Category: Diabetes

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Check Vitamin B12 Levels on Metformin Patients

Patients who use metformin might experience reduced levels of Vitamin B12.  Older patients in particularly can have a decrease in cognitive performance, according to study results published in The Journal of Endocrinology & Metabolism.

Long-term metformin use has been associated with B12 vitamin deficiency. The goal of the study was to investigate the effects of hyperglycemia and metformin use on folate-related B vitamin biomarkers and cognitive performance in older adults.  Researchers assessed 4160 community-dwelling older people (average age, 74.1 years) for biomarkers of folate, vitamin B12, vitamin B6, and riboflavin.

Classified as normoglycemic (n = 1856) or hyperglycemic with (n = 318) or without (n = 1986) metformin treatment, each participant was assessed for cognitive ability according to the Repeatable Battery for Assessment of Neuropsychological Status and the Frontal Assessment Battery.

On average, patients with hyperglycemia were older, more overweight, and had worse renal function than patients who were normoglycemic. All groups demonstrated normal mean scores on all cognitive tests.

Compared with patients with normoglycemia and patients with hyperglycemia not treated with metformin, patients with hyperglycemia who received metformin treatment were at greater risk for deficiency in vitamin B12 (combined B12 index ≤-1; odds ratio, 1.45) and B6 levels (plasma pyridoxal 5-phosphate <30 nmol/L; odds ratio, 1.48).

After adjusting for various confounding factors, results from the Repeatable Battery for Assessment of Neuropsychological Status and Frontal Assessment Battery tests demonstrated that metformin use was associated with elevated risk for cognitive dysfunction (1.36 and 1.34, respectively).

Because of the cross-sectional nature of this study, the researchers noted an inability to confirm causal relationships between diabetes/metformin use and B-vitamin deficiency.

From the ADA 2019 guidelines, “A recent randomized trial confirmed previous observations that metformin use is associated with vitamin B12 deficiency and worsening of symptoms of neuropathy (43). This is compatible with a recent report from the Diabetes Prevention Program Outcomes Study (DPPOS) suggesting periodic testing of vitamin B12 (44)”. The recommendation is to test Vitamin B12 periodically, like once a year to make sure patients have not develop Vitamin B12 deficiencies.

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Review of Insulin Fiasp

Fiasp® (insulin aspart; Novo Nordisk)

Is the first of the next generation of faster-acting mealtime insulin analogues.

How does Fiasp differ from other fast-acting mealtime insulins?

Fast-acting analogues include:

  1. Humalog® (insulin lispro; Lilly)
  2. NovoLog® (insulin aspart; Novo Nordisk)
  3. Apidra® (insulin glulisin; Admelog® (insulin lispro, Lilly)

This next generation insulin, resulted in a more rapid appearance of insulin in the blood after injection and a better coverage of the mealtime excursion in glucose that is associated with Type 1 Diabetes, resulting in fewer peaks and troughs in insulin levels 3–4 hours from injection of the insulin at mealtime.

After the development of continuous glucose monitoring (CGM) systems, we discovered that these fast-acting mealtime insulins were still too slow and that peaks and troughs in glucose levels still occur after meals. We discovered that these insulins should ideally be injected not immediately before meals but 10–20 minutes before the meal.

However, this is not convenient for patients before breakfast when trying to get ready and even before some of the other meals. Many patients inject during their meal or even after the meal if there is uncertainty about what patients will eat (for example children and elderly patients). Hence Industry has been working on extra-fast insulins.

These have altered the excipients in which the insulin aspart is solubilized. They have added L-arginine and vitamin B, two natural agents that are approved by the European Medicines Agency and the US Food and Drug Administration. These facilitate the rapid movement of insulin through the capillaries into the blood. The pharmacokinetic profiles show 5-minute shift to the left.  Fiasp is also 2.5-minute absorption into the blood stream. This will have a great impact on the quality of life of our patients as it will allow them to inject insulin at a time closer to the meal and will better cover glucose excursions.

Insurance coverage

For information go to: https://www.fiasppro.com/getting-patients-started/savings-and-coverage.html#

Are there any limitations of Fiasp?

Studies have compared injections of Fiasp immediately before a meal with insulin aspart and found that Fiasp gives smaller glucose excursions as well as a small but statistically significant difference (around 0.1%) in glycated hemoglobin (HbA1c) after 6 months and 1 year. We have also demonstrated that injection of Fiasp within 20 minutes after starting a meal gives the same effect as if it was injected before the meal. This is useful if people forget their injections or if it is not possible to predict what a patient will eat.

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What to Tell your Patients About Vaping

As more and more of my patients switch to e-cigarettes or vaping when trying to quit smoking. What do you tell patients about vaping? In 2016 the number of middle schoolers who reported they used electronic cigarettes was 63% and 11.3 of high schoolers used e-cigarette reported by CDC.

One of my diabetes patients came in reporting that he had stopped smoking and had switched to vaping now. So is vaping better than smoking cigarette? There are now about 500 different brands of e-cigarettes. The academy of pediatrician reports that it is not vapor but is aerosol because there is particulate matter.

Brief history

2003-2007 the first commercially produced e-cigarettes were produced overseas in Asia and between 2006 and 2007 smokeless e-cigarettes were introduced in the US.

Most of the data reported were done with the first and second generations of e-cigarettes which did not have set amounts of nicotine. In the US we are now using the fourth generation of e-cigarettes. New e-cigarettes were more powerful, more liquid and are now more popular.

What is in the pods?

Ingredients can vary but most contain some toxicants and carcinogens and the pods come in a range of nicotine. Traditional cigarettes contain 10-30 mg of actual absorbable nicotine 0.05-3 mg. Compared to pods that range from 0 to 36 mg/ml. Most of the e-cigarette pods contain:

  • propylene glycol
  • glycerol (sugar)-fruit flavoring
  • diacetyl- bronchiolitis obliterans (popcorn lung)
  • aldehydes
  • metals
  • tobacco alkaloids, nitrosamines
  • hydrocarbons
  • flavors- over 7000 flavors

Toxicants and carcinogens are in less amount than in cigarettes. This are easily accessible in stores and online. One popular vapor product: sales up 641% over one year and had 515% increased in market share and went from 2.2 to 16.2 million in revenue.

Statistics

In 2015 of the adults who used e-cigarettes:

  • 29.8% were former smokers
  • 58.8% were current smokers who also use e-cigarettes (dual users)
  • 11.4% had never been regular smokers

In 2016 there were 3.2 % of US adults. In 2018 e-cigarettes are the most common tobacco product used in US youth. 40% of current ENDS users are age 18-24 years have never been cigarette smokers.

Recent Evidence

Teens who have used e-cigarettes are more likely than those who have not used e-cigarettes to go on to smoke real cigarettes.

FDA declared Teen Vaping an epidemic and now bans tobacco and e-cigarettes to people under age 18.


Does vaping help quit smoking regular cigarettes?

The FDA has not approved e-cigarettes the conclusion was that they are not associated e-cigarettes as smoking cessation products because in the studies done with 1st generation cigarettes were not associated with successful cessation.

The CDC in 2018 stated is not safe for kids, adolescents, pregnant women and any one who is not currently smoking. The American Cancer Society stated that current generation of e-cigarettes are less harmful than smoking tobacco, however long-term harms are unknown.

Known Risks

E-cigarettes can expose others to second hand smoke and third hand aerosol pollutants. Residual aerosol that acts as dust on surfaces that can be re-emitted.

Burns and injury- some have been known to explode

Toxicants and carcinogens

Risks to children of poisoning- children opening and drinking pod contents

Addictive- could be as addictive as cigarettes.

What advice would you give your patient?

First congratulate patients for stop smoking cigarettes. Then would advise patients to start to decrease amount of nicotine and amount of use and try to stop using e-cigarettes. Yf

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Alcohol in Diabetes

Alcohol’s effect on body systems

Alcohol on it’s own can have negative effects on the body but the effects on some one with diabetes can be augmented by the interaction of alcohol and medications. Patients with diabetes should be counselled regarding the negative effects of alcohol on diabetes and possible interactions. Alcohol in diabetes should be avoided and patients should be advised of abstaining from alcohol.

Cardiovascular and Gastro Intestinal

Chronic alcohol use is associated with negative cardiac health events including:
● nonischemic dilated cardiomyopathy (3)
● ventricular dysfunction (3)
● atrial fibrillation (5)
● hypertension (4)
● increased caloric intake and weight gain (4)
Interestingly, alcohol exhibits a “J”-shaped dosing curve for many of these events, where lower risk is observed at approximately 2 drinks/day, but steeply rises beyond this (8) Chronic alcohol is associated with negative GI health events, including:
● injury to gastric mucosa, leading to an increased risk of GI bleeds (12)

Liver/Pancreas

Chronic alcohol is associated with negative hepatic and pancreatic health events, including:
● increased triglyceride secretion which increases the risk of pancreatitis(7)

●increased TGs (>1000 mg/dL) are associated with increased chylomicrons which can obstruct pancreatic capillaries, supporting ischemia and inflammation (16)
● promoting hepatic fibrosis and cirrhosis via fatty acid breakdown mechanisms (8)
● increasing hepatic production of LDL (8)
● decreasing atheroprotective efficacy of produced HDL (8)

Managing Diabetes:  Chronic alcohol use dramatically limits the ability to use ADA recommended antidiabetic agents.

Metformin

Mechanism: AMP kinase activation, decreasing hepatic glucose production Problems raised with chronic alcohol use:
● Both metformin and alcohol have individually demonstrated a risk of causing lactic acidosis (10,11)
● Concurrent use of metformin and alcohol has demonstrated an increased risk of developing lactic acidosis (9). Limiting use in patients with chronic or binging alcohol intake.
● Would probably think twice about starting metformin in this patient given the risk of lactic acidosis, but if other medication classes are problematic, the patient will still need at least some therapy to manage diabetes.

Sulfonylureas

Mechanism: Blocks K+ channels on pancreatic beta cell membranes, increasing insulin secretion Problems raised with chronic alcohol use:
● Concurrent use of alcohol and sulfonylureas is associated with an increased risk of delayed hypoglycemia (19)
● Chronic alcohol use is associated with decreased insulin secretion response in the presence of elevated blood glucose levels (2)      Use in these patients?
● Probably not, given the added risk of delayed hypoglycemia
● Additionally, starting a medication in this class might not be very effective in managing chronic diabetes anyway, given the decreased insulinogenic response.

Thiazolidinediones

Mechanism: PPAR-gamma activation, increasing insulin sensitivity and glucose uptake in peripheral tissues Problems raised with chronic alcohol use:
● Pioglitazone has been reported in post-marketing surveillance to cause hepatic failure, but actual risk remains unknown (18)
● Chronic alcohol use is known to be associated with hepatic injury.  Use in these patients?
● Probably not, given multiple risk factors for liver injury
● If given, would have to closely monitor hepatic function tests

DPP4 Inhibitors

Mechanism: Inhibits DPP enzyme, prolonging effects of endogenous GLP1/GIP to increase insulin secretion and decrease glucagon secretion Problems raised with chronic alcohol use:
● Sitagliptin has been reported in post-marketing surveillance to cause acute pancreatitis, but actual risk remains unknown (0.1 per 100 patient years in both study and placebo) (17)  ○ Pancreatitis was reversible

● Chronic alcohol use is known to be associated with increased risk of pancreatitis via increased triglyceride levels (16) Use in these patients?
● Probably not, considering multiple risk factors for pancreatitis, but possible with monitoring
● Also, the value of this class (post-prandial control) in a patient with an A1c close to 9% would seem limited.

SGLT2 Inhibitors

Mechanism: Inhibits SGLT2 in nephrons, reducing renal glucose reabsorption Problems raised with chronic alcohol use:
● Empagliflozin can induce diabetic ketoacidosis even at glucose levels

GLP1 Receptor Agonists

Mechanism: Activates GLP 1 receptors to increase insulin secretion, decrease glucagon secretion, slow gastric emptying and promote longer satiety Problems raised with chronic alcohol use:
● Liraglutide has been observed to cause more cases of pancreatitis than control groups (2.2 vs. 0.6 cases per 1000 patient-years), but this has not been fully studied (17) ○ Pancreatitis was reversible, however
● Chronic alcohol use is known to be associated with increased risk of pancreatitis via increased triglyceride levels (16) Use in these patients?
● considering multiple risk factors such as pancreatitis,  possible with monitoring

Insulin

Mechanism: supplements endogenous insulin production Problems raised with chronic alcohol use:
● Concurrent use of alcohol and insulin is associated with an increased risk of delayed hypoglycemia (1)
● Chronic alcohol use is associated with decreased insulin secretion response in the presence of elevated blood glucose levels( (2) Use in this patient?
● patients  already on insulin, are more likely to grow more resistant to insulin as doses increase – higher doses and/or adding bolus dosing might temporarily improve glycemic control, but also contribute to weight gain
● Additionally, compliance with bolus dosing may be unlikely

Statins

Mechanism: inhibits function of HMG-CoA reductase, increasing hepatic LDL breakdowns. Also reduces endothelial inflammation. Problems raised with chronic alcohol use:
● Although statins are rarely causative in hepatic injury or failure (Out of 1188 cases reported to the US Drug Induced Liver Injury Network, only 22 cases could be clearly linked to hepatic injury), a fatality was associated with alcoholic liver disease and statin use (20)  Use in this patient?
●  a statin but is indicated per ADA guidelines for CV mortality reduction. Chronic alcohol use and possible hepatic injury would warrant caution if this class were used, but still possible.

Aspirin

Mechanism: inhibits platelet COX 1 and 2, reducing platelet aggregation and prostaglandin effects Problems raised with chronic alcohol use:
● Aspirin has demonstrated an increased risk of GI bleeds (22)
● Alcohol causing injury to gastric mucosa, leading to an increased risk of GI bleeds (12) Use in these patients?
● aspirin for primary CV prevention, but could be considered per ADA guidelines, considering hypertension and dyslipidemia.
● However, the multiple risk factors for bleeding (including concomitant use of NSAIDS such as naproxen or ibuprofen) would probably make aspirin a poor choice.

References

1. American Diabetes Association. Standards of medical care in diabetes. Diabetes Care 2017; 40 Suppl 1: S1-S135.
2. Nguyen, Lee, & Nyomba. (2011). Ethanol causes endoplasmic reticulum stress and impairment of insulin secretion in pancreatic β-cells. Alcohol, 46(1), 89-99.
3. Mozaffarian, D. (2016). Dietary and Policy Priorities for Cardiovascular Disease, Diabetes, and Obesity A Comprehensive Review. Circulation, 133(2), 187-225.
4. Núñez-Córdoba, J., Valencia-Serrano, F., Toledo, E., Alonso, A., & Martínez-González, M. (2009). The Mediterranean diet and incidence of hypertension: The Seguimiento Universidad de Navarra (SUN) Study. American Journal of Epidemiology, 169(3), 339-46.
5. Larsson, Drca, & Wolk. (2014). Alcohol Consumption and Risk of Atrial Fibrillation: A Prospective Study and Dose-Response Meta-Analysis: A Prospective Study and Dose-Response Meta-Analysis. Journal of the American College of Cardiology, 64(3), 281-289.
6. Sacks, F., Svetkey, L., Vollmer, W., Appel, L., Bray, G., Harsha, D., . . . Cutler, J. (2001). Effects on Blood Pressure of Reduced Dietary Sodium and the Dietary Approaches to Stop Hypertension (DASH) Diet. The New England Journal of Medicine, 344(1), 3-10.
7. Berglund, Lars, Brunzell, John D, Goldberg, Anne C, Goldberg, Ira J, Sacks, Frank, Murad, Mohammad Hassan, & Stalenhoef, Anton F H. (2012). Evaluation and treatment of hypertriglyceridemia: An Endocrine Society clinical practice guideline. The Journal of Clinical Endocrinology and Metabolism,97(9), 2969-89.
8. Brinton, E. (2010). Effects of ethanol intake on lipoproteins and atherosclerosis. Current Opinion In Lipidology, 21(4), 346-351.
9. Krzymień, J., & Karnafel, W. (2013). Lactic acidosis in patients with diabetes. Polskie Archiwum Medycyny Wewnetrznej, 123(3), 91-7.
10. Müssig, Schleicher, Häring, & Riessen. (2008). Satisfactory Outcome After Severe Ethanol-Induced Lactic Acidosis and Hypoglycemia. Journal of Emergency Medicine, 34(3), 337-338.
11. Glucophage (metformin). [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; August 2008. 17
12. Macmath, T. (1990). Alcohol and gastrointestinal bleeding. Emergency Medicine Clinics of North America,8(4), 859-72.
13. Handelsman, Y., Henry, R., Bloomgarden, Z., Dagogo-Jack, S., Defronzo, R., Einhorn, D., . . . Weir, M. (2016). AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY POSITION STATEMENT ON THE ASSOCIATION OF SGLT-2 INHIBITORS AND DIABETIC KETOACIDOSIS. Endocrine Practice, 22(6), 753-762.
14. Kitabchi, A., Umpierrez, G., Miles, J., & Fisher, J. (2009). Hyperglycemic crises in adult patients with diabetes. Diabetes Care, 32(7), 1335-43.
15. Mcguire, L., Cruickshank, A., & Munro, P. (2006). Alcoholic ketoacidosis. Emergency Medicine Journal, 23(6), 417-420.
16. Yadav, D., & Pitchumoni, C. (2003). Issues in hyperlipidemic pancreatitis. Journal Of Clinical Gastroenterology, 36(1), 54-62.
17. Januvia (sitagliptin). [prescribing information]. Whitehouse Station, NJ: Merck & Co. Inc.; August 2018.
18. Actos (pioglitazone). [prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America; July 2011.
19. Glucotrol (glipizide). [prescribing information]. New York, NY: Pfizer Inc.; October 2016.
20. Victoza (liraglutide). [prescribing information]. Princeton, NJ: Novo Nordisk Inc.; January 2010.
21. Russo, M., Hoofnagle, J., Gu, J., Fontana, R., Barnhart, H., Kleiner, D., . . . Bonkovsky, H. (2014). Spectrum of statin hepatotoxicity: Experience of the drug‐induced liver injury network. Hepatology,60(2), 679-686.
22. Pignone, M., Alberts, M., Colwell, J., Cushman, M., Inzucchi, S., Mukherjee, D., . . . Kirkman, M. (2010). Aspirin for primary prevention of cardiovascular events in people with diabetes: A position statement of the American Diabetes Association, a scientific statement of the American Heart Association, and an expert consensus document of the American College of Cardiology Foundation. Diabetes Care, 33(6), 1395-1402.

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Why is it so Hard to Control Blood Sugars?

Often patients get very frustrated because even if they are eating healthier and smaller amounts, blood sugars may still not be controlled. Why is it so hard to control blood sugars? Our bodies are wonderful machines that can modify and adjust to different situations when is working the way it was design to do. For patients with diabetes, is up to them to control several factors and adjust medication, exercise and food.

Factors that can affect blood sugars

According to one of my favorite blogs, diatribe.org there are about 22+ factors that affect blood sugars. Many of which come to us easily such as carbohydrates, amount of food, protein and alcohol.  Some that are not as obvious such as inaccurate blood sugar readings and expired insulin. Patient with diabetes need to realize that they will not have perfect blood sugar numbers and that fluctuations are part of living diabetes. Living with diabetes is hard, the only thing healthcare professionals and patients can expect is for them to try their best.

Change your mind setting

Change the way you think about living with diabetes, instead of thinking about all the foods you should avoid think about eating healthy to become healthier. Instead of thinking about exercise as a chore to control blood sugars, think about exercise as a way of becoming heathier and feeling better. Think about medication as another way to feel better and preventing diseases like brushing your teeth to prevent cavities or washing your hands to prevent spread of colds or flu.

Medications and Blood sugars

We know the medications and insulin used to treat diabetes affect blood sugars. Tthere are other medications that can affect the way you respond to sugars.
Statins: medications for cholesterol can increase blood sugars and can increase risk for developing Type 2 diabetes. Most experts think that the benefits of reducing cardiovascular complications outweigh the risks for most patients.

Vitamin B12: metformin, first line medication for type 2 diabetes can interfere with absorbing vitamin B12. Your Doctor or health care provider can test your level and let you know if you need to take vitamin B 12. The American diabetes Associations guideline recommend testing for vitamin B12 once a year. Low Vitamin B12 can lead to Vitamin B12 anemia which is a lack of healthy red blood cells caused when you have lower than normal amounts of certain vitamins. Vitamins linked to vitamin deficiency anemia include folate, vitamin B-12 and vitamin C

Beta blockers: (metoprolol, atenolol, nadolol, carvedilol) Can mask symptoms of low blood sugars like fast heartbeat, sweating or anxiety. Niacin might increase blood sugar. People with diabetes who take niacin should check their blood sugar carefully.

Steroids: like prednisone, can increase blood sugars and lead to weight gain. Weight gain can lead to higher blood sugars.

Niacin: a form of B3, can increase blood sugars.
Diuretics: like furosemide and hydrochlorothiazide, don’t lead to higher blood sugars but increase the risk of dehydration in patients who have high blood sugars leading to more problems.

Vitamin D: Low vitamin D levels have been correlated to uncontrolled diabetes, your doctor or health care provider can check your vitamin D level and recommend replacement if levels are low. There is enough evidence to show that low levels of vitamin D make it hard to control blood sugars.

Herbals:

Many herbals do not have enough information regarding drug interactions and actual effects.
• Aloe Vera drinks can sometimes enhance low blood sugars.
• Stinging Nettle can drop blood sugars, sometimes fast. This is also a natural diuretic, see above.
• Goldenseal, asparagus extract, dandelion, green tea and Matcha tea are natural diuretics, see above.
• Spirulina and chlorophyll usually added to green drinks are said to reduce blood sugars after weeks of use.
• The following have all been reported to decrease blood sugars, again not enough data to verify claims. Fernugreek, Gymmena sylvestre, bitter melon extract, stinging nettle, myrrh, marshmallow, alfalfa, holy basil, alpha-lipoic acid.
Taking supplements is not recommended unless prescribed by your doctor or health provider. Getting all your nutrients from your diet is the prefer way.

Weight and Exercise:

Insulin resistance can make it hard to control blood sugars. The higher your weight the more insulin resistance you have. Insulin resistance can be o your indigenous (own) insulin or the insulin you inject, requiring more insulin to work. Higher body weight can lead to increased insulin resistance. This is a complex topic and how weight makes you more resistance is not well understood. What we know is that losing weight, as little as 7% can lead to better blood sugar control. Patients on insulin who have uncontrolled blood sugars may need more insulin or adjustment of when and how much insulin to inject.

Always consult your doctor, your health care provider, pharmacist or certified diabetes educator for help controlling blood sugars.

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Groceries or Insulin

The high Cost of Insulin

Many patients are finding themselves unable to afford insulin, they must make a choice between buying groceries or insulin. As a follow up to my blog the High Cost of Insulin , the human cost of insulin. NBC News (8/15) reported on patients rationing insulin and leading to death. One of my favorite bogs also addressed this topic, E&M Blogosphere . In the article Hyma Gogineni, Pharm. D, MSc, BCACP, TTS, talks about why the high cost and list available programs that both insured, and uninsured can use to help afford insulin.

Recently USA today published an article calling for free medications for those who need it and can not afford it. This is a growing problem that is only getting worst. In January the New York Times wrote an article about drug makers accused of fixing insulin prices, that lead to a law suit. It seems like everyone from manufacturers, PBM and all middle players are getting rich while the neediest patients go without much needed insulin as reported by PBS news hour.

President Trump promised to lower prices of high cost medications as reported by AARP and Bloomberg.  We are still waiting for something to be done about high price medicines. Many practitioners have taken to petition state and federal law makers to curtail the cost of much needed medicines but not much has been accomplished. Meanwhile, many patients find themselves going without or rationing insulin to last them longer leading to many complications and in some cases as reported above to death.

Biosimilar

Two biosimilars recently approved with lower prices but still too high for patients to afford. Basaglar a biosimilar to Lantus and Admelog biosimilar to Humalog.  Whole sale prices of $348.78 for 15 milliliters (5 pens) of Basaglar and $251.83 for 10 milliliters of Humalog. Compared to Lantus price $430.14 and Humalog $294.85, the difference is not much. These biosimilars (almost an identical copy of an original product) are still too expensive for needy patients to afford.
Rightcare Alliance a petition directed to manufacturers to help patients afford insulin.

The Story behind  Rightcare Alliance was reported on WBUR, A Mother’s Day Message To Pharma: Lower Your Insulin Prices. Many more petitions can be found and many more tragic stories. Contact your senators and congress representatives and tell them make insulin affordable.

Sign the ADA’s petition

The American Diabetes Association has set an online petition to make insulin affordable: Sign the petition now.

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To Check or Not to Check Blood Sugars.

The question is: To Check or Not to Check Blood Sugars.

For patients on insulin the answer is that we always recommend checking blood sugars. For patients on only oral medications, there is an ongoing clinical debate about the benefits of Self-monitoring of blood glucose (SMBG). There are Health Systems and insurances that limit quantity due to high cost. Many practitioners do not see the need or benefit for patients to monitor unless they are on insulin, I don’t agree as many of those patients can benefit from SMBG to better control their blood sugars.

In a recent article published in JAMA Internal Medicine, a randomized study of 450 individuals originally enrolled, 418 completed the study. The objective of the study was to look at hemoglobin A1C levels and health-related quality of life (HRQOL) of the enrolled patients based on their randomization to one of three groups: no Self-monitoring of blood glucose (SMBG) once-daily SMBG or once-daily SMBG with enhanced messaging feedback on the blood glucose meter. The measured outcomes were change in hemoglobin A1C and HRQOL at 52 weeks. The results of the data were no significant difference in the three groups hemoglobin A1C and HRQOL. Leading the authors to conclude that regular testing of the blood glucose by patients with non-insulin treated type 2 diabetes is not necessary. Here is the citation for the study: Young, L et al. “Glucose Self-monitoring in Non–Insulin-Treated Patients with Type 2 Diabetes in Primary Care Settings: A Randomized Trial”, JAMA Intern Med. 2017;177(7):920-929.

Many insurances like Medicare B will cover strips for patients with diabetes on oral medications but just one strip per day. Choosing carefully when to ask patients to test becomes very important to get the information and patterns needed to maximize treatment.

In practice, I manage patients whose blood sugars are very uncontrolled diabetes which for my Health System means any patient with an A1C greater than 9. While an A1C can give us a lot of information, it cannot give us detail information such as how high blood sugars are going in the morning or after meals. I often ask patients to check fasting blood sugars first in the morning and work on controlling these sugars first. Once the morning fasting blood sugars are under control, I will ask to ROTATE time of finger stick check (before meals, at bedtime) over the course of 1-2 weeks. This allows reducing testing frequency while allowing me to see patterns over time. At every visit re-assess the need for continue SMBG, frequency and timing.

Why Test?

Testing for the sake of testing does no one good. For the patient, testing can help see what certain foods do to their blood sugars, what helps or make the blood sugars worst and when to act. For this to happen, patients need to be educated and shown how SMBG can help them manage their diabetes.

For the Health Care professional, SMBG can give feedback regarding daily choices such as foods, alcohol, exercise, illnesses and stress. SMBG can also help make informed decisions about foods, activity level and medications. It can help see what the impact of stress, injury, illness and disruption in routine do to the patient’s blood sugars. The use of data to know when to advanced therapy and when to stop certain therapies that might not be right for the patient.

Data shows that in type 1 diabetes, patients who test tend to have a lower A1C and a lower number of acute complications. Data also shows that patients who do SMBG have better control regardless of treatment or type of diabetes.

Other reasons why to consider SMBG, it can emphasize the importance of medication adherence for the patient. Another thing is that we want patients to be familiar with the process, and able to accurately self-monitor, once they are using insulin. Learning how to use the glucometer, insulin injection techniques, storage, and when to inject tend to be too much to spring on a patient all at once. Introducing the concepts more gradually may help them adopt the information easier and not feel overwhelmed.

When to Check

• Before and after exercise: can help prevent low blood sugars and it can show the patient the benefits of exercise in lowering blood sugars.

• Before and after meals: to determine insulin to carb ratios, adequacy of meal time insulin dose, effects of foods or portion size on blood sugars.

• Illnesses: patients should check more frequent when they are sick, patients should be educated about a sick day plan.

• Pregnancy: will need to check more frequent before, after meals and before bedtime; to avoid complications for the unborn baby.

What if the Patient is Resistant to checking Blood Sugars?

Sometimes patients who are VERY resistant to checking, it could be because they don’t see the need for SMBG, they dislike needles, checking hurts, they don’t want to check when they are outside the house, they work overnight or financially checking can be a burden. Trying to find out the barriers to checking is the first step, then working closely with the patient to problem solve those barriers and get them to check their blood sugars.

Sometimes I can only convince the patient to check 3 times per week. Once SMBG readings and A1C are at goal, I advise the patient to continue to check BG 2-3x/week and contact me if pre-meal BG rises above a certain level (150mg/dl OR 180mg/dl if elderly or higher A1C goal). I also encourage them to continue to learn what the different foods do to their blood sugars by checking after meals.

Patients who “fall off the wagon” and glycemic control worsens is usually because they stop testing, taking their medications and managing their diabetes. If you don’t know how high your blood sugars are going, you can not do anything about it. For these patients not being motivated has a lot to do with it. Sometimes patients are depressed, ashamed of not being able to manage their blood sugars, have social barriers such as financial barriers, homelessness, job loss and food insecurities.

It is my belief that SMBG is a very good tool in self management of diabetes, when used correctly can help patients and their Health Care providers manage blood sugars. SMGB should be part of every diabetes plan to get blood sugars to goal. To the question to check or not check? When ever possible educate and motivate patient to use this tool to get their blood sugars under control.

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Vitamin D and Diabetes

Vitamin D and Diabetes

There is evidence between the relationship between vitamin D and Diabetes. Patients who are vitamin D deficient are at higher risk of developing diabetes.  The question remains weather or not Vitamin D deficiency worsens the markers of diabetes.

Vitamin D

Vitamin D is a fat soluble vitamin that helps maintain enough calcium and Phosphate levels in the blood. Vitamin D is also needed in bone growth, remodeling and helps promotes calcium absorption from the gastrointestinal tract.

Chronic insufficient levels of vitamin D can cause osteoporosis and in severe cases rickets or osteomalacia. Other functions of vitamin D in the body include cell growth, neuromuscular, immune function and reduction of inflammation.

What is Vitamin D Deficiency?

Vitamin D is most accurately measured by 25(OH)D as it has a long half-life, reflects both vitamin D produced by the skin and obtained through diet.  It is hard to get enough vitamin D from food alone, most of the vitamin D is absorbed through the skin from sun light.

Vitamin D levels are categorized as follows:

  • < 10 ng/ml = severe deficiency
  • 10–24 ng/ml = mild-mod deficiency
  • 25–80 ng/ml = optimal
  • > 80 ng/ml = toxicity possible

Who is at risk of Vitamin D deficiency:

  • Have either liver or kidney dysfunction
  • GI disorders (ex. celiac disease, pancreatitis, low bile levels)
  • Aging skin
  • Darker skin color
  • Living at a higher latitude with less yearly sun exposure
  • Obesity (BMI >/=30)

Vitamin D deficiency can lead to consequences such as heart attack, poor immune function nd diabetes.  Vitamin D also has a protective role in breast cancer, prostate and colon cancer.  Your doctor can test you vitamin D level and tell you if you are vitamin D deficient.

Nutritional Vitamin D

Put this foods in your plate: wild cold-water salmon, mackerel, tuna, sardines, cod, and halibut. Also try milk, liver, egg yolks and fortified cereal.

Other ways to get Vitamin D

Sunshine: 15 to 30 minutes of sunlight without any sunscreen, can be done in small doses and not at high noon to avoid sun burn.

Vitamin D supplements for adults: try 4,000 to 5,000 IU daily of vitamin D3 (Cholecalciferol) which is the equivalent of fortified milk.  Excessive sun exposure does not cause vitamin D toxicity. Excessive intake in foods that contain large quantities of vitamin D are also very unlikely to cause toxicity. Toxicity is usually the result of high intake of vitamin D containing supplements.

How can Vitamin D deficiency lead to diabetes?

There are vitamin D receptors on different immune cells as well as the beta cells of the pancreas which are responsible for insulin secretion. There are a few different proposed mechanisms of how vitamin D is related to diabetes:

  • Active form of vitamin D, 1,25-dihydroxyvitamin D works by:
    (1) Improving insulin sensitivity of target cells in the liver, skeletal muscle, and adipose (fat) tissue.
    (2) Enhancing and improving B cell function in the pancreas.
    (3) Protecting B cells from immune cells by influences proliferation and differentiation of immune cells such as macrophages, dendritic cells, and T cells.
  • Vitamin D binding proteins, vitamin D receptors and 1alpha-hydroxylase (CYP1alpha) may affect insulin release and result in insulin resistant.
  • Affects glucose homeostasis through these mechanism:
    (1) Vitamin D helps to maintain adequate calcium levels. When calcium levels are low there is less glucose stimulated insulin secretion that occurs from the B cells.
    (2) Inadequate vitamin D can lead to increased PTH levels. This causes decreased glucose uptake by liver, muscle and adipose cells as well as suppression of insulin release.
  • Vitamin D may stimulate insulin secretion by the vitamin D receptors when there is enough calcium.

**Pancreatic Beta cell make insulin.

Studies finding a correlation between vitamin D Deficiency and type 2 Diabetes (T2DM).

(a) Randhawa F et al. Pak J Med Sci 2017;33:881-885: The purpose of this study was to access the effect of vitamin D supplementation on A1C for patients recently diagnosed with T2DM. Results: There was no significant difference between both groups’ A1C at 1, 3 and 6 months.
(b) Dalgard C et al. Diabetes Care 2011;34:1284-1288: This study looked at 668 participants who were all between the ages of 70-74. They lived in a North Atlantic fishing community where a large part of their diet consisted of fatty fish.
Of the 668 patients 24% had type 2 diabetes mellitus (T2DM) and >50% were considered vitamin D deficient (25(OH)D3 level <20 ng/ml).  There were not correlations found between vitamin D deficiency and plasma glucose levels (rs = -0.01; P = 0.78).  Vitamin D deficiency was associated with having an 80% increase in sex-adjusted odds of having diabetes compared with sufficient vitamin D levels (OR 1.8, 95% CI 1.23-2.64, P = 0.002). This was also adjusted to take BMI, serum triacylglycerides, serum HDL, PCB exposure, smoking & month of blood sampling into account (OR 1.67, 95% CI 1.11-2.50, P=0.013). Conclusion: Vitamin D deficiency (25(OH)D <20 ng/ml) doubles the risk of newly diagnosed diabetes. This data suggests that vitamin D may play a protective role preventing the development of T2DM.
(c) Pittas AG et al. Diabetes Care 2006;29:650–65: This study consisted of 83,779 women who were all greater than 20 years of age. They found that patients who had low vitamin  were at an increased risk of T2DM. When patients were treated with a combination of vitamin D 800 IU and calcium 1,000 mg they found their risk for T2DM was reduced by 33%.
(d) NHANES group (2003– 2006): This group evaluated 9,773 U.S. adults who were greater than 18 years old and had T2DM. They found that there was a correlation between serum vitamin D levels, glucose homeostasis, and the evolution of diabetes.  They concluded that patients with an elevated A1C should be evaluated for vitamin D insufficiency.
(e) Talaei A et al. Diabetol Metab Syndr 2013;5:8: This study looked at 100 patients with T2DM between 30 and 70 years old. Of all the patients, 24% had a vitamin D deficiency (25(OH)D ≤20 ng/m). All of these patients were given 50,000 unit of vitamin D3 orally per week for eight weeks. When comparing these patients baseline results to the results at the end of the study they found: Their conclusion was that vitamin D supplementation could reduce insulin resistance in patients with T2DM.
(f) Zhang J et al. Can J Opthalmol 2017;52:S39-44: This study looked at the correlation between diabetic retinopathy (both T1DM and T2DM) and vitamin D deficiency. This was a meta-analysis of 14 observational studies with a total patient population of 10,007. They found a statistically significant association between diabetic retinopathy and vitamin D deficiency. There were statistically significant lower serum vitamin D levels in patients with diabetic retinopathy than in the control group. The higher the degree of vitamin D deficiency, the higher the grade of diabetic retinopathy. Studies finding a correlation between vitamin D Deficiency and diabetes (T1DM)4.  Overall there is a lack of studies to support that vitamin D supplementation would improve treatment of T1DM after diagnosis.
(g) Hypponen E, et al. Lancet 2001;358:1500–1503. This study observed that children who took 2,000 IU of vitamin D daily were 80% less likely to develop T1DM.

Conclusion:

There is evidence to the relationship between vitamin D and diabetes.  Patients who are vitamin D deficient are at a higher risk of developing diabetes. There is also sufficient evidence showing a positive correlation between vitamin D deficiency and increased insulin resistance, decreased insulin production and higher A1Cs.

Patient with prediabetes and vitamin D deficiency can benefit from Vitamin D supplementation. Patients with diabetes who are obese, have a high A1C and have vitamin D deficiency, can also benefit from Vitamin D supplementation.

***A very special thanks to M. Langton PharmD candidate for her help in gathering information for this topic.

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Weight Loss in Diabetes

There is a known connection between obesity and Type 2 diabetes. It is known that the obesity epidemic is driving the Type 2 Diabetes epidemic world wide. There is strong evidence that modest weight loss can delay the progression from pre-diabetes to type 2 diabetes (1,2,3).  Weight loss in diabetes is beneficial in managing type 2 diabetes. Why lose weight question, for many type 2 diabetics is an important one to get their diabetes under control.
Studies have shown that reduction in calories lead to a reduction in A1C of 0.3% to 2.0% in adults with type 2 diabetes, leads to reduction in medication doses and improvement in quality of life (1). Maintaining weight loss is challenging (4) but offers long-term benefits. For example, maintaining weight loss for 5 years is associated with sustained improvements in A1C and cholesterol levels (5). Weight loss in diabetes can be attained with lifestyle programs that offer a 500–750 calorie energy deficit or offer 1,200–1,500 calorie for women and 1,500–1,800 calorie for men. For many obese individuals with type 2 diabetes, losing >5% can produce beneficial outcomes in sugar control, cholesterol, and blood pressure, and sustained weight loss of ≥7% is optimal (4).

Definition of Obesity

Body Mass Index, or BMI, is used as a screening tool for overweight or obesity.
• If your BMI is less than 18.5, it falls within the underweight range.
• If your BMI is 18.5 to <25, it falls within the normal.
• If your BMI is 25.0 to <30, it falls within the overweight range.
• If your BMI is 30.0 or higher, it falls within the obese range.
To calculate BMI, see the Adult BMI Calculator or determine BMI by finding your height and weight in this BMI Index Chart.

How does Obesity Lead to Type 2 Diabetes?

Increase weight leads to increase fat (adiposity), increase adiposity leads to insulin resistance which eventually will lead to diabetes.
To have weight loss in diabetes, there are three modalities: bariatric surgery, weight loss medications (pharmaceuticals) and energy deficit. A combination of any of the three modalities with behavior modification can help patients achieve weight loss.

Bariatric surgery

Bariatric surgery is indicated for patients with a BMI equal or greater than 40 or a BMI equal or greater than 35 with co-morbidities such as diabetes. The two most popular types of bariatric surgery are Roux-en-Y gastric bypass and Gastric sleeve surgery also known as vertical sleeve gastrectomy. Gastric sleeve is more popular because the number of side effects are less than with the Roux-en-Y bypass but is not as effective.

Weight loss Medications (Pharmaceuticals)

Prescription weight loss drugs: Belviq, Contrave, Saxenda, phentermine, and Qsymia. Over the counter you can find orlistat. Lifestyle intervention plus pharmacotherapy intervention lead to better response to calorie restriction. For patients on weight loss medications see an increase magnitude of response, average percentage of weight loss is greater. Overall pharmaceuticals can help extend weight loss sustained response. SEQUEL study data showed amount of weight loss group on pharmaceutical treatment lead to greater weight loss more than the placebo group.

Who can benefit from the use of Pharmaceuticals for weight loss?
Patients who report early hunger shortly after eating, patients who tend to have more than one plate of food to feel full, Patients with persistent food thoughts, strong emotional response to food or eating, and less than robust response to dietary plan. For some, pharmaceuticals can be use indefinitely or in maintenance can be use when needed.

Calorie Restriction

Type 2 diabetes is potentially reversible via an 8-week, very low-calorie diet followed by careful weight management for up to 6 months, new research shows. The findings were published online March 21, 2016 in Diabetes Care by Dr Sarah Steven of Newcastle University, United Kingdom, and colleagues.

The best weight loss response was seen in Younger age patients, in those with shorter duration of diabetes and not on insulin. STAMPEDE trial followed 150 patients with a BMI of 27-43 1 for five years 1 out of 3 patients were in remission after 5 years after bariatric surgery. Look AHEAD and DIRECT trial achieve 50% remission on an average weight loss of 10 kgs.
Calorie restriction paired with exercise provides patients with type 2 diabetes with a plan to lose weight and control blood sugars. Before starting any exercise, program consult your Primary care physician.
Lifestyle is always recommended to manage diabetes, for some patients with type 2 diabetes it may not be enough. Pharmaceuticals and bariatric surgery are other tools that can help. For patients who are morbidly obese bariatric surgery maybe the best alternative. Talk to your Primary Care Physician to find out what they recommend for you.
Weight loss in type 2 diabetes can lead to remission or well control diabetes at the levels of prediabetes leading to decrease complications from diabetes. Make weight loss part of your diabetes action plan.

References
  1. https://jandonline.org/article/S2212-2672(17)30333-7/abstract
  2. http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002095
  3. http://annals.org/aim/fullarticle/2395729
  4. https://jandonline.org/article/S2212-2672(15)00259-2/fulltext
  5. http://drc.bmj.com/content/5/1/e000259
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In Diabetes, think lower carbs

Lower Carbohydrate diet

My advice in diabetes, think lower carbs. Eating fewer carbohydrates with every meal is one of the most important changes in your diet that you can make to control blood sugars. Eating fewer carbohydrates sounds restrictive but meals can be made tasty and think about the benefits that come with it.

How many carbohydrates should you eat per day

While reducing carbohydrates will help with blood sugars, it is a very personal journey to find what foods work for you. Based on a 2500 calorie per day diet, I would recommend 100-150 gm of carbohydrate per day. If you want to lose weight reduce not only your calorie intake but also your carbohydrate intake down 75-110 per day.

Is there a diet that is better for diabetes?

The best diet is the one that works for you, your goals and activity. Everyone is different, the diet that works for you might not work for someone else, and vice versa. If you are trying to build strength and muscles, you shouldn’t follow the same diet as when you are trying to lose weight.
In the same way, someone who runs every day has different dietary requirements than someone who sits in an office all day and doesn’t exercise.

Moderate carbs

The general recommendation for a non-diabetic person is to get 40-60% of their daily calories from carbs. If you eat 2,000 calories a day, that’s between 200 and 300 grams of carbs a day.
For people with diabetes, this is generally too many carbs, but for people with diabetes that exercise a lot and/or are trying to build muscle mass 30-50% might be better than low carb.
One possible problem is that if you do not maintain the high level of exercise your blood sugars can go out of control easily.

Low carbs

There is no clear definition of exactly what a “low carb” means, low carb can be approximately 50-90 grams of complex carbs a day (not including vegetables). Patients with diabetes go this low when they want to slim down, like when wanting to drop a few pounds.

The benefits of lower carbs

The benefits of lower carbs are not surprising, Carbs raise blood sugars far more than fat and protein do. Limit the amount of carbs to get blood sugars under control, to use less insulin, avoid weight gain and avoiding the complications of diabetes.
Eating less carbs is one of the most important changes patients with diabetes can make. Lower carbs can make their blood sugars steady and will help avoid the roller coaster ups and downs that come with eating a high carb diet. For patient s with Type 2 diabetes this should be the first approach to manage high blood sugars effectively. For type 1 diabetes is the best way to manage it along with insulin.
Eating fewer carbs will lead to less insulin and less oral medications use. Eating just one low carb meal per day can make a difference, especially if it is the largest meal of the day. Reduce carbs slowly and be patient, it takes your body about 2-3 weeks to get used to it.
Other benefits are lower cholesterol, lower triglycerides, lower weight, and reduction in cardiovascular disease. For a place to start healthy eating refer to the plate method. Combine lower carbs with lean protein and good fats, to see low or no blood sugar fluctuations after meals.

The negatives of low carbs

Low carb is great for weight loss and can help with blood sugar control, but it also decreases your metabolism and energy levels. If you live an active lifestyle (and especially if you do resistance training), the moderate carb diet provides you with the energy you need to fuel your workouts, while still allowing for great blood sugar control.

The no-carb (ketogenic) diet

The theory behind the ketogenic diet is that by consuming almost no carbs (less than 5% of your total calories), your body will start converting fat into fatty acids and ketones.

Benefits of no-carb

Ketones can replace glucose as your body’s main energy source, meaning that your body mainly relies on fat for energy. In theory, this should make it very easy to lose excess body fat if you limit your calorie intake at the same time. By eating almost no carbs, you also, in theory, need very little insulin, making blood sugar control easier.

The negatives of no-carb

For most insulin dependent patients their insulin sensitivity fluctuates. Since he theory is that fat is released more slowly into the bloodstream than complex or refined carbs, there should be no blood sugar fluctuations. Insulin resistance is based on the amount of fat you have specially in your abdomen, for those with little or no fat the increase in fat intake can lead to fluctuations in insulin needs.
Many patients also experience weight gained from the increase fat intake. For patients with type 2 diabetes wanting to lose weight this maybe an alternative for a short term. Long term will lead to little energy level and can induce patients to end up eating more because they feel hungry all the time.

As I wrote in the beginning, what the optimal diet depends on your goals.