Diabetes and Technology Saturday, September 9, 2017 Aimee G sell, APRN, ANP-C, CDE
Disclosure Speaker s Bureau: Janssan Pharmaceuticals
Current Technology V-Go by Valeritas Continuous Sensors (personal and professional) Insulin pumps
Exciting Times in Diabetes Insulin discovered ~ 95 years ago First insulin pump introduced ~ 3 decades ago First analog (lispro) insulin FDA approved > 2 decades ago First CGM (Medtronic sensor) ~ 18 years ago Artificial intelligence
V-Go by Valeritas Insulin device = patch Wearable, disposable q24 hours Approved for use with Novolog and Humalog
How V-Go Works Worn like a patch with no batteries, electronics or programming Basal rate is spring driven 24 hour basal rate begins with the push of the needle button Basal rate flow restrictor * Floating needle (4.6 mm, 30 gauge) Piston On demand bolus is manually activated in a 2-step process *Fast-Acting Insulin Data on File, Valeritas, Inc.
V-Go by Valeritas 1 insulin device for both bolus and basal Clicks for prandial delivery Preset basal rate over 24 hr period EZ fill with analog insulin vial
Improve Adherence by Removing the Barriers Simplify with V-Go Basal-Bolus therapy with MDI requires a long or intermediate acting insulin plus a short or rapid acting insulin and typically 4 injections/day. Basal-Bolus therapy with V-Go requires only a rapid acting insulin and 1 application/day Conceptual depiction of basal-bolus therapy delivery options 2017, Valeritas, Inc. 8
Why use V-Go? Lower A1c Lower TDD Patient compliance
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Change in HbA1c V-Go Real World Clinical Experience SIMPLE 1 8.8% N=87 3 months VALIDATE 2 9.6% N=204 ~ 7 months NEFEDA 3 Jones 4 UPP 5 UMASS 6 Ray 7 9.1% 8.9% 9.7% N= 83 ~ 5 months N=69 NR 8.8% N=23 3 months 10.7% N=14 3 months N=26 3 months -0.7-1.8* -1.6-0.8-1.2-1.6-2.4 Insulin Change 18% 41% 22% 8 20% 13% 46% 32% Baseline Insulin Doses U/day: Simple-62, VALIDATE 1 Study-99, NEFEDA-86, Jones-76, UPP-49, UMASS-119, and Ray-74 *HbA1c change reported using least square means, Insulin change reported based on comparison to prescribed upper limit at baseline NR= Not reported 1. Grunberger G, et al. Poster presented at: American Association of Clinical Endocrinologists 23rd Annual Scientific and Clinical Congress. May 2014. 2. Lajara R, et al. Diabetes Therapy. 2015;6(4):531-545. 3. Sutton D, et al. Poster presented at 76th Scientific Sessions of the American Diabetes Association. June 2016. 4. Sink J, et al Poster Presented at Diabetes Technology Meeting Nov. 2014. 5. Rosenfeld CR, et al. Endocr Pract. 2012;18(5):660-667. 6. Omer A, et al. Poster presented at: American Diabetes Association 73rd Scientific Sessions. June 2013. 7. Ray R, et al. Abstract published at 11 the American Diabetes Association 75 th Scientific Sessions. June 2015. 8. Data on file, Valeritas. Inc.
Glucose Sensors Personal Dexcom G4/ G5 Medtronic Enlite Medtronic Guardian 3 Professional Dexcom Medtronic ipro Abbott Freestyle Libre
CGM = Continuous Glucose Monitors FDA- approved system Blood glucose, direction, and speed Insight to help with diabetes management AACE/ ACE Guidelines All T1DM All T2DM on multiple insulin injections, basal insulin or sulfonylureas At risk for hypoglycemia and/ or have hypo unawareness
Accurate and Reliable
Personal Sensor
Dexcom G 4 - Animas VIBE pump
CGM information to make a treatment decision: BG reading Trend arrow Trend graph Alert/ alarms
Dexcom G 5 Clarity Summary Report
DiaMonD Study: T1DM
Brands of Insulin Pumps Medtronic 670G, 630G Tandem Tslim, Tflex, X2 Insulet Omnipod Animas VIBE, PING Accu-chek Spirit Combo
Why pump provide better control Why Pumps Provide Better Control 1. Pumps use rapid-acting insulin Minimizes insulin variability 2. Pumps deliver insulin in two ways: Basal: Replaces long-acting insulin Covers hepatic glucose production / maintains glycemic stability in fasting states (between meals & overnight) Automatically delivers precise programmed dose Adjusted to match diurnal variations Bolus: Covers food intake and corrects high BG levels
Insulin Pumps Deliver Insulin in Two Ways Pumps Use Basal and Bolus Insulin Delivery Breakfast Lunch Dinner Snack 12am 3am 7am 12pm 6pm 9pm Time of Day Insulin delivery more closely mimics insulin secretion of a healthy pancreas
Insulin Infusion Rate Pumps Are Designed for Multiple Basal Rates Example of a Basal Profile Basal rates can be programmed to increase for dawn phenomenon Basal rates can be decreased Higher rate can be programmed if needed after dinner Basal infusion 12a m 2am 4am 6am 8am 10a m 12p m Time of Day 2pm 4pm 6pm 8pm 10p m 12a m Pumps can be programmed to deliver basal insulin at different rates throughout the day according to each patient s unique requirements Lenhard MJ, Reeves GD. Arch Intern Med. 2001;161:2293-2300. Reused with permission.
Specific Characteristics of Patients Who Are Not Good Candidates for Insulin Pump Use Unable or unwilling to perform MDI injections ( 3-4 daily), frequent SMBG ( 4 daily), and carbohydrate counting Lack of motivation to achieve tighter glucose control and/or a history of non-adherence to insulin injectionprotocols History of serious psychological or psychiatric condition(s) (e.g., psychosis, severe anxiety, or depression) Substantial reservations about pump usage interfering with lifestyle (e.g., contact sports or sexual activity) Unrealistic expectations of pump therapy (e.g., belief that it eliminates the need to be responsible for diabetes management) AACE/ ACE consensus statement on insulin pump management ENDOCRINE PRACTICE Vol 20 No. 5 May 2014
Suitable Insulin Pump Candidates Patients with DM who do not reach glycemic goals despite adherence to maximum MDI, especially if they have: Very labile diabetes (erratic and wide glycemic excursions, including recurrent DKA) Frequent severe hypoglycemia and/or hypoglycemia unawareness Significant dawn phenomenon, extreme insulin sensitivity Special populations (e.g., preconception, pregnancy, children, adolescents, competitive athletes) AACE/ ACE consensus statement on insulin pump management ENDOCRINE PRACTICE Vol 20 No. 5 May 2014
Questions?