What is Diabetes and Why is Prediabetes Controversial?
You may have heard of diabetes before, but do you know what it is?
Essentially, diabetes is the term given when someone’s body is unable to produce enough, or any, of the hormone, insulin, which helps control blood glucose (the sugar in your blood). Glucose, which is used as energy in the body, is a sugar in your blood that comes from the food you eat. Without enough insulin, our cells would not be able to uptake glucose, which would then cause our glucose (sugar) levels to rise in the bloodstream, leading to dehydration and destruction of body tissue over time. With the absence of insulin, glucose in the blood is unable to enter the cells and be used for energy.
There are two types of diabetes:
Folks who have type 1 diabetes typically develop it during childhood or adolescence. Sometimes, type 1 diabetes is labeled as “juvenile diabetes”, but adults may also find themself being diagnosed, which makes the term inaccurate. Type 1 diabetes is an autoimmune disorder, which means that the body mistakenly attacks its own pancreas, believing it to be of an unknown origin. This attack on the body causes the pancreas to stop making insulin or to make very little of it. Thus, people must inject their own insulin via syringe or pump for survival.
Folks who have type 2 diabetes can be diagnosed at any point in their lives, most often in young adulthood and beyond. With type 2 diabetes, the cells in the body become resistant to insulin over time, which results in decreased uptake of glucose from the bloodstream into the cells. Type 2 diabetes is a progressive condition. Depending on a multitude of factors, the management of it will look different for each person. Some folks will need insulin or medications that support their body's insulin production, while others may manage blood sugar levels with lifestyle factors, such as mindful movement, dietary intake, stress management, and sleep management. It is not uncommon for the way a person manages the condition to change over time.
It is estimated that 37.3 million people, or 11.3% of the U.S. population, have diabetes. Of these 37.3 million Americans, 28.7 million are diagnosed type 2 cases, 8.5 million (23%) are undiagnosed type 2 cases, and 1.9 million (5%) are type 1 cases.
Research shows that a person is much more likely to be diagnosed with diabetes if they are of Native American/Alaskan Natives descent, non-Hispanic black descent, Hispanic descent, or Asian descent, when compared to non-Hispanic white people. There is no concrete reason as to why this may be the case, but it may be due to the fact that the BIPOC community is more likely to experience barriers to healthcare, including care that may reduce the likelihood of developing diabetes.
In order to be diagnosed with diabetes, your hemoglobin A1C (HbA1C), commonly referred to as your “A1C”, must be 6.5% or higher. Your A1C is a blood test that measures your average blood glucose (blood sugar) levels over the past three months. The reason why an A1C test represents your average blood sugar levels is due to the fact that glucose sticks to hemoglobin, a protein in red blood cells, for as long as the red blood cells live (which is about 3 months).
Now, onto the more controversial topic of “Prediabetes”. What is it? Who created the term and why?
Prediabetes is a term that is meant to characterize blood sugar levels, measured by an A1C, that are higher than “normal,” but not high enough to warrant a type 2 diabetes diagnosis. Prediabetes is NOT a disease, but it is instead a set of characteristics that may suggest that someone is at an increased risk to develop a disease–diabetes type 2.
The A1C ranges are as follows:
Normal: Below 5.7%
Prediabetes: 5.7% to 6.4%
Diabetes: 6.5% or above
Did you know that the term “prediabetes” is only about 20 years old? Since 1980, the World Health Organization (WHO) has used two criteria to define an increased risk of developing diabetes: impaired glucose tolerance and impaired fasting glucose. Impaired glucose tolerance means that blood glucose levels are consistently higher than the normal range but lower than the diabetic range. Impaired fasting glucose means that when fasting, blood glucose levels are consistently higher than the normal range but lower than the diabetic range. Impaired fasting glucose can exist in the absence of impaired glucose tolerance.
In 2003, the American Diabetes Association (ADA) lowered the impaired fasting glucose threshold from 125 mg/dl to 100 mg/dl. Shortly after, the term “prediabetes” was introduced into the literature, and the ADA eliminated “impaired fasting glucose” and “impaired glucose tolerance” altogether. In 2009, an international expert committee, which included the ADA, recommended that people with hemoglobin A1C readings between 6.0 and 6.4 “receive demonstrably effective preventive interventions.” A year later, an A1C test was added to the ADA’s prediabetes diagnosing guidelines, and the diagnostic threshold was lowered to 5.7. Neither the International Diabetes Federation (IDF) nor WHO endorsed lowering the A1C threshold, but the Centers for Disease Control and Prevention (CDC) did adopt these guidelines.
The combination of lowering the different blood sugar test thresholds and the new A1C standard created “about 72 million potential new prediabetes cases in the United States alone—and could create hundreds of millions more if embraced worldwide.”
Following the new A1C ranges, it would be estimated that about 96 million adult Americans could be diagnosed with “prediabetes”, or 1 in 3 adults. On top of that, of the folks with “prediabetes”, only about 20% of them are aware of their “diagnosis.”
A 33.33% chance of having prediabetes seems very high. That must mean that the chances of progressing to having diabetes must be very high as well in order for the CDC and ADA to have created this diagnosis, right?
Well, the data examining the likelihood of progression from prediabetes to diabetes is actually inconclusive and varied from a 5.3% progression rate in 1 year, to ~2.5% in 2 years, to 10% progression rate in 5 years.
Research on this topic also points out variations in results when interventions for prevention are involved versus not. Furthermore, people who do progress usually start out at the higher end of the ADA prediabetes test range. *** Please refer to appendix A, found below, for more details of the research results.
According to an ADA expert panel, up to 70% of individuals with prediabetes will eventually develop diabetes. However, most articles that the ADA used to back up this claim are NOWHERE NEAR 70% progression. In fact, only 1 of the 7 articles presented data close to 70%, and the article does not even use the current prediabetes parameters set but rather uses the old parameters prior to change in 2003. *** Please refer to appendix B, found below, for more details of the research results.
If the chance that prediabetes will progress to diabetes is both shown as being low in many studies and also varied depending on many factors, then why is the pharmaceutical industry developing drugs specifically targeted for people with prediabetes? That seems a bit overkill. Is it possible that those who do progress from prediabetes to diabetes may have other contributing factors like genetics, other health or medical conditions, family history, or other medications?
Medication is not a light subject. For many, going on medication means a long-term or life-long commitment. When making such a commitment, it is crucial to determine if the benefits of the drug outweigh the risks.
As of July 2023, there is not a single drug on the market approved by the FDA for adult “prediabetes”. However, Big Pharma has at least 10 classes of drugs in the works that will be targeted to folks with “prediabetes”.
Considering that the risk of progressing from prediabetes to diabetes is so low, whether interventions are in place or not, are the possible benefits of these drugs worth the side effects? MedlinePlus notes common side effects of metformin include “diarrhea, bloating, stomach pain, gas, indigestion, constipation, and more.”
It makes sense why there is such a big push for medication when the ADA accepts an exorbitant amount of donor money from drugmakers and questionable donors each year.
“The ADA came under fire for accepting money from sugary food companies like Coca-Cola and Cadbury Schweppes, the manufacturer of Dr Pepper and Cadbury eggs. In exchange for Cadbury’s $1.5 million donation, the company received permission to use ADA’s label on their diet drinks.” Additionally, the ADA receives millions of dollars each year from drug companies and other firms in the diabetes and prediabetes markets, including many donations of $500,000 to $1 million per year.
A recent study from 2023 reveals financial conflicts of interest with the ADA’s Standards of Medical Care in Diabetes (2021) and drug companies. “Of the 25 guideline authors… eight (32.0%) and 12 (48.0%) received one or more industry payments one year and three years prior to the guideline publication, respectively. The median total payments (interquartile range) per author were $33,262 ($4,638‒$101,271) in 2020 and $18,053 ($2,529‒$220,659) in 2018-2020. One author received a research payment of over $10,000 undeclared. Of 471 recommendations, 61 (13.0%) and 97 (20.6%) were supported by low-quality evidence and expert opinions, respectively.”
Science reports that “seven of the 14 ADA experts got between $41,000 and $6.8 million between mid-2013 and 2017 from makers of diabetes drugs or candidate prediabetes medicines or devices. The payments covered consulting, travel, and research and included an average of $276,000 for personal fees.”
Additionally, the CDC's budget for diabetes prevention increased from $66 million in 2010 to $170 million in 2017—a 157% increase. At the same time, the CDC’s cancer prevention budget decreased by 11.4% from $341 million in 2010 to $302 million in 2017.
Why is it that the budget for diabetes prevention skyrocketed while the budget for cancer prevention decreased when someone is 5.8 times more likely to die from cancer compared to diabetes in America? Could it be due to the fact that diabetes is a much more profitable disease compared to cancer? Not only can companies target the millions of people diagnosed with diabetes, but they can also target the 96 million people with prediabetes.
Richard Kahn, the ADA’s chief scientific and medical officer, reported that “there's never been a study to show that a population can lose sufficient weight and keep it off over more than a few years in order to prevent diabetes over the long run. Never. Not one.”
So why are doctors pushing weight loss on folks who have “prediabetes”? Is it because the diet/weight loss industry is also incredibly profitable and worth around $224.27 billion in 2021 and is estimated to hit approximately $405.4 billion by 2030? Not only can businesses and folks profit off the pharmaceutical industry but also the weight loss industry…especially with the new concerning diabetes/weight loss drugs, like Ozempic.
Thank you for reading! Look for our next blog post about a weight-inclusive approach for diabetes.
Appendix A:
The Centers for Disease Control and Prevention (CDC) reports progression from prediabetes to diabetes at less than 2% per year, or less than 10% in five years.
A comprehensive 2018 review of 103 studies showed that up to 59% of prediabetic patients returned to normal glycemic values over 1 to 11 years with no treatment whatsoever. The review also noted that studies of people labeled prediabetic often fail to account for weight, age, and physical activity, which can all affect glucose, as can daily stress, inflammation, and other factors.
A study looking at adults 65 years and older estimates a 5.3% progressive rate per year.
A Diabetes Prevention Program study lasting 2-8 years found that only 11% of prediabetes cases progressed to diabetes without any interventions, 7.8% of cases progressed even when using Metformin, and 4.8% of cases progressed even with an intensive lifestyle intervention (the main goal was weight loss). During the 10 year follow-up, only an additional 5.6% of folks with prediabetes progressed to developing diabetes without any intervention, 4.9% progressed who used Metformin, and 5.9% progressed who used an intensive lifestyle intervention (the main goal was weight loss).
Two studies show that around 5%-10% of people with prediabetes are diagnosed with diabetes annually, although the conversion rate varies by population characteristics and the definition of prediabetes.
A study from 2018 exemplifies the low risk of being on the lower end of the prediabetes A1C spectrum. Out of 77,000 people whom doctors deemed had prediabetes, regardless of BMI, ~2.5% of people who had an A1C of 5.7–5.8 progressed to diabetes within two years. However, folks who had an A1C of 6.3 to 6.4, regardless of weight, ~7.5-21% of them progressed to diabetes within 2 years. Only about 5% of individuals with prediabetes are at greater than 10% risk of developing diabetes in the next 2 years, whereas more than 80% are at much lower risk of T2DM (< 2%).
Appendix B:
Study 1: The progression to diabetes, over 4 years, was 11% in the intervention group and 23% in the control group without treatment. The population consisted of 522 middle-aged folks (~55 y/o) with an average BMI of 31.
Study 2: The progression to diabetes, over ~2.8 years, was 11.0% for no intervention, 7.8% for metformin intervention, and 4.8% for lifestyle intervention.
Study 3: had no results showing progression.
Study 4: Without any intervention, the progression to diabetes, over 10 years, was 12.1% for folks with Impaired Glucose Tolerance, but Normal Fasting Glucose (IGT/NFG), 11.9% for folks with Impaired Fasting Glucose, but Normal Glucose Tolerance (IFG/NGT), and 20% for folks with Impaired Glucose Tolerance & Impaired Fasting Glucose (IGT/IFG)–which was not significantly higher than in IFG/NGT and IGT/NFG (p = 0.53). Of folks with normal fasting glucose & normal glucose tolerance, 3.9% progressed to diabetes.
Study 5: The pooled relative risk for new diabetes cases is 6.02% in people with IGT, 4.70% in people with IFG, and 12.2% in people with both disorders.
Study 6: At baseline, there were 607 subjects with IGT and 266 subjects with IFG. There were 297 subjects who developed diabetes by 1992. Only 26% of subjects that progressed to type 2 diabetes were predicted by their IFG values, but a further 35% could be identified by also considering IGT.
Study 7: As a consequence of the definitions used, the cumulative incidence of diabetes was highest according to the WHO-1999 criteria: 9.9% compared with 6.1% and 8.3% according to the WHO-1985 and the ADA criteria, respectively. Of the 1231 participants with NGT at baseline, 46 (3.7%) had diabetes at follow-up, according to the WHO-1985 criteria. For participants with IGT, the cumulative incidence was 32.4% (WHO-1985 criteria). According to the ADA criteria, the cumulative incidence was 5.0% for participants with NFG and 38.0% for those with IFG. The cumulative incidence (WHO-1999 criteria) among participants with both impaired fasting and impaired postload glucose levels was 64.5%, compared with 4.5% for those with both normal fasting and normal postload glucose levels.
