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):
ClinicalTrials.gov. 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