Today s Goals 10/6/2017. New Frontiers in Diabetes Technology. Disclosures
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1 New Frontiers in Diabetes Technology Marie E. McDonnell, MD Director, Brigham and Women's Diabetes Program Division of Endocrinology, Diabetes and Hypertension Brigham and Women s Hospital Today s Goals Review the current technologies and practice guidelines for glucose monitoring Identify emergent technologies for insulin pump therapy Remote monitoring for patient tracking will this be useful? No disclosures Disclosures Marie E. McDonnell, MD Director, Brigham and Women's Diabetes Program Division of Endocrinology, Diabetes and Hypertension Brigham and Women s Hospital 221 Longwood Avenue Boston, MA Office:
2 Other statements: AACE ADA SFE (French society) Traditional Glucometers on the market Accuracy of SMBG meters Currently most Blood Glucose meters are still more accurate than continuous Interstitial Glucose meters FDA standards Oct 2016(ISO) 95% of readings must be within 15% of true 99% of readings must be within 20% This applies to low range as well For meters that do not meet this at the low end they can only claim accuracy down to proven level and anything lower reads low 2
3 Continuous Glucose Monitoring Components of CGM system Sensor inserted subcutaneously Transmitter Receiver Sensor technology All current sensors use glucose oxidase embedded in the sensor to generate electric signal Sensor and transmitter Time Delay All CGM devices measure interstitial (IS) fluid glucose (none are IV or IP) Time delay between plasma and IS glucose = 5 10 minutes Most relevant when rate is rapidly changing Predictive algorithms decrease difference between simultaneous POC and sensor values Diabetes Tech and Ther S2:3,
4 Professional Stand alone Blinded or unblinded Personal Stand alone Integrated Types of CGM Professional devices Personal devices G5 transmitter and receiver Fingerstick calibration required? YES The Freestyle Libre Flash Approved in Europe 2016, and 9/2017 in the US for personal use Fingerstick calibration required? NO 4
5 Current CGM/pump integrated devices (US) Medtronic 530G T:slim G4 Animas Vibe Threshold Suspend Pump programmed to suspend basal insulin infusion when a particular level of glucose is reached (such as 60 mg/dl) Alarm will trigger as well Insulin will stop infusing and restart after 2 hours Reduces risk of nocturnal hypoglycemia Next Generation: Predictive Low Glucose Suspend Study in type 1 children Less hypoglycemia with modest increase in glucose Diabetes Care 38:1197,
6 How accurate is CGM? Accuracy is proximity to true value, reported as Mean Absolute Relative Difference (MARD) Example: Simultaneous use of the sensor systems with comparison to q15 minute samples with GlucoScout venous bedside system Precision is reproducibility Sensor MARD % Enlite in pump use 13.6% Enlite in ipro2 11% SofSensor in ipro2 9.9% Dexcom G4 13% DexCom G5 9% These numbers are mostly from the companies as submitted to FDA, not from a comparison study Diabetes Tech and Ther 18:S DC 31:1160, 2008 J DST 3:1146, 2009 Is CGM an effective tool for diabetes management? Sample Printout: Dexcom 6
7 Question A 48 year old woman with type 1 diabetes for 25 years and Addison s disease has an A1c of 8.2% and progressive c fiber neuropathy and macular edema. She self manages with an insulin pump. Hypoglycemia is a problem for her overnight about 2 times per week despite adjusting her basal insulin doses and reducing alcohol intake in the evening. You suggest she consider using a continuous glucose monitor after education based on which of the following proven benefits in type 1 diabetes: A. Adults with A1c >7% have a greater reduction in A1c if they use a CGM vs. self monitoring of blood glucose alone. B. Unlike self monitoring of blood glucose, the improvement seen in A1c with CGM use is not accompanied by an increase in biochemical hypoglycemia. C. Similar benefit is achieved when the CGM device is worn 7 days of the month compared with 28 days of the month. D. Answer A and B All of the above. You suggest she consider using a continuous glucose monitor after education based on which of the following proven benefits in type 1 diabetes: A. Adults with A1c >7% have a greater reduction in A1c if they use a CGM vs. self monitoring of blood glucose alone. B. Unlike self monitoring of blood glucose, the improvement seen in A1c with CGM use is not accompanied by an increase in biochemical hypoglycemia. C. Similar benefit is achieved when the CGM device is worn 7 days of the month compared with 28 days of the month. D. Answer A and B All of the above. 7
8 CGM in type 1 DM pump users lowers hypoglycemia BMJ 343:d3805, 2011 Effectiveness of CGM in Type 1D: meta analysis Lowers A1C vs SMBG BMJ 343:d3805, 2011 What about patients not on a pump, and those with type 2 diabetes? (DIaMonD)Study of RT CGM in T1D and T2D on multiple daily injections of insulin (MDI) N= 158 randomized participants Mean age, 48 years [SD, 13]; 44% women Mean baseline HbA 1c level, 8.6% [SD, 0.6%] Median diabetes duration, 19 years [interquartile range, years]) 155 (98%) completed the study. In the CGM group, 93% used CGM 6 d/wk or more in month 6. Beck RW, et al. DIAMOND study group JAMA
9 Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes (DIaMonD) Does CGM (Dexcom G4) x 6 months improve BG in MDI patients? Reduction in A1c of 0.9% CGM vs. 0.4% controls Less time in hypoglycemia by 30% (23 fewer minutes per day) Less time >180 mg/dl by 83 minutes per day Adds to evidence that CGM improves time inrange, reduces highs and lows, and improves A1c Drawbacks to CGM Can be overwhelming for some patients I feel like a machine Alarms can be annoying Cost Comfort Accuracy Frustration- analog ( fast ) insulin is slow! Acetaminophen Acetaminophen is oxidized by glucose oxidase produces peroxide falsely elevates glucose reading Acetaminophen can interfere even with some meters Maahs et al., Diabetes Care 38:e158,
10 CGM results in normal volunteers after 1 g of acetaminophen Basu et al. Diab tech and ther 18:s2 43, 2016 New Additions! FreeStyle Libre Consumer version under FDA review Suspend before low: halt basal 30 min before predicted low, then restart Auto Mode adjusts basal q5 minutes Expected Spring 2017 Bionic Pancreas eta
11 Summary: who can benefit from CGM? Patients with type 1 diabetes continuous use With A1C <7.0% to maintain control with lower risk of hypoglycemia With A1C above goal, if they can use it on a daily basis Severe hypoglycemia unawareness Intermittent, retrospective CGM useful in certain situations Type 1 or type 2 diabetes on insulin therapy who want to get to goal without increasing hypoglycemia To identify glucose patterns that are difficult to capture: Concern for nocturnal hypoglycemia Dawn phenomena Post-prandial hyperglycemia What about on a population level? Tracking devices 11
12 Glucose data in EHR platforms Data does not replace the TEAM Patient Endocrinologists NP s and PA s Certified Diabetes Educator RD s PharmD s Exercise specialists Mental Health Specialists Community Health Workers/social service PCP s Other Specialist Physicians The Patient Office Staff 12
13 Summary There are many options available for professional and personal CGM. CGM improved outcomes in both pump and insulin injection users who use the device regularly. Most available data support use in type 1 diabetes New CGM algorithms are accurate enough for devices to replace frequent blood glucose monitoring. Barriers include cost and accuracy is still not optimal Diabetes population tracking and remote monitoring of glucose and adherence is available. Best practice for incorporation into usual care is still unknown. 13
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