CASE STUDIES IN DIABETES: Practical Pointers for Evidenced Based Practice Debbie Hinnen APN, BC-ADM, CDE, FAAN University of Colorado Health- Colorado Springs [email protected]Let’s think through some things • 56 y/o Hispanic male • Type 2 diabetes • 2 years on Metformin 1,000 mg BID • A1c increasing to 8.9% over past year • Further attempts at lifestyle change unsuccessful Case 1 Case 1 More background info : Electric co. lineman Well insured Copays $10-40 100% office visit attendance Declines injectables HTN, on lisinopril, Hyperlipidemia rosuvastatin Father CAD Objective findings : Obese, BMI 36.5 BP 142/84 Acanthosis nigricans ECG: normal A1c 8.9%, FPG 177 Cr 1.1 (eGFR >60) LDL 84, HDL 38, TG 256
• 56 y/o Hispanic male• Type 2 diabetes• 2 years on Metformin 1,000 mg BID• A1c increasing to 8.9% over past year• Further attempts at lifestyle change unsuccessful
Case 1
Virginia Valentine APRN-CNS, BC-ADM, CDE, FAADE
Case 1More background info:
Electric co. lineman
Well insured
Copays $10-40
100% office visit attendance
Declines injectables
HTN, on lisinopril,
Hyperlipidemia rosuvastatin
Father CAD
Objective findings:
Obese, BMI 36.5
BP 142/84
Acanthosis nigricans
ECG: normal
A1c 8.9%, FPG 177
Cr 1.1 (eGFR >60)
LDL 84, HDL 38, TG 256
Case Worksheet• Set goals:
• A1c• Glucose goals• Lipid goals
• Priorities• Patient preferences• Cost/Formulary
• Initiation and Follow up• SMBG/CGM-Frequency of contact• Adverse events• other
Treatment Recommendations Specify Multiple Individualized Goals for Patients With T2DM
Weight loss: ≥ 5%For overweight or obese patients, based on achievement of individualized health goals1,2
A1C: < 7.0%1 or ≤ 6.5%2
More stringent for some (eg, < 6.5%), if safely achieveable1,2
Higher (eg, < 8.0%) may be appropriate for others1,2
BP: < 140/901 mm Hg or < 130/802 mm HgLower targets (eg, < 130/80 mm Hg) may be appropriate for patients at high risk of CVD, if achievable without undue treatment burden1
Statin therapy according to CVD risk1,2
LDL-C based on CVD risk2
- High risk: < 100 mg/dL- Very high risk: < 70 mg/dL- Extreme risk: < 55 mg/dL
1. . Garber AJ, et al. Endocr Pract. 2017;23:207-238.
ADA: Standards of Medical Carein Diabetes – 2019 Diabetes Care
January 2019, 42 Suppl 1 S90-S102
ADA: Standards of Medical Carein Diabetes – 2019 Diabetes Care
January 2019, 42 Suppl 1 S90-S102
ADA: Standards of Medical Carein Diabetes – 2019 Diabetes Care
January 2019, 42 Suppl 1 S90-S102
Education Point: Complementary Agents Address Different Aspects of Disease Pathophysiology1-3,a
a Commonly used agents according to ADA guidelines.
• Finger tip formulary• https://lookup.decisionresourcesgroup.com/
• TriCare – Express Scripts• https://www.express-
scripts.com/static/formularySearch/2.9.2/#/formularySearch/drugSearch• Retail cost of drugs GoodRx
• https://goodrx.com
Case Worksheet• Set goals:
• A1c: 6.5-7%• Glucose goals: Fasting 80-110, After meals <140mg• Lipid goals: ~70 or 30% lower than baseline
• Priorities• Patient preferences: No Injections• Cost/Formulary: reasonable co-pays
• Initiation and Follow up: Add low dose SGLT2 on formulary or GLP• SMBG/CGM-Frequency of contact: 4x/d 2 days/week. Call/fax BG
1-2 weeks. F/U 3 months. A1C• Adverse events: GMI, UTI• Other: drink extra 12 oz water/day. Good hygiene. Stop if not
eating/drinking, procedures.
SGLT2 Inhibitors Improve Glycemic Control When Added to Metformin Monotherapy
-0.8
-0.5-0.6
-1.0
-0.8
-0.6
-0.4
-0.2
0.0
PBO
-sub
trac
ted,
%
Δ A1C1,a
a Data do not represent head-to-head comparisons; similar duration ( 6 months) and baseline values across trials.
1. US FDA. Drugs@FDA. http://www.accessdata.fda.gov/scripts/cder/daf/.2. Rosenstock J, et al. Diabetes Care. 2015;38:376-383.
3. Forst T, et al. Diabetes Obes Metab. 2016 Dec 23. [Epub ahead of print].
58%, 41%, and 39% of patients achieved A1C < 7%, respectively1
CANA (300 mg) DAPA (10 mg) EMPA (25 mg)
-40
-18
-29
-75
-50
-25
0
PBO
-sub
trac
ted,
mg/
dL
Δ FPG1,a
-50
-70-75
-50
-25
0
BL-s
ubtr
acte
d, m
g/dL
Δ 2-h PPG1,2,a
All significant vs PBO
All significant vs PBO
EMPA also decreases PPG when added to MET monotherapy3
Be a Hero, GGo the extra mile for your patients
Case 264 y/o FemaleType 2 diabetes for 14 yrs on Metformin 1,000 BID and Sitagliptin 100 mg dailyRecently hospitalized for ACS / stentDiastolic dysfunction by echoPrior A1C’s stable at 7-7.5%A1C currently at 8.4%Cardiologist told her to seek your counsel about improving metabolic control
Case 2
More background info:
Grade school teacherWell insuredNo copaysCAD s/p MI; HTN, hypothyroid, breast caAtorvastatin, quinapril, tamoxifen, ASAOpen to injections
Objective findings:
Obese, BMI 32.1
BP 118/76
ECG: old MI
A1c 8.4%, FPG 188
Cr 1.4 (eGFR 44)
LDL 67, HDL 54, TG 123
Case Worksheet• Set goals:
• A1c• Glucose goals• Lipid goals
• Priorities• Patient preferences• Cost/Formulary
• Initiation and Follow up• SMBG/CGM-Frequency of contact• Adverse events• other
Less motivated, nonadherent, poor self-care capabilities
Usually not modifiable
Potentiallymodifiable
More stringent Less stringent Hazard ratio (95% CI)
CANVAS Program EMPA-REG OUTCOME 1.00.5 2.0
Favors PlaceboFavors SGLT2i
Nonfatal myocardial infarction
Progression to macroalbuminuria*
Renal composite*
Hospitalization for heart failure
CV death, nonfatal myocardial infarction, or nonfatal stroke
CV death
Nonfatal stroke
Key Outcomes in the CCANVAS Program and EMPA-REG OUTCOME
*CANVAS Program endpoints comparable with EMPA-REG OUTCOME.
0.25
Zinman Bet al. N Engl J Med. 2015 ;373(22):2117-2128.Wanner K et al. N Engl J Med. 2016;375(4):323-334.Neal et al N Eng J Med. 2017. Published June 12. doi:10.1056/NEJMoa1611925
c Not FDA-approved for weight loss. Zaccardi F, et al. Diabetes Obes Metab. 2016;18:783-794.
P < .05 for all DBP changes vs PBO (-1.5 to -2.0 mm Hg)
7.7
3.52.7
1.5 1.91.2
0
2
4
6
8
10LDL-C Change
Mea
n Ch
ange
vs P
BO, m
g/dL
Significant increase with CANA vs PBO and all treatment groups
Case 3• 67 year old Latino male• 8 year diagnosis of T2DM• Retired public high school teacher; MCare and Humana supplement• BMI 38.3kg/m• BP 142/92• A1C 8.9% Prior A1C’s 7-7.6%• Current DM Meds
• +pedal pulses, + reflexes,+ vibratory and monofilament
• Labs:• -FPG 135mg• Lipids
• LDL 95mg/dl• HDL 43 mg/dl• TG 197mg/dl
• LFT – WNL• GFR ->60• TSH WNL
Case Worksheet• Set goals:
• A1c• Glucose goals• Lipid goals
• Priorities• Patient preferences• Cost/Formulary, Use MMIT, finger tip formulary…..
• Initiation and Follow up• SMBG/CGM, Frequency of contact• Adverse events, patient education• Other
GLP-RAs vs SGLT2s (Invokana) 12 month A1Cs
a Meta-analysis of 34 studies of 14,464 participants, RCTs were 24-32 weeks long, background therapies of MET, SU, TZD, or insulin alone or in combination.b All P < .05 vs PBO.c Agents not approved for weight loss at doses indicated for diabetes management. Htike ZZ, et al. Diabetes Obes Metab. 2017;19:524-536.
Efficacy of GLP-1 RAs in Combination With Other Agentsa
-0.7
-0.6
-1.2-1.1
-1.2
-1.5
-1.0
-0.5
0.0A1C Change
Mea
n Ch
ange
vs P
lace
bo, %
b
-16.7-13.1
-33.5-32.0
-35.5
-50
-40
-30
-20
-10
0FPG Change
Mea
n Ch
ange
vs P
lace
bo, m
g/dL
b
-1.7
-0.8
-2.0
-1.5 -1.6
-3
-2
-1
0Weight Change
Mea
n Ch
ange
s Pla
cebo
, kgb
cEXN BID LIXI LIRA EXN ER DULA
SGLT2 Label Precautions: Recommendations for Reducing Risks
a Assess blood ketones rather than urinary ketones.b Potential consequence of intravascular volume contraction.c Predisposing factors include pancreatic insulin deficiency, caloric restriction, alcohol abuse.
1. Drugs@FDA. http://www.accessdata.fda.gov/scripts/cder/daf/.2. Monami M, et al. Diabetes Res Clin Pract. 2017;130:53-60.
3. Handelsman Y, et al. Endocr Pract. 2016;22:753-762.
Elevated LDL-C1
Monitor, treat as appropriate
Lower limb amputation (eg, toe, mid-foot, leg below knee)1
2-fold risk increase with CANA, possibly higher risk with ERTU
Consider predisposing factors before starting (eg, prior amputation, PVD, neuropathy)
Discontinue temporarily in cases of fluid loss/low fluid intake
Monitor – discontinue SGLT2i and treat if injury occurs
Hypotension1,b
Assess, correct volume status for individuals at higher risk (eg, elderly, with renal impairment, on diuretics)
Monitor
Ketoacidosis1-3
Low risk when properly prescribed2
Consider as a possible diagnosis, assessa if signs and symptoms, regardless of BG level,1,3 and treat if suspected1,3
To minimize risk• Stop before invasive procedures, stressful activity2
• Avoid excessively decreasing or stopping insulin3
• Consider predisposing factors before starting1,c
Case 4
• 79 year old African American man• Long standing T2DM ~ 20 years• Retired naval officer and postal worker. Insurance: TriCare for Life• Married, 3 adult children• Requested appt due to hypoglycemia• A1C 8.3%• Current DM meds
Total 194mg/dl• LFT- WNL• SrCr -1.6mg/dl GFR 49.7 ml/min
Case Worksheet• Set goals:
• A1c• Glucose goals• Lipid goals
• Priorities• Patient preferences• Cost/Formulary, Use MMIT, finger tip formulary…..
• Initiation and Follow up: Ultra long basal, meal time insulin, FRC Soliqua or Xultophy?• SMBG/CGM, Frequency of contact• Adverse events, patient education• Other
Clinical Characteristics of Basal Insulins vs U-100 Glargine in T2DM
Statistically significant differences indicated by arrows.
1. Rys P, et al. Acta Diabetol. 2015;52:649-662.2. Rosenstock J, et al. Diabetes Obes Metab. 2015;17:734-741;
3. Ritzel R, et al. Diabetes Obes Metab. 2015;17:859-867.4. Zhang XW, et al. Acta Diabetol. 2018 Feb 8. [Epub ahead of print].
5. Marso SP, et al. N Engl J Med. 2017;377:723-732.
See Resource section for more recommendations on SMBG and CGM use in T2DM.
1. Devices@FDA. https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/. 2. Fonseca VA, et al. Endocr Pract. 2016;22:1008-1021.
3. Peters AL, et al. J Clin Endocrinol Metab. 2016;101:3922-3937.4. Danne T, et al. Diabetes Care. 2017;40:1631-1640.
Blood Glucose MonitoringCGM Catches Glycemic Excursions that SMBG May Miss1
Some CGM Systems Can Replace SMBG1
As of February 2018, the following systems meet these criteria1:
Abbott FreeStyle Libre Flash Dexcom G5 Mobile CGMxcom G5 Mobile CGM
Case 5 Gestational DM
• 23 y/o G2 P1, • 29 weeks gestation• 2 year old son at home, Zachary. • Tiffany cleans houses part time, • Boy friend, Dan, works at McDonalds.• Medicaid
Gestational Case
• More Background• Completed GDM classes, • Testing BG 3-4 times/day• Following meal plan as best she
can. • 2 Food Banks most weeks• No diabetes meds• Grandmother on insulin, had toe
