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Presentation by
Paresh Dandona, BSc, MD, DPhil,
FRCP, FACP, FACC, FACE
SUNY Distinguished Professor of Medicine and Pharmacology
School of Medicine and Biomedical Sciences
Division Head, Endocrinology and Metabolism
State University of New York at Buffalo
Founder, Diabetes-Endocrinology Center of Western New York,
Buffalo, New York
In partnership with
Confidential:
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Study 1:
CDE-Ambassador
A Novel Approach To Comprehensive
Diabetes Care At The Primary Care Level
Presented at American Association of Diabetes Educators
(AADE) 2015 Conference based on research led by
Paresh Dandona, BSc, MD, DPhil,
FRCP, FACP, FACC, FACE
Study 1:
CDE-Ambassador
A Novel Approach To Comprehensive
Diabetes Care At The Primary Care Level
Presented at American Association of Diabetes Educators
(AADE) 2015 Conference based on research led by
Paresh Dandona, BSc, MD, DPhil,
FRCP, FACP, FACC, FACE
Study Summary:
https://www.ajmc.com/journals/evidence-based-diabetes-management/2016/december-2016/utilization-of-cdes-in-primary-
care-under-the-guidance-of-an-endocrinologist-better-than-any-new-drug-researcher-says
Link to PDF of article:
https://ajmc.s3.amazonaws.com/_media/_pdf/EBDM_1216_final.pdf
ADDITIONAL REFERENCES
From 2015 AADE Conference:
https://www.aademeeting.org/news/team-approach-helps-patients-reduce-a1c-levels/
Link to full set of slides with detailed data presented at 2015 AADE Conference below:
https://www.diabeteseducator.org/docs/default-source/default-document-library/f27b.pdf?sfvrsn=0
“When he dispatched CDEs to work alongside a primary care physician (PCP), but under his guidance, the educators were able to gain significant improvements in
glycated hemoglobin (A1C) in patients with diabetes, which Dandona deemed “better than any new drug.”
100 patients managed by the CDEs had a mean A1C reduction of 1.6% after 6 months, while a control group of 45 patients treated only by the PCP saw a reduction
of only 0.26%. Patients treated by the CDEs lost more weight, as well, with their body mass index falling by 1.3 kg/m2 in the intervention group compared with 0.1
kg/m2 for the control group. The CDE-treated group also recorded improvements in blood pressure, low-density lipoprotein (LDL) cholesterol, and triglycerides
superior to those in the controls.
There were some differences between the 2 groups: the intervention group was slightly younger (mean age of 58 years vs 61 years in the control group), and a much
higher share of the group had been diagnosed within the past 5 years (62% vs 42%). But as Dandona explained, that may be the point. Too often, he said, PCPs fail
to make timely adjustments to treatment regimens early in the course of the disease, which is when patients are known to respond better to therapy.
Deploying trained CDEs into primary care can help tackle the “mountain of diabetes,” he said. This is a group that is highly committed, but they need guidance from
specialists. The data reveal that the CDEs were more aggressive in making medication changes: 52% of the CDE group had modifications to their regimen compared
with 37.7% of the PCP group. Of note, the A1C decline was greater among patients who had a therapy change (mean of 1.9%) compared with those whose therapy
was not changed (1.1%).
After the 6-month intervention, when patients returned to management by the PCP alone, the A1C reduction in the intervention group diminished somewhat, to 1.2%
at 12 months. This was still greater than the decline in the control group, which was 0.7% at 12 months. Notably, the average A1C for the intervention group was
below 7% at 6 months, but crept back up to 7.8% after patients stopped seeing the CDE. In the control group, the average A1C was 8% at 6 months and 7.9% at 12
months. Benefits in blood pressure, weight loss, triglycerides, and LDL cholesterol were largely maintained in the CDE group, despite the rise in A1C at 12 months.
Dandona said the results highlight the problem of clinical inertia, which affect his ability to change patient behavior when patients progress and are referred to him.
“There are a lot of patients who need attention, but we are basically sitting there doing nothing,” he said. When these patients get to the endocrinologist, “they are
already reticent in changing their habits, because for years, they’ve been told they are perfectly OK.”
Study 1:
CDE-Ambassador: A Novel Approach To Comprehensive
Diabetes Care At The Primary Care Level
Summary
Study 2:
Certified Diabetes Educator-Ambassador (CDE-A)
Involvement Improves Diabetic Control and
Cardiovascular Risk Factors
at Primary Care Level
Presented at Endocrine Society 2016 Meeting:
Research led by
Paresh Dandona, BSc, MD, DPhil,
FRCP, FACP, FACC, FACE
View Full Study at: https://endo.confex.com/endo/2016endo/webprogram/Paper27541.html
Presented at Endocrine Society 2016 Meeting:
“We have previously shown that the involvement of a CDE, empowered by guidance from a diabetologist, termed CDE-Ambassador (CDE-A), in the management of
the diabetes at the primary care level, results in marked benefits. Retrospective analysis of data obtained from 100 such patients showed improvements in glycemic
control (HbA1c from 8.4% to 6.8%; p<0.0001), body weight (from 102 to 99Kg; p<0.0001), systolic blood pressure (from 134 to 128 mm; p<002), diastolic blood
pressure (from 80 to 77 mm; p<0.003) and serum triglycerides (from 189 to 162 mg/dl; p<0.003) and LDLc concentrations (from 108 to 96 mg/dl; p<0.0004) following
2 to 3 consultations over a period of 6 months. [Micro-albuminuria did not alter significantly.] There was no significant change in any of these indices in 45 control
patients who did not consult with the CDE-A. We have now investigated the durability of this effect by getting follow up data at 12 months without further intervention
after 6 months. The beneficial effect on HbA1c diminished from a reduction of 1.6% from the baseline at 6 months to 1.1% over the following 6 months without further
visits to the CDE-A. However, the benefits in BMI, blood pressure, triglycerides and LDLc were largely maintained, without significant attenuation. These indices did
not change in the control group. We conclude that the involvement of the empowered CDE-A can contribute to improvements in diabetic control and indices of
cardiovascular risk. While the maintenance of HbA1c probably requires repeated visits to CDE-A, the other indices related cardiovascular risk are effectively
controlled for at least one year. A network of CDE-As, empowered by diabetologists at the primary care level could help prevent diabetic microvascular and
macrovascular complications.”
Study 2:
Certified Diabetes Educator-Ambassador (CDE-A)
Involvement Improves Diabetic Control and
Cardiovascular Risk Factors
at Primary Care Level
Summary
One of the first Diabetes Ambassadors is Lori Crassi, RD,
CDE. Lori is currently a Diabetes Ambassador for the major
health plan in Western New York and was trained by Dr.
Dandona.
Prior to that, Lori worked with the Seneca Nation of Indians
in Western NY for 16 years. A quote from Lori regarding
the excellent results of the Diabetes Ambassadors
program is below:
• "During my 16 years of employment with the Seneca Nation of
Indians in Western NY, as a Registered Dietitian and Certified
Diabetes Educator (CDE), I had many opportunities to work with
Native Americans and provide health care, specializing in diabetes
and nutrition. The Seneca Nation is one of many tribes that applied
for and received funding through the Special Diabetes Project for
Indians from Congress, which was administered by Indian Health
Services.
• One of the most amazing programs was bringing endocrinologist, Dr.
Paresh Dandona to our clinic to assist in coordinating diabetes care
for our patients. Dr. Dandona developed an innovative and effective
approach to best utilize endocrinologists, CDEs and primary care
doctors to make a positive difference in the lives of people with
diabetes. Though dedication to each individual patient, helping them
to see improvement in their diabetes control. Always demonstrating
commitment and positivity that their blood sugars can and will
improve. Watching people transform their attitudes about diabetes
and medical care and their own ability to be successful in making a
difference in their health was priceless.
• The vast knowledge that was shared with me made me a better
clinician and allowed me to bring new treatment and education
options to my patients.”
Program Implementation at Blue Cross Blue Shield of
Western New York
THERAPEUTIC PLAN FOR PEOPLE WITH TYPE 2 DIABETES
• Less than 50% of people with diabetes have good control of their A1C—with numbers <7%. They are therefore vulnerable to the development of diabetes
complications and it is imperative that we take strong measures to improve diabetic control—since diabetes is the most common cause of adult blindness,
end stage kidney disease and peripheral neuropathy.
• Diabetes also contributes to the pathogenesis of atherosclerosis. This leads to an increased risk of myocardial infarction, stroke and peripheral vascular
disease and amputations.
• The innovations in the treatment of diabetes over the past 25 years have been phenomenal. However, knowledge about the appropriate use of these drugs is
lacking. We need to make primary care physicians aware of these novel innovations and their effective and appropriate use.
• Another important issue is the cost of these drugs—especially those that are still under patent. The cost of insulin has escalated enormously over the past
decade.
• This makes the issue of good control of diabetes doubly difficult: knowledge of appropriate use, and the excessive cost. It is, therefore, essential that we
attempt to deal with both of these issues.
• While we are attempting to deal with the problems at the primary care level with our network of CDE-Diabetes Ambassadors, we should also consider the
containment of cost.
• With this in mind, we have set out a simple therapeutic approach using four oral agents:
• 1) Pioglitazone—which also has definitive evidence of cardioprotection.
• 2-3) Acarbose and metformin—may also be cardioprotective.
• 4) Glimepiride—has recently been shown to be non-inferior to Linagliptin in terms of cardiovascular outcomes.
• Because of the potency of each of these 4 oral agents, it should be possible to reduce A1C by 3-4%, from a baseline of 10%, when they are used in
combination. This would translate into adequate control of 80% of patients with type 2 diabetes. Since the cost of each of these drugs is minimal, this
approach would potentially reduce treatment costs for type 2 diabetes enormously.
• The use of insulin and GLP-1RA could be reserved for those patients who are still not under control. Similarly, the use of GLP-1RA and SGLT2 inhibitors
could be reserved for those who have established atherosclerotic disease, cardiac failure or high cardiovascular risk.
• 60 year old male with family history of
diabetes
• BMI 34
• BP 150/100
• LDLc 130
CASE STUDY 1
• Measure HbA1c
• Treat LDLc with a statin
• Treat BP with an ACE-I or ARB
• If HbA1c is >5.7% and <6.5% (prediabetes), treat with
metformin and pioglitazone
• Review in 3-6 months
MANAGEMENT CASE 1
52 year old female with history of 20 years of diabetes
Smoker for 35 years
Absent foot (PT and DP) pulses
HbA1c 9.5%
BP 160/105
LDLc 135
Current treatment: metformin, glipizide, basal insulin
CASE STUDY 2
• Regular measurement of glucose, possibly CGM
• Introduce pioglitazone, and a GLP-1RA
• Titrate basal insulin to achieve FBS of 90-120 mg/dl
• Treat LDLc with a potent statin (rosuvastatin) to reduce
LDLc to <70 mg/dl
• Treat BP with ACEi/ARB, β blocker, calcium channel
blocker
• STOP SMOKING
MANAGEMENT CASE 2
• 50 year old obese male, diabetes for 15 years, erectile
dysfunction, tingling and numbness in toes, worse at night,
absent ankle reflexes. On treatment with metformin, glyburide,
basal and prandial insulin
• BP 145/100, LDLc 125 mg/dl
• HbA1c 11%
CASE STUDY 3
• Measure testosterone, LH and FSH in the morning
(8 to 9 am)
• Assess BP to confirm hypertension
• Reduce LDLc with a statin
• Commence treatment with pioglitazone, acarbose and a
GLP-1RA
• Replace testosterone if hypogonadal-testosterone is an
insulin sensitizer and reduces adiposity
MANAGEMENT CASE 3

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Cdea 2020

  • 1. Presentation by Paresh Dandona, BSc, MD, DPhil, FRCP, FACP, FACC, FACE SUNY Distinguished Professor of Medicine and Pharmacology School of Medicine and Biomedical Sciences Division Head, Endocrinology and Metabolism State University of New York at Buffalo Founder, Diabetes-Endocrinology Center of Western New York, Buffalo, New York In partnership with
  • 3. Study 1: CDE-Ambassador A Novel Approach To Comprehensive Diabetes Care At The Primary Care Level Presented at American Association of Diabetes Educators (AADE) 2015 Conference based on research led by Paresh Dandona, BSc, MD, DPhil, FRCP, FACP, FACC, FACE
  • 4. Study 1: CDE-Ambassador A Novel Approach To Comprehensive Diabetes Care At The Primary Care Level Presented at American Association of Diabetes Educators (AADE) 2015 Conference based on research led by Paresh Dandona, BSc, MD, DPhil, FRCP, FACP, FACC, FACE Study Summary: https://www.ajmc.com/journals/evidence-based-diabetes-management/2016/december-2016/utilization-of-cdes-in-primary- care-under-the-guidance-of-an-endocrinologist-better-than-any-new-drug-researcher-says Link to PDF of article: https://ajmc.s3.amazonaws.com/_media/_pdf/EBDM_1216_final.pdf ADDITIONAL REFERENCES From 2015 AADE Conference: https://www.aademeeting.org/news/team-approach-helps-patients-reduce-a1c-levels/ Link to full set of slides with detailed data presented at 2015 AADE Conference below: https://www.diabeteseducator.org/docs/default-source/default-document-library/f27b.pdf?sfvrsn=0
  • 5. “When he dispatched CDEs to work alongside a primary care physician (PCP), but under his guidance, the educators were able to gain significant improvements in glycated hemoglobin (A1C) in patients with diabetes, which Dandona deemed “better than any new drug.” 100 patients managed by the CDEs had a mean A1C reduction of 1.6% after 6 months, while a control group of 45 patients treated only by the PCP saw a reduction of only 0.26%. Patients treated by the CDEs lost more weight, as well, with their body mass index falling by 1.3 kg/m2 in the intervention group compared with 0.1 kg/m2 for the control group. The CDE-treated group also recorded improvements in blood pressure, low-density lipoprotein (LDL) cholesterol, and triglycerides superior to those in the controls. There were some differences between the 2 groups: the intervention group was slightly younger (mean age of 58 years vs 61 years in the control group), and a much higher share of the group had been diagnosed within the past 5 years (62% vs 42%). But as Dandona explained, that may be the point. Too often, he said, PCPs fail to make timely adjustments to treatment regimens early in the course of the disease, which is when patients are known to respond better to therapy. Deploying trained CDEs into primary care can help tackle the “mountain of diabetes,” he said. This is a group that is highly committed, but they need guidance from specialists. The data reveal that the CDEs were more aggressive in making medication changes: 52% of the CDE group had modifications to their regimen compared with 37.7% of the PCP group. Of note, the A1C decline was greater among patients who had a therapy change (mean of 1.9%) compared with those whose therapy was not changed (1.1%). After the 6-month intervention, when patients returned to management by the PCP alone, the A1C reduction in the intervention group diminished somewhat, to 1.2% at 12 months. This was still greater than the decline in the control group, which was 0.7% at 12 months. Notably, the average A1C for the intervention group was below 7% at 6 months, but crept back up to 7.8% after patients stopped seeing the CDE. In the control group, the average A1C was 8% at 6 months and 7.9% at 12 months. Benefits in blood pressure, weight loss, triglycerides, and LDL cholesterol were largely maintained in the CDE group, despite the rise in A1C at 12 months. Dandona said the results highlight the problem of clinical inertia, which affect his ability to change patient behavior when patients progress and are referred to him. “There are a lot of patients who need attention, but we are basically sitting there doing nothing,” he said. When these patients get to the endocrinologist, “they are already reticent in changing their habits, because for years, they’ve been told they are perfectly OK.” Study 1: CDE-Ambassador: A Novel Approach To Comprehensive Diabetes Care At The Primary Care Level Summary
  • 6. Study 2: Certified Diabetes Educator-Ambassador (CDE-A) Involvement Improves Diabetic Control and Cardiovascular Risk Factors at Primary Care Level Presented at Endocrine Society 2016 Meeting: Research led by Paresh Dandona, BSc, MD, DPhil, FRCP, FACP, FACC, FACE
  • 7. View Full Study at: https://endo.confex.com/endo/2016endo/webprogram/Paper27541.html Presented at Endocrine Society 2016 Meeting: “We have previously shown that the involvement of a CDE, empowered by guidance from a diabetologist, termed CDE-Ambassador (CDE-A), in the management of the diabetes at the primary care level, results in marked benefits. Retrospective analysis of data obtained from 100 such patients showed improvements in glycemic control (HbA1c from 8.4% to 6.8%; p<0.0001), body weight (from 102 to 99Kg; p<0.0001), systolic blood pressure (from 134 to 128 mm; p<002), diastolic blood pressure (from 80 to 77 mm; p<0.003) and serum triglycerides (from 189 to 162 mg/dl; p<0.003) and LDLc concentrations (from 108 to 96 mg/dl; p<0.0004) following 2 to 3 consultations over a period of 6 months. [Micro-albuminuria did not alter significantly.] There was no significant change in any of these indices in 45 control patients who did not consult with the CDE-A. We have now investigated the durability of this effect by getting follow up data at 12 months without further intervention after 6 months. The beneficial effect on HbA1c diminished from a reduction of 1.6% from the baseline at 6 months to 1.1% over the following 6 months without further visits to the CDE-A. However, the benefits in BMI, blood pressure, triglycerides and LDLc were largely maintained, without significant attenuation. These indices did not change in the control group. We conclude that the involvement of the empowered CDE-A can contribute to improvements in diabetic control and indices of cardiovascular risk. While the maintenance of HbA1c probably requires repeated visits to CDE-A, the other indices related cardiovascular risk are effectively controlled for at least one year. A network of CDE-As, empowered by diabetologists at the primary care level could help prevent diabetic microvascular and macrovascular complications.” Study 2: Certified Diabetes Educator-Ambassador (CDE-A) Involvement Improves Diabetic Control and Cardiovascular Risk Factors at Primary Care Level Summary
  • 8. One of the first Diabetes Ambassadors is Lori Crassi, RD, CDE. Lori is currently a Diabetes Ambassador for the major health plan in Western New York and was trained by Dr. Dandona. Prior to that, Lori worked with the Seneca Nation of Indians in Western NY for 16 years. A quote from Lori regarding the excellent results of the Diabetes Ambassadors program is below: • "During my 16 years of employment with the Seneca Nation of Indians in Western NY, as a Registered Dietitian and Certified Diabetes Educator (CDE), I had many opportunities to work with Native Americans and provide health care, specializing in diabetes and nutrition. The Seneca Nation is one of many tribes that applied for and received funding through the Special Diabetes Project for Indians from Congress, which was administered by Indian Health Services. • One of the most amazing programs was bringing endocrinologist, Dr. Paresh Dandona to our clinic to assist in coordinating diabetes care for our patients. Dr. Dandona developed an innovative and effective approach to best utilize endocrinologists, CDEs and primary care doctors to make a positive difference in the lives of people with diabetes. Though dedication to each individual patient, helping them to see improvement in their diabetes control. Always demonstrating commitment and positivity that their blood sugars can and will improve. Watching people transform their attitudes about diabetes and medical care and their own ability to be successful in making a difference in their health was priceless. • The vast knowledge that was shared with me made me a better clinician and allowed me to bring new treatment and education options to my patients.”
  • 9. Program Implementation at Blue Cross Blue Shield of Western New York
  • 10. THERAPEUTIC PLAN FOR PEOPLE WITH TYPE 2 DIABETES • Less than 50% of people with diabetes have good control of their A1C—with numbers <7%. They are therefore vulnerable to the development of diabetes complications and it is imperative that we take strong measures to improve diabetic control—since diabetes is the most common cause of adult blindness, end stage kidney disease and peripheral neuropathy. • Diabetes also contributes to the pathogenesis of atherosclerosis. This leads to an increased risk of myocardial infarction, stroke and peripheral vascular disease and amputations. • The innovations in the treatment of diabetes over the past 25 years have been phenomenal. However, knowledge about the appropriate use of these drugs is lacking. We need to make primary care physicians aware of these novel innovations and their effective and appropriate use. • Another important issue is the cost of these drugs—especially those that are still under patent. The cost of insulin has escalated enormously over the past decade. • This makes the issue of good control of diabetes doubly difficult: knowledge of appropriate use, and the excessive cost. It is, therefore, essential that we attempt to deal with both of these issues. • While we are attempting to deal with the problems at the primary care level with our network of CDE-Diabetes Ambassadors, we should also consider the containment of cost. • With this in mind, we have set out a simple therapeutic approach using four oral agents: • 1) Pioglitazone—which also has definitive evidence of cardioprotection. • 2-3) Acarbose and metformin—may also be cardioprotective. • 4) Glimepiride—has recently been shown to be non-inferior to Linagliptin in terms of cardiovascular outcomes. • Because of the potency of each of these 4 oral agents, it should be possible to reduce A1C by 3-4%, from a baseline of 10%, when they are used in combination. This would translate into adequate control of 80% of patients with type 2 diabetes. Since the cost of each of these drugs is minimal, this approach would potentially reduce treatment costs for type 2 diabetes enormously. • The use of insulin and GLP-1RA could be reserved for those patients who are still not under control. Similarly, the use of GLP-1RA and SGLT2 inhibitors could be reserved for those who have established atherosclerotic disease, cardiac failure or high cardiovascular risk.
  • 11. • 60 year old male with family history of diabetes • BMI 34 • BP 150/100 • LDLc 130 CASE STUDY 1
  • 12. • Measure HbA1c • Treat LDLc with a statin • Treat BP with an ACE-I or ARB • If HbA1c is >5.7% and <6.5% (prediabetes), treat with metformin and pioglitazone • Review in 3-6 months MANAGEMENT CASE 1
  • 13. 52 year old female with history of 20 years of diabetes Smoker for 35 years Absent foot (PT and DP) pulses HbA1c 9.5% BP 160/105 LDLc 135 Current treatment: metformin, glipizide, basal insulin CASE STUDY 2
  • 14. • Regular measurement of glucose, possibly CGM • Introduce pioglitazone, and a GLP-1RA • Titrate basal insulin to achieve FBS of 90-120 mg/dl • Treat LDLc with a potent statin (rosuvastatin) to reduce LDLc to <70 mg/dl • Treat BP with ACEi/ARB, β blocker, calcium channel blocker • STOP SMOKING MANAGEMENT CASE 2
  • 15. • 50 year old obese male, diabetes for 15 years, erectile dysfunction, tingling and numbness in toes, worse at night, absent ankle reflexes. On treatment with metformin, glyburide, basal and prandial insulin • BP 145/100, LDLc 125 mg/dl • HbA1c 11% CASE STUDY 3
  • 16. • Measure testosterone, LH and FSH in the morning (8 to 9 am) • Assess BP to confirm hypertension • Reduce LDLc with a statin • Commence treatment with pioglitazone, acarbose and a GLP-1RA • Replace testosterone if hypogonadal-testosterone is an insulin sensitizer and reduces adiposity MANAGEMENT CASE 3