Virtual DiabetesEd Session 8 - PowerPoint Presentation

1. Virtual DiabetesEd Session 8 Technology: From CGM to Insulin Pumps Diana Isaacs, PharmD, BCPS, BC-ADM, BCACP, CDCES

2. Overview of CGM Technology and Available DevicesDiana Isaacs, PharmD, BCPS, BC-ADM, BCACP, CDCESClinical Pharmacy SpecialistCleveland Clinic Diabetes Center

3. DisclosuresDiana Isaacs, PharmD, BCPS, BC-ADM, BCACP, CDCES is a consultant or speaker for the following companies: Lifescan, Companion Medical, Dexcom, Xeris Pharmaceuticals, Novo NordiskDr. Isaacs also serves as a member of the NCBDE Credentialing committeeThis program is not endorsed by NCBDE

4. Learning ObjectivesDescribe continuous glucose monitoring (CGM) and the clinical benefits for managing diabetes mellitusCompare and contrast the CGM devices available for personal and professional use

5. Evolution of Glucose Monitoring19571964197019871999PresentFirst reagent strip using glucose oxidation reaction – ClinistixModified reagent strip for blood glucose – DextrostixFirst blood glucose meter – Ames Reflectance MeterPortable blood glucose meters – OneTouchDevelopment of Continuous Glucose Monitors (CGMs)Clarke SF, Foster JR. A history of blood glucose meters and their role in self-monitoring of diabetes mellitus. Br J Biomed Sci 2012;69:83–93

6. How Does Continuous Glucose Monitoring (CGM) Work?Measures glucose from interstitial fluid (ISF) every 1-5 minutes and records glucose every 5-15 minutes (up to 288 readings/day)Slight delay compared with whole blood glucose (lag time)ADCES Practice Paper. The diabetes care and education specialist role in CGM.

7. SMBG vs CGMUndetected hypoglycemia= glucometer readingsUndetected hyperglycemiaSMBG, self-monitoring of blood glucose.Image created and permission to use granted by John Moorman, PharmD.

8. CGM ConsiderationsReal time vs retrospectiveBlinded vs unblindedSensorTransmitterReceiver/readerWarm-upCalibrationTrend arrowsFDA approved for dosing decisionsMean absolute relative difference (MARD)

9. Guideline UpdatesTechnology section added in 2019Ambulatory glucose profile (AGP) and time in range discussed as glycemic targets (in addition to A1C)Real-time CGM (rtCGM) and intermittently scanned CGM (isCGM) are useful to lower A1C and/or reduce hypoglycemia in adults who are not meeting glycemic targets, have hypoglycemia episodes, and/or unawarenessThere is no “one-size-fits-all” approach to technology use in people with diabetesCGM use requires robust and ongoing diabetes education, training, and support

10. Types of CGMWright LA, Hirsch IB. Diabetes Technol Ther. 2017;19(suppl 2):S16-S26; Kruger DF, et al. Diab Educ. 2019;45(suppl 1):S3-S20.ProfessionalPersonalOwned by the clinicOwned by the patientBlinded and unblinded (real-time feedback) optionsReal-time feedback or scan for feedback (flash device)Short-term use (3-14 days)Long-term use Insurance coverage for most people with type 1 or type 2 diabetesInsurance coverage more focused on type 1 diabetes or those on intensive insulin regimensNot compatible with insulin pumpsCompatible with smartphones and insulin pumps with select devices

11. CGM: Real-Time Data

12. Integrated CGM ClassificationNew FDA classification: Integrated Continuous Glucose Monitoring (iCGM)– Class II with Special ControlsBenefits: Streamlined premarket review processMinimizes the FDA review time for new productsEasily integrated with digitally connected devicesKey criteria: Performance and accuracy standards are robust and stringent: %15/15 accuracy at various glucose ranges>80% iCGM must be within 15/15% when the lab results >180mg/dL>70% iCGM must be within15/15% when the lab results 70-180mg/dL>85%, iCGM ust be within 15/15% when the lab results <70mg/dLFDA Authorizes First Fully Interoperable Continuous Glucose Monitoring System, Streamlines Review Pathway for Similar Devices. https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-fully-interoperable-continuous-glucose-monitoring-system-streamlines-review. Accessed November 18, 2019.

13. Professional CGM OptionsMedtronic iPro2Abbott FreeStyle Libre ProDexcom G6 Pro

14. Professional CGM Comparison iPro2G6 ProLibreProBlinded vs unblindedBlindedBothBlindedMaximum wear time of sensor6 days10 days 14 daysCalibration3-4 per dayNoneNoneDownloading reportsCareLinkCLARITYLibreViewCare between transmitter useClean and disinfect transmitterDisposable 1-time useDisposable 1-time useAlarms for high/low glucose alertsNoYes NoInterfering substancesAcetaminophenHydroxyureaSalicylic acid and high-dose vitamin CADCES Practice Paper. The diabetes care and education specialist role in CGM. Product websites

15. Personal CGM OptionsAbbott FreeStyle Libre Flash Dexcom G6Medtronic Guardian Connect and Guardian 3Senseonics EversenseDexcom G5

16. Dexcom G610-day wear2-hour warm-upNo calibrations required: optional1-touch inserter, must attach transmitterReusable transmitter: 3 monthsFDA approved for dosing decisionsChoice of receiver or cell phone (Android or iPhone)High, low, predictive alertsNo drug interferenceCLARITY app offers user insights Integration with Tandem X2 insulin pump iCGMDexcom G6 CGM system. Available at:. dexcom.com/g6-cgm-system

17. Guardian Connect & Guardian 37-day wearUp to 2-hour warm-upNot FDA-approved for dosing decisionsCalibrations required 2+ times/dayAcetaminophen interferenceGuardian Connect compatible works with iPhone or IpadGuardian 3 compatible with 670G pumpRequires extra steps of attaching transmitter and tapingCharge every 7 days, transmitter lasts for ~1 yearGuardian Connect AppPowered by IBM Watson via Sugar.IQ diabetes assistant to determine likelihood of hypoglycemia (predictive lows up to 4 hours in advance)Provides predictive glycemic patterns based on user inputGuardian Connect CGM. Available at:. medtronicdiabetes.com/products/guardian-connect-continuous-glucose-monitoring-system

18. Freestyle Libre Flash14-day wear1-hour warm-upFDA approved for insulin dosing, except for the first 12 hours after insertionMay use phone to scan with LibreLink Must scan every 8 hours to avoid data gapsAspirin and high-dose vitamin C interference1 press inserter, disposable transmitter included with sensor No real-time alerts FreeStyle Libre. Available at:freestylelibre.us/index.html

19. Eversense Implantable CGMSensor lasts 90 days (no new starts)FDA submission for 180 day sensorMRI safe when outer transmitter is removedFDA approved for insulin dosingFalse elevations with IV mannitol and sorbitol24-hour warm-up, dressing stays on 2 days after insertionRequires 2 calibrations/dayIf no calibration after 16 hours, will shut offSlim rechargeable smart transmitter taped above sensorCommunicates to iPhone or Android app (no separate receiver)On-body vibe alertsEversense. Available at: eversensediabetes.com

20. Personal CGM Comparison G6Libre FlashGuardian Connect or Guardian 3EversenseInsulin pump integrationT:SlimNoMedtronic 670G, 630G (Guardian 3)NoReceiveriPhone, Android or receiveriPhone, Android, or readeriPhone (Guardian Connect)iPhone, AndroidMaximum wear time10 days14 days7 days90 daysWarm-up time2 hours1 hourUp to 2 hours24 hoursCalibrations required/day002-4 + occasional diagnostic2Downloading softwareDexcom CLARITYLibreViewCareLinkEversense data management systemFDA approved for dosingYesYesNoYesData sharingYesYesYes YesAlarms for high/lowYesNoYesYesFDA approved ages (years)Over 2Over 18Guardian 3: Over 2Guardian Connect: Over 7Over 18Product labels

21. Which of the following CGM devices provides real time alerts and can be worn up to 10 days? Dexcom G6Freestyle LibreEversense Guardian Connect

22. Data Management ToolsSystemWebsite Associated Mobile AppsWhat it DownloadsGlookoglooko.comGlookoInsulin pumps (Omnipod, Tandem), Dexcom, Eversense, many glucose metersCLARITYclarity.dexcom.comDexcom G5, G6, Clarity, Dexcom FollowDexcom LibreViewlibreview.comLibreLink, LibreLinkUpFreeStyle LibreCarelinkcarelink.medtronic.comGuardian Connect, Carelink, Sugar IQ Diabetes AssistantMedtronic insulin pump and Medtronic CGMTidepooltidepool.orgTidepool MobileInsulin pumps (Medtronic, Tandem, Omnipod), FreeStyle Libre, Dexcom, Guardian Connect, many glucose metersEversense Data Management Systemeversensedms.comEversenseEversense

23. The Evidence

24. Increased BG Monitoring Leads to Lower A1C in T1DMMiller KM et al. Diabetes Care. 2013;36:2009-2014Type1 DM ExchangeN=20,555

25. DIAMOND Trial: T1DM MDIA1C Treatment Group DifferencesP<.001P<.001Week 24Week 12Baseline Beck RW et al., JAMA. 2017;317(4):371-378.Mean A1c %A1C: 0.6% difference at 24 weeks (N=158)

26. DIAMOND Trial-T2DM MDIA1c Treatment Group DifferencesP<.005P<.02Week 24-Week 12 Baseline Beck RW et al. Ann Intern Med. 2017 Sep 19;167(6):365-37A1C: 0.3% difference at 24 weeks (N=158)

27. DIAMOND Trial-T2DM MDIGreater Benefit with Higher Baseline A1CBaseline HbA1cChange in HbA1c From BaselineDifferenceP valueCGM GroupUsual Care Group≥ 7.5%-0.9% (n=79)-0.5% (n=79)0.4%0.02≥ 8.0%-0.9% (n=63) -0.6% (n=57)0.3%0.05≥8.5%-1.1% (n=39 ) -0.7% (n=39)0.4%0.02≥ 9.0%-1.4% (n=17) -0.7% (n=21)0.7%0.04Beck RW et al. Ann Intern Med. 2017 Sep 19;167(6):365-37

28. Flash CGM in T1DMProspective, randomized controlled trial241 participants with type 1 diabetes and A1C<7.5%, mean A1C=6.7%Bolinder, et al. Lancet 2016; 388: 2254–63Days38% reduction in hypoglycemia19% reduction in hyperglycemia

29. Flash CGM in T2DM and MDIProspective, randomized, controlled trial, 6 monthsParticipants with type 2 diabetes and MDI (N=224)Primary outcome: change in A1CSecondary outcomes compared to usual careHypoglycemia reduced by 43% (BG<70 mg/dL) and 53% (BG<55 mg/dL )Nocturnal hypoglycemia reduced by 54%Glucose variability reduced Increased treatment satisfactionHaak et al. Diabetes Ther 2016;8:55–73

30. What has the greatest impact on A1C lowering for people with type 1 diabetes? Insulin pumpCGMMobile apps for carb counting30

31. COMISAIR StudyProspective, non-randomized trial with T1D (N=94)rtCGM+MDI vs rtCGM+CSII vs SMBG+MDI vs SMBG+CSII Primary endpoint: A1C, Baseline=8.2%Other endpoints: hypoglycemia, time in range, hyperglycemiaCGM groupsA1C: 6.9% (pump), 7.0% (MDI)Non CGM groupsA1C: 7.7% (pump), 8.0% (MDI)Soupal J et al. Diabetes Care 2019 Sep; dc190888.

32. Downloading CGM Data

33. How does exercise affect glucose levels? IncreaseDecreaseNo effectI have no idea33

34. At least 42 factors affect glucose!Adapted from Brown A. DiaTribe Learn: Making sense of diabetes... diatribe.org/42factors↑↑ Carbo-hydrate quantity→↑Carbo-hydrate type→↑ Fat→↑ Protein→↑ Caffeine↓↑Alcohol↓↑ Meal timing↑Dehydration? Personal microbiome→↓Dose↓↑ Timing↓↑ Inter-actions↑↑ Steroid administration↑ Niacin (vitamin B3)→↓ Light exercise↓↑ High/ moderate exercise→↓ Level of fitness/training↓↑ Time of day↓↑ Food and insulin timing↑ Insufficient sleep↑ Stress and illness↓ Recent hypoglycemia→↑ During-sleep blood sugars↑ Dawn phenomenon↑ Infusion set issues↑ Scar tissue and lipodystrophy↓↓ Intramuscular insulin delivery↑ Allergies↑ A higher glucose level↓↑ Menstruation↑↑ Puberty↓ Celiac disease↑ Smoking↑ Expired insulin↑ Inaccurate BG reading↓↑ Outside temperature↑ Sunburn? Altitude↓ Frequency of glucose checks↓↑ Default options and choices↓↑ Decision-making biases↓↑ Family relationships and social pressures

35. CGM Data: Key MetricsCGM MetricMeasureStandardized visualization of dataAmbulatory glucose profile (AGP)Mean glucoseCalculatedHypoglycemia<70 mg/dLVery low/clinically significant hypoglycemia<54 mg/dLHyperglycemia>180 mg/dLVery high/clinically significant hyperglycemia>250 mg/dLTime in range70-180 mg/dLGlycemic variability (coefficient of variation)Standard deviation/mean, stable ≤36%Glucose management indicator (GMI)CGM version of estimated A1CRecommended data sufficiency70% sensor use over 14 daysBattelino T, et al. Diabetes Care. 2019;42(8):1593-1603.

36. Time in RangePercentage of readings in range of 70-180 mg/dL per unit of time for most patientsExpressed as ‘‘% of glucose readings’’ or ‘‘hours per day’’Clinical utility: higher is better and means less hypoglycemia and hyperglycemia, correlates with improved outcomes vs A1C aloneAgiostratidou G, et al. Diabetes Care. 2017;40(12):1622-1630.

37. What is the goal time in range for most adults with type 1 or 2 diabetes? ≥50%≥70%≥80%≥90%

38. Time in Range (TIR) Goals: International ConsensusBattelino T, et al. Diabetes Care. 2019;42(8):1593-1603.

39. Time in Range and A1C CorrelationMeasured TIRA1C 95% CI40%8.4%7.1%-9.7%50%7.9%6.6%-9.2%60%7.4%6.1%-8.8%70%7.0%5.6%-8.3%80%6.5%5.2%-7.8%N = 545 participants with type 1 diabetesBeck RW, et al. J Diabetes Sci Technol. 2019;13(4):614-626.

40. Ambulatory Glucose Profile (AGP)

41. Spaghetti GraphImage obtained from Dexcom CLARITY report.

42. Snapshot to Assess HypoglycemiaImage obtained from LibreView report.

43. Comparing Day to DayImage obtained from LibreView report.

44. CGM Counseling PointsImportant to check glucose when indicatedSymptoms do not match sensor valueDuring warm-up period When making dosing decisions for select devicesSensors are waterproofShowering, bathing, swimming OKPreferable to avoid hot tubs, saunasAvoid with MRI, CT, diathermy Exception: Eversense implantable, transmitter should be removedNot FDA approvedPregnancy, dialysis, critically illIf people choose to use, it is important they know it is off-label and discuss potential risks

45. CGM Device SelectionInsurance Coverage/CostNonadjunctive IndicationAlarms for High/LowData SharingInsulin Pump CompatiblePredictive AlertsEase of DownloadReceiver FunctionalityCalibrations***Individual Preferences***Kruger DF, et al. The Diabetes Educator. 2019;45(suppl 1):S3-S20.

46. Troubleshooting Site Adhesivenesshttps://diatribe.org/CGMtips

47. Patient Cases

48. Meet Derek48-year-old man, type 2 diabetes x 10 years, maxed out on metformin, GLP-1 agonist, SGLT2 inhibitor, sulfonylureaA1C = 9%-9.5% for 12 months, FBG and pre-dinner SMBG ≈150 mg/dLHe agreed to wear a professional CGM for 7 daysDerek was shocked by what happened between breakfast and dinner; he agreed to start insulin.

49. Meet Adriane47 year old with T1DMA1C = 6.4%Insulin glargine 16 units BIDInsulin aspart: 1 unit for10 grams CHOCorrection factor: 1:25

50. Adriane’s AGPWhat do you notice? Is Adriane meeting targets? What questions to ask?

51. Meet Jane56-year-old woman with type 2 diabetes x 5 yearsMeds: Metformin 1000 mg BID, Insulin glargine 20 units daily, insulin lispro 5 units TID a.c.+ ss#1 (1 unit for every 50 over 150)7.3%glucose management indicator

52. Exploring Day by DayAsk about the best day firstThen explore areas of lowsAsk permission to discuss highs

53. The DCES RoleAsk Jane how she takes her insulinMissed doses, administration times in relation to mealsDiscuss typical daily routine, meal schedule, physical activityOther factors that can impact BG: stress, sleepUse information above to come up with individualized self-management recommendationsEat consistently with insulin lispro to avoid hypoglycemia, take 30 before the mealReduce higher carbohydrate foods like potato chipsConsider smart pen to track insulin doses

54. Conclusion There are several CGM options, and the DCES can help patients select the best device for their individual needsThere are many benefits to CGM including reduction in hypoglycemia and reduced A1CCGM data can be used to discussion diabetes self-management with the person with diabetes and help to make meaningful changes

55. Additional CGM ResourcesDiabetes Advanced Network Access (DANAtech)danatech.orgAssociation of Diabetes Care and Education Specialists (ADCES) glucose monitoring resourcesdiabeteseducator.org/practice/educator-tools/diabetes-management-tools/self-monitoring-of-blood-glucosediaTribediatribe.org Senseonics Eversenseeversensediabetes.com Medtronic Guardian Connecthcp.medtronic-diabetes.com.au/guardian-connectDexcom G6dexcom.com/g6-cgm-systemAbbott FreeStyle Librefreestylelibre.us

56. Diabetes Technology: Insulin PumpsDiana Isaacs, PharmD, BCPS, BC-ADM, BCACP CDCESClinical Pharmacy Specialist/CGM Program CoordinatorCleveland Clinic Diabetes Center

57. DisclosuresDiana Isaacs, PharmD, BCPS, BC-ADM, BCACP, CDCES is a consultant or speaker for the following companies: Lifescan, Companion Medical, Dexcom, Xeris Pharmaceuticals, Novo NordiskDr. Isaacs also serves as a member of the NCBDE Credentialing committeeThis program is not endorsed by NCBDE

58. Learning ObjectivesDescribe critical teaching content before starting insulin pump therapyDescribe appropriate candidates for insulin pump therapyState important safety measures to prevent hyperglycemic crises crises.Explain the currently available and future pipeline of insulin pumpsList inpatient considerations for insulin pump therapy and CGMs

59. How a Pump Delivers InsulinInsulinTimeNormal Insulin SecretionInsulin Pump DeliverySchematic representation only.

60. Pump BasicsPumps use rapid-acting insulinMinimizes insulin variabilityPumps deliver insulin in two waysBasal:Replaces long-acting insulinCovers hepatic glucose production/maintains glycemic stability in fasting stagesAutomatically delivers precise programmed doseAdjust to match diurnal variationsBolus: Covers glucose consumption and corrects hyperglycemiaPumps use Bolus Calculator

61. Ideal PatientsMotivated Checking BG 4+ times/day or wearing CGMA1c<10%Carb countingAbility to learn pump programmingWilling to follow up regularly with health care teamCan afford the pump/suppliesCounting carb gramsAccuracy mattersFollowing hyperglycemia treatment instructions

62. Onboarding a New PatientPre-pump group classIndividual CDCES visit(s) for advanced carb counting as neededPump start (2-3 hour individual CDCES visit)Pt sends BGs regularly for rate adjustmentsAdvanced pumping follow-up visit with CDCES in 2-4 weeks MD/NP follow-up in 4-6 weeksBase on Cleveland Clinic insulin pump program

63. Common Pump FeaturesBolus calculatorTemporary basal or temp targetInsulin-on-board/active insulin featureMultiple basal patternsSmall dose incrementsIntegration with CGMDesigned to work with U100 insulin4-year warranty/contract

64. Extended BolusesGreat for high-fat foods or gastroparesis

65. Safety FeaturesAlarms for occlusion or low insulin reservoirActive insulin to prevent stacking Keypad lockWaterproof or watertightCommunication with CGM for auto-suspend, auto adjustment of basalReminders to bolus, change infusion set, etc

66. Safety PearlsBack up plan for pump failureRx for long acting insulin, insulin pens, syringesWritten insulin pump settingsSick day managementKetone testingPump rotationInsulin spoilage in high temperaturesAlways carry back up suppliesEx: Infusion sets/reservoirs, test strips/meter, insulin, batterieshttps://www.diabeteseducator.org/docs/default-source/practice/educator-tools/troubleshooting_final.pdf?sfvrsn=4

67. Infusion SetsInfusion sets are usually TeflonAvailable in different sizes (ex. 9mm vs 6mm) Silhouette (angled) may be better for kids/thinner/very active people Steel infusion sets a good option for people with frequent site occlusionsInsert at least 1 inch from CGM siteAuto-injectors vs. manually injectingSite selection/rotationLonger tubing optionsGood if connected on leg, arm or wearing pump further from siteCaution with kids/babies/pets-pouches available to hide pumpWhen changing out infusion set, check glucose or CGM 1-2 hours afterDon't change right before bed

68. What Happens with a Bent Cannula? HyperglycemiaHypoglycemiaNo effect

69. Filling the PumpOnly fill with how much insulin you expect to use in 3 days + ~30 unitsEach pump is differentTandem takes the longest to fillCaution with air bubblesFill cannula amountSteel needle (0 units)6mm cannula (0.3 units)9mm cannula (0.5 units)If cannula overfilled, can lead to lowsIf cannula under-filled or air bubbles, can lead to highs

70. Where to Wear?

71. Available Pumps in U.S.Omnipod (Insulet) Dasht:slim X2 with G6 CGM (Tandem/Dexcom)Basal IQControl IQ670G with Guardian 3 (Medtronic)Valeritas VGo

72. Older Pumps in U.S.Omnipod (Insulet)Medtronic 630G with Guardian 3Minimed 530G with Enlite

73. Valeritas V-Go24 hr. basal/bolus patch pumpApproved for adults with T2DMAllows 20, 30, 40 unit basal rate options (0.83 U/hr, 1.25 U/hr, or 1.67 U/hr)On-demand bolus doses in 2 unit increments Up to 36 U/24 hrsDoses administered via clicks directly on the deviceMust be changed daily 73Valeritas Wearable Insulin Delivery Device : V-Go Insulin Delivery. Retrieved from https://www.valeritas.com/v-go/insulin-delivery-with-v-go/default.aspx

74. Insulet OmnipodNo tubingPod (pump) includes infusion setAll programming done via PDMLocked Android smartphoneBluetooth connectionRechargeable batteryFood database200 unit reservoirDash blue tooth connected with contour meter

75. Medtronic 670G SystemAuto Mode adjusts basal rates every 5 min. based on sensor glucoseIndicated age ≥ 7 years with TDD ≥ 8 unitsGuardian 3 continuous glucose monitor (CGM) 7 day wear timeRequires charging between use2-4 calibrations/daySuspend before/on low options (in manual mode) Additional BG checks to stay in auto modeBG target=120Temp target of 150 available300 unit reservoir

76. Medtronic 670G: Tips for SuccessThe more time in auto mode the betterMust wear sensor to stay in auto modeThe only settings that can be changed in auto mode are active insulin time and carb ratiosPeople do best when they bolus BEFORE eatingAdvise patients to give correction doses when above target (will correct down to 150mg/dL)Double check basal rates and sensitivity in manual mode, try to match to auto mode settings for unexpected auto mode exitsAlways suspend when not wearing pumpWhen exiting auto mode, suspend feature must be manually turned back on!

77. Medtronic 670G Example

78. 670G: The Phantom Bolus

79. Touch screenLithium rechargeable battery300-unit reservoirIndicated ages ≥ 6 years 0.001 unit basal incrementIntegration with Dexcom G6Basal IQ- suspends basal if CGM predicted to decrease to < 80 mg/dl within 30 minutesTandem T:Slim X2 with Basal IQ

80. Basal IQ Example: Pregnant80

81. Basal IQ in Pregnancy: ContinuedWhat changes (if any) would you recommend?

82. What Changes Do You RecommendNo changes, patient is doing great!Increase 9pm-12am basalIncrease (De-intensify) dinner time carb ratioIncrease overnight basal 12-6am

83. Advanced HCL systemAlgorithm adjusts insulin delivery from programed “manual” settingsAutomatic correction dosesUp to 1 every hourCalculated at 60% of programmed correction factor(target of 110)User must still bolus for carbs (and additional correction doses)FDA approved 14+ yearsBasal-IQ users who update to Control-IQ cannot switch back to Basal-IQ modeTandem T:Slim X2 with Control-IQ

84. Start-up: Enter weight and total daily insulinSet limits on algorithm (max doses, etc)Automatic basal attenuation (uses programmed rates)Increases basals if predicted >160 mg/dLDecreases basals if predicted <112.5 mg/dLSuspends if predicted <70 mg/dLControl-IQ: Basal Modulation

85. Sleep scheduleTarget range to 112.5-120 mg/dLNo automatic bolusesControl-IQ: Sleep and ExerciseExercise “Activity” scheduleTemporary target range: 140-160 mg/dLUse like temp basal

86. Control IQ Example

87. Control IQ Example: ContinuedWhat changes (if any) would you recommend?

88. What Changes Do You Recommend? No changes, patient is at targetIncrease basal overnight 10p-6amIncrease basal daytime 10a-6pIntensify (decrease) carb ratio overnight 10-6am

89.  MiniMed 670GControl-IQCalculateAutomatic basal delivery based on TDDAutomated basal delivery based on basal rates Delivers auto-correction dose 1/hAdjustCan modify:- I:C ratios, insulin action timeCan modify:- Basal rates, I:C ratios, sensitivitiesRevertWill revert to OL: Prolonged hyperglycemia, max/min insulin, no CGM data, sensor integrity Will revert to OL: if loss of CGM data EducateFollow system prompts to stay in Auto mode (entering BGs)Increase I:C ratios to make more aggressiveSet sleep schedule Do not override boluses: extra insulin present from auto-correctionsRead bolus prompts carefullySensor/ShareGuardian Sensor 3: 2-4 calibrations/dayNo remote monitoringDexcom G6 sensor:Factory calibratedCan use for insulin dosingPhone view and remote monitoring Control-IQ vs Medtronic 670GBG = blood glucose; CGM = continuous glucose monitoring; I:C = insulin to carbohydrate; OL = open loop; TDD = total daily dose.Messer LH et al. Diabetes Technol Ther. 2019;21(3):1-8.

90. Using Control-IQ, what percentage of the total calculated correction dose will be automatically delivered every hour if algorithm predicts SG to remain >180 mg/dL? 50%60%80%100%90

91. Data Management SystemsSystemWebsiteWhat it DownloadsGlookowww.glooko.comOmnipod, Dexcom T:Connecthttps://tconnecthcp.tandemdiabetes.com/hcp_accountTandem insulin pumps including basal IQ (dexcom data included)Carelinkhttps://carelink.medtronic.com/Medtronic insulin pumps 530G/630G/670GTidepoolhttps://tidepool.org/All insulin pumps, Libre, Dexcom, many glucose meters

92. Critical ThinkingWhen should a provider consider discontinuing an insulin pump during hospitalization?

93. Technology in the HospitalSeveral inpatient studies have shown that CGM detected a greater number of hypoglycemic events than POC glucose testingOverall, did not improve glucose controlPatients who are comfortable using their diabetes devices (insulin pumps, sensor) should be given the chance to use them in an inpatient setting if they are competent to do so.Health care institutions must have clear policies and procedures to maximize safety and to comply with existing regulations related to self-management of medication.Diabetes Care 2020 Jan; 43(Supplement 1): S77-S88Umpierrez G et al. Diabetes Care 2018 Aug; 41(8): 1579-1589..

94. Umpierrez G et al. Diabetes Care 2018 Aug; 41(8): 1579-1589.

95. Contraindications to Insulin Pumps in the HospitalImpaired level of consciousness (except during short-term anesthesia)Patient’s inability to correctly demonstrate appropriate pump settingsCritical illness requiring intensive carePsychiatric illness that interferes with a patient’s ability to self-manage diabetesDiabetic ketoacidosis and hyperosmolar hyperglycemic stateRefusal or unwillingness to participate in self-careLack of pump suppliesLack of trained health care providers, diabetes educators, or diabetes specialistPatient at risk for suicideUmpierrez G et al. Diabetes Care 2018 Aug; 41(8): 1579-1589.

96. CGM in the HospitalDexcom G6 and Freestyle Libre available for inpatient remote monitoringFDA has temporarily approved due to the public health crisis of COVID-19 and the need to preserve PPE and reduce hospital staff exposure to coronavirusIn partnership with ADA, Abbott donating 25,000 FreeStyle Libre 14 day sensors to U.S. hospitalsRequires scanning with a smart phoneDexcom offering a discount program to hospitalshttps://www.dexcom.com/news/dexcom-cgm-hospital-covid19https://abbott.mediaroom.com/2020-04-08-Abbotts-FreeStyle-R-Libre-14-Day-System-Now-Available-in-U-S-for-Hospitalized-Patients-with-Diabetes-During-COVID-19-Pandemic

97. Dexcom CLARITYSmart Phonewith G6 AppDexcom TransmitterCLOUDDexcom Follow

98. The Pipeline

99. JDRF RoadmapMEDTRONIC 530G, 630GMEDTRONIC 640G (EU/Australia)Tandem X2 Basal-IQMedtronic 670GTandem X2 Control- IQ??Diabetes Care 2015 Jun; 38(6): 1036-1043.

100. Medtronic 770GHybrid-closed loop (670G) with blue tooth technologyAge indication: 2 years and overSmartphone AppOver the air firmware updates, will make for an easy transition to 780GAutomatic upload to carelinkLaunch planned with apple and androidWill require users to get a new transmitter, which will still be a guardian 3

101. Medtronic 780GHybrid-closed loopPivotal trial completedCorrection boluses every 5 minutesTarget 100-120mg/dLTIR goal >80% with >90% auto mode1 calibration per dayExtended wear infusion set

102. Omnipod HorizonDexcom G6 sensor communicates to PodPod contains hybrid closed loop algorithm Personal smartphone used as controllerSelect target glucose from 110 to 150 mg/dLHypoprotect (*exercise mode) will deliver less insulin at BG target of 150 mg/dLAlgorithm adjusts based on total daily insulin102

103. Tidepool LoopTidepool Loop iphone app (hybrid closed loop algorithm)Communicate via bluetooth with interoperable ACE pumps and iCGMInsulet, Dexcom, Medtronic official iCGM and ACE pump partnersOngoing study, planned FDA submission

104. Beta Bionics iLEThttps://www.betabionics.com/Hybrid-closed loopRequires meal announcements: small, medium, large mealCompatible with Dexcom G6 and eversense CGMNo carbohydrate countingNo basal or bolus rates160 unit insulin cartridgeOnly enter body weight to startThe Future: dual hormone with glucagon and insulinExpected launch: 2021

105. CeQur Simplicity3 day mealtime insulin patch for bolus dosesEach click delivers 2 units200 unit max insulin capacity Approved for adults with T1 or T2DMInsulin delivery method: flexible teflon cannula105U.S. Department of Health & Human Services, U.S. Food & Drug Administration. 510(k) Premarket Notification. Finesse Personal Insulin Delivery Patch. Retrieved from https://www.accessdata.fda.gov/cdrh_docs/pdf10/K100947.pdf

106. Which if the following systems does not require the person to count carbohydrates? Tandem t:slim X2 w/ Control-IQMedtronic 780g Omnipod Horizon Beta Bionics iLet106

107. In SummaryMany insulin pump optionsNew era of hybrid closed loopsPre-pump education is essentialAlways have a back-up planNo artificial pancreas yet, but we are getting closer to closing the loopGive PWD a choice!107

108. Additional ResourcesIntegrated Diabetes Serviceshttps://integrateddiabetes.com/updated-insulin-pump-comparisons-and-reviews/ADCES Insulin pump therapy resourceshttps://www.diabeteseducator.org/practice/practice-tools/diabetes-management-tools/ipt-resourcesDiatribe.orgDiabeteswise.org

109.

110. Thank YouPlease email us with any questions.info@diabetesed.netwww.diabetesed.net