Complementary and Alternative Medicine Capstone Project
Type 1 Diabetes (T1D) is an autoimmune condition where there is a deficiency in insulin in the body (DiMeglio, Evans-Molina & Oram, 2018). A decrease or lack of insulin in the body will result in elevated blood glucose levels. Elevated blood glucose in T1D patients affect the entire body and all its systems. Systems most often affected are the kidney, digestive, urinary, metabolic, circulatory, reproductive, and cardiovascular (Dresden, 2019). The most common complaints related to high blood glucose in T1D patients are cardiovascular issues, damage to the kidneys and weight fluctuations (Skyler, 2017).
Before being diagnosed with T1D, the patient’s symptoms generally include diabetic ketoacidosis (DKA), extreme thirst, weight loss, and polyuria (DiMeglio, Evans-Molina & Oram, 2018). Diagnosis of T1D includes at least one positive autoantibody test. The test most often administered is the Diabetes Autoantibody Panel. The tests included in this panel are Insulin autoantibodies, Islet cell cytoplasmic autoantibodies, Insulinoma-associated-2-autoantibodies, and Glutamic acid decarboxylase autoantibodies (Diabetes Autoantibody Panel, 2021). C-peptide and fasting insulin are also tests for diagnostic purposes. Additionally, a fasting blood glucose level at diagnosis is usually above 126 mg/dL, any single blood glucose higher than 200 mb/dL and an A1C greater than 6.5% (DiMeglio, Evans-Molina & Oram, 2018). It is important to note that not all T1D patients test positive for autoantibodies.
The pathophysiology of T1D includes both environment and genetics. Risks are increased if a relative has T1D. Diet, gut microbiome composition, endocrine disruptors and diet are all common environmental factors (Skyler, 2017). Other common factors include viruses and, interestingly, climate (Serena et al., 2015). Diet is largely overlooked to be of importance in the environmental category. Dairy and gluten have been shown to have a high potential to be dietary triggers for T1D (Hogg-Kollars, Dulaimi, Trait & Rostami, 2014) as well as low vitamin D levels (Rak & Bronkowska, 2018).
The CDC reports that there is a significant increase in new cases of T1D among the youth, with the sharpest rise in populations that are black and Hispanic. In 2020 there were 187,000 children and 1.4 million adults with T1D (“National Diabetes Statistics Report”, 2020). This totals near 1.6 million people in American with T1D and this is up 30% since 2017 (Mulvey, 2020). Depending on the country of origin, a T1D patient can expect a mortality rate 3-18 times higher than what would normally be expected (Secrest, Washington & Orchard, 2018).
The most common complication causing death in T1D patients are renal and cardiovascular complications. Cardiovascular complications accounts for 2/3 of the T1D related deaths (Secrest, Washington & Orchard, 2018). Long term complications from T1D are DKA, neuropathy, skin complications, eye complications, kidney disease, cardiovascular disease, high blood pressure, and stroke (“Diabetes Complications”, n.d.).
Exogenous insulin is insulin made outside the body. Studies have shown that high concentrations of insulin can have a carcinogenic effect, promote tumorigenesis and has associations with several cancers (Donner & Sarkar, 2019). Additionally, absorption of exogenous insulin is variable and is clinically significant. Some things that can affect insulin absorption are exercise of area injected, local massage, temperature, site of injection, and physical status. Lastly, the degradation profile of exogenous insulin is altered as compared to endogenous insulin. What all this means is that exogenous insulin cannot and does not act exactly in the same capacity in the body as human insulin and high amounts of insulin (most often associated with high carbohydrate intake and insulin resistance) can cause damage to the body. High carbohydrate diets also equate to higher insulin which equates to higher cost.
The cost of diabetes is about $327 billion in the United States and is the highest costing chronic disease as of today. The raw cost of insulin is around $48 million or roughly 20% of the cost to treat diabetes. After rebates, this percentage adjusts to 6.3%. The average per capita cost of insulin is $6000 per year, up 11% annually since 2001 (“Insulin Cost and Pricing Trends”, 2020).
The CDC recommends getting half of one’s daily calories from carbohydrates. This equals about 200-225g of carbohydrates per day (“Carb Counting”, 2021). The American Diabetes Association suggests a plate that is ½ non starchy vegetables (while lower in carbohydrates, they still have carbohydrates), ¼ lean meats and ¼ carbohydrates. In the carbohydrates section they picture a potato and a pear (American Diabetes Association, 2019). Additionally, they recommend the Mediterranean diet, DASH diet and a plant based diet as the most beneficial diabetic diets without mention of carbohydrate restriction. Low carbohydrate is mentioned as possibly having benefit but they follow it with concerns and restrictions.
As great as it would be to know what the motives are behind why by the CDC and ADA recommend such a high daily carbohydrate intake, it is not a measurable or attainable discovery process. A low carbohydrate diet is not new and the studies showing the great benefit to diabetics are plentiful. Therefore, the purpose of this paper is to examine the effectiveness of blood glucose control and management in Type 1 diabetics by way of a low carbohydrate diet.
This paper investigated and included only high quality, scholarly articles retrieved from reputable databases. Only peer reviewed studies, articles and case studies were evaluated for inclusion. PubMed, the Alternative HealthWatch Database, and Google Scholar were the databases searched for articles to include. The search strings used were “low carbohydrate type 1 diabetes”, “keto type 1 diabetes”, and “CDC diabetes diet”. These search strings produced quite a few results to choose from. The number of articles originally obtained was 3,285. Articles without full text or if bias was noted were removed and 1,008 remained. Of these, exclusion criteria of 5 years old was applied, leaving 397 articles. Articles too similar were excluded and the remaining articles were included in this paper.
Priority was given to original studies and case studies. However, literature reviews and reports were also included. Qualitative and quantitative articles were both included. They both offered unique perspectives and valuable data to the discussion. This paper prioritized quantitative research when a choice needed to be made. Most of the studies revolved around a dietary plan with monitoring of blood glucose and the response to the dietary change. In most cases the dietary plan was designed by the researchers, but in some cases the participant themselves designed the plan so long as they stayed under an agreed upon carbohydrate count.
Low Carbohydrate Diet
Arora & McFarlane (2005) performed a literature review to examine the use of low carbohydrate diets in general diabetes management. How a low carbohydrate diet positively effects metabolic abnormalities commonly associated with diabetes was also studied. The review reported that a low carbohydrate diet has a positive effect on the following for diabetes: weight loss, glycemic control, decrease of postprandial hyperglycemia, improving characteristic dyslipidemia, increased insulin sensitivity, and decrease in inflammation. The conclusion was that the concerns over a low carbohydrate diet for diabetics are not substantiated by data. Rather, it compares more favorably to diets such as the standard low fat diet.
Lennerz et al. (2018) performed an online survey of T1D patients who follow a very low carbohydrate diet (VLCD). The survey was conducted across social media groups internationally. The pool of patients consisted of 316 adults with T1D and parents of T1D children. HbA1c was the primary measure of the survey, along with insulin dosage and any adverse effects. The mean diagnosis age of the participants was 16+- 14 years and a very low carbohydrate diet was followed for a mean of 2.2 +- 3.9 years. The mean carbohydrate intake was 36g +- 15g (n=223). The mean HbA1c was 5.67 (n=300). Some of the participants wore a continuous glucose monitor and reported their mean blood glucose was 104 +- 16. Participants adhered to less than 30g/day of carbohydrates, mostly from vegetables and nuts. Statistical analysis was performed using SAS version 9.3 with p < .01. It was noted that the only significant predictor was carbohydrate intake. For every 10g of carbohydrates consumed, HbA1c went up by .1%. The authors note that further studies may be needed to generalize these results to the T1D population.
Leow, Guelfi, Davis, Jones & Fournier (2018) performed an observational study to determine if the ketogenic diet would result in improved glycemic control without causing negative effects in T1D patients. The study consisted of 11 adults (4 women and 7 men) who ate less than 55g of carbohydrates daily for a mean of 2.6 +- 3.3 years. Participants wore a continuous glucose monitor for 7 days and fasting blood sampling and analysis occurred. The mean HbA1c levels of the participants was 5.3 +- 1.3 mmol/l. Participants spent 74+- 20% in normal range (4-8mmol/l), 3+-8% in hyperglycemic range (> 10mmol/l) and 3.6% of the time in the hypoglycemic range (< 3 mmol/l). It was also shown that the participants had very little glycemic variability.
Feinman et al. (2015) wrote a report detailing how a low carbohydrate diet can be a great adjunct to pharmacology in T1D patients. This report gave many valid reasons why it is important for T1D patients to adhere to a low carbohydrate diet. It did point out that there is a lack of definition around what low carbohydrate diets mean and it attempted to clarify those parameters for the basis of the report. A very low carbohydrate ketogenic diet consisted of 20-50 g/day of carbohydrates with less than 10% of a 2000 kcal/d diet coming from carbohydrates. A low carbohydrate diet is considered less than 130 g/day or less than 26% of the total energy coming from carbohydrates. A moderate carbohydrate diet is 26%-45% of the total energy coming from carbohydrates and finally greater than 45% is considered a high carbohydrate diet. The primary goal of diabetes management is glycemic control and restricting carbohydrates has the greatest effect on blood glucose and thereby giving that control. The studies analyzed showed T1D participants to have a great decrease in blood glucose levels while eating a low carbohydrate diet without the side effects that can accompany intense pharmacological treatment. It was concluded to be a great adjunct diet for T1D management.
Toth & Clemens (2014) performed a case study on a 19 year old T1D male patient. He was newly diagnosed and immediately put on insulin therapy. His initial blood glucose was 384 mg/dL. His first treatment consisted of a standard low fat, high carbohydrate diet. This diet included 240g of carbohydrates daily and 38 IU of insulin. He followed this diet for a total of 20 days. His blood glucose ranged from 68-267 mg/dL. This diet yielded no improvements and he therefore began eating a paleolithic ketogenic diet (inherently low carbohydrate). His meals consisted of meat, organ meat, eggs and fat, with suboptimal vegetable intake. His blood sugars returned to normal levels without a postprandial raise. Therefore, he was able to discontinue insulin usage. The average post prandial rise on the standard diet was 23 mg/dL and the average rise on the paleolithic ketogenic diet was 5.4 mg/dL. The patient’s average blood glucose on the paleolithic ketogenic diet was 85 mg/dL. His carbohydrate restricted diet allowed for normal blood glucose levels.
Öz, Arslanoglu, Cangür, Bolu & Kocabay (2021) performed a short term randomized cross over study of 28 T1D girls. The goal of the study was to observe risks and benefits when eating a short term low carbohydrate diet. The participants were hospitalized for 7 days with a continuous glucose monitor (CGM) and either started on a low carbohydrate diet (LCD) or regular diet. The low carbohydrate diet consisted of approximately 25% of calories from carbohydrates. The standard diet consisted of 55% of calories from carbohydrates. The 128 hour study began with a 12 hour CGM warm up period, 60 hours as the first diet period of either LCD or standard, 36 hours of free eating, and the final 60 hours was for the alternate diet. Throughout the entire study, no hypoglycemic episodes occurred. Low blood sugar was defined as lower than <80 mg/dL (4.4 mmol/L). It was reinforced that there is no short term risk of ketosis or hypoglycemia with a 24% carbohydrate intake.
Obesity and Insulin Resistance
Scott, Anderson, Morton, Wagenmakers & Riddell (2019) performed a literature review that investigated positives and negatives of a low carbohydrate diet as an effective and safe therapy for improved metabolic health and improved glycemic control of T1D patients. One benefit that resulted from a low carbohydrate diet was weight loss. This is important because their data suggested obesity among T1D patients is increasing. In fact, from 1988 to 2007, the obesity prevalence of T1D patients went from 3% to 26%. It was also noted that obesity could be the result of intense insulin therapy with the addition of a positive energy balance. Therefore, restricting carbohydrates may aid in weight loss because insulin requirements likely go down.
Additionally, it was also noted that insulin resistance is common in T1D patients. This may be the result of a higher intake of exogenous insulin. Yet another reason for carbohydrate restriction.
Decrease in cardiovascular disease
As discussed, Feinman et al. (2015) wrote a report detailing how a low carbohydrate diet can be a great adjunct to pharmacology in T1D patients. They stated that T1D (as well as T2D) patients are at increased risk for cardiovascular disease (CVD). A large study on T2D patients found that for every 1% decrease in HbA1c, there is a corresponding 14% decrease in myocardial infarction and a 37% decrease in the end points for microvascular risk. It is noted in the report that low carbohydrate is reliable for decreasing HbA1c and thereby decreasing risk for CVD.
Potential reversal and prevention
Bolla, Caretto, Laurenzi, Scavini & Piemonti (2019) performed a literature review of how low carbohydrate and ketogenic diets can be used with T1D as well as T2D. One interesting thing that they found in their investigation was that a low-calorie, low-carbohydrate, low-protein, high fat 4 day diet (FMD) was shown to reprogram islet cells and reverse insulin deficiency in mouse models. In human cells from T1D patients, it was shown to reverse insulin deficiency defects. This is a fast mimicking diet (similar to a water fast) and only done in 4 day increments. It is noted by the authors that this should definitely be investigated further in the future as it shows promise.
In addition to what was already discussed in the case study by Toth & Clemens (2014), the result also showed an amazing 3-fold increase in the patient’s C-Peptide values. The patient’s initial C-Peptide was measured at 0.6 ng/mL. After only 10 weeks, it was 2.2 ng/mL. This is indicative of the restoration of insulin production. It was noted that further studies should be done to determine if this diet could halt or reverse the destruction of beta cell function.
Impact on Insulin
Dressler et al. (2010) performed a case study report on a T1D girl who was 3.5 years old with T1D and epilepsy. She was put on a ketogenic diet which consisted of 800-1200 calories, 18g of protein and 27.2g of carbohydrates. This diet was adjusted with age. At the start of the ketogenic diet, her HbA1c was 7.9 and ended at 6.2 after 15 months. Her weight, height, metabolic profile, blood count, selenium and zinc were all normal at the conclusion of the study. No hypoglycemic events or ketoacidosis occurred. The insulin requirements were .76 IU but immediately dropped to .38 IU at the start of the ketogenic diet. This is an immediate cut in half of the required insulin. The insulin was adjusted over time as the diet was adjusted, but at the conclusion of the study, her insulin intake was .45 IU which is still drastically less that what she started the study on. Despite the success of the case study, the ketogenic diet was discontinued due to the child not wanting to eat ketogenic foods any longer.
As discussed previously, Öz, Arslanoglu, Cangür, Bolu & Kocabay (2021) performed a short term randomized cross over study of 28 T1D girls with T1D consuming a low carbohydrate diet. The study resulted in the participants having have better glycemic control overall. The participants in the study had no hypoglycemic events either. Across the board, the amount of prandial insulin that they used was also decreased.
Reduction in errors
In the report by Feinman et al. (2015), insulin usage is also discussed. It was shown through study analysis that reducing carbohydrates reduces insulin. Less insulin has also been shown to reduce errors. Errors can often occur when calculating insulin doses for carbohydrates at meals. This correlates to reduced hypoglycemic events (too much insulin) and reduced hyperglycemic events (not enough insulin).
Nielsen, Gando, Joensson & Paulsson (2012) conducted a study to assess adherence to a low carbohydrate diet in T1D patients. They aimed to assess adherence over a 4 year time period using individuals who have attended an educational course. This was assessed by examining HbA1c as well as reports from the T1D patients. There were 48 participants who had T1D for 24+-12 years. Out of 48 participants, 25 did not adhere to the low carbohydrate diet long term. Their HbA1c started at 7.6% +- 1%, was 6.3 +-.7% after 3 months and then 6.9 +- 1% after 4 years. The remaining 23 who did adhere to the diet for those 4 years started with an HbA1c of 7.7 +-1%, after 3 months it was 6.4% +-.9% and after 4 years it was 6.4% +-.8%. The group that adhered to the diet maintained their lower HbA1c. The group that did not adhere did not maintain their original decrease.
Bolla, Caretto, Laurenzi, Scavini & Piemonti (2019) noted that one of the drawbacks to a low carbohydrate diet is a lack of adherence. Their literature review found that many participants stopped following a low carbohydrate diet within 1-2 years. The stated reasons from the participants varied, but the most common answer was due to smaller food choices. A clinical audit of T1D patients following a low carbohydrate diet suggested that roughly 50% of the patients stopped the low carbohydrate diet within 2 year and most of the rest stopped within 4 years. The authors note that long term adherence and feasibility are an unknown with a lack of proper data.
Sheard et al. (2004) performed a literature review to evaluate the effectiveness of carbohydrate type and source in the management of T1D. While the focus of this paper was not about carbohydrate restriction, it was mentioned that the ADA does not recommend a low carbohydrate diet. The paper admitted that dietary carbohydrates increase (and has the greatest influence on) postprandial blood glucose, yet it stated that low carbohydrate diets are not recommended because carbohydrate containing foods contain vitamins and minerals, glucose is the brain and central nervous system’s primary fuel, and that carbohydrates are part of a healthy diet. It therefore defaulted to the standard recommendation of 45-65% of calories from carbohydrates.
Mayer-Davis, Laffel, & Buse (2018) published a series of responses to a study that showed a low carbohydrate diet is beneficial to T1D patients. The study that was being critiqued was by Lennerz et al. (2018) that was also discussed in this paper. Many objections were noted, namely selection bias and that the participants had other tools that also contributed to their excellent glycemic control. An additional objection noted was if the low carbohydrate diet was so low in calories and insulin that diabetic ketoacidosis may happen faster in the case of illness. This is due to the fact that with a mild starvation ketosis and therefore lower serum insulin levels, diabetic ketoacidosis is potentially more likely to develop.
Patients did not want to talk to their doctors
As discussed, Lennerz et al. (2018) performed an online survey of T1D patients and parents of T1D patients who followed a low carbohydrate diet. One thing the participants noted was that they had a high level of satisfaction for their current health. However, they were not happy with their diabetes care in general. Of the participants, 27% of the participants did not discuss their diet with their diabetes care team. Of that 73% that did discuss their low carbohydrate diet with their diabetes care team, only 49% said that their care team supported their low carbohydrate diet. Reasons for not discussing the low carbohydrate diet with their diabetes care team were that they felt unsupported, their diabetes care team was unfamiliar with the low carbohydrate diet, parents of T1D children were afraid of being accused of child abuse, disagreement on treatment goals, and general disinterest from the care team. Having said that, 82% of the providers perceived the patient relationship to be good or excellent. Providers also perceived their support to be much higher than was perceived by the patients.
As discussed, Nielsen, Gando, Joensson & Paulsson (2012) conducted a study to assess adherence to a low carbohydrate diet in T1D patients. They used their education program to teach about the diet. Their study concluded that the group that adhered to the diet maintained their lower HbA1c. The group that did not adhere, did not maintain their original decrease. The adherence to the diet long term is attributed to the education program that the participants went through. Approximately 50% of the T1D patients made lasting changes to a low carbohydrate diet after their program.
Arora & McFarlane (2005) state in their examination of data of low carbohydrate diets that physicians are reluctant to prescribe a low carbohydrate diet to their patients. Even in cases where the T1D patient fails to thrive with the standard low fat, higher carbohydrate diet, it is not considered in most cases. The reasons that they uncovered in their review are that a low carbohydrate diet is often confused with the Atkins diet and therefore immediately rejected. Additionally, researchers downplay the evidence of benefits, there is a simple misinterpretation of data and health organizations have been slow to adopt the emerging data. Together, all this makes it difficult for it to be considered by physicians.
One of the main goals for treatment success for T1D is glycemic control. These values are measured most often with HbA1c, fasting blood glucose and post prandial blood glucose. As Lennerz et al. (2018) importantly noted, carbohydrates are the most significant determinant of blood glucose. It would be prudent to not thoroughly investigate the use of a low carbohydrate diet for better glycemic control. The use of insulin is ultimately required with T1D but does come with certain risks, namely hypoglycemia and hyperglycemia. Tempering these risks would require lowering the intake of carbohydrates as that is what most directly impacts the usage of and the dosage of insulin. Uncontrolled or predominantly high blood sugars can result in a huge array of health complications as well as death. The current diet that is suggested is rarely much different than that of the general population. The Acceptable Macronutrient Distribution Range (AMDR) for Americans for carbohydrates is 45-65% (Williams, Rawson & Branch, 2019). Based on a 2000 Calorie diet, that is 225-325 grams per day. As discussed, the CDC recommends 200-225 grams per day of carbohydrates for diabetics (“Carb Counting”, 2021).
This paper used qualitative and quantitative articles to examine the effectiveness of blood glucose control and management in T1D patients by way of a low carbohydrate diet. The key findings of this paper support a low carbohydrate diet for an adjunct therapy to manage T1D. It lowers HbA1c and blood glucose. It can be safe, it is well tolerated, and it provides for excellent glycemic control, with little variability, and has positive outcomes.
Across the board, this paper shows evidence for positive and safe outcomes with the low carbohydrate diet and reinforcing carbohydrate intake being directly linked to HbA1c. Leow, Guelfi, Davis, Jones & Fournier (2018), Lennerz et al. (2018) and Feinman et al. (2015) all demonstrate a near normal blood glucose and/or near normal HbA1c in the study participants or patients eating a low carbohydrate diet. A T1D patient should experience as normal blood glucose levels as possible in order to maintain health. None of these studies showed or suggested any adverse effects on the diet.
Not only did Toth & Clemens (2014) demonstrate with a case study that in a newly diagnosed T1D patient insulin was able to be halted (possibly prolonging the honeymoon period), but he was also able to experience normal blood glucose levels in the absence of insulin. The interesting part of this case study was the c-peptide values tripled, which effectively is a return of insulin production. Additional studies in this area should be conducted as there does existing a period after initial diagnosis where insulin usage is often quite low and sometimes zero. This is referred to as the honeymoon period. It should be studied to see if, in fact, the honeymoon period can be indefinitely prolonged with greater endogenous insulin production.
Outside of glycemic control, safety and adherence are big concerns when using a low carbohydrate diet with T1D patients. Arora & McFarlane (2005) clearly showed that the benefits are numerous and the current concerns over the low carbohydrate diet simply are not substantiated by data. Bolla, Caretto, Laurenzi, Scavini & Piemonti (2019) showed that adherence tends to drop off after one to two years with a mostly complete drop off after 4 years. While Nielsen, Gando, Joensson & Paulsson (2012) also found that people start to drop off the diet after 1-2 years, they also noted that educational programs seem to help roughly 50% of people adhere long term. This argues for a need for educational programs around the low carbohydrate diet along with the long term benefits of the diet.
Not only does taking insulin leave room for potentially dangerous errors as Feinman et al. (2015) pointed out, but insulin costs money. Insulin is necessary for T1D, but the amount of insulin is dependent on carbohydrate intake. It is logical to conclude that a reduction in insulin would lead to a reduction in potentially deadly errors, but would also lead to a reduction in cost. Eating a low carbohydrate diet allows for less insulin as Feinman et al. (2015), Toth & Clemens (2014), Dressler et al. (2010), Öz, Arslanoglu, Cangür, Bolu & Kocabay (2021), and Mayer-Davis, Laffel, & Buse (2018) all point out.
The contributions this study is making to the literature are a compelling case for using a low carbohydrate diet to effectively manage T1D in addition to insulin therapies as well as a display that it can be implemented safely and efficiently. The outcome of this project indicated that implementing a low carbohydrate diet for T1D is an effective and necessary approach to management in order to mitigate complications and even death. It is time that the governing health agencies that have the most authority over T1D guidelines come up to date with the current data. It is not acceptable to continue to perpetuate a diet that is not consistent with the disease management and the disease itself. Guidelines that put the health of the patient first need to be made. The guidelines that worry more about the taste of food and mistrust of a patient to adhere need to be removed and replaced with education and patient-first guidelines.
The outcome of this project reinforces that a low carbohydrate diet is effective in assisting with the management of blood glucose levels and general T1D management. Studies and evidence strongly support the use of a low carbohydrate diet in T1D patients. It lowers blood glucose, lowers HbA1c, reduces insulin requirements and corresponding errors, and reduces diabetic complications. It does all this without complications or risk of DKA. It can be a safe adjunct management protocol with regular insulin therapy.
This project also identified the need for educational programs. There needs to be educational programs for the patients regarding the benefits of a low carbohydrate diet, the importance of adherence and even healthy eating suggestions. In addition to patients, doctors need to be educated on the importance of low carbohydrate protocols as an immediate protocol in T1D patients upon diagnosis. Lastly, health institutions and governing agencies need to update their protocols to reflect current, evidence-based science for the health of their patients.
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