Download Slide 1

ASSESSMENT OF DIABETES MANAGEMENT
IN FAMILY CARE CLINIC AT RCRMC FROM
2004-2007
Presented by
Dr. Keyla Blandon & Dr. Sabeen Abdul-Sattar
1
GENERAL OBJECTIVE
TO DETERMINE TO WHAT EXTENT HAVE
DIABETIC PATIENTS MANAGED IN FAMILY
CARE CLINIC (RCRMC) REACHED THEIR
DIABETIC GOALS, AND WHAT ARE THE MAIN
OBSTACLES TO AHIEVE THEM
2
SPECIFIC OBJECTIVES
1- To determine what percentage of diabetic patients managed in family
care clinic have achieved the ABCs of diabetes (A=HA1c<7%, B=blood
pressure <130/85, C=LDL<100 or <70 if high risk for cardiovascular
events
2- To identify what treatment modalities are used more frequently
3- To identify which treatment modalities are more effective in getting
patients to achieve their diabetes goals
4-To identify if exercise and nutrition are part of the assessment/plan
during clinic visits for diabetes management
5-To identify obstacles in the management and treatment of diabetes
patients
3
METODOLOGIC DESIGN
TYPE OF STUDY
Retrospective chart review
SAMPLE
300 charts of diabetic patients seen in family care clinic
(RCRMC), were reviewed
Each clinic visit where diabetes was assessed was
included
4
INCLUSION CRITERIA
1-Diabetic patients seen in FCC for at least six
months
2-Age >18 years old
3-No visual or hear impairment that limits their
ability to follow the doctor recommendations at
home
4-No diagnosis of dementia that compromise
patient’s capacity to follow doctor’s
recommendations
5
EXCLUSION CRITERIA
1- To have been a diabetic patient in FCC for less than
six months
2-To have another outside doctor that also manage
patient’ diabetes
3-Patients with dementia that impairs patients’ abilities
to follow up doctor’s recommendations
4-Patients with visual or hear impairment that limits
their abilities to follow doctor’s recommendations
5-Age< 18 years old
6
VARIABLES
SOCIODEMOGRAPHIC VARIABLES
-Age
-Sex
-Number of years being a patient in FCC
DIABETES VARIABLES
-HA1c
-LDL
-HDL
-Triglycerides
-Blood pressure
-Annual eye exam
7
EDUCATIONAL VARIABLES
-Exercise as part of the treatment plan
-Education on nutrition
-Number of visits to Diabetes Class
TREATMENT VARIABLES
-Sulfonilureas
-Biguanides
-Thiazolidinediones
-Combination of oral therapy
-Insulin basal
-Insulin mixed preparations
-Combination basal insulin with rapid acting insulin
-Combination insulin with oral therapy
8
BACKGROUND INFORMATION
9
EPIDEMIOLOGY
• Diabetes has reached epidemic proportions, more then 20.8
million Americans are affected by diabetes (7% of the population)
(3)
• Type 2 diabetes accounts for 90 to 95% of all diagnosed
diabetes cases
• An alarming situation is the fact that although still rare in
children and adolescents, diabetes now is being diagnosed more
frequently in these groups; particularly in American Indians,
African Americans, and Hispanic/Latino Americans (2)
10
11
COMPLICATIONS OF DIABETES IN THE UNITED STATES (2)
• Heart disease and stroke account for about 65% of deaths in people
with diabetes
• About 73% of adults with diabetes have blood pressure greater than or
equal to 130/80 millimeters of mercury (mmHg) or use prescription
medications for hypertension
• Diabetes is the leading cause of new cases of blindness among adults
aged 20-74 years
• Diabetes is the leading cause of kidney failure, accounting for 44% of
new cases in 2002
• About 60-70% of people with diabetes have mild to severe forms of
nervous system damage: impaired sensation or pain in the feet or hands,
slowed digestion of food in the stomach, carpal tunnel syndrome
12
• More than 60% of nontraumatic lower-limb amputations occur in
people with diabetes
• Almost one-third of people with diabetes have severe periodontal
disease with loss of attachment of the gums to the teeth measuring 5
millimeters or more
• Poorly controlled diabetes before conception and during the first
trimester of pregnancy can cause major birth defects in 5-10% of
pregnancies and spontaneous abortions in 15% to 20% of pregnancies,
while poorly controlled diabetes during the second and third trimesters of
pregnancy can result in excessively large babies, posing a risk to both
mother and child
*The risk of unfavorable outcomes is particularly great for patients whose
care has not emphasized the importance of glycemic control and risk
factor intervention (5)
13
ESTIMATED DIABETES COSTS IN THE UNITED STATES IN
2002 (2)
• Total (direct and indirect): $ 132 billion
• Direct medical costs: $ 92 billion
• Indirect costs: $ 40 billion (disability, work loss,
premature mortality)
14
PREVENTING DIABETES COMPLICATIONS
15
• Type 2 diabetes is a progressive disease requiring individualized strategy
and a team approach to achieve and maintain long-term, near normal blood
glucose and blood pressure levels
16
*Several large trials, including the Diabetes Control and
Complications Trial (DCCT) and the United Kingdom
Prospective Diabetes Study (UKPDS) have demonstrated the
benefits of tight glucose control in reducing risk for
microvascular complications
*Increasing body of evidence to support the theory that
normalizing blood glucose decreases risk of macrovascular
complications, with A1C a good predictor of ischemic
heart disease.
*Recent study from the American Diabetes Association noted
that 50% of patients are not treated to target even if
there are complications (3)
17
18
GLUCOSE CONTROL
*Every percentage point drop in A1C reduces the risk of microvascular
complications (eye, kidney and nerve diseases) by 22-35%
*Note that AIC is the sum of both fasting and postprandial glucose
excursions(2)
*Recent studies point to the effect postprandial glucose has on A1C compared to the
usual correlation of fasting glucose levels. Postprandial state can be 16-18
hours per day in the patient with type 2 diabetes, with as much as a 70%
variance in determining A1C versus the fasting state (3)
19
BLOOD PRESSURE CONTROL
-Blood pressure control reduces the risk of cardiovascular disease
(heart disease or stroke) among persons with diabetes by 33% to 50%,
and the risk of microvascular complications by approximately 33%
-In general, for every 10mmHg reduction in systolic blood pressure,
the risk for any complications related to diabetes is reduced by
12% (2)
CONTROL OF BLOOD LIPIDS
-Improved of cholesterol or blood lipids (HDL, LDL and triglycerides) can
reduce cardiovascular complications by 20% to 50% (2)
20
PREVENTIVE CARE PRACTICES FOR EYES, KIDNEYS AND
FEET
• Detecting and treating diabetic eye disease with laser
therapy can reduce the development of severe vision loss
by an estimated 50% to 60%
• Comprehensive foot care programs can reduce amputation
rates by 45% to 85%
• Detecting and treating early diabetic kidney disease by
lowering blood pressure can reduce the decline in kidney
function by 30% to 70% (2)
21
TREATMENT GOALS IN DIABETES
22
To prevent all diabetes complications the health team in charge of diabetic
patients must try to achieve what is called the ABCs of diabetes control
A→ HgA1C <7% by the American Diabetes Association (ADA) or lowest
possible without unacceptable hypoglycemia, or below 6.5% by the
American Association of Clinical Endocrinologists (AACE)
B→ Blood pressure equal or below 130/80mmHg or further lowering if
tolerated by patients
C→ Cholesterol < 100 or below 70 for high risk patients with diabetes and
CVD
23
OTHER IMPORTANT TREATMENT GOALS
• Fasting/preprandial glucose level <110 mg/dl by the American College of
Endocrinologists (ACE) , and between 90-130mg/dl by the AMERICAN
DIABETES ASSOCIATION (ADA)
• 2-hr postprandial <140 mg/dl by the ACE, and <180 by the ADA
• HDL > 40mg/dl in men; >50 mg/dl in women
• Triglycerides < 150 mg/dl
24
• The earlier we achieve these goals the better, studies have shown that when current
glycemic goals are achieved early, beta cells are preserved
• The traditional management approach is to wait until one treatment is failing
before adding another agent or intensifying therapy
• The United Kingdom Diabetes Study (UKDS) showed the gradual failure of therapy
over time correlating with a decline in insulin secretion and an increase in plasma
glucose concentration, after 6 years of antihyperglycemic monotherapy,
approximately 55% of patients were able to attain A1C levels below 7%,
but by 9 years only 24% were able to do so
•The American Association of Clinical Endocrinologists (AACE) issued a
comprehensive report titled “STATE OF DIABETES IN AMERICA”, a report on
diabetes management in the United States, the report was conducted during 2003
and 2004 in 39 states The results were compared with the HA1c level goal set by
the AACE of 6.5% or less. It included more than 157,000 people with type 2
diabetes. The result revealed that 67% or two out of three people analyzed
in the study failed to meet the AACE target A1c goal
25
TREATING DIABETES
26
* Diabetes is aprogressive disease that requires the patient to be not a passive but
an active participant of the plan of care
* The ideal health care team would have a nurse practitioner and/or nutritionist plus
the physician to educate and follow patients and intervene promptly when
deficiencies are found
* Diabetes self-management education (DSME) gives the idea that patient
participation is key to achieve treatment goals in diabetes; patients who are
involved in their treatment are likely to have better outcomes
* Blood glucose self-monitoring is an important tool for self-management
Having patients assess fasting and postprandial glucose gives a more
complete picture of metabolic control and allows the clinician to introduce
basal and prandial insulin when appropriate (3)
27
28
-The addition of insulin to sulfonylurea therapy improves
glycemic control, as shown by a subset analysis of the United
Kingdom Prospective Diabetes Sudy (UKPDS), without
promoting weight gain or increased risk of hypoglycemia
-Additional benefits or early insulin therapy include prevention
of glucose toxicity, slowed deterioration of existing beta-cell
function, and delayed vascular complications
-An A1C greater than 7% is the trigger for a change in
therapy according to the American Diabetes Association
Standards of Care. (3)
29
30
TREATMENT OPTIONS
31
32
33
- Considerations in whether to add supplemental insulin to an
existing oral regimen or to replace oral therapy with an allinsulin regimen include the likelihood of adverse effects,
patient acceptance, and the cost of therapy
- Faced with a patient who is failing a maximal oral
antihyperglycemic regimen, many experienced diabetologists
would institute a simple basal insulin regimen in addition to
continued oral therapy. Most often the regimen is a oncedaily injection of an intermediate-acting or a longacting insulin preparation, given at bedtime (currently the
most popular option), or at breakfast (5)
34
35
• Most recently, the Treat-to-Target Trial (6) addressed the
impact of adding a once-daily basal insulin injection to a
failing oral regimen, which included a combination of agents
(eg, sulfonylurea plus metformin, sulfonylurea plus TZD) in
two thirds of study subjects:
Using bedtime NPH insulin or insulin glargine, HbA1c
levels fell from a mean of 8.6% to the target of less than
7% in nearly 60% of participants. In this study, the insulin
dose was adjusted weekly to attain target fasting glucose
levels below 100mg/dl, and by study’s completion the
average dose was 47 U/day for the insulin glargine group
and 42 U/day for the bedtime NPH insulin group. Nighttime
hypoglycemia was significantly less frequent in the
insulin glargine group
36
• Daytime sulfonylurea plus bedtime NPH insulin The addition of bedtime
insulin at a starting dose of 15 to 20 U (or 0.2 U/kg) has been shown to reduce
HbA1c levels by at least 0.8% to 1.3% when added to failing oral
regimens of glyburide or glipizide (7,8)
• Sulfonylurea plus insulin glargine In an RCT, Frische (10) compared the
efficacy and hypoglycemic frequency of treatment with glimepiride plus insulin
glargine to that of treatment with glimepiride plus bedtime NPH insulin. The
glimepiride/insulin glargine combination was further studied by comparing morning
versus bedtime insulin administration. In this 28 week study, HbA1c, levels
improved by 1.24% in the morning insulin glargine group, by 0.96% in the
bedtime insulin glargine group, and by 0.84% in the bedtime NHP insulin
group. Frequency of nocturnal hypoglycemia was significantly less in the
morning (17%) and bedtime (23%) insulin glargine groups than in the
evening NPH insulin group (38%)
37
• Sulfonylurea plus suppertime 70/30 insulin
Riddle et al (9) compared once-daily (before breakfast)
glyburide plus once-daily (before supper) 70% NPH
insulin/30% regular insulin with insulin alone in a 16-week
study involving 21 obese patients who had failed monotherapy
with glyburide 20mg/day (average baseline HbA1c, 11%).
Patients were randomized to receive insulin before supper and
placebo before breakfast or insulin before supper and glyburide
10mg before breakfast. HbA1c levels decreased 1.3% in the
combined therapy group compared with 0.8% in the
insulin monotherapy group
38
• Metformin plus insulin
Several RCTs comparing insulin monotherapy with insulin plus metformin suggest a
synergistic effect of combined therapy. In a study by Yki-Jarvinen et al (11) patients
failing sulfolnyurea only therapy (mean baseline HbA1c, 9.9%) were randomized to
bedtime NPH insulin plus: 1) glyburide, 2)metformin, 3)glyburide and
metformin, or 4) a second injection of NPH insulin in the morning. At 1-year
follow-up, patients receiving metformin plus bedtime NPH insulin had the
lowest attained mean HbA1c (7.2%) as well as the least weight gain and lowest
incidence of hypoglycemia (both at P <0.05)
• TZD plus insulin
Raskin et al (12) conducted an 8-week trial comparing twice-daily insulin plus
placebo with twice-daily insulin plus rosiglitazone in 319 patients (mean
baseline HbA1c, 8.9%). In the insulin plus rosiglitazone group, HbA1c dropped
by 1.2% compared with no changes in the insulin plus placebo group. Edema may be
anticipated in 15% or more of patients using the combination (13)
39
40
41
42
BARRIERS TO SUCCESSFUL DIABETES
MANAGEMENT
43
CLINICIAN BARRIERS
•
•
•
•
Excluding postprandial blood glucose patterns
Complexity of adding more aggressive therapies
Weak support for self-management of diabetes
Few incentives to change practices and behavior
(3)
PATIENTS BARRIERS
• Resistance to starting insulin therapy
- Misconceptions about insulin
- Anxiety about weight and hypoglycemia
• Feelings of failure to manage diabetes
• Feelings of loss of control
• Doubt about managing an insulin regimen
44
OUR FINDINGS
45
Patient distribution by age
180
163
160
Number of patients
54%
140
127
120
42%
100
80
60
40
20
10
0
3%
18-35
36-55
>56
Age range
46
Patient distribution by sex
Male
110
37%
Female
190
63%
47
Number of years
Patient distribution by years in FCC*
3
2
26% 78
1
29%
0
20
*Family Care Clinic
40
60
80
45%
135
120
140
87
100
160
Number of patients
48
Number of visits to FCC
60
61%
38%
Number of patients
50
40
45%
24%
38%
21%
30
28%
16%
20
11%
10
6%
6%
4%
0% 0%
1%
0
1
2
3
Number of years in FCC
<3
4-7
8-11
12-15
>16
49
USE OF ASPIRIN
38 (49%)
42
(48%)
92 (68%)
OF 300 PATIENTS
172 (57%), WERE
ON ASPIRIN
One Year
Two Years
Three Years
50
Number of Electrocardiograms done
33 (42%)
33
(38%)
90 (67%)
OF 300 PATIENTS
156 (52%) HAD
AN EKG DONE
One Year
Two Years
Three Years
51
Distribution of patients by Systolic blood pressure ranges
Number of patients
40
35
29%
30
24%
25
38%
24%
23%
20
15
10
25%
25%
23%
29%
26%
13%
5
19%
0
*Most patients with
Systolic pressures of
<130 were in their
40’s
1
2
3
Number of years in FCC
<130
130-140
141-150
>151
52
Microalbumin screened
73
80
Number of patients
70
52
60
39
50
40
33
Positive
39
66
28
Negative
30
27
14
20
10
19
17
29
8
14
12
9
10
7
1 Time
2 Times or
more
1 Time
2 Times
3 Times or
more
0
1 Time or
more
1 YEAR
(52 screened)
2 YEARS (67 screened)
3 YEARS
(129 screened)
*Of the one year patients 33 positives, 8 (24%) were not on an ACE or ARB
*Of the two years patients 41 positives, 5 (12%) were not on an ACE or ARB
*Of the three yearS patients 103 positives, 8 (8%) were not on an ACE or ARB
53
*One year
(45%)
*Two years
(41%)
*Three years
(42%)
54
*One year
(63%)
*Two years
(64%)
*Three years
(76%)
55
Most Recent Hemoglobin A1C Levels
45
31%
40
Number of patients
35
23%
30
25
15%
20
15
25%24%
17%
19% 19%
9%
16%
10
13%
11%
7% 7%
11%
13%
8%
5
5%
4%
5%
3%
6%
2% 3%
4%
1%
0%
0
1
2
3
Number of years in FCC
<7
7-8
8-9
9-10
10-11
11-12
12-13
13-14
>14
56
Low Density Lipoprotein Ranges
34%
45
31%
40
Number of patients
35
37%
30
36%
32%
25
17%
23% 24%
13%
20
15
12%
11%
10
5%
7%
6%
7%
2%
5
3%
0%
0
1
2
3
Number of years in FCC
<70
71-100
101-130
131-160
161-190
>191
57
58
59
*247 (82%)
of 300
patients were on
an ACE or ARB
60
61
*212 (71%)
of 300 patients
were on a statin
62
63
64
IMPORTANT FINDINGS
• There were 25 patients in whom hypoglycemic episodes were reported
at least one time, most of them were older than 55 years old, and were on
one of the following:
Maximum doses of glucovance, or glyburide or combination of oral agents
(15)
Combination of oral agents and lantus (3)
NPH BID (2)
NPH BID and oral agents (1)
NPH BID and regular insulin (2)
Lantus and regular insulin (1)
Lispro and lantus (1)
• Most frequent intervention was to stop or decrease the dose of
glucovance or glyburide, although in a few occasions, glucovance or
glyburide were continued and avandia and or lantus were stopped
65
• In most of the clinic visits a chemstick was documented, although the number found
didn’t impact the plan, unless there were more than 250’s, when sometimes
medications were increased or there was a clear statement indicating need for patient
to bring diabetes log book in next clinic visit
• There was a good proportion of clinic visits were blood glucose levels at home were
documented although most of the time, was written in the form of a range, instead of
fasting or postprandial values
• Patients that were on insulin alone and/or in combination with oral agents, there
was a trend towards documenting both fasting and postprandial blood glucose levels
with a clear improvement on HA1c levels with time
• In some patients were doctors were more aggressive in increasing medications or
starting insulin just by the levels of chemstick in FCC and without a documentation of
glucose levels at home, there was a trend towards lowering the HA1c levels faster
• In several clinic visits there was intention of initiating insulin use, but patients
refused
66
• Since 2006 there has been a tendency towards starting insulin earlier,
most commonly lantus, and also in documenting the postprandial glucose
values at home
• There is also documentation were patients started on lantus were
taught to increase the dose by themselves at home based on the fasting
glucose values, although most of the time on follow up visits the doctor
ended up increasing the dose him or herself
• Most of the time lantus dose is increased by 2 or 3 points per visit
• In some cases the number of visits correlated with glucose control
(more visits better control), but this was not a consistent finding
67
• On many occasions the HA1C, was high and fasting blood sugars were
between 120’s to 200’s and the plan was to bring log book next visit
• In some occasions the plan was to increase a medication or to add on a
new one that was already increased in a previous visit
• In a few occasions when patients were changed from NPD BID to
lantus, there was worsening of control, and in some cases patients were
put back to NPH BID
• In some patients there were compliance or insurance issues that
aggravated glycemic control
• Sometimes there was documentation of fasting blood sugars in good
range, but HA1c of more than 7, in which the plan was to continue with
same management
68
CONCLUSIONS
• Diabetes is a progressive disease that requires the active
participation of both the physician and the patient to promptly
achieve the goals of therapy and prevent complications
• Postprandial glucose levels need to be monitor by the patients to
help the physician in implementing the best treatment strategies
• Patients need to know their goals of therapy and the increments in
their health risks when these goals are not achieved
• Insulin as a treatment option needs to be mentioned to patients
early, with emphasis in the fact that diabetes is a progressive
disease in which most likely insulin will be needed at some point,
this need not to be seen by patients as a failure in treatment
• Physicians need to ask patients early their beliefs about insulin to
clarify any misconceptions with time
69
REFERENCES
1-State of Diabetes in America ( a comprehensive report issued by the American
Association\
Of Clinical Endocrinologists
2-National Diabetes Fact Sheet Unites States, 2005, CDC Division of Diabetes
3- Diabetes, Optimizing Outcomes with insulin for patients with type 2 Diabetes a
team
Approach management
4-ACE/AACE Diabetes Recommendations Implementation Conference, Road
Map for the
Prevention and treatment type 2 Diabetes
5- Summary of Revisions for the 2007 Clinical Practice Recommendations, ADA
70