Presentation on theme: "Insulin Pump Management"— Presentation transcript:
1 Insulin Pump Management Consensus Statement by the AACE/ACEInsulin Pump Management Task ForceGeorge Grunberger, MD, FACP, FACE*Jill M. Abelseth, MD, FACETimothy S. Bailey, MD, FACP, FACE, ECNUBruce W. Bode, MD, FACEYehuda Handelsman, MD, FACP, FACE, FNLARichard Hellman, MD, FACP, FACELois Jovanovič, MD, MACEWendy S. Lane, MDPhilip Raskin, MD, FACEWilliam V. Tamborlane, MDENDOCRINE PRACTICE: TBD
2 Presentation Outline Introduction Preamble State of Insulin Pump TechnologyClinical EvidencePatient and Provider SelectionInsulin Pump Use in Various Patient PopulationsEducation and TrainingPatient Safety IssuesCoding and Reimbursement Issues in PracticeEconomics of Insulin Pump TherapyFuture Needs and Conclusions
4 IntroductionFirst AACE consensus statement on insulin pump management published in 2010Current consensus statement includes:Extensive updates on state of insulin pump technologyExpanded discussion of CSII in pediatric patientsData on use of concentrated regular U-500 insulin in CSIIDiscussion on need to develop uniform trainingSuggestions of what uniform training should coverDiscussion of device-related pump problemsImpact of patient selection and education on safe CSII useAACE: American Association of Clinical EndocrinologistsCSII: continuous subcutaneous insulin infusion
6 PreambleRoughly 20% - 30% of patients with T1DM and fewer than 1% of insulin-treated patients with T2DM use an insulin pumpIn 2007, the US FDA estimated that the number of patients with T1DM using CSII was ~375,000By 2050, up to one-third of US residents may have T2DM; many of these individuals will be insulin-requiringTherefore, more clinicians must develop a comprehensive understanding of these devicesT1DM: type 1 diabetes mellitusT2DM: type 2 diabetes mellitusFDA: U.S. Food and Drug AdministrationCSII: continuous subcutaneous insulin infusionHSBC Global Research. Healthcare US Equipment & SuppliesU.S. FDA. General Hospital and Personal Use Medical Devices Panel. 2010U.S. CDC. CDC Media Relations - Press Release: October 22, 2010.
8 State of Insulin Pump Technology Insulin pumps now include features such asColor touch screensUSB-rechargeable batteriesPre-filled insulin cartridges, andDisposabilityThe availability of multiple infusion set types, choices of catheter tubing lengths, and tubeless pumps have enhanced pump therapy accessibility and led to increased pump usageLook up USB...
9 Current Developments in Insulin Pump Technology Clinical trials are underway to validate methods that accelerate insulin actionData supporting the feasibility of locating infusion sets and CGM catheters in close proximity make it likely that combination sensor and infusion sets will be developedInsulin pumps can now display CGM data on the same screen and share display data on other remote devicesMedtronic’s MiniMed 530G with Enlite (approved in 2013) is the first device that alters insulin delivery in response to CGM sensor dataCGM: continuous glucose monitoring
10 Insulin Pumps on the Market Accu-Chek Combo SystemAsante Snap Insulin Pump SystemMiniMed Paradigm Real-Time Revel System (523/723)MiniMed 530G with Enlite (551/751)OmniPod Insulin Manage-ment SystemOneTouch Pingt:slim Insulin PumpV-Go Disposable InsulinDelivery DeviceRoche Health SolutionsAsante SolutionsMedtronic MiniMedInsulet CorporationAnimasTandem Diabetes CareValeritas, Inc.
11 Clinical Evidence for Insulin Pump Therapy in Diabetes
12 Type 1 DiabetesA 2010 Cochrane review compared the use of CSII vs. MDI insulin regimens (23 randomized studies involving 976 patients with T1DM)A significant difference was documented in HbA1c response, favoring CSIICSII users demonstrated greater improvements in quality of life measuresSevere hypoglycemia appeared to be reduced in CSII usersCSII: continuous subcutaneous insulin infusionMDI: multiple daily injectionT1DM: type 1 diabetes mellitusMisso ML, et al. Cochrane Database Syst Rev. 2010;(1):CD doi(1):CD005103
13 Type 1 DiabetesThe STAR-3 study showed significantly greater HbA1c reductions in patients with T1DM randomly assigned to sensor-augmented insulin pump therapy vs. MDIA higher proportion of patients randomly assigned to pump therapy achieved an HbA1c <7% without any increase in severe hypoglycemia rates or weight gain vs. the MDI groupBased on currently available data, CSII is justified for basal-bolus insulin therapy in patients with T1DMSTAR-3: Sensor-Augmented Pump Therapy for A1C ReductionT1DM: type 1 diabetes mellitusMDI: multiple daily injectionCSII: continuous subcutaneous insulin infusionBergenstal RM, et al. N Engl J Med. 2010;363(4):
14 Key Findings: CSII Meta-Analyses (T1DM and T2DM) Published Since 2003 ReferenceFindingsWeissberg-Benchell et al, Diabetes Care. 2003;26(4):Compared with MDI, CSII therapy was associated with significant improvements in glycemic control based on HbA1c and mean blood glucose decreasesJeitler et al, Diabetologia. 2008;51(6):HbA1c reduction greater and insulin requirements lower with CSII than with MDI in adults and adolescents with T1DM; hypoglycemia risk comparable among adult patients (data unavailable for adolescent subjects); no conclusive CSII benefits for patients with T2DMFatourechi et al,J Clin Endocrinol Metab. 2009;94(3):In patients with T1DM, HbA1c was mildly decreased with CSII vs. MDI; CSII effect on hypoglycemia unclear; similar CSII and MDI outcomes among patients with T2DMPickup and Sutton, Diabet Med. 2008;25(7):HbA1c was lower for CSII than for MDI, with greatest improvement in patients with highest initial HbA1c values on MDI; severe hypoglycemia risk was decreased with CSII vs. MDI; greatest reduction in patients with diabetes of longest duration and/or highest baseline rates of severe hypoglycemiaMonami et al,Exp Clin Endocrinol Diabetes. 2009;117(5):HbA1c was significantly lower with CSII vs. MDI; HbA1c reduction was only evident for studies with mean patient age >10 years; severe hypoglycemia occurred at comparable rates with CSII and MDI therapyCSII, continuous subcutaneous insulin infusion; DKA, diabetic ketoacidosis; HbA1c, hemoglobin A1c; MDI, multiple daily injections; RCT, randomized controlled trial; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus
15 Type 2 DiabetesFewer clinical investigations have examined CSII in patients with T2DMIn an analysis of four randomized controlled trials involving patients with T2DM:No significant HbA1c improvements, differences in hypoglycemic risk, or weight differences were observed with CSII vs. MDI over 12 to 52 weeksCSII: continuous subcutaneous insulin infusionT2DM: type 2 diabetes mellitusMDI: multiple daily injectionBode BW. Diabetes Technol Ther. 2010;12 Suppl 1:S17-21.
16 Randomized Clinical Trials Comparing CSII and MDI for Patients With T2DM HbA1c (%)ReferenceDesignBaselineCSIIMDIP-valueNoh et al, Diabetes Metab Res Rev. 2008;24(5):30-week observational study (N=15)7.95.0NA<0.001Parkner et al, Diabetes Obes Metab. 2008;10(7):Observational study, 3 successive nights (N=10)Fasting plasma glucose: 209 mg/dL99.1 mg/dL<0.0001Berthe et al, Horm Metab Res. 2007;39(3):Crossover study, 2 12-week periods (N=17)9.07.78.6<0.03Herman et al, Diabetes Care. 2005;28(7):1 year parallel study (N=107)CSII: 8.4MDI: 188.8.131.52.19Raskin et al, Diabetes Care. 2003;26(9):24 week parallel study (N=132)CSII: 8.2MDI: 8.07.67.5NSWainstein et al, Diabet Med. 2005;22(8):Crossover study, 2 18-week periods (N=40)CSII-MDI: 10.1MDI-CSII 10.2−0.8+0.40.007CSII: continuous subcutaneous insulin infusion; MDI: multiple daily injection; T2DM: type 2 diabetes mellitus
18 Characteristics of the Ideal CSII Candidate The ideal CSII candidate is:A patient with T1DM or intensively managed insulin-dependent T2DMCurrently performing ≥4 insulin injections and ≥4 SMBG measurements dailyMotivated to achieve tighter blood glucose controlWilling and intellectually and physically able to undergo the rigors of insulin pump therapy initiation and maintenanceWilling to maintain frequent contact with their health care teamCSII: continuous subcutaneous insulin infusionT1DM: type 1 diabetes mellitusT2DM: type 2 diabetes mellitusSMBG: self-monitored blood glucose
19 Specific Characteristics of Patients Who Are Not Good Candidates for Insulin Pump Use Unable or unwilling to perform MDI injections (≥3 to 4 daily), frequent SMBG (≥4 or 5 daily), and carbohydrate countingLack of motivation to achieve tighter glucose control and/or a history of non-adherence to insulin injection protocolsHistory 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)MDI: multiple daily injectionSMBG: self-monitored blood glucose
20 Proposed Clinical Characteristics of Suitable Insulin Pump Candidates – T1DM Patients Patients with T1DM who do not reach glycemic goals despite adherence to a maximum MDI, especially if they have:Very labile diabetesFrequent severe hypoglycemia and/or hypoglycemia unawarenessSignificant “dawn phenomenon,” extreme insulin sensitivityPatients with T1DM who feel that CSII would be helpful in managing their diabetesSpecial populations (e.g., preconception, pregnancy, children, adolescents, competitive athletes)T1DM: type 1 diabetes mellitusMDI: multiple daily injectionCSII: continuous subcutaneous insulin infusion
21 Proposed Clinical Characteristics of Suitable Insulin Pump Candidates – T2DM Patients Selected patients with insulin-requiring T2DM who satisfy any or all of the following:C-peptide positive, but with suboptimal control on a maximal program of basal/bolus injectionsSubstantial dawn phenomenonErratic lifestyle (e.g., unpredictable schedules leading to difficulty maintaining meal timing)Severe insulin resistance, candidate for U500 insulin by CSIIAlso, selected patients with other types of diabetes mellitus (e.g., post-pancreatectomy)T2DM: type 2 diabetes mellitusCSII: continuous subcutaneous insulin infusion
23 Insulin Pump Provider Selection About 2000 US physicians prescribe insulin pumpsOnly providers whose practice can assume full responsibility for a comprehensive pump management program should offer the technologyThe availability of adequate patient education, training, and follow-up is essential to ensure optimal use of this technologyProviders should conduct periodic audits of pump settings in the context of current glucose dynamicsSkyler JS, et al. Clinical Diabetes. 2007(25):50-56Chait J
24 Insulin Pump Use in Various Patient Populations
25 Adult Patients (1)Before therapeutic initiation, the patient should have a multidisciplinary CSII health care team in placeThe health care team should develop a comprehensive education and training plan, including information on:Insulin pump and infusion set operationMaintenance and troubleshootingInfusion site preparationThe calculation and configuration of basal insulin infusion rates, initial insulin-carbohydrate ratios, boluses, and insulin sensitivity factorCSII: continuous subcutaneous insulin infusion
26 Adult Patients (2)At CSII initiation, the patient should have daily contact with the pump trainerA return visit with the endocrinologist/diabetologist within 3 to 7 days of initiation is advisedEducational consults should be scheduled weekly or biweekly at first, then periodically as neededSpecialist follow-up visits should be scheduled at least monthly until the pump regimen is stabilized, then at least once every 3 monthsCSII: continuous subcutaneous insulin infusion
27 Pediatric PatientsPediatric diabetes specialists agree that CSII is indicated for pediatric patients with:Elevated HbA1c levels on injection therapyFrequent, severe hypoglycemiaWidely fluctuating glucose levelsA treatment regimen that compromises lifestyleMicrovascular complications and/or microvascular risk factorsIdeal pediatric candidates have motivated families, with a working understanding of diabetes management, and committed to monitoring blood glucose ≥ 4 times/dayPatient age and duration of diabetes should not be factors in determining the transition from injections to CSIIPhillip M, et al. Diabetes Care. 2007;30(6):CSII: continuous subcutaneous insulin infusion
28 Calculations for Insulin Pump Settings Clinical GuidelinesStart with 1 basal rate, adjust according to glucose trends over 2-3 daysAdjust to maintain stability in fasting state (between meals & during sleep)Add additional basals according to diurnal variation (dawn phenomenon)Method 1.Pre-Pump TotalDaily Dose (TDD)Basal Rate(Pump TDD x .5) / 2- hPre-Pump TDD x .75Carb Ratio450 / TDD-Adjust based on low-fat meals with known carbohydrate content-Acceptable 2-h post-prandial rise is ~60mg/dL above pre-prandial BGAdjust carb ratio in 10%-20% increments based on post-prandial BGALTERNATE METHODSCarb Ratio: (6x Wt in kg / TDD) or (2.8 x Wt in lbs / TDD)Fixed Meal Bolus = (TDD x .5) / 3 equal meals (not carb counting)Pump TDDMethod 2.Patient WeightSensitivity Factor / Correction1700 / Pump TDD-Sensitivity Factor is correct if BG is within 30 mg/dL of target range within 2 hours after correction-Make adjustments in 10%-20% increments if 2-hr post- correction BGs are consistently above or below targetWt kg x .5 or lb x .23Clinical Considerations on Pump TDD-Average values from Method 1 & 2-Hypoglycemic patients start at lower value-Hyperglycemic, elevated A1C, or pregnant start at higher valueTDD: total daily doseBG: blood glucose
29 Pregnant Women with Diabetes – T1DM Insulin pump therapy has not been shown to be superior to MDI for maintaining HbA1c levels in pregnant womenA 2007 Cochrane review analyzed 5 randomized controlled trials comparing CSII with MDI in pregnant women with diabetes; no significant differences were found in any outcomes measuredOverall, the literature does not provide clear evidence that CSII is necessary for optimal treatment of women with T1DM during pregnancyMDI: multiple daily injectionCSII: continuous subcutaneous insulin infusionT1DM: type 1 diabetes mellitusCohen O, et al. Gynecol Endocrinol. 2008;24(11):Farrar D, et al. Cochrane Database Syst Rev. 2007;(3)(3):CD005542
30 Pregnant Women with Diabetes – T2DM and GDM Research is limited on pregnant women with T2DMHowever, insulin pump therapy seems to be safe and effective for maintaining glycemic control in pregnancies complicated by GDM/T2DM and requiring large insulin dosesDuring pregnancy, intensive education and surveillance of the infusion site and sets are requiredT2DM: type 2 diabetes mellitusCSII: continuous subcutaneous insulin infusionGDM: gestational diabetes mellitusSimmons D, et al. Diabetes Care. 2001;24(12):
31 Suggested Protocol for Insulin Pump Use During Pregnancy Insulin infusion rates for women with T1DM:Total basal insulin requirement for 24 hoursGestationUnits × Weight (in kg)Pre-pregnancy0.3First trimester0.35Second trimester0.4Third trimester0.45Term pregnancy (>38 weeks’ gestation)0.5Hourly infusion rate changes based on time of day(divide the total basal units by 24)Time of DayInfusion Rate12-4 AM½ calculated basal rate4-10 AM1½ calculated basal rate10 AM - 6 PMCalculated (may need adjustment based on stress & exercise in the time period)6 PM – 12 AMMeal-related insulin bolus*GestationUnits × Weight (in kg)(divided into thirds for a dose before each meal)Pre-pregnancy0.3First trimester0.35Second trimester0.4Third trimester0.45Term pregnancy (>38 weeks’ gestation)0.5After second trimester, in case of dislodgment at infusion siteDose of NPH 0.1 × weight (in kg) before bed; then lower early morning insulin infusion rate* Use only rapid-acting insulin analoguesT1DM: type 1 diabetes mellitus
32 Insulin Pumps in Inpatient Settings When CSII users are evaluated for a non-acute hyper- or hypoglycemic crisis, they typically have more insulin pump knowledge and expertise than the medical professionals handling their hospital stayAt emergency room or hospital admission, the specialist(s) responsible for the patient’s ambulatory pump management should be contacted promptly to make decisions about infusion adjustmentsPatients should be instructed to not discontinue the pump infusion, unless directed by their diabetes specialistCSII: continuous subcutaneous insulin infusion
33 Using U-500 Insulin in a Pump Several studies have shown that concentrated regular (R) U-500 insulin delivered by CSII is safe and effectiveAlthough R U-500 insulin is not FDA-approved for use in CSII, this treatment appears to be effective in delivering insulin to patients with T2DM who have high insulin requirements and are failing other treatment regimensKnee TS , et al. Endocr Pract. 2003;9(3):Schwartz FL. Endocr Pract. 2004;10(2):Lane WS. Endocr Pract. 2006;12(3):Bulchandani DG, et al. Endocr Pract. 2007;13(7):Reutrakul S, et al. J Diabetes Sci Technol. 2011;5(4):Lane WS. Endocr Pract. 2010;16(5):ClinicalTrials.gov. November 2013.CSII: continuous subcutaneous insulin infusionFDA: U.S. Food and Drug AdministrationT2DM: type 2 diabetes mellitus
35 Insulin Pump TrainingTraining patients on insulin pump use is necessary to reduce the risk of adverse eventsPatient diabetes education and pump training should be implemented by a multidisciplinary team under the direction of an experienced endocrinologist/diabetologistThe health care team should periodically reevaluate whether pump therapy is appropriate for the patient
36 Developing Uniform Training An introduction to insulin pump therapy should include:A description of the different devices available and a demonstration of the benefits of eachThe technical aspects of using the deviceChoice of infusion sets and their correct usePreventing infusion site and infection site reactionsPatients should be taught:The meaning of pump alarmsTo keep backup supplies on handTo make recommended pump setting changes at home
37 Training Patients and Their Families Patients and their families should:Be provided with a written summary of responses to different emergency situationsHave periodic skills retesting to maximize the effectiveness of pump therapy and maintain safetyBe re-trained when switching to a new pump modelBe periodically reminded of the manufacturer’s emergency number
39 Patient Safety IssuesUsability and human factors should be used as criteria to judge new insulin pumpsEvery patient using an insulin pump should have an experienced, pump-knowledgeable diabetes care teamAll patients should have periodic re-education and re-training to address knowledge gapsPatient suitability for pump use must be re-examined over a patient’s lifetime
41 Threshold Time to Bill Code 99354 (min) Coding for CSIIPayment for existing codes for diabetes education has not been established across the private and public sectorsExisting evaluation and management (E/M) codes for office encounters are usedThese involve initial or follow-up use (dependent on the complexity of the visit)If the physician time involved exceeds appropriate visit time, use prolonged visit codesCodeTypical Timefor CodeThreshold Time to Bill Code (min)99203306099204457599205909921315992142555992154070CSII: continuous subcutaneous insulin infusion
42 Reimbursement CMS also covers CSII, contingent upon certain criteria: Patient must be insulinopenic, defined as having a fasting C-peptide level ≤110% of the laboratory’s lower limit of normal, with a concurrently obtained fasting glucose ≤225 mg/dLOr patient must be β-cell autoantibody-positiveMost private insurers provide reimbursement for insulin pumps for patients with T1DM and T2DM, as well as for qualified insulin-dependent diabetes patients, without regard to diabetes typeT1DM: type 1 diabetes mellitusT2DM: type 2 diabetes mellitusCMS: Centers for Medicare and Medicaid ServicesCSII: continuous subcutaneous insulin infusionCMS.
43 Centers for Medicare & Medicaid Services (CMS) Insulin Pump Reimbursement Requirements Patient has completed a comprehensive diabetes education program and has been receiving MDI insulin with frequent self-adjustments for at least 6 months before pump initiation. Patient has documented SMBG frequency an average of ≥4 times per day during the previous 2 months. Patient must also meet ≥1 of the following criteriaHbA1c >7.0%History of recurrent hypoglycemiaWide fluctuations in blood glucose before mealtimeDawn phenomenon with FPG frequently >200 mg/dL, or a history of severe glycemic excursionsPatient on pump therapy before enrollment and has documented SMBG an average of ≥4 times per day during the month before enrollmentFasting C-peptide ≤110% lower limit of normal or ≤200% lower limit of normal if CrCl ≤50 ml/min with concurrent FPG ≤225 mg/dL; or beta-cell autoantibody positive (+ICA or GAD antibodies)CMS.CrCl, creatinine clearance; FPG, fasting plasma glucose; GAD, glutamate decarboxylase, HbA1c, hemoglobin A1c; ICA, islet cell antibodies; MDI, multiple daily injections; SMBG, self-monitored blood glucose
45 Cost-effectiveness Analyses Comparing CSII vs Cost-effectiveness Analyses Comparing CSII vs. MDI in Patients with T1DM and T2DMSeveral studies have found that CSII is either cost-saving or cost-effective vs. MDI1-3Research also indicates that CSII represents a good value for cost4-6One study found that reduced insulin and drug‐related expenditures offset initial CSII investment within 3 years for the most costly insulin users7Another study found that SAPT, in its currently state of development, was not economically attractive in the US for adults with T1DM81) St. Charles et al, Value Health. 2009;12(5): ) St. Charles et al, Clin Ther. 2009;31(3):3) Cummins et al, Health Technol Assess. 2010;14(11):1-181.4) Nørgaard K, et al, Ugeskr Laeger. 2010;172(27): ) Cohen N et al, Pharmacoeconomics. 2007;25(10):6) Roze et al, Diabet Med. 2005;22(9): ) David G, et al, Value Health 2012;15(4):A65.8) Kamble S, et al, Value Health. 2012;15(5):CSII: continuous subcutaneous insulin infusionMDI: multiple daily injectionT1DM: type 1 diabetes mellitusT2DM: type 2 diabetes mellitusSAPT: sensor-augmented pump therapy
47 Future Needs and Conclusions Further enhancements are needed to improve the configurability and safety of insulin pumpsThere is a clear need for educational programs to provide patients with initial and follow-up trainingResearch continues on an “artificial pancreas” that can dose the correct amount of insulin at the right timePeer reviewed research studies must continue to be conducted and research findings need to be translated for use in clinical practice