of diabetes-related hair loss. One academic survey suggests that African American women with diabetes could have a 68 percent increased risk of severe hair loss in the central scalp area, though these results were based only on self-reported responses to an online questionnaire.  

Here are different ways in which this chronic condition affects hair.  

Poor blood circulation 

The hair follicles need oxygen-rich blood flow to grow. Chronic hyperglycemia (high blood sugar levels) will damage blood vessels, including those carrying blood to the hair follicles. This, in turn, will disrupt hair regrowth and lead to shedding. A 2016 article suggests that uncontrolled diabetes leads to diffuse hair loss, characterized by hair thinning and low hair density. 

In fact, your blood sugar concentrations affect hair so directly that your hair preserves evidence of your recent blood glucose history. Some researchers have even proposed using chemical analysis of hair to improve upon a traditional A1C measurement.

Diabetes-induced vascular damage can make you lose hair in other parts of the body, like in the legs or the arms. Losing hair in the extremities could be a definite sign of high blood sugar levels, which should be addressed immediately.

The diabetes -autoimmune relationship

People with type 1 diabetes frequently experience additional autoimmune conditions. One interest here is alopecia areata (AA). According to Everyday Health, AA is a condition where the body’s immune system attacks the hair follicles, leading to hair loss. 

A 2013 study analyzed the prevalence of AA in 3,568 individuals between 2000 and 2011. According to this study, 11.1 percent of individuals with AA also had type 1 diabetes. If you have type 1 diabetes and experience an itchy, tingly scalp with hair falling out in clumps, talk to your healthcare provider so they can test you for this autoimmune condition.  

Use of certain diabetic medications

Certain diabetic medications may encourage excess hair loss. In particular, dipeptidyl peptidase 4 (DPP-4) inhibitors have been associated with hair loss and alopecia in case reports. 

Semaglutide (Ozempic), the diabetes drug the world’s raving about, reportedly causes hair loss. Ozempic controls type 2 diabetes by increasing insulin secretion, reducing appetite, and promoting weight loss. While semaglutide doesn’t directly affect the hair follicles, the dramatic weight loss can cause hair loss due to a condition named telogen effluvium. The metabolic stress of rapid weight loss leads to thinning hair, but thankfully, Ozempic-induced hair loss appears to be temporary.

Other medications commonly taken by people with diabetes are also associated with hair loss, including medications for hypertension, high cholesterol, gout, and depression.

Interestingly, some studies say that metformin, one of the most commonly used medications for treating type 2 diabetes, may actually be beneficial in promoting hair follicle regeneration and helping individuals with male or female pattern hair loss. 

The diabetes -thyroid relationship 

Did you know that there is a relationship between diabetes, thyroid dysfunction, and hair loss? People with diabetes, particularly type 1 diabetes, have a higher risk of developing both hyperthyroidism and hypothyroidism. 

These thyroid conditions are strongly associated with hair loss. According to a 2023 study, 33 percent of people with hypothyroidism and 50 percent of people with hyperthyroidism may experience excessive hair shedding.

Diabetes-induced iron deficiency 

There is a positive correlation between higher A1C levels and iron deficiency. Iron deficiency, on the other hand, directly contributes to both androgenetic alopecia (pattern baldness) and telogen effluvium (excessive hair shedding due to stress).

Polycystic ovarian syndrome (PCOS)

PCOS may affect as many as 10 percent of women during their reproductive years. It shares a common cause with type 2 diabetes — insulin resistance — and the two conditions often coexist.

Polycystic ovarian syndrome is generally characterized by an excess of androgen, a family of sex hormones associated with masculinity, including testosterone. When women secrete too much testosterone, hair thinning is a common side effect, along with facial hair growth, weight gain, and irregular periods. There is no cure for PCOS, but doctors can use many medications to help manage its diverse symptoms, including hair loss.

Mental health challenges

We all agree that managing a chronic condition like diabetes can get challenging. People with diabetes have a higher risk of developing diagnosable mental health issues like depression and anxiety, or of experiencing diabetic distress.

These mental health conditions can affect the body in different ways, including increasing your stress hormone called cortisol. Higher levels of cortisol reduce the levels of certain proteins needed for the hair follicles to function well, causing hair loss. Some studies suggest that stress can also extend the hair resting phase, reducing regrowth. 

Tips to Manage Diabetic Hair Loss

Managing blood sugar levels

If high blood sugars are causing alopecia, stabilizing it as quickly as possible with drugs, diet, and lifestyle changes may help curb and hopefully reverse the condition. 

Early screening for hair loss

If you have type 1 or type 2 diabetes, speaking to a doctor can help you understand what’s your ‘normal’ hair loss. If you think you are suddenly losing a lot of hair, spotting bald patches, or finding an unexplained reduction in hair density, early screening will help identify the root cause and get preventive measures in place.

Medications

There are many medications approved to treat hair loss.

Minoxidil is an FDA-approved topical medication that may help in hair regrowth. Minoxidil also comes in a pill — in this form, it is only approved as a therapy for hypertension, but some doctors prescribe it off-label to help with hair loss.

Corticosteroids (oral, injectibles, and topical) are commonly used in treating AA. However, there is a risk of steroids causing or worsening hyperglycemia, which may make them less appropriate for people with diabetes.

Other medications that may be used to treat hair loss include:

  • Birth control pills that contain estrogen can help address androgenetic alopecia.
  • Spironolactone (topical and oral applications) to treat both male and female androgenic alopecia.
  • Finasteride (5-alpha reductase inhibitor for male pattern baldness).
  • Dutasteride (for male hair loss)

Dietary supplements

There is a strong connection between diabetes and nutritional deficiencies, which studies may cause changes in hair structure and affect hair regrowth.  

Metformin can cause vitamin B12 deficiency, which can lead to hair loss. Low vitamin D levels, which are common in people with types 1 and 2 diabetes, may also contribute to hair loss. It is possible that dietary supplements could help address these deficiencies.

Aesthetic solutions 

A more direct approach is to adapt your look to hide hair loss. Everyday Health recommends experimenting with coverings, including wigs, scarves, and hats, or using other cosmetics to camouflage hair loss. A new haircut or hairstyle could help, as well as clip-in extensions and wiglets.

Platelet-rich plasma (PRP) is a treatment in which your own blood is collected, refined, and injected directly into the skin along the scalp. This refined blood is especially rich in platelets, which secrete growth factors that can act directly on hair follicles, stimulating hair growth. PRP is used specifically to treat androgenetic alopecia.

Finally, hair transplant surgery is always a solution to permanent balding or excessive hair shedding. 

Takeaways

Diabetes is one of many factors that can contribute to excessive hair shedding. There are no easy answers, but optimal blood sugar control, good nutrition, and stress reduction can all help curb hair loss and may even promote new hair regrowth. While you concentrate on getting your diabetes management under control, a doctor can also recommend medications that may help your scalp, and there are many aesthetic solutions available, from wigs to hair transplant surgery.

CBD for Type 2 Diabetes: What Are the Benefits and Risks?

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You probably don’t have to look further than your local drugstore or beauty product supplier to know CBD has taken a starring role in everything from sparkling water and gummies to tincture oils and lotions. Some may even say that cannabidiol (CBD) — which, like THC, is a component of the cannabis plant, but doesn’t contain its psychoactive effects — is the “it” ingredient of our age.

You’ve probably also heard that CBD can help lessen stress, anxiety, and pain. “When people are in pain, they have a stress response, which causes an increase in cortisol and an increase in blood sugar,” says Veronica J. Brady, PhD, CDCES, a registered nurse and an assistant professor at the Cizik School of Nursing at the University of Texas in Houston. Relieving pain can help alleviate the stress response and improve blood sugar levels, as well as aid sleep, she says.

If you’re managing type 2 diabetes, it’s natural to be curious about whether CBD might help you manage those symptoms, too, to help stabilize your blood sugar. In fact, the prevalence of cannabis use increased by 340 percent among people with diabetes from 2005 to 2018, according to one study, which surveyed people on their use of cannabis (CBD or THC, in any form) in the previous 30 days.

But will popping some CBD gummies for diabetes work  Some healthcare professionals say CBD may have a role to play, but it’s important to understand that the only health condition CBD has proved effective for is epilepsy in kids. The jury is unfortunately still out, owing to the lack of comprehensive research on CBD for diabetes.

Still, in the aforementioned survey, 78 percent of people used cannabis that was not prescribed by a doctor. “Diabetes patients might still use cannabis for medical reasons, but not have a prescription,” says Omayma Alshaarawy, MBBS, PhD, an assistant professor in the department of family medicine at Michigan State University in East Lansing, who led the study. Recreational use is another factor. She points to a separate study that found that more than 50 percent of people with medical conditions such as diabetes or cancer use cannabis recreationally.

How People With Type 2 Diabetes Are Using CBD

In Nevada, where Dr. Brady used to work as a certified diabetes educator, her patients with type 2 diabetes used CBD for nerve pain. She says patients would use CBD in a tincture or in oils that they rubbed on painful areas, including their feet. Patients could buy CBD at medical marijuana dispensaries, which would offer dosing instructions. “They worried about the impact on their blood sugars,” says Brady.

Ultimately, though, Brady says that her patients reported that CBD reduced their nerve pain and improved their blood sugar. She adds that those people who used CBD oils for nerve pain also reported sleeping better.

Heather Jackson, the founder and board president of Realm of Caring in Colorado Springs, Colorado, a nonprofit that focuses on cannabis research and education, senses a community interest in CBD for diabetes. “In general, especially if they’re not well controlled, people are looking at cannabinoid therapy as an alternative, and usually as an adjunct option,” says Jackson. Callers have questions about CBD for neuropathy pain, joint pain, gastrointestinal issues, and occasionally blood glucose control, according to a spokesperson for Realm of Caring.

The organization receives thousands of inquiries about cannabis therapies a month. It keeps a registry of these callers, where they live, and their health conditions. Jackson says that people with type 2 diabetes are not a large percentage of the callers, but they currently have 540 people with diabetes in their database.

Jackson says that Realm of Caring does not offer medical advice, and it does not grow or sell cannabis. Instead, it offers education for clients and doctors about cannabis, based on its ever-growing registry of CBD users, their conditions, side effects, and administration regimen. “We are basically educating,” says Jackson. “We want you to talk to your doctor about the information you receive.”

Scientific Studies on CBD and Type 2 Diabetes and Barriers to Research

Despite interest among people with type 2 diabetes, large, rigorous studies showing how CBD may affect type 2 diabetes are lacking, says Y. Tony Yang, MPH, a doctor of science in health policy and management and a professor at George Washington University School of Nursing in Washington, DC. Specifically absent are randomized controlled trials, which are the gold standard of medical research.

At the very least, a case report from 2021 suggests that CBD is unlikely to cause harm or worsen diabetes control. (The American Diabetes Association also stresses that CBD should not be considered a replacement for traditional diabetes management.)

Other research suggests the use of CBD for diabetes is indeed worth further study. For example, a small study in the United Kingdom looked at 62 people with type 2 diabetes and found that CBD did not lower blood glucose. Participants were not on insulin, but some took other diabetes drugs. They were randomly assigned to five different treatment groups for 13 weeks: 100 milligrams (mg) of CBD twice daily; 5 mg of THCV (another chemical in cannabis) twice daily; 5 mg CBD and 5 mg THCV together twice daily; 100 mg CBD and 5 mg of THCV together twice daily; or placebo. In their paper, the authors reported that THCV (but not CBD) significantly improved blood glucose control.

Other CBD research is still evolving. Some research on CBD for diabetes has been done in rats, which leads to findings that don’t always apply to human health. Other research has looked more generally at the body’s endocannabinoid system, which sends signals about pain, stress, sleep, and other important functions. Still other studies have looked at marijuana and diabetes, but not CBD specifically.

That there are so few studies of CBD in people with type 2 diabetes has to do with a lack of focus on CBD as an individual component. Historically, cannabinoids (a group of chemicals in the cannabis plant) have been lumped together, including CBD, THC, and more than 100 others. The 1970 U.S. Controlled Substances Act classifies cannabis as a Schedule 1 drug with the highest restrictions, according to the Alcohol Policy Information System. Currently, 38 states allow cannabis for medical use, and 24 states and the District of Columbia have passed legislation allowing cannabis for recreational use, per CNN.

The 2018 Farm Bill removed industrial hemp from the controlled substances list, clearing the way for more production and research of CBD. Meanwhile, growers and manufacturers are better able to isolate CBD, mainly by cultivating industrial hemp that is high in CBD and very low in THC, says Jackson. So, perhaps in the coming years, more research on CBD and diabetes will emerge.

How the FDA Views and Regulates CBD for Disease Treatment

Yet, as evidenced by a previously cited study, people with type 2 diabetes aren’t waiting for further study to hop on the trend. Brady says her patients have been open about using CBD, particularly the younger patients. She says one of her older patients was initially uncomfortable about buying CBD in the same shop that sold marijuana but eventually gave in. Brady adds that many people associate CBD with smoking marijuana, despite their distinctly different effects on the body.

The U.S. Food and Drug Administration (FDA) approved the first CBD medication in 2018, for treating childhood epilepsy. Currently, there is no other FDA-approved CBD medication for diabetes or any other condition, according to the FDA. In December 2018, the FDA said it was unlawful under the Federal Food, Drug, and Cosmetic Act to sell food or dietary supplements containing CBD. But in January 2023 the FDA concluded that a new regulatory pathway for CBD is necessary and that it intends to work with Congress to develop one.

“The FDA, for the time being, has focused its limited enforcement resources on removing CBD products that make claims of curing or treating disease, leaving many CBD products for sale,” wrote Pieter Cohen, MD, and Joshua Sharfstein, MD, in The New England Journal of Medicine. Dr. Cohen is an assistant professor of medicine at Harvard Medical School in Boston, and Dr. Sharfstein is the vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health in Baltimore.

Precautions for People With Diabetes Looking to Try CBD

For the CBD products already on the market, Jackson says it’s often difficult to know what’s inside. One study found that only 30 percent of CBD products were accurately labeled, with under- and over-labeling of CBD content, and some products containing unlisted chemicals such as THC.

Vaping liquids were the most commonly mislabeled CBD products in the study. The Centers for Disease Control and Prevention (CDC) warns that consumers should not purchase any vape products from unregulated and illicit markets or attempt to modify vape products outside of how the manufacturer intended. The Associated Press has shown that some CBD vapes have synthetic marijuana.

Jackson points out that CBD may affect certain cholesterol and blood pressure drugs, and research has detailed these interactions. Other side effects of CBD include tiredness, diarrhea, and changes in weight or appetite, the researchers write.

“What you put in your body is really important,” says Jackson, adding that’s especially true for people with major health conditions like diabetes. Jackson speaks from personal experience as a mom finding CBD treatments for her son’s epilepsy. She says consumers should ask manufacturers whether CBD products are free of mold, pesticides, and other toxins.

Realm of Caring, Jackson’s nonprofit, created a reference sheet for evaluating products and manufacturers. It also endorses products that adhere to standards such as those from the American Herbal Products Association and the FDA’s Current Good Manufacturing Practice regulations.

“There is little known about cannabis health effects, especially among patients with chronic conditions. Research is growing, but still solid evidence evolves,” says Dr. Alshaarawy. For these reasons, she recommends that patients talk to their doctors so they can discuss the benefits and potential harms of cannabis and monitor their health accordingly.

How to Talk to Your Healthcare Provider About Using CBD for Type 2 Diabetes

Jackson and Brady advise people who are considering CBD for diabetes to ask their providers about the complementary therapy before adding it to their treatment plan. Brady says it’s difficult to find research about CBD and type 2 diabetes, even in her capacity as a diabetes educator. Still, in her experience, if people are looking for a natural way to manage pain, it’s worth a conversation with their healthcare provider. “It’s something that should be talked about, especially if they’re having significant amounts of pain, or really any pain at all associated with their diabetes,” says Brady.

“It’s a reasonable alternative,” says Brady. “As it gains in popularity, there needs to be some information out there about it.

Insulin Delivered via Nano-Carriers May Pave Way for Oral Diabetes Treatment

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Australian and Norwegian researchers report they have developed a new method of delivering insulin via nano-carriers which may allow diabetes patients to take it orally as opposed to daily insulin injections. The new technology, described in the journal Nature Nanotechnology, notes that its nano-carriers are 1/10,000th the width of a human hair, and can be ingested via a capsule, or potentially incorporated in a piece of chocolate.

“This way of taking insulin is more precise because it delivers the insulin rapidly to the areas of the body that need it most,” said Peter McCourt, PhD, a professor in the department of medical biology at UiT The Artic University of Norway. “When you take insulin with a syringe, it is spread throughout the body where it can cause unwanted side effects.”

The development of the potentially new oral diabetes treatment, builds on a discovery made a year ago by UiT and University of Sydney, Australia, researchers who found that it was possible to deliver medicines directly to the liver using nano-carriers. While researchers have been attempting to develop nano-carriers that can deliver insulin to the liver, the previous version would break down in the stomach, thus not reaching the areas in the body where it was needed.

But now, McCourt noted, the team has created a coating that protects the insulin carriers from being broken down by stomach acid and other digestive enzymes keeping the medicine safe until it eventually reaches the liver. Even better, the coating is broken down in the liver by enzymes that are only active when blood sugar levels are high, releasing the insulin to act in the liver, muscle and fat, to then lower blood sugar levels.

“This means that when blood sugar is high, there is a rapid release of insulin, and even more importantly, when blood sugar is low, no insulin is released,” said Nicholas J. Hunt, PhD, of the University of Sydney, co-leader of the project. This method provides a better method of insulin delivery for the patient versus injections because it significantly reduces the odds of a hypoglycemic event, and provides for the release of insulin only as dictated by the patient’s needs, as opposed to releasing it all at once via a shot.

Further, the researchers noted, the oral diabetes treatment delivery is much more like how insulin release works in healthy people where the pancreas produces insulin, which then moves through the liver where most of it is absorbed to maintain healthy blood sugar levels. The nano-carriers release insulin in the liver, where it either can be taken up in the liver, or enter the blood stream.

“When you inject insulin under the skin with a syringe, far more of it goes to the muscles and to adipose tissues that would normally happen if it was released from the pancreas, which can lead to the accumulation of fats,” the researchers wrote. “It can also lead to hypoglycemia, which can potentially be dangerous for people with diabetes.”

So far, this oral diabetes treatment has been tested on nematodes, mice, rats, and most recently successfully tested on baboons at the National Baboon Colony in Australia. The oral insulin is now slated to be tested in human, trials beginning in 2025 by Endo Axiom, a spinout company that will seek to commercialize the drug.

In the Phase I trial we will investigate the safety of the oral insulin and critically look at the incidence of hypoglycemia in healthy and type 1 diabetic patients. Our team is very excited to see if we can reproduce the absent hypoglycemia results seen in baboons in humans as this would be a huge step forward,” said Hunt.

If the Phase I trial shows the treatment is safe for humans, it will then be studied for how it can be a replacement for insulin injections by patients. The hope is that successful testing of this potential new treatment method for diabetes can be available within to two to three years.

New Research Proves the Pancreas Can Regenerate

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Beta cell regeneration – progenitor cells (green) can become insulin-producing cells (red) [courtesy of the Diabetes Research Institute]

Type 1 diabetes is caused by an autoimmune attack that destroys the beta cells, the part of the body that produces the essential hormone insulin. It is generally supposed that once these cells have been lost, they are gone forever. In the search for a cure, the most advanced research has concentrated on the transplantation of new beta cells — either from an organ donor or grown in a laboratory — to replace the cells that have been irrevocably lost.

But what if your body could be directed to regrow its own new beta cells? A lead investigator at the Diabetes Research Institute believes that the pancreas can regenerate beta cells, and that his lab has discovered how to make it happen.

A Century of Questions

Many human cells can regenerate themselves. You may have heard that, due to constant cell regrowth, the entire human body is replaced every seven years. That’s not quite right — while most of your skin cells turn over within months, you also have brain cells that never have been and never will be replaced.

The pancreas, like most other internal organs, is slow to regenerate and has a very limited ability to heal itself. But doctors have long suspected that the pancreas harbors the ability to regenerate the islet cells, which contain the insulin-producing beta cells. “The concept has been around for more than 100 years,” since even before the discovery of insulin, says Juan Dominguez-Bendala, PhD. It’s always been a controversial idea, but he believes that the debate has now been settled.

Dr. Dominguez-Bendala is the Director of Stem Cell & Pancreatic Regeneration and Research at the Diabetes Research Institute. His team, in a collaborative effort with his colleague Dr. Ricardo Pastori, recently published a report in Cell Metabolism that finally proves that the adult human body is capable of growing new beta cells:

“I think that this is very definitive. We’re looking at regeneration in the real thing, the real human pancreas. We see this happening in real-time. It’s unequivocal.”

New Evidence

The islet cells that contain both the beta cells and other important exocrine cells only make up a small minority of the pancreas’ mass. Most of the organ is devoted to a ductal system that helps synthesize digestive juices and transport them to the intestines. In the embryo, though, this part of the pancreas also creates the islet cells.

“There are lots of people that don’t believe that this is a process that happens during normal adult life. But what we and others contend is that when there’s extensive damage to the pancreas, there’s a partial reactivation of the embryonic program that brought about islet cells in the first place. There are stem cells in the ducts that give rise to new islets.”

For years, however, the evidence in favor of human islet regeneration only came in the form of samples from the pancreases of deceased people. It had never been possible to observe the regeneration of islet cells in real-time, and “the evidence was rather circumstantial.” There was supporting evidence from mouse models, but Dominguez-Bendala admits that this was of limited value: “We have cured diabetes in mice hundreds of different ways, and none of them have ever worked in humans.”

Scientists received a new tool with the establishment of nPOD, the Network for Pancreatic Organ Donors with Diabetes. Founded and supported by the leading charity JDRF, nPOD encourages people with diabetes to sign up as organ donors and donate their pancreases to science. This national network is the only way for American researchers to receive a reliable supply of viable organs from people with type 1 diabetes.

Dominguez-Bendala’s lab began receiving donations of pancreas slices in 2018. It took some tinkering, but they found a medium that “could extend the life and functionality in vitro for about two weeks, which was plenty for us to start seeing if there’s regeneration.” It provided, for the first time, “a window into the real pancreas.”

How to Stimulate Beta Cell Regeneration

If pancreatic regeneration does occur naturally, it’s obviously not enough to substantially heal people with diabetes or pancreatitis. To make a difference, Dominguez-Bendala would have to find a way to accelerate and amplify the regeneration process. His secret ingredient may be a natural human growth factor named BMP7.

BMP7 is “like a fuel for stem cells across the body,” and Dominguez-Bendala wanted to see if it could have the same effect in the pancreas. The substance is well-studied and is already approved for an unrelated condition: “It’s already in clinical use. It regrows bone, and is used to fuse vertebrae when you have spinal surgery.”

The team at Dominguez-Bendala’s lab would take multiple pancreatic slices from a single donor and treated some with BMP7. When they took a closer look, they saw exactly what they had hoped: new hybrid cells emerging from the ductal mass of the pancreas and creating a bridge towards the area where islet cells are born. A trajectory analysis showed that some of the new hybrid cells “became new islet cells.”

“We showed for the first time, in a human-based model, how regeneration works.”

“We discovered that progenitor cells inside the ducts respond to BMP7 by proliferating, and then when you remove the BMP7, they differentiate into all the different cell types of the pancreas.”

“To me, it doesn’t get any more promising than that,” Dominguez-Bendala said. “You can cure diabetes left and right in mice, but to show that you can induce beta cell regeneration in a type 1 diabetes donor? That’s something really major.”

Next, they had to prove that the new islet cells were actually functional. Could they respond to high blood sugar levels, secrete insulin, and correct hyperglycemia? “When we look at the neogenic cells, the cells that have been formed as a result of BMP7 stimulation, we can see that they respond to glucose stimulation by making insulin.”

It will take several years and “a lot of boring experiments” to convince the FDA that the therapy is safe to try in humans. Studies of mice, at least, show that BMP7 causes no other dysfunctional tissue growth. It also doesn’t stimulate islet cell growth in healthy mice, suggesting that the substance naturally targets injuries: “We think it takes an extreme degree of damage to the pancreas for this very primitive regeneration program to be activated.” Studies in humans help show that BMP7 is safe for general use, including when used to help heal kidney disease.

The Immunity Problem

Beta cell regeneration has the same big problem that every other proposed type 1 diabetes cure has: the immune system. Transplanted islet cells — whether they come from an organ donor or a laboratory manufacturing process — can correct hyperglycemia and grant insulin independence, but thus far nobody has figured out how to protect them from the immune system without the use of powerful drugs (with potentially powerful side effects).

“This doesn’t work unless we do something about the immune system, or else the new cells will be destroyed again and again,” says Dominguez-Bendala. “We envision this as a combination therapy alongside immunotherapies.”

Dominguez-Bendala is gambling, along with the rest of the diabetes world, that better immunotherapies are coming soon. In the meanwhile, the first patient population likely to benefit from any beta cell regeneration therapy are people who have received a kidney transplant, patients who therefore already require anti-rejection medications.

There is at least some hope, however, that naturally regenerated beta cells will be easier to protect from the immune system than transplanted cells, which the body’s defenses identify as foreign. We won’t know yet how the body will respond to neogenic cells: “The truth is that we don’t know. I have spoken to immunologists who believe that the new cells may be able to sneak in and won’t be destroyed as quickly as the ones that were destroyed in the first place. I’m hopeful that it will happen, but I’m not counting on that.”

Timeline

Beta cell regeneration is in its infancy as a therapy, and will require many years of experimentation before it gets anywhere close to FDA approval. I asked Dominguez-Bendala if a more advanced potential cure — such as Vertex’s VX-264 — might succeed first and render his work obsolete. Dominguez-Bendala doesn’t see Vertex as a competitor — his lab has helped contribute to progress in the field of stem cell differentiation — but he is emphatic that VX-264 will not be a full cure and will not end the search for better type 1 diabetes remedies:

“It’s not a cure by any stretch of the imagination. It’s a brute force strategy, putting things in the body, and the body is attacking them. What we are proposing is fundamentally different, to harness the very natural ability of the pancreas to heal itself. That’s a much more holistic approach.”

Several other research groups are investigating parallel therapies. In France, a startup named DiogenX believes it has found another way to regenerate the beta cells. And just last week, an Australian team published a study of another method that could stimulate beta cell regeneration.

“I’m hopeful that it will be available sooner rather than later. We could spend twenty years exploring the little details of the mechanisms, but that’s not what the Diabetes Research Institute is about. We want to have therapies in the clinic as soon as possible. That’s our mission, and that’s what we are going to do.”

Inhaled Insulin: Myths vs. Facts

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Afrezza

Inhaled insulin—Afrezza (insulin human) Inhalation Powder from MannKind—has existed now for several years, but there are many myths floating around the diabetes community about this zero-poke method of taking your insulin.

What Is Afrezza?

  • Afrezza is a man-made insulin that is breathed-in through your lungs (inhaled) and is used to control high blood sugar in adults with diabetes mellitus.
  • Afrezza is not for use in place of long-acting insulin. Afrezza must be used with long-acting insulin in people who have type 1 diabetes mellitus.
  • Afrezza is not for use to treat diabetic ketoacidosis.
  • It is not known if Afrezza is safe and effective for use in people who smoke. Afrezza is not for use in people who smoke or have recently stopped smoking (less than 6 months).
  • It is not known if Afrezza is safe and effective in children under 18 years of age.

Here, we’ll look at the most common myths and misconceptions that we hear about—and the facts—about Afrezza.

Myth #1: It’s Only for People With Type 2 Diabetes.

Fact: Afrezza is approved for use in adult patients with type 1 or type 2 diabetes.

People with type 1 and type 2 diabetes appreciate Afrezza for its ultra-fast action time, how quickly it’s out of your system, and how easy it is to use with a quick inhalation.

Afrezza can be used in both type 1 and type 2 diabetes as your mealtime or short-acting insulin. (In patients with type 1 diabetes, you must use Afrezza with a long-acting insulin.)

Some primary care doctors and endocrinologists believe that Afrezza is intended only for people with type 2, so there can be some resistance when it comes to prescribing it.

There’s also a learning curve to transitioning your blood sugar management to Afrezza from injected rapid-acting insulin.

The differences in Afrezza’s dosages, how quickly it affects your blood sugar, and the length of time it’s in your bloodstream are different enough from injected rapid-acting insulin that you’ll need to increase your glucose monitoring and be ready to make adjustments with your doctor the first few weeks of using it. If your doctor isn’t familiar with Afrezza, they may try to steer you clear of it altogether.

Myth #2: The 4/8/12-Unit Dosing Cartridges Won’t Work for Carb-Counting or Type 1 Diabetes.

Fact: It’s not the same as dosing injected insulin.

Learning how to dose Afrezza can take a few weeks working with your doctor to find the right dose. Afrezza explains the conversion of dosing injected rapid-acting insulin to inhaled insulin like this:

Table

Image source: Beyond Type 1

While you may have used 2 units of rapid-acting insulin, for example, for your high-protein/moderate-carb lunch, you may find that the 4-unit Afrezza dose is equivalent in coverage.

Based on clinical trials, it may take 1.5x the amount of Afrezza to achieve the same blood sugar control as injected insulin.

Another factor to consider is that some people may need to increase their long-acting background insulin dose when switching to Afrezza. In a clinical trial, people reported a 15 percent increase in their background insulin dose on average over the course of the trial.

This is because it’s out of your system so quickly. While other rapid-acting injectable insulins have a 4 to 5 hour duration of action that overlaps with your background dose between meals, Afrezza is out of your system often within 1.5 to 3 hours, depending on the dose.

Myth #3: Afrezza Works Too Fast, Increasing the Risk of Severe Lows.

Fact: In a clinical trial, hypoglycemia with Afrezza was similar to aspart in the first two hours after a meal, and lower 2 to 5 hours after a meal. 

Hypoglycemia is the most common adverse reaction of insulin therapy, including Afrezza, and may be serious and life-threatening.

For years, you’ve been told to take your injected mealtime insulin before you eat—and at the very least, when you start eating. That’s because injected mealtime insulin takes at least 30 minutes to truly start affecting your blood sugar.

Afrezza is fast—really fast. It starts affecting your blood sugar in as little as 12 minutes. If you take Afrezza before you start eating, the fast action time of this insulin may hit your bloodstream before your meal is even being digested.

With Afrezza, you no longer need to pre-bolus your insulin for meals because Afrezza is out of the body so fast it allows for supplemental doses 1 to 2 hours after meals.

Using any type of insulin increases your risk of low blood sugars. That is why it is important for all people with diabetes on insulin to be able to recognize the signs and symptoms of low blood sugar. The risk of low blood sugar depends on many factors, one of which is the type of insulin and how long it works in your body.

Myth #4: Afrezza Causes Lung Cancer.

Fact: Let’s take a closer look at research on Afrezza and lung cancer and lung function…

In short, so far there is no research that suggests Afrezza causes lung cancer. In clinical trials, Afrezza was studied in over 3,000 patients with type 1 or type 2 diabetes. In studies of Afrezza in people with diabetes, lung cancer occurred in a few more people who were taking Afrezza than in people who were taking other diabetes medications.

There were too few cases to know if lung cancer was related to Afrezza. If you have lung cancer, you and your healthcare provider should decide if you should use Afrezza.

In terms of lung function, Afrezza has been found to cause a slight decrease in your overall lung function.

Doctors will perform lung testing before prescribing Afrezza, and a check-up on your lungs after you’ve been using it for 6 months and a year after. Afrezza is not recommended in patients with chronic lung disease such as asthma or COPD. It is also important to take Afrezza at room temperature.

Before an Afrezza cartridge is put in an inhaler, it must be at room temperature for 10 minutes. Having a sip of water before and after inhalation may also help. In the clinical studies, coughs were mild and typically declined with continued use after 1-4 weeks. If you develop a persistent or recurring cough, or have breathing difficulties while using Afrezza, contact your healthcare provider.

Important Safety Information

What is the most important information I should know about Afrezza?

Afrezza can cause serious side effects, including:

  • Sudden lung problems (bronchospasms). Do not use Afrezza if you have long-term (chronic) lung problems such as asthma or chronic obstructive pulmonary disease (COPD). Before starting Afrezza, your healthcare provider will give you a breathing test to check how your lungs are working.

What is Afrezza?

  • Afrezza is a man-made insulin that is breathed- in through your lungs (inhaled) and is used to control high blood sugar in adults with diabetes mellitus.
  • Afrezza is not for use in place of long-acting insulin. Afrezza must be used with long-acting insulin in people who have type 1 diabetes mellitus.
  • Afrezza is not for use to treat diabetic ketoacidosis.
  • It is not known if Afrezza is safe and effective for use in people who smoke. Afrezza is not for use in people who smoke or have recently stopped smoking (less than 6 months).
  • It is not known if Afrezza is safe and effective in children under 18 years of age.

What should I tell my healthcare provider before using Afrezza?

Before using Afrezza, tell your healthcare provider about all your medical conditions, including if you:

  • Have lung problems such as asthma or COPD
  • Have or have had lung cancer
  • Are using any inhaled medications
  • Smoke or have recently stopped smoking
  • Have kidney or liver problems
  • Are pregnant, planning to become pregnant, or are breastfeeding. Afrezza may harm your unborn or breastfeeding baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements.

Before you start using Afrezza, talk to your healthcare provider about low blood sugar and how to manage it.

What should I avoid while using Afrezza?

While using Afrezza do not:

  • Drive or operate heavy machinery, until you know how Afrezza affects you
  • Drink alcohol or use over-the-counter medicines that contain alcohol
  • Smoke

Do not use Afrezza if you:

  • Have chronic lung problems such as asthma or COPD
  • Are allergic to regular human insulin or any of the ingredients in Afrezza.

What are the possible side effects of Afrezza?

Afrezza may cause serious side effects that can lead to death, including:

See “What is the most important information I should know about Afrezza?”

Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:

  • Dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, hunger.

Decreased lung function. Your healthcare provider should check how your lungs are working before you start using Afrezza, 6 months after you start using it, and yearly after that.

Lung cancer. In studies of Afrezza in people with diabetes, lung cancer occurred in a few more people who were taking Afrezza than in people who were taking other diabetes medications. There were too few cases to know if lung cancer was related to Afrezza. If you have lung cancer, you and your healthcare provider should decide if you should use Afrezza.

Diabetic ketoacidosis. Talk to your healthcare provider if you have an illness. Your Afrezza dose or how often you check your blood sugar may need to be changed.

Severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction:

  • A rash over your whole body, trouble breathing, a fast heartbeat, or sweating.

Low potassium in your blood (hypokalemia).

Heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Afrezza may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Afrezza. Your healthcare provider should monitor you closely while you are taking TZDs with Afrezza. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:

  • Shortness of breath, swelling of your ankles or feet, sudden weight gain.

Get emergency medical help if you have:

  • Trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

The most common side effects of Afrezza include:

  • Low blood sugar (hypoglycemia), cough, sore throat

These are not all the possible side effects of Afrezza. Call your doctor for medical advice about side effects.

Please see full Prescribing Information and Medication Guide, including BOXED WARNING on Afrezza.com.

Does Insulin Really Go Bad After 28 Days?

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*DISCLAIMER: This is not medical advice. The author is not a doctor, pharmacist, or chemist. This article is not a guide to managing insulin but a look at different opinions, research, and guidelines regarding insulin expiration dates and temperature limits.

Despite being known as one of the “most powerful” hormones in the human body, insulin can also be pretty darn fragile. Like Goldilocks rummaging through the bears’ house, the fine print on your insulin vial or pen says it can’t be too hot, too cold, or too old.

Time and temperature can both play a big role in the potency of your insulin, and insulin that isn’t stored in perfect conditions must be thrown away — according to the manufacturers. But some independent research and anecdotal patient experiences say otherwise! The truth is that many members of the diabetes community regularly use insulin beyond the 30-day limit, although opinions differ on the wisdom of this approach.

Insulin can be catastrophically expensive, which can make throwing a partially used vial or pen into the trash a tragic event. For some people, especially those in the developing world, using insulin beyond its expiration date may almost be a medical necessity. 

Does an opened vial of insulin really go bad after 30 days? Does a few hours in the hot sun or the bitter cold really kill insulin whether it’s been opened or not? Let’s take a closer look at the official guidelines vs. the real-life experience and independent research.

What the Paperwork Says: 28 to 30 Days for Opened Insulin

According to most manufacturers’ official guidelines, insulin starts to degrade — and should be disposed of — 28 to 30 days after it’s been opened.

It certainly makes sense. Insulin is a protein. It eventually “spoils” — although it doesn’t lose its potency all at once. Instead, it gradually becomes weaker and weaker. Actually, insulin starts degrading immediately upon opening, but the degradation is very slow in the first 28 to 30 days. You really won’t notice it.

When you pass that 28- to 30-day window, it degrades more quickly. 

  • If you usually finish a vial or pen of insulin within 30 days, you don’t have to pay much attention to how many days it’s been since you opened it.
  • If you don’t usually finish a vial or pen within 30 days, don’t be surprised if days beyond 30 leave you feeling frustrated with stubborn highs that won’t budge. 

Most likely, the more sensitive you are to insulin, the more likely you are to notice when its potency is fading. 

How Long Does Insulin Really Last?

What happens if you ignore that 28- to 30-day time frame? I’ve been talking to people about diabetes for 20 years, and I can tell you that there’s no consensus. Some people say nothing happens: Insulin continues to work just fine! Others say they see a noticeable difference; you’ll find a broad mix of opinions when you look at this topic in the Diabetes Daily forums!

Should you toss your insulin after 30 days? Perhaps not and here’s why: It’s not going to go from 100 to 0 potency. Instead, it’s a gradual decline. Chances are you could get more out of it.

Independent research says insulin could last potentially four times longer than the medication guidelines suggest. In 2023, an international group of scientists tested a variety of insulins in real-world unrefrigerated conditions in India, during a season in which temperatures regularly reached as high as 95 degrees Fahrenheit. All of the insulins retained at least 90 percent potency after four months, and most retained more than 95 percent potency. The insulins fared even better when placed into clay pots to keep cool.

A spokesman for the researchers said, “If our results can be confirmed in larger studies, it may drive a change in the requirement to discard insulin kept outside a fridge after one month. The period when insulin may still be used can potentially, in that case, be extended to three or perhaps even four months.”

Extreme Heat and Cold 

Also in the manufacturers’ medication paperwork are plenty of warnings about temperature limits. The paperwork says temperatures that are too hot or too cold can destroy the potency of your insulin in just a few hours of exposure.

Ideally, insulin should be stored in the refrigerator when it’s not being used, and the temperature in your fridge should be between 36 to 46 degrees Fahrenheit. 

The guidelines say insulin can tolerate temperatures up to 77 degrees and as cold as 36 degrees, but ideally not for long. The longer your insulin is at a temperature above 46 degrees, the more likely it’s degrading. And insulin, just like water, freezes solid at 32 degrees; even after defrosting, it may be radically altered and unreliable. 

Is It Really Too Hot for Your Insulin?

Some research suggests that high temperatures are rarely a serious problem for insulin safety and potency.

In many parts of the world, it’s very challenging to protect insulin from temperatures over 77 degrees. A 2021 study led by Doctors Without Borders set out to test the accuracy of these heat limits in real-world conditions at Kenya’s Dagahaley refugee camp, where refrigeration is scarce.

In fact, the temperature in this area hits a typical daily high of around 98.6 degrees and rarely falls below 77 degrees, even at night. As Diabetes Daily editor Ross Wollen explains in his review of this study, according to the manufacturers’ instructions, no insulin should be able to endure these conditions for long. 

After one month, though, “all of those insulins were fully and equally potent. The insulin that warmed up to nearly 100 degrees F — not just once, but every day for a month — was just fine!” They kept the study going for a total of 12 weeks, and the results held up: All the insulin was still potent.

My Take

Insulin doesn’t go bad immediately when it reaches its expiration date. If your vial is only half-empty, and it’ll take another month before you use it up, you might notice it’s not as effective during those last couple of weeks. And if that happens? Well, then toss it.

Most likely, your insulin is still going to be relatively effective, but it will continue to degrade. The more sensitive you are to insulin, the more likely you’ll notice it losing its potency.

What about heat? Personally, I’ve left a pack of three cartridges of Afrezza inhaled insulin in my car for several weeks during a hot July summer. I did this on purpose and wanted to see how it impacted the potency. I used a cartridge and found no change in its efficacy.

So maybe heat doesn’t matter quite as much as we’ve been told? Although, it’s still worth stashing your insulin kit in the shade while you’re hanging at the beach. (And if you like hot tubs: Do not let your insulin pump or patch dip into the water of a hot tub! Yikes! No need to boil insulin.)

But I have experienced the dangerous consequences of damaged insulin from extreme cold.

In high school, I worked at the local movie theater. This is December in Hanover, New Hampshire. The temperature outside was well below freezing, and I was tasked with stringing up Christmas lights on the marquee letter board out front. I also had to update the marquee with the movies coming that Friday.

I was outside with my insulin pump in my jacket pocket for at least an hour.

Little did I know, the freezing temps were destroying my insulin quickly. My blood sugars seemed perfectly fine through the evening. It didn’t even cross my mind to be worried. Mind you, this was around the year 2004, before diabetes blogs or continuous glucose monitors (CGM).

I woke up the next morning in diabetic ketoacidosis (DKA), and my blood sugar was in the 500s. All night, I’d been getting damaged, weak insulin. I puked 15 times before finally going to the emergency room. 

And that, my friends, is a little old story about insulin temperature. So, I am pretty darn careful with my insulin in extreme cold because DKA is not fun.

Okay, so maybe we can meet in the middle. Maybe you don’t toss your insulin out after 30 days but you simply keep a closer eye on its efficacy. If you’re experiencing stubborn highs, maybe your insulin has lost some of its potency. 

If you’re worried about it, here are a few simple methods of keeping an eye on the calendar:

  • Use a permanent marker to write the date you opened it directly on the vial or pen. Do this the moment you open that vial or pen. Just get in the habit of it.
  • Mark your kitchen calendar with an “Insulin is done!” sort of note. (Yes, some people do still have calendars pinned to the wall!)  
  • Set a reminder on your phone or other “smart” devices. “Hey, Alexa, tell me on June 30 at 7 a.m. that my insulin is 28 days old.” Personally, I use my Amazon Echo to remind me of just about everything because I’m getting old.
  • Put an old-school Post-it note in the fridge compartment where you store your insulin and write the “opened” date. Then just keep updating that Post-it note.

Ah, insulin. We rely on it so desperately to keep us alive and yet it’s so darn finicky. Maybe you shouldn’t toss that expensive stuff into the trash just because of the calendar or hot temps. Be careful and be safe, and look closely at how your blood sugars are doing.

Robot pill delivers insulin directly to the gut — replacing injections for diabetes patients

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A robot pill that delivers insulin directly to the gut could replace multiple painful injections for people with diabetes. Researchers at the Massachusetts Institute of Technology say it can also deliver antibiotics, offering hope of battling superbugs with oral medications.

For patients and physicians, taking treatments orally is more desirable. Swallowing pills is safer, more convenient, and less invasive than other methods. However, some drugs often cannot withstand stomach acids before unleashing their payloads. The degradation makes them less effective.

The capsule, called RoboCap, could revolutionize modern medicine. In a swine model, it increased permeability for insulin by more than 10 times. Similar results were seen for pills containing vancomycin, an antibiotic that is usually delivered intravenously.

“Peptides and proteins are important drugs, but the degradative environment of the gastrointestinal tract and poor absorption has limited the ability to deliver these drugs orally,” says co-corresponding author C. Giovanni Traverso, MB, BChir, PhD, from the Division of Gastroenterology, Hepatology, and Endoscopy at the Brigham and the Department of Mechanical Engineering at MIT, in a media release.

Pigs have anatomical, physiological, and biochemical similarities to humans — making them ideal for research.

“RoboCap’s mucus-clearing and churning movements are designed to overcome these barriers and help deliver drugs to where they are needed,” Traverso adds.

How does RoboCap work?

About the size of a blueberry, the inexpensive device is made from biodegradable polymer and stainless-steel components. It makes it through the harsh environment of the stomach, resisting attacks from enzymes, and penetrating the small intestine’s mucus barrier and other obstacles.

Currently, many common drugs including insulin must be delivered through other means. Study authors say when a patients ingests the new pill, RoboCap’s gelatinous coating dissolves in the stomach. The environment of the small intestine activates RoboCap, which vibrates and rotates to clear mucus. This enhances mixing and deposits the drug payload in the small intestine where the body absorbs the drug.

The team says their motivation was to make it easier for patients to take their medications, especially those needing frequent injections. The classic example is insulin, but there are many other medications people are currently unable to take in pill-form.

Diabetes is a global issue

Many diabetics require several doses of insulin to manage their condition daily. The standard delivery method is through injections with small needles many times a day. It can be especially uncomfortable, unwieldy, and is harder than just taking a pill. The Centers for Disease Control and Prevention reports that 37 million Americans – or more than one in 10 – suffer from diabetes.

It is the eighth-leading cause of death in America, responsible for just over 100,00 fatalities each year. Insulin is naturally produced in the pancreas, then travels to the liver where it helps process blood sugar. A person suffering from type 1 diabetes does not produce enough insulin to manage blood sugar. All patients require some sort of dosage to manage the condition.

Those with type 2 diabetes, the form linked to obesity, may also need insulin medication to boost levels of the hormone and manage their blood sugar. The standard injection of insulin is 100 international units (iu) per shot. A vast majority is lost during oral delivery.

Previous attempts to develop an insulin pill have had to carry around 500 iu to properly function.

Humanized mice reveal arsenic may raise diabetes risk only for males

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Chronic exposure to arsenic, often through contaminated groundwater, has been associated with Type 2 diabetes in humans, and there are new clues that males may be more susceptible to the disease when exposed.

A new study – using lab mice genetically modified with a human gene to shed light on the potential link – revealed that while the male mice exposed to arsenic in drinking water developed diabetes, the female mice did not.

These results would not have been possible without using a mouse model engineered to express a human enzyme for metabolizing arsenic, since normal mice process arsenic much more efficiently than humans and require very high levels of exposure before they become diabetic.

In the paper, the researchers also identified a transcription factor called Klf11, which might be the master regulator of the difference in how the livers of males and females respond to arsenic.

“Our paper lays the foundation for future investigations into the mechanism of how arsenic exposure leads to diabetes, why there are striking male-female differences, and potential therapeutic strategies,” said Praveen Sethupathy ’03, professor of physiological genomics and chair of the Department of Biomedical Sciences at the College of Veterinary Medicine, and the study’s senior author.

“It highlights how important it is to use an appropriate genetic model [in this case, humanized mice], because none of these results were seen in the wild-type mice,” said Jenna Todero, a doctoral student in Sethupathy’s lab.

Todero is the first author of “Molecular and Metabolic Analysis of Arsenic-exposed Humanized Arsenic +3 Methyl Transferase (AS3MT) Mice,” which published Dec. 27 in the journal Environmental Health Perspectives.

Arsenic is the top priority substance for study, according to the Agency for Toxic Substances and Disease Registry. Human exposure to arsenic, which is common in the environment, often comes through contaminated groundwater. The safe exposure limit is 10 parts per billion, according to the World Health Organization and the Environmental Protection Agency.

Endemic levels of arsenic above safe limits in both Bangladesh and Mexico led to studies that showed an association between higher levels of arsenic exposure and Type 2 diabetes. Though these studies had very small sample sizes, they offered clues for further research.

The current study was performed on regular lab mice – known as wild-type mice – as a control and humanized mice that were engineered to express a human form of an enzyme, AS3MT, which is found across species, and is important for metabolizing arsenic in the body. Efficiency of this enzyme differs across species, but mice are far faster than humans at metabolizing arsenic.

All the mice were exposed for a month to doses of arsenic in drinking water that were nonlethal but sufficient to potentially promote Type 2 diabetes. The researchers then examined liver and white adipose tissues that are implicated in diabetes. In the humanized male mice alone, they found increased expression in genes related to insulin resistance. Also, in both liver and white adipose tissues of the humanized male mice, they identified a biomarker called miR-34a, which is highly associated with insulin resistance in Type 2 diabetes and other metabolic diseases.

“This would suggest miR-34a is potentially a way to screen individuals who live in areas that have endemic arsenic levels,” Todero said. “If you have elevated miRNA-34a, you might be at risk for Type 2 diabetes onset or other metabolic dysfunction.”

The researchers also identified the transcription factor (which regulates genes) Klf11 in the liver. “This was really exciting because we showed that genes that are highly important for things like regulating glucose or lipid metabolism seem to be targets for Klf11,” Todero said.

They found that Klf11 was significantly turned down in the humanized males, but not in the wild-type mice or the females. The study’s authors speculate that Klf11 might be a master regulator for genes associated with energy usage. It was suppressed in humanized male mice, likely causing dysregulation, and hallmarks of diabetes such as insulin resistance and elevated fasting blood glucose.

In the female humanized mice, the researchers found evidence of elevated expression of genes that support insulin sensitivity.

“We saw the opposite effect in females, where genes that promoted insulin sensitivity and glucose uptake had their expression increased,” Todero said. Previous work by another group suggested that the female sex hormone estradiol may play a role in the sexual divergence in the association between arsenic and Type 2 diabetes.