insulin pump management consensus statement by the aace/ace insulin pump management task force...
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Insulin Pump ManagementConsensus 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, ECNUBruce W. Bode, MD, FACE
Yehuda Handelsman, MD, FACP, FACE, FNLA Richard Hellman, MD, FACP, FACE
Lois Jovanovič, MD, MACEWendy S. Lane, MD
Philip Raskin, MD, FACEWilliam V. Tamborlane, MD
ENDOCRINE PRACTICE: TBD
Presentation OutlineIntroductionPreambleState of Insulin Pump TechnologyClinical Evidence Patient 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
Introduction
IntroductionFirst AACE consensus statement on insulin pump
management published in 2010Current consensus statement includes:
Extensive updates on state of insulin pump technology Expanded discussion of CSII in pediatric patientsData on use of concentrated regular U-500 insulin in
CSII Discussion on need to develop uniform trainingSuggestions of what uniform training should cover Discussion of device-related pump problemsImpact of patient selection and education on safe CSII
use
AACE: American Association of Clinical EndocrinologistsCSII: 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 insulin-requiring
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. 2010U.S. CDC. CDC Media Relations - Press Release: October 22, 2010.
T1DM: type 1 diabetes mellitusT2DM: type 2 diabetes mellitus
FDA: U.S. Food and Drug AdministrationCSII: continuous subcutaneous insulin infusion
State of Insulin Pump Technology
State of Insulin Pump TechnologyInsulin pumps now include features such as
Color touch screensUSB-rechargeable batteriesPre-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 TechnologyClinical 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
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 Disposab
le Insulin Delivery Device
Roche Health Solutions
Asante Solutions
Medtronic MiniMed
Medtronic MiniMed
Insulet Corporation
Animas Tandem Diabetes Care
Valeritas, Inc.
Insulin Pumps on the Market
Clinical Evidence for Insulin Pump Therapy in Diabetes
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 measures Severe hypoglycemia appeared to be reduced
in CSII usersCSII: continuous subcutaneous insulin infusion
MDI: multiple daily injectionT1DM: type 1 diabetes mellitus
Misso ML, et al. Cochrane Database Syst Rev. 2010;(1):CD005103. doi(1):CD005103
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 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 ReductionT1DM: type 1 diabetes mellitus
MDI: multiple daily injectionCSII: continuous subcutaneous insulin infusion
Bergenstal RM, et al. N Engl J Med. 2010;363(4):311-320
Key Findings: CSII Meta-Analyses (T1DM and T2DM) Published Since 2003
Reference Findings
Weissberg-Benchell et al, Diabetes Care. 2003;26(4):1079-
1087
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):941-951
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):729-740
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; HbA1c, hemoglobin A1c; MDI, multiple daily injections; RCT, randomized controlled trial; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus
Type 2 DiabetesFewer 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 infusionT2DM: type 2 diabetes mellitus
MDI: multiple daily injectionBode BW. Diabetes Technol Ther. 2010;12 Suppl 1:S17-21.
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 CandidateThe 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 controlWilling 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 mellitusT2DM: 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 injectionSMBG: self-monitored blood glucose
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
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 injection
CSII: continuous subcutaneous insulin infusion
Proposed Clinical Characteristics of Suitable Insulin Pump Candidates – T1DM Patients
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 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 mellitus
CSII: continuous subcutaneous insulin infusion
Insulin Pump Provider Selection
Insulin Pump Provider SelectionAbout 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):50-56Chait 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 trainerA 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 PatientsPediatric 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
CSII: continuous subcutaneous insulin infusion Phillip M, et al. Diabetes Care. 2007;30(6):1653-1662
Method 1.Pre-Pump Total
Daily Dose (TDD)
Pre-Pump TDD x .75
Method 2.Patient Weight
Wt kg x .5 or lb x .23
Pump TDD
Calculations for Insulin Pump Settings
Basal Rate
(Pump TDD x .5) / 2- h
Sensitivity Factor / Correction
1700 / Pump TDD
-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)
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)
-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
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
Clinical Guidelines
TDD: total daily doseBG: blood glucose
Pregnant Women with Diabetes – T1DMInsulin 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 injectionCSII: continuous subcutaneous insulin infusion
T1DM: type 1 diabetes mellitusCohen O, et al. Gynecol Endocrinol. 2008;24(11):611-613.Farrar D, et al. Cochrane Database Syst Rev. 2007;(3)(3):CD005542
Pregnant Women with Diabetes – T2DM and GDMResearch 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 doses
During pregnancy, intensive education and surveillance of the infusion site and sets are required
T2DM: type 2 diabetes mellitusCSII: continuous subcutaneous insulin infusion
GDM: gestational diabetes mellitusSimmons D, et al. Diabetes Care. 2001;24(12):2078-2082
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
Suggested Protocol for Insulin Pump Use During Pregnancy 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
Calculated (may need adjustment based on stress & exercise in the time period)
Meal-related insulin bolus*
GestationUnits × 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
Insulin Pumps in Inpatient SettingsWhen 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
CSII: continuous subcutaneous insulin infusion FDA: U.S. Food and Drug Administration
T2DM: type 2 diabetes mellitus
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.Reutrakul S, et al. J Diabetes Sci Technol. 2011;5(4):1025-1026. Lane WS. Endocr Pract. 2010;16(5):778-784. ClinicalTrials.gov. http://clinicaltrials.gov/show/NCT01774968 November 2013.
Insulin Pump Training
Insulin Pump TrainingTraining 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 TrainingAn 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 use Preventing infusion site and infection site reactions
Patients should be taught: The meaning of pump alarmsTo keep backup supplies on handTo make recommended pump setting changes at
home
Training Patients and Their FamiliesPatients 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 IssuesUsability 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
Code Typical Timefor 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
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
CSII: continuous subcutaneous insulin infusion
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 mellitusT2DM: type 2 diabetes mellitus
CMS: Centers for Medicare and Medicaid Services CSII: continuous subcutaneous insulin infusion CMS. https://www.cms.gov/manuals/iom/list.asp. 2010
Centers for Medicare & Medicaid Services (CMS) Insulin Pump Reimbursement RequirementsA. 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)
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
CMS. https://www.cms.gov/manuals/iom/list.asp. 2010
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 ConclusionsFurther 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