Summary: American Association of Clinical Endocrinologists Consensus Statement Continuous Glucose Monitoring AACE CGM Task Force Endocrine Practice, Vol 16, No 5, pp 730 – 744, Sept/Oct 2010

Objective Provide a summary of the AACE Consensus Statement on CGM published in the Endocrine Practice, Sept/Oct 2010 edition

AACE CGM Task Force Authors AACE members and CGM thought-leaders Thomas C. Blevins, MD, FACE Bruce W. Bode, MD, FACE Satish K. Garg, MD George Grunberger, MD, FACP, FACE Irl B. Hirsch, MD Lois Jovanovic, MD, MACE Elizabeth Nardacci, FNP, CDE, BC-ADM Eric A. Orzeck, MD, FACP, FACE Victor L. Roberts, MD, MBA, FACP, FACE William V. Tamborlane, MD Objective of Consensus Statement: Provide a credible source of opinions and recommendations on how to best use and succeed with CGM therapy

“ Continuous glucose monitoring (CGM) technology is not only novel, but it can improve the lives of patients who incorporate it into a comprehensive diabetes management plan. ” -- AACE Consensus Statement on CGM 2010

AACE Reinforces CGM Category Names & Definitions OwnershipHealthcare professionals, clinics, hospitals Typically owned by patients Length of wear3 – 5 days per evaluation; Episodic, intermittent use On-going use by patients Display of glucose data “ Blinded ” or “ masked ” data to allow for unbiased assessment of glucose control Continuously displays glucose values and provides alarms that allow for immediate therapeutic adjustments Data analysisRetrospective review by providers “ Real-time ” review by patients Patient TrainingMinimal training and set-up timeRequires education on glucose level targets and alarm thresholds Professional CGMPersonal CGM

Medtronic Offers Comprehensive CGM Solutions Professional CGMPersonal CGM Paradigm ® REAL-Time Revel TM System Guardian ® REAL-Time System iPro TM Professional CGM

AACE Reviews Clinical Evidence on CGM Professional CGMPersonal CGM Can reduce A1C in adult and pediatric patients with type 1 diabetes and A1C > 7.0%, without increasing hypoglycemia in adult and pediatric patients 6,7 In adults and adolescents, more consistent use predicts successful A1C reductions 7 Can reduce hypoglycemia in well-controlled adult and youth patients (A1C<7.0%) with type 1 diabetes, without increasing A1C 8 Can identify undetected hyperglycemia in pregnant women – Professional CGM identified minutes/day of undetected hyperglycemia in studies 1,2,3 Effective in improving maternal glycemic control, infant birth weight, and macrosomia risk in women with type 1 or type 2 diabetes 4,5 1 Jovanovic L. The role of continuous glucose monitoring in gestational diabetes mellitus. Diabetes Technol Ther. 2000;2(Suppl 1):S67-S71. 2 Yogev Y, Chen R, Ben-Haroush A, Phillip M, Jovanovic L, Hod M. Continuous glucose monitoring for the evaluation of gravid women with type 1 diabetes mellitus. Obstet Gynecol. 2003;101: Chen R, Yogev Y, Ben-Haroush A, Jovanovic L, Hod M, Phillip M. Continuous glucose monitoring for the evaluation and improved control of gestational diabetes mellitus. J Matern Fetal Neonatal Med. 2003;14: Murphy HR, Rayman G, Duffield K, et al. Changes in the glycemic profilies of women with type 1 and type 2 diabetes during pregnancy. Diabetes Care. 2007;30: Murphy HR, Rayman G, Lewis K, et al. Effectiveness of continuous glucose monitoring in pregnant women with diabetes:randomised clinical trial. BMJ. 2008;337:a Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Ramborlane WV, Beck RW, et al. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008;359: Chase HP, Beck RW, Xing D, et al. Continuous glucose monitoring in youth with type 1 diabetes: 23-month follow-up of the Juvenile Diabetes Research Foundation continuous glucose monitoring randomized trial. Diabetes Technol Ther. 2010;12: Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes Care. 2009;32:

AACE Supports Broad Range of Ideal Candidates for CGM Patient selection and usage: Patients with type 1 or type 2 diabetes who: are not at their A1C target. have recurrent hypoglycemia or hypo unawareness. All pregnant women with type 1 diabetes. CGM may also facilitate treatment adherence for women with type 2 diabetes or insulin-requiring gestational diabetes. Intermittent use may be useful for youth with type 1 diabetes who are changing their diabetes regimen or are experiencing nocturnal hypo, dawn phenomenon, hypo unawareness, or post-prandial hyperglycemia. Recommended to use Professional CGM on an episodic basis. Professional CGM

AACE Supports Broad Range of Ideal Candidates for CGM Patients with type 1 diabetes with: Hypoglycemia unawareness or frequent hypoglycemia. A1C above target or with excess glucose variability. Requires lowering A1C without increased hypoglycemia. During preconception and pregnancy. Children and adolescents who have met A1C targets (<7.0%) and who may be highly motivated. Youth with A1C levels ≥7.0% and are able to use the device on a near-daily basis. The following might be good candidates and a trial period of 2-4 weeks is recommended: Youth who frequently monitor their blood glucose levels. Committed families of young children (younger than 8 years) especially if the patient is having problems with hypoglycemia. Personal CGM

AACE Explains the CPT Codes Available for CGM Covers sensor placement, hook-up, calibration of monitor, patient training, removal of sensor and printout of report. Modifier (-25) must be appended to the evaluation and management code if this code is billed with code Professional CGM can be billed on either the day the device is inserted and monitoring is initiated, or when the sensor is removed. Personal CGM can be billed at first patient training and subsequently when data is downloaded. CPT Code 95250: Data Collection Does not have to take place in the context of a face-to-face meeting. If billed at a time separate from another evaluation and management service such as an office visit, no additional modifier is needed. CPT Code 95251: Data Interpretation *Neither code can be billed more than every 30 days.

AACE Provides Status of CGM Reimbursement Both codes and cannot be billed more than every 30 days. Many large, private US health plans provide coverage for both Personal and Professional CGM, especially for patients with type 1 diabetes and those with severe hypoglycemia. The U.S. Centers for Medicare and Medicaid Services presently only have reimbursement for Professional CGM. “ With diligent administrative management and follow-up, it is possible to achieve good coverage for Professional CGM. ”

AACE Provides Guidance on Clinic Implementation Professional CGMPersonal CGM Patient follow-up requirements and resources Technology requirements and staff responsibilities for office implementation Minimal patient training an set-up time requirements “ Consider selecting a dedicated practice champion to manage the process and equipment ” “ Offices should be proactive in arranging patient follow-up for data interpretation ” “ Only a few companies have successfully developed intuitive software for downloading CGM results. However, patients and endos find this helpful, if not critical. ”

Reference: Current FDA-Approved Labeling on Medtronic CGM Devices Continuous glucose monitoring systems are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks associated with the use of these systems. Continuous glucose monitoring systems are intended for monitoring interstitial glucose levels in persons with diabetes. These systems provide information regarding potential high and low glucose levels and can provide an indication of when patients should obtain a glucose reading using a home glucose meter. The information provided by continuous glucose monitoring systems is intended to supplement, not replace, readings from a home glucose meter. Patients should always confirm glucose level information provided by a continuous glucose monitoring system before making adjustments to diabetes therapy. Insertion of a glucose sensor may cause bleeding or irritation at the insertion site. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected.

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