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Improving Patient Experience With Insulin Infusion Sets: Practical Guidelines

and Future Directions

Article  in  The Diabetes Educator · April 2016

DOI: 10.1177/0145721716642526

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TDEXXX10.1177/0145721716642526The Diabetes EDUCATOREvert et al

The Diabetes EDUCATOR

470

Improving Patient Experience

With Insulin Infusion Sets
Practical Guidelines and Future
Directions

Alison B. Evert, MS, RD, CDE Purpose

Bruce W. Bode, MD, FACE
Bruce A. Buckingham, MD
Insulin infusion sets (IISs) are an essential component of
safe and effective insulin pump therapy. Establishing
Elizabeth Nardacci, MS, FNP-BC, CDE best practices for their use has been impeded by a lack of
Carol A. Verderese, BA formal study and limited resources for clinician and
patient education. Recent innovations in IIS science
Phyllis Wolff-McDonagh, DNP, ANP, CPNP, CDE
promise to change this status quo by increasing aware-
John Walsh, PA, CDTC ness of such problems as unexplained hyperglycemia and
infusion set occlusion.
Sponsored Special Section
by Becton Dickinson (BD)

Irl B. Hirsch, MD
From the Diabetes Care Center, University of Washington School of
Medicine, Seattle, Washington (Ms Evert, Dr Hirsch); Atlanta Diabetes Methods
Associates / Emory University, Atlanta, Georgia (Dr Bode); Stanford School
of Medicine, Palo Alto, California (Dr Buckingham); St Peter’s Health
In August 2015, a panel of diabetologists and certified
Partners Medical Associates, Albany, New York (Ms Nardacci); Diabetes
Education Group, Lakeville, Connecticut (Ms Verderese); Florida Health diabetes educators from various disciplines was con-
Care Plan, Palm Coast, Florida (Dr Wolff-McDonagh); and Advanced vened to reconsider IIS-related complications of pump
Metabolic Care and Research, San Diego, California (Mr Walsh). therapy, to better characterize infusion set factors affect-
ing patient experience, and to update priorities for opti-
Correspondence to Irl B. Hirsch, MD, Professor of Medicine, University of
mizing current technologies. Actionable guidelines were
Washington Med Ctr-Roosevelt, 4245 Roosevelt Way NE, 3rd Floor, Box
354691, Seattle, WA 98105 (ihirsch@u.washington.edu). provided for addressing common issues, including skin
reactions, site rotation and set changes, dislodgment of
Acknowledgments: This article represents the findings of an Insulin the infusion set, and partial or complete blockage of the
Infusion Set Expert Workshop, convened in New Orleans, Louisiana, catheter. These issues may underlie episodes of IIS fail-
August 2015. Workshop participants (the panel), in addition to the
authors, who reviewed and commented on this paper were Davida F.
ure and/or unexplained hyperglycemia.
Kruger, MSN, APN-BC, BC-ADM, Henry Ford Health System, Detroit,
Michigan; Nugget Burkhart, NP, BC-ADM, CDE, Kaiser Permanente
Medical Center (retired), San Francisco, CA; and Michelle Corcoran, RD,
Conclusion
CDE, Upper River Valley Hospital, New Brunswick, Canada.
Development of practical tools and standardized guide-
Funding: Supported by an educational grant from BD (Becton, Dickinson lines for empowering patients to prevent, diagnose, and
and Company). troubleshoot IIS problems that contribute to unexplained
hyperglycemia will be necessary to realize the full ben-
DOI: 10.1177/0145721716642526
efit of insulin pump therapy along the continuum of
© 2016 The Author(s) diabetes education.

Volume 42, Number 4, August 2016

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I
n 2011, the American Association of Diabetes
Educators issued a comprehensive white paper on
choosing and using insulin infusion sets (IISs;
accessible online).1 The paper encourages proactive
selection and management of IISs. Its recommenda-
tions for best practice are based largely on the clinical
experience of the authors, who at the time noted the relative
lack of evidence on IISs as compared with other compo-
nents of pump therapy. The situation has not changed
markedly since 2011 despite reports that IISs are of major
concern and importance to patients using insulin pumps.2
Recent calls for more methodical assessment of pump
therapy outcomes—notably, the joint statement of the
European Association for the Study of Diabetes and the
American Diabetes Association’s Diabetes Technology
Working Group entitled “Insulin Pump Risks and Benefits:
A Clinical Appraisal of Pump Safety Standards, Adverse
Event Reporting, and Research Needs”—have refocused
attention on the safe and efficient use of IISs.2-5 To further
characterize infusion set factors affecting patient experi-
ence with insulin pump therapy and build on the recom-
mendations put forth in the 2011 American Association of
Diabetes Educators white paper, a panel of diabetologists
and certified diabetes educators from various disciplines
convened in New Orleans in August 2015. The panel
reconsidered IIS-related complications of pump therapy
and updated priorities for optimizing current technolo-
gies. Actionable guidelines were provided for addressing
skin challenges; choosing among different IIS designs;
empowering patients to prevent, diagnose, and trouble-
shoot IIS problems; and incorporating IIS education in
different health care delivery models. This article sum-
marizes the discussion.
Reconsidering IISs
Even when best practices for insulin pump therapy are
observed, infusion set failure occurs, leading to interrup-
tion of insulin flow, hyperglycemia, and possible diabetic
ketoacidosis (DKA). Common sources of IIS failure and
related complications are catheter occlusion, catheter
kinking, leakage following partial or full IIS detachment,
and adhesion problems. Unexplained hyperglycemia and/
or infusion set occlusion occur frequently, as indicated by
a randomized controlled trial of pump therapy patients
(n = 256) in which more than two-thirds of participants
reported at least 1 incidence per month.6
Evert et al
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Insulin Infusion Sets
471
The panel agreed that understanding the actual fre-
quency of these events and their underlying causes is a
pressing priority for the following reasons:
• Insulin pumps are being used more widely by patients with
type 1 and with type 2 diabetes.7
• IIS issues constitute the greatest number of pump-related
recalls by the US Food and Drug Administration.3
• Recent studies show that interruptions of insulin flow during
insulin infusion usually do not trigger occlusion alarms.8-14
• Wide-scale adoption of closed-loop insulin delivery systems
that combine an insulin pump and glucose sensor into a
single unit (also known as “artificial pancreas”) will depend
on reliable performance of IISs.
• Real-world information from patient registries and network-
ing sites is making systematic analysis of IIS issues and
outcomes more feasible.
Choosing an Infusion Set
The panel recommended talking to patients and care-
givers about IIS selection and maintenance of IIS site
health along a continuum of pump use, with the objective
of helping them recognize and reduce the likelihood of
chronic and acute complications, ranging from inflam-
mation at the infusion site to metabolic derangements,
including DKA. A trained clinician should observe
patients inserting their infusion set at the beginning of
pump therapy and as part of regular follow-up to confirm
ongoing coordination of equipment, skills, and circum-
stances of daily living. If possible, criteria for choosing
an IIS should be discussed prior to ordering the insulin
pump in a setting where multiple IIS models are avail-
able. Selection should be guided by age, duration of dia-
betes, dexterity issues, dermatologic conditions, physical
activity, and patient/caregiver preference. Infusion sets
and features that are available or will soon become avail-
able in the United States, as well as patient-specific fac-
tors for choosing among them, are provided in Tables 1
and 2, respectively.
Etiologies of Nonfunctioning
Sets
Inaccuracies of insulin delivery related to IISs have a
multifactorial etiology that is not well understood. In a
study of IIS function for up to 7 days in 20 patients using
either a steel or Teflon catheter for comparison, the
 Table 1

472
Infusion Sets and Features: 2016 Quick-Reference Guidea

Tubing
Cannula Insertion Cannula Length, in;
Material Infusion Set Name Angle Length, mm Gauge Connection Disconnectionb Inserter
Steel Rapid D, Accu-Check® Straight, 90° 6, 8, 10 28-g stainless-steel Luer lock 24, 31, 43; away No
needle from site
Steel Contact Detach™, Uno-medical Straight, 90° 6, 8 29-g stainless-steel Luer lock 23, 43; away from No
needle site
Steel Easy Release, Sooil Straight, 90° 7, 9 27-g intro needle, 25-g Non-Luer lock 28, 43; away from No
cannula site
Steel Sure-T®, Medtronic Straight, 90° 6, 8, 10 29-g stainless-steel Non-Luer lock 18, 23, 32, 43; at No
needle site
Plastic Cleo 90™, Smiths Medical Straight, 90° 6, 9 28-g intro needle, 25-g Luer lock 24, 31; at site Built-in disposable
cannula
Plastic Inset™, Uno-medical, Exclusive to Straight, 90° 6, 9 27-g cannula Luer lock 23, 43; at site Built-in disposable
Animas
Plastic Ultraflex, Accu-Check® Straight, 90° 8, 10 27-g intro needle, 25-g Luer lock 23, 31, 43; at site Manual or Accu-Check
cannula LinkAssist®
Plastic MiniMed™ Pro-set™ with BD Straight, 90° 6 30-g intro needle, 28-g Luer lock and/or non-Luer 24, 42; at site Manual
Flow-Smart™ technology, dual-port cannula lock (paradigm
BD/Medtronic connector)
Plastic Quick-set®, Medtronic Straight, 90° 6, 9 27-g intro needle, 25-g Luer lock and/or non-Luer 18, 23, 32, 43; at Manual or Quick
cannula lock site Serter®

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Plastic Soft Release, Sooil Straight, 90° 9 25-g intro needle, 27-g Non-Luer lock 27, 43; at site No
cannula
Plastic Mio®, Medtronic Straight, 90° 6, 9 27 g Non-Luer lock 18, 23, 32, 43; at Built-in disposable
site
Plastic T-Set™, Tandem Diabetes Care Straight, 90° 6, 9 27-g intro needle; 26-g Luer lock 23, 43; at site Built-in disposable
cannula
Plastic Tender, Accu-Check® Angled 13, 17 27-g intro needle, 25-g Luer lock 24, 31, 43; at site No
cannula
Plastic Silhouette®, Medtronic Angled 13, 17 27-g intro needle, 25-g Luer lock and/or non-Luer 18, 23, 32, 43; at Sil-Serter®
cannula lock site
Plastic Comfort™, Uno-medical Angled 13, 17 Luer lock 23, 43; at site No
Plastic Inset 30™, Uno-medical Angled 13 27 g Luer lock 23, 43; at site All in 1 device
Plastic Soft Release, Sooil Angled 9 25-g intro needle, 27-g Non-Luer lock 27, 43; at site No
cannula
a
Consult manufacturer to confirm current features. Adapted from Diabetesnet.com, “Infusion Set Comparison,” http://www.diabetesnet.com/diabetes-technology/infusion-sets, accessed December 10, 2015.
b
At site: Tubing disconnects at infusion site, leaving needle or cannula and adhesive in place. Away from site: Tubing disconnects a few inches away from infusion site; needle, cannula, adhesive, and a short tail of tubing
remain.
 Insulin Infusion Sets

473

Table 2

Matching Common Patient Factors to Infusion Set Features1,6,14

Patient Factor Infusion Set Factor

Age 90° insertion angle easier for children learning to insert their own IISs
Steel needle sets easier to teach and simpler to insert, with rare dislodgment or kinking
Shorter IIS tubing length generally better for children and most adults
Pregnancy Steel reduces risk of bent/obstructed cannula
30°-45° angle of insertion preferred when abdominal tissue becomes stretched
Dexterity and visual issues 90° angle easier in cases of poor dexterity and/or hard-to-reach sites
Use of an auto-inserter may be easier
Audible “click” of sideway-pull disconnection/reconnection mechanism is reassuring to
visually impaired; twist-and-pull sometimes easier to manipulate
Lean/muscular 30°-45° angle reduces risk of dislodgment for lean patients
Insulin dose Longer-length cannulae better for larger boluses (≥25 units) and higher basal rates
(≥2.5 U/h)
Susceptibility to occlusions Steel IISs eliminate kinking risk
IIS with side-port catheters may reduce risk of subalarm (silent) occlusion due to in-line
rises in pressure from partial or complete blockage
Needle phobia Simplicity of 90° insertion angle may be preferred
Use of a preloaded insertion device, rather than an IIS that needs to be manually placed in
the insertion device by the patient, may be less stressful for some
Allergies and infection Reactions to Teflon or nickel in steel needle may dictate choice
30°-45° angle with viewing window allows monitoring for redness around cannula insertion
site
Lipohypertrophy, scarring, and/or collagen Rotation of the site is crucial; some patients may need to return to injections.
pathologies due to duration of diabetes
Physical activity History of cannula kinking may favor steel
30°-45° angle reduces risk of dislodgment
Abbreviation: IIS, insulin infusion set.

strongest predictor of set reliability was the individual
patient.5 Over the 77-week study period (≈40 insertions
for each type of set), 30% of sets failed because of hyper-
glycemia and a failed correction dose; 13% failed because
of pain at the infusion site; 10% were pulled out acciden-
tally; 5% fell out because of loss of adhesion; 4% were
removed because of infection; and 10% showed erythema
and/or induration >10 mm.5 Anecdotal evidence suggests
that 30% to 50% of set removals are due to unexplained
hyperglycemia, defined as a blood glucose level
>250 mg/dL with no apparent medical, dietary, insulin
dosage, or pump-related explanation.
The panel agreed that unexplained hyperglycemia
remains a particularly frustrating challenge to successful
pump therapy, and it was guardedly optimistic that trans-
lational IIS research studies will yield multipronged clini-
cal solutions. One example of such research cited by the
panel was the development of side-ported cannula tech-
nology that reduces subalarm pressure rise events by
enabling insulin flow out of 2 channels. This dual-port
design was conceived when investigators installed pres-
sure sensors into infusion lines to measure correlations
between in-line pressure variability and insulin flow reli-
ability during continuous basal intradermal infusion. In

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The Diabetes EDUCATOR
474
comparing the measurements with subcutaneous controls,
researchers observed that pressure excursions high enough
to reduce the rate of insulin flow and corresponding
plasma insulin levels seldom surpassed the pressure
thresholds of insulin pumps, giving rise to subalarm (or
“silent”) occlusions associated with hyperglycemia.8
Fluoroscopic imaging and additional pressure studies sub-
sequently showed that the formation of dual depots from
the side-ported cannula, at the clinically relevant basal
insulin delivery rate of 1.0 U/h, was associated with a 75%
reduction in the occurrence of silent occlusions, as com-
pared with standard IISs, for at least 4 hours following
insertion.6,9-14 This design has been approved in the United
States, Canada, and Europe and is expected to become
commercially available in 2016. A controlled multicenter
study of longer duration in pump patients with type 1 dia-
betes is needed to realize the potential of this IIS design
under real-world conditions.14 As of this writing, there is
no similarly published research to guide clinicians. It is
expected that this situation will change with continued
commitment to accelerating the development of artificial
pancreas systems. For example, the Juvenile Diabetes
Research Foundation is supporting initiatives to identify
underlying mechanisms of IIS failure and provide mitiga-
tions to known failure modes when insulin is delivered via
subcutaneous cannula.15
Considering the current landscape, in which the etiol-
ogy of set failure is often not apparent, the panel recom-
mended that patients who experience ≥1 IIS failures a
month review their technique with a clinician or test a
different type of IIS with the guidance of their health care
team. Although more research is needed, observational
evidence suggests that changing the infusion set every 48
to 72 hours may reduce complications of IIS wear in
some patients.7 Using current tools and scientific meth-
odologies to further characterize the interrelationships of
insulin kinetics, device design, and individual physiol-
ogy in IIS-induced hyperglycemia is expected to clarify
the implications of change-frequency and other protocols
for individual patients.
Diagnosing and Addressing
Infusion Set Issues
Infusion set issues often resolve once a pump user
changes technique, switches to a more suitable IIS, and/
or anchors the infusion line. Due to the short half-life of
rapid- or short-acting insulin used in pumps, any delivery
interruption can lead to hyperglycemia within 4 to 8
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hours and, if overnight, DKA in the morning. In a study
of 30-minute IIS disconnection, blood glucose levels
increased by 1 mg/dL (0.06 mmol/L) for each minute (up
to 3 hours) that basal insulin infusion was interrupted.16
With safety in mind, the panel stressed the importance
of alerting patients to common causes of IIS failure at the
outset of pump therapy. Such early education can serve
to prevent self-blame, which can delay effective action;
encourage diagnosis of obvious problems at the time
they occur; and heighten awareness of the infusion set as
a possible source of unexplained hyperglycemia.
Table 3 presents considerations for distinguishing
obvious problems that can be quickly resolved by a well-
educated patient or caregiver—for example, dislodgment
of the cannula from the skin, leakage due to motion of
the infusion set or improper insertion, and the presence
of a hematoma at the cannula tip—from those that
require further investigation or observation by a health
care professional. The latter might include visual impair-
ment, limitations of psychomotor skills or range of
motion, patterns of pump disconnection/suspension of
insulin delivery, and financial concerns.
When a patient presents with IIS failure, clinicians
should review site preparation and set insertion with him
or her; inspect the site, skin, and line anchoring; review
blood glucose and continuous glucose monitoring data
for unexplained hyperglycemia; and help the patient
reconstruct the circumstances surrounding the episode.
The panel observed that the following questions might be
useful in determining the cause of the failure17:
• How many days do you usually wear an IIS?
• How often do your sites fail or stop working, as evidenced
by unexplained hyperglycemia?
• Does the skin where you wear your infusion set feel or look
different from other parts of your body? Do you notice scar-
ring or fatty buildup?
• Do correction boluses sometimes not work?
• Do some highs only correct when you change your infusion
set?
Pump patients with a history of unexplained hypergly-
cemia must be particularly alert to the signs and symp-
toms of hyperglycemia (eg, increased thirst, urination)
and, in the event that they occur, measure blood glucose
immediately.7 Any sudden unexplained (ie, not related to
a meal) glucose elevation >250 mg/dL (13.88 mmol/L)
or episode of nausea or vomiting should prompt a urine
Volume 42, Number 4, August 2016
 Insulin Infusion Sets

475

Table 3

Detecting and Addressing Device Issues That Can Contribute to Unexplained Hyperglycemia1,6

Clinician/Educator
Issue Patient Considerationsa Considerations Action
Dislodged set; no alarm What did the set look like With Teflon sets, patients Patient: Change set if dislodged.
(can be detected and at the time of removal? may not be able to feel Clinician/educator: Visually evaluate insertion
managed immediately Was the Teflon catheter when catheter becomes site; observe patient putting in the IIS; advise
by educated patient/ kinked? Was the needle dislodged: helpful to patient about site rotation and ways to
caregiver) still attached? Did know (1) what the set improve adhesion (eg, anchor the infusion line;
something happen that looked like when patient use over- or underbandaging); consider
could have made the set pulled it out, (2) changing set type if dislodging recurs.
fall out? Was the set circumstances of set
anchored sufficiently? becoming dislodged, (3)
how site was anchored
Leakage; no alarm (can Was there any unusual Insulin contains Patient: Inspect pump, reservoir/cartridge, tubing, and
be detected and smell of insulin around preservatives with infusion set if unexplained hyperglycemia occurs.
managed immediately the infusion site or the detectable odor similar to Change set if leaking is seen, the odor of insulin is
by educated patient/ connection between the railroad ties or detected, or a correction bolus is ineffective.
caregiver) reservoir cartridge and Band-Aids. Clinician/educator: Expose the patient to the odor
tubing prior to the of insulin during initial training so that he or she
episode of can detect leakage; check the patient’s set
hyperglycemia? technique, cartridge/reservoir filling.
Occlusion; may be Was there catheter kinking, Causes of occlusion may be Patient: Change set if an occlusion alarm occurs
associated with a blood in the cannula, multifactorial; subalarm or unexplained hyperglycemia is present but
pump alarm, but often tissue compression? in-line pressure does not respond to a correction bolus; bring
there is no pump excursions (silent any tubing sets and catheters worn that were
alarm (can be occlusions) could be an removed during hyperglycemic episode to
detected and overlooked contributing office visit; ask about alternative sets in the
managed by educated factor. May be associated event of recurrent episodes.
patient/caregiver but with prolonged infusion Clinician/educator: Check meter and continuous
may require clinician set wear (length of wear glucose monitoring downloads for patterns of
involvement) can be patient specific). subalarm occlusions; check for frequency of
infusion set changes; if appropriate, suggest
dual-port insulin delivery to reduce in-line
pressure; consider change of insulin type.
Inadequate insertion; no Does the IIS or the adhesive Choice of auto-inserters Patient: Inspect pump, reservoir/cartridge, tubing,
alarm (can be appear poorly attached may be inappropriate or and infusion set if unexplained hyperglycemia
detected and on visual inspection of technique sensitive; occurs. Change set if leaking is seen, the odor
managed immediately insertion site? Is an auto- spring on reusable of insulin is detected, or a correction bolus is
by educated patient/ inserter being used, and, inserter may be worn ineffective. Consider a slanted IIS that allows
caregiver) if so, is it working out. Is the site suited to visual inspection of the insertion site. Consider
properly? patient’s psychomotor pros and cons of an auto-insertion device.
skills and/or range of Clinician/educator: Observe the patient’s
motion? insertion technique; check whether
auto-inserter is being used effectively and
verify that the spring is not worn out; make
sure patients using auto-inserters have the
ability to manually insert an IIS.
(continued)

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Table 3

(continued)

Clinician/Educator
Issue Patient Considerationsa Considerations Action
Air in the system (can be Was air primed out of pump Air bubbles may be more Patient: Take care to prime out air from the
detected and reservoir? Was air problematic for patients reservoir and tubing; ensure that all
managed immediately primed out of tubing with very low insulin connections are tight and that insulin is at
by educated patient/ when infusion set was requirements. Is patient’s room temperature.
caregiver) changed? Is there a priming technique Clinician/educator: Observe the patient’s skills,
loose connection at correct? Is visual acuity including drawing up insulin, attaching the
either end of tubing? Is sufficient to see bubbles tubing, manually priming the system, loading
insulin at room in the line? the pump, and then engaging the pump’s
temperature (not cold) priming function; ensure that patient is holding
upon filling the reservoir the reservoir/cartridge vertically, plunger down
and inserting the set? to avoid air trapping, and that bubbles in the
line can be seen if present.
Mechanical function of Do the built-in error codes, Toll-free support numbers Patient: Become familiar with pump mechanics
pump; pump alarm battery change indicator/ are on the back of every and know how to locate diagnostic codes;
sounds (can usually alarm, or diagnostic pump model. The use of after mechanical malfunction, verify accuracy
be detected and programs point to pump a pump and glucose of all pump settings, including time set on the
managed immediately malfunctions? Have you monitoring downloads is pump’s internal clock.
by educated patient/ been through x-rays, strongly advised for Clinician/educator: Educate the patient on
caregiver but may computed tomography tracking basal rates, transferring from pump therapy back to
require clinician/ scans, or other medical bolus dosing, and manual injections. Maintain record of pump
manufacturer procedures that might patterns of glycemic settings on each clinic visit and reinforce
involvement) affect your insulin pump? control as related to appropriate sources of assistance (eg, pump
device use and company for mechanical problems and
conditions of daily life. clinicians for glycemic or medical issues).
Delayed insulin When was the last IIS Inadequate site rotation and Patient: Palpate and visually inspect infusion
absorption; no alarm replacement? Have the skin issues, such as sites to determine skin health and the
(can be detected and same sites been used lipohypertrophy, scarring, presence of lipohypertrophy; avoid
managed by educated repeatedly? Are there and infection, are lipohypertrophic sites.
patient/caregiver but signs of skin infection, commonly associated Clinician/educator: Palpate and visually inspect
will often require lipohypertrophy, or with unexplained infusion sites for lipohypertrophy or other skin
clinician involvement) scarring that can delay hyperglycemia and IIS issues at each office visit; review choice of IIS
insulin absorption? failure. and site rotation practices; actively inquire
about skin concerns.
Insulin spoilage Is there evidence of very Currently available Patient: Store opened insulin vials at room
small precipitates or, in rapid-acting insulin is temperature no more than 28 d, and avoid
extreme cases, generally very stable exposure to extreme heat or cold; refrigerate
discoloration? Were there when stored and used as unopened insulin until use or the expiration
circumstances (eg, flying, prescribed. Although date; always pack insulin in a carry-on bag
beach, warm climates) unusual, insulin during air travel.
that could have exposed crystallization has been Clinician/educator: Remind the patient to fill a
insulin to extreme considered as a possible new cartridge/reservoir from a new insulin vial
temperatures? cause of catheter when replacing the infusion set; reinforce the
blockage and associated importance of proper storage conditions for
hyperglycemia insulin at home and during travel.
(continued)

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 Insulin Infusion Sets

477

Table 3

(continued)
Clinician/Educator
Issue Patient Considerationsa Considerations Action
Frequency of set change Is there anxiety around Health insurance and cost Patient: Abide rule of “when in doubt, take it
changing infusion sets or issues can increase out”; replace set more frequently when
inserting the cannula? anxiety around timely set switching between types of IISs and also
What is the glycemic replacement. Does during pregnancy.
effect of delaying set patient reuse reservoirs Clinician/educator: Look at pump priming history
or use every drop of
change beyond the to verify frequency of IIS replacement; talk to
insulin? The length of
recommended period? Is the patient about concerns regarding set
time between
cost of set replacement replacements should be replacement with the goal of establishing a
and other pump-related dictated by the goal of realistic and healthy regimen. Examine
supplies a concern? Is maintaining healthy patterns of pump disconnection/suspended
there a pattern of glycemic control. The insulin delivery between set changes. Explore
disconnecting the pump length of wear is patient barriers (eg, financial, motivational, and
or suspending insulin specific, with some matters of convenience) that delay set change.
delivery between set individuals needing to
changes? change their sets every 2
to 3 d, whereas others
may have 5 to 6 d
between site changes
without hyperglycemia or
local site issues. Is the
tubing or reservoir
removed from the pump
between set changes?
Abbreviation: IIS, insulin infusion set.
a
Patient should be encouraged to write down specific circumstances surrounding these issues.

or blood ketone assessment as well. With blood ketones
>0.6 mmol/L or a failed correction dose (glucose does
not decrease by at least 50 mg/dL [2.77 mmol/L] in an
hour), rapid- or fast-acting insulin should be adminis-
tered by injection, based on the patient’s established cor-
rection dose algorithm.
Excess ketones in the blood or urine suggest a failure
in insulin delivery, mandating that the patient replace the
current infusion set and the infusion reservoir/cartridge.
An unexplained glucose >250 mg/dL (13.88 mmol/L)
that does not lower ≥2 hours after a correction bolus
requires repeat replacement of the IIS and reservoir, with
insulin from a fresh vial, or manual dosing. The patient
should try to determine the cause of IIS failure (eg, dis-
lodgment, blockage, scar tissue, or leakage) and, if pos-
sible, write down the circumstances. Emergent care may
be warranted if glycemic control cannot be restored
within a reasonable period, if nausea and vomiting
p­ ersist, or if the patient’s clinical condition continues to
deteriorate.
In the event of pump disconnection—for example, for
showering or swimming—blood glucose should be
checked before and after the period of the disconnection.
If the disconnection is expected to last an hour or more,
it is commonly recommended that the patient replace
basal insulin by delivering a bolus dose just prior to the
disconnection. This procedure should be repeated if the
disconnection time is extended (with intermittent pump
reconnections) until the period of disconnection has
passed.1
Developing and Reinforcing
Healthy IIS Habits
The panel endorsed the goal of formalizing proactive
steps to prevent or, if necessary, break cycles of suboptimal

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The Diabetes EDUCATOR
478
glycemic control related to IIS failure. Such a cycle may
initially manifest as recurrent hyperglycemia, with or with-
out a pump alarm, followed by repeated infusion set
changes, resulting in the patient running low on supplies.
Due to financial or other concerns, the patient may delay
IIS replacement (manufacturers recommend changing
infusion sets and sites every 48 to 72 hours), which may
increase the risk for site inflammation or infection and
eventually erode confidence in being able to manage
adverse events; a progressive worsening of glycemic con-
trol may then ensue.1-3,18
Citing this pattern, the panel called for a minimum
standard of systematic adverse event prevention in all
practice settings. Site selection, preparation, rotation, and
maintenance were specified as primary areas of educa-
tion for any health care professional seeing pump therapy
patients.
Site Selection
Patients new to pump therapy generally find IIS inser-
tion easiest at viewable sites, such as the abdomen or
thigh. Other common sites are the upper buttocks, the
back of the arm, the lower back, and, for pregnant
patients, just below the waistline at the side of the body.
Sites adjacent to muscle movement may yield less pre-
dictable insulin absorption and potentially cause skin irri-
tation. Consider repeat movements, as with golf or tennis,
when choosing a secure site.
Patients should be educated early and regularly on the
importance of timely site rotation to reduce the risk of
lipohypertrophy and other skin pathologies (eg, scarring,
irritation, infection, and “pump bumps”). These condi-
tions affect insulin absorption and may be disturbing to
patients for cosmetic reasons. Since the initial stages may
be easier to feel than to see, all health care practitioners
(endocrinologists, primary care physicians, physicians
assistants, nurse practitioners, pharmacists, and allied
health professionals) should be trained to palpate IIS
sites and refer the patient to a pump specialist if neces-
sary. Lipohypertrophy is a thickened rubbery swelling of
tissue that may be soft or firm; pump bumps appear as
small reddish papules at IIS insertion sites; and scarring
feels like small to large firm lumps under the skin.
Patients should be trained to feel their own sites—prefer-
ably while in a standing position using a hand lotion or
gel—and be actively encouraged to rotate sites before
problems develop.
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Although site rotation strategies have not been for-
mally studied, empirical evidence supports inserting the
cannula approximately 2 in away from the previous site
for angled sets, approximately 1 in away for 90° sets, and
at least 2 in from current continuous glucose monitoring
sites. The old set may be temporarily left in place to serve
as a reference point until the new set is inserted. Lifting a
skin fold is generally advised if there is little subcutane-
ous fat at the infusion site and the patient is using an
angled set and/or inserting the cannula manually.
Site Preparation and Maintenance
Site preparation and maintenance are crucial to pre-
vent infection and skin irritation. The practical measures
listed in Table 4 should be emphasized at the start of
patient training and reviewed at least annually when
pump supply prescriptions are renewed. Online resources,
such as preapproved YouTube demonstrations of IIS
insertion techniques, may be especially helpful in pri-
mary care or other practice settings where focused pump
therapy education is not feasible. Anchoring the infusion
line about 2 in away from the set with a piece of tape,
creating a so-called safety loop, can reduce the risk of
cannula movement and dislodgment. Tips for improving
tape adherence—a common issue for patients who are
highly physically active, sweat profusely, or have excess
body hair—are listed in Table 4.
Gathering, Organizing, and
Using Information
Systematically documenting IIS information—includ-
ing name of the infusion set, length of the catheter and
tubing, and other specific information (as shown in
Table 1)—is essential to ensuring optimal care for indi-
vidual pump therapy patients. To save time, the process
might begin with a waiting-room handout, in the form of
a questionnaire, to generate discussion about IIS-related
practices and troubleshooting strategies, including the
use and storage of ketone strips and pump therapy sup-
plies. The filled-in questionnaire should serve to supple-
ment, clarify, and/or substantiate the following clinical
information: duration of diabetes; length of time on the
pump; glucose metrics, preferably obtained from down-
loaded pump and glucose data; frequency of bolusing,
including whether a bolus calculator is being used; total
daily insulin dose (including percentage basal versus
Volume 42, Number 4, August 2016

Table 4
Considerations for Skin Preparation and Maintenance
Skin Preparation
Wash hands thoroughly before changing site
Open the IIS package over a clean table or area being used for set
change
Clean top of insulin vial with alcohol
Clean the infusion site with prepackaged skin-cleaning wipes
(preferably nonalcohol) or soap and water
Wipe skin in an outward spiral (vs back and forth) over an area the
diameter of a tennis ball to preserve the center from
contamination
Allow site to air-dry (refrain from blowing) and test for dryness by
touching the outside edge, not center
Abbreviation: IIS, insulin infusion set.
bolus, a change in which could be a signal of impaired
insulin absorption); and infusion site rotation and mainte-
nance practices, including frequency of changing infu-
sion sets. Questions should be practical and contribute to
improvement of care by encouraging patients to report on
their pump/IIS experience. Sample questions are shown
in Table 5.
An education checklist for health care professionals
is shown in Table 6. In addition to ensuring awareness
of key IIS issues during the clinical examination, the
table supports a structured plan for IIS management and
DKA prevention, which should be verbally reinforced
and entered into the medical record at each patient
encounter.
The panel strongly recommended downloading and
evaluating pump and glucose monitoring data reports
(eg, CareLink®, Diasend®, CoPilot®, and CliniPro®)
to assess patients’ actual pump practices. This is an
important means of deciphering possible etiologies of
IIS failure and transferring information to the medical
record.19 The information from the patient question-
naire, education checklist, and the downloaded
reports, preferably used together, can help to identify
barriers to IIS use and facilitate more strategic pump
Evert et al
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Insulin Infusion Sets
479
Skin Maintenance
Use products (eg, IV Prep, Skin-Tac™) to increase IIS adhesion
Use underbandages (eg, Tegaderm™, IV3000 tape™) to reinforce
infusion set stability; use overbandage on steel IIS
Consider alcohol-free antibacterial products:
•• Bard® Protective Barrier Film
•• Bacitracin (forms barrier between skin and adhesive)
Staph carrier consider use of
•• Hibiclens® (use with clean white washcloth)
•• Referral to a dermatologist/infectious disease specialist
Anchor Teflon infusion lines with 1-in tape (eg, Durapore®,
Transpore™, Hypafix®)
Remove tape residue thoroughly when changing infusion sets
therapy management. In the event of significant gaps
in IIS skill and knowledge, the patient/caregiver
should be referred for more specialized pump therapy
education.
At the system level, coordinating the format and lan-
guage of paper-based tools with the terminology of elec-
tronic medical records may allow easier access to patient
information. Practitioners should be able to deduce the
frequency of infusion set change, the nature of skin reac-
tions, the patterns of unexplained hyperglycemia, and
other factors relevant to personalizing IIS selection,
usage, education, and reassessment. Instituting “smart
phrases” or keywords could lead to personalized orders
sets that cue providers to direct the right questions to the
right patients.
The panel cited the T1D Exchange Clinic Registry
(which includes >26 000 individuals with type 1 diabe-
tes) and Glu (a US patient networking site that collects
data on insulin pump use) as examples of large-scale
repositories by which IIS usage data can be collected and
understood.20,21 Expanding the range of IIS-related items
in these databases is expected to advance the integration
of IIS technology design with the practical issues of insu-
lin absorption and day-to-day device wear.
The Diabetes EDUCATOR

480

Table 5

Sample Waiting-Room Handout Questions for Addressing Insulin Infusion Set Issues

Since your last appointment, did you have an insulin infusion set problem or unexplained hyperglycemia that resulted in
•• an episode of diabetic ketoacidosis?
     Yes No
    If yes, how many?
•• a call to your diabetes care provider to assist with troubleshooting the situation?
     Yes No
•• a trip to the emergency room or hospital to seek treatment?
     Yes No
•• a missed day of school or work?
     Yes No
    If yes, how many?

If you responded “yes” to any of the questions above, please answer the following questions for discussion during today’s visit:
•• Do you have unexpired ketone test strips at home?
•• Do you have insulin syringes or unexpired pens to use if your pump malfunctions?
•• How frequently do you change your infusion set?
•• How often do you look at and feel the sites that you use for inserting your infusion set?
•• Do you have a personal plan if you have >1 glucose level >250 mg/dL?
     Yes No
    If yes, please describe.

Improving Education and infusion set, and advise on troubleshooting as needed. It

Oversight
In a discussion of strategies for improving education
about IISs, the panel observed that, historically, insulin
pump and infusion set companies have been largely
responsible for developing training materials, and it
agreed that ongoing IIS practices and maintenance
should be more prominently featured in pump manuals
and brochures. The panel also advocated third-party
reimbursement of at least 1 face-to-face visit soon after
initial training in order to adjust equipment, evaluate IIS
placement and technique, and reinforce healthy IIS hab-
its. Since patients with type 2 diabetes in particular may
have limited access to specialist care, several broad and
adaptable education models were examined. Each fea-
tured a team approach, including a diabetes educator
and/or a nurse practitioner/physician assistant specializ-
ing in diabetes. The most feasible scenario consisted of
an initial 2- to 3-hour session for pump initiation, fol-
lowed by a face-to-face visit a week later to assess sites
and equipment, observe the patient putting in the
was acknowledged that IIS troubleshooting (as described
in Table 3 and in the aforementioned 2011 American
Association of Diabetes Educators white paper1) requires
ongoing and resource-intensive support.
Summary and Conclusion
Recent innovation in IIS technology has shifted
attention to an overlooked but essential component of
insulin pump therapy. Patient and clinician testimony
indicates that the experience of pump therapy is
strongly influenced by infusion set factors—including
dislodgment of the infusion set, partial or complete
blockage of the cannula, skin reactions, the demands of
site rotation and set changes, and unpredictable varia-
tions in insulin absorption. The goal of this article is to
raise awareness of day-to-day practice challenges faced
by clinicians and patients, offer achievable solutions,
and recommend pathways for action and future
research. A summary of key recommendations appears
in Table 7.

Volume 42, Number 4, August 2016

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 Table 6
Education Checklist for Establishing and Maintaining Healthy IIS Practices
Education Visits Prior to Pump Initiation
Goal: Reduce risk of infection at IIS site
Steps: Counsel patient on:
 Clean work space
 Hand washing
 Preparation of insertion site
 Cleaning top of vial with alcohol
 Inserting new infusion set before removing old one
Outcome: Patient understands IIS hygiene practices.
 Yes  No
Goal: Optimize IIS site selection for individual patients
Steps: Counsel patient on site options:
 Abdomen
 Front of thigh
 Upper buttock
 Lower back
 Back of arm
 Consider clothing and potential issues, such as
tubing caught in zippers and cannula placement
near belts and waistbands
 Other
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Outcome: Patient can identify different sites for IIS.
 Yes  No
Goal: Motivate site rotation
Steps: Explain rationale for rotating sites:
 Reduce risk of thickening of skin (lipohypertrophy)
 Maintain consistent insulin absorption
 Reduce risk of unexplained hyperglycemia
Outcome: Patient understands site rotation rationale
and practices.  Yes  No
Goal: Accommodate individual differences in IIS
selection and set change frequency (standard is
every 2-3 d)
481
Annual Education Visits and/or Pump Upgrades
Goal: Reinforce healthy IIS habits
Steps: Counsel patient on:
 Hand washing
 Skin hygiene practices
 Infusion site preparation
 Inspecting pump, tubing, and pump site once or
twice daily; immediately after exercise, if IIS is
pulled or banged
 Troubleshooting unexplained hyperglycemia
 DKA prevention plan
 Emergency supplies
 How to contact clinician/educator between visits
Outcome: Patient can assess and/or improve everyday
IIS practice and manage emergencies.  Yes  No
Goal: Detect site problems
Steps: Visual and manual inspection (palpate while
patient is standing):
 Redness, rash, inflammation
 Adhesive residue
 “Pump bumps,” lipohypertrophy, and other tissue
irregularities
 Avoid sites with lipohypertrophy for several
months. Reevaluate sites at next appointment with
health care provider or diabetes educator
Outcome: Skin problems that may affect insulin
absorption are identified and addressed.
 Yes  No
Goal: Observe actual IIS change practice
Steps: Ask patient to demonstrate:
 Preparation of reservoir
 Preparation of site
 Filling insulin reservoir
 Identification and elimination of bubbles
 Smooth insertion of cannula at appropriate angle
Education Visits due to Adverse Events
Goal: Identify recurring metabolic issues
Steps: Query patient/consult medical record for
evidence of:
 Unexplained hyperglycemia
 DKA
 Emergency room visits
Outcome: Metabolic complications are discussed to
determine IIS involvement.  Yes  No
Goal: Intervene to correct IIS-induced hyperglycemia
Steps: Need to troubleshoot cause and solutions for:
 Kinking and blockage of IIS catheter
 Inappropriate IIS selection
 Pump malfunction
 Irregular absorption of insulin at site
 DKA
Outcome: Patient receives IIS-specific training,
including sick day rules, exercises rules, and
strategies for replacing missed insulin.  Yes  No
Goal: Resolve recurring skin issues
Steps: Suggest possible solutions for:
Rash
 Alcohol-free prep wipes
 Soap and water to clean site
 Tape barrier
Contact dermatitis
 Clobetasol propionate (requires prescription)
• 1-2 drops on site
• Rub it in with clean hands
• Let it dry; may take a few minutes
• Then insert infusion set
Staph carrier
C  leanse site with clean white washcloth and
Hibiclens (chlorhexidine topical)
(continued)
 Table 6

482
(continued)
Steps: Explain patient factors influencing IIS choice Outcome: IIS technique is confirmed.  Yes  No  Wash used washcloths with bleach and dry in a hot
(plastic or stainless-steel catheter; 90° or 30-45° dryer
Goal: Detect IIS-specific issues
angle, tubing length): M  ay need referral to dermatologist/infectious
Steps: Gather information about ongoing IIS use
 Lean/muscular disease doctor
through patient self-report, review of downloaded
 Activity level Tape adherence
pump/glucose data, and clinical examination. Use
 Age U  se adhesive products such as IV Prep Wipes™,
information to evaluate or determine issues such as:
 Visual acuity Skin Tac wipes™, or Mastisol™
 Kinking and blockage of catheter
 Dexterity U  se overtape to reinforce tape that is failing, such
 Varied absorption of insulin due to lipohypertrophy
Outcome: Initial IIS choice and replacement regimen as IV3000™, Tegaderm™, or Hypafix™
 Tape adherence
are deliberately decided.  Yes  No Excess hair:
Outcome: Changing technique or switching IIS type
 Shave area prior to insertion of infusion set
Goal: Promote proficiency in IIS setup and insertion addresses IIS problems.  Yes  No
Sweat/excess perspiration:
Steps: Demonstrate mechanics and ask patient to
 Apply antiperspirant to clean site
redemonstrate:
 Apply overtape to areas of failing tape as needed
 Filling reservoir/cartridge
Outcome: Management of persistent skin problems is
 Connecting reservoir to tubing
individualized to improve IIS adherence.
 Priming
 Yes  No
 Clearing air bubbles from reservoir and tubing
 Insertion with auto-inserter (as applicable)
 Manual insertion (as applicable)
Outcome: Patient demonstrates competency in IIS
setup and insertion.  Yes  No
Goal: Establish formal plan for troubleshooting unexplained hyperglycemia and DKA

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Steps: Teach patient to recognize and manage hyperglycemia and prevent DKA:
 Early signs of DKA (eg, thirst, stomach pain, nausea, and fruity odor of the breath).
 If symptoms are present, check blood glucose and ketones.
 If glucose >250 mg/dLa (13.88 mmol/L), administer correction bolus with pump. Recheck ketones and glucose in 1-2 h.a
 If ketones are moderate/largea and glucose levels are still >250 mg/dL (13.88 mmol/L) 1 ha after the correction bolus, administer correction dose manually with a
syringe or pen.
 Replace IIS and refill cartridge with insulin from new vial.
 More frequent monitoring of ketones and glucose level by use of meter or continuous glucose sensor is recommended until situation resolves.
 Provide contact information for emergent care and clinical assistance.
Outcome: Patient feels confident in ability to recognize and manage unexplained hyperglycemia before DKA develops.  Yes  No
Abbreviations: DKA, diabetic ketoacidosis; IIS, insulin infusion set.
a
Ketone and glucose levels may vary depending on individual health care provider or institution DKA prevention plan or protocols.
 Insulin Infusion Sets

483

Table 7

Observations for Action

Locus of Activity Achievable Goals

Educator/diabetes care team
Patients and caregivers
System administrators and
policy makers
Third-party payers
Insulin pump manufacturers
Researchers
Abbreviations: EMR, electronic medical record; IIS, insulin infusion set.
Systematically educate patients about IIS choices and common causes of IIS failure
Establish a training standard of 2-3 h of initial pump instruction, followed within the week by a
face-to-face visit for more individualized IIS education, adjustments, and troubleshooting guidance
Formalize the following fundamental clinical standards of pump therapy care: palpating and inspecting
sites for lipohypertrophy and other skin pathologies, observing infusion set insertion technique upon
initiation of pump therapy and periodically thereafter, and explicitly asking patients about their IIS
issues (eg, unexplained hyperglycemia)
Actively train patients to do their own detective work when IIS failure occurs; intervene themselves
when possible; take steps to prevent recurrence; and call for help when needed call for help when
needed
Build in an annual IIS “refresher,” and review insertion technique at the time of prescription refill to
reaffirm best practices and to verify that patients’ equipment, skills, and circumstances of daily living
remain well matched over time
Develop formal training on the use of pump, meter, and/or continuous glucose monitoring downloads to
discern IIS issues and document them in EMRs
Lobby for the development and standardization of waiting room questionnaires for purposes of
motivating patient-clinician communication, documenting IIS data for EMRs (eg, using keywords or
“smart phrases”), and substantiating reimbursement
Identify and recommend high-quality print and online learning resources to supplement education about
IISs
Move toward informed problem solving in response to IIS failure
Assume a proactive stance in asking clinicians and pump trainers about IIS choices and best practices
Deliberately note the circumstances surrounding unexplained hyperglycemia or other manifestations of
IIS failure for purposes of reporting, diagnosis, and resolution
Palpate and visually inspect insertion sites regularly for timely detection of IIS problems
Integrate a standardized IIS checklist into EMRs; coordinate this provider checklist with a patient
waiting room questionnaire to facilitate consistent, efficient, and effective communication within and
among organizations
Use electronic databases to develop IIS order sets that cue providers to ask the right questions of the
right patients
Institutionalize and communicate IIS “troubleshooting action plans”
Mine pump therapy databases to generate evidence-based reports on IIS utilization and unmet needs
Collect relevant utilization data to synchronize evolving IIS best practices with rational, evidence-based,
cost-effective reimbursement
Address IIS failure in manuals and other training materials
Expand pump training to include a variety of IIS options
Apply scientific methodologies to guide IIS design and to better characterize the interdependent effects
of insulin, insulin preservatives and excipients, insulin kinetics over length of infusion set wear,
device design, and skin-subcutaneous physiology on therapy outcomes

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 The Diabetes EDUCATOR
484
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Volume 42, Number 4, August 2016