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Insulin Pump Management

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1 Insulin Pump Management
Consensus Statement by the AACE/ACE Insulin Pump Management Task Force George Grunberger, MD, FACP, FACE* Jill M. Abelseth, MD, FACE Timothy S. Bailey, MD, FACP, FACE, ECNU Bruce W. Bode, MD, FACE Yehuda Handelsman, MD, FACP, FACE, FNLA Richard Hellman, MD, FACP, FACE Lois Jovanovič, MD, MACE Wendy S. Lane, MD Philip Raskin, MD, FACE William V. Tamborlane, MD ENDOCRINE PRACTICE: TBD

2 Presentation Outline Introduction Preamble
State of Insulin Pump Technology Clinical Evidence Patient and Provider Selection Insulin Pump Use in Various Patient Populations Education and Training Patient Safety Issues Coding and Reimbursement Issues in Practice Economics of Insulin Pump Therapy Future Needs and Conclusions

3 Introduction

4 Introduction First AACE consensus statement on insulin pump management published in 2010 Current consensus statement includes: Extensive updates on state of insulin pump technology Expanded discussion of CSII in pediatric patients Data on use of concentrated regular U-500 insulin in CSII Discussion on need to develop uniform training Suggestions of what uniform training should cover Discussion of device-related pump problems Impact of patient selection and education on safe CSII use AACE: American Association of Clinical Endocrinologists CSII: continuous subcutaneous insulin infusion

5 Preamble

6 Preamble Roughly 20% - 30% of patients with T1DM and fewer than 1% of insulin-treated patients with T2DM use an insulin pump In 2007, the US FDA estimated that the number of patients with T1DM using CSII was ~375,000 By 2050, up to one-third of US residents may have T2DM; many of these individuals will be insulin-requiring Therefore, more clinicians must develop a comprehensive understanding of these devices T1DM: type 1 diabetes mellitus T2DM: type 2 diabetes mellitus FDA: U.S. Food and Drug Administration CSII: continuous subcutaneous insulin infusion HSBC Global Research. Healthcare US Equipment & Supplies U.S. FDA. General Hospital and Personal Use Medical Devices Panel. 2010 U.S. CDC. CDC Media Relations - Press Release: October 22, 2010.

7 State of Insulin Pump Technology

8 State of Insulin Pump Technology
Insulin pumps now include features such as Color touch screens USB-rechargeable batteries Pre-filled insulin cartridges, and Disposability The availability of multiple infusion set types, choices of catheter tubing lengths, and tubeless pumps have enhanced pump therapy accessibility and led to increased pump usage Look up USB...

9 Current Developments in Insulin Pump Technology
Clinical trials are underway to validate methods that accelerate insulin action Data supporting the feasibility of locating infusion sets and CGM catheters in close proximity make it likely that combination sensor and infusion sets will be developed Insulin pumps can now display CGM data on the same screen and share display data on other remote devices Medtronic’s MiniMed 530G with Enlite (approved in 2013) is the first device that alters insulin delivery in response to CGM sensor data CGM: continuous glucose monitoring

10 Insulin Pumps on the Market
Accu-Chek Combo System Asante Snap Insulin Pump System MiniMed Paradigm Real-Time Revel System (523/723) MiniMed 530G with Enlite (551/751) OmniPod Insulin Manage-ment System OneTouch Ping t:slim Insulin Pump V-Go Disposable Insulin Delivery Device Roche Health Solutions Asante Solutions Medtronic MiniMed Insulet Corporation Animas Tandem Diabetes Care Valeritas, Inc.

11 Clinical Evidence for Insulin Pump Therapy in Diabetes

12 Type 1 Diabetes A 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 CSII CSII users demonstrated greater improvements in quality of life measures Severe hypoglycemia appeared to be reduced in CSII users CSII: continuous subcutaneous insulin infusion MDI: multiple daily injection T1DM: type 1 diabetes mellitus Misso ML, et al. Cochrane Database Syst Rev. 2010;(1):CD doi(1):CD005103

13 Type 1 Diabetes The STAR-3 study showed significantly greater HbA1c reductions in patients with T1DM randomly assigned to sensor-augmented insulin pump therapy vs. MDI A 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 group Based on currently available data, CSII is justified for basal-bolus insulin therapy in patients with T1DM STAR-3: Sensor-Augmented Pump Therapy for A1C Reduction T1DM: type 1 diabetes mellitus MDI: multiple daily injection CSII: continuous subcutaneous insulin infusion Bergenstal RM, et al. N Engl J Med. 2010;363(4):

14 Key Findings: CSII Meta-Analyses (T1DM and T2DM) Published Since 2003
Reference Findings Weissberg-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 decreases Jeitler 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 T2DM Fatourechi 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 T2DM Pickup 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 hypoglycemia Monami 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 therapy CSII, 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 Diabetes Fewer clinical investigations have examined CSII in patients with T2DM In 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 weeks CSII: continuous subcutaneous insulin infusion T2DM: type 2 diabetes mellitus MDI: multiple daily injection Bode BW. Diabetes Technol Ther. 2010;12 Suppl 1:S17-21.

16 Randomized Clinical Trials Comparing CSII and MDI for Patients With T2DM
HbA1c (%) Reference Design Baseline CSII MDI P-value Noh et al, Diabetes Metab Res Rev. 2008;24(5): 30-week observational study (N=15) 7.9 5.0 NA <0.001 Parkner et al, Diabetes Obes Metab. 2008;10(7): Observational study, 3 successive nights (N=10) Fasting plasma glucose: 209 mg/dL 99.1 mg/dL <0.0001 Berthe et al, Horm Metab Res. 2007;39(3): Crossover study, 2 12-week periods (N=17) 9.0 7.7 8.6 <0.03 Herman et al, Diabetes Care. 2005;28(7): 1 year parallel study (N=107) CSII: 8.4 MDI: 8.1 6.6 6.4 0.19 Raskin et al, Diabetes Care. 2003;26(9): 24 week parallel study (N=132) CSII: 8.2 MDI: 8.0 7.6 7.5 NS Wainstein et al, Diabet Med. 2005;22(8): Crossover study, 2 18-week periods (N=40) CSII-MDI: 10.1 MDI-CSII 10.2 −0.8 +0.4 0.007 CSII: continuous subcutaneous insulin infusion; MDI: multiple daily injection; T2DM: type 2 diabetes mellitus

17 Patient Selection for CSII

18 Characteristics of the Ideal CSII Candidate
The ideal CSII candidate is: A patient with T1DM or intensively managed insulin-dependent T2DM Currently performing ≥4 insulin injections and ≥4 SMBG measurements daily Motivated to achieve tighter blood glucose control Willing and intellectually and physically able to undergo the rigors of insulin pump therapy initiation and maintenance Willing to maintain frequent contact with their health care team CSII: continuous subcutaneous insulin infusion T1DM: type 1 diabetes mellitus T2DM: type 2 diabetes mellitus SMBG: 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 counting Lack of motivation to achieve tighter glucose control and/or a history of non-adherence to insulin injection protocols 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) MDI: multiple daily injection SMBG: 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 diabetes Frequent severe hypoglycemia and/or hypoglycemia unawareness Significant “dawn phenomenon,” extreme insulin sensitivity Patients with T1DM who feel that CSII would be helpful in managing their diabetes Special populations (e.g., preconception, pregnancy, children, adolescents, competitive athletes) T1DM: type 1 diabetes mellitus MDI: multiple daily injection CSII: 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 injections Substantial dawn phenomenon Erratic lifestyle (e.g., unpredictable schedules leading to difficulty maintaining meal timing) Severe insulin resistance, candidate for U500 insulin by CSII Also, selected patients with other types of diabetes mellitus (e.g., post-pancreatectomy) T2DM: type 2 diabetes mellitus CSII: continuous subcutaneous insulin infusion

22 Insulin Pump Provider Selection

23 Insulin Pump Provider Selection
About 2000 US physicians prescribe insulin pumps Only providers whose practice can assume full responsibility for a comprehensive pump management program should offer the technology The availability of adequate patient education, training, and follow-up is essential to ensure optimal use of this technology Providers should conduct periodic audits of pump settings in the context of current glucose dynamics Skyler JS, et al. Clinical Diabetes. 2007(25):50-56 Chait 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 place The health care team should develop a comprehensive education and training plan, including information on: Insulin pump and infusion set operation Maintenance and troubleshooting Infusion site preparation The calculation and configuration of basal insulin infusion rates, initial insulin-carbohydrate ratios, boluses, and insulin sensitivity factor CSII: continuous subcutaneous insulin infusion

26 Adult Patients (2) At CSII initiation, the patient should have daily contact with the pump trainer A return visit with the endocrinologist/diabetologist within 3 to 7 days of initiation is advised Educational consults should be scheduled weekly or biweekly at first, then periodically as needed Specialist follow-up visits should be scheduled at least monthly until the pump regimen is stabilized, then at least once every 3 months CSII: continuous subcutaneous insulin infusion

27 Pediatric Patients Pediatric diabetes specialists agree that CSII is indicated for pediatric patients with: Elevated HbA1c levels on injection therapy Frequent, severe hypoglycemia Widely fluctuating glucose levels A treatment regimen that compromises lifestyle Microvascular complications and/or microvascular risk factors Ideal pediatric candidates have motivated families, with a working understanding of diabetes management, and committed to monitoring blood glucose ≥ 4 times/day Patient age and duration of diabetes should not be factors in determining the transition from injections to CSII Phillip M, et al. Diabetes Care. 2007;30(6): CSII: continuous subcutaneous insulin infusion

28 Calculations for Insulin Pump Settings
Clinical Guidelines Start with 1 basal rate, adjust according to glucose trends over 2-3 days Adjust to maintain stability in fasting state (between meals & during sleep) Add additional basals according to diurnal variation (dawn phenomenon) Method 1. Pre-Pump Total Daily Dose (TDD) Basal Rate (Pump TDD x .5) / 2- h Pre-Pump TDD x .75 Carb Ratio 450 / TDD -Adjust based on low-fat meals with known carbohydrate content -Acceptable 2-h post-prandial rise is ~60mg/dL above pre-prandial BG Adjust carb ratio in 10%-20% increments based on post-prandial BG ALTERNATE METHODS Carb 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 TDD Method 2. Patient Weight Sensitivity Factor / Correction 1700 / 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 target Wt kg x .5 or lb x .23 Clinical Considerations on Pump TDD -Average values from Method 1 & 2 -Hypoglycemic patients  start at lower value -Hyperglycemic, elevated A1C, or pregnant  start at higher value TDD: total daily dose BG: 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 women A 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 measured Overall, the literature does not provide clear evidence that CSII is necessary for optimal treatment of women with T1DM during pregnancy MDI: multiple daily injection CSII: continuous subcutaneous insulin infusion T1DM: type 1 diabetes mellitus Cohen 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 T2DM However, insulin pump therapy seems to be safe and effective for maintaining glycemic control in pregnancies complicated by GDM/T2DM and requiring large insulin doses During pregnancy, intensive education and surveillance of the infusion site and sets are required T2DM: type 2 diabetes mellitus CSII: continuous subcutaneous insulin infusion GDM: gestational diabetes mellitus Simmons 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 hours Gestation Units × Weight (in kg) Pre-pregnancy 0.3 First trimester 0.35 Second trimester 0.4 Third trimester 0.45 Term pregnancy (>38 weeks’ gestation) 0.5 Hourly infusion rate changes based on time of day (divide the total basal units by 24) Time of Day Infusion Rate 12-4 AM ½ calculated basal rate 4-10 AM 1½ calculated basal rate 10 AM - 6 PM Calculated (may need adjustment based on stress & exercise in the time period) 6 PM – 12 AM Meal-related insulin bolus* Gestation Units × Weight (in kg) (divided into thirds for a dose before each meal) Pre-pregnancy 0.3 First trimester 0.35 Second trimester 0.4 Third trimester 0.45 Term pregnancy (>38 weeks’ gestation) 0.5 After second trimester, in case of dislodgment at infusion site Dose of NPH 0.1 × weight (in kg) before bed; then lower early morning insulin infusion rate * Use only rapid-acting insulin analogues T1DM: 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 stay At 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 adjustments Patients should be instructed to not discontinue the pump infusion, unless directed by their diabetes specialist CSII: 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 effective Although 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 regimens Knee 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): November 2013. CSII: continuous subcutaneous insulin infusion FDA: U.S. Food and Drug Administration T2DM: type 2 diabetes mellitus

34 Insulin Pump Training

35 Insulin Pump Training Training patients on insulin pump use is necessary to reduce the risk of adverse events Patient diabetes education and pump training should be implemented by a multidisciplinary team under the direction of an experienced endocrinologist/diabetologist The 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 each The technical aspects of using the device Choice of infusion sets and their correct use Preventing infusion site and infection site reactions Patients should be taught: The meaning of pump alarms To keep backup supplies on hand To 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 situations Have periodic skills retesting to maximize the effectiveness of pump therapy and maintain safety Be re-trained when switching to a new pump model Be periodically reminded of the manufacturer’s emergency number

38 Patient Safety Issues

39 Patient Safety Issues Usability and human factors should be used as criteria to judge new insulin pumps Every patient using an insulin pump should have an experienced, pump-knowledgeable diabetes care team All patients should have periodic re-education and re-training to address knowledge gaps Patient suitability for pump use must be re-examined over a patient’s lifetime

40 Coding and Reimbursement

41 Threshold Time to Bill Code 99354 (min)
Coding for CSII Payment for existing codes for diabetes education has not been established across the private and public sectors Existing evaluation and management (E/M) codes for office encounters are used These 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 codes Code Typical Time for Code Threshold Time to Bill Code (min) 99203 30 60 99204 45 75 99205 90 99213 15 99214 25 55 99215 40 70 CSII: 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/dL Or patient must be β-cell autoantibody-positive Most 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 type T1DM: type 1 diabetes mellitus T2DM: type 2 diabetes mellitus CMS: Centers for Medicare and Medicaid Services CSII: continuous subcutaneous insulin infusion CMS.

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 criteria HbA1c >7.0% History of recurrent hypoglycemia Wide fluctuations in blood glucose before mealtime Dawn phenomenon with FPG frequently >200 mg/dL, or a history of severe glycemic excursions Patient on pump therapy before enrollment and has documented SMBG an average of ≥4 times per day during the month before enrollment Fasting 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

44 Health Economics of Insulin Pump Therapy

45 Cost-effectiveness Analyses Comparing CSII vs
Cost-effectiveness Analyses Comparing CSII vs. MDI in Patients with T1DM and T2DM Several studies have found that CSII is either cost-saving or cost-effective vs. MDI1-3 Research also indicates that CSII represents a good value for cost4-6 One study found that reduced insulin and drug‐related expenditures offset initial CSII investment within 3 years for the most costly insulin users7 Another study found that SAPT, in its currently state of development, was not economically attractive in the US for adults with T1DM8 1) 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 infusion MDI: multiple daily injection T1DM: type 1 diabetes mellitus T2DM: type 2 diabetes mellitus SAPT: sensor-augmented pump therapy

46 Future Needs and Conclusions

47 Future Needs and Conclusions
Further enhancements are needed to improve the configurability and safety of insulin pumps There is a clear need for educational programs to provide patients with initial and follow-up training Research continues on an “artificial pancreas” that can dose the correct amount of insulin at the right time Peer reviewed research studies must continue to be conducted and research findings need to be translated for use in clinical practice

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