Transcript GO! Diabetes Train the Trainer Program

GO! Diabetes
Train the Trainer Program
This project was funded by an
educational grant from Sanofi
Faculty Disclosures
• None of the faculty have indicated they have any
relevant financial relationships
• The content of this presentation will promote
quality or improvements in healthcare and will
not promote a specific proprietary business
interest or a commercial interest. Content for
this activity, including any presentation of
therapeutic options, will be well-balanced,
evidence-based and unbiased according to
GAFP policy.
Goals For Today
• Educate you on the 2011 ADA Standards of
Medical Care in Diabetes
• Help you gain a clear understanding of how
the diabetic patients in your practice are
meeting the current standards
• Demonstrate tools for you to implement
system changes
• Reveal how interdisciplinary teams in your
practice will facilitate patient centered care
History of GO! Diabetes
• 2008 the Georgia and Oklahoma (the G
and O in GO!) Chapters of the AAFP
launched a pilot project in their states to
educate family medicine residents and
residency faculty on best practices related
to diabetes
• 2009 the GO! Diabetes project was
expanded to 55 residency programs in 16
states
History of GO! Diabetes
• 2010 the GO! Diabetes project was
expanded to residency programs in most
continental states and a pilot project was
added with Georgia and Oklahoma family
physicians in private practice
• 2011-2012 project was open to family
medicine residency programs and active
members of the AAFP in the continental
US
Why Are We Here?
Diagnosed and undiagnosed diabetes in the
United States, all ages, 2010
• Total: 25.8 million people, or 8.3% of the
U.S. population, have diabetes.
• Diagnosed: 18.8 million people
• Undiagnosed: 7.0 million people
• Future of the epidemic
– 48.3 with DM by 2050
www.cdc.gov/diabetes/pubs/estimates
Why Are We Here?
Group
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Number or percentage with diabetes
Ages 20 years or older
Ages 65 years or older
Men ages 20 years or older
Women ages 20 years or older
Non-Hispanic whites 20 years or older
Non-Hispanic blacks 20 years or older
25.6 million, or 11.3 %
10.9 million, or 26.9 %
13.0 million, or 11.8 %
12.6 million, or 10.8 %
15.7 million, or 10.2 %
4.9 million, or 18.7 %
Center for Disease Control National Diabetes Fact Sheet Jan 2011
The Cost of Diabetes
$116 billion = direct medical costs
$58 billion = indirect costs (disability, work loss,
premature mortality)
Total cost of diabetes in the United States
$174 billion
Center for Disease Control National Diabetes Fact Sheet Jan 2011
Projected Increase in Cost for
Diabetes Care in the US
Projecting the Future Diabetes Population Size and Related Costs for the U.S.
Diabetes Care 32:2225–2229, 2009
Need for Change
• CDC reports 7-10% of DM patients are
receiving all the treatment they should
– Statins
– ASA
– BP lowering drugs
– Insulin and other blood sugar lowering agents
• Stop Clinical Inertia!
How Do We Change?
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Team based practices
Patient Centered Medical Home (PCMH)
Recognize and empower Change Agents
Revamp our approach to diabetes
Identify economic drivers
Use of clinical practice guidelines
Why GO! Diabetes?
• Diabetes is the perfect chronic disease to begin
or continue practice movement to PCMH
• Identify patients at risk and utilize screening for
early diagnosis
• Diagnose individuals with metabolic syndrome,
pre-diabetes
• Discuss appropriate treatment and
management options
How Will GO! Diabetes Help?
• GO! Diabetes offers resources
– Train the Trainer sessions
• clinical update on diabetes
• practice improvement tools
• tasks Change Agents to return to their practices
and initiate change
• patient surveys
• patient registry
– AAFP METRIC to collect and analyze patient data
– Frequent updates and reminders through webinars,
News on the GO! and project coordinators
What is a Team?
“A group of people with complementary
skills, committed to a common
purpose for which they hold
themselves mutually accountable.”
Katzenbach, JR and Smith, DK. The Discipline of Teams. Harvard Business
Review-The High Performance Organization. July-August 2005, pgs. 1-9.
What is a Team?
• Key attributes of a team:
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Shared leadership roles
Individual and mutual accountability
Specific team purpose that the team itself delivers
Collective work products
Encourages open ended discussion and active
problem solving meetings
– Measures performance
– Discusses, decides and does real work together
Katzenbach, JR and Smith, DK. The Discipline of Teams. Harvard Business
Review-The High Performance Organization. July-August 2005, pgs. 1-9.
Change Agent
• Your role as a change agent in your
practice
– Ensure practice is committed to improve
– Determine the goals for the new initiative
– Facilitate the change process
– Manage change – help to resolve problems or
roadblocks during the process
– Ensure good communication throughout
entire process
thethrivingsmallbusiness.com.
Team Based Practices
• Need to transform the traditional family
medicine practice into fully functioning
team
– Get all members of the team involved
• Reminders on chart/EHR about purpose of visit for
schedulers
• MAs to check FBS, foot sensation, review meds
• Appropriate Labs ordered reviewed and available
for providers
– Use of PAs and NPs for care of diabetes
Patient Centered Medical Home
(PCMH)
• Comprehensive primary care for children, youth and
adults
• Personal physician
• Physician directed medical practice
• Whole person orientation
• Integrated/coordinated care
• Hallmarks of quality and safety
• Enhanced access
• Payment
Patient Centered Primary Care Collaborative
Are You Ready For Change?
• Spearhead the effort help your patients
control their diabetes
• Lead the charge to make your practice a
true Patient Centered Medical Home
• Identify the members of your team who will
be the change agents in your practice
• Collaborate with others in your community
who share a similar passion
Team Practice
• Set the standard for a model PCMH in
your community
• Embrace the team as the ideal for a model
practice
• Involve patients and families as part of the
team to improve diabetes care
2010 GO! Project Success
• Participants in the 2010 GO! Diabetes project showed
improvement in the following areas in documentation
and actual practice:
Baseline
– Counseled to quit smoking
– Improved Lipid profile
– A1C measured
– Foot exam
– Retinal exam
Based on 2010 METRIC data
44%
83.2%
89.5%
55.3%
47.2%
Follow up
-
68%
85.4%
91.4%
70.8%
58.9%
2010 GO! Project Success
• Diabetes Master Clinician Program (DMCP)
Registry vs. non GO! Clinics
– 3 of 5 GO! clinics had a higher % of annual eye exam
checks than non GO! clinics
– 4 of 5 GO! clinics had a higher % annual foot checks
– 4 of 5 GO! clinics had a higher % of microalbumin
checks
– 4 of 5 GO! clinics had a higher % of flu shots
– 4 of 5 GO! clinics had a higher % of daily ASA usage
Join our Team Today
• Stay engaged today
• GO! Diabetes Train the Trainer Program
requires audience participation
• Benefit from your faculty and fellow
participant’s experiences
• Move from an episodic care model to a
PCMH
Practice Improvement Tools
Fundamental Questions for
Improvement
• What are we trying to accomplish?
• How will we know that a change is an
improvement?
• What changes can we make that will result
in an improvement?
Purpose
Learn some tools that will enhance
effectiveness in supporting practice
improvement
Why is this important?
Practice Improvement Tool #1
Nominal Group process
Nominal Group Process
1. Present the question or issue and give the group a
few minutes to silently reflect and come up with their
individual ideas.
2. Group members share ideas, each of which is
recorded on a flip chart.
3. The group discusses the ideas, clarifying and
combining similar ideas as needed.
4. The group reviews the ideas silently and each
member ranks the ideas by preference.
5. A preliminary vote is taken.
6. After viewing one another’s rankings, group members
(Andre Delbecq 1970)
vote again.
Nominal Group Process
Exercise
What would ideal care for your
patients with diabetes look
like?
Nominal Group Process
Exercise
Final vote
– Feasibility
– Cost effectiveness
– Organizational priority
–Timeframe – 6 months
GO! Diabetes
Case Studies
Rosita
Case #1
• Rosita is an 18 year old Hispanic female
who is a new mother. She presents for
postpartum care 6 weeks after the birth of
a 9 lb. 2 oz. boy
• She was diagnosed with GDM based on
her 2 hour glucose challenge at 26 weeks
gestation (results FBS 90, 1 hour 179, 2
hour 158)
Rosita’s History
• Her original screening HbA1c was 5.4
• GDM was adequately controlled with MNT
as evidenced by consistent FBS <95 with
2 hour PP <120 with home glucose
monitoring
• She is breastfeeding, desires
contraceptives and otherwise has no
additional concerns
Vital Signs
• Ht. 5 feet 4 inches (162.56 cm), Wt 190
lbs. (86.18 kg.), BMI 32.6 kg/m2, afebrile
and BP 114/61
• Waist circumference: 38 inches
• PE: Obese, lactating female with normal
eye, CV, neuro, monofilament, skin and
GYN exam
Labs
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TG 185
Total Cholesterol 208
LDL 122
HDL 48
FBG 88, 2 hour (75 gm) glucose challenge
WNL
Screening & Diagnosis in Pregnancy
Overt Diabetes
FPG>=126, or
A1C>=6.5, or
Random glucose>=200, confirmed by FPG or A1C
Gestational Diabetes
FPG >= 92 mg/dL, but < 126 at any gestational age, or
75 gm 2hr GTT at 24-28 wk gestation with 1 abnormal:
FBS>= 92, but <126, or
1hr >=180, or
2hr >=153
Metabolic Syndrome
PARAMETERS
NCEP / ATP 3 2005
REQUIRED
IDF 2005
AACE 2003
Waist >= 94 (men) or 80cm
(women)
HR for insulin resistance OR BMI >25
OR Waist >= 102 (men) or 88cm
(women)
# ABNORMALS
>=3 OF:
+2 OF:
+2 OF:
GLUCOSE
(mg/dL)
FBS >=100
FBS >=100
FBS >=110,
2hr >=140
HDL (mg/dL)
<40 (men)
<50 (women)
<40 (men)
<50 (women)
<40 (men)
<50 (women)
TG (mg/dL)
>=150
>=150
>=150
OBESITY (cm)
Waist >= 102 (men) or
88cm (women)
HTN (mmHg)
>=130/85
>=130/85
>=130/85
Risk Factors for Diabetes in
Pregnancy
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Obesity
Family history (Type 2 DM)
Specific ethnic groups
Conditions associated with insulin
resistance
• Other risk factors in pregnancy
Metabolic Syndrome
Patient Education
• Medical Nutrition Therapy (MNT)
– carbs, fats, proteins and calories
• Exercise
• Weight management
• Psychosocial and family implications
Medical Nutrition Therapy
(MNT) for Rosita
USDA Government
Metabolic Syndrome Management
• 5-10% weight loss yields a 58%
reduction in the incidence of diabetes at
the end of four years
What community resources have
benefited your patients?
What about Medications for
Rosita?
• Metformin reduced the development of
T2DM by 31%
• Recommended by the American
Diabetes Association in patients with
pre-diabetes
Diabetes Care, Volume 34, Supplement 1, January 2011
Bottom Line…
Pharmacological intervention with a variety of agents
reduces the rate of conversion of IGT/ IFG to T2DM, but
Therapeutic Lifestyle Change (TLC) remains the
mainstay of rx.
For metabolic syndrome without coexistent prediabetes,
routine pharmacoprevention for DM is not recommended
at this time.
(DeFronzo, J Clin Endocrinol Metab 96: 2354–2366, 2011)
Monitoring your Metabolic Patients
• Laboratory
– Hgb A1C, FPG or GTT
– Lipids
• BP
• Weight
• PE
– Dermatology and neuro manifestations
Rosita
Case #2
Rosita, a 50 year-old obese female patient
presents with blurred vision for several days,
weight loss, and feeling tired all the time.
Who and When to Screen?
• Starting at age 45, a fasting blood glucose every three
years
• Obesity (specifically abdominal) has one of the highest
associations with insulin resistance
• Earlier/more frequent screening if BMI >25, AND a
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Family history
Dyslipidemia
HTN
GDM or baby >9lb
Women with PCOS
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High risk ethnicity
Vascular disease
Prior glucose elevation
Hx or exam findings
Physical inactivity
(2010) Standards of Medical Care in Diabetes-2010. Diabetes Care, 33, Supplement 1, S14.
Diagnosis
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FPG ≥ to 126
HbA1C ≥ to 6.5%
2-hour OGTT using 75gm glucose load
Random plasma glucose ≥ 200 in a patient
with symptoms and signs of
hyperglycemia
(2010) Executive Summary: Standards of Medical Care in Diabetes-2010. Diabetes Care, 33, Supplement
1, S4.
Type 1 Vs Type 2: How To Tell Them Apart
Type 1
Type 2
Treatment
Always insulin; 4+ shots
Pills  Insulin
Age at Onset
10% of adults w/ new dx
50% of children w/ new dx
Weight
~20% obese
~10% thin
Family History
10% w/ a close relative
>50% w/ a close relative
DKA
Can happen
Can happen
Blood Glucose
More variable; big hypo’s
More stable; milder hypo’s
Thyroid Disease
Often
Sometimes
Antibodies
Usually (Anti-GAD)
Not usually
C-peptide
Early: low nl; Late: ~0
Early: high nl; Late: low nl
Atypical Diabetes
• Type 1.5 or Latent Autoimmune Diabetes
in Adults (LADA)
• “Double Diabetes”
Co-Morbidities Assessment
• Screen for depression and diabetesrelated distress, anxiety, eating disorders,
and cognitive impairment when self
management is poor1.
• Bariatric surgery may be considered for
adults with BMI >35 and Type 2 DM1
1Diabetes
Care, volume 34, Supplement 1 January 2011 pg S5-S6
Co-Morbidities Assessment
• Skin exam
– Acanthosis nigricans
– MRSA
– Fungal infections
– Wound care
– Skin tags
• Dental exam
– Gingivitis
– Infection
Eye Care
• Diabetic retinopathy (DR) is the leading
preventable cause of blindness
• Prevalence of DR increases with duration
of diabetes (100% Type 1, 60% Type 2
after 20 years)
• Of all recommendations, eye screening is
the least likely to get done
Reasons to Look at Feet
• Up to 70% of diabetics eventually develop
a neuropathy
• Up to 15%* develop foot ulcers
• More than half of the foot ulcers become
infected at some point
*The Semmes Weinstein Monofilament Exam as a screening tool for Diabetic
peripheral neuropathy Journal of Vascular Surgery; Sept 2009; 675-682.
The real morbidity…
• 10-20% of infected ulcers lead to
amputation
• More than 50% of nontraumatic lower limb
amputations are due to diabetic foot ulcers
• One amputation increases the likelihood of
another
Foot Surveillance
• Examine the feet at every visit
• Annual comprehensive evaluation
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Sensation
Pulses
Skin condition (ulcers, hair, nails)
Anatomic deformities
Shoe evaluation
Consider ABI age >50 and <50 if other risk
factors for PAD
(2010) Standards of Medical Care in Diabetes-2010. Diabetes Care, 33, Supplement 1, S39.
Sensation Exam
• Monofilament PLUS one of the following:
– Vibratory
– Pinprick
– Ankle reflexes
Diabetes Care, Volume 34, Supplement 1, January 2011, Page S8
Foot Exam Sites
• Fewer sites than 10 years ago…
Lab Surveillance
• A1c
• Lipids
• Microalbumin
Anti-platelet Therapy ADA Guidelines
• Recommendations for Aspirin
– ASA 75-162 mg/day for 2o prevention
– ASA 75-162 mg/day for 1o prevention
• Age > 50 in men and > 60 in women with at least
one risk factor
• Consider in any age with multiple CV risk factors
• Not recommended ages < 21 (Reye’s syndrome)
• Clopidogrel 75 mg/day
– Very high risk diabetics; intolerance to ASA
Lipids
American Diabetes Association
LDL <100 mg/dL
(<70 mg/dL in patients at “highest risk”)
HDL >40 mg/dL (>50 mg/dL in females)
TG <150 mg/dL
National Cholesterol Education Program
LDL <100 mg/dL
(<70 mg/dL in patients at “highest risk”)
Non-HDL <130 mg/dL
ADA Guidelines Dyslipidemia
• Fasting lipid profile annually
• Simvastatin 80 mg/day warning
• Without overt CVD
– LDL<100
– At age 40 start on statin regardless of LDL to reduce LDL 3040% if another risk factor for CVD exists
• With overt CVD
– Start statin to reduce LDL 30-40%
– LDL<70 is an option
– Normalizing triglycerides and raising HDL with fibrates reduces
CV events
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm257884.htm
ADA Guidelines Dyslipidemia
• High LDL, High triglycerides, Low HDL
– Consider statin + fibric acid
• Remember the increased risk of rhabdomyolysis
– Consider statin + niacin
• Remember niacin can increase glucose levels
• moderate doses = mild changes in glycemia
ADA Guidelines - 2011
• Hypertension control individualized
– for most 130/80 is ideal
• Glycemic control individualized
– for most < 7% is ideal
• Nephropathy management
– Table included for diagnosis and surveillance
– Advances CKD management guidelines (modified
from NKF)
• Chronic health care delivery systems
restructuring paramount (NDEP resources)
Health Maintenance
• Vaccinations
– Influenza
– Pneumovax
• Smoking cessation
– Counseling
– Pharmacotherapy
Diabetes Education
• Diabetes education
– is a collaborative process
– develop knowledge and skills needed to change behavior
– successfully self-manage the disease and its related conditions
• Goals of education
– improve health
– better quality of life
– reduce the need for costly healthcare
• Diabetes Educators
– Prepared in diabetes knowledge
– Use principles of teaching, learning, and counseling
– Behavior change for successful self-management
Value of the Diabetes Educator:
Summary of Findings
• People with diabetes education:
– Save money and have better outcomes.
– Are more likely to adhere to recommendations for
screening/HEDIS measures.
– Are younger, more likely to be female, located in more
affluent areas, have lower clinical risk, higher
adherence to diabetes care recommendations and
lower average costs.
• Physicians and patients exhibit high variation in
their use of diabetes education.
Diabetes Prevention Project (DPP)
A randomized clinical trial to prevent Type 2
Diabetes that evaluated the efficacy of 3 treatments
Incidence of Diabetes
Risk reduction
31% by Metformin
58% with
modest lifestyle change
sustained for 4 years
Lifestyle (n=1079, p<0.001) vs. Metformin (n=1073, p<0.001)
vs. Placebo (n=1082)
SOURCE: The DPP Research Group, NEJM, 2002;346:393-403
Diabetes Education Resources
http://www.diabeteseducator.org
/DiabetesEducation/Find.html
http://www.diabetes.org/
http://www.cdc.gov/diabetes/
Patient Education
Who’s responsible?
EVERYONE!
Glycemic Control – Oral Agents
Rosita’s A1C
7.5
How The Body Handles Glucose
(Fed State)
LIVER
PANCREAS
GLUCAGON
GLUCAGON
AMYLIN
INSULIN
BRAIN
Blood
Glucose
Glucose
60-90 mg/dL
90-140
mg/dL
I
N
S
U
L
I
N
FAT
GI TRACT
MUSCLE
Pathophysiology of Type 2 Diabetes
PANCREAS
LIVER
Metformin
TZDs
BRAIN
GLUCAGON
GLUCAGON
GLUCAGON
AMYLIN
INSULIN
INSULIN
A1C < 7%
Premeal
~ 100mg/dL
Hyperglycemia
PPG < 200 mg/dL
II
N
N
S
S
U
LU
L
II
N
N
Insulin
Sulfonylureas
Glinides
Incretin tx
FAT
Pramlintide
GI TRACT
Dietary Composition
Portion Control
-Glucosidase Inhibitors MUSCLE
Weight Loss
Exercise
TZDs
(Metformin)
General Rules
Hyperglycemic Therapy
• Normalize fasting glucose levels first
– Many patients will achieve glycemic targets
• When to target postprandial glucose levels?
– Pre-prandial values are at goal
– A1C levels are not met
• Measure 1-2 hours after beginning of the meal
– Glucose are generally at their peak
Glycemic Goals of Therapy
Goal
ADA
Premeal plasma glucose (mg/dL)
90-130
2-h postprandial plasma glucose
<180*
A1C
<7%**
ACE
Verbal Target
~100
<<200
<140
As low as
<6.5%
possible w/o
unacceptable adverse
effects
<110
* Evaluation and treatment of postprandial glucose may be useful in the setting of
suspected postprandial hyperglycemia, with the use of agents targeting postprandial
hyperglycemia and for suspected hypoglycemia
** More stringent glycemic goals (i.e. a normal A1C, <6%) may further reduce
complications at the cost of increased risk of hypoglycemia
Diabetes Care 2009;32:S6-12
Biguanides: Metformin
Mechanism of action
– Reduces hepatic glucose production
– Depends upon presence of insulin
Safety and efficacy
– Decreases A1C 1-2%
– Adverse effects: diarrhea and nausea; main risk:
lactic acidosis
– Discontinuation rate 5%
– Contraindications: renal, cardiac, hepatic insufficiency; IV contrast
– No direct effect on kidney
Dosing
– Initial dose: 500 mg once a day; dosing: usually BID
– Maximum effective dose: 2,000 mg per day
– Titration frequency: week(s) to months
– Alternate formulations: “XR” and combinations
Insulin Secretagogues:
Sulfonylureas (SFU) and “Glinides”
Mechanism of action
– Stimulate basal and postprandial insulin secretion
– Require functioning beta cells (no effect on beta
cell dysfunction)
– Work quickly
Safety and efficacy
– Decrease A1C approximately 1-2%
– Lower fasting glucose 20%
– Adverse events: weight gain, allergy (rare);
main risk, hypoglycemia
Dosing
– Initial dose: 1/8 to 1/4 maximum dose;
dosing: 1-2 times/day (SFU), 3 times/day (Glinides)
– Maximum effective dose: 1/2 maximum
(full dose with nateglinide)
– Titration frequency: day(s) to weeks
Preferred Sulfonylureas
• All available as generic agents
Glipizide ER 5-20 mg once per day
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Once daily, flat profile, low plasma levels resulting in a low risk
of weight gain and hypoglycemia
Glipizide 2.5 to 20 mg twice a day
•
Twice daily. Half-life 2-4 hours, peaks in 2-3 hours.
By taking it once a day at low dose it stimulates insulin
secretion for 6-12 hours
Glimepiride 1-8 mg per day
•
Once daily. Half-life 9 hours, peak action for 4 hours. Special
utility like with glipizide but with longer half-life
Buse J. Personal Opinion
Melander A. Diabetes 2004;53 Suppl 3:S151
Thiazolidinediones (TZD’s or Glitazones): Pioglitazone and
Rosiglitazone
Mechanism of action
–Enhance insulin sensitivity in muscle, adipose tissue
–Inhibit hepatic gluconeogenesis
–Reduced rate of beta cell dysfunction
Safety and efficacy
–Decrease A1C 1-2%
–Adverse events: edema, weight gain, anemia;
more serious risk: liver failure
Dosing
–Initial dose (monotherapy): 1/2 to 2/3 maximum;
dosing,1-2 x/day
–Maximum effective dose: maximum dose
–Titration frequency: weeks to month(s)
TZDs: Weight Gain and Edema
• Derived from an increase in body fat and possibly
increased fluid retention
• Severity appears to be proportional to level of
glycemic control achieved
• Not inevitable and diet helps
• Accentuated by combination with Secretagogues
or insulin
• Usually mild to moderate and well tolerated
Patients should be instructed to inform their
doctors of rapid or excessive weight gain
Lebovitz H. Diabetes Metab Rev 2002;18:S23
Fonseca V. Am J of Med 2003;115:42S
TZDs Lipid Effects and Serious Risks
• Rosiglitazone (Avandia)
– +LDL
– +HDL
– +Triglycerides
• Pioglitazone (Actos)
– +LDL
– +HDL
– -Triglycerides
• Rosiglitazone – Black box warning for CHF and ischemic heart
disease; warnings about increased fracture risk in women
• Pioglitzaone – Black box warning for CHF and warning about
increase fracture risk. No evidence to suggest increased ischemic
heart disease. There is a potential increased risk of bladder cancer
with long term use.
http://www.natap.org/2011/newsUpdates/052111_07.html
AHA/ADA Consensus
Statement for TZDs
• Not recommended for patients with NY Heart Association class III or IV
heart failure
• TZDs alone, or particularly in combination with insulin, may cause fluid
retention which can lead to heart failure
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Incidence of CHF <1% with TZD monotherapy
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Increased to 2%-3% in combination with insulin
• Patients should be observed for signs and symptoms
of heart failure
• TZDs should be discontinued if any deterioration in cardiac status
occurs
Nesto RW et al. Diabetes Care 2004;27:256
Alpha-Glucosidase Inhibitors:
Acarbose And Miglitol
Mechanism of action
– Delay absorption of carbohydrates
–
Depend upon postprandial hyperglycemia
Safety and efficacy
– Decrease A1C 0.5-1%
– Adverse events: flatulence;
main risk: rare liver enzyme elevation
Dosing
– Initial dose: 1/4 maximum once daily;
dosing: 3 times daily
– Maximum effective dose: 1/2 maximum dose
–
Titration frequency: week(s) to months
Incretin-Based Therapies
PROS
Preserve beta cell function
Weight loss (GLP-1 mimetics: exenatide and liraglutide)
Less hypoglycemia risk vs. insulin and Secretagogues
Enhanced postprandial glucose control
CONS
Expensive
GI (nausea)
May exacerbate renal failure
Concern for pancreatitis and thyroid tumors
Key Points to Consider for Therapy
Maximal benefits of Metformin are observed
at the recommended daily dose of 2000 mg (1 g BID)1
Thiazolidinediones should be started at low doses and
slowly increased to minimize side effects2
Glucose-lowering effects of a sulfonylurea plateau at half
the maximum recommended dose3
1.Garber AJ et al. Am J Med 1997;103:491
2.Nesto RW et al. Diabetes Care 2004;27:256
3.Stenman S et al. Ann Intern Med 1993;118:169
Practice Improvement Tool #2
Process Mapping
Process Mapping
• What are the steps that you would go through
as a patient for an office visit in primary care?
• Procedure
– Identify who is involved in the process
– Identify the starting and end points
– Draw swim lines and post the steps in the
process over time
– Map the process using sticky notes
– Use 2 words for the process (noun + verb)
Work Flow and Process
Mapping
Patient
Home
Front Desk
MA
Nurse
Provider
Lab
Pharmacy
Process Mapping
• Where does the task match the skill set of the
person?
• Where does work back up?
• Where does the patient wait?
• Where does the provider wait?
• Is the right information available at the right
time?
• Can the work flow be simplified?
Work Flow and Process
Improvement
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•
•
Patient flow
Availability of information and supplies
Waits and delays
Distance traveled
Facility promotes team function and supports
EMR use
• Teamwork and communication
Rosita
Case #3
• Rosita is now 60 years old and has been diagnosed with
Type 2 DM since the age of 50. Her treatment regimen
included diet, exercise and oral medications with which
she has been intermittently adherent (lisinopril,
metformin and sitagliptin).
• Over the past two years, Rosita has been working more
and exercising less and her last visit to her PMD was 18
months ago.
• How do I know my patient does not already have
cardiovascular disease???
Risk factors for CV Disease
•
•
•
•
•
Male age >45 and female Age >55
Current cigarette smoking
Hypertension
HDL <40
Family history of CV disease-Definite MI or
sudden death in male first degree relative <55 or
female first degree relative < 65
• HDL >60 counts as a negative risk factor
http://www.nhlbi.nih.gov/guidelines/cholesterol/atglance.pdf
Coronary Heart Disease Risk
Equivalents
•
•
•
•
Symptomatic Carotid Artery Disease
Abdominal Aortic Aneurysm
Peripheral Vascular Disease
In ATP III, Diabetes is considered a CHD
Equivalent
http://www.nhlbi.nih.gov/guidelines/cholesterol/atglance.pdf
Screening for CV Disease
• In asymptomatic pts, routine screening for
CAD is not recommended as it does not
improve outcomes as long as risk factors
are treated.
Diabetes Care, volume 34, Supplement 1 January 2011 pg S7
Screening for CV Disease
• ACC/AHA – persons with multiple risk factors (including
patients with T2DM) =IIb indication (usefulness/efficacy
not well established by evidence/opinion).
• ADA –Stress testing in abnormal ECG (ST-T
abnormalities, ischemia, or infarction), and ≥2 risk
factors.
• Before exercise-Both the ACC/AHA and the ADA
recommend that an exercise stress test be performed
(ACC/AHA guidelines as a class IIa indication, weight of
evidence/opinion is in favor of usefulness/efficacy)
http://circ.ahajournals.org/content/119/25/3244.full?sid=74e4098a-f84a-4abd-ad60-647a7da0ca9f.
(accessed Aug 11, 2011)
Rosita’s A1C…..
9.1
Management Options
• Medications-maximizing orals and
considering injectables
• Lifestyle-including exercise and diet
Beta Cell Function Declines
UKPDS Data
• Beta cell function
declines with time
• 5-10% failure per
year
• Eventually Insulin
Needed
63% of Patients with Diabetes are
Not at ADA A1C Goal <7%
Adults aged 20-74 years with previously diagnosed diabetes who
participated in the interview and examination components of the National
Health And Nutrition Examination Survey (NHANES), 1999-2000
100
80
% of
Subjects 60
n=404
40
12.4%
7.8%
63%
7%
20
0
Saydah SH et al. JAMA 2004;291:335
17.0%
25.8%
37.2%
>8%
A1C
>10%
>9%
>8%
7-8%
<7%
37.0%
Challenges with Achieving
Target A1C Values
• Challenges
• Late diagnosis and initiation of therapy
• Therapeutic inertia
• Lack of effective lifestyle intervention
• Secondary failure
• Adverse events associated with antihyperglycemic
therapies
• Complexity of care
• Role of postprandial glucose in failure
Insulin Therapy
• ACE and AACE recommend insulin when:
initial A1C is >9, DM is uncontrolled >7
despite optimal oral meds
• Not contraindicated at any time
• Fasting glucose > 250mg/dl
• Random glucose >300mg/dl
• Polyuria, polydipsia, weight loss, ketones
Petznick, Allison. Insulin Management of Type 2 DM. American Family Physician. July 2011 Volume 84
(2); 183-189.
What are some common
patient concerns when
transitioning to insulin?
Common Patient Concerns when
Transitioning to Insulin
• Fear of needles or pain from injections
• Fear of hypoglycemia
• Weight gain
Funnel M. Self-management Support for Insulin Therapy in Type 2 Diabetes. The Diabetes Educator
2004;30:274
Common Patient Concerns When
Transitioning To Insulin
• Adverse impact on lifestyle; inconvenient; loss of personal freedom
and independence
• Belief that insulin means diabetes is worse or more serious disease
• Insulin as a personal failure
• Insulin causes complications
• Treated differently by family members
Funnel M. Self-management support for insulin therapy in type 2 diabetes.
The Diabetes Educator 2004;30:274
What are your concerns when
transitioning a patient to
insulin?
Insulin Initiation
Provider Concerns
•
•
•
•
•
Which insulin?
How much?
How do I adjust?
How do I teach?
How often do I change dosages?
Potential Insulin Regimens
 Insulin pump
Physiologic/COMPLEX/Flexible
 Multiple daily injections
 Free mixing - twice daily
 Pre-mixed - twice daily
 Basal only
SIMPLE/Inflexible
How do we balance simplicity and flexibility
to achieve glycemic control?
Insulin Initiation
Answers to Provider Concerns
• Normalize the fasting glucose
– Fasting FSBS 70-130
– Once Daily Options
• Start 10 units or 0.2 u/kg
– Basal Insulin (glargine or detemir)
– NPH (bedtime)
– Premixed before dinner
• Increase 2-3 units every 3 days prn to reach target
of 70-130 fasting
• Decrease 3 units for fasting < 70
Once Daily Insulin Options
Basals vs. NPH vs. Premixed
INSULIN TYPE
ADVANTAGES
DISADVANTAGES
Glargine
Peakless, less
hypoglycemia, less wt
gain; simple
Cost; can’t mix; no
meal time coverage
Detemir
Less wt gain, less
hypoglycemia; simple
Cost, shorter duration
than glargine; can’t
mix, basal only
Pre Mixed 70/30 or
75/25
Covers meal time and
basal; easy transition
to bid
More hypoglycemia
and weight gain than
basals
NPH
Less expensive
More hypoglycemia
than basals
Analogue vs. Human
No difference in glycemic control
but slightly decreased
hypoglycemia with analogue
Petznick, Allison. Insulin Management of Type 2 DM. American Family
Physician. Volume 84 (2); 183-189.
Insulin therapy
• Augmentation –use of either basal or bolus with
partial beta-cell failure. Basal regimen may offer
slight benefit with fewer adverse side effects vs..
premixed or bolus. Dose is 0.3 u/ kg/day
• Replacement- use of basal and bolus insulin
when beta cell function is absent. Includes
basal, bolus, correction, and premixed insulin.
Dose is 0.6 u/kg/day. Fifty percent given as
basal and fifty percent given as bolus in divided
doses
1Petznick,
Allison. Insulin Management of Type 2 DM. Am. Fam. Physician. July 2011 Vol. 84 (2); 183-189.
Oral Meds When Starting Insulin
• Metformin
– Continue unless contraindicated
– Reduces CV risk in overweight Type 2 DM pts
• Sulfonylureas
– Continue with basals generally
– Stop if using large doses of insulin
– Stop if using premixed insulin
• TZDs
– Proceed with caution
– Exacerbates weight gain and edema
Oral Meds When Starting Insulin-Pearls
• Secretagogues should be tapered and
discontinued
• Sitagliptin is currently only incretin based
therapy approved for use with insulin
• http://care.diabetesjournals.org/content/32/
1/193/F2.expansion.html -algorithm for
type 2 DM
Petznick, Allison. Insulin Management of Type 2 DM. American Family Physician. Volume 84 (2); 183-189
Carbohydrate Counting
•
Technique based on the concept that most
meal-related glucose increase is due to the
carbohydrate content
•
Patients count either:
Carbohydrate choices (milk, fruit, breads,
sweets, starchy vegetables) OR
–
Grams of “total carbohydrates” on food
label
–
Carbohydrate Counting
•
Providers prescribe insulin-to-carbohydrate ratio
Start with 1 unit per choice or 1 unit per 15
grams
–
Typical dose is 2-4 units per choice in type 2
diabetes
–
•
Titrate based on postprandial glucose monitoring
•
Generally, start with glulisine/ lispro/ aspart
administered just before meals
Causes of Hypoglycemia
• Incorrect amount of insulin/oral agents
• Skipped or delayed meal/snack
• Carbohydrate intake less than normal
• Alcohol intake without food
• Exercise without insulin/food adjustment
• Not re-testing 1 to 2 hours after hypoglycemia
treatment if meal or snack is not eaten
Treatment of Hypoglycemia
• Definition of hypoglycemia: Plasma glucose <70 mg/dL
• Symptoms may or may not be present
– Sweaty, cold, unable to concentrate, dizzy
• Treatment
– Treat with 15 g carbohydrate; wait 15 minutes; test BG,
if BG not >70 mg/dL, treat again
– All carbohydrates raise blood glucose
– On average, 15 g of glucose can increase BG from
60 to ~110 mg/dL (50mg/dL) over ~40 minutes
– BG starts to fall at 60 minutes and reaches previous treatment
level at 2 hours
Cryer et al. Diabetes Care 2003;26:1902
15 Gram Carbohydrate Choices
BG
½ cup juice or 2Tbsp raisins or 7 saltines
or 6-8 hard candies =
=
Glucose
Increase
~50 mg/dL
Instruct patients on insulin therapy (or on insulin Secretagogues) to carry
source of carbohydrate that is convenient, readily available, easily and
quickly consumed and doesn’t spoil
Treatment of Hypoglycemia
• Hypoglycemia increases gastric emptying from
~50 minutes to ~25 minutes; emptying rates of
solid foods and liquids are the same
• Adding protein to carbohydrate does not help in
the treatment and does not prevent subsequent
hypoglycemia
Schvarcz et al. Diabetic Med 1993;10:660
Gray et al. J Clin Endocrinol Metab 1996;81:1508
Treatment of Severe Hypoglycemia
•
Definition: Requires assistance to treat
•
Inject glucagon with loss of consciousness or
seizure
•
Administered by another person
– May be given intramuscular
or subcutaneous
•
Standard dose
– 1.0 mg for adults; 0.5 mg for
children under 5 yrs
•
Prescription is required
•
Precautions
– May cause nausea/vomiting/headache
•
Call 911
Hypoglycemia Prevention
• Instruct patients to…
– Follow food and insulin
plan
– Test blood glucose daily
– Carry carbohydrate
– Wear medical
identification
– Teach others how to
inject glucagon
Continuous Glucose Monitoring
• CGM and intensive insulin regimens can be useful to
lower A1C in selected adults >25 YOA
• CGM may also help in children, teens and younger
adults although evidence is less strong
• CGM may be supplemental tool for those with
hypoglycemia unawareness and/or frequent
hypoglycemic episodes1.
• Reliability concerns do not eliminate need for SMBG
• Effectiveness on glycemic control has not been
established
1Diabetes
Care, volume 34, Supplement 1 January 2011 pg S4.
Key Attributes of Good
Candidate for Insulin Pump
• Patients must be able to:
– Learn and apply basic diabetes self
management skills
– Learn and apply advanced diabetes self
management skills
– Learn to operate an insulin pump
– Follow their prescribed regimens
http://clinical.diabetesjournals.org/content/25/2/50.full.
Accessed August 31, 2011.
Key Attributes of Good
Candidate for Insulin Pump
• Patients must be able to:
– Learn and apply troubleshooting skills
– Meet with their healthcare team as scheduled
– Pay for their insulin, insulin pump, glucose
monitoring device and all disposables ($6500
initially and $2000-3000 per year)
http://clinical.diabetesjournals.org/content/25/2/50.full Accessed August 31, 2011
.
Insulin Pumps
• Used by Adolescents-often with a
Behavior contract
• Pre-pump training to include basic
diabetes management and basal bolus
training
• Start up training-up to two days
• Maintenance and expansion of
competencies
http://clinical.diabetesjournals.org/content/25/2/50.full Accessed August 31,
2011
Management of Diabetes in the
Hospitalized Patient
• Critically Ill: Insulin treatment for persistent BG
>180 to maintain a range of 140-180 mg/dl
• Non-critically ill: No clear evidence. Pre-meal
goal of <140mg/dl and random BG of <180
mg/dl if treated with insulin
• More stringent goals in pts with previous tight
control and less stringent goals in pts with
multiple co morbidities
Diabetes Care, volume 34, Supplement 1 January 2011 pg S9.
Rosita
Case #4
• Rosita is now 80, living in a
multigenerational household
• Her daughter Maria cares for her great
grandchildren while granddaughter and
son-in-law work
• Rosita has her own room near a bathroom
• Rosita’s daughter prepares all meals,
administers medications, and assists with
transportation to her many doctor visits
including her:
– family physician -ophthalmologist
– cardiologist
- orthopedic surgeon
– nephrologist
- neurologist
Rosita’s Meds and Labs
• Medications: lisinopril, furosemide,
acetaminophen, aspirin, glargine, insulin aspart,
statin, carvedilol, gabapentin, colace, metamucil,
glucosamine chondroitin, ginko biloba
• Her last HbA1c was 8.1
• LDL 105
• Creatinine 3.2
• MMSE 21
SOUND FAMILIAR?
Individualize Treatment Goals
• Patients who are functionally and cognitively
intact should be treated with same goals as
younger patients
• Glycemic goals may be relaxed and
individualized to avoid symptoms of hyper and
hypoglycemia
• CV treatment goals are based on quality of life
and life expectancy
• Continue to screen for complications that would
lead to functional impairment
Incident Counts & Adjusted Rates,
By Primary Diagnosis of ESRD
Early Treatment Makes a Difference
Brenner, et al., 2001
Definitions of Abnormalities
In Albumin Excretion
Category
Spot urine collection albumin/
creatinine (microgram/mg
creatinine)
Normal
<30
Microalbuminuria
30-299
Macroalbuminuria
(clinical)
>/= 300
Screening for Chronic Kidney Disease
In individuals with diabetes with initial
microalbuminuria detected:
• Spot urine albumin to creatinine ratio (on 2
out of 3 occasions over 3-6 months)
− Affected by exercise, infection, fever, CHF,
marked hyperglycemia
• Measure serum creatinine, estimate the
GFR and stage the level of CKD
Diabetes Care, Volume 34, Supplement 1, January 2011, Page S34
Stages Chronic Kidney Disease
Stage
Description
GFR
1
Kidney damage with normal or inc. GFR
>=90
2
Kidney damage with mild decrease in
GFR
60-89
3
Moderate decrease in GFR
30-59
4
Severe decrease in GFR
15-29
5
Kidney failure
<15 or dialysis
Drug Levels With Impaired Renal Function
Drug Level
Time
Age-Related Pharmacokinetic Changes
• Absorption
– Decreased gut motility
– Decreased secretion of digestive enzymes
• Distribution
– Increased total body fat
– Decreased muscle mass
– Decreased total body water
• Metabolism
– Decreased ability of the liver to metabolize
• Elimination
– Decreased creatinine clearance due to age
Treatment to Prevent Progression of
CKD to Kidney Failure
• Intensive glycemic control lessens
progression from microalbuminuria in type 1
diabetes
• Anti-hypertensive therapy with ACE
inhibitors lessens proteinuria and
progression
• Low protein diets in later stages of CKD
may improve function
Diabetes Care, Volume 34, Supplement 1, January 2011, Page S33
Meta-Analyses
Medication Safety in Seniors
• Lower doses should be used initially
• Upward titration at a slower rate
Start Low-Go Slow-Check Creatinine Clearance!
• Have a high level of suspicion for drug SE
• Establish a routine for drug monitoring
• Consult with Clinical pharmacist
WHO -HCT team. World Health Organization. Adherence to Long Term Therapies: Evidence for Action.
(2003).
To improve, you must make changes
But…
Not all changes lead to improvement
Practice Improvement
Tools # 3 and 4
Why an Aim Statement?
• Answers and clarifies “What we are trying
to accomplish?”
• Creates a shared language to
communicate the project to others.
Setting the Aim
• Focused
• Manageable
• Data available or obtainable
Aim Statement
S – pecific
M – easureable
A – ttainable
R – elevant /realistic
T - imely
Defining the Measures
A good aim statement helps define the
measures.
– Measurement should not slow things down
– Seek usefulness, not perfection
– Use sampling
– Use accessible measures (don’t wait for IT)
Aim Exercise
• Choose an area in your theme you want to
improve
• Write an aim statement for the next few
months of the project
• How will you measure it?
Model for Improvement
What are we trying to accomplish?
Aim
How will we know a change is an
improvement?
Measures
What change can we make that will result in
Improvement?
Plan
Act
Do
Study
Ideas
PDSA Cycle for Learning Improvement
Plan Do
•
•
•
•
Objective
Questions and predictions
Plan to carry out the cycle
(who, what, where, when)
Plan for data collection
•
•
•
Carry out the plan
Document the problems and
unexpected observations
Begin analysis of the data
Act Study
• What changes are to be
made?
• Next cycle?
• Complete the analysis of the data
• Compare data to predictions
• Summarize what is learned
PDSA Pitfalls
•
•
•
•
Plan, Plan, Plan, Panic
The Nike Model “Just do it”
The research model – Plan-do-study-publish
Neglecting to follow up on previous changes
introduced (leaving out the “s”)
• Piloting on a large scale – more than just a test
• “Do” and “Act” are NOT a PDSA cycle
PDSA Cycle Exercise
• Write out the Plan section for 2 PDSA cycles
– Objective
– Questions and predictions
– Plan to carry out the cycle (who, what, where,
when)
– Plan for data collection
• Report out on one Plan
Call to Action
What is the Problem with Our
Healthcare System?
• Clinicians and healthcare providers care and are working
hard, but are we working smart?
• “A significant part of the quality problem in healthcare is
surprising and counterintuitive - Performance is rarely
measured”.
Donald Berwick MD Administrator, CMS
• “Mandatory measurement and reporting of results is the single
most important step in reforming healthcare”.
Porter and Teisberg
Diabetes as a Model for Reform
• Nationally many patients not receiving adequate care
• Reaching ADA goals??
– 56% reach HbA1c <7%
– 40% reach LDL <100 and B/P < 130/80
– 7 to 10 % reach goal for all three at the same time
• Excellent evidence (DCCT & UKPDS) that reducing
HbA1c by 1% DECREASES blindness, renal disease
and neuropathy by 33%
• Reaching goal for LDL and B/P DECREASES MI and
stroke by 30 to 40%
• Significant Cost Savings when goals are reached
The Diabetes Master Clinician Program
A Diabetes Registry
• Internet-based system created by the Florida
Academy of Family Physicians Foundation that:
– Measures achievement of evidenced-based
guidelines from the ADA, NCEP, JNC7
– Is driven by family physician users
– produces reports to aid in the achievement of
excellence in diabetes care.
Diabetes Registry
Option for 2011 GO! Participants
• Our grant will fund up to 10% of the GO! Diabetes
enrollees to participate in the DMCP
• Dr. Ed Shahady, DMCP Medical Director and his
staff will visit each clinic to train staff
• Frequent follow up and resources will be provided to
facilitate implementation of the DMCP in each clinic
in order to:
– utilize the registry report card with every diabetic patient
– develop a team system to encourage accountability
– create standing orders for staff to implement
DMCP Preventive Measures
Values
All Clinics 2011
GO! Clinics 9/08 GO! Clinics 2011
Group visits
3%
0%
9%
Eye exams
19%
22%
33%
Foot exams
31%
16%
42%
Microalbumin
28%
16%
49%
Pneumovax
30%
0%
39%
Flu vaccine
19%
32%
38%
Aspirin use
47%
29%
33%
Impact of Medical Assistants
over 8 months in 140 Patients
Eye check
2%
59%
Foot check
10%
82%
HbA1c<
7.8
7.4
Total chol
189
184
LDL
112
106
HDL
43
45
Non-HDL
146
139
Triglycerides
175
166
U microalb
6%
63%
Pneumovax
32%
76%
Flu shot
1%
66%
Daily ASA
45%
65%
1. MA gave patients
and physicians
report cards
2. MA did the
monofilament
exams
3. MA ordered tests
per protocol
New in 2011-Patient Survey
• The GO! Diabetes grant will pay for up to 10% of
GO! Diabetes enrollees to implement a patient
survey to assess patient knowledge of their
diabetes management
• A provider-patient education guide will be shared
to use with patients during an office visit
• Patients will be re-surveyed after several months
to determine knowledge gains and to assess their
perceptions about the quality of care they
received.
Change Agent Role
•
•
•
•
•
•
Champion of the project
Help give a local presentation
Actively recruit METRIC participation
Nurture collaborative environment and
Guide practice change using the PI tools
Encourage research
Change Agent Resources
Susan Reichman, BSN, Project Director, Purple Team
Coordinator
[email protected] or 1-888-388-8215
Kara Sinkule, Blue Team Project Coordinator
[email protected] or 1-888-388-8216
Karen Suiter, Green Team Project Coordinator
[email protected] or 1-888-388-8217
Change Agent Resources
www.godiabetes.org
News on the GO!
[email protected]
Change Agent Next Steps
• Recruit participants for METRIC
• Determine if METRIC data will be used for
individual change or clinic changes
• Present local program
• Implement practice improvement choices
• Measure change using METRIC
• Develop research
GO!