Transcript Insulin Pump Consensus Statement Slide Presentation

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
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
Introduction
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
Preamble
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 insulinrequiring
 Therefore, more clinicians must develop a
comprehensive understanding of these devices
HSBC Global Research. Healthcare US Equipment & Supplies. 2005.
U.S. FDA. General Hospital and Personal Use Medical Devices Panel. 2010
U.S. CDC. CDC Media Relations - Press Release: October 22, 2010.
T1DM: type 1 diabetes mellitus
T2DM: type 2 diabetes mellitus
FDA: U.S. Food and Drug Administration
CSII: continuous subcutaneous insulin infusion
State of Insulin Pump Technology
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
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
Insulin Pumps on the Market
Accu-Chek
Combo
System
Roche
Health
Solutions
Asante
Snap
Insulin
Pump
System
Asante
Solutions
MiniMed
Paradigm
Real-Time
Revel
System
(523/723)
MiniMed
530G with
Enlite
(551/751)
OmniPod
Insulin
Management
System
OneTouch
Ping
Medtronic
MiniMed
Medtronic
MiniMed
Insulet
Corporation
Animas
t:slim
Insulin
Pump
Tandem
Diabetes
Care
V-Go
Disposable
Insulin
Delivery
Device
Valeritas,
Inc.
Clinical Evidence for
Insulin Pump Therapy in Diabetes
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
Misso ML, et al. Cochrane Database Syst Rev. 2010;(1):CD005103.
doi(1):CD005103
CSII: continuous subcutaneous insulin infusion
MDI: multiple daily injection
T1DM: type 1 diabetes mellitus
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
Bergenstal RM, et al. N Engl J Med. 2010;363(4):311-320
STAR-3: Sensor-Augmented Pump Therapy for A1C Reduction
T1DM: type 1 diabetes mellitus
MDI: multiple daily injection
CSII: continuous subcutaneous insulin infusion
Key Findings: CSII Meta-Analyses
(T1DM and T2DM) Published Since 2003
Reference
Findings
Weissberg-Benchell et al,
Diabetes Care. 2003;26(4):10791087
Jeitler et al, Diabetologia.
2008;51(6):941-951
Fatourechi et al,
J Clin Endocrinol Metab.
2009;94(3):729-740
Compared with MDI, CSII therapy was associated with significant improvements in glycemic
control based on HbA1c and mean blood glucose decreases
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
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):765-774
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):220-222
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; HbA 1c, hemoglobin A1c; MDI, multiple
daily injections; RCT, randomized controlled trial; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus
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
Bode BW. Diabetes Technol Ther. 2010;12 Suppl 1:S17-21.
CSII: continuous subcutaneous insulin infusion
T2DM: type 2 diabetes mellitus
MDI: multiple daily injection
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):384-391.
30-week observational study
(N=15)
7.9
5.0
NA
<0.001
Parkner et al, Diabetes Obes Metab.
2008;10(7):556-563.
Observational study, 3
successive nights (N=10)
Fasting plasma
glucose:
209 mg/dL
99.1
mg/dL
NA
<0.0001
Berthe et al, Horm Metab Res.
2007;39(3):224-229.
Crossover study, 2 12-week
periods (N=17)
9.0
7.7
8.6
<0.03
Herman et al, Diabetes Care.
2005;28(7):1568-1573.
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):2598-2603
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):1037-1046.
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
Patient Selection for CSII
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
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
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
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
Insulin Pump Provider Selection
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. http://www.diabetesselfmanagement.com/articles/insulin/insulin_pumps/1/. April 2013
Insulin Pump Use in
Various Patient Populations
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
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
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):1653-1662
CSII: continuous subcutaneous insulin infusion
Calculations for Insulin Pump Settings
Clinical Guidelines
Basal Rate
Method 1.
Pre-Pump Total
Daily Dose (TDD)
(Pump TDD x .5) / 2- h
Pre-Pump TDD x .75
Carb Ratio
Pump TDD
450 / TDD
Method 2.
Patient Weight
Wt kg x .5 or lb x .23
Sensitivity Factor
/ Correction
1700 / Pump TDD
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
-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)
-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)
-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 postcorrection BGs are consistently above or below target
TDD: total daily dose
BG: blood glucose
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
Cohen O, et al. Gynecol Endocrinol. 2008;24(11):611-613.
Farrar D, et al. Cochrane Database Syst Rev. 2007;(3)(3):CD005542
MDI: multiple daily injection
CSII: continuous subcutaneous insulin infusion
T1DM: type 1 diabetes mellitus
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
Simmons D, et al. Diabetes Care. 2001;24(12):2078-2082
CSII: continuous subcutaneous insulin infusion
GDM: gestational diabetes mellitus
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)
Hourly infusion rate changes based on time of day
(divide the total basal units by 24)
Time of Day
Infusion Rate
Pre-pregnancy
0.3
12-4 AM
½ calculated basal rate
First trimester
0.35
4-10 AM
1½ calculated basal rate
Second trimester
0.4
10 AM - 6 PM
Calculated (may need adjustment based on
Third trimester
0.45
Term pregnancy
(>38 weeks’ gestation)
0.5
Meal-related insulin bolus*
Units × Weight (in kg)
Gestation
(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
stress & exercise in the time period)
6 PM – 12
AM
Calculated (may need adjustment based on
stress & exercise in the time period)
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
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
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):181-186.
Schwartz FL. Endocr Pract. 2004;10(2):163-164.
Lane WS. Endocr Pract. 2006;12(3):251-256.
Bulchandani DG, et al. Endocr Pract. 2007;13(7):721-725.
CSII: continuous subcutaneous insulin infusion
Reutrakul S, et al. J Diabetes Sci Technol. 2011;5(4):1025-1026.
FDA: U.S. Food and Drug Administration
Lane WS. Endocr Pract. 2010;16(5):778-784.
T2DM: type 2 diabetes mellitus
ClinicalTrials.gov. http://clinicaltrials.gov/show/NCT01774968 November 2013.
Insulin Pump Training
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
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
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
Patient Safety Issues
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
Coding and Reimbursement
Coding for CSII
 Payment for existing codes for
Code
Typical Time
for Code
Threshold
Time to Bill
Code 99354
(min)
99203
30
60
99204
45
75
99205
60
90
99213
15
45
99214
25
55
99215
40
70
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
CSII: continuous subcutaneous insulin infusion
Reimbursement
Most private insurers provide
reimbursement for insulin
pumps for patients with
T1DM and T2DM, as well as
for qualified insulindependent diabetes patients,
without regard to diabetes
type
CMS. https://www.cms.gov/manuals/iom/list.asp. 2010
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
T1DM: type 1 diabetes mellitus
T2DM: type 2 diabetes mellitus
CMS: Centers for Medicare and Medicaid Services
CSII: continuous subcutaneous insulin infusion
Centers for Medicare & Medicaid Services (CMS)
Insulin Pump Reimbursement Requirements
A. 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
B. Patient on pump therapy before enrollment and has documented SMBG an
average of ≥4 times per day during the month before enrollment
C. 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. https://www.cms.gov/manuals/iom/list.asp. 2010
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
Health Economics of
Insulin Pump Therapy
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):674-686. 2) St. Charles et al, Clin Ther. 2009;31(3):657-667.
3) Cummins et al, Health Technol Assess. 2010;14(11):1-181.
4) Nørgaard K, et al, Ugeskr Laeger. 2010;172(27):2020-2025.
5) Cohen N et al, Pharmacoeconomics. 2007;25(10):881-897.
6) Roze et al, Diabet Med. 2005;22(9):1239-1245. 7) David G, et al, Value Health 2012;15(4):A65.
8) Kamble S, et al, Value Health. 2012;15(5):632-638.
CSII: continuous subcutaneous insulin infusion
MDI: multiple daily injection
T1DM: type 1 diabetes mellitus
T2DM: type 2 diabetes mellitus
SAPT: sensor-augmented pump therapy
Future Needs and Conclusions
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