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DIABETES MELLITUS IN THE AMBULATORY SETTING

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Title: DIABETES MELLITUS IN THE AMBULATORY SETTING


1
DIABETES MELLITUS IN THE AMBULATORY SETTING
  • Evaluation and Treatment Strategies in the
    General Internal Medicine Clinic
  • Jan Cooper, M.D.

2
How big is the problem in the U.S.?Diabetes
Mellitus (DM) was declared an epidemic in the
U.S. by the CDC in 2001.
  • 11 of people age 20, including 27 of those
    age 65, have DM!
  • Another 35 of people age 20, including 50 of
    those age 65, have pre-diabetes!
  • This is no surprise, as 67 of people age 20,
    including 70 of those age 65, are overweight
    or obese!
  • Whats even worse is that 27 of those with DM
    dont even know that they have it!
  • CDC.National Diabetes Fact Sheet,2011 CDC/NCHS
    Obesity and Overweight FastStats,2010 CRC
    Obesity Among Older Americans,2009.

3
Why is DM so important?
  • Diabetics have a 2 to 4 times increased risk of,
    and death from, cardiovascular disease (CVD).
  • Diabetic retinopathy is the 1 cause of new
    blindness in adults in our country.
  • Diabetic nephropathy is the 1 cause of end
    stage renal disease in our country.
  • Diabetic neuropathy and PVD are the major causes
    of non-traumatic amputations in our country.
  • DM is responsible for about 10 of our countrys
    healthcare costs.
  • CDC. National Diabetes Fact Sheet, 2011.

4
Type 1 DM vs Type 2 DM
  • Type 1 DM is a disease of beta cell destruction
    and insulin deficiency. It accounts for 5 - 10
    of cases.
  • Type 2 DM is a disease of insulin resistance and
    progressive beta cell failure, resulting in
    relative or absolute insulin deficiency. It
    accounts for 90 - 95 of cases.
  • 90 of patients with DM are managed by primary
    care physicians, but many/most patients with Type
    1 DM are managed by endocrinologists and
    pediatricians.
  • Todays discussion is limited to Type 2 DM.
  • Recommendations are from the guidelines of the
    American Diabetes Association (ADA) - newest
    guidelines issued January 2013 (hyperglycemia
    management updated 6/12).

5
First Case
  • A 61 year old African American woman comes to see
    you for a checkup after being told her BP was
    elevated at a church screening. She is
    asymptomatic. She has no PMH, has not seen a
    doctor in many years, and is on no prescription
    or OTC medications. She does not exercise or eat
    a healthy diet, and she does not smoke or drink.
    She has no health insurance. Her mother and 2
    sisters have DM and HTN.
  • On PE her BP is 155/95, she weighs 220 pounds, is
    52 tall, and has a BMI of 40. Otherwise, her
    PE is normal.
  • What labs would you order at this point?

6
Who should be screened for DM?
  • Everyone age 45 and over.
  • Everyone under 45 with a BMI 25 kg/m² and one
    other risk factor for DM
  • ? Family history in a 1st or 2nd degree
    relative.
  • ? Race/ethnicity of Native American, African
    American,
  • Latino, Asian American, or Pacific
    Islander.
  • ? History of gestational DM or delivery of a
    baby 9 lbs.
  • ? Polycystic ovary syndrome, HTN, lipid
    disorder,
  • acanthosis nigricans, CVD or sedentary
    lifestyle.
  • If screening is normal, it should be repeated
    every 3 years.
  • ADA.Diabetes Care,201336(Suppl 1)S3-S66.

7
First Case (cont)Lab Results
  • Fasting glucose 150 mg/dl
    Chol 240 mg/dl
  • CMP otherwise normal
    TG 250 mg/dl
  • CBC normal
    HDL 36 mg/dl
  • TSH normal
    LDL 154 mg/dl
  • U/A normal
    HBA1C 8.8
  • What diagnoses would you give her at this time?

8
How do you diagnose DM?
  • Fasting plasma glucose 126 mg/dl, or
  • 2 hour plasma glucose 200 mg/dl during an oral
    glucose tolerance test, or
  • Symptoms of hyperglycemia and a random plasma
    glucose 200 mg/dl, or
  • HBA1C 6.5.
  • All should be repeated before making the
    diagnosis, unless 2 different tests are both
    consistent with DM.
  • ADA.Diabetes Care.201336(Suppl 1)S3-S66.

9
How do you diagnose pre-diabetes?
  • Impaired Fasting Glucose (IFG) fasting plasma
    glucose 100 mg/dl and 125 mg/dl, or
  • Impaired Glucose Tolerance (IGT) 2 hour plasma
    glucose 140 mg/dl and 200 mg/dl during an
    oral glucose tolerance test, or
  • HBA1C 5.7 - 6.4.
  • All should be repeated before making the
    diagnosis.
  • ADA.Diabetes Care.201336(Suppl 1)S3-S66.

10
Why and how should we treat pre-diabetes?
  • It confers an increased risk of CVD, and without
    intervention, most will develop DM within 10
    years.
  • Aim for a weight loss of 5 - 10 and at least 150
    minutes of moderate activity per week.
  • Consider metformin for obese patients under the
    age of 60 who have both IFG and IGT, plus any one
    of the following
  • ? HBA1C 6.0 - 6.4.
  • ? HTN.
  • ? Low HDL cholesterol.
  • ? Elevated triglycerides.
  • ? Family history of DM in a 1st degree
    relative.
  • Monitor at least yearly.
  • ADA.Diabetes Care.201336(Suppl 1)S3-S66.

11
First Case (cont)
  • What treatment would you institute for this
    patient with newly diagnosed DM and a HBA1C of
    8.8?

12
How do you manage DM?
  • Referral to a Diabetes Education Program to
    assist in education on Medical Nutrition Therapy
    (MNT), exercise, and all aspects of the disease,
    including treatment, self monitoring,
    complications, and the concept that it is a
    progressive disease leading to insulin therapy in
    most patients.
  • Medication for glycemic control.
  • Monitoring for complications.
  • Treatment of HTN, lipids and hypercoagulability.
  • Smoking cessation.
  • Consider referral for bariatric surgery if BMI
    35.
  • ADA.Diabetes Care.201336(Suppl 1)S3-S66.

13
What are the glycemic goals?
  • HBA1C lt 7.
  • Fasting/Preprandial/Bedtime (AC and HS) capillary
    blood glucose (CBG) 70 - 130 mg/dl.
  • Postprandial CBG 1 - 2 hours after starting a
    meal lt 180 mg/dl.
  • Goal is to achieve glycemic target without
    causing hypoglycemia.
  • Reaching goal glycemia has been clearly shown to
    prevent microvascular complications its effect
    on the prevention of macrovascular complications
    is less clear, but seems to be most important
    when attained early in the course of DM. Control
    of BP lipids, use of ASA, and smoking cessation
    are essential in preventing CVD.
  • ADA.Diabetes Care, 201336 (Suppl 1)S3-S66.

14
Does tight glycemic control prevent macrovascular
disease?
  • Based upon the findings of the UKPDS, ACCORD,
    ADVANCE and VADT trials, the ADA, AHA, and ACC
    issued a joint statement supporting the
    individualization of treatment goals, and
    stressing the importance of aggressive treatment
    and control early in the course of the disease.
  • Patients with a history of severe hypoglycemia,
    limited life expectancy, advanced microvascular
    and macrovascular complications, extensive
    comorbidities, or longstanding difficult to
    control DM, may reasonably have a HBA1C goal that
    is gt 7.
  • Patients with a shorter duration of DM, a long
    life expectancy, and no significant
    complications, may reasonably have a HBA1C goal
    that is lower, lt 6.5 or even lt 6.0.
  • Skyler etal.Diabetes Care.200932187-192.

15
How do you choose medication for glycemic control?
  • Choose based upon potency, safety, side effects,
    ease of use, effect on other risk factors, and
    cost.
  • There is no good data yet showing that one
    class of medication prevents complications better
    than another, other than through the level of
    glycemic control and effects on other risk
    factors.
  • New guidelines June 2012 are less prescriptive
    and algorithmic, and are more patient-centered.

16
Medications for DM
  • ? Biguanides - Metformin (Glucophage) -
    decrease hepatic glucose output - weight neutral
    or mild loss, no hypoglycemia, cheap - GI side
    effects, contraindicated in CRI and unstable CHF
    because of risk of lactic acidosis, B12
    deficiency.
  • ? Sulfonylureas - Glipizide (Glucotrol),
    glimeperide (Amaryl) - enhance insulin secretion
    - cheap - weight gain, hypoglycemia.
  • Glyburide and chlorpropamide are not
    recommended because of long half lives and risk
    of severe hypoglycemia.
  • ? Insulins - Lispro (Humalog), aspart
    (Novolog), glulisine (Apidra) Regular NPH
    glargine (Lantus), detemir (Levemir) and fixed
    combinations - no dose limit, NPH and Regular are
    cheap, improve lipids - injections, weight gain,
    hypoglycemia, analogs are expensive.
  • Inhaled insulin (Exubera) was taken off
    of the market because of poor sales.

17
Medications for DM(cont)
  • ? Thiazolidinediones (TZDs or Glitazones) -
    Pioglitazone (Actos) - increase sensitivity to
    insulin - improve lipids, potential decrease in
    MI, no hypoglycemia - fluid retention, weight
    gain, CHF, fractures, expensive, ?bladder cancer
    (taken off of market in France and Germany).
  • Rosiglitazone (Avandia) is not
    recommended because of
  • possible cardiovascular risks, taken off
    the market in Europe, and its use restricted by
    the FDA in 9/10.
  • ? DPP-4 Inhibitors - Sitagliptin (Januvia),
    saxagliptan (Onglyza), linagliptin (Tradjenta),
    alogliptin (Nesina) - increase glucose-mediated
    insulin secretion, suppress glucagon secretion -
    weight neutral, no hypoglycemia - expensive,
    ?effects on immune system, long term effects not
    known.
  • ? GLP-1 Agonists (Incretin Mimetics) -
    Exenatide (Byetta, Bydureon), liraglutide
    (Victoza) - potentiate glucose-stimulated
    insulin secretion, suppress glucagon secretion,
    slow gastric motility - weight loss,
    ?delay/prevention of beta cell failure, no
    hypoglycemia - injections, expensive, GI side
    effects, ?pancreatitis, ?medullary CA of the
    thyroid, long term effects not known.

18
Other Medications for DM
  • ? a-Glucosidase Inhibitors - Acarbose
    (Precose), miglitol (Glyset) - reduce the rate of
    digestion of polysaccharides - weight neutral, no
    hypoglycemia - severe GI side effects, expensive,
    three times daily.
  • ? Glinides - Nateglinide (Starlix),
    repaglinide (Prandin) - stimulate insulin
    secretion - weight gain, three times daily,
    expensive, hypoglycemia.
  • ? Amylin Agonists - Pramlintide (Symlin) -
    slow gastric emptying, decrease glucagon
    secretion - weight loss, no hypoglycemia -
    injections, expensive, GI side effects, long term
    effects not known.
  • ? Bile Acid Resins - Colesevelam (WelChol) -
    mechanism of action unknown.
  • ? Dopamine Receptor Agonists - Bromocriptine
    (Cycloset) - mechanism of action unknown, but
    probably normalizes aberrant hypothalamic
    neurotransmitter activities.
  • Sodium-glucose Transporter-2 Inhibitors
    (SGLT2s) - Dapagliflozin, canagliflozin (neither
    yet approved by the FDA) - block reabsorption of
    glucose in the kidneys.

19
How potent are these medications?If initial
HBA1C is 9, use 2 medications. If initial
glucose is 300-350mg/dl, or HBA1C is 10-12,
use insulin.
  • Medication
  • Biguanides
  • Sulfonylureas
  • Insulin
  • TZDs
  • DPP - 4 Inhibitors
  • GLP - 1 Agonists
  • a - Glucosidase Inhibitors
  • Glinides
  • Amylin Agonists
  • Colesevelam
  • Bromocriptine
  • Expected decrease in HBA1C
  • 1.0 - 2.0
  • 1.0 - 2.0
  • No limit
  • 0.5 - 1.4
  • 0.5 - 0.8
  • 0.5 - 1.0
  • 0.5 - 0.8
  • 0.5 - 1.5
  • 0.5 - 1.0
  • 0.5 - 1.0
  • 0.5 - 1.0

20
Diabetes Care, Diabetologia. 19 April 2012 Epub
ahead of print
T2DM Antihyperglycemic Therapy General
Recommendations
21
Diabetes Care, Diabetologia. 19 April 2012 Epub
ahead of print
T2DM Antihyperglycemic Therapy General
Recommendations
22
Diabetes Care, Diabetologia. 19 April 2012 Epub
ahead of print
T2DM Antihyperglycemic Therapy General
Recommendations
23
Diabetes Care, Diabetologia. 19 April 2012 Epub
ahead of print
24
Diabetes Care, Diabetologia. 19 April 2012 Epub
ahead of print
T2DM Anti-hyperglycemic Therapy General
Recommendations
25
Diabetes Care, Diabetologia. 19 April 2012 Epub
ahead of print
Adapted Recommendations When Goal is to Minimize
Costs
26
Diabetes Care, Diabetologia. 19 April 2012 Epub
ahead of print
Adapted Recommendations When Goal is to Avoid
Hypoglycemia
27
First Case (cont)
  • She was referred to the Diabetes Center for MNT
    and general teaching.
  • She was started on metformin 500 mg twice daily,
    and was told to increase to 1000 mg twice daily
    after 2 weeks.
  • She was referred to Ophthalmology.
  • She was scheduled to return to clinic in 3 months
    for follow-up, with a HBA1C and a urine
    microalbumin/creatinine one week before her
    appointment.
  • Should any other medications be prescribed at
    this time?

28
What other disorders need treatment in patients
with DM?
  • In addition to treating the glucose, we must also
    treat the HTN, lipid abnormalities and
    hypercoagulability.
  • ? ACE Inhibitor (or ARB) for HTN, with a
    goal BP of 130/80 140/80 (per ACCORD tight
    control of HTN arm), although lower may be
    appropriate for some patients. Take at least one
    medication at bedtime.
  • ? Statin if above goal. Statin if overt
    CVD, or over 40 with one or more other risk
    factors, regardless of baseline LDL. Goal LDL
    less than 100 mg/dl, and less than 70 mg/dl for
    overt CVD (or 30 - 40 below baseline). May need
    additional treatment for TG and HDL if abnormal
    (ACCORD found no benefit of fibrate added to
    statin if TG and HDL are already at goal).
  • ? Low dose ASA if overt CVD. Low dose ASA
    for men over 50 and women over 60 who have one or
    more other risk factors. Clopidogrel (Plavix)
    should be used in the case of ASA allergy.
  • ADA.Diabetes Care,201336(Suppl 1)S3-S66.

29
First Case (cont)
  • Lisinopril 20 mg daily was added, and a
  • chem-7 was ordered for 2 weeks.
  • Atorvastatin 40 mg daily was added, and lipids
    and LFTs were ordered for one week before her 3
    month appointment.
  • ASA 81 mg daily was added.

30
How do you monitor therapy?
  • HBA1C level every 3 months if uncontrolled or if
    therapy is changed, otherwise every 6 months.
  • Self monitoring of blood glucose is definitely
    indicated for patients on multiple daily doses of
    insulin, and may be indicated for patients on one
    dose of insulin daily, or on non insulin therapy
    particularly if there is a risk of hypoglycemia.
  • Novel methods of monitoring are being evaluated
    e.g. continuous monitoring, service dogs and
    tattoos.

31
First Case (cont)
  • She returns to clinic in 3 months. She has lost 5
    lbs.
  • HBA1C is 6.1, BP is 145/85, Chol is 180 mg/dl,
    LDL is 68 mg/dl, HDL is 40 mg/dl, and TG is 210
    mg/dl.
  • HCTZ 25 mg daily is added.
  • Fenofibrate 145 mg daily is added.
  • You are satisfied with her DM control.
  • She is scheduled to return to clinic in 3 months
    with a lipid profile and Chem-7 before.

32
First Case (cont)
  • She unfortunately does not return to see you for
    one year, but she has continued to take her
    medications as prescribed. She has gained 15
    pounds.
  • Now her BP is 120/75, HBA1C is 7.8, CMP is
    normal, Chol is 152 mg/dl, TG is 148 mg/dl, HDL
    is 50 mg/dl and LDL is 69 mg/dl.
  • What medication adjustments, if any, do you make
    at this time?

33
First Case (cont)
  • You add glipizide ER 10 mg daily.
  • You send her back to diabetes education to
    reinforce diet and exercise.
  • She returns to clinic in 3 months with a HBA1C of
    7.4. She has lost 10 lbs.
  • What medication adjustments, if any, do you make
    at this time?

34
First Case (cont)
  • You add NPH 10 units twice daily. (She knows how
    to use insulin from giving it to her mother.)
  • She returns to clinic in 3 months with a HBA1C of
    6.0. She has lost another 5 lbs.
  • You are happy with her control, and schedule her
    to return to clinic in 6 months with a HBA1C
    before.

35
Are we doing a good job with treatment?
  • Only 57 of diabetics have a HBA1C lt 7.
  • Only 46 of diabetics have a BP lt 130/80.
  • Only 47 of diabetics have an LDL cholesterol
  • lt 100 mg/dl.
  • Only 12 of diabetics are meeting all 3 goals!
  • Cheung etal.Amer J of Med.2009122 443-453.

36
Why do we do such a poor job?
  • Patient reasons Cost, side effects, fear of
    side effects, fear of injections, and denial of
    disease.
  • Physician reasons Clinical inertia - not
    enough time, not enough resources, concern about
    cost and pill burden, care directed at acute
    problems, and lack of knowledge of goals.

37

38

39
Complications Macrovascular
  • DM increases the risk of coronary artery disease,
    stroke, and peripheral vascular disease 2 to 4
    times.
  • Although controlling the glucose may be
    important early in the disease, controlling the
    BP and lipids, avoiding smoking, and taking ASA
    when indicated are much more important for
    prevention.

40

41
Complications Neuropathy
  • Present in 60 - 70 of diabetics. Symmetric
    distal polyneuropathy is the most common type,
  • and leads to Charcot joints, dislocations,
    fractures, ulcers, infections, and amputations.
  • Prevention/Treatment Control glucose, teach
    good foot care, do a foot exam yearly, refer to
    Podiatry if neuropathy or its complications are
    present, and control pain tricyclics, topicals
    and anticonvulsants.

42

43

44
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45

46
Complications MicrovascularNephropathy
  • Present in 20 - 40 of diabetics.
  • Prevention/Treatment Maintain BP 140/80, keep
    glucose at goal, and check urine
    albumin/creatinine ratio yearly. Use ACE
    inhibitor or ARB to treat BP.

47

48
Complications MicrovascularRetinopathy
  • Present in 40 - 45 of diabetics.
  • Prevention/Treatment Control BP and glucose to
    previously mentioned goals, and refer to
    Ophthalmology for yearly screening exam/treatment.

49
Health Maintenance
  • Pneumovax once, then repeat after age 65.
  • Hepatitis B vaccine now recommended by the
    ACIP/CDC.
  • All other vaccinations as are appropriate for
    age.
  • Routine dental exams.
  • Contraception counseling for women of child
    bearing age.
  • Age appropriate cancer screening only (the
    meaning of the increased risk of liver, pancreas,
    uterus, colon, breast and bladder cancers, and
    the decreased risk of prostate cancer, is
    unclear).

50
Second Case
  • This is a 69 year old Hispanic woman who has been
    followed elsewhere for DM for 15 years, HTN for 8
    years, osteoporosis for 3 years, and
    hyperlipidemia for 5 years. She has had several
    episodes of hypoglycemia recently, usually after
    being late for a meal, and once in the middle of
    the night requiring an ER visit after a fall.
    She does not smoke or drink, lives alone, and has
    no family in town.
  • Meds Glyburide 5 mg daily, metformin 1000 mg
    twice daily, ramipril 10 mg daily, chorthalidone
    12.5 mg daily, simvastatin 40 mg daily, ASA 81mg
    daily, alendronate 70 mg weekly, and OTC calcium
    with vitamin D.

51
Second Case (cont)
  • BP 128/78, BMI 35, fundi are normal, she has
    decreased sensation to filament exam on both
    feet, and the remainder of the PE is normal.
  • She checks her CBGs AC breakfast and dinner, and
    they are 75-110 AC breakfast and low 200s AC
    dinner.
  • HBA1C is 7.9, but the remainder of her labs are
    normal.
  • What medication adjustments, if any, do you make?

52
Second Case (cont)
  • Glyburide was D/Cd.
  • Exenatide 5 ug SQ twice daily was added, and
    titrated up to 10 ug twice daily at her next
    visit.
  • She was referred to the Diabetes Educator to
    learn injection and reinforce prior teaching.
  • Follow-up HBA1C is 6.8, her CBGs are at goal,
    and she has had no further episodes of
    hypoglycemia.
  • She has also lost 10 pounds.

53
Third Case
  • A 42 year old man with HTN, hyperlipidemia and an
    ischemic cardiomyopathy with an EF of 25 and
    severe SOB on minimal exertion, is referred to
    you by his cardiologist for management of fairly
    newly diagnosed DM.
  • Meds Metformin 500 mg twice daily, pioglitazone
    15 mg daily, carvedilol 25 mg twice daily,
    furosemide 40 mg daily, lisinopril 40 mg daily,
    rosuvastatin 20 mg daily, and ASA 325 mg daily.

54
Third Case (cont)
  • BP 110/60, Wt 240 lbs, BMI 35, fundi difficult
    to visualize, elevated neck veins, S3 gallop,
    holosystolic murmur, 1 edema, but foot exam was
    otherwise normal.
  • He brings in a copy of recent labs
  • HBA1C 10.2, FBS 252 mg/dl, Crt 1.8 mg/dl,
    and Ur Alb/Crt 50 mg/g (nl lt 30).
  • What medication adjustments, if any, would you
    make?

55
Third Case (cont)
  • Metformin and pioglitazone were both D/Cd.
  • Insulin glargine 30 units daily was started, and
    he was sent to the Diabetes Educator to learn
    injection, self monitoring techniques, and self
    titration of insulin to reach a target FBS.
  • He was also referred to Ophthalmology.
  • He returned to clinic in 3 months on 45 units of
    insulin glargine daily with a glucose log showing
    fasting CBGs at goal, but a HBA1C of 7.9.

56
Third Case (cont)
  • He then began checking AC and HS CBGs. The AC
    breakfast and dinner CBGs were at goal, but the
    AC lunch and HS CBGs were high, prompting the
    addition of 3 units of insulin lispro before
    breakfast and dinner. He was instructed on self
    titration of the insulin lispro, which was raised
    to 6 units at both times, resulting in AC and HS
    CBGs that were all at goal.
  • A follow up HBA1C in 3 months was 6.8.

57
What should you remember?
  • Screen for DM its an EPIDEMIC!
  • Treat glucose, BP and lipids early, aggressively,
    and to goal use ASA when appropriate insist on
    smoking cessation and watch for complications.
  • Empower patients to be involved in their DM
    management.
  • Remember that DM is a progressive disease, so
    expect to change therapy over time let patients
    know this at diagnosis.
  • Stay informed about the current management of DM
    its changing constantly!

58
Suggested Reading
  • American Diabetes Association Standards of
    Medical Care in Diabetes - 2013. Diabetes Care 36
    (Supplement I) S3-S66, 2013.
  • Inzucchi SE, Bergenstal RM, Buse JB, etal.
    Management of Hyperglycemia in Type 2 Diabetes A
    Patient-Centered Approach. Diabetes Care 35
    1364 1379, 2012.
  • Skyler JS, Bergenstal R, Bonow RO, etal.
    Intensive Glycemic Control and the Prevention of
    Cardiovascular Events Implications of the
    ACCORD, ADVANCE, and VA Diabetes Trials. Diabetes
    Care 32 187 - 192, 2009.
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