The OneTouch Ultra Plus Flex Blood Glucose Monitoring System: Evaluation ™

of a Meter that Meets the Requirements of EN ISO 15197:2015 and Offers

Ease-of-Use for a Broad Range of Patients with Diabetes. The OneTouch Ultra
Plus Flex meter features ColourSure technology and Bluetooth Connectivity.
™ ™ ®

Figure 1
Key Points
The OneTouch Ultra Plus Flex TM

Accuracy and Precision meter with ColourSure technologyTM

The OneTouch Ultra Plus Flex blood glucose ™

and Bluetooth Connectivity®

monitoring system (BGMS) provides accuracy

that patients can trust. Studies performed in the
clinic (capillary blood) and laboratory (venous
blood) settings have demonstrated that the
OneTouch Ultra Plus Flex BGMS meets the EN ™

ISO 15197:2015 requirements for system accuracy.

ISO uses the term “system accuracy” to describe
the ability of the BGMS to produce measurement
results that agree with true glucose values.
The concept of "system accuracy" includes
measurement bias and measurement precision.

User Performance Evaluation

An ethics committee approved clinical study has
demonstrated that the OneTouch Ultra Plus Flex ™
The OneTouch Ultra Plus Flex meter with
TM

BGMS meets the user accuracy criteria of EN ISO ColourSure technology makes it easy for
TM

15197:2015. patients to understand a blood glucose result.

Hematocrit Performance ColourSure Technology

™

Studies have demonstrated that the OneTouch

Effective utilization of structured SMBG requires
Ultra Plus Flex BGMS meets the requirements for
™

that patients are able to correctly interpret their

hematocrit performance as specified in EN ISO
blood glucose (bG) results and take appropriate
15197:2015 for all donors, hematocrit and glucose
actions when needed.
levels, and test strip lots tested.
With ColourSure technology, the OneTouch
™

Interferences Ultra Plus Flex meter instantly shows if a blood

™

The OneTouch Ultra Plus Flex BGMS meets the ™

glucose result is low, high or in range. When
EN ISO 15197:2015 performance requirements a blood glucose result is displayed, the Range
for common endogenous and exogenous Indicator Arrow points to a corresponding
substances tested at their high normal or high Range Indicator Colour Bar; blue (below range),
therapeutic concentrations (for some substances, green (in range) or red (above range). The low
considerably in excess of normal). A total of 28 and high range limits can be customized to
potential interferents were tested. individual target ranges.

In a 6-month clinical study, patients with Type 1

Wireless Connectivity
and Type 2 diabetes reported that ColourSure ™

The One Ultra Plus Flex meter is equipped with

™

technology, on the OneTouch Ultra Plus Flex ™

both USB and Bluetooth connectivity. ® i

meter, made it easy to understand their blood

glucose result and follow their health care
professionals’ recommendations.

i
The Bluetooth word mark and logos are registered trademarks owned by
®

Bluetooth SIG, Inc. and any use of such marks by LifeScan Scotland Ltd. is under
license. Other trademarks and trade names are those of their respective owners.
Introduction Table 1
The OneTouch Ultra Plus Flex BGMS provides
™
OneTouch Ultra Plus Test Strip
®

a no-coding test strip platform that has been Features and Specifications
designed to meet the requirements of EN ISO
15197:2015.
Feature Specification
The studies described in this paper (system
accuracy, user performance, hematocrit Operating Glucose in the blood sample
performance, repeatability precision, intermediate principle mixes with the enzyme
precision, and effect of interferences) were FAD-GDH (flavin adenine
dinucleotide dependent
conducted to evaluate the performance of glucose dehydrogenase)
the OneTouch Ultra Plus Flex system. system.
™
in the test strip and a small
electric current is produced.
Ethics committee approval was granted both for
clinical protocols where informed consent of the
participants was required and where consent was Sample types Fresh capillary (fingertip)
whole blood
required to allow use of participants’ blood samples
in laboratory investigations.
Calibration Plasma-equivalent
Evaluations were performed in a manner consistent
with guidelines published by the International Coding Calibration codes not
required
Organization for Standardization (ISO). 1

The OneTouch Ultra Plus Flex meter is designed to

™
Result range 1.1 mmol/L to 33.3 mmol/L
take the guesswork out of blood glucose readings.
It features a proprietary on-meter support tool, Operating
6°C to 44°C
ColourSure™ technology, that assists users in temperature
interpreting their blood glucose results. The meter
provides fast, accurate results with a tiny blood Altitude Up to 3,048 meters
sample and features easy-to-read numbers. The
meter’s small and slim design makes it easy for Hematocrit range 20% to 60%
patients to test on the go.
Test time 5 seconds

Sample volume 0.4 µL

Figure 2 Figure 3
OneTouch Ultra Plus Flex Meter ™
OneTouch Ultra Plus Test Strip
®

OneTouch Ultra Plus Test Strip

®

Test strip port

Display

Data port
Unit of measure: mmol/L is
Range Indicator the preset unit of measure
Arrow and cannot be changed

OK button
Range Indicator
Color Bars

Up and down
buttons

2
System Accuracy Table 2

EN ISO 15197:2015 minimum system accuracy OneTouch Ultra Plus Flex BGM ™

performance criteria 1
System Accuracy
• For each test strip lot, 95% of the measured
glucose values shall fall within either ±0.83 A. Overall System Accuracy
mmol/L of the average measured values of the
reference measurement procedure at glucose
EN ISO 15197:2015 SPECIFICATION
concentrations <5.55 mmol/L or within ±15% at
glucose concentrations ≥5.55 mmol/L.
Within ±0.83
mmol/L 595/600 99.2%
• 99% of individual glucose measured or ±15% of
values shall fall within zones A and B of the reference
Consensus Error Grid for type 1 diabetes.
Difference Plot: The difference plot (Figure 4)
Methods represents the difference between each OneTouch
• Testing was performed by study facilitators at Ultra Plus Flex BGMS result and corresponding
TM

the clinic sites using capillary blood samples reference result (y-axis) vs. the corresponding
reference result (x-axis). The dashed lines represent
from 100 subjects and for 3 individual test
the system accuracy performance criteria of EN
strip lots.
ISO 15197:2015, with 99.2% (595/600) of measured
• The number of samples within the glucose glucose values meeting these criteria.
concentration ranges was defined by EN ISO
15197:2015.
• For each subject, the facilitator tested 6
OneTouch Ultra Plus Flex™ meters using
fingertip capillary blood.
• Reference glucose testing was performed
using the reference YSI 2300 STAT Plus™
Biochemistry Analyzer (YSI, Inc., Yellow
Springs, Ohio, USA).
• The ISO acceptance criteria, based on
percentage of accurate results, were used to
evaluate the results.

Results
• Overall accuracy (Table 2 and Figure 4): 99.2%
(595/600) of the OneTouch Ultra Plus Flex ™

BGMS results meet all requirements of the EN

ISO 15197:2015 system accuracy performance
criteria.
• The EN ISO 1517:2015 consensus error grid
criteria was also met with 100% of results within
zones A and B (Figure 5).
• Accuracy at glucose concentrations <5.55
mmol/L: 100.0% (186/186) of OneTouch Ultra
Plus Flex BGMS results were within ±0.83
™

mmol/L of reference values.

• Accuracy at glucose concentrations ≥5.55
mmol/L: 98.8% (409/414) of the OneTouch
Ultra Plus Flex™ BGMS results were within ±15%
of reference values.
• Linear regression analysis yielded the following
results: slope=1.01; y-intercept=−0.12 mmol/L;
standard error (Sy,x )=0.64 mmol/L; r2=0.99. ii
 uplicate tests were included with 3 test strip lots, creating 6 total blood
D
glucose tests.

3
Figure 4 User Performance Evaluation
OneTouch Ultra Plus Flex System ™
EN ISO 15197:2015 user performance evaluation 1

Accuracy: Difference Plot of Meter

• For each lot, 95% of the measured glucose
Results (N=600) values shall fall within either ±0.83 mmol/L of
YSI Reference / mmol / L the average measured values of the reference
0 5 10 15 20 25 30 35
1 50 8 result at glucose concentrations <5.55 mmol/L
6 or within ±15% at glucose concentrations ≥5.55
1 00

4
mmol/L.
50

Bias / mmol / L
Bias / mg / dL

0 0 Methods
-2
-50 • 166 evaluable subjects took part in an open,
-4
non-randomized clinical evaluation across 4
-1 00
-6
clinic sites.
-8
-1 50
0 1 00 200 300 400 500 600 7 00
• Subjects were briefed on study procedures
YSI Reference / mg / dL
and requirements but received no training
Consensus Error Grid Analysis on the use of the OneTouch Ultra Plus Flex ™

The consensus error grid for type 1 diabetes (Figure BGMS.

5) is a plot of OneTouch Ultra Plus Flex BGMS results ™

(y-axis) vs. the corresponding reference results (x-axis) • Each study subject lay-user collected their
that is overlaid with a grid that divides the plot into own blood sample by skin puncture (finger
zones. Each zone signifies the degree of clinical risk stick) and performed one test using the
posed by inaccuracy of the BGMS result. According OneTouch Ultra Plus Flex meter and test strip,
™

to the error grid, 99.7% (598/600) of OneTouch Ultra which was chosen from 3 OneTouch Ultra
Plus Flex™ BGMS results were in zone A (no effect on Plus test strip lots.
®

clinical action).
• Following this test, the study staff (healthcare
Figure 5 professionals) collected blood from the same
finger puncture for hematocrit and reference
OneTouch Ultra Plus Flex ™

plasma glucose testing (duplicate tests on the

Consensus Error Grid: YSI 2300).
EN ISO 15197:2015 Criteria
YSI Reference / mmol / L
Results
7 00
0 5 10 15 20 25 30 35
• 97.0% (161/166) (Table 3; Figure 6) of OneTouch
E D C B A

600 A
35 Ultra Plus Flex BGMS lay user self-test results
™

were within the EN ISO 15197:2015 user

Meter Response / mmol / L
Meter Response / mg / dL

30
500

B
25 accuracy performance acceptance criteria.
400
20

300
• Consensus Error Grid analysis (Table 4; Figure
15
C 7) shows 100.0% (166/166) of OneTouch Ultra
200
10
Plus Flex BGMS lay user self-test results were
™

1 00 D 5
in zone A (no effect on clinical action).
0 0
0 1 00 200 300 400 500 600 7 00
• Linear regression analysis yielded the
YSI Reference / mg / dL
following results: slope=1.02; y-intercept=
Zone definitions:
-0.08 mmol/L; standard error (S )=0.75
y,x

Zone A: No effect on clinical action mmol/L; r =0.99 (N=166).

2

Zone B: Altered clinical action - little or no efffect on clinical outcome

Zone C: Altered clinical action - likely to affect clinical outcome
Zone D: Altered clinical action - could have a significant medical risk
Zone E: Altered clinical action - could have dangerous consequences

4
Table 3 Figure 6
OneTouch Ultra Plus Flex BGMS ™
OneTouch Ultra Plus Flex BGMS ™

Lay User Performance Acceptance Lay User Difference Plots of Meter

Criteria: EN ISO 15197:2015 Results: EN ISO 15197:2015 (N=166)
EN ISO 15197:2015 Requirement Specification
(95% of the individual glucose measure values YSI Reference / mmol / L
0 5 10 15 20 25 30 35
within ±0.83 mmol/L or ±15% of reference) 1 50 8

6
1 00

Lay Users 4
50

Bias / mmol / L
Bias / mg / dL
2

161/166 0 0

97.0% -2
-50
-4

-1 00
-6
Table 4 -8
-1 50

OneTouch Ultra Plus Flex BGMS ™ 0 1 00 200 300 400

YSI Reference / mg / dL
500 600 7 00

User Performance:
Consensus Error Grid Analysis Figure 7
OneTouch Ultra Plus Flex BGMS Lay ™

Lay User / Self-Test (N=166) User Performance Consensus Error

Zone N % Grid: EN ISO 15197:2015 (N=166)
A 166 100.0%
B - -
C - -
D - -
E - -

Zone definitions:
Zone A: No effect on clinical action
Zone B: Altered clinical action - little or no efffect on clinical outcome
Zone C: Altered clinical action - likely to affect clinical outcome
Zone D: Altered clinical action - could have a significant medical risk
Zone E: Altered clinical action - could have dangerous consequences

Zone definitions:
Zone A: No effect on clinical action
Zone B: Altered clinical action - little or no efffect on clinical outcome
Zone C: Altered clinical action - likely to affect clinical outcome
Zone D: Altered clinical action - could have a significant medical risk
Zone E: Altered clinical action - could have dangerous consequences

5
Packed Cell Volume (Hematocrit) Methods
Performance • Venous blood from 3 donors was adjusted in
EN ISO 15197:2015 packed cell volume the laboratory to 5 target hematocrit levels
(hematocrit) interference performance criteria: ranging from 19% to 61% and 6 target glucose
levels ranging from 2.2+0.3 mmol/L to 31.1+1.6
The packed cell volume effects shall be described mmol/L.
in the instructions for use if they meet either of the
following performance criteria: • Blood glucose testing was performed using 8
production-equivalent OneTouch Ultra Plus
• For glucose concentrations <5.55 mmol/L, the Flex meters and 3 lots of OneTouch Ultra Plus
™ ®

difference between the average measured value test strips.

at each packed cell volume level and the average
measured value at the mid-level packed cell • The verage measured value to plasma glucose
volume exceeds 0.55 mmol/L. concentration was calculated for each
combination of glucose levels and hematocrit
• For glucose concentrations ≥5.55 mmol/L, the (all donors, meters, and test strip lots).
difference between the average measured value
at each packed cell volume level and the average Results
measured value at the mid-level packed cell
volume exceeds 10%. 1
• The OneTouch Ultra Plus Flex BGMS met the EN
™

ISO 15197:2015 hematocrit acceptance criteria.

• Figure 8 shows that the OneTouch Ultra Plus

Flex™ BGMS is insensitive to hematocrit levels
of 20-60% as the average measured value for
each test strip lot tested was within 0.55 mmol/L
or 10% of the mid-level (nominal) hematocrit
volume.

Figure 8
OneTouch Ultra Plus Flex BGMS Hematocrit Performance: Average
™

Bias at high and low Glucose for each Hematocrit Level tested

Bias to nominal equates to the average measured value at each hematocrit level tested compared to the nominal hematocrit level of 42%

6
Precision: Repeatability Precision: Intermediate Precision

Methods
• From one venous blood donor (one sample),
100 replicates were tested per 5 target glucose
levels ranging from 1.94 mmol/L to 21.21
mmol/L as defined in EN ISO 15197:2015.
Methods
• The testing procedure involved 3 control
solution levels determined by the BGMS
system as: low (2.05 mmol/L); mid (6.55
mmol/L); high (19.54 mmol/L); 3 lots of
OneTouch Ultra Plus test strips, and 30
®

• The testing procedure involved 3 lots of OneTouch Ultra Plus Flex meters (10 meters
™

OneTouch Ultra Plus test strips and 30

®

per test strip lot).

OneTouch Ultra Plus Flex meters (10 meters
™

per test strip lot). • Testing was executed by multiple operators

• Testing (10 replicates per meter at each
glucose level) was executed by a single
operator on a single day.
• For each glucose level, the pooled mean
glucose, pooled SD, and pooled CV were
calculated.
Results
• Pooled values were ≤0.10 mmol/L SD at
glucose levels less than 5.55 mmol/L, or ≤2.13%
CV at glucose levels at 5.55 mmol/L or above
(Table 5), indicating that from test strip to test
strip, the OneTouch Ultra Plus Flex BGMS
™
provides repeatable test results with blood.
over a 10-day period.
• On each day of testing, duplicate tests were
performed with each meter at each control
solution level.
• For each glucose level, the mean glucose (all
test strip lots, meters, and days), SD (pooled for
the test strip lots), and CV were calculated.
Results
• Pooled values were ≤0.05 mmol/L SD at
glucose levels less than 5.55 mmol/L, or
≤2.25% CV at glucose levels at 5.55 mmol/L
or above (Table 6), demonstrating that the
OneTouch Ultra Plus Flex BGMS provides
™

reproducible test results with control solution.

Table 5
OneTouch Ultra Plus Flex BGMS ™ Table 6
Within-Run Precision: Pooled Data OneTouch Ultra Plus Flex BGMS ™

for 3 Test Strip Lots (N=300 tests for Intermediate Precision: Pooled Data
each glucose level) for 3 Test Strip Lots (N=600 for each
control solution level)
OneTouch Ultra
SD CV
Plus Flex Average
™

mg/dL % OneTouch Ultra Plus

Glucose mmol/L SD CV
Flex Mean Glucose
™

mg/dL %
mmol/L
1.94 0.05
5.48 0.10 2.05 0.05
7.73 2.11 6.55 1.86
12.34 1.92 19.54 2.25
21.21 2.13

7
Interferences Results
EN ISO 15197:2015
• The study showed that the accuracy of
The EN ISO standard requires that interference the OneTouch Ultra Plus Flex BGMS is not
™

effects be described in the instructions for use if compromised by 26 interferents tested

they meet either of the following performance (Table 8), even in excess of high normal/high
criteria: therapeutic levels.

• The OneTouch Ultra Plus Flex BGMS is not to

™

• For glucose concentrations <5.55 mmol/L, the

be used when PAM (Pralidoxime) is known or
average difference between the test sample
suspected to be in the patient's whole blood
and the control sample exceeds 0.55 mmol/L.
sample, as it may display inaccurate results.
• For glucose concentrations ≥5.55 mmol/L, the The OneTouch Ultra Plus Flex™ BGMS should
average difference between the test sample not be used within 24 hours of receiving a
and the control sample exceeds 10%. 1 D-xylose absorption test as it may display
inaccurate results.
Methods
• The OneTouch Ultra Plus Flex system was
™

tested in the presence of all 24 substances

listed in Annex A of EN ISO 15197:2015 as well
as with urea, ephedrine, tetracycline, and
lactose (Table 7). Twenty compounds were
tested in a paired difference study, and an
additional 8 compounds were tested in a dose
response study.

• In the paired difference studies, 2 glucose

concentrations (3.89 mmol/L and 16.65
mmol/L) and 2 concentrations (normal/
therapeutic and high normal/high therapeutic)
of the potentially interfering substances were
tested. The average bias was calculated at the
normal/therapeutic and the high normal/high
therapeutic levels of the interferent and the
difference between them obtained. A 2-sided
95% confidence interval for the average bias
was also calculated to ensure the acceptance
criteria were met.

• In the dose response testing, meter results

were obtained at the nominal level of the
interferent and 4 additional control levels. At
each glucose level, a linear regression for bias
versus interferent level was performed. The
fitted regression parameters were used to
determine the level of interferent at which the
allowable average bias shift (0.55 mmol/L or
10%) is breached.

8
 Table 7
List of substances tested and shown not to interfere with the OneTouch Ultra
Plus Flex BGMS ™

Endogenous Exogenous Saccharides

Ascorbic Acid* Acetaminophen Galactose

Bilirubin Dopamine Icodextrin

Cholesterol EDTA Lactose

Creatinine Ephedrine Maltose

Glutathione Gentisic Acid

Hemoglobin Heparin

Triglycerides Ibuprofen

Urea Levodopa

Uric Acid Methyldopa

Salicylate

Tetracycline

Tolazamide

Tolbutamide

* L-ascorbic acid: Listed as endogenous analyte by CLSI. 2

9
OneTouch Ultra Plus Test Strips
®
Figure 9

The OneTouch Ultra Plus test strips are

® OneTouch Ultra Plus Test Strip
®

easy to apply blood to and only require a Design

speck of blood to either side of the test strip.
Designed for accuracy and precision, the Precious metals
innovative features and precise manufacturing are sputtered onto polyester
of the OneTouch Ultra Plus test strip lay the
®
substrates in thin layers,
creating highly uniform
foundation for advanced processing through
surfaces of palladium and
specific design features discussed below. gold that deliver excellent
conductivity.
Each blood sample is scanned 500 times over
the 5 second test time, correcting for common
interferences to provide an accurate and FAD-GDH chemistry
precise result. dissolves quickly to produce
a nearly instantaneous
reaction that is highly specific
OneTouch Ultra Plus Test Strip
®
for glucose and is not
sensitive to oxygen.
Design
By placing electrodes opposite each other to Opposing electrodes
form a reaction chamber and applying a produce a unique response
complex potential waveform, a complex that enables the system to
extract rich information that
current response is elicited, read by the meter, is used to account for the
and analyzed (Figure 9). effect of hematocrit and
correct for interferences.

OneTouch Ultra Plus Test Strip

®

Algorithm
Manufacturing precision
The blood sample is scanned 500 times controls the size of the
over a 3-phase application of voltage. The reaction chamber to the
resultant current response is interrogated micron level, reducing
variability for a consistent
to deliver high accuracy readings that take and accurate results with
account of variations in hematocrit and also no-coding convenience.
common interfering substances that may be
present in a blood sample.

Fast-wicking side-fill design

provides a visual
confirmation of blood fill
and lets patients apply just
a speck of blood (0.4 µL) to
either side.

10
Enabling effective use of SMBG ColorSure Technology
™

Effective utilization of structured SMBG requires The OneTouch Ultra Plus Flex meter features
™

that patients are able to correctly interpret their
blood glucose results and take appropriate
actions when needed. Studies suggests that
4
many patients with diabetes do not know how
to identify and interpret SMBG results. This
not only impacts patients’ ability to achieve and
maintain their target blood glucose but can also
negatively affect adherence to their prescribed
testing frequency. 7
ColourSure™ technology, a range indicator that
instantly shows if a blood glucose result is low,
high or in range. When a blood glucose result
is displayed, the Range Indicator Arrow points
5,6
to a corresponding Range Indicator Colour Bar;
blue (below range), green (in range) or red (above
range). Studies have evaluated the clinical utility
and perceived benefits of support tool use by
individuals with type 1 (T1D) and type 2 diabetes
(T2D).6.8

The OneTouch Ultra Plus Flex meter has been ™

designed to improve understanding of blood Simulation studies assessing 179 diabetes

glucose results and can be customized to subjects’ (139 T2D and 40 T1D) ability to correctly
patients’ individual target ranges. interpret blood glucose values demonstrated
that OneTouch blood glucose meters with
®

ColourSure™ technology significantly improved

participants’ ability to categorize BG results into
low, in range, and high glycemic ranges by 27.9%
(T2DM) and 27.2% (T1DM) (each P < .001). In a
6

Figure 10 6-month clinical study among 128 Type 1 and

ColourSure Technology ™
Type 2 diabetes patients using a meter with
ColourSure technology, participants reported
™

this feature made it easy to understand their

blood glucose result (89%) and follow their health
care professionals recommendations (72%). In 8

this study, subjects agreed that the OneTouch ®

meter with ColourSure technology could help

™

Date Time them better manage their highs and lows to avoid
Unit of measure: hypoglycemic and hyperglycemic events.
Range Indicator mmol/L is the
Arrow preset unit of
measure and Range Indicator Settings
cannot be
changed • The OneTouch Ultra Plus Flex meter is preset
™

with low and high glucose range limits to let

Range Indicator
Color Bars
the patient know when a test result is within,
below, or above these range limits (Figure 10).
Below In Above
Range Range Range • The preset range limits can be changed as
recommended by health care professionals.
The pre-set low range limit is 3.9 mmol/L and
the pre-set high range limit is 10.0 mmol/L.

8 The low and high range limits set in the OneTouch Ultra Plus Flex meter apply
™

to all glucose test results. This includes tests taken before or after mealtimes,
medications, and around any other activities that may affect blood glucose.
Patients are advised to talk to their healthcare professional about the high and
low limits that are right for them.

11
Conclusions
The accuracy, precision, hematocrit, and
interference performance of the OneTouch Ultra
Plus Flex have been assessed in laboratory and
™
clinical studies. In both the system accuracy
and the user performance studies, accuracy
levels met the recognized EN ISO 15197:2015
criteria. The OneTouch Ultra Plus Flex BGMS
is not sensitive to 26 common interfering
substances at high normal/high therapeutic
levels and has been shown to deliver accurate
blood glucose readings according to the EN ISO
15197:2015 standards. The OneTouch Ultra Plus
Flex meter features Bluetooth connectivity
™ ®
and ColourSure™ technology that makes it
easy for patients to instantly know if their blood
glucose readings are high, low, or in range. The
ColourSure technology helps patients better
™
understand their test results. If patients know
when they are in or out of range, it may help
them to stay in better control and reach their
blood glucose goals. 6
© LifeScan, Division of Cilag GmbH International 2017 CO/UPX/0817/0080a
References
1. EN ISO 15197:2015 In vitro diagnostic test
systems - Requirements for blood-glucose
monitoring systems for self-testing in
managing diabetes mellitus (ISO 15197:2013)
2. Clinical and Laboratory Standards Institute
™ (CLSI). Appendix D: interference test
concentrations for endogenous analytes,
EP7-A2. Interference Testing in Clinical
Chemistry; Approved Guideline - 2nd Ed. 2005.
3. Rankin D, Cooke D, Heller S, Elliot J, Amiel S,
Lawton J. Experiences of using blood glucose
targets when following an intensive insulin
regimen: a qualitative longitudinal investigation
involving users with Type 1 diabetes. Diabetic
Medicine. 2012;29:8.
4. International Diabetes Federation. Global
guideline on self-monitoring of blood glucose
in non-insulin treated type 2 diabetes. 2009.
No updates since 2009. Accessed online at
https://www.idf.org/e-library/guidelines.html.
August 3, 2017
5. Silva DD, Bosco AA. An educational program
for insulin self-adjustment associated with
structured self-monitoring of blood glucose
significantly improves glycemic control
in patients with type 2 diabetes mellitus
after 12 weeks: a randomized, controlled
pilot study. Diabetol Metab Syndr. 2015;7:2
doi:10.1186/1758-5996-7-2.
6. Grady M, Katz LB, Cameron H, Levy BL. A
comprehensive evaluation of a novel color
range indicator in multiple blood glucose
meters demonstrates improved glucose range
interpretation and awareness in subjects
with type 1 and type 2 diabetes. J Diabetes
Sci Technol. 2016;10:1324-1332 Based on
interactive computer simulations.
7. Peel E, Douglas M, Lawton J. Self-monitoring
of blood glucose in type 2 diabetes:
longitudinal qualitative study of patients’
perspectives. BMJ. 2007;335:493.
8. Grady et al. Diabetes App-Related Text
Messages From Health Care Professionals in
Conjunction With a New Wireless Glucose
Meter With a Color Range Indicator Improves
Glycemic Control in Patients With Type 1 and
Type 2 Diabetes: Randomized Controlled Trial.
JMIR DIABETES 2017, vol 2
12