Role of SMBG in Non-Insulin Treated Subjects with T2DM Richard M. Bergenstal, MD

Transcription

1 Role of SMBG in Non-Insulin Treated Subjects with T2DM Richard M. Bergenstal, MD International Diabetes Center and Health Services University of Minnesota Minneapolis, MN

2 We have lots of choices! Roche Menarini HDI Hypoguard BD Bayer LifeScan Abbott International Diabetes Center

3 E. Ipp M. Davidson International Diabetes Center

4 SMBG Improves Glycemic Control in Non Insulin Insulin-Treated Patients Meta-analysis of 8 RCTs involving 1307 patients found a link between SMBG and lower HbA 1C Kwon, 2004 Davidson, 2004 Guerci, 2003 Schwedes, 2002 Jaber, 1996 Muchmore, 1994 Estey, 1990 Fontbonne, 1989 Fixed effects Random effects WMD (95% CI) (-1.35,-0.33) (-1.01, 0.55) (-0.51, -0.05) (-0.78, -0.14) (-2.79, -0.31) (-2.07, 0.69) (-0.85, 0.05) 0.14 (-0.56, 0.84) (-0.54, -0.23) (-0.63, -0.21) Favors SMBG Favors non-smbg Difference between groups in HbA 1C reduction Adapted with permission from Sarol JN et al. Curr Med Res Opin. 2005;21:

5 SMBG Users Had >2-Fold Reduction in HbA 1C From Baseline vs Non-SMBG HbA 1C Reductions in SMBG and Non-SMBG Groups: Sarol et al Meta-Analysis HbA 1C Reduction (%) Baseline Effect of Non-Insulin Therapy Additive Effect of SMBG Non SMBG-Based Therapy Intervention Groups SMBG (Random-Effects Model) Sarol JN et al. Curr Med Res Opin. 2005;21: International Diabetes Center

6 Meta-Analysis of 5 RCTs Comparing SMBG to Control Groups Welschen LM et al. Diabetes Care. 2005;28: International Diabetes Center

7 Meta-Analysis of 5 RCTs Comparing SMBG to Control Groups Study N WMD (95% CI) WMD (random) 95% CI Davidson 2005 Fontbonne 1989 Guerci 2003 Muchmore 1994 Schwedes (-0.98, 0.58) 0.14 (-0.69, 0.97) (-0.63, -0.17) (-2.07, 0.69) (-0.79, -0.13) Total (-0.56, -0.21) Overall effect was a significant decrease of 0.39% in HbA 1C for SMBG compared with control (95% CI: to -0.21, P<.0001) Favors SMBG Favors Control Welschen LM et al. Diabetes Care. 2005;28: International Diabetes Center

8 International Diabetes Center

9 T2DM : Self Monitoring of Blood Glucose (SMBG) Mean differences (95% CI) in changes of HbA1c for SMBG & no SMBG Study SMBG Control* WMD (Fixed) n mean n mean 95% Cl Fontbonne, (-0.56, 0.84) Muchmore, 1994 Jaber, 1996 Schwedes, 2002 Guerci, (-2.07, 0.69) (-3.86, -0.34) (-0.79, -0.13) (-0.51, -0.05) Davidson, (-0.98, 0.58) Farmer, (-0.33, 0.03) Total (-0.37, -0.12) * Control = no SMBG Z=3.74 (p=0.0002) Poolsup et al Diabetes Technology and Therapeutics, 2008

10 T2DM : Self-monitoring of Blood Glucose (SMBG) Mean differences (95% CI) in changes of HbA1c for SMBG & no SMBG RCTs SMBG Control* WMD (Fixed) n mean n mean 95% Cl Total n= (-0.37, -0.12) Z=3.74 (p=0.0002) Total n= (-0.41, -0.14) Utilising SMBG to modify treatment Z=3.98 (p<0.0001) Total n= (-0.32, -0.08) NOT using SMBG to modify Rx Z=1.15 (p=0.25) * Control = no SMBG SMBG useful only if results used to adjust therapy RCTs needed with standard protocol for SMBG intervention Poolsup et al Diabetes Technology and Therapeutics, 2008 Poolsup et al 2008

11 Systematic Reviews/Meta-analyses of Randomised Controlled Trials Insulin naïve T2DM: Summary of studies Meta analyses of change in HbA1c: SMBG vs no SMBG Randomised Control Trials (n) WMD 95% CI 2000 Coster (4) 2005 Sarol (8) (-0.61,-0.010) (-0.63,-0.21) 2005 Welschen (5) (-0.56,-0.21) 2006 Jansen (13) 2008 Poolsup (7) (-0.70,-0.07) (-0.37,-0.12) Favours SMBG

12 Association Between SMBG Frequency and Glycemic Control Large cohort study (N=24,312) of the Northern California Kaiser Permanente Diabetes Registry Compared HbA 1C in patients testing at or above a defined SMBG frequency vs below the defined frequency Defined frequency Type 1 Type 2 + insulin Type 2 + OAD Type 2 + diet and lifestyle 3 times daily Daily Daily Any SMBG use OAD=oral antidiabetic drug. Karter AJ et al. Am J Med. 2001;111:1-9. International Diabetes Center

13 SMBG Testing At or Above Defined Frequencies Associated With Better Glycemic Control Independent of Diabetes Type or Therapy HbA 1C (%) All Comparisons P= Type 1 Type 2 + Insulin *Compared any SMBG frequency with no SMBG Type 2 + OAD Karter AJ et al. Am J Med. 2001;111: Type 2 + Lifestyle* Less than defined frequency At or above defined frequency HbA 1C reductions: Type 1: -1.0% T2 + Insulin: -0.6% T2 + OAD: -0.6% T2 + Lifestyle: -0.4% International Diabetes Center

14 Self monitoring and glycemic control from Kaiser Permanente Northern California an integrated health care system Longitudinal study of New user cohort (patients starting SMBG) 16,091 Ongoing user cohort (prevalent users) 15,347 International Diabetes Center

15 Karter, A et al. International Diabetes Center

16 Karter, A et al. International Diabetes Center

17 International Diabetes Center

18 International Diabetes Center

19 T2 DM : Efficacy of self-monitoring of BG (SMBG) ESMON Study Prospective RCT in newly diagnosed T2DM (184, 60% M), age <70 yr to assess effect of SMBG versus no-smbg (control) over 12 months on HbA1c, psychological indices, weight, hypos etc Methodology : Structured education for all; SMBG group advice on SMBG monitoring : SMBG x4 fasting & x4 postprandial per week Results: SMBG group ~66% carried out >80% of requested tests Analysis of co-variance for effect of SMBG (adjusted for sex) 9 HbA1c (%) 36 BMI (kg/m 2 ) Variable βcoefficient* (SE) p value Time (months) SMBG (96) No SMBG (88) Depression 6.05 (2.4) 0.01 Anxiety 5.86 (3.2) 0.07 Positive 4.16 (2.9) 0.15 well being Energy (2.8) 0.77 * Corresponds to % change O Kane et al BMJ 2008

20 NO If you just test International Diabetes Center

21 Clinical Recommendations Clear goals agreed on by patients International Diabetes Center

22 Diabetes Goals Triple Goal -- A1C<7, BP <130/80, LDL<100 International Diabetes Center

23 A1C, BP & LDL <7, <130/80, < : % 12% International Diabetes Center

24 Efficacy of Exenatide QW Through Week 52 (Evaluable Population) A1C FPG 0.0 Baseline = 8.3% 0 Baseline = 172 mg/dl A1C (%) % FPG (mg/dl) mg/dL Time (weeks) Time (weeks) 52-wk Evaluable Population (N=120); LS Mean (SE) International Diabetes Center

25 Efficacy of Exenatide QW Through Week 52 (Evaluable Population) Body Weight (kg) Body Weight Baseline = 103 kg kg Time (weeks) Body Weight (kg) Body Weight & A1C 21% 77% 2% 1% A1C (%) 52-wk Evaluable Population (N=120); LS Mean (SE) International Diabetes Center

26 Patients achieving ADA goals at Week 52 (Evaluable Population) 80 Baseline Endpoint 71% 71% ADA goals: A1C <7.0% SBP <130 mm Hg LDL <100 mg/dl % at Goal % 49% 39% 52% 36% % 0% A1C SBP A1C + SBP SBP + LDL 0% A1C + SBP + LDL Evaluable Population (N=120); Mean (SE) International Diabetes Center

27 Diabetes Goals Triple goal A1C<7 & BP <130/80 & LDL<100 Glycemia plus goal A1C <7 & Wt Loss (no gain) & no hypoglycemia Glycemia A1C <7, SMBG in goal > 50%, no serious hypoglycemia International Diabetes Center

28 Diabetes Goals Triple goal A1C<7 & BP <130/80 & LDL<100 Glycemia plus A1C <7 & Wt Loss (no gain) & no hypoglycemia Glycemia A1C <7, SMBG in goal > 50%, no serious hypoglycemia International Diabetes Center

29 Estimated Average Glucose - eag International Diabetes Center

30 A1C to Estimated Average Glucose - eag

31 Design of Intensive Glycemia Intervention Group A1C Targets Intensification Thresholds A1C > 50% of SMBG Results Intensive < 6% > 5.9% Fasting > 100 (5.6) OR 2 Hr PP > 140 (7.8) Setting Glycemic Target 3 part 1.A1C (eag) 2.SMBG (premeal, ppg) -50% 3.Monitor and avoid severe hypoglycemia 4.(Minimize glycemic excursions) Even if the A1C not available Rx was reduced in the presence of significant hypoglycemia. International Diabetes Center

32 Clinical Recommendations Clear goals agreed on by patients Professionals advising about SMBG should give consistent message about when to test and how to interpret readings Teach patients how to respond to highs and lows Teach difference between individual readings and patterns Explain the connection between SMBG and HbA1c International Diabetes Center

33 What is your current treatment? Not on Insulin 3 times/day 2-33 times/week On Insulin Depends on the # of injections

34 Step 3: Record Glucose Values Target: mg/dl Date Breakfast Lunch Supper Bedtime 8 A BG Med BG 12N BG On Meal Plan Only Assess SMBG patterns what needs action? Med BG 5P BG Med BG 10P BG Med

35 Adjusting Meal Plan & Exercise Based on SMBG Treatment Goals Fasting and Premeal mg/dl Postmeal < 160 mg/dl SMBG 3 times / day 3 days/ week Every 2-4 weeks patient looks at SMBG If >50% of SMBG above target at a give time Adjust meal plan (reduce number of CHO s Increase exercise (# of steps or time walking) Before the SMBG elevation pattern BRK sn Lunch sn Dinner Bed sn

36 Adjusting Meal Plan & Exercise Based on SMBG Treatment Goals Fasting and Premeal mg/dl Postmeal < 160 mg/dl SMBG 3 times / day 3 days/ week Every 2-4 weeks patient looks at SMBG If >50% of SMBG above target at a give time Adjust meal plan (reduce number of CHO s Increase exercise (# of steps or time walking) Before the SMBG elevation pattern BRK sn Lunch sn Dinner Bed sn

37 Clinical Recommendations Professionals advising about SMBG should give consistent message about when to test and how to interpret readings Clear goals agreed on by patients Teach patients how to respond to highs and lows Teach difference between individual readings and patterns Explain the connection between SMBG and HbA1c International Diabetes Center

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39 :00 AM 2:00 AM 4:00 AM 6:00 AM 8:00 AM 10:00 AM 12:00 PM 2:00 PM 4:00 PM 6:00 PM 8:00 PM 10:00 PM 12:00 AM

40 Step 4: Look for Glucose Patterns Where are your sugars above or below your glucose targets?

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46 Glucose Monitoring - Principles Everyone with diabetes should test their glucose if they use the SMBG data Know your glucose targets - before and after meals Keep records - log book or computer Look for patterns of high or low blood sugars Correct an abnormal pattern call you doctor or diabetes educator or make the change yourself 1 st Correct low glucoses 2 nd Correct high glucoses by adjusting food, exercise or medications Compare your blood sugars with your A1C and estimated Average Glucose

47 Numerous approaches have been tried to improve care but, with one exception, most have been ineffective. Disease management (reminders, lab info, specific treatment recommendations) ineffective Only effective interventions include: Use of specially trained staff (nurses or pharmacists), under appropriate supervision, with authority to make medication changes as long as the changes fell within approved algorithms Davidson MB. Diabetes Care, 32: 370, 2009 Davidson MB. Curr Diabetes Rev 3: , 2007

48 We must shift or thinking of SMBG from Self Monitoring of Blood Glucose to Self Management of Blood Glucose International Diabetes Center