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Monitoring and Management Jennifer Danielson, PharmD, MBA, CDE Clinical Assistant Professor University of Washington School of Pharmacy Learning Objectives 1. 2. 3. 4. 5. 6. Identify patients who would benefit from self-monitoring of blood glucose (SMBG). Recommend how often patients should SMBG. Interpret readings from SMBG. Apply results of SMBG to recommending appropriate drug therapy (e.g. pattern management). Relate results from glucose meters to HbA1c results. Discuss use of continuous glucose monitoring (CGM) and interpret CGM trend results. Treatment Guidelines Healthy eating Being active Monitoring Taking medication Problem solving Healthy coping Reducing risks Glycemic Goals 10.0 ADA A1c Goal < 7% •Pre-prandial 80-130 mg/dL •Post-prandial (PPG) < 180mg/dL 9.0 8.0 7.0 6.0 AACE A1c Goal < 6.5% •Fasting plasma (FPG) < 110 mg/dL •PPG < 140 mg/dL Inpatient setting: Acute care 140-180mg/dL Upper range of normal Critical care 110-140mg/dL A1c 5.0 ADA. Diabetes Care 2013: 36 (supp 1): S1-S10. AACE. Endocr Pract 2011; 17(supp 2): 1-53. ADA Standards for SMBG • SMBG for patients on multiple insulin injections or pumps – – – – – – Prior to meals/snacks Occasionally post-prandial Bedtime Prior to exercise Hypoglycemia Prior to critical tasks (such as driving) • SMBG is a useful guide for less frequent insulin injections and non-insulin therapies • When prescribing SMBG, ensure patients receive ongoing instruction & evaluation, plus follow-up to adjust therapy ADA. Diabetes Care 2013: 36 (supp 1): S1-S10. ADA Standards for SMBG • CGM is a useful tool to lower A1c in adults ≥25yo on multiple injections per day or using a pump (Type 1) • CGM may be useful for people younger than 25yo • CGM is a supplemental tool for patients with hypoglycemia unawareness or frequent hypoglycemia ADA. Diabetes Care 2013: 36 (supp 1): S1-S10. AACE Standards for SMBG In general, SMBG recommended for all patients with diabetes. Patients using insulin: Patients not using insulin: • • • ≥2 times per day qnd before injections More often, if not at A1c goal or hypoglycemia Recommended but the frequency of testing should be individualized CGM is a good for obtaining better A1c control and for patients with hypoglycemia AACE. Endocr Pract 2011; 17(supp 2). Randomized Trials in Type 2 Patients Not Using Insulin Study Design Fontbonne et al. 19961 Randomized Allen et al. 19902 Randomized (n) Duration Results 68 = SMBG 72 = urine 68 = control 6 months •50% compliance w/twice QOD •A1c reduction 0.5% 0.1% (not significant) 27 = SMBG 27 = urine 6 months •87% compliance w/before meals QOD •A1c reduction 2% both groups (not significant) •25% compliance w/six Muchmore et al. Randomized 12 = SMBG* 40 weeks times daily 3 1994 = control Farmer A, Wade A, Goyder E, 11 et al. Impact of self monitoring of blood glucose •A1c reduction 1.5% & in the management of patients*more with intensive non-insulin treated diabetes:0.8% open group (notparallel significant) nutrition counseling randomised trial. BMJ.2007; 335:132. N=453, 3etyears, mean A1c 7.5%, reduction60.17% •100% compliance w/6 Schwedes al. Randomized 113A1c = SMBG* months(not significant) 20024 times per day •A1c reduction 1% & 0.5% (not significant) 110 = control *more intensive nutrition counseling Guerci et al. 20035 Randomized Davidson et al. 20056 Randomized 345 = SMBG 344 = control 6 months* 43 = SMBG 45 = control 6 months (but >40% drop out in both groups) (both received diet counseling/mgmt) •Compliance unclear w/6 times per week •A1c reduction 0.9% & 0.5% (significant) •45% compliance w/before and after meals 6 days/wk •A1c reduction 0.8% & 0.6% (not significant) Non-Randomized Trials in Type 2 DM Using Insulin Not Using Insulin • Non-randomized trials • At least 8 trials, consistently showing – Over dozen studies, most relationship between showing no relationship between SMBG and A1c reduction monitoring and A1c reduction but not all randomized, Fullerton B, flaws et al. 2SMBG in patients Type diabetes who arehave – with Those that2 show difference many with with uneven treatment or using Cochrane Review: flaws Jan 2012. • not Still, A1c insulin. reduction 1 self-selection 12 trials 0.16% included meta analysis, N=3259, A1c reduction 0.3% range: to in0.88% Meta-analyses & Reviews (significantatin6mos all cases) (significant but not at •12mos) – Conflicting results but suggest that SMBG may be helpful in gaining better glycemic control – Significant reduction in A1c of (depending on time measured and statistical model used)2,3 1McAndrew, et al. Does patient blood glucose monitoring Improve diabetes control? Systematic Review. Diabetes Educator 2007 33: 991. 2Welschen, Bloemendal, Nijpels, et al. SMBG in patients with Type 2 diabetes not using insulin: a systematic review. Diabetes Care 28:1510-1517, 2005. 2Ramachandra, Ellis. SMBG in insulin-requiring type 2 diabetes. Diabetes Tech and Thera 2008;10:S1. 3Fullerton B, et al. SMBG in patients with Type 2 diabetes who are not using insulin. Cochrane Review: Jan 2012. SMBG in Type 2 Diabetes Pre-requisites Consequences Awareness •Diagnosis •Knowledge •Skills •Achieve glycemic control Understanding in Cultural Context •Reduce complications Interpretation •Improved quality of life •Less symptom distress •Improved patient attitudes Response MK Song, TH Lipman. Concept analysis: Self-monitoring in type 2 diabetes mellitus. Intnl Jour Nurs Stud. 45 (2008) 1700-1710. ADA Standards for A1c Testing Patient at goal: A1c at ≥2 times/yr Patient not at goal: A1c quarterly Use point of care technology to provide opportunity for timely changes http://wilburnmedicalusa.com/-c-0/siemens-dca-vantage-analyzer-p-149274?clid=CJK59qb7k8MCFVSSfgodnnkASQ Cases 1 and 2 Pattern Management Applying results of home blood glucose monitoring to drug therapy management. • • • Recognizing highs/lows that occur in patterns. Adjusting drug therapy to address the patterns of highs and lows seen. Follow-up on results for changes made. Lower Fasting blood glucose Postprandial blood glucose Glucose Triad A1c Higher Effect on Blood Glucose Basal drugs Fasting Bolus drugs Postprandial • • • • • Short and rapid acting insulin Metformin TZDs Sulfonylureas Intermediate and longacting insulin – Lantus® – Levemir® – NPH – – – – • • • • • Regular Humalog® Novolog® Apidra® Sulfonylureas Meglitinides Acarbose DPP-4 inhibitors GLP-1 analogues Effect on Blood Glucose Basal drugs Fasting Bolus drugs Postprandial • • • • • Short and rapid acting insulin Metformin TZDs Sulfonylureas Intermediate and longacting insulin – Lantus® – Levemir® – NPH – – – – • • • • • Regular Humalog® Novolog® Apidra® Sulfonylureas Meglitinides Acarbose DPP-4 inhibitors GLP-1 analogues Slide adapted from Zane Brown, MD Professor UW Medicine Case Example B 104 106 118 120 126 122 L 146 136 132 D 110 HS 176 164 126 222 148 138 134 116 212 Case Example B 104 106 118 120 126 122 L 146 136 132 D 110 HS 176 164 126 222 148 138 134 116 212 Case Example B 110 98 118 112 96 102 L 126 72 110 120 64 102 D 118 56 126 100 HS 196 202 188 164 212 194 Estimated Average Glucose (eAG) http://professional.diabetes.org/GlucoseCalculator.aspx Formula: 28.7 x A1C – 46.7 = eAG eAG (CI 95%) 97 126 154 183 212 249 269 298 (76-120) (100-152) (123-185) (147-217) (170-249) (192-282) (217-314) (240-347) A1c •wide CIs •weighted most to last 30 days 5% 6% 7% 8% 9% 10% 11% 12% Diabetes Care 2008. 31:1473-1478 What if you saw it like this? 250 200 150 100 50 0 SD Actual Download Print-Out Print out image from: CliniPro by Numedics Cases 3 through 5 Continuous Glucose Monitoring • Alternative site testing – Measures subcutaneous fluid not blood – ~10 minute delay in results – Must know the caveats with hypoglycemia • Continuous Glucose Monitoring Systems – – – – Medtronic Guardian REALtime CGMS Dexcom SEVEN Minimed Paradigm Abbott FreeStyle Navigator Daily Use • Glucose change is gradual. • Glucose is increasing moderately. • Glucose is increasing rapidly. • Glucose is decreasing moderately. • Glucose is decreasing rapidly. CGM Interpretation • What should the patient do to respond? 72 mg/dL 11:10 am CGM Interpretation • What should the patient do to respond? 72 mg/dL 11:25 am CGM Interpretation • What should the patient do to respond? 118 mg/dL 12:20 pm CGM Interpretation • What should the patient do to respond? 196 mg/dL 2:02 pm