Can a montméd Coloured Pen Needle (mCPN) Intervention Improve Injection Site Rotation Habits in Established Insulin Users
Phase: NA
Conditions: Injection Site Rotation, Diabete Mellitus
Sponsor: Pink Pearls Inc

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
 
 
 
 
 
VERSION 1.1
Jul 23, 2018
      
STUDY PROTOCOL 
 

Can a montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
 
 
VERSION 1.1 
Jul 23, 2018 
      
STUDY PROTOCOL 
 
I acknowledge receipt of the Clinical Study 
Protocol for the Study entitled “Can a 
montméd Coloured Pen Needle (mCPN) 
Intervention Improve Injection Site 
Rotation Habits in Established Insulin 
Users?” (Version 1.1; Jul 23, 2018) 
Name 
Signature 
Date 

Can a montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
1. Steering Committee 
• Lori D Berard RN CDE 
 
Chair and Principal Investigator 
Winnipeg, MB ׀ Fax: 1-204-272-3354 ׀ Email: mcpndata@gmail.com 
• Sherri Pockett RN CDE  
• Robert Roscoe BScPharm ACPR CDE CPT 
• Rick L Siemens BScPharm BSc Biology CDE CPT 
 
2. Overview 
The Forum for Injection Technique (FIT)1 was established to provide guidance and evidence-
based best practice recommendations to health care professionals working with people with 
diabetes who are using injectable therapies. The 3rd Edition of the Canadian FIT 
recommendations2 states that all insulin-using patients should receive education on proper 
insulin injection technique including site rotation at the time of insulin initiation. Patient 
technique should be assessed at least annually, and education on proper insulin injection 
technique should be reinforced at every follow-up visit. The importance of site rotation must 
be underscored at these education sessions and patients should be made aware that the act 
of switching injection sites will help keep the injection site tissue healthy thereby promoting 
insulin absorption and reducing glycemic variability. The most significant complication of poor 
injection technique is lipohypertrophy.3-10 
 
Lipohypertrophy is an abnormal accumulation of fat underneath the surface of the skin that 
usually presents as lumpy skin.11, 12 Diabetes-associated lipohypertrophic lesions arise in part 
because insulin concurrently promotes lipogenesis, inhibits lipolysis and accordingly hinders 
the breakdown of adipose tissue. However, lipohypertrophy in diabetes has primarily been 
linked with repeated trauma due to lack of injection site rotation.12, 13 While it has been 
posited that needle reuse may also contribute to and enhance the presentation of 
lipohypertrophy, this school of thought has not been validated.4-6, 8, 9 
 
Patient education emphasizing the importance of injection site rotation as best practice is 
provided as a standard of care management strategy.2 However, the same has not been 
translated into routine self-care practice. Indeed, data accumulated over the last 10 to 15 
years from injection practice surveillances and a meta-analysis suggest that the incidence of 
lipohypertrophy4, 6-10, 14-16 is on the rise despite the availability of new insulin therapies, and 
smaller and finer needles. Notably, participants of the Worldwide Injection Technique 
Questionnaire Study reported general lack of knowledge about the need for site rotation or 
perceived lack of education regarding the importance of site rotation.8, 15 
 

Can a montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
Improving injection site health by reducing lipohypertrophy is essential for people living with 
diabetes. Injection of insulin into the anatomical areas, zones and/or sites affected by 
lipohypertrophy has been reported to increase glycemic variability, unexplained 
hypoglycemia as well as increased insulin doses.6  
 
Given the rising awareness of lipohypertrophy occurrences amongst diabetes care providers, 
assessment of patient injection technique and education emphasizing the importance of site 
rotation is slowly being incorporated into diabetes-focused visits. These initiatives, however, 
appear to remain inconsistent across all diabetes care providers. Indeed, insulin-injecting 
individuals living with diabetes who do not have access to health care professionals who are 
aware of the importance of site rotation likely have not had their injection routines/sites 
assessed recently or participated in discussions about the significance of site rotation. 
 
For a variety of reasons, access to a diabetes care provider can be extremely challenging for 
people with diabetes including those who are using injectable insulin therapies.17 In contrast, 
these individuals regularly visit their pharmacies to collect prescriptions and injection-related 
supplies. Pharmacists are well positioned to assess and discuss injection technique when 
dispensing a box of insulin pen needles. Although pharmacists are rarely involved in the 
initiation of insulin therapy, routine follow-up of the injection practice can be quite effectively 
incorporated into their routine overall assessment of their clients. Granted, many 
pharmacists may not feel comfortable, confident nor have the necessary facilities to examine 
for and assess lipohypertrophy. It is quite feasible, however, for them to ask key questions at 
the dispensing counter to help determine if their clients may be at risk for lipohypertrophy. 
 
A busy pharmacy may limit the time that a pharmacist is able to devote to lipohypertrophy 
queries and examinations. As with other diabetes healthcare providers, pharmacists are likely 
to also have a wide range of knowledge and experience (from very little to substantial) with 
lipohypertrophy and how proper injection site rotation can influence their manifestation. 
 
Each box of montméd Coloured Pen Needles (mCPN) has the following five features: 
i. 
Distinctively coloured pen needles  
ii. 
A user-defined association tool which is intended to help the patient associate each 
colour to a specific injection zone 
iii. 
A concise and intuitive educational message “Change color, change site” siteTM” 
iv. 
Unique packaging with educational content 
v. 
Four distinctive message-in-a-box educational sound-chips which serve to reinforce 
the recommended educational message on site rotation at home and come on every 
tenth time the pen needle box is opened 

Can a montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
The current research study has accordingly been designed to determine if a “pharmacist-
dispensed montméd Coloured Pen Needle (mCPN) intervention” will improve injection site 
rotation relative to the standard dispensing of non-mCPN insulin pen needles.  
 
3. Background and Rationale 
The Canadian FIT2 recommends considering the anatomical areas of the body, the zone 
(injection area divided into quadrants) and the site (point of insertion) when initiating 
injection site rotations. Proper rotation within a zone includes the use of the entire zone while 
ensuring that the new injection site is at least 1 to 2 cm from a recently used site. Currently, 
diagrams delineating anatomical areas and the zones within the area comprise the primary 
form of educational tools. However, these diagrams do not sufficiently emphasize the 
availability of multiple zones within the area to facilitate utilization of more of the anatomical 
area. Within zone site rotation is also poorly addressed. 
 
Individuals with diabetes who use insulin tend to favour certain anatomical areas when 
administering their daily insulin dose. Potential, but not as yet verified, reasons for preferring 
these “hot spots” may include accessibility, habit or reduced discomfort due to the presence 
of lipohypertrophy. 
 
FIT Canada has recently taken proactive steps to improve the available educational tools with 
the overarching goal to increase awareness of proper injection site rotation. These 
updated/new tools together with other similar initiatives have been designed to promote 
self-care actions and encourage insulin users to develop new injection practices. These 
include administering their insulin at a specific area at a particular time during the day or 
utilizing a rotation tool to enhance within site rotations. 
 
Integration of a site rotation injection aid to facilitate injection site rotation should 
theoretically expand the injection area and injection zone. However, such a practice has never 
been evaluated previously. The montméd Coloured Pen Needles were specifically designed 
to encourage injection site rotation amongst people with diabetes. Importantly, montméd 
Coloured Pen Needles can be easily dispensed within the normal workflow of retail 
pharmacies with little additional explanation needed thereby imposing minimal disruption on 
the pharmacists’ other obligations. 
 
4. Significance 
This 30-day research study will provide insight and evidence regarding the usability and 
feasibility of a mCPN intervention to improve the practice of injection site rotation. It will also 
evaluate the educational components that have been incorporated as part of the packaging. 

Can a montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
The impact of the mCPN intervention will be determined by comparing the percentage of 
participants in the intervention (mCPN) group who has exhibited an improvement in injection 
site rotation at study end relative to the same measure in the group that was randomized to 
receive their usual insulin pen needles. 
 
5. Study Design and Conduct 
5.1. Overview 
This is a 30-day, two-arm, randomized, controlled study. 
Enrolled participants will be randomly assigned to one of the following study arms: 
• Control group: participating pharmacists will dispense boxes of standard insulin pen 
needles to the patient participants 
• mCPN group: participating pharmacists will dispense boxes of montméd Coloured Pen 
Needles to the patient participants 
 
5.2. Study Sites and Participating Pharmacists 
All pharmacies in Canada that provide services to individuals with diabetes who use injectable 
insulin therapy will be eligible to participate in this study. All participating pharmacists who 
will play an active role in participant enrollment and the follow-up visits will be required to 
complete a participation consent form and 2 surveys. The first (Pre-study survey) should be 
completed after they have been fully trained on the study protocol and their study 
obligations, and before commencement of study enrollment. The second (Post-study survey) 
should be completed after the last patient has completed the 30-day follow-up visit. (Refer 
to Section 11 for the Study Flow). 
 
5.3. Randomization Process 
Participating pharmacists will dispense one of the two study pen needles according to a 
computer-generated list that will be provided to the participating pharmacy upon site 
activation. 
 
5.4. Hypotheses, Objectives and Endpoints 
5.4.1. Primary Hypothesis 
A pharmacist-initiated mCPN intervention at point of dispensing will enhance injection 
site rotation amongst individuals with diabetes who are using insulin therapy.  
5.4.2. Primary Objective 
To determine if a retail pharmacy-based, pharmacist-led mCPN intervention will facilitate 
and improve injection site rotation amongst insulin-using people with diabetes. 
5.4.3. Primary Endpoint 
The percentage of participants in the mCPN group who demonstrate an improvement (vs 

Can a montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
baseline performance) in the recommended site rotation techniques relative to the 
proportion of that in the control group. 
5.4.4. Secondary Hypotheses 
Pharmacists have a variable knowledge foundation on the importance of injection site 
rotation with injectable therapy and this dampens their comfort and confidence in 
providing injection site rotation counselling. A pharmacist-led mCPN intervention will 
promote overall good injection site rotation practices.  
5.4.5. Secondary Objectives 
To determine if a retail pharmacy-based, pharmacist-led mCPN intervention will 
i. 
improve the knowledge base of pharmacists around injection site rotation and 
increase their comfort and confidence in providing injection site rotation 
counselling 
ii. 
Expand the injection zone size 
iii. 
Increase needle change 
iv. 
Increase mCPN use following study completion 
5.4.6. Secondary Endpoints 
The change in the level of confidence in providing injection site rotation counselling 
(Confidence and Importance Scale), and knowledge about the importance of site rotation 
among pharmacists at the follow-up from baseline. Other secondary endpoints that will 
be assessed include the increase/change in injection zone size, percentage of participating 
patients who change their needles more often (patient reported), and the percentage of 
participating patients who decide to continue using mCPN upon study completion.  
 
6. Study Population 
6.1. 
Inclusion Criteria 
• Adults (18 years or older) with type 1 diabetes mellitus or type 2 diabetes mellitus who 
have been using daily insulin therapy for 1 year or more 
• Able to read the English text on the boxes of the pen needles 
 
6.2. 
Exclusion Criteria 
• Individuals currently treated with a glucagon-like peptide 1 receptor agonist (GLP-1RA) 
• Current or previous user of mCPN 
• Individuals who are unable to understand or communicate in English 
• Pregnant women 
• Individuals with serious mental illnesses eg. dementia, schizophrenia disorders, bipolar 
disorders, major depression, etc. 
 

Can a montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
7. Data Collection 
Participating patients and pharmacists will be required to complete 2 questionnaires/surveys. 
The data from these 4 documents will be collated and used to inform on the potential benefits 
of the mCPN intervention. 
 
The Participating Patient Questionnaires (please refer to Appendix 7 and Appendix 8) will 
capture basic demographic details, the number of injections the participant administers each 
day, the length of the needle, the injection area and the participant’s injection site rotation 
practices. Every participant will be asked to complete the first questionnaire prior to study 
intervention and the second at study end (30 days after the intervention). 
 
The Pharmacist Surveys (please refer to Appendix 9 and Appendix 10) will capture the 
pharmacists’ perspectives on the importance of injection site rotation and their level of 
knowledge about lipohypertrophy. The pharmacist investigators will also be asked about 
their confidence around providing counseling on injection site rotation to individuals at the 
pre- and post-intervention visits. The first survey should be completed and submitted 
immediately after study training has been completed. 
 
8. Sample Size 
Sample size calculation was based on the primary endpoint. To ensure an 80% power to 
detect a difference in the proportion of 0.2 (20%) between the intervention and control group 
at a significance level of 5%, 90 participants are required for each study arm. Adjusting for 
the clustering of participants around sites via an intra-cluster correlation coefficient of 0.01 
and accounting for a 5% participant dropout rate, a minimum of 117 participants per study 
group will be required.  
 
Twenty pharmacies (sites) will be recruited to participate in this study and each site will be 
expected to enroll 12 participants. Accordingly, a total of 240 insulin-using individuals (120 
per group) will be enrolled into the study. Each pharmacy site will be asked to recruit 6 
individuals who are on ≤2 injections and 6 individuals who are on ≥3 injections of insulin each 
day. The rationale behind including these 2 specific subgroups is to ensure individuals with 
both type 1 and type 2 diabetes are represented in the final analyses. Of note, the education 
requirements and support access vary according on the type of diabetes each person lives 
with. The sub-grouping will therefore also facilitate the capturing of a broader scope of real-
world experience with site rotation. Randomization will be facilitated at the site level versus 
the study level. Randomization codes for each subgroup will be scrambled and provided to 
the sites to be opened after consent is obtained. 
 

Can a montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
The study will employ a convenience sampling with 1:1 randomization of eligible subjects to 
the standard of care education with one arm utilizing the mCPN intervention and the other 
maintaining the current insulin pen needle. A control group of 120 persons (60 on ≤2 
injections a day and another 60 on ≥3 injections a day) will be randomized to keep using their 
current pen needle. An intervention group of 120 (60 on ≤2 injections a day and another 60 
on ≥3 injections a day) will be randomized to receive mCPN Intervention. 
 
Of note, the mCPN packaging contains educational information that will not be promoted but 
instead distributed without any direct emphasis on the instructions provided. Subjects will be 
asked to evaluate this information. 
 
9. Data Analysis 
Data from the completed patient and pharmacist surveys will be entered into a Microsoft 
Access database. Categorical and continuous data, collected for the baseline and follow-up 
visits, will be evaluated by frequency distribution and univariate analysis, respectively. A 
generalized linear regression model will be used to compare the relative changes in the 
primary and secondary endpoints determined for the control and intervention groups. All 
data will be adjusted for baseline age, daily number of injections, duration of diabetes and 
duration of insulin use All analyses will be conducted with SAS software version 9.4. 
 
10. End of Study 
As an appreciation of their participation and to facilitate retention, all patient participants 
regardless of the study arm that they were randomized to will be invited to choose between 
taking home a Home Blood Pressure Monitor or a FRIO Insulin Cooling Case. Participants who 
were allocated to the Control Group will be eligible to receive a set of the insulin study pen 
needles at no cost, if they wish to try these pen needles. Participants who were allocated to 
the mCPN Group will have the option of continuing with the insulin study pen needle or 
returning to the insulin pen needle that they previously used. 
 
 
 

Can a montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
11. Procedures and Study Flow 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Identify potential Pharmacies 
Obtain letter of intent/consent 
from Pharmacies 
Identify 
Participating Pharmacists 
Virtual training from the 
Coordinating Staff 
Pharmacist completes the 
Pre-study survey 
Provide the study binder and 
randomization codes 
Patient Participant provides 
informed consent 
Pharmacist answers any concerns or 
questions 
Pharmacist opens the 
randomization envelope 
Pharmacist provides the 
Intervention or Control 
insulin pen needles 
Pharmacist and Patient Participant 
schedule the 30-day follow up 
Site identifies 
Patient Participants 
Patient Participant completes 
Post-study questionnaire 
Pharmacist completes the 
Post-study survey 
Pharmacist provides participant 
with a box of mCPN 
Patient Participant completes 
Pre-study questionnaire 
Pharmacist submits confirmation of 
completion to Study Control Centre 

Can a montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
12. References 
 
1. 
Hicks 
D, 
Berard 
L, 
Twamley 
H. 
Forum 
for 
Injection 
Technique 
(FIT). 
http://www.fit4diabetes.com/canada-l/ 
2. 
Berard L, Desrochers F, Hagerty D, MacNeill G, Roscoe R. FIT Forum for Injection 
Technique Canada. 2016 
3. 
Al Ajlouni M, Abujbara M, Batieha A, Ajlouni K. Prevalence of lipohypertrophy and 
associated risk factors in insulin-treated patients with type 2 diabetes mellitus. Int J 
Endocrinol Metab. 2015;13:e20776 
4. 
Al Hayek AA, Robert AA, Braham RB, Al Dawish MA. Frequency of Lipohypertrophy and 
Associated Risk Factors in Young Patients with Type 1 Diabetes: A Cross-Sectional Study. 
Diabetes Ther. 2016;7:259-267 
5. 
Baruah MP, Kalra S, Bose S, Deka J. An Audit of Insulin Usage and Insulin Injection Practices 
in a Large Indian Cohort. Indian J Endocrinol Metab. 2017;21:443-452 
6. 
Blanco M, Hernandez MT, Strauss KW, Amaya M. Prevalence and risk factors of 
lipohypertrophy in insulin-injecting patients with diabetes. Diabetes Metab. 2013;39:445-
453 
7. 
Deng N, Zhang X, Zhao F, Wang Y, He H. Prevalence of lipohypertrophy in insulin-treated 
diabetes patients: A systematic review and meta-analysis. J Diabetes Investig. 2017 
8. 
Frid AH, Hirsch LJ, Menchior AR, Morel DR, Strauss KW. Worldwide Injection Technique 
Questionnaire Study: Injecting Complications and the Role of the Professional. Mayo Clin 
Proc. 2016;91:1224-1230 
9. 
Ji L, Sun Z, Li Q, Qin G, Wei Z, Liu J, Chandran AB, Hirsch LJ. Lipohypertrophy in China: 
Prevalence, Risk Factors, Insulin Consumption, and Clinical Impact. Diabetes Technol Ther. 
2017;19:61-67 
10. 
Pozzuoli GM, Laudato M, Barone M, Crisci F, Pozzuoli B. Errors in insulin treatment 
management and risk of lipohypertrophy. Acta Diabetol. 2018;55:67-73 
11. 
Thow JC, Johnson AB, Marsden S, Taylor R, Home PD. Morphology of palpably abnormal 
injection sites and effects on absorption of isophane(NPH) insulin. Diabet Med. 
1990;7:795-799 
12. 
Richardson T, Kerr D. Skin-related complications of insulin therapy: epidemiology and 
emerging management strategies. Am J Clin Dermatol. 2003;4:661-667 
13. 
Hauner H, Stockamp B, Haastert B. Prevalence of lipohypertrophy in insulin-treated 
diabetic patients and predisposing factors. Exp Clin Endocrinol Diabetes. 1996;104:106-
110 
14. 
Frid AH, Hirsch LJ, Menchior AR, Morel DR, Strauss KW. Worldwide Injection Technique 
Questionnaire Study: Population Parameters and Injection Practices. Mayo Clin Proc. 
2016;91:1212-1223 
15. 
Kalra S, Mithal A, Sahay R, John M, Unnikrishnan AG, Saboo B, Ghosh S, Sanyal D, Hirsch 
LJ, Gupta V, Strauss KW. Indian Injection Technique Study: Injecting Complications, 
Education, and the Health Care Professional. Diabetes Ther. 2017;8:659-672 

Can a montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
16. 
Kalra S, Mithal A, Sahay R, John M, Unnikrishnan AG, Saboo B, Ghosh S, Sanyal D, Hirsch 
LJ, Gupta V, Strauss KW. Indian Injection Technique Study: Population Characteristics and 
Injection Practices. Diabetes Ther. 2017;8:637-657 
17. 
Canadian Diabetes Association. An economic tsunami, the cost of diabetes in Canada. 
2009 
 
 
 
 

Can a montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
Receipt of Study Documents Checklist 
 
 
□ 
Clinical Study Protocol (Version 1.1; dated Jul 23, 2018) 
 
□ 
Invoice Templates (Appendix 1) 
 
□ 
Patient Participant Recruitment Script (Appendix 2) 
 
□ 
Injection Area, Zone and Site Chart (Appendix 3) 
 
□ 
Study Intervention (mCPN Packaging) (Appendix 4) 
 
□ 
Information Letter and Consent Form for Patient Participants (Appendix 5) 
 
□ 
Pharmacists’ Letter of Agreement (Appendix 6) 
 
□ 
Pre-study Questionnaire for Patient Participants (Appendix 7) 
 
□ 
Post-study Questionnaire for Patient Participants (Appendix 8) 
 
□ 
Pre-study Survey for Pharmacists (Appendix 9) 
 
□ 
Post-study Survey for Pharmacists (Appendix 10) 
 
□ 
Follow up/Tracking Form (Appendix 11) 
 
□ 
Site Information Sheet 
 
 
 
 
 
Please return the completed checklist to the attention of Lori Berard 
Fax: 1-204-272-3354 ׀ email mcpndata@gmail.com 
 
 
 

Can a montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
 
 
 
Jul 23, 2018 
      
APPENDICES 
 

Can a montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
 
 
 
 
 
Appendix 1 
Invoice Templates 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Invoice Templates 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
 
Invoice for Completion of Study  
 
Study Title: Can a Montméd Coloured Pen Needle (mCPN) Intervention Improve 
Injection Site Rotation Habits in Established Insulin Users? 
 
 
 
Site #:  
¨¨  
 
 
 
Participant #: ¨¨ 
 
Name of Pharmacist Investigator: 
 
 
___________________________________ 
 
 
 
 
 
 
No. of completed patient pre-participation questionnaires:  
 
¨ 
No. of completed patient post-participation questionnaires: 
 
¨ 
No. of completed pharmacist post-participation questionnaires: 
 
¨ 
 
Total compensation requested:  
 
 
$¨¨¨.¨¨ 
 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Invoice Templates 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
 
 
Invoice for Purchase Costs of Control Group Pen Needles  
 
Study Title: Can a Montméd Coloured Pen Needle (mCPN) Intervention Improve 
Injection Site Rotation Habits in Established Insulin Users? 
 
 
 
Site #:  
¨¨  
 
 
 
Participant #: ¨¨ 
 
Name of Pharmacist Investigator: 
 
 
___________________________________ 
 
 
 
 
 
 
Type of insulin pen needles dispensed: 
 
___________________________________  
 
No. of boxes provided for the study period:  
¨¨ 
 
Cost for each box of pen needles: 
 
 
$¨¨.¨¨ 
 
Total reimbursement requested:  
 
 
$¨¨¨.¨¨ 
 
 
 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
 
 
 
 
 
 
Appendix 2 
Patient Participant Recruitment Script 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Participant Recruitment Script 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
 
 
Dear XXXX, 
 
I am currently involved in a nationwide study that is looking at whether use of a specific type of 
insulin pen needle will alter how individuals administer their insulin. If you decide to participate 
in this study after the pharmacist has reviewed with you the study goals and expectations, you 
will be required to provide written consent as well as complete 2 short surveys over the 30-day 
long study period. 
 
As a reminder, participation in this study is completely voluntary and you may choose to 
withdraw from the study at any time. 
 
You will be asked to complete the first survey today. Once you have handed in your completed 
survey, you will be randomly assigned to one of the following two groups: 
Group 1: 
You will receive your usual insulin pen needles 
Group 2: 
You will receive the insulin study pen needles instead of your usual insulin pen 
needles 
 
Please note that during the 30-day study period, you will not incur any costs for the insulin 
pen needles that you need to use, regardless of whether they are the study pen needles or 
your usual pen needles. 
 
You are required to use the assigned insulin pen needles you were given today for at least 30 
days. At the end of the minimum 30-day period, you will need to complete the second survey.  
 
Once you have completed the second survey, 
1. You will be invited, as a token of our appreciation for participating in this study, to choose 
between taking home a Home Blood Pressure Monitor or a FRIO Insulin Cooling Case, a 
carrier that will help you keep and transport your insulin safely. 
2. If you were in Group 1, you will be eligible to receive a set of the insulin study pen needles 
at no cost. 
3. If you were in Group 2, you will have the option of continuing with the insulin study pen 
needle or returning to the insulin pen needle that you previously used. 
 
Please note that during the 30-day study period and prior to you completing the second survey, 
we will not be able to answer any questions related to the injection technique. However, we 
would be more than pleased to discuss any queries you may have once the 30-days are up and 
you have handed in the second survey. 
  
With best regards, 
 
 
 
XXXX 
 

Can a montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
 
 
 
 
 
Appendix 3 
Injection Area, Zone and Site Chart 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Injection Area, Zone 
Improve Injection Site Rotation Habits in Established Insulin Users? 
And Site Chart 
Version 1.1 | Jul 23, 2018 
 
 
 
INJECTION AREA, ZONE AND SITE CHART 
 
 
 
 

Can a montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
 
 
 
 
 
Appendix 4 
Study Intervention (mCPN Packaging) 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Study Intervention 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Version 1.1 | Jul 23, 2018 
 
 
 
STUDY INTERVENTION (mCPN PACKAGING) 
 
 
 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Study Intervention 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Version 1.1 | Jul 23, 2018 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Study Intervention 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Version 1.1 | Jul 23, 2018 
 
 
 
The messages below will be played one at a time each time the box is opened followed by 15 
silent box openings. The cycle will repeat thereafter.  
 
Message 1 
Site Rotation maters! 
Did you know that always injecting into the same place can damage the tissues? 
This can affect your blood sugar levels. 
It can increase your risk of low blood sugars and it can even increase how much insulin you take. 
Unique color coding of SiteSmart pen needles reminds you to rotate injection site. 
Change color, Change Site. 
For more information ask your pharmacist. 
 
Message 2 
Change color change site 
Check your SiteSmart packaging. 
Use of the 2 readymade popular injection plans or develop your own plan that works for you by 
assigning a color to each of the recommended injection site. Every time you grab a needle simply 
inject it to the site matching the color of the pen needle. 
It is as simple as that. 
 
Message 3 
Injection Technique Best Practice Tip 
In addition to performing regular site rotation, Canadian injection technique experts recommend 
using a pen needle once, discarding it, and using a new one for each injection to keep your tissues 
healthy. 
 
Message 4 
Congratulations! 
I hope you have appreciated these few educational sound bites, and that by now SiteSmart has 
helped you to adopt a healthy injection site rotation routine that easily fits into your daily life. 
Keep going! 
 
 

Can a montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
 
 
 
 
 
Appendix 5 
Information Letter and Consent Form for Patient Participants 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Participant Letter 
Improve Injection Site Rotation Habits in Established Insulin Users? 
And ICF 
Version 1.1 | Jul 23, 2018 
 
 
INFORMED CONSENT TO PARTICIPATE IN A RESEARCH STUDY 
____________________________________________________________________________ 
 
STUDY NAME: Can a Montméd Coloured Pen Needle (mCPN) Intervention Improve Injection 
Site Rotation Habits in Established Insulin Users? 
 
SPONSOR AND FUNDER: montméd Canada  
 
 
PRINCIPAL INVESTIGATOR: Lori D Berard, RN, CDE ׀ Winnipeg Regional Health Authority 
 
You are invited to consider taking part in a research study. Participation is voluntary. If you choose 
to participate, you will need to sign the consent document and you will receive a copy of this 
signed document for your records. You may withdraw from the study at any time. Before you 
decide to participate, please take as much time as you need to read this document carefully.  
 
Declaration of Conflicts 
montméd Canada will be paying the pharmacy and pharmacists to conduct the study. 
 
Information on the Research 
I. Study Background, Purpose and Description: You have been using insulin for more than 1 year 
to manage your diabetes. Previously, you may or may not have been advised that it is important 
you rotate your injection sites to ensure that your insulin dose is delivered effectively every time. 
You are now invited to participate in this 30-day long study that will assess if montméd Coloured 
Pen Needles will help individuals like yourself remember to always rotate your injection site. This 
study will enroll approximately 240 people from about 20 retail pharmacies across Canada. As 
part of the study, you will be asked to complete 2 questionnaires, the first on the day you sign 
this consent form and the second on day 30 of the study. 
II. Restrictions and Potential Risks/Benefits: There are no restrictions. There are no potential 
risks. You are unlikely to experience any additional discomfort relative to your usual pen needles. 
You may or may not benefit from your participation in this study. 
III. Who Should Not Participate in this Study: Do not participate in this study if you are pregnant, 
trying to get pregnant, or if you think you may be pregnant. Please speak to your pharmacist if 
you think you may be pregnant, or if you are unsure. 
  
Protecting Your Privacy 
Any personal identifying information that is recorded or stored for study purposes will be “de-
identified” by replacing your personal identifying information with a “unique code/number”.  
 
Study Results 
The study results may be presented at a scientific conference or published in a scientific journal. 
If the study results are published, your identity will NOT be disclosed in any of the publications. 
 
 
 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Participant Letter 
Improve Injection Site Rotation Habits in Established Insulin Users? 
And ICF 
 
 
Version 1.1 | Jul 23, 2018 
 
Costs of Study Needles and Reimbursement 
You will not be charged for the cost of any of the insulin pen needles you will need during the 30-
day long study. You will not receive any payment for taking part in this study. As an appreciation 
of your participation, you will be invited to choose between taking home a Home Blood Pressure 
Monitor or a FRIO Insulin Cooling Case, after you have completed the second survey at the end 
of the 30-day study. If you are allocated to the group that will continue with your usual pen 
needles during the study and you wish, upon completion of the study, to try the montméd 
Coloured Pen Needles, you will be eligible to receive a set of these insulin pen needles at no cost. 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Participant Letter 
Improve Injection Site Rotation Habits in Established Insulin Users? 
And ICF 
Version 1.1 | Jul 23, 2018 
 
 
STATEMENT OF CONSENT to participate in the study entitled: 
 
Can a Montméd Coloured Pen Needle (mCPN) Intervention Improve Injection Site Rotation 
Habits in Established Insulin Users? 
 
By signing this consent form, I acknowledge that: 
● The research study has been explained to me, and my questions have been answered to my 
satisfaction.  
● I know that I have the right not to participate and the right to withdraw.  
● The potential harms and benefits (if any) of participating in this research study have been 
explained to me. 
● I have been told that I have not waived my legal rights nor released the investigator, sponsor, 
or involved pharmacy from their legal and professional responsibilities.  
● I know that I may ask now, or in the future, any questions I have about the study.  
● I have been told that records relating to me and my care will be kept confidential and that no 
information will be disclosed without my permission unless required by law.  
● I have been given sufficient time to read the above information.  
● I will be given a copy of the signed and dated consent form. 
 
I consent to participate in this study.  
 
 
 
______________________________________ 
 
 
 
 
Printed Name of Participant 
 
 
______________________________________ 
¨¨/¨¨/¨¨¨¨ 
Signature of Participant 
 
 
 
 
Date/Time 
 
 
 
______________________________________ 
 
 
 
 
Printed Name of Person Obtaining Consent 
 
 
______________________________________ 
¨¨/¨¨/¨¨¨¨ 
Signature of Person Obtaining Consent 
 
 
Date/Time
m m 
d 
d 
y 
y 
y 
y 
m m 
d 
d 
y 
y 
y 
y 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Version 1.1 | Jul 23, 2018 
 
 
 
 
 
 
 
Appendix 6 
Pharmacists’ Letter of Agreement 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Pharmacist LOA 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
 
 
STATEMENT OF AGREEMENT to participate in the study entitled: 
 
Can a Montméd Coloured Pen Needle (mCPN) Intervention Improve Injection Site Rotation Habits 
in Established Insulin Users? 
 
By signing this consent form, I acknowledge that: 
● The research study has been explained to me, and my questions have been answered to my 
satisfaction.  
● I have received all the necessary study documents and I will sign, date and return all the 
relevant acknowledgement pages to the office of the Principal Investigator 
● I understand that I will receive training on my responsibilities in this study.  
● I will conduct the study ethically, to the best of my abilities and as per detailed in the training 
that I will receive. 
● I will be provided with a copy of the signed and dated agreement letter. 
 
 
I consent to participate in this study.  
 
 
 
______________________________________ 
 
 
 
 
Printed Name of Participating Pharmacist 
 
 
______________________________________ 
¨¨/¨¨/¨¨¨¨ 
Signature of Participating Pharmacist 
 
Date 
 
 
 
______________________________________ 
 
 
 
 
Printed Name of Participating Pharmacy Manager 
 
 
______________________________________ 
¨¨/¨¨/¨¨¨¨ 
Signature of Participating Pharmacy Manager 
 
Date 
 
m m 
d 
d 
y 
y 
y 
y 
m m 
d 
d 
y 
y 
y 
y 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Version 1.1 | Jul 23, 2018 
 
 
 
 
 
 
Appendix 7 
Pre-study Questionnaire for Patient Participants 
(To be completed during pharmacy visit) 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Participant 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Pre-Study Questionnaire 
Version 1.1 | Jul 23, 2018 
 
 
 
PARTICIPANT PRE-STUDY QUESTIONNAIRE 
 
Site #: 
¨¨ 
 
 
 
 
Participant #: 
¨¨ 
 
Thank you for agreeing to participate in the mCPN Intervention Study. The information you 
provide in this questionnaire will be used to improve training and education for all people using 
injections to manage their diabetes. 
 
 
1) How old are you?  
 
__________ years 
 
2) Please indicate your gender 
□ Male  
□ Female □ Prefer not to answer 
 
3) What type of diabetes do you have? 
□ Type 1 
□ Type 2 
□ Do not know 
 
4) How many years have you been living with diabetes?  
 
__________ years 
 
5) How many years have you been using insulin to manage your diabetes?  
 
__________ years 
 
6) How many total insulin injections do you use per day? 
□ 1 
□ 2 □ 3 □ 4 □ 5 or more 
 
7) What is the length of the needle you currently use to inject your insulin (tick all that apply)? 
□ >8 mm 
□ 8 mm 
□ 6 mm 
□ 5 mm 
□ 4 mm 
 
8) What was the total number of units of all insulins you injected yesterday? 
 
 _____________ Units (add up the units of all the doses given) 
 
 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Participant 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Pre-Study Questionnaire 
Version 1.1 | Jul 23, 2018 
 
9) On the body charts below, please mark with an "X" exactly where you have injected over the 
last 7 days. Place as many X’s per site to represent the last 7 days of injections. You should 
make as many X’s as injection per day for 7 days – example – 2 injections per day – 14 X’s. 
 
 
 
 
 
10) Thinking of each of the injection areas that you have marked in the body charts in Question 
9, please read and choose one of the following responses that most closely reflects the size 
of your injection area: 
□ I usually use an area the size of a post card to give my injections  
□ I usually use an area the size of a playing card to give my injections  
□ I usually use an area the size of a credit card to give my injections  
□ I usually use an area the size of a postage stamp to give my injections 
 
 
 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Participant 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Pre-Study Questionnaire 
Version 1.1 | Jul 23, 2018 
 
11) How many occurrences of "low blood sugars" have you had over the last 30 days? 
□ None 
□ 1 to 3  
□ 4 to 7  
□ 8 to 13  
□ 14 to 28 
□ more than 1 per day 
 
12) Over the past 7 days, how many times did you use a needle before replacing it with a new 
needle?  
□ Once  
□ 2 to 3  
□ 4 to 5  
□ 6 or more 
 
13) How do you think your diabetes may change if you were to inject in the same spot over a 
long period of time? Choose all that apply.  
□ Don't know 
□ My injection site does not hurt 
□ I may need more insulin 
□ I may need less insulin 
□ I may have higher blood sugars 
□ I may have lower blood sugars 
□ I might experience more "swings" of blood sugars from lows to highs 
□ Nothing will happen 
 
 
 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Participant 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Pre-Study Questionnaire 
Version 1.1 | Jul 23, 2018 
 
 
To be completed by the Pharmacist Investigator: 
 
Has the participant reviewed and signed the Informed Consent Form? 
 
 
□ Yes  
□ No 
Has the participant completed the questionnaire? 
 
 
□ Yes  
□ No 
The participant has been randomized to: 
□ Group 1 (usual pen needles) 
□ Group 2 (mCPN needles) 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
 
 
 
 
 
 
Appendix 8 
Post-study Questionnaire for Patient Participants 
(To be completed during pharmacy visit) 
 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Participant 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Post-Study Questionnaire 
Version 1.1 | Jul 23, 2018 
 
 
 
PARTICIPANT POST-STUDY QUESTIONNAIRE 
 
Site #: 
¨¨ 
 
 
 
 
Participant #: 
¨¨ 
 
Thank you for participating in the mCPN Intervention Study. The information you provide in this 
questionnaire will be used to improve training and education for all people using injections to 
manage their diabetes. 
 
 
1) Did you have any difficulty using the needle that was provided to you for this study? 
□ No 
□ Yes, please explain 
 
__________________________________________________________________________
__________________________________________________________________________ 
 
 
2) Since completing the first questionnaire, has anyone spoken to you about your insulin 
injection technique? 
□ No 
 
□ Yes 
 
 
3) How many insulin injections do you use each day? 
□ 1 
□ 2 
□ 3 
□ 4 
□ 5 or more 
 
 
4) What was the total number of units of all insulins you injected yesterday? 
 
_____________ Units (add up the units of all the doses given) 
 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Participant 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Post-Study Questionnaire 
Version 1.1 | Jul 23, 2018 
 
 
5) On the body charts below, please mark with an "X" exactly where you have injected over the 
last 7 days. Place as many X’s per site to represent the last 7 days of injections. You should 
make as many X’s as injection per day for 7 days – example – 2 injections per day – 14 X’s. 
 
 
 
6) Over the last 30 days do you believe you have changed sites  
□ More frequently than previously 
□ Less frequently than previously 
□ About the same 
 
7) Thinking of each of the injection areas that you have marked in the body charts in Question 
5, please read and choose one of the following responses that most closely reflects the size 
of your injection area: 
□ I usually use an area the size of a post card to give my injections  
□ I usually use an area the size of a playing card to give my injections  
□ I usually use an area the size of a credit card to give my injections  
□ I usually use an area the size of a postage stamp to give my injections 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Participant 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Post-Study Questionnaire 
Version 1.1 | Jul 23, 2018 
 
 
 
8) How many occurrences of “low blood sugars” have you had over the last 30 days? 
□ None  
□ 1 to 3  
□ 4 to 7  
□ 8 to 13  
□ 14 to 28 
□ more than 1 per day 
 
 
9) Over the past 7 days, how many times did you use a needle before replacing it with a new 
needle?  
 
□ Once  
□ 2 to 3  
□ 4 to 5  
□ 6 or more 
 
  
10) How do you think your diabetes may change if you were to inject in the same spot over a 
long period of time? Choose all that apply. 
□ Don't know 
□ My injection site will not hurt 
□ I may need more insulin 
□ I may need less insulin 
□ I may have higher blood sugars 
□ I may have lower blood sugars 
□ I might experience more “swings” of blood sugars from lows to highs 
□ Nothing will happen

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Participant 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Post-Study Questionnaire 
Version 1.1 | Jul 23, 2018 
 
 
 
If you were assigned to Group 2 (you received a box of the coloured pen needles), please answer 
the following questions: 
 
1) How would you compare the coloured pen needles to your usual pen needles? 
 
 
Strongly 
Agree 
Agree 
Neither 
Agree 
nor 
Disagree 
Disagree 
Strongly 
Disagree 
I found it easier to remember to rotate my 
injection site 
□ 
□ 
□ 
□ 
□ 
I varied my injection site more often 
□ 
□ 
□ 
□ 
□ 
I changed my pen needle more often 
□ 
□ 
□ 
□ 
□ 
The phrase “Change colour, change site” was 
a helpful reminder to consider changing 
injection site more often  
□ 
□ 
□ 
□ 
□ 
The coloured pen needles helped remind me 
consider other injection sites for my 
injections 
□ 
□ 
□ 
□ 
□ 
 
 
2) The packaging of the coloured pen needles includes an educational message about injection site 
rotation. Please rate your satisfaction with receiving this type of diabetes care education tool 
from your pharmacist. 
 
Very 
Satisfied 
Satisfied 
Neither 
Satisfied 
nor 
Dissatisfied 
Dissatisfied 
Very 
Dissatisfied 
Impact of the educational message 
about injection site rotation on the 
packaging of the coloured pen 
needles 
□ 
□ 
□ 
□ 
□ 
 
 
3) How would you rate the coloured pen needles against your usual pen needles? 
 
Very 
Satisfied 
Satisfied 
Neither 
Satisfied 
nor 
Dissatisfied 
Dissatisfied 
Very 
Dissatisfied 
Compared to my usual pen needles, 
I was _____________ with the 
coloured pen needles. 
□ 
□ 
□ 
□ 
□ 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Participant 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Post-Study Questionnaire 
Version 1.1 | Jul 23, 2018 
 
 
 
4) If the cost for the coloured pen needles is comparable and not more expensive than your 
current pen needles, would you consider switching to the coloured pen needles? 
□ Yes 
□ Not sure 
□ No 
 
 
5) Please provide any additional comments you would like to share below: 
 
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________ 
 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
 
 
 
 
 
 
Appendix 9 
Pre-study Survey for Pharmacists 
(To be completed and submitted via Fax/Scan to email) 
 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Pharmacist 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Pre-Study Questionnaire 
Version 1.1 | Jul 23, 2018 
 
 
 
PRE-PARTICIPATION IN THE mCPN INTERVENTION STUDY 
 
Site #: 
¨¨ 
 
 
Pharmacist Study Code #: 
¨¨ 
 
 
1) Prior to agreeing to participate in this study, on a scale of 1 to 5 how important is injection 
site rotation education in insulin therapy (1 = unimportant and 5 = very important)? 
 
Unimportant 
Slightly 
Unimportant 
Neither 
Slightly 
Important 
Very 
Important 
1 
2 
3 
4 
5 
 
 
2) Prior to agreeing to participate in this study, on a scale of 1 to 5 how confident are you in 
providing education about proper injection site rotation for insulin therapy (1 = not 
confident and 5 = very confident)? 
 
Not confident 
Little Confidence 
Neither 
Somewhat 
Confident 
Very confident 
1 
2 
3 
4 
5 
 
3) We are interested in knowing your current knowledge regarding insulin injection techniques. 
Please answer the following.  
a. Have you heard the term lipohypertrophy? □ Yes □ No 
 
b. On a scale of 1 to 5 (1 = no knowledge to 5 = excellent understanding), how would you rate 
your knowledge of the effect of lipohypertrophy? 
No Knowledge 
(None) 
Somewhat  
Aware 
(Poor) 
Aware of some 
information 
(Adequate) 
Aware and have a 
useable 
background of 
information 
(Good) 
Very Aware and 
Knowledgeable 
(Excellent) 
1 
2 
3 
4 
5 
 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Pharmacist 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Pre-Study Questionnaire 
Version 1.1 | Jul 23, 2018 
 
 
c. 
On a scale of 1 to 5, what is your level of comfort in pen needle tip selection and use (1 = 
uncomfortable to 5 = very comfortable)? 
Uncomfortable 
Somewhat 
Uncomfortable 
Neither 
Somewhat 
Comfortable 
Very 
Comfortable 
1 
2 
3 
4 
5 
 
 
d. On a scale of 1 to 5, what is your level of comfort discussing injection site rotation (1 = 
uncomfortable to 5 = very comfortable)?  
Uncomfortable 
Somewhat 
Uncomfortable 
Neither 
Somewhat 
Comfortable 
Very 
Comfortable 
1 
2 
3 
4 
5 
 
 
4) When providing insulin pen needles, what percentage of the time do you discuss proper site 
rotation?  
 □ 0-20%  
□ 21-40% □ 41-60% □ 61-80% □ 81 – 100% 
 
 
5) What percentage of your insulin-injecting patients do you believe properly rotate their sites?  
□ 0-20%  
□ 21-40% □ 41-60% □ 61-80% □ 81 – 100% 
 
 
6) What percentage of your insulin-injecting patients do you believe reuse their needles more 
than once?  
□ 0-20%  
□ 21-40% □ 41-60% □ 61-80% □ 81 – 100% 
 
7) OPTIONAL QUESTION  
Approximately, what percentage of patients that purchase insulin pen needles are provided 
with counselling regarding proper injection rotation technique? 
□ 0-20%  
□ 21-40% □ 41-60% □ 61-80% □ 81 – 100% 
 
Please return the completed form to the attention of Lori Berard 
Fax: 1-204-272-3354 ׀ email mcpndata@gmail.com

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
 
 
 
 
 
 
Appendix 10 
Post-study Questionnaire for Pharmacists 
(To be completed and submitted via Fax/Scan to email) 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Pharmacist 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Post-Study Questionnaire 
Version 1.1 | Jul 23, 2018 
 
 
 
POST-PARTICIPATION IN THE mCPN INTERVENTION STUDY 
 
Site #: 
¨¨ 
 
 
Pharmacist Study Code #: 
¨¨ 
 
 
1) After participating in this study, on a scale of 1 to 5, how important is injection site rotation 
education in insulin therapy (1 = unimportant and 5 = very important)? 
Unimportant 
Slightly 
Unimportant 
Neither 
Slightly 
Important 
Very 
Important 
1 
2 
3 
4 
5 
 
 
2) After participating in this study, on a scale of 1 to 5, how confident are you in providing 
education about proper injection site rotation for insulin therapy (1 = not confident and 5 = 
very confident)?  
Not confident 
Little Confidence 
Neither 
Somewhat 
Confident 
Very confident 
1 
2 
3 
4 
5 
 
 
3) We are interested in knowing your current knowledge (after participating in the study) 
regarding insulin injection techniques. Please answer the following.  
 
a. Have you heard the term lipohypertrophy? □ Yes □ No 
 
b. After participating in this study, on a scale of 1 to 10 (1 = no knowledge to 10 = excellent 
understanding), how would you rate your knowledge of the effect of lipohypertrophy? 
No Knowledge 
(None) 
Somewhat  
Aware 
(Poor) 
Aware of some 
information 
(Adequate) 
Aware and have a 
useable 
background of 
information 
(Good) 
Very Aware and 
Knowledgeable 
(Excellent) 
1 
2 
3 
4 
5 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Follow-up/Tracking Form 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
 
c. 
After participating in this study, on a scale of 1 to 10, what is your level of comfort in pen 
needle tip selection and use (1 = very uncomfortable to 10 = extremely comfortable)? 
Uncomfortable 
Somewhat 
Uncomfortable 
Neither 
Somewhat 
Comfortable 
Very 
Comfortable 
1 
2 
3 
4 
5 
 
 
d. After participating in this study, on a scale of 1 to 10, what is your level of comfort discussing 
injection site rotation (1 = very uncomfortable to 10 = extremely comfortable)?  
Uncomfortable 
Somewhat 
Uncomfortable 
Neither 
Somewhat 
Comfortable 
Very 
Comfortable 
1 
2 
3 
4 
5 
 
 
4) After participating in this study, when providing insulin pen needles in the future, what 
percentage of time do you foresee discussing proper site rotation?  
  □ 0-20%  
□ 21-40% □ 41-60% □ 61-80% □ 81 – 100% 
 
 
5) After participating in this study, what percentage of your study participants using the mCPN, 
do you believe properly rotate their sites?  
□ 0-20%  
□ 21-40% □ 41-60% □ 61-80% □ 81 – 100% 
 
6) After participating in this study, what percentage of your study participants using the mCPN, 
do you believe reuse their needles more than once? 
  □ 0-20%  
□ 21-40% □ 41-60% □ 61-80% □ 81 – 100% 
 
7) OPTIONAL QUESTION 
After participating in this study, approximately what percentage of patients that purchase 
insulin pen needles do you anticipate will be provided with counselling regarding proper 
injection rotation technique?  
□ 0-20%  
□ 21-40% □ 41-60% □ 61-80% □ 81 – 100% 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Pharmacist 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Post-Study Questionnaire 
Version 1.1 | Jul 23, 2018 
 
 
 
Thinking of the mCPN intervention, please complete these questions,  
 
1) Does this intervention improve injection technique with regards to: 
a. Site rotation?  
 
 
 
 
 
 
 
□ Yes  
□ No 
b. Increased number of zones? 
 
 
 
 
 
□ Yes  
□ No 
c. 
Increased area of use within zones? 
 
 
 
 
□ Yes  
□ No 
d. Needle re-use? 
 
 
 
 
 
 
 
□ Yes  
□ No 
 
e. Do you believe that simply providing patients using insulin, with pen needles with 
educational tools, like the mCPN packaging may change patient behavior regarding needle 
re-use?  
□ Yes  
□ No 
 
f. 
Do you believe that simply providing patients using insulin, with pen needles with 
educational tools, like the mCPN packaging may change patient behavior regarding proper 
site rotation? 
□ Yes  
□ No 
 
2) Do you believe that the mCPN intervention may change pharmacy staff behavior regarding 
assessment of proper injection technique?  
□ Yes  
□ No 
 
 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Pharmacist 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Pre-Study Questionnaire 
Version 1.1 | Jul 23, 2018 
 
 
POST-PARTICIPATION IN THE mCPN INTERVENTION STUDY 
 
Since receiving the education provided during the site training: 
 
1) Do you feel that your pharmacy staff have acquired skills that can be incorporated into 
everyday practice? 
□ Yes 
 
□ No 
 
2) Not considering patients included in the 30-day trial period, have you begun to assess insulin 
pen needle users when they come for refills? 
□ Yes 
 
□ No  
3) After completion of the study, do you plan on providing the option of providing patients with 
proper injection site educational tools like the Site Smart system to your patients? 
□ Yes 
 
□ No 
 
4) Does having an educational tool on your shelves help your staff to consider discussing proper 
injection technique with patients? (ie seeing coloured needle beside the conventional insulin 
pen needle packaging)? 
□ Yes 
 
□ No 
 
5) Do you feel that counselling on proper insulin injection technique would be as effective for 
patients without the use of colored needles? 
□ Yes 
 
□ No 
 
Please provide any additional comments/learnings/customer comments you would like to share 
below: 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________ 
______________________________________________________________________________ 
 
Please return the completed form to the attention of Lori Berard 
Fax: 1-204-272-3354 ׀ email mcpndata@gmail.com

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Version 1.1 | Jul 23, 2018 
 
 
 
 
 
 
 
 
Appendix 11 
Follow up/Tracking Form 
 
 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Follow-up/Tracking Form 
Improve Injection Site Rotation Habits in Established Insulin Users? 
 
Version 1.1 | Jul 23, 2018 
 
 
Follow up/Tracking Form 
 
 
Site #: ¨¨¨ 
 
 
Pharmacist 
Study Code #: ¨¨¨ 
Pre-study survey completion date:  
 
¨¨/¨¨/¨¨¨¨ 
Post-study survey completion date:  
 
¨¨/¨¨/¨¨¨¨ 
 
 
Patient 
 
Name (for site use only): 
________________________ 
 
Telephone Number (for site use only): 
 
¨¨¨¨¨¨¨¨¨¨ 
 
 
 
Study Code #: ¨¨¨ 
 
Pre-study questionnaire completion date:  
¨¨/¨¨/¨¨¨¨ 
Reminder Call Date for Second Visit: 
 
¨¨/¨¨/¨¨¨¨ 
 
2nd Vist and 
Post-questionnaire completion date: 
 
¨¨/¨¨/¨¨¨¨ 
 
m m 
d 
d 
y 
y 
y 
y 
m m 
d 
d 
y 
y 
y 
y 
m m 
d 
d 
y 
y 
y 
y 
m m 
d 
d 
y 
y 
y 
y 
m m 
d 
d 
y 
y 
y 
y 

Can a Montméd Coloured Pen Needle (mCPN) Intervention 
Study Protocol 
Improve Injection Site Rotation Habits in Established Insulin Users? 
Version 1.1 | Jul 23, 2018 
 
 
 
 
Appendix 12 
Study Binder Contents 
 
1. Final Study Protocol 
2. Protocol signature page 
3. LOI 
4. Invoice Template – Completion of study 
5. Invoice Template – Standard of Care Pen needles 
6. Question and Answer documents for Pharmacist Investigators 
7. Study flow chart 
8. Participant recruitment script 
9. Pre- and Post-Participation Questionnaires for the Pharmacist Investigators 
10. Randomization list 
11. Subject files – 12 per site – Consents, pre- and post-participation questionnaires – tracking 
forms 
12. Enrollment and Dropout log 
13. Training documents and Signature log