Download pre-diabetes - Indiana Pharmacists Alliance

PRE-DIABETES:
PREVENTIVE MEDICINE TO BATTLE
A GROWING EPIDEMIC
Susan Cornell, BS, Pharm.D., CDE, FAPhA, FAADE
Associate Director of Experiential Education
Associate Professor of Pharmacy Practice Midwestern
University Chicago College of Pharmacy
Downers Grove, IL
Wednesday, April 20, 2016
Objectives
• Outline the prevalence of pre-diabetes in Indiana as compared to the
national prevalence.
• Describe screening methods for pre-diabetes including specific examples
of communities that have successfully launched screening events.
• Explain current treatment paradigms for pre-diabetes.
• Outline the role of communities and pharmacy partnerships to support
patients with pre-diabetes. (include discussions of nutrition information,
exercise programs, etc.)
• Describe the nature and component parts of a national initiative, The
National Diabetes Prevention Program and any initiatives by county health
departments, CHCs, or hospitals to participate in this initiative.
• Provide specific examples of ways that pharmacists in different practice
settings can assist patients and communities to address the prevalence of
pre-diabetes.
Disclosure to Participants
• Susan Cornell, BS, PharmD, CDE, FAPhA,
FAADE
– Advanced Practitioner Advisory Board and
Speaker bureau for:
• Sanofi
• Novo Nordisk
• Susie King
– No disclosures to report
Pre-Assessment Question #1
• Which of the following statements regarding prediabetes is correct?
1. People with pre-diabetes will eventually develop
diabetes.
2. People with pre-diabetes have elevated postprandial glucose and normal fasting glucose.
3. People with pre-diabetes have an A1c between
6.5-7%.
4. Pre-diabetes is a result of insulin deficiency.
Pre-Assessment Question #2
• Which of the diabetes medications classes directly
targets insulin resistance?
1.Alpha-glucosidase inhibitors
2.Glucagon-like peptide-1 receptor agonists
3.Sulfonylureas
4.Thiazolidinediones
Pre-Assessment Question #3
• Which of the diabetes medications classes has
NOT been studied and used to treat pre-diabetes?
1.Biguanides
2.Glucagon-like peptide-1 receptor agonists
3.Sulfonylureas
4.Thiazolidinediones
29.1 million
with Diabetes
86 million
with Prediabetes
Centers for Disease Control and Prevention
National Diabetes Statistics Report, 2014
Type 2 Diabetes with Severe Insulin Resistance Due to
Obesity and Physical Inactivity
Obesity
Age-adjusted percent
0 - 19.4
19.5 - 23.8
23.9 - 27.0
27.1 - 30.7
> 30.8
Diagnosed with Diabetes
Age-adjusted percent
Physically Inactive
Percent
0 - 6.3
0 - 20.0
6.4 - 7.5
20.1 - 24.4
7.6 - 8.8
24.5 - 28.2
8.9 - 10.5
28.3 - 32.7
> 10.6
> 32.8
Centers for Disease Control and Prevention: National Diabetes Surveillance System.
Available online at: http://apps.nccd.cdc.gov/DDTSTRS/default.aspx.
Diagnosed Diabetes Prevalence, Indiana, 2012
0 – 6.3 %
6.4 – 7.5 %
7.6 – 8.8 %
8.9 – 10.5 %
10.6 %+
Source: Centers for Disease Control and Prevention. (2015) Interactive Diabetes Atlas
Pre-Diabetes Prevalence in Indiana
Population of Indiana 6.5 million (2014)
1.9 million Hoosiers over the age of 20 living with pre-diabetes
- According to the ADA
9 out of 10 people with pre-diabetes do not know they have it
- According to the CDC
Why is Glucose Control Important?
• 60% of people with type 2 diabetes have
at least 1 complication because of
diabetes
( > 50%
before or at diagnosis)
State of diabetes complications in America. Impact of diabetes complications in America.
http://www.stateofdiabetes.com/impact_of_diabetes.html
The American Diabetes Association
Estimates That By The Time A Patient Is
Finally Diagnosed With Type 2 Diabetes
They Have Actually Had Diabetes For
About 9 Years!
Early screening and intervention is
needed in order to prevent pre-diabetes
moving to diabetes
By the time a person is diagnosed with T2DM,
approximately how much β-cell function has
been lost?
A.
B.
C.
D.
E.
< 10%
10 – 30%
30 – 50%
50 – 80%
100%
Progressive Loss of ß-Cell Function
in Pre-Diabetes/Type 2 Diabetes
Progressive loss of β-cell function
occurs prior to diagnosis
β-Cell Function (%)
100
80
60
40
Sulfonylurea
Diet
Metformin
20
0
–5
-4
–3
–2
–1
Years with pre-diabetes
0
1
2
3
4
5
Years Since Diagnosis
Adapted from U.K. Prospective Diabetes Study Group. Diabetes. 1995; 44:1249-58.
6
Natural History of Type 2 Diabetes
Years from
diagnosis
-10
-5
Onset
0
5
10
15
Diagnosis
Insulin resistance
Insulin secretion
Postprandial glucose
Fasting glucose
Pre-diabetes
Microvascular complications
Macrovascular complications
Type 2 diabetes
Ramlo-Halsted BA et al. Prim Care. 1999; 26:771-89.
Nathan DM. N Engl J Med. 2002; 347:1342-9.
Fasting vs. Postprandial Glucose Relationship to
Complications
• Fasting Glucose
– Microvascular complications
• Retinopathy
• Neuropathy
• Nephropathy
• Postprandial Glucose
– Macrovascular complications
• Dyslipidemia
• Hypertension
The better glucose control,
the more important PPG becomes!
FPG
PPG
120
% contribution
100
80
60
40
20
0
<7.3
Adapted from Monnier L, et al.
Diabetes Care 2003:26;881-885
7.3 to 8.4
8.4 to 9.3
A1c Range
9.3 to 10.2
>10.2
ADA Diagnostic Criteria
Test
Normal
Pre-Diabetes
Diabetes
(IFG =Impaired Fasting Glucose)
(IGT = Impaired Glucose Tolerance)
Fasting
glucose
< 100
100 – 125
> 126
2 hr BS
< 140
140 – 199
> 200
< 5.7
5.7 - 6.4
> 6.5
Oral glucose
tolerance test
A1C
Diabetes Care 2016:39(suppl 1)
18
How many “broken” organs are there in
Pre-diabetes/T2DM?
What causes Insulin Resistance?
The Ominous Octet
HGP = hepatic glucose production
Defronzo RA. Diabetes. 2009;58(4):773-795.
Classification and Treatment
• Leaders in Diabetes are calling for a
change in how diabetes is classified
–Focus should be ß-cell centric
• Opposed to Type 1, Type 1.5, Type 2, etc.
Schwartz SS, et al. Diabetes Care 2016:39(2)
Egregious Eleven – Circa 2016
7) Brain
10) ↓ immune
dysregulation /
inflammation
GI tract
8) Colon/biome
-abnormal
microbiota
↓ GLP-1
production
↑ appetite
↓ morning
dopamine
1) Pancreatic ß-cell
↓ ß-cell function
↓ ß-cell mass
↓ amylin
2) ↓ incretin
effect
3) α-cell defect
↑ glucagon
4) Adipose
↑ lipolysis
Hyperglycemia
9) Stomach and
small intestine
↑ glucose
absorption
Insulin
resistance
5) Muscle
↓ uptake
6) Liver
↑ glucose
production
11) Kidney
↑ glucose reabsorption
Schwartz SS, et al. Diabetes Care 2016:39(2)
Insulin Resistance
•
•
•
•
•
Major defect in individuals with pre-diabetes/T2DM
Reduced biological response to insulin
Closely associated with obesity
Associated with cardiovascular risk
Type 1 diabetes patients can be insulin resistant as
well
American Diabetes Association. Diabetes Care 1998; 21:310–314.
Beck-Nielsen H & Groop LC. J Clin Invest 1994; 94:1714–1721.
Bloomgarden ZT. Clin Ther 1998; 20:216–231.
Boden G. Diabetes 1997; 46:3–10.
Insulin Resistance
• Diet & Exercise
– Additive effects: 3X higher improvement than diet or
exercise alone
– Even if a person cannot exercise, can improve insulin
sensitivity with 5‐10% weight loss
– Calorie-reduced diet of any composition is effective
– Exercise typically 30‐45 minutes at moderate level, 3‐5
times per week
Diabetes Self-Management Education (DSME) is the
cornerstone to successful control
Lifestyle plays a crucial role
80% of prediabetes/diabetes management is about
Lifestyle
Self-Monitoring
Activity
Lifestyle
Education
Nutrition
Anderson RM, The Art of Empowerment.
American Diabetes Association. 2005.
Weight
Management
Healthy eating
Being active
Monitoring
Taking medication
Problem-solving
Healthy coping
Reducing risks
AADE, The Diabetes Educator, Sept/Oct, 2003
Take- Aways
• Take 60 seconds to share with your
“neighbor” at least 2 “take-aways”
How many classes of drugs are currently
available to treat type 2 diabetes?
Pharmacotherapy Options
•
Insulin
– Bolus insulin
• Insulin lispro
– U100
– U200
• Insulin aspart
• Insulin glulisine
• Insulin human inhaled
• Regular human insulin
•
– Biguanides
– Bile acid sequestrants (BAS)
– Dipeptidyl peptidase-4 inhibitors
(DPP-4i or gliptins)
– Dopamine agonists
– Glitinides
– Sulfonylureas
– sodium glucose cotransporter-2 inhibitors
(SGLT-2i)
– Basal insulin
• Insulin NPH
• Insulin detemir
• Insulin glargine U100
• Insulin glargine U300
• Insulin degludec U100
• Insulin degludec U200
Oral Medications
– Alpha-glucosidase inhibitors (AGIs)
– Thiazolidinediones (TZDs or glitazones)
•
Non-insulin injectable agents
– Glucagon-like peptide-1 receptor agonists
(GLP-1-RA)
– Amylinomimetic
Pharmacotherapy to “Fix” T2DM Dysfunctional Organs
Dopamine
agonists
(brain)
Amylinomimetics
(GI tract -stomach/small intestine,
liver, pancreas - α & ß-cells, brain)
Insulin Secretagogues
(pancreas- ß-cell)
DPP-4i
(liver, pancreas α & ß-cells)
TZD’s
(Peripheral tissue, liver & fat)
Biguanides
(liver, colon (?))
Muscle/tissue
AGI’s
(GI tract- stomach/small intestine)
Cornell S, et al. Postgrad Med. 2012;124:84-94.
Schwartz SS, et al. Diabetes Care 2016:39(2)
GLP-1 Agonists
(GI tract -stomach/small intestine,
Colon(?), liver, pancreas - α & ßcells, brain)
SGLT-2i
(kidney)
Which agents target insulin resistance?
What pharmacotherapy agents are being
used for Pre-diabetes?
Drug Class
Targets Insulin
Resistance
Used in Pre-diabetes
AGIs
No
Yes
Amylinomimetic
No
No
Bile acid sequestrant
No
No
Biguanides
Maybe
Yes
DPP-4 inhibitors (gliptins)
No
Possible – not yet
Dopamine agonist
No
No
GLP-1 agonists
No
Yes
Insulin
No
No
Secretagogues
sulfonylureas & glinides
No
No
SGLT-2 inhibitors
Maybe
No
TZDs (glitazones)
Yes
Yes
AMA and CDC
Partnership
Prevent Diabetes STAT: Screen, Test, Act – Today
A multi-year initiative that expands on each organization’s
work to reach more Americans with pre-diabetes and
stop the progression to type 2 diabetes.
“The time to act is now. We need a national, concerted
effort to prevent additional cases of type 2 diabetes
in our nation – and we need it now.”
- Quote from Dr. Ann Albright, Director of CDC’s
Division of Diabetes Translation (March 2015)
The Diabetes Prevention Program (DPP)
Research Study
Published New England Journal of Medicine, 2002
GOAL:
To determine whether losing modest amounts of weight
through improving diet and increasing physical activity, or
taking metformin, could prevent or delay type 2 diabetes
in people with pre-diabetes or at high risk for developing
the disease.
The Diabetes Prevention Program (DPP)
Research Study
• This was a large randomized clinical trial involving 3,234
participants
• Participants were American adults 25+ years of age, classified
as pre-diabetic or rating high risk for developing DM
• 27 clinical centers throughout the United States
• Funded primarily by the NIH
• Study took place between 1996-1999
• The study was stopped one year early as the data obtained
had already shown great statistical significance
• Eligible participants were randomly assigned to one of three
intervention groups
The Diabetes Prevention Program (DPP)
Research Study
Three randomized groups:
Group 1: Standard lifestyle recommendations plus
metformin 850 mg twice daily
Group 2: Standard lifestyle recommendations plus
placebo twice daily
Group 3: Intensive program of lifestyle modification
The Diabetes Prevention Program (DPP)
Research Study
• Standard Lifestyle Recommendations:
– Provided written information at an annual 20-30 minute visit that
emphasized the importance of a healthy lifestyle
– Asked to reduce weight and increase activity
• Intensive Lifestyle Intervention:
– Involved a 16-session curriculum covering diet, exercise and behavior
modification
– Taught by case managers on a one-on-one basis during the first 24
weeks
– Subsequent individual session (usually monthly) and group sessions
to reinforce behavioral changes after the first 24 weeks.
– Goals:
• Achieve & maintain weight reduction of at least 7% initial body weight
• Engage in physical activity 150 minutes/week
What Were the DPP Research Study Findings?
New England Journal of Medicine, 2002
100
90
71%
80
Reduced chance of
developing diabetes
70
60
58%
50
31%
40
30
20
10
0
Lifestyle - total Lifestyle - 60+
Metformin
Lifestyle intervention sharply reduced the chances of developing
type 2 diabetes (58%)
• 71% for aged 60+
Metformin group reduced their risk but not as much as the
lifestyle intervention group (31%)
The Diabetes Prevention Program (DPP)
Research Study
Published New England Journal of Medicine, 2002
Conclusions:
Lifestyle changes and treatment with metformin both
reduced the incidence of diabetes in persons at high
risk. The lifestyle intervention was more effective than
metformin.
How can we identify people with
pre-diabetes/diabetes sooner
Risk Factors for Pre-Diabetes
• Age 45 or older (?)
• Overweight
• Sedentary lifestyle
• First degree relative with
diabetes
• Excess abdominal fat
• High risk race/ethnicity
(Latino, African American,
Asian, American Indian,
Pacific Islander)
• Hypertension (≥140/90
mmHg or on therapy)
• HDL (<35 mg/dL)
• Triglyceride (≥250 mg/dL)
• Acanthosis Nigricans
• Polycystic ovary syndrome
(PCOS)
• History of gestational
diabetes or large baby (>9
lbs.)
SCREENING ALGORITHM
Consider screening:
● Individuals age 45 and older
● Individuals at any age with BMI ≥ 25 with additional risk
factors
● Individuals 18 and older with BMI ≥ 30
Obtain:
● A1C, or
● Fasting Plasma Glucose (FPG), or
● 75 gm Oral Glucose Tolerance Test (OGTT), or
Adapted by ADA 2014
Patient Diagnosed
TREATMENT
Diabetes
Initiate therapy,
screen for diabetes
related
complications,
refer for selfmanagement
education and
medical nutrition
therapy
Pre-Diabetes
Consider lifestyle intervention
treatment. Targets:
● Weight Loss: 7% total body weight
then weight maintenance
● Physical Activity: 150 minutes/week
moderate or 75 minutes/week vigorous
activity (examples include: walking,
biking, dancing, swimming, Pilates, yoga)
• Refer to structured programs such as
Diabetes Prevention Program, Weight
Watchers, Curves, YMCA, and health
clubs
• * Follow up every 3 months
Normal
Continue to
screen at least
every three
years or more
frequently with
risk factors
TREATMENT ALGORITHM (Continued)
Pre-Diabetes
No
Is Patient Achieving Targets?
Consider starting medication:
Metformin
Pioglitizone
Acarbose
GLP-1
Follow-up: Every 1-3 months
Yes
Give positive feedback,
continue to reinforce
lifestyle changes;
screen for diabetes at
least annually
Pharmacists Role
• What can pharmacists do to improve
education and care for people with prediabetes/diabetes?
• Tell me your ideas !
Sample Pharmacist Led Interventions
• Many community pharmacies offer BG, A1c, BP
and/or lipid screenings
– In-store
– Retirement communities
– Employer groups
• ADA collaboration
– ADA expo
• Health-system collaboration
– Health fairs
Sample Pharmacist Led Interventions
• Dept of Public Health collaborations
– Black Barbershop movement
– Certified Diabetes Outpatient Educator (CDOE)
programs (RI)
• APhA –ASP and College of Pharmacy
collaborations
– Operation Diabetes
• Community outreach – churches, cultural centers, grocery
stores, food pantries, mosques, etc.
• Health Fairs
Lifestyle Tips for Pre-Diabetes
Prevention
• Eat Breakfast
– should be the bigger meal of the day
– Include protein
• Don’t skip meals
– Eat ~ every 4 hours
– Don’t overeat
– Dinner should be the smallest meal of the day
• Get 7-8 hours of sleep each night
– Watch for obstructive sleep apnea
Lifestyle Tips for Pre-Diabetes
Prevention
• Be active
– Avoid sitting for long periods of time.
– Stand up every 20 minutes and stretch/walk
– Park further away
– Take stairs
• Reduce stress
– Try yoga or tai chi or meditation
– Be mindful of the moment
Take- Aways
• Take 60 seconds to share with your
“neighbor” at least 2 “take-aways”
Take Home Message
• Early intervention, aggressive lifestyle
modification and possibly pharmacotherapy can
delay or prevent progression from pre-diabetes
to diabetes
• Post-prandial glucose screening may identify
people sooner than fasting glucose screening
– PPG contributes to macrovascular complications
• Pharmacists can identify people at risk and help
them with lifestyle medication, education and
care
PRE-DIABETES in INDIANA:
The National Diabetes
Prevention Program
SUSIE KING
Diabetes Prevention Coordinator
Cardiovascular Health and Diabetes Section
Chronic Disease Prevention and Control
Indiana State Department of Health
Let me introduce you to the….
NATIONAL DIABETES
PREVENTION PROGRAM!
• Research now translated into an evidence-based
program by the CDC
• The Diabetes Prevention Recognition Program
(DPRP) was developed by CDC to assure program’s
quality and fidelity to scientific evidence.
– Only CDC-recognized programs will be reimbursed.
• Being implemented nationwide
PROGRAMS BEING IMPLEMENTED
NATIONWIDE: (700+)
 YMCAs (membership not required)
 Community Centers
 Local Health Departments
 Hospital Systems
 Physician Group Practices
 Pharmacies
 Employer Groups (e.g. Dow Chemical, Bayer, Costco)
 Faith-Based Organizations
 Virtual programs available (Jan 2015)
55
WHO CAN PARTICIPATE?
Program eligibility:
Be at least
18 years old or older
AND
BMI of 24 or greater
(Asian Americans: > 22)
Participants must meet one or more of these criteria:
Medical diagnosis
of pre-diabetes
History of
gestational diabetes
Screen positive for prediabetes based
on the Prediabetes Risk Test
(CDC or ADA)
CDC PREDIABETES
SCREENING TOOL
 Baby > 9 lbs. at birth
 Sibling or parent with
diabetes
 At risk height/weight
chart
 Under 65 and get little
to no exercise
 Age
ADA’s
PREDIABETES
SCREENING TOOL
NUTS AND BOLTS OF THE
NATIONAL DIABETES PREVENTION PROGRAM:
National DPP is a lifestyle change program:
 First six months: Weekly one-hour sessions
 Second six months: Monthly one-hour sessions
A trained Lifestyle Coach works with participants in a group setting to
reduce risk by helping them:

Lose weight (5% of starting body weight)

Increase physical activity (30 minutes/day 5 X per week)

Session topics help to identify and address barriers to healthy
eating and physical activity
Program relies on self-monitoring, goal setting, and group process.
FIRST SIX MONTHS
(all sessions required)
Skills
Controlling the
external environment
Psychological and
emotional
1.
2.
3.
4.
5.
6.
7.
Welcome
Be a Fat and Calorie Detective
Three Ways to Eat Less Fat and Fewer Calories
Healthy Eating
Move Those Muscles
Being Active: A Way of Life
Tip the Calorie Balance
8. Take Charge of What’s Around You
9. Problem Solving
10. Four Keys to Healthy Eating Out
11.
12.
13.
14.
15.
16.
Talk Back to Negative Thoughts
The Slippery Slope of Lifestyle Change
Jump Start Your Activity Plan
Make Social Cues Work for You
You Can Manage Stress
Ways to Stay Motivated
SECOND SIX MONTHS
(6 to 8 topics are chosen by the group)
Introduction
(1 topic)
• Goal setting and self-monitoring
Healthy Eating
and Nutrition
(5 topics)
• Different types of fat
• Food preparation and recipe modification
• Not skipping meals, healthy meal and snack
planning
• Fruits and vegetables, mindful eating
• Adding fiber, water, and whole grains
Physical Activity
(2 topics)
• Overcoming barriers, health benefits
• Lifestyle activity, using a pedometer, flexibility
and balance
SECOND SIX MONTHS
(continued)
Chronic Disease
(2 topics)
• Heart disease, cholesterol, and blood pressure
• Type 2 diabetes
Managing Stress
and Preventing Relapse
(4 topics)
• Overcoming self-defeating thoughts,
assertiveness
• Handling holidays, vacations, and special
events
• Preventing relapse
• Stress management and relaxation techniques
Program Conclusion
(1 topic)
• Long-term goals, strategies, and self-review
INDIANA ORGANIZATIONS
OFFERING THE PROGRAM:
 Statewide YMCAs (list is growing)
 Indiana Minority Health Coalition (Indianapolis)
 Major Hospital (Shelbyville)
 Franciscan WELLCARE (Munster)
 Posey County Health Department (Mt. Vernon)
 Memorial Hospital & Health Care Center (Jasper)
 Floyd Memorial Hospital & Health Services (New Albany)
 Vanderburgh County Health Department (Evansville)
 Columbus Regional Hospital (Columbus)
63
COMMUNITIES
WITH DIABETES
PREVENTION
PROGRAMS
(INDIANA 2016)
64
REIMBURSEMENT
Private insurance:
• Insurers are beginning to add as a covered benefit.
•
HSAs/HRAs (example: I. U. Health Plans – Medicare Advantage)
United HealthCare:
National coverage established; coverage is market-specific.
Medicare coverage?
•
•
Medicare Diabetes Prevention Act of 2013 (H.R. 962 and S. 452)
Effective January 1, 2016, a new CPT code (category III) was
established for the program: CPT 0403T
Medicaid coverage?
Montana. (Indiana is pursuing)
YOU CAN HELP MAKE A
DIFFERENCE WITH
DIABETES PREVENTION
►
►
Increase prediabetes awareness (use risk test or actively test
for pre-diabetes)
Actively counsel patients/customers on the importance of
preventing diabetes
-Lifestyle changes are necessary
(healthy foods + 150 mins physical activity per week!)
►
Refer your patients/customers to a Diabetes Prevention
Program to learn and consistently reinforce lifestyle changes
For further information on the National Diabetes Prevention
Program, please contact:
Susie King
Diabetes Prevention Coordinator
Cardiovascular Health and Diabetes Section
Indiana State Department of Health
Office: (317) 233-7343
[email protected]
Post-Assessment Question #1
• Which of the following statements regarding prediabetes is correct?
1. People with pre-diabetes will eventually develop
diabetes.
2. People with pre-diabetes have elevated postprandial glucose and normal fasting glucose.
3. People with pre-diabetes have an A1c between
6.5-7%.
4. Pre-diabetes is a result of insulin deficiency.
Post-Assessment Question #2
• Which of the diabetes medications classes directly
targets insulin resistance?
1.Alpha-glucosidase inhibitors
2.Glucagon-like peptide-1 receptor agonists
3.Sulfonylureas
4.Thiazolidinediones
Pre-Assessment Question #3
• Which of the diabetes medications classes has
NOT been studied and used to treat pre-diabetes?
1.Biguanides
2.Glucagon-like peptide-1 receptor agonists
3.Sulfonylureas
4.Thiazolidinediones