Insulin Pumps and Continuous Glucose Sensors- Embracing Technology Susan Cavalier, BS, RN, CDE Manager, Diabetes Educator Sanford Diabetes Education
Diabetes Management Tools in 1974
Insulin pump history 1963 -First insulin pump developed by Dr. Arnold Kadish 1974 Development of the Biostator 1976- Autosyringe Inc. started to manufacture and market the first wearable pump
Who might be a good pump candidate? Individuals with type 1 diabetes who are struggling with glucose control Individuals with type 2 diabetes requiring insulin who struggle with glucose control Please note that Medicare does require qualifying labwork Women who are planning pregnancy or are pregnant. (some products are considered off label for pregnancy) Insulin pumps are not for everyone!
Benefits of Insulin Pump Therapy Improved blood glucose control -minimize fluctuations Managing the Dawn Phenomenon Fewer and less severe episodes of hypoglycemia Improvement in Hypoglycemia Unawareness Flexibility with lifestyle without losing control (variable meal times and amounts, travel, variable day to day schedule) Preventing, delaying or reversing complications of diabetes Improved blood glucose control during exercise Tighter blood glucose control prior to and during pregnancy
Evaluation and Considerations: Highly motivated regarding diabetes self management Currently practicing Intensive Diabetes Management. (Includes multiple daily injections, blood glucose tests 3-4 times daily documented.) Competence in or willingness to learn carbohydrate counting Physician support for pump therapy documentation of medical necessity
Evaluation and Considerations (cont.) Individual willingness to maintain ongoing contact with physician and other health care team members Realistic expectations of pump therapy Adequate support systems- physician and education staff experienced in pump and sensor use Adequate financial resources Physical and intellectual ability to learn how to operate the pump
Insulet - OmniPod OmniPod Tubeless pump Pod can be worn for 72 hours and is waterproof at 25 ft. for 60 minutes 200 unit cartridge Basal range: 0.05-30 units/hr. with 0.05 unit increments Bolus range: 0.05-30 units. Insulin to carb ratio In whole unit increments PDM is used for activating and programming the pod Built in blood glucose meter, list of 1000 common foods Download options: Glooko, Tidepool, Diasend. Can sync Dexcom account to Glooko account so that the sensor reports overlay
Insulet- OmniPod OmniPod DASH system Filed with the FDA earlier this year Bluetooth capability allowing communication with a color touchscreen PDM Higher concentration insulin pods with U500 version and U200 version ( 2019-2020) Horizon Closed Loop system will bring an artificial pancreas component. (2019)
Tandem Diabetes Care T:slim X2, T:flex Rechargeable battery Color touch screen. X2 integrated with Dexcom G5 300 unit cartridge, T:flex 480 unit cartridge Basal range: 0.1-15 units/hr. T:flex 0.5-15 units/hr. in 0.001 unit increments Bolus range: 0.05-25 units in 0.1 unit increments T:Flex: 0.05-60 units. I:C ratio allows fractions of grams Water tight- 3 ft for 30 minutes T:slim 2x integration with Dexcom G5 Sensor Tandem Device Updater allows software updates Download options: T-Connect, Tidepool
Tandem Diabetes Care Next Up? Predictive Low Glucose Suspend Filed with FDA Q1 2018 Launch goal summer 2018 Will use CGM data to predict future lows and adjust insulin
Tandem Diabetes Care Next Up? Hybrid Closed Loop Type Zero Technologies- treat to target algorithms Dexcom G6 sensor Possible launch 2019
Medtronic Diabetes Minimed 630G System 300 unit reservoir Basal range: 0.025-35 units/hr. 0.025, 0.05 and 0.1 unit increments Bolus range:0.025-25 units Increments of 0.025, 0.05 and 0.1 units. Allows I:C ratios in fractions of grams Contour Next Link meter Waterproof for 12 ft. up to 24 hours SmartGuard technology Carelink Personal Software
Medtronic Diabetes Minimed 670G System- Hybrid Closed Loop All of the previous features Plus- Integrated with Guardian 3 Sensor Auto Mode delivery automatically adjusts basal delivery based on sensor readings, active insulin, food boluses and corrections SmartGuard Technology Carelink Personal Software
Points to Consider when reviewing reports Frequency of blood glucose tests per day Carbohydrate intake entered and use of the bolus calculator vs manual boluses, assess response to boluses Over-rides Frequency of infusion set changes Suspend time Average daily insulin use including basal / bolus balance Assess for patterns of hypoglycemia and hyperglycemia
Points to consider when reviewing reports Auto mode use Sensor wear time Basal/ bolus use Carbohydrate intake and timing of boluses Time in range Reasons for auto mode exits Response to meal boluses and corrections
Dexcom Dexcom G4 Platinum Available for Personal use or Professional CGM Studies Sensor duration: 7 days. 2 hour warm up time. Requires calibrations every 12 hours Transmitter battery has 6 month warranty, Receiver is rechargeable Dexcom Share2 App, Dexcom Follow App Receiver can be blinded for professional studies Management System options: Dexcom Studio, Dexcom Clarity, Glooko and Tidepool
Dexcom Dexcom G5 Mobile First CGM system FDA approved for making treatment decisions Sensor duration: 7 days. 2 hour warm up. Requires calibrations every 12 hours Transmitter battery: 3 month warranty Smart device compatible using Dexcom G5 Mobile App ios and Android Dexcom Clarity Reports allows sharing with clinic Management System options: Dexcom Clarity, Glooko, Tidepool.
Dexcom Next Up? Dexcom G6 - Approved by the FDA 3/27/18!! Expected ship- May 2018 Sensor duration: 10 days No calibration required Transmitter is lower profile No acetaminophen interference
Freestyle Freestyle Libre Pro System Sensor duration: 14 days No calibration required Reader is used to start the sensor, read the data and upload to Libreview
Freestyle Freestyle Libre (personal system) Sensor duration: 10 days Measures and stores readings every 15 minutes No calibration required No acetaminophen interference Also uses Freestyle Precision Neo test strips Available at participating pharmacies for discounted rate ( CVS, Walgreens, Walmart) Cost should be no more than approximately $65 for the reader-one time cost and $25 per sensor or $75 per month, cash pay: $79-$84 for the reader and $41-44 per sensor.
Freestyle Freestyle Libre Reader gives trend arrow, current glucose, 8 hr trend, daily pattern, low glucose events, time in target, visual alerts Reader can be uploaded to Libreview
Medtronic Guardian Connect Uses the Guardian 3 sensors and Guardian Connect Transmitter Guardian Connect App Works with the Sugar.IQ App Diabetes Assistant Displays sensor data, trends and alerts, can log events Predictive alerts Planned launch later this year
Medicare Coverage for CGM
Medicare Coverage for CGM Dexcom G5 Required Documents: Medicare CMN Assignment of Benefits Form Copies of Insurance Cards Notice of Non-coverage Form Last 2 office notes - note must state the previous Medicare requirements
Medicare Coverage for CGM Freestyle Libre Complete Freestyle Libre Intake Form and fax to a DME Supplier Office notes with required documentation will need to be sent For a full list of DME suppliers visit: www.freestylelibre.us/dme-suppliers