Diabetes UpdateNOSSCR Fall 2011

Social Security Disability Law ConferenceSan Antonio, Texas

Suzanne Villalón-Hinojosa, Esq.1-800-481-0302

suzanne@disabilitylegalhelp.comDr. Melissa Kempf, MD

210-491-1509kempfmelissa@hotmail.com

Why Diabetes?Diabetes affects 25.8 million people of all ages

8.3 percent of the U.S. population

DIAGNOSED18.8 million people

UNDIAGNOSED7.0 million people

33% of the US adult population could have diabetes by 2050

http://diabetes.niddk.nih.gov/dm/pubs/statistics/#fast

Diabetes BeltPeople living in the diabetes belt counties were more likely to be:•black (23.8 percent in diabetes belt counties versus 8.6 percent in the rest of the country), and•obese (32.9 percent in the diabetes belt compared to 26.1 percent in the rest of the country). •And, a sedentary lifestyle was more common in the diabetes belt areas than nationally (30.6 percent versus 24.8 percent, respectively).

http://www.ajpmonline.org/article/PIIS0749379711000353/abstract

Diabetes listing eliminated

• We have determined that, with one exception, we should no longer have listings in sections 9.00 and 109.00 based on endocrine disorders alone.

• Revised Medical Criteria for Evaluating Endocrine Disorders – 76 Fed. Reg. 19692, April 8, 2011

Historical Changes to Diabetes Listing

• Diabetes listing 1985-2001– neuropathy, episodic Acidosis, lower extremity amputation (LEA), retinopathy

• Diabetes listing 2001-2011– referral to neurological & visual listings, elimination of LEA but referral to

new musculoskeletal listing.

• Diabetes listing 2011 Explanatory and referrals to listings 1,4, 5, 6, 11, 12: – Disease (type 1 & 2)

– Non-exhaustive list of reasons for inadequate control• Hypoglycemia unawareness

• Other disorders affecting blood glucose levels

• Mental disorders

• Inadequate treatment

– distinction between Hyperglycemia & Hypoglycemia• acute & chronic DKA in Hyperglycemia

Table 21. Distribution, by diagnostic group, December 1996-2010

Year All GroupsTotal

Endocrine Diseases Numbers

Endocrine Diseases

Percentage

1996 4,399,932 197,272 4.5

2000 5,042,333 244,456 4.8

2005 6,519,001 252,933 3.9

2010 8,203,951 288,146 3.5

SSA, Annual Statistical Report on the Social Security Disability Insurance Program, 2010http://www.ssa.gov/policy/docs/statcomps/di_asr/2010/sect01c.pdf

Why is SSA eliminating the Current listing for Diabetes?

• Since 1985, medical science has made significant advances in detecting endocrine disorders at earlier stages…• and newer treatments have resulted in better

management of these conditions.

• Adequate glucose regulation is achievable…• with improved treatment options…

– 76 Fed. Reg. 19692

History of Diabetes treatment• Prior to 1920s

– diagnosis of diabetes was a death sentence, although doctors experimented with restrictive diets

• 1921 – discovery of insulin

• 1942 – first “anti-diabetes” drug: sulphonylurea (Glimepiride)

• 1994 – Metformin marketed in US

• Late 1990s – more medication therapy: thiazolidinedione (Avandia, Actos, Resulin)

• Today• DPP-4 inhibitors

Examples of listing level diabetes complications

• Cardiac arrhythmias

• Intestinal necrosis

• Cerebral edema & seizures

• Recurrent episodes of DKA resulting from mood or eating disorders

• Diabetic peripheral neurovascular disease leading to amputation

• Diabetic retinopathy

• Coronary artery disease and peripheral vascular disease

• Diabetic gastroparesis resulting in abnormal gastrointestinal motility

• Diabetic nephropathy

• Diabetic peripheral and sensory neuropathies

• Cognitive impairments

• Altered mental status and cognitive deficits

Medical advances have not reduced the incidences and prevalence of Diabetes

• Better management of diabetes has not been achieved.– It requires a team approach and not all diabetics have

access to team members.

• Medication management is not the panacea as suggested by SSA.– The ADA frowns on the use of medications to treat

and prevent diabetes. • ADA, Standards of Care, 1/2010 p. S16

Potential negative efffect of new regulation

• Adjudicators will view the elimination of the diabetes listing changes as a more stringent standard at both Step 3 and Step 5.

• Hypothetical question to VE must include all impairments found by the ALJ.

–Bowling v. Shalala, 36 F.3d 431 (5th Cir. 1994)–Baugus v. Secretary, 717 F.2d, 443 (8th Cir. 1983)

–Diabetes case: Clifton v. Astrue, 2011 WL777889 W.D.La., 2/8/2011

Two Types of DiabetesType 1 Diabetes• Old name:

– insulin-dependent diabetes mellitus (IDDM) or juvenile-onset diabetes

• an autoimmune disease in which the body's own immune system attacks the pancreas, rendering it unable to produce insulin

Type 2 Diabetes• Old name:

– non–insulin-dependent diabetes mellitus (NIDDM) or adult onset diabetes

• a resistance to the effects of insulin or a defect in insulin secretion may be seen; gestational diabetes; and other types.

Comparison of Type 1 and Type 2 Diabetes

Type 1 diabetes• Onset primarily in childhood and adolescence

• Often thin or normal weight

• Prone to ketoacidosis

• Insulin administration required for survival

• Pancreas is damaged by an autoimmune attack

• Absolute insulin deficiency

• Treatment: insulin injections

• Increased prevalence in relatives

• Identical twin studies: <50% concordance

• HLA association: Yes

Type 2 diabetes• Onset predominantly after 40 years of age• Often obese• No ketoacidosis• Insulin administration not required for

survival• Pancreas is not damaged by an autoimmune

attack• Relative insulin deficiency and/or insulin

resistance• Treatment: (1) healthy diet and increased

exercise; (2) hypoglycemic tablets; (3) insulin injections

• Increased prevalence in relatives• Identical twin studies: usually above 70%

concordance• HLA association: No

The Genetic Landscape of Diabetes [Internet].Dean L, McEntyre J.Bethesda (MD): National Center for Biotechnology Information (US); 2004.

Criteria for the diagnosis of diabetes

• A1C 6.5%. The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay. or

• FPG 126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 h.* or

• 2-h plasma glucose 200 mg/dl (11.1mmol/l) during an OGTT. The test should be performed as described by the World Health Organization, using a glucose load containing the equivalent of 75 ganhydrous glucose dissolved in water.*

• In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose 200 mg/dl (11.1mmol/l)

“Standards of Medical Care in Diabetes-2011” by ADA, DIABETES CARE, VOLUME 34, SUPPLEMENT 1, JANUARY 2011

prediabetes

• FPG 100–125 mg/dl (5.6–6.9 mmol/l): IFG

• 2-h plasma glucose in the 75-g OGTT 140–199 mg/dl (7.8–11.0 mmol/l): IGT

• A1C 5.7–6.4%

“Standards of Medical Care in Diabetes-2011” by ADA, DIABETES CARE, VOLUME 34, SUPPLEMENT 1, JANUARY 2011

long-term complications of diabetes & physical activity

• Retinopathy– Vigorous & resistance may be contraindicated

• Peripheral neuropathy– Moderate intensity walking (only if no foot injury or open sore)

• Autonomic neuropathy– Cardiac evaluation is recommended before beginning a new exercise

program

• Albuminuria & nephropathy– No need for any specific exercise restrictions

“Standards of Medical Care in Diabetes-2011” by ADA, DIABETES CARE, VOLUME 34, SUPPLEMENT 1, JANUARY 2011pg. S24-25

Forms of Diabetic Neuropathy• Peripheral neuropathy

– pain or loss of feeling in the toes, feet, legs, hands, and arms.• Autonomic neuropathy

– changes in digestion, bowel and bladder function, sexual response, and perspiration. It can also affect the nerves that serve the heart and control blood pressure, as well as nerves in the lungs and eyes. Autonomic neuropathy can also cause hypoglycemia unawareness, a condition in which people no longer experience the warning symptoms of low blood glucose levels.

• Proximal neuropathy – pain in the thighs, hips, or buttocks and leads to weakness in the legs.

• Focal neuropathy – Sudden muscle weakness or pain one nerve or group of nerves (Bells

palsy, chest pain can be mistaken for heart attack).

About 60 to 70 percent of people with diabetes have some form of neuropathy

http://diabetes.niddk.nih.gov/DM/pubs/neuropathies/

• Peripheral neuropathy affects– toes– feet– legs– hands– arms

• Most common

• Autonomic neuropathy affects– heart and blood vessels– digestive system– urinary tract– sex organs– sweat glands– eyes– lungs

• More deadly

Autonomic neuropathy may be disabling• Symptoms of autonomic neuropathy may be intermittent

[but]…are responsible for…the most troublesome and disabling problems of diabetic neuropathy.– urinary incontinence– syncopal episodes– gastropathy can result in vicious cycles of glycemic control

problems, poor nutritional status, and advanced gastrointestinal complications.

• http://journal.diabetes.org/diabetesspectrum/98v11n4/pg224.htm– Due to strong association with CVD, ADA against vigorous

exercise. • http://care.diabetesjournals.org/content/33/Supplement_1/

S11.full.pdf+html

Foot damage• Five simple clinical tests are considered useful

in the diagnosis of loss of protective sensation (LOPS) an indicator of risk of ulcers and amputation.– 10-g monofilament– Vibration testing using a 128-Hz tuning

fork– Tests of pinprick sensation– Ankle reflex assessment– Testing vibration perception threshold

with a biothesiometer• ADA, Diabetes Care, Volume 33, Supplement

1, January 2010

– Nerve conduction studies add little.• J Neurol Neurosurg Psychiatry 2003; 74

(Suppl II)ii15-ii19

Amputation and foot ulceration are the most common consequences of diabetic neuropathy and major causes of morbidity and disability in people with diabetes.

ADA, Diabetes Care, Volume 28, Supplement 1, January 2005

Distal symmetric polyneuropathy (DPN) with autonomic neuropathy

1. Up to 50% of DPN may be asymptomatic

2. Autonomic function tests show abnormalities in 97% of patients with DSNP

3. Autonomic neuropathy may involve every system in the body

4. Cardiovascular autonomic neuropathy causes substantial morbidity and mortality.

5. Specific treatment for nerve damage is not available other than improved glycemic control, which may slow progression but not reverse neuronal loss.

6. Strict glucose control provides no clinically significant improvement from the patient’s perspective, despite modest improvement in vibration threshold and nerve conduction studies.

ADA Diabetes Care, Volume 33, Supplement 1, January 2010 & J Neurol Neurosurg Psychiatry 2003; 74 (Suppl II)ii15-ii19

Eye damage

• Diabetic retinopathy is estimated to be the most frequent cause of new cases of blindness among adults aged 20-75 years.

• ADA, Diabetes Care, Volume 28, Supplement 1, January 2005

Stages of retinopathy• Mild non-proliferative retinopathy

– small areas of balloon-like swelling occur in the retina's tiny blood vessels.

• Moderate non-proliferative retinopathy– some blood vessels that nourish the retina become blocked.

• Severe non-proliferative retinopathy– The damaged retina signals the body to produce new blood vessels.

• Proliferative retinopathy– New blood vessels are abnormal, they can rupture and bleed, causing

hemorrhages in the retina or vitreous. – Scar tissue can develop and can tug at the retina, causing further

damage or even retinal detachment.• http://www.nei.nih.gov/health/diabetic/retinopathy.asp

Symptoms of diabetic retinopathy• Blurred or double vision• Flashing lights, which can indicate a retinal

detachment• A veil, cloud, or streaks of red in the field of

vision, or dark or floating spots in one or both eyes, which can indicate bleeding

• Blind or blank spots in the field of vision– http://www.visionaware.org/how-diabetes-affects-

eyes-and-vision

Functional effects of retinopathy• Fluctuating vision in response to changing blood glucose

levels; vision can change from day-to-day, or from morning to evening

• Blurred central vision from macular edema can interfere with reading

• Decreased visual acuity can interfere with seeing the markings on an insulin syringe or the display on a standard blood glucose monitor

• Irregular patches of vision loss or "blind spots" can make it difficult to judge the size of food portions on a plate.

• Decreased depth perception, in combination with decreased visual acuity, can make it difficult to see curbs and steps, or walk to the diabetes clinic.

Does treatment of long-term complications cure?

• Similar question: With good control, does damage reverse?

• No.

• “…interventions do not change the underlying pathology and natural history of the disease process, but may have a positive impact on the quality of life of the patient.”

“Standards of Medical Care in Diabetes-2011” pg. S36 by ADA, DIABETES CARE, VOLUME 34, SUPPLEMENT 1, JANUARY 2011

Type 2 diabetes is difficult to control

• Only 37% of adults with diagnosed diabetes achieved an A1C of <7%, only 36% had a blood pressure <130/80 and just 48% had a cholesterol level <200 mg/dl.

• Only 7.3% of diabetes subjects achieved all three treatment goals.

• Saydah SH, Fradkin J, Cowie CC: Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. JAMA 291:335-342, 2004.

ADA Treatment Guidelines • Initial referral to a diabetes educator with an annual follow up.

– http://www.diabeteseducator.org

• Quarterly check-up– Blood work (AIC quarterly if uncontrolled, 2 times a year if under control)

• Annual examinations

– Urine test (screening for microalbuminuria)

– Eye exam (opthalmologist or optometrist)

– Foot exam with nerve testing (Semmes-Weinstein monofilament & tuning fork )

– Cardiovascular exam (with cholesterol and triglyceride profile)

– Influenza vaccine

Diabetes Management• People with diabetes should receive medical care

from a physician-coordinated team:– Physicians– Nurse practitioners– Physician’s assistants– Nurses– Dietitian– Pharmacists– Mental health professionals with expertise and a

special interest in diabetes.ADA Standards of Care, 1, 2010

Different types of insulin

Different types of oral medication

The choices of oral drug therapy for type 2 diabetes have become extremely complex. AACE Diabetes Guidelines, 2002

Use of diabetes pills up, insulin use down

• The proportion of Americans taking insulin fell from 38 percent to 24 percent from 1997-2007.

• During that same period, the proportion of Americans who took oral medications increased from 60 percent in 1997 to 77 percent in 2007—a 28 percent increase.– Sulfonylureas declined from 51 percent to 40 percent.– Biguanides rose from 21 percent to 55 percent.– Thiazolidinediones increased from 5 percent to 25

percent.

http://www.ahrq.gov/research/nov10/1110RA25.htm

Side Effects of Metformin

• Diarrhea – this occurs to up to 53.2 percent of people

• Nausea or vomiting – this happens to 25.5 percent

• Gas – this occurs to up to 12.1 percent of people

• Weakness – this happens to up to 9.2 percent of people

• Indigestion – this usually occurs to 7.1 percent of people

• Abdominal discomfort – this merely happens to 6.4 percent of people

• Headache – this is experienced by 5.7 percent of people

http://www.metforminsideeffects.org/

ADA accommodations“tight control”

• a private area – to test blood sugar levels or to take insulin

• a place to rest – until blood sugar levels become normal

• breaks – to eat or drink, take medication, or test blood sugar levels

• leave – for treatment, recuperation, or training on managing diabetes

• modified work schedule or shift change

• allow a person with diabetic neuropathy to use a stool.