Medications Used in the Treatment of Diabetes Mellitus

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Faculty/Steering Committee
Steering Committee:
• Pamela Allweiss, MD, MPH
Medical Officer
Centers for Disease Control and Prevention
Division of Diabetes Translation
Atlanta, GA
The findings and conclusions of this presentation are those of the presenter and do not necessarily
represent views of the Centers for Disease Control and Prevention
• Roger P. Austin, MS, RPh, CDE
Clinical Pharmacy Specialist – Diabetes
Henry Ford Health System
Sterling Heights, MI
Steering Committee and Speaking Faculty:
• Pamella Thomas, MD, MPH, FACPM, FACOEM
Chief Medical Officer
Med MatRx, LLC
Consulting Medical Director
E & P Business Strategy Solutions
Lithonia, GA
Pre-Symposium Survey
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Faculty/Steering Committee Disclosures
The steering committee/faculty reported the following relevant financial
relationships that they or their spouse/partner have with commercial
interests:
• Pamela Allweiss, MD, MPH: Nothing to disclose.
• Roger P. Austin, MS, RPh, CDE: Dr. Austin’s spouse is a faculty
member at: Johnson & Johnson Diabetes Institute.
• Pamella Thomas, MD, MPH, FACPM, FACOEM: Nothing to disclose.
Non-faculty/Reviewer Disclosures
Non-faculty content contributors and/or reviewers reported the following
relevant financial relationships that they or their spouse/partner have with
commercial interests:
• Matthew Horn, MD; Bradley Pine; Blair St. Amand; Jay Katz,
Dana Simpler, MD: Nothing to disclose.
Educational Objectives
At the conclusion of this activity, participants should be able to
demonstrate the ability to:
• Explain the impact of inadequate control of blood glucose levels on
workers’ overall health, work productivity, and safety
• Translate guideline recommendations into individualized therapeutic
decisions to manage hyperglycemia, as well as reduce hypoglycemia
risk, to best fit an employee’s needs and schedule
• Differentiate the mechanisms of action of diabetic medications,
including agents that act on the enteroinsular axis, and explain which
agents have a lower risk of hypoglycemia
• Build a partnership with employees by providing individualized
counseling (e.g. self-management education) and resources to
optimally manage blood glucose levels in the workplace and optimize
adherence
Overview
• The landscape of employer health
 The benefits and framework for worksite health and diabetes initiatives
 Making the business case for diabetes initiatives at the workplace
 How do we address the needs of the person with diabetes at the
worksite?
 How does the worksite keep its employees productive?
• Case studies of employer health and diabetes initiatives
• Resources for practitioners
• Getting started – worksites are a potential site for education
and diabetes educators can play a role.
Diabetes Is Hitting Hard During The
Working Years
• Diabetes affects almost 26 million Americans (8.3%), onequarter of whom don’t know they have it
• Another 79 million Americans have pre-diabetes, which raises
their risk of developing type 2 diabetes, heart disease, and
stroke
• About 1.9 million new cases of diabetes were diagnosed in
people age 20 years or older in 2010
• One-third will have diabetes by 2050 if current trends continue
• Cost: $174 billion
Available at: www.ndep.nih.gov or www.DiabetesAtWork.org.
Darwin Rules
Evolution of Perceptions and Diabetes
• Endocrine view of the world: normal glucose is the best;
NEVER over 140
• Previous occupational medicine view: No reactions at the
workplace; Current view: Control and prevent chronic
disease
Examples: Why Are We Discussing This?
• Box cutter and hypoglycemia
• Short-term use of insulin in type 2 diabetes in an employee
who drives a forklift
• Special occupations: Firefighters, law enforcement officers,
drivers
• Disposal of needles: pens, ADA guidelines
• Shift work
By 2050, if Current Trends Continue,
1 in 3 Americans Will Have Diabetes
Age-adjusted Percentage of US Adults Who
Were Obese or Who Had Diagnosed Diabetes
Obesity (BMI ≥30 kg/m2)
1994
No Data
Diabetes
No Data
<14.0%
2000
14.0-17.9%
1994
18.0-21.9%
2009
22.0-25.9%
2000
<4.5%
4.5-5.9%
6.0-7.4%
CDC’s Division of Diabetes Translation. National Diabetes Surveillance System.
Available at: www.cdc.gov/diabetes/statistics.
≥26.0%
2009
7.5-8.9%
≥9.0%
Diabetes Also Means:
• 2x the risk of high blood
pressure
• 2 to 4x the risk of heart
disease
• 2 to 4x the risk of stroke
• #1 cause of adult blindness
• #1 cause of kidney failure
• Causes more than 60% of
non-traumatic lower-limb
amputations each year
National Institute of Diabetes and Digestive and Kidney Diseases.
National Diabetes Statistics Fact Sheet. HHS, NIH, 2011.
Every 24 hours:
• 5205 new cases of
diabetes are diagnosed
• 180 non-traumatic lower
limb amputations are
performed
• 133 people begin treatment
for end-stage renal disease
• 829 people die of diabetes
or diabetes is a contributing
cause of death
Why Pick Diabetes for a Health Promotion
Intervention at a Business?
• Effective interventions promote • Unique opportunity for
education
multiple good outcomes
• Loss of productivity due to
uncontrolled diabetes may be
improved with better glucose
control
• Improve quality of life for
employees
• Many employees (both current
and future) have or may be at
risk for developing diabetes
• Less time away from work
• Improves employeremployee relations and
shows employer cares
about employees
Don’t Get Lost in Translation
Know the Language
Occupational Medicine Terms
Diabetes Education Terms
• Presenteeism
• CDE, DSME
• Absenteeism
• Prediabetes vs diabetes
• Timing of shift work
• Timing of insulin
• Short-term disability
• Acute and chronic
complications
• Placement
• Productivity
Diabetes in the Workplace
Employer Perspectives
Employee Perspectives
• Knowledge of numbers
of diabetic workers
• Problems in obtaining
employment
• Specific employment
policies
• Problems in maintaining
employment
• Employer attitudes
toward diabetic workers
• Discrimination??
• Confidentiality
Why Control Diabetes?
• Better control translates into fewer complications: DCCT in
type 1, UKPDS in type 2
• Fewer complications translate into fewer days lost to
absenteeism and disability, and future savings on health
care expenditures
Diabetes and the Workplace
General Considerations
• Type of job
• Desk job
• Physical activity
• Physically active job
• Hours
• Stress
• Coworkers
• Supervisor
• Physical environment
• Handling equipment
• Physical requirements
• Special license or
qualifications
Concerns
• Hypoglycemia, hypoglycemia, hypoglycemia
• Testing logistics
• Safety and correct disposal of syringes and other supplies
Job Restrictions
• Job placement
• Temporary or permanent restrictions
• Health status: temporary or permanent
Complications of Diabetes
Issue for Disability
• Balance between appropriate
therapies to PREVENT
complications and
accommodations such as
needles at the worksite and
breaks for snacks
• Wellness programs to
PREVENT and improve
control
Tug of War Between Ability to Do Work
• Tug of war between ability to do the job, blanket ban,
perceived limitations
• Multiple ADAs: Americans with Disabilities Act and
American Diabetes Association
• 2009 amendment: People with diabetes and other chronic
illnesses are within the law’s umbrella of protection
• Education of everyone: preconceived notions
Can This Person With Diabetes Do This Job?
The three hallmarks of successful individual assessment are:
• Individual job and the individual applicant – not blanket rules
– In most jobs there is no valid safety issue
• Expertise of both health care professionals with knowledge of
occupational medicine and those with knowledge of the
medical condition at issue
– Include treating physician
• Realizing there simply is not going to be one test and one
cut-off score
Individual Assessment
• LEO (law enforcement officers): ACOEM
• Avoid blanket bans!
• Focus on specific complications: eyes, neuropathy just like
other physical conditions such as back pain, repetitive
motion injuries, etc.
Reasonable Accommodations for
People with Diabetes
• Usually small, easy to accomplish, little or no cost to employer
• Daily care
– Time to check blood glucose and treat by administering insulin or food
– Place for blood glucose checking/treatment (work station except in rare
circumstances)
– Consistent shift for some people
• Responding to long-term complications
– Larger computer screen
– Chair
– Avoiding walking long distances
– Part-time or modified work schedules
Practical Considerations in
Current Diabetes Drug
Therapy
Natural History of Type 2 Diabetes
Adapted from: International Diabetes Center (Minneapolis, MN).
Therapy for Type 2 Diabetes: Sites of Action
Gut
Pancreas
Impaired Insulin
Secretion
=
Insulin
Deficiency
Carbohydrate Metabolism
Exogenous Insulin Rx
Acarbose
Sulfonylurea
Meglitinide
Hyperglycemia
Liver
HGP
Metformin
Muscle
Glucose
Uptake
Pioglitazone
=
Insulin
Resistance
Insulin Secretagogues
Sulfonylureas (SFUs) and Meglitinides
First-generation SFUs (introduced in the 1950s):
Chlorpropamide (Diabinese)
Tolbutamide (Orinase)
Tolazamide (Tolinase)
Seldom used; cause prolonged hypoglycemia
Insulin Secretagogues
Sulfonylureas
Second Generation SFUs: Introduced in the 1960s
Glyburide (Micronase, Diabeta)
Glipizide (Glucotrol)
Glimepiride (Amaryl)
Stimulate insulin secretion, but unlike normal physiology: risk
of unpredictable hypoglycemia
Glyburide use has been associated with cardiac ischemia
Insulin Secretagogues
Meglitinides (Glinides)
Examples: Repaglinide (Prandin)
Nateglinide
Increase pancreatic insulin production (like SFUs)
Short-acting secretagogues: decrease post-meal hyperglycemia
Less potential for prolonged hypoglycemia compared to
sulfonylureas
Biguanide(s)
Example: Metformin (Glucophage)
Decreases hepatic glucose production
Does not cause hypoglycemia when used as monotherapy
May decrease appetite; weight loss or weight-neutral
Long durability of effect (as contrasted w/ SFUs)
Thiazolidinediones (TZDs)
Examples: Pioglitazone (Actos)
Rosiglitazone (Avandia)
Enhance insulin sensitivity in muscle, adipose tissue
Inhibit hepatic gluconeogenesis
Do not increase insulin production, but rather reduce insulin
resistance (low risk of hypoglycemia as monotherapy)
Star-crossed class of drugs: Rezulin removed from US market in
1997; Avandia severely restricted in use in the US in 2008
Alpha-Glucosidase Inhibitors
Examples: Acarbose (Precose)
Meglitol
Decrease or slow carbohydrate absorption in the intestine
Infrequently used in the US d/t GI s/e’s
Low risk of hypoglycemia when used as monotherapy
GLP-1 Agonists
GLP-1 (glucagon-like peptide 1) is a hormone produced in
the small intestine in response to food entering the stomach
GLP-1 signals the pancreas to produce insulin and to
decrease glucagon in a glucose-dependent manner
GLP-1 agonists are biosynthetic peptides that mimic native
GLP-1 actions
Examples: Exenatide (Byetta)
Liraglutide (Victoza)
Exenatide long-acting (Bydureon)
GLP-1 Agonists
Occupational Medicine Terms
• Increases mealtime insulin
production and down-regulates
glucagon production
• Earlier satiety
• Slows gastric emptying time
• Cardioprotective
• Weight loss
• May slow apoptosis of
pancreatic beta cells
• Once daily dosing (Victoza)
Diabetes Education Terms
• Nausea (dose and time
dependent, decreases over
time)
• Injectable
• Expensive
• Twice daily dosing w/ 45-60 min
lead time prior to meals (Byetta)
Dipeptidyl-Peptidase-4 Inhibitors
(DPP-4 Inhibitors)
Examples: Sitagliptin (Januvia)
Saxagliptin (Onglyza)
Inhibit enzyme (DPP-4) that deactivates endogenous GLP-1
Increase insulin secretion (beta cells) & decrease glucagon
secretion (alpha cells) in the pancreas
Low risk of hypoglycemia when used as monotherapy
Insulin Therapy
No longer the option of last resort; in many cases, may be
necessary at time of diagnosis
Several options:
Basal insulin (glargine, detemir)
Mealtime insulin (aspart, lispro)
Mixtures (Novolog Mix 70/30; Novolin 70/30;
Humalog Mix 75/25)
Byetta (exenatide) now has an FDA-approved indication in
combination with basal insulin glargine (Lantus)
Type 2 Diabetes
A Failure of Mealtime Insulin Secretion (as Hyperglycemia
Worsens, Insulin Secretion Is further Impaired)
Adapted from Caotes PA et al. Diabetes Res Clin Pract. 1994;26:177-187.
Practical Aspects of Insulin Therapy
• Timing of dose in relationship to meals is critical
• Mixtures (70/30) work best for patients who eat on a
regular schedule
• Rapid-acting insulins (Novolog, Humalog, Apidra) must be
given at start of meals
• Matching dose to carbohydrate content of meals is critical
Blood Glucose Testing (SMBG)
• General Targets:
– Pre-meal and Fasting: 80 to 140 mg/dl
– 2 hours post-meal: 140 to 180 mg/dl
• Dangers of “insulin sliding scale” dosing
• Risks of skipped/missed meals
• Importance of BG testing at the worksite, especially for
workers who use insulin
Landscape of Employer
Health and Business Case
for Diabetes Initiatives
Population Changes
• Aging
• Changing Ethnic Mix
• Obesity
• Unhealthy Lifestyles
• Caregiving Demands
Impact on Employers
• Depletion of human capital
• Productivity losses
- Presenteeism
- Absenteeism
- FMLA
- Disability: Short-term and Long-term
- Workers’ compensation cost, liability
- Double-digit increase in health care expenditure
- Loss of highly skilled employees
It’s More Than Health Care Costs…
The Economic Toll of Poor Health Includes Direct
and Indirect Costs
Source: National Business Group on Health.
Economic Benefits of Improved
Glycemic Control
• Workers with better A1c have fewer days
lost to absenteeism*
• Fewer days of restricted activity
* Testa MA, Simonson DC. JAMA. 1998;280:1490-1496.
A1c
Glucose Avg Charge/Patient
mg/dL No Complications
6%
100
$8,576
7%
135
$8,954
Avg Charge/Patient
Complications
~ $30,000
$38,726
$40,230
~ $31,000
8%
9%
10%
170
205
240
$9,555
$10,424
$11,629
$42,230
~ $32,000
~ $32,000
$38k
Gilmer TP et al. Diabetes Care. 1997;20:1847-1853.
$42,467
$49,673
Access to Diabetes Management
• Time, cost, distance
• Adult learning theories
• Workplace culture
• Employee empowerment
• Impact of low health literacy
Adult Learning Theories for
Health Behavior Change
• Need to feel actions will lead to outcomes
• Hands-on interactive sessions
• Role-play exercises
• Small groups
• Readiness to change
Workplace Culture
• Capture senior level support and leadership
• CEO leading charge
• Benefit design to support efforts and reduce barriers,
also pay for value, not just care
• Educate employees on their benefit coverage
• Create teams
• Choose appropriate interventions
• Create a supportive environment
• Solicit employee input
• Make health behavior change fun!!
Employee Empowerment
• Known barriers to disease management compliance
• Leads to
– Poor problem-solving skills
– Needs assessment
– Poor health outcomes
– Little or no knowledge of benefit-plan coverage
Health Literacy
• Definition from IOM: the degree to which an individual
has the capacity to obtain, process, and understand
basic health information and services needed to make
appropriate health care decisions
• In the US
– Proficient: 12%
– Intermediate: 53%
– Basic: 22%
– Below Basic: 14%
• Cost $106-$238 billion dollars per year
Patient Recall After MD Visit
• Truth is stranger than fiction
• Forget 40%-83% of what they hear before
leaving the office
• Only 50% of what is remembered is correct
Examples of Programs
and Resources
Worksite Diabetes Intervention Programs
at Chrysler Corporation 2005-2008
The “Diabetes Coach”
Coaching vs Counseling vs Consulting:
A Single Role, or a Blend of All Three?
Chrysler HQ Diabetes Intervention
A1c Data (Pre-/Post-Intervention)
A1c
Aug-05
Feb-06
>9%
6 ( 5%)
2 (2.3%)
>8% <8.9%
18 (14%)
6 (7%)
>7% <7.9%
21 (17%)
15 (18%)
>6% <6.9%
45 (35%)
25 (30%)
>5% <5.9%
37 (29%)
33 (39%)
<5%
Total
3 (3.6%)
127
84
Assembly Plant Pilot Data
(Feb 2007 to Apr 2008)
n = 22
A1c (%)
RBG (mg/dl) DBP (mmHg) SBP (mmHg) Total Chol (mg/dl)
Pre-
8.5
195.8
132.1
81.6
198.9
Post-
7.2
139.0
122.5
79.6
172.0
Avg Diff
1.3
56.8
9.6
2.0
26.9
Lost Hours 2006
2872.2
Lost Hours 2007
1435.3
Difference
1436.9
n = 18
www.DiabetesAtWork.org
• www.diabetesatwork.org can help businesses and managed care
companies assess the impact of diabetes in the workplace, and provide
intuitive information to help employees manage their diabetes and take
steps toward reducing risks for related complications
www.DiabetesAtWork.org Content
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General diabetes education
Managing diabetes complications
Cardiovascular disease risk factors
Nutrition, physical activity, and weight
control
Emotional well-being
Feet care
Guide to choosing a health plan
“Lunch and Learns” topics
Shift work
Supervisor’s guide
Links to NDEP websites
Resource List
American Diabetes Association
www.diabetes.org
American College of Occupational
Environmental Medicine
www.acoem.org
Centers for Disease Control (CDC)
www.cdc.gov/workplacehealthpromotion
www.cdc.gov/NationalHealthyWorksite
Diabetes at work
www.diabetetesatwork.org
Healthy People 2020
www.healthypeople.gov
National Business Coalition on Health
www.nbch.org
National Business Group on Health
www.businessgroup.org
National Diabetes Education program
www.ndep.nih.gov
Partnership for Prevention
www.prevent.org
Wellness Councils of America
www.welcoa.org
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