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type 1 and type 2 diabetes. People with type 1 diabetes (n with an A1C reduction of 1.12% (−1.32 to −0.91%, I2 = 0).12
= 516) saw an overall A1C decrease of 0.49% (95% CI [−0.94 The authors did not identify a potential cause for this phe-
to −0.04%]), while those with type 2 diabetes (n = 1,027) saw nomenon, although a separate study found similar results.13
a slightly higher A1C reduction of 0.57% (−0.82 to −0.32%), Two possibilities for this difference in impact between dia-
though there was significant heterogeneity noted among the betes types are 1) the small sample size in the studies inves-
trials within each study population (I2 = 84% and 77% for tigating health professional feedback in type 1 diabetes, and
type 1 and type 2 diabetes, respectively). Of interest, feed- 2) the different types of challenges faced daily by individuals
back from health professionals was negatively correlated living with type 1 and type 2 diabetes.
with A1C reduction in type 1 diabetes, while the opposite
held true for individuals with type 2 diabetes. In the type 2 Apps for calorie tracking and meal
diabetes population, low-frequency feedback (i.e., as needed planning
or once monthly) was associated with an A1C reduction of Numerous mobile apps are commercially available for calo-
0.33% (−0.59 to −0.07%, I2 = 47%), whereas high-frequency rie tracking and meal planning. Table 3 features some of the
feedback (i.e., more than once per month) was associated most common ones. The general functionalities of the apps
www.pharmacist.com MAY 2019 • PharmacyToday 45
vary, but most provide the ability to log meals, exercise, details about why the product received that specific grade
weight, and even water intake, at a minimum. and a list of healthier alternatives (if available). Additional
The more mainstream apps have internal databases that functionalities include somewhat-customizable meal plans
feature the nutrition information of foods from popular res- (e.g., person-specific calorie and macronutrient goals), social
taurants in addition to many foods and ingredients avail- elements (e.g., ability to comment on and applaud others’
able at your local grocery store. Most also feature the abil- entries), and general information on health and wellness
ity to turn a smartphone’s camera into a barcode scanner to (e.g., blog posts, articles, fitness videos).
instantly import the nutrition information from the product It is important to emphasize that the customized meal plan
packaging. For dishes that may not be found in a database, should not replace a dietitian’s expertise. If a patient is under
such as a family recipe, MyFitnessPal also provides the abil- a dietitian’s care, make sure the app’s recommendations are
ity to enter the full recipe for a specific dish on its website consistent with the dietitian’s specified clinical recommen-
(not on the smartphone app). This feature compiles the nutri- dations. This will prevent confusion and enhance collabora-
tion information of each ingredient and translates it into a tion among the care team. In addition, to maximize patient
per-serving breakdown, which in turn becomes accessible convenience, if a patient is using a specific device or app (e.g.,
within the user’s database on their smartphone when log- fitness tracker, running app) to track other meaningful data,
ging that meal. check whether it interfaces with the calorie tracking and
Another app that offers a unique functionality, Fooducate, meal planning app of interest.
provides “grades” for specific foods (range: A–F), including A drawback of using calorie tracking and meal planning
Figure 1. Strategies to activate patients using mobile applications based on level of engagement with health care
apps in diabetes is that they are not diabetes-specific, so The app can also use the individual data points to provide
there is no ability to log additional data that may be impor- the patient with an estimated A1C, although this practice can
tant for living well with diabetes, such as glucose readings have unintended consequences. For example, if the logged-in
and insulin doses. Comprehensive diabetes-specific apps do glucose levels are all within the goal range, but the patient’s
exist, however, and will be discussed later in this article. glucose levels are substantially elevated at other times of the
day (i.e., not captured in the log), this may create a false sense
Apps for logging glucose and other data of security for the patient and subsequent confusion when an
It is time to say goodbye to paper glucose logbooks with tiny actual lab test measure shows a discrepant value. Therefore,
boxes that are difficult to see and practically impossible to it is important to educate patients about the limitations
write in or read. Like calorie tracking apps, glucose monitor- (mainly related to sampling bias) of calculating an estimated
ing apps enable users to log their glucose readings as well A1C from a glucose log.
as other pertinent information (e.g., mealtimes, medications Other features of these apps may include feedback on the
administered, symptoms). Table 3 features some common results logged, ability to upload photos of meals and track
apps used for logging glucose readings. One benefit of log- additional data (i.e., weight, blood pressure), and social sup-
ging electronically is the app’s ability to quickly transform port. In addition, many of these types of apps sync with
the data into a visual or graphic representation of overall other apps, wearable technologies (e.g., smart watches, fit-
glucose patterns. These graphic renderings of data (e.g., per- ness trackers), glucometers, and even continuous glucose
centage of readings above or below a certain goal, averages monitors. This feature helps automate this data collection so
at certain times of day, trend lines) may be easier for a patient users don’t have to take the extra steps of logging the data
to understand. separately.
www.pharmacist.com MAY 2019 • PharmacyToday 47
MyFitnessPal Apple: 4.7 out of 5 (494 K) Basic version is free. ■■ Ability to log
(iTunes: #5 in Health/Fitness) Android: 4.6 out of 5 (1.96 M) Premium version: – Meals
$9.99/mo – Exercise
$49.99/y
– Weight
SparkPeople Calorie Tracker Apple: 4.6 out of 5 (8 K) Basic version is free. – Water intake
(Calorie counter and diet tracker) Android: 4.5 out of 5 (33 K) Premium version: ■■ Internal nutrition lists and calorie
$4.99/mo database
My Diet Diary Calorie Counter Apple: 4.6 out of 5 (911) Free ■■ Customized meal plans
Android: 4.1 out of 5 (19 K) ■■ Sync with other apps, devices,
and wearable technology
Fooducate Nutrition Tracker Apple: 4.7 out of 5 (29 K) Basic version is free. ■■ Social element
(iTunes: #110 in Health/Fitness) Android: 4.4 out of 5 (15 K) Premium version: ■■ Articles
$0.99–$7.99/mo ■■ Fitness videos
$29.99–$99.99/y
mySugr Apple: 4.7 out of 5 (1.9 K) Basic version is free. ■■ Log glucose levels, meals, meds,
Android: 4.6 out of 5 (23.8 K) Premium versions: BP, weight, A1C
$2.99–19.99/mo ■■ Report estimated A1C (eA1C)
$27.99–199.99/y ■■ Motivating challenges and
feedback
Sugar Sense Diabetes App Apple: 4.6 out of 5 (4.1 K) Free
■■ Sync with other apps, devices,
Android: 4.2 out of 5 (1.2K)
and wearable technology
Health2Sync Diabetes Care Apple: 4.7 out of 5 (69) Basic version is free. ■■ Upload photos of meals
Android: 4.6 out of 5 (6.4 K) Premium versions: ■■ Social support (designated
$2.99/mo partners)
$7.99/3 mo
$14.99/6 mo
Glucose Buddy Apple: 4.8 out of 5 (10.8 K) Basic version is free. ■■ Log glucose levels, insulin,
Android: 4.4 out of 5 (14.4 K) Premium version: meals, weight, ketones, eA1C,
$14.99/mo cholesterol, BP
$59.99/y ■■ Provide insights into daily trends
■■ Track carb intake, steps, and
MyNetDiary Diabetes Tracker Apple: 4.5 out of 5 (576) $9.99
activity
Android: 4.6 out of 5 (564)
■■ Scan food labels for carbs
Diabetes:M Apple: 4.6 out of 5 (403) Basic version is free. ■■ Sync with other apps, devices,
Android: 4.6 out of 5 (17.7 K) Premium versions: and wearable technology
$4.99/mo ■■ Import/export and reminder/
$49.99/y target capabilities
Glucosio Apple: 3 out of 5 (4) Free ■■ Receive help/motivation from
Android: 4 out of 5 (290) friends/community
■■ Calculate insulin bolus doses
Glooko Apple: 3 out of 5 (64) Free ■■ Set reminders to take meds,
Android: 4 out of 5 (928) Optional subscription: $5/mo with exercise
payment for the first year upfront ■■ Share data (either anonymously
Diabetes Connect Apple: 4.5 out of 5 (50) Free or with caregivers)
Android: 4.5 out of 5 (4.3 K) Optional in-app purchases ■■ Search food or medication
databases
PredictBGL Insulin Dose Calc Apple: 3.7 out of 5 (15) Free
■■ Insulin dose calculator with
Android: 3.5 out of 5 (47) Optional upgrade
predictive analytics
■■ Predict blood glucose levels; has
alerts warning of predictive low
■■ Coaching and just-in-time
education
Sources: References 5 and 6.
Apps for titrating basal insulin doses monitoring. These apps combine multiple aspects of the
Clinical inertia has been a significant and common barrier products previously discussed (e.g., logging glucose lev-
to helping patients achieve their diabetes-related goals.14 els, meals, insulin doses; scanning food labels; socializa-
This phenomenon is especially applicable to titrating basal tion aspects; syncing with other apps, devices, and wear-
insulin doses after initiation,15,16 despite previous research able technologies) as well as provide additional features for
leading to the development of simple treat-to-target insulin people living with diabetes. Depending on the amount and
algorithms that patients with type 2 diabetes can use on their quality of data compiled, the apps can provide insights into
own—without needing to schedule a clinic appointment or a patient’s daily trends, including use of predictive analytics
call a health professional for advice (e.g., increase two units to inform treatment considerations (e.g., calculating a meal-
every 3 days until the mean fasting glucose is 100 mg/dL).17,18 time insulin dose, warning of a predictive low, coaching/
Mobile apps that help patients feel more comfortable about just-in-time education). These apps can also facilitate sharing
increasing their basal insulin doses have sought to fill this of various data with family members, social networks, and
gap. Two examples are My Dose Coach and Insulia, which health professionals.
work very similarly. These apps integrate information a One particular app, mDiabetes, was evaluated in a
patient enters about their glucose patterns and apply an algo- 24-week, multicenter, randomized controlled trial in a South
rithm to recommend dose modifications. In addition to pro- Korean adult population with type 2 diabetes.23 In this study,
viding the patient a number, both apps explain why a spe- patients were randomized to use either the app (n = 90) or
cific dose was chosen. It is important to emphasize that these a paper logbook (n = 82). The primary outcome was change
apps are for basal insulin titrations only, as bolus insulin in A1C at 24 weeks. Use of the app resulted in an additional
doses are much more difficult to titrate based off a broadly 0.35% reduction in A1C over the paper logbook group (0.14–
generalizable algorithm. 0.55%, P = 0.001), as well as a larger percentage of patients
having an A1C below 7% without hypoglycemia (odds ratio
Apps for diabetes education and 1.82 [95% CI 1.03–3.21] P = 0.024).
empowerment
Recognizing that many people with diabetes have limited Modernizing diabetes management and
time to pursue formal education in diabetes self-manage- patient care
ment, developers have also created apps that help bridge this As people with diabetes can attest, living with the disease
gap. One such app, KingFit, features quick and convenient is not easy. Granted, advances in diabetes care over the last
videos, generally 10 minutes or less, on a variety of diabetes- 30 years have dramatically improved patients’ ability to
related topics. The app’s developers state on their website manage their diabetes. Development of recombinant insu-
that the educational information is provided by a certified lins in the 1980s resulted in fewer insulin hypersensitivity
diabetes educator, which is another positive attribute. reactions, and development of insulin analogs in the 1990s
Another app in this area is WellDoc BlueStar, an FDA- increased the likelihood of people safely achieving tighter
cleared Class II medical device.19 This app provides a vari- glucose goals. Portable glucometer technology has evolved
ety of features to enhance the patient experience, including continually throughout the 21st century, making them more
personalized messages analyzing glucose patterns based on accessible and accurate than ever before.24,25 These evolutions
patient-derived data and computerized algorithms, diabetes in technology have substantially decreased production costs,
education videos, tailored coaching messages, and weekly which over the years has generally driven down the costs
challenges to engage and motivate users. The app also has a to patients for obtaining these tools and devices. However,
prescription version (BlueStar Rx) that has all the same func- decreased production costs do not always translate directly
tionalities as the nonprescription version, in addition to an into affordability for patients.26–28
insulin dose calculator that aids in calculating the dose of Despite all these breakthroughs and developments, there
insulin needed for a given amount of carbohydrates and/or are still many challenges and limitations in helping people
current blood glucose value.20 with diabetes achieve their health goals. Barriers to medica-
In one randomized controlled trial, this app helped tion adherence will always be a problem, especially those
patients decrease A1C approximately 1% beyond that of the related to remembering when to take a medication and deter-
control group within 3 months (−2.03% vs. −0.68%, P < 0.02). mining if a patient actually took their medication. It is easy
In the intervention group, an additional 60% of patients had to look at a pillbox to see if the tablets that were supposed to
their medications titrated or changed by their health profes- be taken at a specific time are still in that cube. However, it
sional, compared with the standard of care group, over the is not possible to apply the same principle for an injectable
same time period (84% vs. 23%, P = 0.002).21 A sustained A1C medication, and the result may be a patient repeating one or
reduction of a similar magnitude was seen over 1 year in a more doses.
slightly longer study.22 Another challenge is the accuracy of the available data.
Although health data are abundant in today’s era of por-
Comprehensive diabetes apps table glucometers and wearable technologies, the infor-
This last app-related section considers apps that address mation derived from these sources is still limited by fac-
multiple facets of living with diabetes, such as meal plan- tors that affect their accuracy (e.g., approval standards for
ning, exercise habits, medication use, and blood glucose glucometers, limitations with A1C testing).29 Furthermore,
www.pharmacist.com MAY 2019 • PharmacyToday 49
self-monitoring of blood glucose at specific time points does market (i.e., upon initial FDA approval). The manufacturers
not capture out-of-range values in between these checks (an are not required to update their technology to meet newer
issue affecting all individuals with diabetes, but especially standards that take effect after their meter is approved.32
those with type 1 diabetes). The information derived from these types of studies can
Last, developments in technology do not always consider be used to inform decisions about diabetes care, includ-
the patient’s experience (i.e., whether these new devices and ing which glucometer(s) to recommend to a patient, which
tools are user-friendly and convenient) or accessibility to the glucometer(s) a health plan should cover, and how to modify
average patient (e.g., affordability, coverage by third-party a patient’s medication regimen on the basis of self-monitored
payers). In light of these challenges and limitations, the next blood glucose data derived from a glucometer.
few sections of this article highlight some recent develop- Although the accuracy of the results derived from a glu-
ments in technology that can help patients and clinicians cometer is very important, practitioners must consider other
overcome these barriers to managing their diabetes. factors when determining the ideal glucometer for a patient.
Today’s meters have many more functions beyond simply
Glucometer considerations providing a glucose value. These include providing feed-
The accuracy of commercially available glucometers is inher- back, reminders, and alerts to the patient (and potentially to
ently at a crossroad between the accuracy of the results the caregivers/family members); integrating Bluetooth and USB
glucometer can provide and the cost associated with ensur- technology to communicate with mobile apps, and generat-
ing that level of accuracy. These two variables are directly ing reports for self-evaluation and/or dissemination to the
correlated, whereby increasing one undoubtedly increases patient’s health care provider. These functions are only ben-
the other. Realizing that there will likely never be a “perfect” eficial for patients who use them, so a discussion about the
meter, the Diabetes Technology Society (DTS) established basic functionalities a patient looks for in their meter and
the Blood Glucose Monitor Surveillance (BGMS) program whether they would actually use them is critical for evalu-
to determine the current level of accuracy of several meters ating whether a glucometer with more advanced functions
available on pharmacy shelves.30 would be helpful.
The DTS study evaluated 18 different meters (constituting For patients with retinopathy or other forms of visual
90% of the commercially available systems used between impairment, other factors to consider include screen size,
2013 and 2015) purchased directly off the shelves of various text display size, and backlighting. Patients with diminished
consumer outlets. Study participants (n = 1,035) were adults manual dexterity may have difficulty with certain glucom-
with type 1 diabetes, type 2 diabetes, prediabetes, or no dia- eters that have small parts, vials that need to be screwed on
betes. Three different clinical sites were used in a way that and off (vs. flip-tops), and complex lancet devices. Last, peo-
ensured all 18 blood glucose meters were tested at all three ple with type 1 diabetes who may need to test periodically for
sites. Each participant was tested on six different meters in ketones may benefit from a glucometer that can test for both
addition to having a capillary glucose drawn (i.e., control substances (e.g., Precision Xtra, NovaPlus Max), although test
value). The study implemented a triple-blinded methodology, strips designed specifically for measuring ketones will also
in which the investigators, laboratory staff, and statisticians need to be purchased separately.34
did not have enough information to break the code until after
all the results were calculated and finalized. The investiga- Continuous glucose monitoring (CGM)
tors compared each glucometer with standards derived from systems
the International Organization for Standardization and FDA CGM systems, a technology that is increasingly available,
2016 guidance.31,32 Glucose levels above 100 mg/dL needed to addresses the challenge of not knowing specific glucose
be within 15% of a reference plasma value, whereas glucose patterns between individual glucose checks. These systems
levels below 100 mg/dL needed to be within 15 mg/dL of a come with three components: a wearable sensor, a transmit-
reference plasma value. ter, and a receiver. Once the sensor is placed on the patient
To pass the test, at least 91% of the samples within each and calibrated (if applicable), the CGM system automatically
study had to be within the specified standard range. A seal and repeatedly checks the glucose levels of the interstitial
of approval was awarded to any glucometer that passed the fluid surrounding the sensor at regular time intervals (usu-
studies performed at all three study sites. Table 4 gives an ally 5–15 min).35 Depending on the device, this information
overview of the main results. Additional details are avail- is transmitted to a receiver—often the patient’s glucometer,
able at the DTS website (www.diabetestechnology.org/ insulin pump, or smartphone device—at regular intervals
surveillance.shtml), including the overall variation in each (i.e., real-time CGM) or when requested by the patient (i.e.,
meter’s data, percentage of values within specified error lim- flash CGM).
its, and other information.33 This technology is especially beneficial for people living
It is important to note that meters that did not receive a DTS with type 1 diabetes, and for anybody with diabetes of either
seal of approval are not inherently “bad” meters. However, type who is 1) taking multiple daily injections of insulin and
the study represents an important step for increasing trans- has a mismatch between their A1C values and glucometer
parency in glucometer accuracy. Many people do not know readings, 2) at high risk for hypoglycemia (including hypo-
that meters available for purchase today are only required to glycemia unawareness), and/or 3) experiencing clinically
meet the accuracy standards in place when they entered the significant glycemic variability.35–37 The first CGM systems
Table 4. Results of the 2018 Diabetes Technology Society (DTS) Blood Glucose Monitor System (BGMS)
Surveillance Program
Brand BGMS Test strip Study sites Compliant (N) Valid trials Compliant (%)
passed
Source: Adapted with permission from Diabetes Technology Society (DTS) Blood Glucose Monitor System Surveillance (BGMS) Program website.
approved by FDA were professional, or “blinded,” CGM sys- over flash CGM technology is the ability to send alerts to the
tems, in which the sensor regularly recorded the patient’s patient and caregiver(s) regarding predicted dangerous glu-
glucose levels, but the data could not be obtained until the cose levels (i.e., hyperglycemia, hypoglycemia) if the current
sensor was brought back to the clinic to be uploaded and ana- trend is not corrected. Table 5 provides an overview of the
lyzed by a health professional retrospectively. Over time, the various FDA-approved personal CGM systems.38–42
technology has evolved to include personal, or “unblinded,” Glucose levels in the interstitial fluid often lag 5 to 15
CGM devices that provide information about glucose trends minutes behind blood glucose levels, especially when
directly to the patient.35 blood glucose levels are changing rapidly. Because the
Personal CGM systems can be further subdivided into sensor is measuring glucose in the interstitial fluid rather
real-time and flash CGM systems. Real-time systems actively than capillary glucose, complex calibration algorithms
report data at regular intervals independent of the patient’s embedded within CGM systems translate the data derived
actions, while flash systems require the patient to request into a useable blood glucose value that can be reported
the data at specific intervals to evaluate the information ret- on the patient’s receiver and acted upon.35 To increase the
rospectively. Although both systems have inherent benefits level of accuracy, some systems may require calibration
and drawbacks, one clear advantage of real-time systems with a capillary blood glucose measurement (check using
www.pharmacist.com MAY 2019 • PharmacyToday 51
patient’s glucometer) periodically (e.g., every 12 h). the cost, as this technology may still be more costly than tra-
CGM technology comes with its own set of terminology. ditional blood glucose monitoring with a glucometer.
One important term to be aware of is warm-up time: the time In evaluating the effect of these systems on patient out-
it takes for the sensor to calibrate once it is placed, before it comes, one review concluded that use of CGM in type 1 dia-
can start to accurately report data. This time period generally betes results in approximately 0.5% improvement in A1C and
ranges between 1 and 2 hours (Eversense implant requires a mild decrease in hypoglycemia.45 Another review evaluated
24 h). During this time, the patient must use a glucometer to the literature surrounding use in several patient populations,
check blood glucose. This time is an essential component for including patients at high risk for hypoglycemia (type 1 and
ensuring the accuracy of the sensor by allowing it to calibrate type 2 diabetes), hospitalized patients with type 2 diabetes,
after it is placed. and pregnant women with diabetes. These analyses generally
Another commonly used term with CGM systems is trend favored CGM use in these patient populations.46
arrows. These arrows are displayed next to the glucose level Although these data are positive, it is important to remem-
on the patient’s receiver and are designed to help the patient ber that these systems are solely for monitoring and still
put the number into context. For example, if the patient sees require the patient to act on the health information provided.
one or two upward arrows next to the current glucose read- A clinical benefit will not be seen unless the patient is appro-
ing, they will know what their current glucose level is, as well priately engaged in their own care and has the health literacy
as be notified that their glucose level is rapidly increasing at and numeracy skills to interpret and act on the information.
a rate greater than 2 mg/dL/min.43,44 This additional informa- Therefore, to get the most benefit from these systems, health
tion is especially helpful for informing treatment decisions, professionals will need to select the ideal patient candidates
particularly when compared with a glucometer, which can matching the characteristics previously described, train them
only give the current glucose reading without any additional on how to use the device and interpret the data derived from
context about the trends. it, and follow up with them periodically.
Because the cost of this technology has decreased substan-
tially over the years, access to these devices is becoming much Insulin pens and injectable devices
more mainstream, with some being sold right out of the local Disposable pens may not seem like a technological advance-
community pharmacy. Since there are multiple limitations in ment by today’s standards, but it is safe to say they have
using a 3-month average (i.e., for A1C) to evaluate a patient’s significantly improved diabetes care. Their convenience
overall approach to diabetes management, this technology and relative ease of use have increased their availability to
can provide an additional objective measure: time in range. patients (a welcome change from vials and syringes), which
Think of how much more useful it would be for a person in turn has been shown to improve adherence to therapy.47
to know that their glucose levels in the last 3 months were These disposable pen devices were subsequently adapted for
within the goal range approximately 80% of the time rather use in administering noninsulin injectable medications (e.g.,
than that their 3-month average (A1C) suggested they were glucagon-like peptide-1 agonists), as well as a safer way to
above goal at some point in the past 3 months. However, the administer concentrated insulin by eliminating the need to
benefit on patient outcomes must be robust enough to justify convert a U-100 syringe into its equivalent units.
Despite these improvements in technology, patient safety automatically via Bluetooth and AppleHealth from a synced
concerns abound with the use of disposable pens. Concerns glucometer or CGM device), factor in active insulin time, and
center on keeping pen needles attached to the pen and/ document carbohydrate intake. It offers many of the same
or reusing pen needles, not removing the inner cap prior functionalities as an insulin pump without the high upfront
to injection, dialing the pen back down instead of pushing cost and requirement of having a device permanently con-
the plunger in to administer the dose, and using a syringe nected to the person using it. InPen is approved for use in
to withdraw the insulin out of the pen, among other behav- individuals aged 12 years and older taking multiple daily
iors.48 Therefore, it is critical that pharmacists employ the S.C. insulin injections (i.e., not on an insulin pump). It is com-
teach-back method to educate patients on proper use of these patible with insulin lispro and insulin aspart cartridges and
devices and periodically re-evaluate to determine if patients administers up to a maximum of 30 units per dose in 0.5-unit
are using good administration technique. increments. Available by prescription only, the InPen requires
A further complication is that whereas insulin pens used a health care provider to input patient-specific parameters
to be fairly standardized (i.e., 100 units/mL, 3 mL/pen, gener- (e.g., glucose targets, carb-to-insulin ratio, correction factor)
ally five pens/box, and a 28-day beyond-use dating at room into the mobile app.53
temperature), nowadays there are many different varia-
tions in product formulations and beyond-use dating. These Insulin pumps and the pursuit of the
options are meant to accommodate the highly variable insu- artificial pancreas
lin needs of people living with diabetes, but they increase the This article would be incomplete if it did not discuss recent
potential for medication errors and prescription discrepan- updates in insulin pump technology. As these devices are
cies.49 Pharmacists should be aware of the similarities and often sold and managed by the pump companies themselves
differences among the various pen devices so they can field and are limited to a very niche patient population, this will
questions that patients and other health professionals will not be an extensive review. However, it is important to be
undoubtedly have. aware of this technology should you come across a patient
Needle technology has also dramatically improved, from who may be an ideal candidate or is asking about obtaining
the original 12.7-mm needle length (suitable for an I.M. injec- an insulin pump.
tion), to a pen needle as short as 4 mm and syringe needle of 6 The basic premise behind an insulin pump is the ability to
mm. Because of the risk of I.M. injections and concerns about supply a continuous infusion of low-dose rapid- or short-act-
highly variable insulin absorption and kinetics, international ing insulin subcutaneously to satisfy the patient’s basal insu-
consensus recommendations on insulin delivery now advise lin needs. In addition, an insulin pump can provide larger
using the 4-mm needle for all adults and children. If 4-mm bolus doses to manage the body’s mealtime insulin needs.
needles are not readily available, the advice is to at least avoid The pump contains a reservoir that can store a range of 200 to
needles longer than 8 mm for adults and 6 mm for children.50 300 units of insulin. The pump is connected to the user’s body
Although the new pen and needle technologies are helpful via an infusion set that must be changed approximately every
for improving adherence, they do not necessarily help people 3 days. The pump can also factor in additional information it
remember if they actually administered their insulin dose. To receives from various sources to provide a situation-specific
address this problem, Novo Nordisk developed the NovoPen recommendation to the patient when determining an appro-
Echo, a reusable pen device that is compatible with insulin priate mealtime bolus dose. This information includes current
aspart cartridges. This pen is capable of administering half- blood glucose levels, blood glucose trends (if the patient has
unit doses, with a maximum of 30 units per dose. It also has CGM), anticipated amount of carbohydrate intake, patient-
a dose memory feature on the pen cap that displays how specific carb-to-insulin ratio and correction factor, glucose
much insulin was injected during the most recent adminis- target ranges, and active insulin time. A thorough overview
tration and how many hours have passed since that dose was of these terms specific to insulin pumps is available online
administered.51 from Medtronic.54
Another technological innovation to help remember Currently, three major companies manufacture insu-
whether a dose was administered (and how much) has been lin pumps: Insulet Corporation (Omnipod), MedTronic
developed by Diabnext. The device, called Clipsulin C3, sim- (MiniMed), and Tandem (T:slim). In addition to these more
ply clips on to most FDA-approved insulin pens that dial in traditional pumps is an emerging technology: the dispos-
1-unit increments. It subsequently transmits the informa- able insulin patch pump (e.g., V-Go), which provides a fixed
tion related to the dose of insulin being administered to the basal rate of insulin as well as customizable mealtime doses
patient’s smartphone via Bluetooth technology. The informa- in fixed-unit increments (e.g., up to 36 units for the V-Go in
tion is then automatically documented in a virtual logbook 2-unit increments). These types of insulin pumps adhere
that can be transmitted to others (e.g., caregiver, health care directly to a user’s skin and therefore require no tubing. The
provider) if desired.52 fixed parameters associated with these patch pumps make
One final product is InPen, a reusable pen that not only them difficult to meet every patient’s needs, but they offer a
documents how much and when the last insulin dose was substantially lower-cost option to the right patient.55
administered but can also assist with calculating bolus doses One misconception many patients have about insulin
using a Bluetooth-paired smartphone app. The app can be pumps is that the pump can “do all the work.” However, as
used to document glucose readings (either manually or you can see from the list above, the pump is merely a tool
www.pharmacist.com MAY 2019 • PharmacyToday 53
to help inform the patient’s clinical decision making. The In addition to mobile devices and apps, the technologic
patient must still count carbohydrates, factor in the impact of innovations related to medication administration and glu-
other macronutrients (fat and protein) and activity level, and cose monitoring are also dramatically evolving. As the pro-
understand the patient-specific symptoms they may be expe- duction costs for this technology decrease, many of these
riencing. If interested in learning more about the nuances of products will likely be sold at the local community phar-
each individual insulin pump, see the comprehensive review macy. Therefore, pharmacists are in a critical position to
published annually by ADA.55 educate patients on these devices, periodically evaluate how
Fortunately, ongoing research is helping to further decrease patients are doing with them, and collaborate with the rest of
the impediments that remain with use of insulin pump tech- the patient’s care team to help patients manage their diabetes
nology. The initial evolutions in this process included the using the technology available, both now and in the future.
integration of CGM technology, which paved the way for the
pump to automatically initiate a low-glucose-threshold sus-
pend. This feature automatically stops the flow of insulin for References
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mia threshold, thereby decreasing the risk of serious hypo-
2. Pew Research Center. Mobile fact sheet. http://www.pewinternet.
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of the Medtronic 670G system, the first hybrid closed-loop dia.com/definition/2953/mobile-application-mobile-app. Accessed
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2guidance.com/325000-mobile-health-apps-available-in-2017/.
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7. United States Food & Drug Administration. Mobile Medical Applica-
Despite these benefits, this system is still not a panacea tions. https://www.fda.gov/MedicalDevices/DigitalHealth/MobileMedi-
for people with type 1 diabetes. The user is still required to calApplications/ucm255978.htm. Accessed February 25, 2019.
count carbohydrates and enter this data into the pump, know 8. Health on the Net Foundation. The HON Code of Conduct for medi-
when and how to override the system if warranted, regularly cal and health websites (HONcode). https://www.hon.ch/HON-
change and rotate sites, and troubleshoot issues that may code/Patients/Conduct.html. Accessed February 25, 2019.
9. Singh K, Drouin K, Newmark LP, et al. Developing a framework for
arise (e.g., line occlusions, extreme hyperglycemia, discrep-
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study: a bionic pancreas that can autonomously administer mobile applications for self-management of diabetes. J Gen Intern
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might be more specific to your patient population and verse clinical inertia, and medication non-adherence in type 2 dia-
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18. Davies M, Storms F, Shutler S, et al. Improvement of glycemic tes: the HAT study in Brazil. Diabetol Metab Syndr. 2018;10:83.
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tes Care. 2005;28(6):1282–8. com.com/g5-mobile-cgm. Accessed March 25, 2019.
19. WellDoc. BlueStar. https://www.welldoc.com/product/. Accessed 39. Dexcom. Dexcom Coninuous Glucose Monitoring. https://www.
February 25, 2019. dexcom.com/g6-cgm-system. Accessed March 25, 2019.
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non-prescription version of BlueStar digital therapeutic for type betes.com/products/guardian-connect-continuous-glucose-mon-
2 diabetes. https://www.welldoc.com/news/welldoc-receives- itoring-system. Accessed March 25, 2019.
fda-510k-clearance-to-offer-a-non-prescription-version-of-blue- 41. Abbott. Freestyle Libre. https://www.freestylelibre.us. Accessed
star-digital-therapeutic-for-type-2-diabetes/. Accessed February March 25, 2019.
25, 2019. 42. Senseonics. Eversense. https://www.eversensediabetes.com/
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behavioral outcomes and patient and physician satisfaction. Dia- trend arrows in the FreeStyle Libre flash glucose monitoring sys-
betes Technol Ther. 2008;10(3):160–8. tems in adults. J Endocr Soc. 2018;2(12):1320–37.
22. Quinn CC, Shardell MD, Terrin ML, et al. Cluster-randomized trial 44. Laffel LM, Aleppo G, Buckingham BA, et al. A practical ap-
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25. Clarke SF, Foster JR. A history of blood glucose meters and Technol Ther. 2017;19(Suppl 3):S25–S37.
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26. Cefalu WT, Dawes DE, Gavlk G, et al. Insulin access and afford- 48. Truong TH, Nguyen TT, Armor BL, et al. Errors in the adminis-
ability working group: conclusions and recommendations. Diabe- tration technique of insulin pen devices: a result of insufficient
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27. Kirk JK, Stegner J. Self-monitoring of blood glucose: practical 49. Bzowyckyj AS. Embracing the insulin revolution in the ambulatory
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28. Endocrine Society. Position Statement: Access to affordable and 50. Frid AH, Kreugel G, Grassi G, et al. New insulin delivery recom-
adequate diabetes supplies. https://www.endocrine.org/-/media/ mendations. Mayo Clin Proc. 2016;91(9):1231–55.
endosociety/files/advocacy-and-outreach/position-statements/ 51. Novo Nordisk. NovoPen Echo User Guide. https://www.novonord-
all/accesstoaffordableadequatediabetessupplies.pdf?la=en. Ac- isk.com/content/dam/Denmark/HQ/Patients/DiabetesCare/Pen-
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29. American Diabetes Association. 6. Glycemic targets: Standards February 25, 2019.
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30. Klonoff DC, Parkes JL, Kovatchev BP, et al. Investigation of the 53. Companion Medical. InPen website. https://www.companionmed-
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diabetes mellitus. https://www.iso.org/standard/54976.html. Ac- 55. American Diabetes Association. Diabetes Forecast Consumer
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32. United States Food & Drug Administration. Self-monitoring blood insulin-pumps.pdf. Accessed March 27, 2019.
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dustry and Food and Drug Administration staff. https://www.fda. cose control in children and adolescents with type 1 diabetes.
gov/downloads/ucm380327.pdf. Accessed February 25, 2019. Expert Opin Drug Deliv. 2017;14(12):1367–77.
33. Diabetes Technology Society (DTS). Blood Glucose Monitor- 57. Garg SK, Weinzimer SA, Tamborlane WV, et al. Glucose out-
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testechnology.org/surveillance.shtml. Accessed February 25, livery system in adolescents and adults with type 1 diabetes.
2019. Diabetes Technol Ther. 2017;19(3):155–63.
34. Dolson L. How to test your blood with a home ketone meter. 58. Scheiner G. 670G and me: Insights and incites on Medtronic’s lat-
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35. Klonoff DC, Ahn D, Drincic A. Continuous glucose monitoring: 25, 2019.
a review of the technology and clinical use. Diabetes Res Clin 59. El-Khatib FH, Balliro C, Hillard MA, et al. Home use of a bihor-
Pract. 2017;133:178–92. monal bionic pancreas versus insulin pump therapy in adults with
36. Sugawa T, Murakami T, Yabe D, et al. Hypoglycemia unaware- type 1 diabetes: a multicenter randomized crossover trial. Lancet.
ness in insulinoma revealed with flash glucose monitoring sys- 2017;389(10067):369–80.
CPE assessment
This assessment must be taken online; please see “CPE information” in the sidebar below for further instructions. The
online system will present these questions in random order to help reinforce the learning opportunity. There is only one
correct answer to each question.
1. A patient with type 2 diabetes (on oral medications 4. Which of the following functionalities is only avail-
only) is looking for an app that can help her track her able in the prescription version of the WellDoc Blue-
calories and exercise. She would like something that Star app?
is easy to use and free, and she doesn’t want or need a. Diabetes education videos
extra features. Which app would be most appropriate b. Insulin dose calculator
to discuss with her? c. Tailored coaching messages
a. MyFitnessPal d. Weekly challenges to engage users
b. KingFit
c. MyNetDiary Diabetes Tracker 5. Scientific evidence suggests that use of commercially
d. Insulia available apps
a. May improve some short-term diabetes-related out-
2. A patient with type 2 diabetes is started on insulin comes such as A1C
glargine U-300 at 10 units once daily. Which of the fol- b. Are only effective when combined with frequent
lowing apps can help him titrate his basal insulin to a support from a health care provider
safe and effective dose? c. Improve quality of life but do not improve other
a. Fooducate diabetes-related outcomes
b. Glooko d. Improve A1C in patients with type 2 diabetes but not
c. Insulia in patients with type 1 diabetes
d. Glucose Buddy
6. Which one of the following patients can benefit most
3. A patient with type 1 diabetes is interested in finding from using a mobile app to help manage their
a free app that can help him log several diabetes-re- diabetes?
lated data points (i.e., glucose, insulin doses, carbohy- a. A 64-year-old woman with type 1 diabetes who does
drate intake) and also help him decide the appropriate not own a smartphone
dose to administer with meals based on his glucose b. A 43-year-old man who is in denial about his type 2
patterns. Which of the following apps is most appro- diabetes diagnosis
priate for this patient? c. A 37-year-old woman with type 2 diabetes who is
a. mySugr legally blind in both eyes
b. Health2Sync d. A 52-year-old man with type 2 diabetes who is into
c. MyNetDiary Diabetes Tracker wearable technology
d. PredictBGL Insulin Dose Calc
CPE information
To obtain the 2.0 contact hours (0.2 CEUs) of To claim credit Assistance is available Monday through Friday
CPE credit for this activity, you must complete 1. Go to http://apha.us/CPE0519. from 8:30 am to 5:00 pm ET at APhA InfoCenter
the online assessment with a passing grade 2. Log in to your APhA account or register as a at 800-237-APhA (2742) or by e-mailing info-
of 70% or better, complete the evaluation, and new user. center@aphanet.org.
CLAIM CREDIT at http://apha.us/CPE0519. 3. Select “Enroll Now” or “Add to Cart” (click
You will have two opportunities to successfully “View Cart” and “Check Out”).
complete the assessment, and the questions 4. Complete the assessment and evaluation.
will be in randomized order. The current policy 5. Click “Claim Credit.” You will need to provide
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release the correct answers to any of our CPE print your statement of credit.
tests. This policy is intended to maintain the
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cessfully complete this activity by the expiration
date can receive CPE credit. Please visit CPE
Monitor for your statement of credit/transcript.
7. Which of the following accurately describes the best c. Glucometer value is within 10 mg/dL of a reference
approach to enhancing diabetes care with use of plasma value for values below 70 mg/dL.
apps? d. Glucometer value is within 25 mg/dL of a reference
a. Advise patients to avoid using apps that are not ap- plasma value for values above 200 mg/dL.
proved by FDA.
b. Identify other apps that a patient may be using to 13. Which of the following is correct about the accuracy of
sync up with the app. continuous glucose monitoring (CGM) devices?
c. Recommend to patients three to four apps that are a. Abbott Freestyle Libre requires calibration twice daily.
your personal favorites. b. Senseonics Eversense requires a 2-hour warm-up
d. Refer patients to apps that rely solely on automated before reporting data.
feedback from the app. c. Medtronic Guardian Connect requires calibration
every 12 hours.
8. A patient heard from a friend about a new app that d. Dexcom G6 sensors can be worn for only 7 days
seems too good to be true. She is thinking about pur- before needing replacement.
chasing it but is not sure if it is worth the high upfront
cost. Which of the following sources of information 14. Which of the following CGM systems is considered a
would be the most helpful for her decision? flash CGM device?
a. iTunes App Store User Ratings a. Dexcom G6
b. FDA Medical Device Database b. Guardian Connect
c. iMedicalApps Clearinghouse c. Eversense
d. National Library of Medicine Mobile Apps d. FreeStyle Libre
9. Which of the following characteristics describes one 15. A patient at your pharmacy has a daughter with type 1
of the core HONcode principles of the Health On the diabetes. She heard on the news that an artificial pan-
Net Foundation? creas was recently approved by FDA. She is excited
a. Attribution about the idea but has some questions. Which of the
b. User ratings following most correctly describes what is currently
c. Functionality available for patients as an artificial pancreas?
d. Update frequency a. A fully automated insulin pump/CGM system that
allows the patient to be completely hands-off
10. Which of the following is important to consider when b. A hybrid, closed-loop insulin pump/CGM system
evaluating an app’s online user ratings? that automatically adjusts basal insulin delivery
a. Read only those reviews from people who rated the based on CGM data
app poorly. c. A partially automated insulin pump/CGM system
b. Read only those reviews from people who rated the that alerts the patient if CGM data indicate the pa-
app highly. tient is hypoglycemic
c. Read a mix of reviews from people who rated it d. A combination system that includes an insulin
highly and poorly. pump and a CGM, but the two devices do not inte-
d. Do not read the reviews; just focus on the numerical grate for clinical decision-making purposes
rating to save time.
16. Which of the following meters contains the functional-
11. Which of the following glucometers received a seal ity to test blood samples for both glucose and ketones?
of approval based on the results of the 2018 Diabetes a. Precision Xtra
Technology Society (DTS) Blood Glucose Monitor b. OneTouch Ultra2
System (BGMS) Surveillance Program? c. Accu-Chek Aviva Plus
a. TrueTrack d. Bayer Contour Next EZ
b. One Touch Ultra2
c. Prodigy AutoCode 17. CGM would be most beneficial for which one of the
d. Accu-Chek Aviva Plus following patients with type 2 diabetes?
a. A patient on multiple daily insulin injections and
12. Which of the following correctly describes the with hypoglycemia unawareness
standard used during the DTS BGMS Surveillance b. A patient taking metformin and a sulfonylurea who
Program? occasionally experiences nocturnal hypoglycemia
a. Glucometer value is within 5% of a reference plasma c. A patient who has a glucose log that is consistent
value for values below 150 mg/dL. with her or his most recent A1C
b. Glucometer value is within 15% of a reference d. A patient who is legally blind in both eyes with no
plasma value for all values above 100 mg/dL. permanent caregiver living with her or him
18. Which of the following statements is true about dis- 20. Which of the following devices is able to record the
posable insulin pen devices? times and amounts of insulin doses administered on
a. Can deliver insulin in half-unit increments a Bluetooth-paired smartphone app?
b. Can track the time of the last insulin dose to prevent a. NovoPen Echo
stacking b. Clipsulin C3
c. Should be stored without a pen needle attached c. Solostar Max
d. Can integrate with smartphone apps to deliver ac- d. FlexTouch
curate insulin doses based on carb-to-insulin ratios
and correction factors