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MIDDLE EAST AND NORTH AFRICA

INSULIN DELIVERY RECOMMENDATIONS


FOR CHILDREN AND YOUNG ADULTS

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Content

Introduction 3
Contributors 4
KEY 4
Acknowledgment 4
1.0 Insulin Injection 5
2.0 Insulin Infusion 9
3.0 Lipodystrophy 11
4.0 Psychology 14
5.0 Golden Rules 19
Conclusion 23
Abbreviations 24
References 25
Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults

Introduction
Intramuscular (IM) injections should be avoided, especially with
long-acting insulins, because severe hypoglycemia may result.
Lipodystrophy is a frequent complication of therapy that
delays insulin absorption, and, therefore, injections and
Many healthcare professionals manage the care of people infusions should not be given into these lesions.
with diabetes who use insulin. To date very few guidelines or
clinical recommendations have been made available to help Correct site rotation will help prevent lipodystrophy.
clinicians manage insulin injection and infusion therapies. Effective long-term therapy with insulin is critically
This is a particular challenge for children and young adults. dependent on addressing psychological hurdles upstream,
even before insulin has been started.
The New Insulin Delivery Recommendations published in
Inappropriate disposal of used sharps poses a risk of
Mayo Clinic Proceedings 20161 is the latest in a series of
infection with blood-borne pathogens; and mitigation is
international expert recommendations based upon the very
possible with proper training, effective disposal strategies,
latest evidence and best clinical practice. It is informed by
and the use of safety devices.
one of the largest international clinical surveys of insulin
delivery. The survey titled "Injection Technique Questionnaire" Adherence to these new recommendations should lead to
(ITQ) was published in 2016 alongside the New Insulin Delivery more effective therapies, improved outcomes, and lower
Recommendations. It took over one year to complete and costs for patients with diabetes.
included 13.289 patients and their clinicians from 42 countries.
Following the success of the international congress FITTER
A smaller Infusion Technique Questionnaire survey was and the publication of the recommendations in Mayo Clinic
undertaken concurrently with the ITQ in 356 patients using Proceedings1, ASPED (Arab Society for Paediatric
continuous subcutaneous insulin infusion (CSII) in four Endocrinology and Diabetes) FITTER Scientific Advisory
countries and informed the drafting of the new infusion Board (SAB) was established and a scientific workshop was
recommendations. The ITQ survey results (for injection and held in Abu Dhabi, UAE, on December 13, 2017, at which
infusion) and the initial draft of these recommendations 24 of the regions pre-eminent clinical experts from 14 countries
reviewed the existing recommendations and created the first
were presented at the Forum for Injection Technique
Middle East and North Africa ASPED FITTER Insulin
and Therapy: Expert Recommendations (FITTER)
Delivery Recommendations for Children and Young
workshop held in Rome, Italy, on October 23 and 24, 2015,
Adults. These recommendations focus on four primary
at which 183 physicians, nurses, educators, and allied
clinical care topics:
health care professionals (HCPs) from 54 countries met to
• Insulin Injection • Insulin Infusion
debate, revise, and adapt these proposals. FITTER was the
• Lipodystrophy • Psychology
fourth in a series of expert workshops that have issued
recommendations on insulin delivery.2-5
Evidence shows that full implementation of these
recommendations can significantly improve the health
Recommendations are organized around the themes of:
outcomes and wellbeing of children and young adults living
• Anatomy • Physiology • Pathology
diabetes who use insulin.
• Psychology • Technology
These recommendations will be made available to all
Key Recommendations healthcare professionals who care for young adults and
The shortest needles (currently the 4-mm pen and 6-mm children with diabetes throughout the region.
syringe needles) are safe, effective, less painful and should
be the first-line choice in all patient categories. Please visit www.fitter4diabetes.com for more information
about FITTER.

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Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults

ASPED FITTER
Scientific Advisory Board
Asma Deeb (Chair)
Abdelhadi Habeb
Abdelsalam Abulibdeh
UAE
KSA
Palestine
Key
Abdulaziz Al Twaim KSA Scientific Advisory Board (SAB) used a previously
established scale2,4,6 for the strength of each
Ali Jumaili Iraq
recommendation:
Asma Jassim UAE
A Strongly recommended
Asmahane Ladjouz Algeria
B Recommended
Attia Radhouène Tunisia
C Unresolved issue
Bassam Bin Abbas KSA
Elham Al Amiri UAE For the strength of scientific support for each
Farida Jennane Morocco recommendation, the following scale is used:
Hala Al Shaikh Oman 1 At least one rigorously performed study that is
peer-reviewed and published
Haya Al Khayat Bahrain
2 At least one observational, epidemiologic or
Iman Albasiri Kuwait population-based published study
Jamal Al Jubeh UAE 3 Consensus expert opinion based on extensive patient
Mariette Akle UAE experience
Mohamed Al Dubayee KSA
Thus, each recommendation is followed by both a letter
Mohamed Abdulla Sudan and number in bold (e.g. A2). The letter indicates the
Mongia Hachicha Tunisia importance that the recommendation should have in
Nancy Elbarbary Egypt practice, and the number indicates its level of evidence in
Rasha Odeh Jordan the medical literature. There are few randomized clinical
Saif Al Yarubi Oman
trials in the field of injection technique so judgements such
as ‘strongly recommended’ versus ‘recommended’ are
Samar Hassan Sudan
based on a combination of the weight of clinical evidence,
Sarah Ehtisham UAE the implications for patient therapy and the judgement of
Suliman Abusrewil Libya the group of experts.

Guest Advisors These recommendations apply to the majority of people


Kenneth Strauss Belgium
with diabetes using injectable therapy, but there will
inevitably be individual exceptions for which these
Mike Smith UK
recommendations must be adjusted.
Sanjay Kalra India

Acknowledgment
New Insulin Delivery Recommendations, Mayo Clin Proc. 2016;91(9):1231-1255 informed these recommendations
and we thank the editors of the Mayo Clinic for permission to use material from this article.

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Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults

01
2

01
01

2
2
1.0
Insulin Injection
Insulin absorption rates from IM injections differ Patients may be unaware that they are injecting IM.
according to the activity of the muscle. IM-injected insulin Unexplained glycemic variability and episodes of
is absorbed differently in resting, active and exercising hypoglycemia may suggest IM injection. At special risk
muscle, with the rate increased as one progresses through are children, thin people and people using longer
the three stages. needles or following improper technique.

Human insulins and analogues have different absorption


profiles when deposited into muscle. IM injections can lead
to frequent and unexplained hypoglycemia according to a
number of studies.7-9

lifted skinfold

Skin layer - don't inject here

Subcutaneous layer - inject here

Muscle layer - dont inject here

Figure 1: Intramuscular Injection (IM)

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Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults
STRONGLY RECOMMENDED
RECOMMENDED
UNRESOLVED ISSUE

At least one rigorously performed study, peer-reviewed and published


At least one observational, epidemiologic or population-based study.
Consensus expert opinion based on extensive patient experience.

1.0
Insulin Injection
1.1 Needle Length • The 4 mm needle should be inserted perpendicular to
the skin (at 90° to skin surface), not at an angle,
The needle lengths that were once recommended for regardless of whether a skin fold is raised. A1
subcutaneous (SC) injection (for children, ≥6 mm and for
adults, needles ≥8 mm) are now known to be too long • The safest currently-available syringe needle for all
because they increase the risk of IM injections without any patients is 6 mm in length. However, when any syringe
evidence for improved glucose control. 10-12 Shorter needles needle is used in children (6 years and older) or
are much safer, better tolerated and less painful. They may adolescents, injections should always be given into a
lifted skin fold. A1
be used in all children, teens and adults13-15 including obese
pediatric and adult patients.16 All studies on needle • Use of syringe needles in very young children (less than
length17-25 have also shown similar glucose control (HbA1c, 6 years old) and extremely thin adults (BMI <19) is not
glycated albumin or fructosamine) without increased recommended, even if they use a raised skin fold,
leakage with the shorter length needle. The shortest-length because of the excessively high risk of IM injections. A1
pen needle is 4 mm, but the shortest syringe needle today
is 6 mm long (syringe needle has to be passed through vial • Health care authorities and payers should be alerted to
septum or stopper). the risks associated with using syringe or pen needles
6mm or longer in children. A2
Recommendations
• Children still using the 5mm pen needle should inject
• The 4mm needle is long enough to traverse the skin
using a lifted skin fold. Children using pen needles ≥
and enter the SC tissue, with little risk of IM (or
5mm should be shifted to 4 mm needles if possible;
intradermal) injection. Therefore, it is considered
and if not, should always use a lifted skin fold. A2
the safest pen needle for children and adolescents
regardless of age, gender, ethnicity or BMI. A1 • If arms are used for injections with needles 6mm
or longer, a skinfold must be lifted. This requires
• The 4 mm needle may be used safely and effectively
that the injection be given by a third party. A2
in all obese children and adolescents. Although it is
the needle of choice for these patients, a 5mm • Avoid pushing the needle hub in so deeply that it indents
needle may also be acceptable. A1 the skin as this increases the risk of IM injections. B3

• Very young children (6-years old and under) should • Children who shift from a pen needle to a syringe needle,
use the 4 mm needle by lifting a skin fold and or vice versa, must be counselled about the need to
inserting the needle perpendicularly into it. Other change injection technique, due to the difference in
children and adolescents may inject using the 4 mm needle length. A2
needle without lifting a skin fold. A1

6
Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults
STRONGLY RECOMMENDED
RECOMMENDED
UNRESOLVED ISSUE

At least one rigorously performed study, peer-reviewed and published


At least one observational, epidemiologic or population-based study.
Consensus expert opinion based on extensive patient experience.

1.0
Insulin Injection

1.2 Injection Port Recommendations


• An injection port is a one-time, single patient use device.
A subcutaneous injection port combines the injection port Reuse of the port may damage the cannula in the device
with an aid for insertion. The injection port is an integrated and increases the risk of the tape becoming loose. Reuse
part of the inserter. Two injection port models are available: of the port may result in infection or site irritation and
a 6 mm or 9 mm cannula length. Injection port is indicated inaccurate medication delivery. A1
for patients who administer or receive multiple daily
subcutaneous injections of physician prescribed medications, • It should not be used for longer than 72 hours. B1
including insulin. The device may remain in place for up to
• Needles with a gauge smaller than 28 or greater than 32
72 hours to accommodate multiple injections without the
should not be used. Doing so may damage the septum
discomfort of additional needle sticks. It may be used on a
and may cause incorrect medication delivery. A1
wide range of patients, including adults and children.
• Use of needles shorter than 8mm (5/16 in.) is
suitable when injecting into the injection port. Longer
needles may damage the device causing unnecessary
punctures of the skin, or tearing or puncturing of the
soft cannula, which may result in unpredictable
Use with syringe medication delivery. A1
or pen needle

• Use of needles shorter than 5mm (3/16 in.) is not


Needle never touches skin recommended when injecting into t injection port.
Shorter needles may not pass through the port septum,
Surface of skin which may prevent the medication from properly
entering the body. A1

• Blood glucose 1 to 3 hours after using the injection port


should be tested to ensure insulin delivery performs as
anticipated and blood glucose measurement should
continue on a regular basis as specified by the
healthcare professionals. Applying the injection port to
Delivered medication Soft cannula sites that contain scar tissue, lipodystrophy, stretch marks
or are injected/bruised should be avoided. A3
Figure 2: Injection port

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Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults
STRONGLY RECOMMENDED
RECOMMENDED
UNRESOLVED ISSUE

At least one rigorously performed study, peer-reviewed and published


At least one observational, epidemiologic or population-based study.
Consensus expert opinion based on extensive patient experience.

1.0
Insulin Injection

1.3 Injection Site Care


The recommended injection and infusion sites are the
abdomen, thigh, buttocks and upper arm.26-30

Recommendations
• Children (and/or parents) and adolescents should
inspect the site prior to injection. Injections should only
be given into clean sites using clean hands.31-33 A2

• If the site is found to be unclean it should be


disinfected. Disinfection is also required in institutional
settings such as hospitals. If alcohol is used, it must be
allowed to dry completely before the injection is
given.34,35 A2

• Disinfection is usually not required when injections are Arm Arm


given in non-institutional settings such as the home, Abdomen

restaurants or schools as long as the skin is socially Buttocks

clean.36-40 A3

• Patients should never inject into sites of lipodystrophy, Thigh Thigh


inflammation, edema, ulceration or infection.38-46 A1

Moving away from lipohypertrophy injections may


require significant reduction in insulin dose. Ensure
that blood glucose levels are checked frequently
and insulin is adjusted according results.

• Patients should not inject through clothing since they


cannot inspect the site beforehand or easily lift a skin
fold.34 B2
Figure 3: Recommended injection sites.

8
Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults
STRONGLY RECOMMENDED
RECOMMENDED
UNRESOLVED ISSUE

At least one rigorously performed study, peer-reviewed and published


At least one observational, epidemiologic or population-based study.
Consensus expert opinion based on extensive patient experience.

2.0
Insulin Infusion
2.1 Insulin Infusion Sets for Recommendations
• Population studies suggest that CSII cannula should be
continuous subcutaneous changed every 48–72 hours with a goal of minimizing

insulin infusion (CSII) infusion site adverse events and potential metabolic
deterioration. However, these times are
CSII using an insulin pump has been a treatment modality patient-dependent and should be adjusted accordingly.
for patients with diabetes, primarily those with type 1, for A1
over 30 years.47 Insulin infusion sets (IIS) are required to
• All CSII users should be taught to rotate infusion sites
deliver insulin into the subcutaneous tissue, but their role in
along the same principles that injecting patients are
CSII therapy is often underappreciated by health care
taught to rotate injection sites. A1
professionals (HCPs). As a result, advances in IIS technology
are stagnant & overshadowed by the innovative advances of • All CSII patients with unexplained glucose variability
insulin infusion pumps. There are, never the less, a large including frequent hypoglycemia/hyperglycemia should
variety of IIS options available. have infusion sites checked for lipodystrophy, nodules,
scarring, inflammation or other skin and SC conditions
Complications related to IISs are common and include
that could affect insulin flow or absorption. A1
infusion site, technical, and metabolic manifestations; for
these reasons, IISs are considered the Achilles heel of • All CSII patients should have their infusion sites checked
CSII.48 regularly (preferably at every clinic visit) for
lipodystrophy by an HCP. A1
Similar criteria for choosing needle length for pen needles
should apply to choosing optimal IIS cannula length. Skin • If lipodystrophy is suspected, the patient should be
thickness studies suggest that short cannula lengths are instructed to stop infusing into these areas and to insert
appropriate to help reduce the risk of IM insertion. The the catheter into a healthy tissue. A1
studies provide visual evidence that IIS cannulas
measuring 9 mm or longer may increase the risk of IM • All CSII patients should be considered for the shortest
insertion, particularly in body area of reduced adipose needle/cannula available, along the same principles as
tissue, such as the back of the arm and the thigh. insulin injectors, to minimize the risk of IM infusion.
Young children and very thin individuals may need to
insert into a lifted skin fold, if manually inserted, to
avoid IM insertion. B2

9
Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults
STRONGLY RECOMMENDED
RECOMMENDED
UNRESOLVED ISSUE

At least one rigorously performed study, peer-reviewed and published


At least one observational, epidemiologic or population-based study.
Consensus expert opinion based on extensive patient experience.

2.0
Insulin Infusion
• The smallest diameter needle/cannula should be • We recommend securing the infusion line about 2
considered in CSII patients to reduce pain and insertion inches away from the set with a piece of tape, creating
failure. B2 what is often referred to as a ‘‘safety loop,’’ which can
help to keep the cannula in place and reduce the risk of
• Angled insertion sets should be considered in CSII dislodgment. B3
patients who experience infusion site complications
with 90-degree infusion sets. B2 • Disinfection of the infusion site is not necessary if
patients employ normal hygiene practices, such as
• All CSII patients who experience a hypersensitivity washing with mild soap and water. Nevertheless,
reaction to cannula material or adhesive should be antimicrobial body washes may be helpful in patients
considered for alternative options (alternative sets, prone to skin infection. This is important in hot and
tapes, transparent dressings and film barrier). A3 humid climate where high temperatures and humidity
also contribute to heat rash and skin irritation. A2
• CSII patients who are lean, muscular or active and have
a high probability of the cannula or tubing being • Emphasis should be placed at educating patients to
dislodged may benefit from angled (30-45 degree) recognize unexplained hyperglycemia. IIS should be
insertion of their IIS.49 C3 changed if no response to correction bolus after 2 hours.
In addition we recommend giving correction bolus by
• CSII patients who have difficulty inserting their infusion
insulin pen if ketones are present. A1
set manually for any reason should insert their infusion
sets with the assistance of a mechanical insertion • Patients should be educated about the risk of DKA if
device. C3 insulin infusion failure persists for more than 4-6 hours
without intervention to resume adequate insulin dosing.
• Patients should be educated early and regularly on the
B1
importance of inserting the cannula into healthy SC fat
tissue, avoiding underlying muscle as well as areas of • Cannula & infusion set should be changed if occlusion
skin irritation, infection, scarring, ‘‘pump bumps’’ and occurs. A1
lipodystrophy. A1
• Continuous glucose sensor or transmitter insertion
should be at least 1 inch away from insulin pump
infusion site. B3

10
Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults
STRONGLY RECOMMENDED
RECOMMENDED
UNRESOLVED ISSUE

At least one rigorously performed study, peer-reviewed and published


At least one observational, epidemiologic or population-based study.
Consensus expert opinion based on extensive patient experience.

3.0
Lipodystrophy
Lipodystrophy is a disorder of fat tissue. There are 2 main Recommendations
types of lipodystrophy: lipoatrophy (LA), which is loss of • Sites should be examined by the HCP for LH ideally at
adipocytes that clinically manifests as indenting and cratering, each clinic visit. It is often easier to palpate LH than to
and lipohypertrophy (LH), which is enlargement of adipocytes see it. Use of a lubricating gel facilitates palpation.52-53 A2
that manifests as swelling or induration of fat tissue.
• The physical exam for LH is ideally performed with the
LH is common affecting as many as 76% of people with patient lying down with the areas of insulin injection
Type 1 diabetes.50 The exact etiology of LH is unclear; sites fully exposed. But in circumstances that preclude
however, it is strongly associated with not rotating or this, examination of the patient sitting, standing or
incorrectly rotating injection sites and to lesser extent partially-clothed is acceptable. A3
needle reuse. Duration of insulin use is also implicated in
the formation of LH; however, given that we all aspire to • Patients/care givers may be taught to self-inspect & palpate
long lives for our patients, it is even more important that the injection sites. (Self IE: self-insulin site examination) A3
we protect them from the complications of suboptimal
• Patients/caregivers should be trained in site rotation,
insulin delivery.
proper injection technique as well as in detection and
prevention of LH. A2
Insulin absorption and action is substantially blunted when
injected into LH compared to normal adipose tissue. Insulin • Visualization of the lipohypretrophied area can be
absorption and action from LH are considerably less useful for patients. After obtaining consent, make two
reliable than from normal adipose tissue as indicated by ink marks at the extreme edges of LH with a single-use
higher intra-subject variability in PK and PD parameters. skin-safe marker. This will allow the LH to be visualized
Injections into lipohypertrophy should be avoided.51 and measured for future assessment. If visible, the
lesions could also be photographed. A2
Injections in the LH sites have been strongly linked with
unexplained hypoglycemia, glycemic variation, increased • Patients should be encouraged to avoid injecting into
use of insulin and above target HbA1c.50 areas of LH until the next exam by an HCP. Using larger
injection zones, correct injection site rotation and
non-reuse of needles should be recommended.54-55 A2

• Switching injections away from LH and to normal tissue


often requires a decrease in the dose of insulin injected.
The amount of decrease varies from one individual to
another and should be guided by blood glucose
measurements. Reductions often exceed 20% of their
Figure 4: Avoid injections into lipohypertrophy original dose.41 A1

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Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults
STRONGLY RECOMMENDED
RECOMMENDED
UNRESOLVED ISSUE

At least one rigorously performed study, peer-reviewed and published


At least one observational, epidemiologic or population-based study.
Consensus expert opinion based on extensive patient experience.

3.0
Lipodystrophy
3.1 Rotation of Injection Sites
A number of studies have shown that the best way to Recommendations
safeguard normal tissue at injection sites is to consistently • Injections should be systematically rotated in order to
and properly rotate injecting sites.56,57 Injections can be avoid LH. This means injecting at least 1 cm (or
rotated from one body region to another (abdomen to approximate the width of an adult finger) from previous
thigh, to buttock, to arm) but note that absorption injections, a vital procedure which requires careful
characteristics change depending on the type of insulin planning and attention. A2
given.
• Patients should be given an easy-to-follow rotation
Analogues may be given at any injection site with scheme from the beginning of injection/ infusion
similar uptake & action (pharmacokinetics and therapy. The HCP should review the site rotation
pharmacodynamics) but human insulins (regular, NPH)
scheme with the patient at least once a year. 57-63 A2
vary substantially, with absorption being fastest from the
abdomen and slowest from the buttocks. Correct rotation • One evidence-based scheme involves dividing injection
involves spacing injections a least 1 cm (approximately sites into quadrants (or halves when using the thighs or
the width of an adult finger) apart even within an buttocks), using one quadrant per week and rotating
injection zone. quadrant to quadrant in a consistent direction (e.g.
clockwise).64 A3

Choose a site (4 on the abdomen and Injections in each spot should be 1cm Rotate your sites regularly using abdomen,
one on each for buttocks, arm and thigh). from the last injection. thigh, buttocks and arms if possible.

Figure 5: Rotation of Injection Sites

12
Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults
STRONGLY RECOMMENDED
RECOMMENDED
UNRESOLVED ISSUE

At least one rigorously performed study, peer-reviewed and published


At least one observational, epidemiologic or population-based study.
Consensus expert opinion based on extensive patient experience.

3.0
Lipodystrophy
3.2 Needle Reuse and Hygiene • Reuse of needles increases the risk of contamination
and infection. A3
The United States Food and Drug Administration
• In an attempt to be hygienic, some patients clean
recommends single use of insulin injection needles. In
the needle with alcohol prior to reusing it. This
MENA countries, however, insulin needle reuse is very
practice removes the silicone lubricant and results in
common, this is believed to be primarily for economic
a more painful injection. This practice should be
reasons. It is advised to counsel such patients about the
discouraged. A3
potential hazards of reuse. The importance of not sharing
syringes between individuals should also be emphasized. • Repeated use of insulin needles particularly reuse
frequency can also result in damage to the tissues and
an increased risk of lipohypertrophy. A1

Unused needle • Insulin pen delivery systems, when used properly, are
extremely accurate. Improper use of pens with needles
left attached after use bears more chance for the air to
pass into the insulin chamber and an increased risk of
Reused needle contamination. Furthermore, there is a higher chance
for dosage inaccuracy due to the air bubble formation.
Hence, manufacturers recommend removing insulin pen
needles immediately after use. A1
Following aspects of the reuse should be discussed with
patients: • There is association between needle reuse and LH,
although a causal relationship has not been proven.
• When reusing, the thin tip of the needles gets damaged, There is also an association between reuse and injection
needles bend and the silicone lubricant coating of the pain or bleeding. Patients should be made aware of
needles is also lost. All these contribute to a more these associations. A2
painful injection, with bleeding and bruising. Repeat
usage can also result in breaking off and lodging of the • Ideally reusing insulin needles is not an optimal
needles under the skin. Furthermore, there is a higher injection practice and patients should be discouraged
chance for insulin to get deposited within the needle from doing so unless it is neither affordable nor
with reuse, making it harder to press on the plunger and available. Pen needles (and syringe needles) should only
deliver proper insulin doses. A1 be used once. They are no longer sterile after
use.3,4,37,38,42,65-67 A2

13
Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults
STRONGLY RECOMMENDED
RECOMMENDED
UNRESOLVED ISSUE

At least one rigorously performed study, peer-reviewed and published


At least one observational, epidemiologic or population-based study.
Consensus expert opinion based on extensive patient experience.

4.0
Psychology
Disclosing the diagnosis of diabetes and beginning
insulin therapy can be fraught with psychological hurdles,
regardless of the age of the patient. This may be termed
as insulin distress.68 It is important that team members
get training in handling this distress with sensitivity and
empathy, and assess the need for psychological support
in a timely manner. If psychology service is available,
involving a psychologist from the onset of diagnosis is
recommended.

Foremost among these is the fear of pain. Insulin


injections are usually not painful, except in the event that
the needle hits a nerve ending, which is quite infrequent.
Nevertheless, some patients are quite sensitive to
sensations & injection is described as painful. Patient
awareness of injection discomfort has been studied
extensively and is related to 3 key factors: needle length,
needle diameter, and injection context.

Injection context includes the environment (eg, noise and


the presence of other people), the appearance of the
needle, and the anxieties of the HCP and the family. The
more apprehension the latter display, the greater the
pain and anxiety felt by the patient.69,70 This reverse
transference places a large responsibility on caregivers to
assess their own attitudes toward injection pain. Some
patients note discomfort when injecting insulins that
have a low pH. This seems, anecdotally, to be reported
more commonly in children.

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Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults
STRONGLY RECOMMENDED
RECOMMENDED
UNRESOLVED ISSUE

At least one rigorously performed study, peer-reviewed and published


At least one observational, epidemiologic or population-based study.
Consensus expert opinion based on extensive patient experience.

4.0
Psychology
4.1 Emotional and
Psychosocial Issues
Recommendations
• Involving a psychologist from the time of diagnosis • Patients, especially adolescents, should be given
as one of the multidisciplinary team members is as much control as possible in designing their
recommended if the service is available. A3 regimen to fit their lifestyle. This could include basal
bolus therapy, carbohydrate counting, using insulin
• Show empathy by addressing the patients' pens and insulin pumps. Minimize intrusion into
emotional concerns first. The HCP should explore lifestyle. A3
worries and barriers to treatment and acknowledge
that anxiety is normal when beginning any new • Involve and empower the child using age
medication, especially injection therapy. A2 appropriate educational tools (eg. choosing injection
sites), get the feedback about the needle preference
• All patients, especially adolescents, should be and subjective pain experiences. A3
encouraged to express their feelings about
injecting/infusing, particularly their anger, frustration
or other struggles.A3

• Patients of all ages should be reassured that this is a


learning process and the health care team is there to
help along the way. The message is: ‘you are not
alone, we are here to help you; we will practice
together until you are comfortable giving yourself an
injection’. A3

15
Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults
STRONGLY RECOMMENDED
RECOMMENDED
UNRESOLVED ISSUE

At least one rigorously performed study, peer-reviewed and published


At least one observational, epidemiologic or population-based study.
Consensus expert opinion based on extensive patient experience.

4.0
Psychology
4.2 Strategies for Reducing
Fear, Pain, and Anxiety
4.2.1 Educational Approach
Recommendations • If bleeding or bruising occur, reassure the patient
• Include caregivers and family members both parents that these do not affect the absorption of insulin or
in the planning and education of the patient and overall diabetes control. If bruising continues or
tailor the therapeutic regimen to the individual hematomas develop, observe the injection technique
needs of the patient.A3 and suggest improvements (e.g. better rotation of
injection sites). A3
• Have a compassionate and straight-forward
approach when teaching injection technique.
Demonstrate the injection technique to the patient.
Have the patient follow along and then demonstrate
correct technique back to the educator or HCP.A3

• Integrate diabetes management in the patient’s life


and minimize the disruption of ongoing care.

• Children have a lower threshold for pain.71 The HCP


should ask about pain. For young children consider
distraction techniques or play therapy (such as
injecting a soft toy (animal or doll)). Older children
often respond better to cognitive behavioral
therapies (CBT).72 CBT includes guided imagery,
relaxation training, active behavioral rehearsal,
graded exposure, modeling and positive reinforcement
as well as incentive scheduling. A2

16
Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults
STRONGLY RECOMMENDED
RECOMMENDED
UNRESOLVED ISSUE

At least one rigorously performed study, peer-reviewed and published


At least one observational, epidemiologic or population-based study.
Consensus expert opinion based on extensive patient experience.

4.0
Psychology
4.2.2 Minimizing Anxiety and Pain
Recommendations • Insulin pens with very short needles (if available) may
• Fear and anxiety may be significantly reduced by having be more acceptable to patients than the syringe and
the parent and child give themselves a dry injection. vial. This should be discussed with the patient and
Often, they are surprised and relieved at how painless family when teaching injection therapy. The 4 mm pen
the injection is. A3 needle is reported by patients to be less painful than
longer needles.73,77-79 A2
• If patients occasionally experience sharp pain on
injection they should be reassured that the needle may • Keep insulin at room temperature by getting out of the
have touched a nerve ending which happens randomly fridge prior to the injection for a more comfortable
and will not cause any damage. If pain persists the HCP injection. Injecting insulin while it is still cold often
should see the patient and evaluate the injection produces more pain. A3
technique. A3

• Consider use of devices which hide the needle in case of


anxiety provoked by seeing sharps. Also consider use of
vibration, cold temperature or pressure to ‘distract’ the
nerves (gate theory) from the perception of pain. A3

• Use of injection ports at the commencement of therapy


may help reduce anxiety and fear of injections and its
associated pain.73-76 B1

17
Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults
STRONGLY RECOMMENDED
RECOMMENDED
UNRESOLVED ISSUE

At least one rigorously performed study, peer-reviewed and published


At least one observational, epidemiologic or population-based study.

5.0
Consensus expert opinion based on extensive patient experience.

Tips for Injection Education


and Golden Rules
5.1 Tips for Injection Education
Recommendations
• Demonstrate proper injection technique to the patient • HCPs should teach the importance of rotation and
and family. Then have the patient and family create a rotation pattern with the patient when
demonstrate proper technique back to the HCP. A3 initiating injection therapy. The message should be:
‘Insulin will not be well-absorbed if it is always injected
• Be sure the skin is clean and dry before injecting.
into the same area’. It is important to move injections
Patients usually do not need to use a disinfectant on the
at least half an inch (1 cm) away from the previous
skin, but if they do, they should allow it to dry
injection and to use all injection sites on the body (back
completely before injecting. A3
of the arms, buttocks, thighs and abdomen)’. A1
• Use needles of shorter length (4mm or shortest if • If the same injection site is used repeatedly it may
available), smaller diameter (highest gauge number), become lumpy, firm and enlarged. The insulin will not
and the tip with the lowest penetration force to work correctly if injected into these areas. Explore the
minimize pain. Use a sterile, new needle with each site rotation barrier. A1
injection. A1
• If pain is experienced when injecting large volumes of
• Insert the needle through the skin in a smooth but not insulin, the dose may need to be divided into two
jabbing movement. Pain fibers are in the skin and going injections of a smaller volume or the concentration of
through the skin too slowly or too forcefully may insulin may need to be increased. A3
increase the pain. A1
• Refer the patient to a psychologist for an evaluation of
• Inject the insulin slowly ensuring the plunger (on the the psychological issues related to injection technique if
syringe) or thumb button (on the pen) has been fully required. A3
depressed and all insulin has been injected. With pens
the patient should count to 10 after the button has
been depressed before withdrawing the needle in order
to get the complete dose. A3

18
Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults

5.0
Tips for Injection Education
and Golden Rules
5.2 Golden Rules
5.2.1 Injection Technique 4. Correct rotation of injection sites must be followed at all
times to prevent LH. 4-mm pen needles should be used
in Children and Young for all children and young adults regardless of age, sex,

Adults ethnicity, or BMI.

1. Insulin must be injected into healthy subcutaneous 5. Children and young adults are at risk for accidental IM
fat tissue, avoiding the intradermal and IM spaces injection. A 2-finger lifted skinfold usually prevents IM
as well as scars and LH or LA. injection but is much less effective in the thigh than in
the abdomen. Lean children should use a lifted skinfold
when the presumed skin surface to muscle distance is
2. Injection should avoid bony prominences by one to
less than the needle length plus 3 mm.
two adult fingerbreadths. Preferred sites are:

a. Abdomen, two adult finger breadths away


from the umbilicus

b. Upper third anterior and lateral aspects of


both thighs

c. Posterior and lateral aspects of both upper


buttocks and flanks

d. Middle third posterior and lateral aspects of


the upper arm

3. Consideration should be given to the type of


insulin and the time of day when selecting
injection sites.

19
Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults

5.0
Tips for Injection Education
and Golden Rules
5.2.2 Insulin Infusion
Technique
1. Insulin infusion cannula must be inserted into healthy 4. Infusion cannula sites should be rotated to avoid
subcutaneous fat tissue, avoiding underlying muscle complications. This usually involves moving to a new
as well as areas of skin irritation, scarring, LH and LA. location. In-site duration should be individualized but
typically should not be more than 72 hours.

2. If bleeding or significant pain occurs on insertion, the 5. If kinking occurs, consider a shorter cannula or an
set should be removed and replaced. oblique or steel set. If frequent silent occlusions or
unexplained hyperglycemia occur, consider using a
different type of infusion set, including a cannula with
3. Preferred sites for infusion cannula should be
a side port, if available.
individualized but include:

a. Abdomen, avoiding bony prominences & the


umbilicus

b. Upper third anterior lateral aspect of both


thighs

c. Posterior lateral aspect of both upper buttocks


& flanks

d. Middle third posterior aspect of upper arm

20
Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults

5.0
Tips for Injection Education
and Golden Rules
5.2.3 Treating and Preventing LH
c. Supported by an HCP to monitor glucose levels
1. All patients who inject or infuse insulin must have their frequently due to the risk of unexpected
sites checked at regular visit: hypoglycemia

a. HCPs in diabetes must be trained to correctly screen d. Assisted in the reduction of their insulin doses in line
for LH and other site complications. with glucose results, knowing that reductions often
exceed 20% of their original dose
b. All people who self-inject/infuse insulin must be
taught to self-inspect sites and be able to distinguish e. Optimized to 4-mm pen needles/6-mm insulin
healthy from unhealthy tissue. syringes or the shortest needle length available to
minimize accidental IM risk

2. Clinicians must monitor and record the evolution of LH, f. Optimized to advanced needle geometry, including
possibly using photography (with the patient’s consent), thin-walled and extra-thin-walled needles (if
body maps with descriptors for size, shape, and texture; available) to minimize pain and discomfort and to
or transparent graduated recording sheets. maximize ease of dosing when injecting into healthy
tissue

3. With patient consent, clinicians can mark the border of


all LH and other site complications with skin- safe 5. All patients must be supported to correctly rotate
single-use markers and instruct patients to avoid using injection/infusion sites and cautioned about the risks of
marked areas until instructed otherwise. reusing needles to minimize risk of injection site
complications.

4. Patients with LH who have been instructed to stop a. Principles of correct rotation technique must be
injecting/infusing into affected tissue must be: taught to patients, and rotation technique must be
assessed at every clinic visit.
a. Allowed to experience the actual metabolic
difference it makes to use normal tissue instead of b. Correct rotation ensures that injections are spaced
LH (this is a key to long-term adherence) out approximately 1 cm (a fingerbreadth) from each
other & that a single injection site is used no more
b. Informed that some mild pain may be experienced
frequently than every 4 weeks.
when injecting into normal tissue

21
Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults

5.0
Tips for Injection Education
and Golden Rules
5.2.4 Psychological Issues
around Insulin Therapy
& Administration
1. All patients and caregivers should be offered
general and individualized education/counseling
which will facilitate optimal care.

2. Ensure that all patients and caregivers are


supported by their HCP using patient-centered
evidence-based psychological educational tools
and strategies to achieve mutually agreed goals.

3. Diabetes HCPs should be skilled in identifying


psychological issues that impact insulin delivery.

4. HCPs must have a range of therapeutic


behavioral skills to minimize the psychological
distress and the impact of insulin therapy.

5. Various methods of minimizing pain and fear of


injection should be used to reduce the
psychological impact.

22
Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults

5.0
Tips for Injection Education
and Golden Rules
5.2.5 Needlestick Injuries
and Sharps Disposal
1. All HCPs, employers, and employees must comply with 4. Safe disposal requires that:
relevant international, national, and local legislation for
a. Correct disposal procedures and personal
the use of sharps.
responsibility be taught to patients and caregivers
by the dispensing clinician (including pharmacists)
2. Sharp medical devices present a potential risk of injury& and be regularly reinforced
transmission of disease. All HCPs, employers, and b. Safe sharps disposal systems and processes be
employees must ensure the safest possible working present and known to all persons at risk for sharps
environment by: contact
a. Conducting regular risk assessment and providing c. Environments where others are at risk (eg,
continuing education and training schools) be provided safety education and safety
b. Providing and using a means of safe disposal of devices
used sharps d. Patients diagnosed as having blood borne
c. Prohibiting needle recapping diseases such as HIV, HBV and HCB be supported
to use safety-engineered devices if available and
d. Encouraging reporting of incidents dispose them safely

e. Sharps never be placed directly in public or


3. Safety engineered devices (if available) must be household trash
used by all HCPs and by all third-party caregivers
using sharps (eg, injections, blood testing, infusion)
in all hospitals, clinics, & other institutions. Best
practice for pen needles requires that both ends of
the needle be protected.

23
Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults

Conclusion We also need to remember the 5 key points for


optimal insulin delivery:
1. Correct insulin regimen
Using contemporaneous evidence and best practice techniques
2. Correct insulin preparation
these Middle East and North Africa Insulin Delivery
3. Correct insulin delivery device
Recommendations for Children and Young Adults if fully
4. Correct insulin dosage
implemented offer significantly improved health outcomes for
5. Correct injection technique
patients and may also reduce the burden and cost of care. To
This guidance ensures safe and effective
support implementation of the recommendations 5 sets of
insulin usage in all children and adolescents
Golden Rules have been created, offering clear and concise
living with diabetes.
information for clinicians and patients.

Abbreviations
ASPED Arab Society for Paediatric Endocrinology and Diabetes
BMI Body Mass Index

CBT Cognitive Behavioral Therapy


CSII Continuous Subcutaneous Insulin Infusion

FITTER Forum for InjectionTechnique & Therapy: Expert Recommendations


HbA1c Hemoglobin A1c, glycated hemoglobin

HBV Hepatitis B Virus


HCB Hepatitis C Virus
HCP Healthcare Professional

HIV Human Immunodeficiency Virus

IIS Insulin Infusion Set


IM Intramuscular
ITQ Injection Technique Questionnaire
LH Lipohypertrophy

LA Lipoatrophy
MENA Middle East and North Africa
NPH Neutral Protamine Hagedorn (also known as Insulin N)
SAB Scientific Advisory Board
SC Subcutaneous

SII Subcutaneous Insulin Infusion

24
Middle East & North Africa Insulin Delivery
Recommendations for Children and Young Adults

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27
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