Intermittently Scanned CGM Versus Usual Care With Diabetes Education and Feedback, in Adults With Non-Insulin Dependent Type 2 Diabetes (iCUDE): A Randomized Trial
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Sponsor: University of Alberta

 
 
 
 
 
Intermittently Scanned CGM Versus Usual Care With Diabetes Education and Feedback, 
in Adults with Non-Insulin Dependent Type 2 Diabetes (iCUDE) 
A Randomized Trial 
 
 
Short Title: isCGM With Education and Feedback for Non-Insulin Dependent Type 2 Diabetes 
 
 
 
 
 
 
 
 
Protocol Version (2.3): September 12, 2022 
 
Primary Investigator: Dr. Darren Lau 
 
Lead Statistician:  
To be determined 
 
 
Co-investigators: 
Dr. Roseanne O. Yeung 
Dr. Donna P. Manca 
 
 
Trial Coordinating Centre:  
EPICORE Centre 
Room 362, Heritage Medical Research Centre 
University of Alberta, 
Edmonton, Alberta, Canada 
 
 
 
 
 
 
 

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Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
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STUDY SYNOPSIS 
 
Title 
Intermittently Scanned CGM Versus Usual Care With Diabetes 
Education and Feedback, in Adults with Type 2 Diabetes (iCUDE):  
A Randomized Trial 
Investigator(s)/center/study 
location 
Edmonton, Alberta 
Study Objectives 
This trial will examine the effectiveness of intermittently-scanned 
continuous glucose monitoring (isCGM) when applied on an episodic 
basis and combined with diabetes education / feedback, in adults with 
type 2 diabetes on non-insulin therapy. 
Study Design 
The trial is an investigator-initiated prospective, single-center, open-
label, randomized controlled trial. 
 Inclusion criteria: 
1. Age >= 18 years with type 2 diabetes. 
2. HbA1c > 7.0% within the last 6 months. 
3. Non-insulin therapy. 
4. Able to attend two in-person study visits. 
5. English-speaking. 
6. Community-dwelling. 
7. In possession of a cell phone capable of accessing the internet and 
receiving FreeStyle Libre 2 sensor readings 
8. Has a primary care provider who has been in contact with the patient 
for diabetes in the last 12 months. 
Exclusion criteria: 
1. Type 1 diabetes or diabetes clearly identified as having monogenetic 
etiology (e.g.: MODY). 
2. Steroid-induced diabetes if steroid use is on-going or most recently 
taken within the last 3 months. 
3. Pregnancy, plans to become pregnant within 6 months, or breast-
feeding 
4. Any use of insulin in the previous year. 
5. Current or previous use of isCGM or rtCGM. 
6. Cognitive dysfunction (SPMSQ score >= 5). 
7. Symptoms of acute metabolic decompensation (extreme thirst, high 
urinary output, and weight loss, accompanied by acute fatigue or 
dyspnea). 
8. Any terminal condition that would limit life expectancy to < 1 year. 
9. Inability or refusal to use isCGM (e.g.: afraid of the device). 
10. Inability or refusal to be reached by telephone. 
11. Concurrent participation in another diabetes-related trial. 
12. Has not already received two doses of a Health Canada-approved 
vaccine against SARS-CoV-2. 
Evaluation criteria 
Primary Outcome: Change in glycated hemoglobin (HbA1c) at 3 
months compared to baseline. 
Secondary Outcomes:  
Feasibility of recruitment 
Blood pressure, body weight, waist circumference, and patient-reported 
outcomes, measured as change in continuous score at 3 months 
compared to baseline on validated instruments of: 
• Diabetes treatment satisfaction 
• Diabetes self-management empowerment 
• Diabetes-related distress 
• Diet 
• Physical activity 

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Safety Outcomes: Any reported adverse events, major adverse events 
– hospitalization or ED visits. isCGM-related reactions (e.g.: skin 
reactions). 
Treatment 
Following informed consent, eligible adults will be randomly allocated 
to isCGM + education and feedback with a certified diabetes educator 
(CDE) or enhanced usual care with education and feedback using a 1:1 
allocation ratio. The intervention (isCGM or enhanced usual care) will 
last 6-8 weeks. Those in the isCGM arm are free during the 
intervention or afterwards to obtain or fund their own supplemental 
isCGM sensors. 
Randomization  
Patients will be randomly assigned using a REDCAP based 
randomization system using variable block size. The computer-
generated allocation table would be generated in a formal and secure 
manner. 
Sample size 
A target sample of 100 patients was chosen based on funding 
constraints, power / sample size considerations, and expected loss to 
follow-up of 20-30%. The minimum number of trial completers 
required to have 80% power to detect an HbA1c difference of 0.5% is 
80. 
Follow-up 
Follow-up (week 5-6) CDE virtual education and feed-back session. 
12-week bloodwork encounter at outpatient lab. 
12-week in-person study encounter to complete study measurements. 
After conclusion of the 12 week trial period: 
Post-trial qualitative interviews with select consenting participants. 
Post-trial administrative linkage to examine outcomes at 24-52 
weeks from randomization – no direct participant involvement. 
 
 

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Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
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1. OVERVIEW OF STUDY DESIGN 
 
Figure 1: Overview of Study Design 
 
 

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Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
2. INTRODUCTION AND RATIONALE 
 
Glycemic control is an important treatment target for adults with diabetes.1 Though rates of 
adults meeting glycated hemoglobin (HbA1c) targets of <= 7.0-7.5% have probably improved in 
the last decade, a large proportion of adults do not achieve their glycemic targets,2-5 for a variety 
of reasons.6  
 
Self-monitoring of blood glucose can help adults with type 2 diabetes (T2DM) progress towards 
their glycemic targets.7 Continuous glucose monitoring (CGM), an alternative to traditional 
capillary blood glucose, uses a wearable sensor that continuously samples interstitial fluid 
glucose. Real-time CGM (rtCGM) continuously transmits blood glucose values, while 
intermittently scanned CGM (isCGM) requires scanning of the sensor to obtain the cumulated 
readings. CGM is painless, provides information on glucose trends, and has consistently 
demonstrated improved patient satisfaction compared to CBG, which tends to be limited by its 
“snap-shot” one-time perspective, and the inconvenience and discomfort associated with 
fingersticks.8,9  
 
While rtCGM has demonstrated effectiveness in reducing HbA1c compared to traditional 
capillary blood glucose monitoring, in adults with T2DM on insulin,10-13 the lower monthly cost 
of isCGM (FreeStyle Libre $180)14 compared to rtCGM (Dexcom G6 $395)15 makes isCGM an 
attractive alternative. However, the evidence for isCGM in T2DM is limited.16 Several cohort 
studies have shown improved HbA1c in adults initiating isCGM, but these studies are limited by 
lack of relevant comparators.17-20 Only two trials have examined isCGM in T2DM. In the 
REPLACE study of adults on insulin, no difference was detected in HbA1c between isCGM and 
CBG groups at 6 months, though isCGM participants had lower time in hypoglycemia and 
higher treatment satisfaction.21 Yaron et al., randomized adults on prandial insulin and found a 
statistically significant 0.5% greater improvement in HbA1c in isCGM participants.22 The reason 
for the contrasting results may be related to the absence of structured one-on-one diabetes 
educator interactions in REPLACE; a previous study of adults with type 1 and type 2 diabetes 
has shown the importance of education in potentiating the effect of isCGM.23 Overall, the 
effectiveness of isCGM at reducing HbA1c in T2DM remains unresolved.  
 
Adults with “earlier diabetes”, i.e.: on non-insulin therapy only, comprise the majority of adults 
with T2DM. Yet, they are underrepresented in the current CGM literature.24 Because their 
hypoglycemia risk and their opportunities for day-to-day medication adjustments are lower 
compared to adults on multiple daily doses of prandial insulin, it has been more challenging to 
demonstrate the value of glucose monitoring among these individuals.25-27 However, capillary 
blood glucose studies have shown that glucose self-monitoring can improve lifestyle and 
accelerate medication intensification, leading to lower HbA1c compared to usual 3-monthly 
HbA1c-driven care, in those with diabetes not on insulin therapy.28-31 Some trials of rtCGM have 
examined this sub-population of T2DM and found benefit.10,12 For example, Vigersky et al. 
randomized adults with T2DM not on prandial insulin to intermittent use of rtCGM (2 weeks on, 
1 week off) for 3 months versus CBG only. This trial showed reduced HbA1c in the intermittent 
rtCBG group at 3 months, that persisted up to 12 months, long after the intervention had 
stopped.13 Given the expense of CGM, intermittent sensor deployment is an important cost-

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Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
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savings measure applicable to the real world use of CGM. Neither of the two trials of isCGM in 
T2DM, above, have examined this subpopulation, leaving the effectiveness of isCGM in earlier 
T2DM largely unknown.  
 
3. STUDY HYPOTHESIS 
 
isCGM combined with nurse certified diabetes educator (CDE) education and feedback will 
improve glycemic control and patient self-management of diabetes compared to enhanced usual 
care with CDE education and feedback only. 
 
 
4. STUDY OBJECTIVES 
 
Primary Objective 
To evaluate the effectiveness of isCGM with CDE education and feedback on 
glycemic control at 12 weeks, in adults with type 2 diabetes and uncontrolled 
HbAc (> 7.0%) not on insulin therapy. 
Secondary Objectives 
To determine the feasibility of recruiting adults with diabetes in Edmonton-area to a 
trial of glucose self-monitoring and education. 
 
To determine the effectiveness of isCGM with CDE education and feedback on 
patient self-management of diabetes, measured using patient reported instruments for 
diabetes-related quality of life, diabetes treatment satisfaction, diabetes self-
management empowerment, diet, and physical activity – at 6 weeks and at 12 weeks.  
 
To determine the safety of isCGM with CDE education and feedback with respect to 
emergency department visits or hospitalizations, and isCGM-specific reactions (e.g.: 
skin reactions). 
 
To understand the reasons why or how isCGM with CDE education is effective or 
ineffective from the perspective of involved participants and their providers. 
 
To evaluate the effectiveness of isCGM with CDE education and feedback on 
glycemic control at 24-52 weeks (post-trial observational follow-up). 
 
 
5. isCGM (INTERMITTENTLY SCANNED CONTINUOUS GLUCOSE MONITOR) – 
DESCRIPTION OF TECHNOLOGY 
 
Technology – The only isCGM on the market at this time is the FreeStyle Libre 2 system 
produced by Abbott. FreeStyle Libre 2 sensors use a subcutaneous, wired enzyme glucose-

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Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
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sensing technology, factory-calibrated to detect glucose levels in interstitial fluid by way of a 
thin filament implanted under the skin. The sensors are water-proof, affix to the skin by medical 
adhesive, last 14 days each, and are roughly the size of two stacked quarters. They measure 
interstitial glucose every minute, with readings stored in 15-minute intervals. Patients can scan 
sensors on-demand, using either a near-field communication-enabled smart phone or the 
FreeStyle Libre 2 Reader, to receive a glucose result along with historic results for the preceding 
8 hours. The FreeStyle Libre 2 system is fully marketed in Canada; in 2020, it’s predecessor, the 
similar FreeStyle Libre flash glucose monitoring system, had over 2 million users 
internationally.32 
 
Market Access / Licensing – The Libre 2 flash glucose monitoring system has been licensed by 
Health Canada since November 30, 2020 (No. 105518) for measuring interstitial fluid glucose 
levels in children aged 4 years and older and adults with diabetes mellitus.33,34 
 
Accuracy – Compared to reference venous blood glucose measurements, Libre 2 sensors had a 
mean absolute relative difference (mARD) of 9.2%, with over 78% of values within +/- 15% of 
reference values, and over 88% of values within +/- 20% of reference values, across the 
physiologic range of blood glucose.35 These values are improved from the preceding Libre flash 
glucometer system, which demonstrated mARD 11.4% (overall 85% of values within +/- 20% of 
reference).36 An error analysis of the preceding Libre flash glucometer system showed that the 
difference between Libre glucose readings and capillary blood glucose measurements would lead 
to a difference in treatment in < 1% of readings.36 Based on these data, interstitial glucose values 
can be used interchangeably with capillary blood glucose measurements, though users should be 
aware that interstitial glucose may lag behind venous blood glucose by 2.4 +/- 4.6 minutes.35 
 
Reliability – Simultaneous tests of paired sensors yielded blood glucose results with a coefficient 
of variation of 5.7%, indicating good agreement between sensors.35 
 
Data presentation – Upon scanning the sensor, the current glucose result is displayed for the 
patient, along with arrows indicating current glucose trends (i.e.: rising quickly, rising, changing 
slowly, falling, falling quickly) based on the rate of glucose change. Historic results are 
displayed in the “daily graph” as a line plot, providing a visual reference for the day’s glucose 
peaks and valleys.  
 
Remote patient telemonitoring – Internet-enabled smart phones can be configured to 
automatically push glucose data to LibreView, an online portal for patients and providers to 
review glucose data. Similar functionality using the Libre 2 Reader requires users periodically to 
connect their reader to a computer via USB. Providers can set up a LibreView account for their 
clinics, allowing access to glucose reports for multiple enrolled patients. LibreView provides 
sophisticated glucose reports, including glucose statistics and ambulatory glucose profiles 
(median and inter-quartile range), in addition to daily glucose profiles. 
 
 
6. STUDY DESIGN 
 

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Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
This trial is an investigator-initiated prospective, single-center, open-label, randomized controlled 
trial of isCGM with CDE education and feedback. All participants will receive standard treatment 
at the discretion of their physicians. 
 
Setting 
• Tertiary care ambulatory referral clinic in Alberta, Canada, with recruitment of 
patients from urban primary care practices. 
 
Intervention – isCGM + CDE Education and Feedback 
• Short Term Use of isCGM – Participants will be given three FreeStyle Libre 2 sensors 
during the study period. Each sensor, once worn, provides glucose measurements for 
14 days. The three sensors will provide 6 weeks of isCGM. Participants will not be 
encouraged to use FreeStyle Libre 2 sensors outside of the intended study periods, but 
neither will they be discouraged from doing so if they choose to of their own accord. 
The first sensor will be initiated with the assistance of a study team member, who will 
also set up the Libre 2 smart phone app and link it to the study LibreView account 
during the baseline visit. Subsequent sensors will be participant-initiated. Should 
participants encounter difficulty with sensor placement, replacement sensors will be 
made available, and participants will be referred to their local retail pharmacist to 
assist with sensor initiation. A small number of FreeStyle Libre 2 Readers will be 
available for those with unforeseen technical difficulties. Patients using the readers 
will be asked to upload their data to LibreView online via USB adapter connection to 
their computers, on a weekly basis.  
• Initial Patient isCGM Training – Participants will be provided multimedia materials 
(written booklet and link to bespoke introductory videos) to help them understand and 
trouble shoot the Libre 2 system, and to help them understand their glucose readings 
and act on them. These materials will be designed with patient and CDE-input using a 
human-centred design process via the University of Alberta’s Physician Learning 
Program (in process), and may also include multimedia resources produced by Abbott, 
the manufacturer of the Libre 2 isCGM. Additionally, participants will be referred to 
Alberta Health Service’s standard diabetes education group classes and advised to 
register according to their interest and motivation. Diabetes Canada and Alberta 
Health Services-concordant advice and handouts will be provided to isCGM 
participants on recognizing and managing hypoglycemia 
(https://www.albertahealthservices.ca/assets/mha/diabetes/mha-diabetes-
hypoglycemia-the-basics.pdf).  
• CDE Education and Feedback – A CDE nurse will assess the participant and review 
her/his LibreView data. The CDE nurse will provide general diabetes education and 
advice on using isCGM, and individualized recommendations on lifestyle (diet and 
physical activity) changes to improve glycemic control. Two encounters will take 
place with the CDE nurse. The first will occur during weeks 1-2, and the second 
during weeks 5-6,. During the second encounter, CDE nurses may also consider 
sending recommendations to participants’ usual care providers for medication titration, 
if appropriate. CDE nurses will provide education and advice according to their usual 
training and practices. General guidance on incorporating isCGM readings into 

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Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
individualized advice for participants and their care providers will be provided in the 
form of a clinical algorithm, which will also be designed with patient and CDE-input 
using a human centred design process via the University of Alberta’s Physician 
Learning Program (in process). CDE encounters will take place either in-person, or 
virtually, over Zoom. 
 
Control – Enhanced Usual Care With CDE Education and Feedback Only 
• No specific monitoring of glucose – Participants will be discouraged from accessing 
FreeStyle Libre 2 glucometers or other CGM during the study period. They will be 
free to use capillary blood glucose monitoring according to their own interest and 
motivation, or as directed by the CDE nurse. Advice and handouts will be provided to 
isCGM participants on recognizing and managing hypoglycemia. 
• Alberta Health Services Diabetes Education Group Classes – Participants will be 
referred to Alberta Health Service’s standard diabetes education group classes and 
advised to register according to their interest and motivation. 
• CDE Education and Feedback – A CDE nurse will assess the participant. The CDE 
nurse will provide general diabetes education, and individualized recommendations on 
lifestyle (diet and physical activity) changes to improve glycemic control. Two 
encounters will take place with the CDE nurse. The first will occur during weeks 1-2, 
and the second during weeks 5-6. CDE nurses will provide education and advice 
according to their usual training and practices. CDE encounters will take place either 
in-person, or virtually, over Zoom. 
 
Study period – The trial period will be 12 weeks. From 12 weeks onwards, select participants 
will be approached to participate in semi-structured qualitative interviews. Linkage of participant 
information to Alberta administrative health care data may occur up to 3 years after trial 
completion to allow examination of diabetes outcomes on an observational basis up to 52 weeks 
from randomization. 
 
Blinding 
• This trial is open-label. Neither patients, investigators, nor statistical analysts will be 
blinded to treatment allocation. 
 
Post-Trial Observational Follow-Up – Patients will be reviewed on NetCare for laboratory 
values and health care utilization at 24 and 52 weeks following randomization. NetCare data 
accrued up to 64 weeks post-randomization will be reviewed to identify nearest lab values for the 
52-week time point. 
 
Post-Trial Qualitative Study of Experiences Using isCGM – Consenting patients and providers 
will be contacted after the 12 week study period to participate in semi-structured interviews 
exploring their experiences using isCGM or managing their blood glucose without isCGM. 
 
 
7. STUDY POPULATION 

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Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
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Adults (age >= 18 years) with type 2 diabetes an uncontrolled blood sugars, defined as 
HbA1c > 7.0%, not on insulin therapy. 
 
Inclusion Criteria: 
1. Age >= 18 years with type 2 diabetes. 
2. HbA1c > 7.0% within the last 6 months. 
3. Non-insulin therapy. 
4. Able to attend two in-person study visits. 
5. English-speaking. 
6. Community-dwelling 
7. In possession of a cell phone capable of accessing the internet and receiving FreeStyle 
Libre 2 sensor readings 
8. Has a primary care provider who has been in contact with the patient for diabetes in the 
last 12 months. 
 
Exclusion Criteria: 
1. Type 1 diabetes or diabetes clearly identified as having monogenetic etiology (e.g.: 
MODY). 
2. Steroid-induced diabetes if steroid use is on-going or most recently taken within the last 
3 months. 
3. Pregnancy; plans to become pregnant within 6 months; breast-feeding.  
4. Any use of insulin in the previous year. 
5. Current or previous use of isCGM or rtCGM. 
6. Cognitive dysfunction (SPMSQ score >= 5). 
7. Symptoms of acute metabolic decompensation (extreme thirst, high urinary output, and 
weight loss, accompanied by acute fatigue or dyspnea). 
8. Any terminal condition that would limit life expectancy to < 1 year. 
9. Inability to use isCGM (e.g.: afraid of the device). 
10. Inability to be reached by telephone. 
11. Concurrent participation in another diabetes-related trial. 
12. Has not already received two doses of a Health Canada-approved vaccine against 
SARS-CoV-2. 
 
 
8. RECRUITMENT STRATEGIES 
 
A multifaceted recruitment strategy will be deployed to identify patients meeting study criteria 
from the following sources: 
 
1. Kaye Edmonton Clinic (KEC) General Internal Medicine (3D), Endocrinology (3B), and 
Family Medicine (1A) clinics.  
2. Regional Diabetes Program (RDP) clinics 
3. C-ENDO, a multi-site privately administered endocrinology and internal medicine clinic 
in Edmonton 

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Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
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Version (2.3): September 12, 2022 
 
4. Primary Care Networks (PCN) and family medicine clinics, including Covenant Health 
sites. 
5. Participant self-referral 
 
For sources (1) through (4), above, outreach efforts will involve  
• Identification of site “champions” to promote with recruitment – most likely to involve 
non-physician personnel (diabetes educators, dieticians). 
• Presentations to clinic providers (physicians, diabetes educators, and dieticians) at 
staff/business meetings or divisional meetings. 
• Dear Provider Letters – Appendix 1. 
• Brochures featuring large graphics placed in exam and waiting rooms (with permission) 
– Appendix 2. 
• Social media advertising via Facebook, Twitter, and study landing page, and through 
recruitment networks such as Bethecure.ca  
 
We will ask providers – both physicians and non-physicians – to refer interested patients to study 
investigators for the study team to contact and screen. In our recruitment materials, we 
emphasize the potential benefit to participants being access to FreeStyle Libre 2 sensors on a trial 
basis with linkage to personalized CDE advice; regardless of randomization group, participants 
will be remunerated for the time and inconvenience of study participation (including labwork) 
with a honoraria consisting of gift cards (Walmart or Safeway or similar grocery store) of $40 
CAD upon receipt of baseline and 12-week follow-up HbA1c measurements, and will have their 
parking fees paid. Study investigators will not enroll their own patients. 
 
 
9. PARTICIPANT CONSENT 
 
Following a screening phone call, eligible patients will attend a baseline visit to complete 
consent for participation and randomization, as well as completion of baseline measures. For the 
initial screening, verbal consent (Appendix 3.1) will be obtained from potential study 
participants to access their provincial NetCare electronic medical records and confirm that they 
meet the HbA1c inclusion criteria. 
 
A study investigator or research assistant will review the nature of the clinical trial, and the 
anticipated risks and benefits. An electronic trial information sheet and consent form will be 
created by EpiCore Centre (Appendix 3.2). The trial consent form will be signed by the patient 
either using a touch-interface (e.g.: iPad or similar device) or using a mouse to draw a signature 
(desktop computer), and witnessed by the study investigator or research assistant. The patient’s 
email address will be collected, and once the consent is signed, a copy will be emailed to the 
participant. In the event of technical difficulties, a participant without email access, or a 
participant that refuses electronic signing, paper copies of both the trial information sheet and 
consent forms will be available. An additional paper copies of the consent form, in that case, will 
be signed and given to the participant to take home.  
 

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Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
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Select providers (referring physicians / educators / dieticians and the study CDE nurse) will be 
approached and consented for semi-structured interviews to contribute their perspective on the 
use of isCGM. A specific information package and consent form for the qualitative sub-study 
(providers only – patients are covered by the full trial consent package) has been developed 
(Appendix 3.3). 
 
Patients will be free to withdraw consent / withdraw from the study at any time, and will be 
given written instructions on termination of Libre 2 data sharing as part of the study information 
package (Appendix 4). 
 
 
10. STUDY OUTCOMES AND VARIABLES  
 
Case report forms are provided in Appendix 5. These will be translated into electronic 
documents to be completed by participants via a password protected webportal (EpiCore). 
 
Primary Outcome: 
• Change in HbA1c at 12 weeks compared to baseline. 
 
Secondary Outcomes:  
• Feasibility of recruitment 
o Participant referral, screening, and randomization rates over time 
o Reasons for inclusion / exclusion of all participants referred. 
• Change in scores at 6 and 12 weeks compared to baseline, on the patient-reported 
outcomes shown in Table 1, below. 
• isCGM participants only – change in time-in-target range, coefficient of variation, 
and glucose management indicator at 12 weeks compared to baseline. 
 
Table 1: Patient-Reported Outcomes  
Outcome 
Instrument 
Number of items 
Diabetes treatment satisfaction – 
Status score 
Diabetes Treatment Satisfaction Questionnaire 
(DTSQs)37 (weeks 6 and 12) 
8 
Diabetes treatment satisfaction – 
Change score 
Diabetes Treatment Satisfaction Questionnaire 
(DTSQc) (week 6 only) 
 
Self-management empowerment 
Diabetes Empowerment Scale – Short Form (DES-
SF) 38 (weeks 6 and 12) 
8 
Diabetes-related distress 
Problem Areas in Diabetes (PAID) Questionnaire39 
20 
Diet 
UK Diabetes and Diet Questionnaire (UKDDQ)40 
(weeks 6 and 12) 
25 
Physical activity 
International Physical Activity Questionnaire 
(IPAQ) short form41,42 (weeks 6 and 12) 
7 
Health status 
Euroqol EQ-5D-5L (weeks 6 and 12) 
5 
* In addition to collection at baseline. 
 
Safety outcomes at 12 weeks:  
• Any adverse events (serious and non-serious) occurring from baseline to 12 weeks will 
be identified and tracked at the 12 week study visit by patient interview, and reviewed 

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Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
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by study investigators to determine whether clinically attributable to diabetes, diabetes 
management, or isCGM. isCGM issues (e.g.: skin reactions) will be specifically sought.  
• Emergency department visits or hospital admission for any reason, identified from 
patient interview and from NetCare review. 
 
Qualitative Outcomes: Semi-structured interviews will undergo thematic analysis using 
constant comparative methods. The starting point will be the participant and provider experience 
with isCGM or enhanced usual care, with a particular focus on barriers and enablers of 
effectiveness (see Appendix 6, interview guides). Semi-structured interviews will take place for 
participants after trial completion (from 12-24 weeks). 
 
24-52 Week Post-Trial Observational Follow-up: After the trial ends, we will send out 
reminder letter to all participants and their providers encouraging them to have routine diabetes 
assessments, including laboratory measures, done. We will ascertain the effect of the 
intervention on HbA1c at 24 and 52 weeks, by review of NetCare. NetCare data up to 64 weeks 
post-randomization may be reviewed to assign the nearest lab value to the 52 week time point. 
 
Other Quantitative Variables Measured: 
Case report forms are provided in Appendix 5. 
 
 
11. MITIGATION OF ANTICIPATED MINOR RISKS 
 
Skin reaction to the device may occur, namely local dermatitis or allergy-type reactions (redness, 
itching, localized swelling, blisters, oozing). This reaction is usually due to a contact allergy to a 
component of the adhesive, e.g.: isobornyl acryate. Systemic reactions have not been described 
with the device. If sufficiently bothersome or severe, skin reactions can be managed with topical 
steroid cream or ointment. We will refer participants to their usual providers for assessment. 
Subsequent sensor placement can be facilitated (if the participant remains willing) by placing a 
barrier product (i.e.: 3M Cavilon no sting barrier film, Tegaderm Advanced barrier, or 
hydrocolloid blister patch) prior to initiating a sensor.  
 
12. MITIGATION STRATEGIES FOR COVID-19 RISKS 
 
1. Study personnel interacting with participants face-to-face will complete and document 
the Alberta Health Services COVID-19 Assessment for Healthcare Workers and 
Workers in High Risk Settings daily (https://myhealth.alberta.ca/journey/covid-
19/Pages/HWAssessLanding.aspx).  
2. Both participants and research personnel will be required to wash hands with alcohol-
based hand sanitizer and don masks during the interaction.  
3. Participant-facing spaces will be disinfected with a hard surface cleaner with a broad-
spectrum virucidal claim or a virucidal claim against coronaviruses, approved by Health 
Canada. Alcohol-based handwash will be available.  

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Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
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4. A brief screening call will take place ahead of the baseline study visit to ensure that all 
participants have received at least 2 doses of a Health Canada-approved vaccine against 
COVID-19. 
5. Participants will be asked to reschedule their in-person encounters if they have any 
symptoms of COVID-19, or any close contact with an individual newly diagnosed with 
COVID-19 in the previous 10 days. Participants will have infrared surface temperature 
screening for fever at the beginning of the visit (screening form included under 
Documentation).  
 
In Alberta, the current recommended isolation period for an individual with COVID-19 is 5 days 
(fully immunized) or 10 days (not fully immunized). Although our participants will all be fully 
immunized, out of an abundance of caution we will reschedule their visit for >= 10 days from 
symptom onset (or exposure to a COVID-19 case), as long as symptoms by then have improved 
and the participant is afebrile for >= 24 hours. 
 
 
13. TREATMENT-EMERGENT ADVERSE EVENTS 
 
Included participants belong to a population (adults with type 2 diabetes and are not on insulin) 
that does not typically experience hypoglycemia, and do not typically measure their glucose 
levels. No serious adverse events are expected. However, this protocol has several features to 
identify unexpected adverse events during the study. 
 
• All emergency department visits and hospitalizations occurring from randomization to 
week 12 will be reviewed and adjudicated (see Appendix 5.6 for adverse event reporting 
forms) by study investigators. If a serious adverse event occurred because of the trial or 
trial intervention, study protocols will be reviewed and amended to mitigate the harm. 
• We are performing in-person visits with participants to measure BP and weight. There is 
the possibility that we detect extremely abnormal physical parameters (e.g.: severe 
hypertension >= 180/110 mmHg, severe hypotension SBP < 90 mmHg). A study 
investigator will be paged if a result this extreme is detected and the participant will be 
advised to attend the emergency department. 
• For emotional or psychological distress disclosed during a study visit or interview, the 
interviewer will offer supportive listening, remind participants of their right to withdraw 
from the trial, offer to connect the participant with a study investigator, and refer 
participants back to their usual care provider. 
 
 
14. STATISTICAL AND ANALYTICAL METHODS 
 
Our sample size calculation was intended to detect an HbA1c difference of 0.5%, presuming a 
standard deviation of HbA1c values at 3 months of 0.78% based on a recent similar trial of 
capillary blood glucose monitoring. To have 80% power to detect this HbA1c difference at a 
type 1 error rate of 5%, we would need 40 trial-completers in each arm. Given expected loss-to-
follow-up rates of 20% or more, our enrollment target will be 100 participants.  

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Data will be analyzed according to intention-to-treat principles. Patients will be kept in the study 
group to which they were randomized, and efforts will be taken to ascertain outcome events in 
all patients randomized. Discontinuation of study treatment (isCGM) or no-show to CDE 
encounters are not equivalent to withdrawal from the study, and efforts will be made to contact 
study participants for HbA1c measurements and patient-reported outcomes at 12 weeks 
regardless.  
 
Outcomes (HbA1c and patient-reported outcomes) are continuous scores – the difference at 12 
weeks from baseline will be presented using simple means and standard deviations. On change in 
HbA1c, our primary outcome, we will test for a difference between intervention and enhanced 
usual care arms using linear regression with adjustment for age and sex. Secondary outcomes 
and diabetes-related distress will be analyzed in similar fashion, including follow-up values for 
patient-reported outcomes obtained at 6 and 12 weeks. Safety outcomes are dichotomous (e.g.: 
ED visits), and differences between trial arms will be assessed using Fisher’s exact test. The 
primary outcome will be considered statistically significant at p < 0.05. Secondary and safety 
outcomes are considered hypothesis-generating and will also be considered statistically 
significant at p < 0.05. No correction for multiple comparisons is planned a priori. If the primary 
outcome is statistically significant at p < 0.05, the Benjamini-Hoochberg procedure will be 
performed on secondary outcomes targeting a false discover rate of 20%, if requested by 
reviewers. 
 
Secondary analyses are planned, and include: 
• Post-hoc analysis of outcomes in clinically relevant groups, e.g.: by sex, baseline self-
management empowerment, etc., using the above methods. 
• Partitioning participants into those who improved their HbA1c by 0.5% or more, and 
examining predictors of improvement using logistic regression with simultaneous 
incorporation of other explanatory variables. 
 
For the post-trial cohort study, the relationship between outcomes (HbA1c and health care 
utilization) and study allocation will be examined using linear (log-transformed or un-
transformed) and logistic regression models with simultaneous adjustment for multiple other 
variables, selected using a mixed purposeful / stepwise method.  
 
For the qualitative sub-study, semi-structured interviews will be transcribed verbatim, 
anonymized, and will undergo thematic analysis using constant comparative methods. Co-
investigators will interview transcripts independently and meet to develop a coding manual. The 
qualitative research associate will then code the remaining transcripts line by line. Team 
members will meet periodically to review and refine codes using a constant comparison method, 
with further sampling guided by emerging themes until content saturation is achieved. 
 
 
15. TRIAL ORGANIZATION 

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This study will be conducted in Edmonton through the University of Alberta. The study 
staff consist of: 
• A research assistant (roughly support staff grade 4-6 [per University of Alberta-
Non-Academic Staff Association support staff wage scales]), who will have Alberta 
NetCare access through Alberta Health Services.  
• CDE nurses, one or more community-based practitioners with active CDE practice 
and experience. 
• A qualitative research associate (roughly support staff grade 8) with a graduate 
degree and previous experience in semi-structured interviews or focus group and 
thematic analyses. 
Study staff will be hired by the principal investigator (Division of General Internal 
Medicine, Department of Medicine). The Epidemiology Coordination and Research 
(EPICORE) Centre (Division of Cardiology, Department of Medicine – 
www.epicore.ualberta.ca) provide study database, secure online database access, 
computerized participant allocation, and statistician services.  
 
 
16. DATA MANAGEMENT 
Study data, including the generation and maintenance of electronic case report forms, 
will be managed by EPICORE. The data will be housed on EPICORE’s secure servers 
hosted at the University of Alberta Faculty of Medicine and Dentistry. Data access is 
limited to authorized EPICORE and study personnel, who will be provided with unique 
credentials. Study personnel will use the REDCap interface to complete electronic data 
entry; the collected data will be accessible via encrypted virtual private network. 
 
As an innovation, EPICORE has designed a patient portal in REDCap to enable self-
completion of patient-reported outcomes. While the baseline and follow-up visits will 
still be in-person, participants may choose to finish filling in patient-reported outcomes 
from home, on their computers or smart phones. 
 
A copy of the locked and final study data will be stored on the principal investigator’s 
secure server. This server space is hosted by the Data Analytics and Research Core 
(DARC) at the University of Alberta’s Faculty of Medicine and Dentistry, and is also 
only accessible to authorized personnel via virtual private network. This will facilitate 
compliance with university policies on data retention, as well as satisfy the secondary 
analyses and the follow-up observational study once EPICORE’s services are 
complete. 
 
 
17. FEASIBILITY AND LIMITATIONS 
Feasibility of the trial:  
 

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The trial is small, features a short follow-up period, and deploys existing (licensed and 
marketed) technologies, which have demonstrated benefits in other sub-populations of 
adults with diabetes. Trial needs are relatively straightforward.  
 
The EPICORE Centre has extensive experience in clinical trials, supporting numerous 
investigators, with a lengthy list of completed and on-going projects 
(https://www.epicore.ualberta.ca/home/). They will provide data base and analysis support. 
 
The team of study investigators is small, but collectively covers formal expertise in clinical 
epidemiology and sophisticated statistical analyses, diabetes care from both specialist and 
primary care lenses, and significant experience with clinical trials and qualitative / mixed 
methods evaluations in the context of primary care quality improvement.43 The more 
experience study investigators are well established in local and regional clinical care 
organizations, and we expect to leverage their interpersonal contacts to enable participant 
recruitment. 
 
Limitations and Design Issues: 
• Episodic and short-term use of isCGM. We have designed the intervention to test 
the effectiveness of episodic isCGM, recognizing that, in the current cost and 
insurance coverage environment, many patients will only be able to afford isCGM 
on an episodic basis. Our results may not generalize to continuous or longer duration 
use of isCGM, or to a longer, more continuous CDE education and feedback. 
• Enhanced usual care control group does not formally feature support for capillary 
blood glucose monitoring. Our control group is usual care enhanced with CDE 
education and feedback, which may include CDE recommendation that patients 
undergo self-monitoring of blood glucose with capillary blood glucose monitors, but 
not on a protocolized or formal basis. There is variable evidence that capillary blood 
glucose monitoring can improve glycemic control in this population, but a formal 
test of isCGM compared to capillary blood glucose monitoring is beyond the scope 
of the present trial. 
• Limited trial period of 12 weeks. There is the possibility that insufficient time may 
have elapsed by the 12 week study HbA1c to see the effect of the intervention, since 
the 12 week HbA1c may be influenced by blood glucose exposure early in the trial 
period, before isCGM-based changes are made. Additionally, the 12 month outcome 
will not be able to speak to the sustainability of any isCGM benefits detected. We 
have designed a post-trial observational follow-up to address the longer term 
outcomes of episodic isCGM, recognizing that the follow analysis will no longer 
benefit from the expected confounder balance of randomization, as participants who 
consent to data linkage and who have HbA1c measurements post-trial will represent 
a non-random subset of those initially randomized. 
• Limited support to titrate anti-hyperglycemic medications. The presumptive 
mechanism for any improvement in glycemic control is improved diet and lifestyle 
modification in adults randomized to isCGM. An alternative mechanism may be 
more rapid medication titration based on isCGM data, instead of HbA1c 
measurements, which are recommended at intervals no less than 90 days. While the 

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CDE algorithm (currently under development) may have a role for CDE-to-provider 
suggestions for medication changes, the intervention is not intended to provide 
further support or practice change related to provider prescribing (e.g.: decision 
support, alternate prescribers, provider training).   
• Sample size still has a 20% risk of type 2 error – Our study is powered to detect a 
0.5% difference in HbA1c at a power of 80%. The type 2 error rate (failure to detect 
a difference on such a difference truly exists) is still 20%, though may be slightly 
lower if loss-to-follow-up is minimized and recruitment approaches the full 100 
participants. 
 
 
18. ETHICAL CONSIDERATIONS 
The study will be conducted in accordance with the Tri-Council Policy Statement.44  
 
Informed Consent of the Patient - Patients who meet all inclusion criteria and none of the 
exclusion criteria are deemed eligible. Before being enrolled into the clinical study, the patient 
must provide written consent to participate in the study after the nature, scope and possible 
consequences of the clinical study have been explained both orally and in writing. 
 
Approval of the Study Protocol - Before the start of the study, the study protocol and the 
informed consent form used at the site and other appropriate documents must be submitted to 
and approved by the local Ethics Committee or Institutional Review Board (REB) and the 
appropriate regulatory authorities in accordance with local legal requirements. 
 
Maintenance of Records - The Investigator agrees to obtain a correctly completed informed 
consent form for each patient included in the study. The investigator will maintain a personal list 
of patient numbers and patient names to enable records to be found at a later date. As per 
University policy data will be kept for 5 years from completion of the study. The REDCap 
database will be maintained for a period of 25 years from study completion. 
 
Generation and Sharing of Remote Patient Data – isCGM data will automatically be shared with 
the clinic LibreView account to facilitate CDE nurse education and feedback, via internet-
capable smart phones. Participants will be provided with written, graphic instructions on 
terminating data sharing. Data sharing will be terminated by study personnel during the 12 week 
in-person visit, or by special appointment if participants wish to terminate data sharing earlier 
and are unable to do so themselves. 
 
 
19. STUDY MONITORING 
 
We will adhere to the Data and Safety Monitoring Board Guidance for University of Alberta 
Sponsored PI-Initiated Studies.45 Because the completed PI-Initiated Study Risk Assessment 
Worksheet identifies this trial as being low overall risk (Appendix 7), the data safety and 
monitoring will be undertaken by the principal investigator, who will provide an annual 

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review of the data and safety information to Quality Management in Clinical Research, a 
research oversight department at the University of Alberta. 
 
 
20. ADMINISTRATIVE RULES 
 
Curriculum vitae - An updated copy of the curriculum vitae for each Investigator and co-
Investigator will be provided to the principal investigator prior to the beginning of the study. 
 
Confidentiality agreement - All goods, materials, information (oral or written) and unpublished 
documentation provided to the Investigators, inclusive of this protocol and the patient case report 
forms are the exclusive property of the Division of General Internal Medicine, University of 
Alberta. 
 
They may not be given or disclosed by the Investigator or by any person within his authority 
either in part or in totality to any unauthorized person without the prior written formal consent 
of the PI. 
 
It is specified that the submission of this protocol and other necessary documentation to the 
Ethics Research Committee is expressly permitted, the Ethics Committee members having 
the same obligation of confidentiality. 
 
The Investigator shall consider as confidential and shall take all necessary measures to ensure 
that there is no breach of confidentiality in respect of all information accumulated, acquired 
or deduced in the course of the trial, other than that information to be disclosed by law. 
 
Record retention in investigating center(s) - The Investigator must maintain all study records, 
patient files and other source data for the maximum period of time permitted by the institution. 
 
 
21. OWNERSHIP OF DATA AND USE OF THE STUDY RESULTS 
 
The investigators of the study have ownership of all data and results collected during this 
study. Full publication rights of the study data solely reside with the investigators. 
 
 
22. PUBLICATIONS 
 
All study presentations and/or publication of the results will be based on clean, checked and 
validated data in order to ensure the accuracy of the results. The responsibility for 
presentations and/or publications belongs to the investigators. The final content of the 
manuscript is the responsibility of the investigators. Publication of the main findings of this 
study will be authored based on the contributions of the individuals to the overall study. 
 
23. POTENTIAL IMPACT OF STUDY 

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This trial will estimate the effectiveness of episodic isCGM paired with CDE education and 
feedback on glycemic control and a number of patient-reported constructs relevant to 
patient self-management of diabetes. Post-trial investigations will shed light on barriers and 
facilitators of isCGM, participant experience with isCGM, and factors mediate the 
effectiveness (if any) of isCGM. This sub-population of adults with diabetes is relatively 
un-studied, and the results will not only contribute new knowledge to guide clinical 
application of isCGM, but may also have implications for public insurance funding policies. 
The results will be disseminated in peer-reviewed journals. The intervention package 
(patient education materials and CDE management algorithms), being developed using a 
human-centred design process, will be revised post-trial and made available for use 
regionally. The results of the trial will also feed into local policy and prioritization efforts 
related to improving the care of adults with diabetes in Alberta. 
 
 
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Bodoarca R, Yeung RO, Lau D. New Diabetes Guidelines: Impact on Eligibility for 
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Leiter LA, Cheng AYY, Ekoé JM, et al. Glycated Hemoglobin Level Goal Achievement 
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Yoo HJ, An HG, Park SY, et al. Use of a real time continuous glucose monitoring system 
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Miller E, Brandner L, Wright EE, Jr. 84-LB: HbA1c Reduction after Initiation of 
FreeStyle Libre System in Type 2 Diabetes Patients on Long-Acting Insulin or 
Noninsulin Therapy. Diabetes. 2020;69. 
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Elliott T, Beca S, Beharry R, Tsoukas MA, Zarruk A, Abitbol A. The impact of flash 
glucose monitoring on glycated hemoglobin in type 2 diabetes managed with basal 
insulin in Canada: A retrospective real-world chart review study. Diab Vasc Dis Res. 
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Kröger J, Fasching P, Hanaire H. Three European Retrospective Real-World Chart 
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Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Flash Glucose-
Sensing Technology as a Replacement for Blood Glucose Monitoring for the 
Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized 
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Yaron M, Roitman E, Aharon-Hananel G, et al. Effect of Flash Glucose Monitoring 
Technology on Glycemic Control and Treatment Satisfaction in Patients With Type 2 
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23. 
Hermanns N, Ehrmann D, Schipfer M, Kröger J, Haak T, Kulzer B. The impact of a 
structured education and treatment programme (FLASH) for people with diabetes using a 
flash sensor-based glucose monitoring system: Results of a randomized controlled trial. 
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Jackson MA, Ahmann A, Shah VN. Type 2 Diabetes and the Use of Real-Time 
Continuous Glucose Monitoring. Diabetes Technol Ther. 2021;23:S27-S34. 
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Davis WA, Bruce DG, Davis TM. Is self-monitoring of blood glucose appropriate for all 
type 2 diabetic patients? The Fremantle Diabetes Study. Diabetes Care. 2006;29:1764-
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26. 
Malanda UL, Welschen LM, Riphagen, II, Dekker JM, Nijpels G, Bot SD. Self-
monitoring of blood glucose in patients with type 2 diabetes mellitus who are not using 
insulin. Cochrane Database Syst Rev. 2012;1:Cd005060. 
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Machry RV, Rados DV, Gregório GR, Rodrigues TC. Self-monitoring blood glucose 
improves glycemic control in type 2 diabetes without intensive treatment: A systematic 
review and meta-analysis. Diabetes Res Clin Pract. 2018;142:173-87. 
28. 
Durán A, Martín P, Runkle I, et al. Benefits of self-monitoring blood glucose in the 
management of new-onset Type 2 diabetes mellitus: the St Carlos Study, a prospective 
randomized clinic-based interventional study with parallel groups. J Diabetes. 
2010;2:203-11. 
29. 
Polonsky WH, Fisher L, Schikman CH, et al. Structured self-monitoring of blood glucose 
significantly reduces A1C levels in poorly controlled, noninsulin-treated type 2 diabetes: 
results from the Structured Testing Program study. Diabetes Care. 2011;34:262-7. 
30. 
Polonsky WH, Fisher L, Schikman CH, et al. A structured self-monitoring of blood 
glucose approach in type 2 diabetes encourages more frequent, intensive, and effective 
physician interventions: results from the STeP study. Diabetes Technol Ther. 
2011;13:797-802. 
31. 
Parsons SN, Luzio SD, Harvey JN, et al. Effect of structured self-monitoring of blood 
glucose, with and without additional TeleCare support, on overall glycaemic control in 
non-insulin treated Type 2 diabetes: the SMBG Study, a 12-month randomized controlled 
trial. Diabet Med. 2019;36:578-90. 
32. 
Abbott Laboratories. New Real-World Data Show That Abbott’s FreeStyle Libre System 
Delivers Positive Health Outcomes for People with Type 1 and Type 2 Diabetes. Madrid, 
Spain: PRNewswire; 2020. 
33. 
Health Canada Health Products and Food Branch, Medical Devices Directorate. Active 
licence listing by company (ABBOTT DIABETES CARE LTD. 134918). https://health-
products.canada.ca/ 2022; https://health-products.canada.ca/mdall-
limh/information.do?companyId_idCompanie=134918&lang=eng. Accessed Feb. 22, 
2022, 2022. 
34. 
Bayshore Specialty Rx Ltd.. FreeStyle Libre 2 Sensor. https://libre.myfreestyle.ca 2022; 
https://libre.myfreestyle.ca/freestyle-libre-2-sensor-i200010. 
35. 
Alva S, Bailey T, Brazg R, et al. Accuracy of a 14-Day Factory-Calibrated Continuous 
Glucose Monitoring System With Advanced Algorithm in Pediatric and Adult Population 
With Diabetes. J Diabetes Sci Technol. 2022;16:70-7. 
36. 
Bailey T, Bode BW, Christiansen MP, Klaff LJ, Alva S. The Performance and Usability 
of a Factory-Calibrated Flash Glucose Monitoring System. Diabetes Technol Ther. 
2015;17:787-94. 
37. 
Bradley C, Lewis KS. Measures of psychological well-being and treatment satisfaction 
developed from the responses of people with tablet-treated diabetes. Diabet Med. 
1990;7:445-51. 
38. 
Anderson RM, Fitzgerald JT, Gruppen LD, Funnell MM, Oh MS. The Diabetes 
Empowerment Scale-Short Form (DES-SF). Diabetes Care. 2003;26:1641-2. 
39. 
Welch GW, Jacobson AM, Polonsky WH. The Problem Areas in Diabetes Scale. An 
evaluation of its clinical utility. Diabetes Care. 1997;20:760-6. 

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40. 
England CY, Thompson JL, Jago R, Cooper AR, Andrews RC. Development of a brief, 
reliable and valid diet assessment tool for impaired glucose tolerance and diabetes: the 
UK Diabetes and Diet Questionnaire. Public Health Nutr. 2017;20:191-9. 
41. 
Ekelund U, Sepp H, Brage S, et al. Criterion-related validity of the last 7-day, short form 
of the International Physical Activity Questionnaire in Swedish adults. Public Health 
Nutr. 2006;9:258-65. 
42. 
Duclos M, Dejager S, Postel-Vinay N, di Nicola S, Quéré S, Fiquet B. Physical activity 
in patients with type 2 diabetes and hypertension--insights into motivations and barriers 
from the MOBILE study. Vasc Health Risk Manag. 2015;11:361-71. 
43. 
Manca DP, Fernandes C, Grunfeld E, et al. The BETTER WISE protocol: building on 
existing tools to improve cancer and chronic disease prevention and screening in primary 
care for wellness of cancer survivors and patients - a cluster randomized controlled trial 
embedded in a mixed methods design. BMC Cancer. 2018;18:927. 
44. 
Canada Institutes of Health Research, Natural Sciences and Engineering Research 
Council of Canada, Social Sciences and Humanities Research Council. Tri-Council 
Policy Statement. Ethical Conduct for Research Involving Humans. Ottawa, ON: 
Secretariat on Responsible Conduct of Research (Government of Canada); 2018. 
45. 
Nothern Alberta Clinical Trials + Research Centre. Data and Safety Monitoring Board 
(DSMB) Guidance for University of Alberta PI-Initiated Studies. 2012; 
https://www.ualberta.ca/research/media-library/quality-management-in-clinical-
research/qmcr-templates-and-tools/qmcrdataandsafetymonitoringboard.doc. Accessed 
Feb. 25, 2022. 

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APPENDIX 1: Dear Provider Trial Letter 
 
Separately attached. 
 
APPENDIX 2: Brochure for waiting room and exam rooms – for hand-out to patients and 
for provider information 
 
 Separately attached. 
APPENDIX 3: Consent Information Package and Form 
Appendix 3.1: Verbal Consent for NetCare Access to Screen for Study Eligibility 
 
Separately attached. 
 
 
Appendix 3.2: Consent for patients with diabetes participating in the trial 
 
Separately attached. 
 
 
Appendix 3.3: Consent for diabetes providers for qualitative interviews 
 
Separately attached. 
 
 
 
 

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APPENDIX 4: Instructions to Terminate LibreView Data Sharing 
 
 
 
 
 
 
Terminating Libre 2 Glucose Data Sharing With the iCUDE Study Team 
Instructions 
 
 
Open the Libre 2 app. 
Open the menu. 
Select “Connected Apps”. 
Select “Manage” 
next to LibreView. 
Select the “UA iCUDE 
Trial” connected practice. 
UA iCUDE Trial 
Press STOP SHARING. 
UA iCUDE Trial 

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APPENDIX 5: Case Report Forms 
 
Electronic case report forms with the following content 
 
Appendix 5.1: Screening and Randomization Form 
Screening 
Patient study ID 
Patient name 
Patient health care number 
Patient date of birth 
Screening date 
Inclusion Criteria 
1. Age >= 18 years with type 2 diabetes. 
2. HbA1c > 7.0%. 
3. Non-insulin therapy. 
4. Able to attend two in-person study visits. 
5. English-speaking. 
6. Community-dwelling 
7. In possession of a cell phone capable of accessing the internet and receiving FreeStyle 
Libre 2 sensor readings 
8. Has a primary care provider who has been in contact with the patient for diabetes in the 
last 12 months. 
Exclusion Criteria 
1. Type 1 diabetes or diabetes clearly identified as having monogenetic etiology (e.g.: 
MODY). 
2. Steroid-induced diabetes if steroid use is on-going or most recently taken within the last 
3 months. 
3. Pregnancy; plans to become pregnant within 6 months; breast-feeding.  
4. Any use of insulin in the previous year. 
5. Current or previous use of isCGM or rtCGM. 
6. Cognitive dysfunction (SPMSQ score >= 5). 
7. Symptoms of acute metabolic decompensation (extreme thirst, high urinary output, and 
weight loss, accompanied by acute fatigue or dyspnea).  
8. Any terminal condition that would limit life expectancy to < 1 year. 
9. Inability to use isCGM (e.g.: afraid of the device). 
10. Inability to be reached by telephone. 
11. Unwillingness to participate. 
12. Has not already received two doses of a Health Canada-approved vaccine against 
SARS-CoV-2. 
Consent completion (yes / no) 
Patient address 
Patient telephone numbers 
• Primary  
• Secondary 
• Best time to call 

27 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
Patient alternate contact name 
Patient alternate contact phone number 
Patient email address 
Patient’s usual diabetes provider name 
Patient’s usual diabetes provider phone number 
 
 
Randomization 
Patient study ID 
Randomization date 
Randomization group 
 
 
 

28 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
Appendix 5.2: Baseline visit 
Patient study ID 
Baseline visit date 
Patient demographics 
• Age  
• Sex 
• Ethnicity (White, Asian, Black, Latin American, Arab, Indigenous (including Metis or 
First Nations)) 
• Marital status 
• Income quintile (pre-tax: < $36,500, $36,500-<$62,000, $62,000-<$92,000, >=$92,000, 
refuse answer) 
• Smoking status 
Medical conditions 
• Hypertension  
• Dyslipidemia 
• Heart disease 
• Heart attack 
• Heart failure 
• Atrial fibrillation 
• Stroke or TIA 
• Peripheral artery disease 
• COPD 
• Asthma 
Diabetes-related quantities 
• Duration of diabetes 
• Retinopathy (problem with the back of your eye that you were told was due to diabetes?) 
• Diabetic nerve disease (problem with loss of sensation or with nerve pain that you were 
told was due to diabetes?) 
• Foot infection without ulcer (an infection in your foot that you were told was due to 
diabetes?) 
• Foot ulcer (a wound or hole in your foot that you were told was due to diabetes?) 
• Amputation 
• Chronic kidney disease (defined as eGFR <= 60 mL/min/1.73m2 or UACR >= 3 
mg/mmol or UPCR >= 15 mg/mmol or semi-quantitiative urine dipstick >= 1+) 
• Most recent eGFR on NetCare (date) 
• Most recent proteinuria indicator on NetCare (date) 
o UACR 
o UPCR 
o Semi-quantitative urine dipstick proteinuria 
• Previous use of fingerstick blood sugar measurement 
Physical parameters 
• BP 
• Height (cm)  

29 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
• Weight (kg)  
• BMI (kg/m2) 
Medication list 
• Medication names, total daily dose 
• Medication compliance: Frequency of missed doses (0%, 1-20%, 21-50%, > 50%) 
Health care utilization 
• ED visits in the last 6 months 
• Hospital admission in the last 6 months 
• Family physician visits in the last 6 months 
• Diabetes specialist visits in the last 6 months 
 
 
 

30 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
Appendix 5.3: Follow-up visit 
Patient study ID 
Follow-up visit date 
Diabetes-related quantities 
• Retinopathy (problem with the back of your eye that you were told was due to diabetes?) 
• Diabetic nerve disease (problem with loss of sensation or with nerve pain that you were 
told was due to diabetes?) 
• Foot infection without ulcer (an infection in your foot that you were told was due to 
diabetes?) 
• Foot ulcer (a wound or hole in your foot that you were told was due to diabetes?) 
• Amputation 
• Most recent eGFR on NetCare since baseline visit (date) 
• Most recent proteinuria indicator on NetCare since baseline visit (date) 
o UACR 
o UPCR 
o Semi-quantitative urine dipstick proteinuria 
• Use of fingerstick blood sugar measurement since baseline visit 
o Number of weeks using fingerstick blood sugar measurement 
o Number of fingerstick blood sugar measurements per day while using it 
• Use of isCGM 
o Number of sensors since baseline visit 
o Number of scans per day (self-report) while sensor active 
Adverse events 
• Any adverse event that might be related to diabetes, diabetes treatment, or glucose 
monitoring (open adverse event reporting form) 
• Skin reactions related to CGM 
o Type of skin reaction: Hives, dermatitis, bleeding 
o Able to continue using CGM? 
o Any treatment applied? 
§ Barrier film 
§ Steroid cream 
§ Other 
CDE compliance 
• Number of CDE education and feedback sessions attended 
Medications 
• Medication names, total daily dose 
• Any medication changes since baseline? 
o Number of new medications since baseline 
o Number of medications with dose increase since baseline 
o Number of discontinued medications since baseline 
o Number of medications with dose decrease since baseline 
• Medication compliance: Frequency of missed doses (0%, 1-20%, 21-50%, > 50%) 
Health care utilization 
• ED visits since last study visit 

31 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
• Hospital admission since last study visit 
• Family physician visit since last study visit 
• Diabetes specialist visit since last study visit 
 
 
 
 
 

32 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
Appendix 5.4: Patient-reported outcomes forms 
 
isCGM Use 
Follow-up time: 6 weeks, 12 weeks 
 
In the last 6 weeks, have you used a continuous glucose monitoring sensor? 
If yes, please indicate how many? 
 
In the last 6 weeks, have you measured your blood sugars by finger prick? 
 
 
 

33 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) 
Follow-up time: Baseline, 6 weeks, 12 weeks 
Date completed 
 
Customized prompt: The following questions are concerned with the treatment for your diabetes 
(including blood glucose measurement, if applicable, and tablets and/or diet) and your 
experience over the past few weeks. Please answer each question by circling a number on each 
of the scales.  
 
 
 
 
 

JQ
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35 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
Diabetes Empowerment Scale – Short Form (DES-SF) 
Follow-up time: Baseline, 6 weeks, 12 weeks 
Date completed 
 
In general‚ I believe that I: 
1. know what part(s) of taking care of my diabetes that I am dissatisfied with. (DESSF1) 
5 – Strongly Agree. 4 – Somewhat Agree. 3 – Neutral. 2 – Somewhat Disagree. 1 – 
Strongly Disagree. 
2. am able to turn my diabetes goals into a workable plan. (DESSF2) 
5 – Strongly Agree. 4 – Somewhat Agree. 3 – Neutral. 2 – Somewhat Disagree. 1 – 
Strongly Disagree. 
3. can try out different ways of overcoming barriers to my diabetes goals. (DESSF3) 
5 – Strongly Agree. 4 – Somewhat Agree. 3 – Neutral. 2 – Somewhat Disagree. 1 – 
Strongly Disagree. 
4. can find ways to feel better about having diabetes. (DESSF4) 
5 – Strongly Agree. 4 – Somewhat Agree. 3 – Neutral. 2 – Somewhat Disagree. 1 – 
Strongly Disagree. 
5. know the positive ways I cope with diabetes related stress. (DESSF5) 
5 – Strongly Agree. 4 – Somewhat Agree. 3 – Neutral. 2 – Somewhat Disagree. 1 – 
Strongly Disagree. 
6. can ask for support for having and caring for my diabetes when I need it. (DESSF6) 
5 – Strongly Agree. 4 – Somewhat Agree. 3 – Neutral. 2 – Somewhat Disagree. 1 – 
Strongly Disagree. 
7. know what helps me stay motivated to care for my diabetes. (DESSF7) 
5 – Strongly Agree. 4 – Somewhat Agree. 3 – Neutral. 2 – Somewhat Disagree. 1 – 
Strongly Disagree. 
8. know enough about myself as a person to make diabetes care choices that are right for 
me. (DESSF8) 
5 – Strongly Agree. 4 – Somewhat Agree. 3 – Neutral. 2 – Somewhat Disagree. 1 – 
Strongly Disagree. 
 
Scoring 
DES-SF score (average of the 8 items) (DESSFscore). 
 
 
 

36 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
Problem Areas in Diabetes Questionnaire 
Follow-up time: Baseline, 6 weeks, 12 weeks 
Date completed 
 
Items PAID01 – PAID20, scored 0-4 as below. 
 
 
 
Scoring 
Sum of for each item PAID01-PAID02 multiplied by 1.25 (PAIDscore). 
 
 
 

JY
"#$%&'($$%#$)*!+,-##%.!/01!2%&343!534-)!/-&%!(#!6.4)$3!7($8!9*:%!;!<(-=%$%3!>?$!?#!"#34)(#!@(/5<AB
C&?$?,?)!D!C&?EEFFGHEI!
2%&3(?#!@;JIBK!+%:$%'=%&!F;L!;E;;
Qd)@&,6#"#1),!-)@&#")c2#1"&7!!,&$#)DQd@@cE
7$))$S<3?!&(D*+!]5,*)(6*L!K!S**9,L!UA!S**9,
>5&*!4$D?)*&*2
=&*D,!No>>nZU<ARL!,4$%*2!P<7 5,!8*)$SB
Think about your diet over the last MONTH.  Circle the answer that best applies to you . Put the letter score in the ovals.
1. How often did you eat a portion of vegetables?  
Include fresh, tinned and frozen vegetables and pulses like lentils and kidney beans.
Never or very 
rarely (F)
Once a week or 
less often (E)
2 4 times a 
week (D)
5  6 times a 
week (C)
1  2 times a 
day (B)
3 or more times a 
day (A)
2. How often did you eat a portion of fruit? Include fresh, frozen, tinned and dried fruit. Do not count fruit juices.
Never or very 
rarely (F)
Once a week or 
less often (E)
2 4 times a 
week (D)
5  6 times a 
week (C)
1  2 times a 
day (B)
3 or more times a 
day (A)
A portion of vegetables or fresh, frozen or tinned fruit is 80g (2.9oz) or about a handful. These are some examples:
3 heaped tablespoons of cooked vegetables 
A dessert bowl of salad
1 medium fruit 
2 small fruits
A handful 
A 5cm slice 
A tablespoon of dried 
fruit (30g or 1/2 handful)
10 chunks 
2 florets 
7 cherry tomatoes
3. How often did you eat a cake, a sweet pastry like a Danish pastry, a donut or a sweet biscuit?
4. How often did you eat sweets, chocolate or sugary foods like gulab jamun, halva or sweet popcorn?
5. How often did you drink sugary drinks?  Include nondiet fizzy drinks, squashes, mixers, energy drinks, fruit juices, 
sweetened milk drinks or coffee, tea or other hot drinks with sugar or flavoured syrups.
6. How often did you use butter, fullfat margarine, ghee, lard or coconut oil or palm oil on your bread, potatoes or 
vegetables or in cooking?
7. How often did you eat oily fish? Think about fresh or tinned salmon, trout, sardine, mackerel, pilchards, herring, 
red mullet, or fresh tuna.
Never or very 
rarely (A)
Once a week or 
less often (B)
2 4 times a 
week (C)
5  6 times a 
week (D)
1  2 times a 
day (E)
3 or more times a 
day (F)
Never or very 
rarely (A)
Once a week or 
less often (B)
2 4 times a 
week (C)
5  6 times a 
week (D)
1  2 times a 
day (E)
3 or more times a 
day (F)
Never or very 
rarely (A)
Once a week or 
less often (B)
2 4 times a 
week (C)
5  6 times a 
week (D)
1  2 times a 
day (E)
3 or more times a 
day (F)
Never or very 
rarely (A)
Once a week or 
less often (B)
2 4 times a 
week (C)
5  6 times a 
week (D)
1  2 times a 
day (E)
3 or more times a 
day (F)
Never (F)
Less than once 
a week (E)
Once a week 
(B)
Twice or more per 
week  (A)
8. How often did you drink alcohol?
Never or very 
rarely (A)
Once a week or 
less often (A)
2 4 times a 
week (B)
5  6 times a 
week (C)
1  2 times a 
day (E)
3 or more times a 
day (F)
Score:
Score:
Turn over to answer questions on page 2 
Page 1 
© The University of Bristol, 2017     Version 3 26/01/2017 self scored  
Score:
Score:
Score:
Score:
Score:
Score:
Name:
Date:

Ja
"#$%&'($$%#$)*!+,-##%.!/01!2%&343!534-)!/-&%!(#!6.4)$3!7($8!9*:%!;!<(-=%$%3!>?$!?#!"#34)(#!@(/5<AB
C&?$?,?)!D!C&?EEFFGHEI!
2%&3(?#!@;JIBK!+%:$%'=%&!F;L!;E;;
9. How often did you eat fullfat cheese? Include cheese in sandwiches, on biscuits, in sauces and when used as a 
topping. Include hard cheeses like cheddar, blue cheeses and soft cheeses like brie, cream cheese, pannier or fullfat 
goat cheeses.
10. How often did you eat processed meat? Include processed meat in sandwiches, ready meals and if eaten as a snack.
Processed meat includes foods like bacon, ham, spam, sausages, salami or chorizo.
11. How often did you eat savoury foods like crisps, corn chips, corn puffs, salted nuts or Bombay mix?
12. How often did you eat a savoury pastry? Think about food like pies, pasties, samosas, sausage rolls, patties or volau
vents. 
13. How often did you eat 'fast foods' from a takeaway or in a restaurant?
Think about foods like burgers, fish and chips, fried chicken, donor kebabs, pizza, fried rice or curries with cream or ghee.
14. How often did you eat pudding or dessert, apart from fruit, with your meals?
Never or very 
rarely (A)
Less than once a 
week (B)
1  2 times a 
week (C)
3  5 times a 
week (D)
Nearly every 
day or daily (E)
Twice or more per 
day (F)
Never or very 
rarely (A)
Less than once a 
week (B)
1  2 times a 
week (C)
3  5 times a 
week (D)
Nearly every 
day or daily (E)
Twice or more per 
day (F)
Never or very 
rarely (A)
Less than once a 
week (B)
1  2 times a 
week (C)
3  5 times a 
week (D)
Nearly every 
day or daily (E)
Twice or more per 
day (F)
Never or very 
rarely (A)
Less than once a 
week (B)
1  2 times a 
week (C)
3  5 times a 
week (D)
Nearly every 
day or daily (E)
Twice or more per 
day (F)
Never or very 
rarely (A)
Less than once a 
week (B)
1  2 times a 
week (C)
3  5 times a 
week (D)
Nearly every 
day or daily (E)
Twice or more per 
day (F)
Never or very 
rarely (A)
Less than once a 
week (B)
1  2 times a 
week (C)
3  5 times a 
week (D)
Nearly every 
day or daily (E)
Twice or more per 
day (F)
Think about your diet over the last MONTH.  Circle the answer that best applies to you . Put the letter score in the ovals
15. How often did you have 3 or more regular meals in a day? 
Include light meals like a sandwich, a soup and roll or something on toast.  Don’t include snack times when you ate only 
a biscuit or cake or a piece of fruit or vegetable sticks or a packet of crisps or piece of cheese.
16. How often did you eat breakfast (more than just a drink or one or two sweet biscuits) within about 2 hours of 
waking?
17. How often did you 'snack' or 'pick' on highfat or highsugar foods between meals? Think about food like biscuits, 
chocolate, cakes, crisps, nuts and cheese.
Never or very 
rarely (F)
Less than once a 
week (E)
Once a week 
(D)
2  4 times a 
week (C)
56 times a 
week (B)
Every day (A)
Never or very 
rarely (A)
Less than once a 
week (B)
Once a week 
(C)
2  4 times a 
week (D)
56 times a 
week (E)
Every day (F)
Never or very 
rarely (F)
Less than once a 
week (E)
Once a week 
(D)
2  4 times a 
week (C)
56 times a 
week (B)
Every day (A)
Now answer the questions on page 3 
Page 2 
Score:
Score:
Score:
Score:
Score:
Score:
Score:
Score:
Score:

Jc
"#$%&'($$%#$)*!+,-##%.!/01!2%&343!534-)!/-&%!(#!6.4)$3!7($8!9*:%!;!<(-=%$%3!>?$!?#!"#34)(#!@(/5<AB
C&?$?,?)!D!C&?EEFFGHEI!
2%&3(?#!@;JIBK!+%:$%'=%&!F;L!;E;;
18. How often did you eat a portion of bread? Include bread in sandwiches and wraps.
A portion of bread is 1 small slice of bread, a bread roll, half a baguette, a bagel, a pikelet a tortilla wrap, a small naan, 
a chapatti or a paratha. 
Think about your diet over the last MONTH.  Circle the answer that best applies to you . Put the letter score in the ovals.
Never or very 
rarely
Once a week or less 
than once a week
2 6 times a 
week
1 – 2 times a 
day
3 – 4 times a 
day
More than 4 
times a day
19. When you ate bread did you choose higher fibre breads? 
Breads that are high in fibre include wholemeal, granary or wholegrain wheat and rye breads. If you follow a gluten 
free diet include high fibre gluten free breads.
20. How often did you eat a bowl of breakfast cereal, porridge or muesli?
21. When you ate cereal did you choose higher fibre cereals?
Cereals that are high in fibre include porridge, muesli, Weetabix, Shredded Wheat, multigrain cereals and wheat or oat 
bran cereals.
22. How  often did you eat a serving of rice, pasta or noodles? A serving is 23 tablespoons cooked rice, cooked pasta or 
noodles.
Never or very 
rarely
Less than once a 
week
Once a week
2 – 5 times a 
week
Nearly every day 
or daily
Twice or more 
per day
Never or very 
rarely
Less than once a 
week
Once a week
2 – 5 times a 
week
Nearly every day 
or daily
Twice or more 
per day
Each photo is a serving or portion. Use them to help work out how many servings you eat each week or day.
All of the time 
(A)
Most of the 
time (B)
About half 
the time (C)
Less than half 
the time (D)
Never (E)
I did not eat bread 
(no score)
All of the time 
(A)
Most of the 
time (B)
About half 
the time (C)
Less than half 
the time (D)
Never (E)
I did not eat cereal 
(no score)
23. When you ate rice, pasta or noodles did you choose brown rice or wholegrain pasta / noodles?
All of the time 
(A)
Most of the 
time (B)
About half 
the time (C)
Less than half 
the time (D)
Never (E)
I did not eat  rice / 
noodles / pasta (no 
score)
3 tablespoons cereal or 
porridge (about 30g or 1oz)
Breads  (about 28g or 1oz)
23 tablespoons cooked rice, cooked pasta or 
noodles (about 80g or 2.9oz)
Page 3 
Now go to page 4 for scoring 
© The University of Bristol, 2017     Version 3 26/01/2017 self scored  
Score:
Score:
Score:
Circle the answer that applies. There is no score because there is no most healthy or least healthy choice. Use this 
question with question 19 to see if bread could be an important source of fibre for you. 
Circle the answer that applies. There is no score because there is no most healthy or least healthy choice. Use this 
question with question 21 to see if cereal could be an important  source of fibre for you. 
Circle the answer that applies. There is no score because there is no most healthy or least healthy choice. Use this 
question with question 23 to see if rice, pasta or noodles could be an important source of fibre for you. 
24. And finally, what type of milk did you usually use, if any?
Full fat (cow, 
goat or sheep) 
(F)
Semiskimmed 
(cow, goat or 
sheep) (B)
Skimmed (cow, 
goat or sheep) 
(A)
Sometimes full fat, 
sometimes skimmed 
or semi skimmed (D)
Soya, oat, rice 
or other non
dairy milk (A)
None (A)
Score:
Name:
Date:

40 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
 
 
 
Summary scores 
UKDDQ_AB – Total number of questions answered A or B. 
UKDDQ_CD – Total number of questions answered C or D. 
UKDDQ_EF – Total number of questions answered E or F. 
UKDDQscore – Converted A = 5, B = 4, C = 3, D = 2, E = 1, F = 0; sum of scores from 
UKDDQ01-UKDDQ24 omitting UKDDQ18 and UKDDQ20. 
 
 
 
 
Page 4  
Fruit: Be aware that large portions of fruit in one go MAY contribute to raised blood glucose levels. 
Spread fruit out evenly through the day. 
Oily fish: Contains essential omega-3 fatty acids. For vegetarians, or people who dislike oily fish, the best alternate sources 
are walnuts, ground linseeds (flaxseeds) and linseed oil. Other sources are rapeseed oil (commonly vegetable oil), walnut 
oil, chia seeds and edamame (cooked soy beans) and tofu. If appropriate consider foods fortified with omega-3s, such as 
omega-3 eggs. 
Alcohol: Scoring for alcohol does not take into account binge drinking. Drinking more than 14 units of alcohol a week 
exceeds guidelines. A unit is half a pint beer, a small glass of wine or a  single shot of spirits. 
Milk: If you drink  soya, oat, rice or other non dairy milk or no milk  try to include other sources of calcium such as calcium 
fortified foods and drinks, tofu set with calcium salts, tinned fish with bones, broccoli and spring greens. 
Notes: 
26. 
How important is it to you to 
change your diet? 
Not at all important 
Extremely important 
 
 
How confident are you that  
you could change your diet? 
Not at all confident 
Extremely confident 
27. 
 
 
0 
5 
10 
7 
3 
0 
3 
5 
7 
10 
Fruit and vegetable images except dried fruit produced by the Department of  Health © Crown copyright 2003 
25. Are you concerned about your weight? 
I am not  
concerned about my weight  
I am a little  
concerned about my weight  
I am moderately concerned 
about my weight   
I am  very  
concerned about my weight  

41 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
International Physical Activity Questionnaire (IPAQ) 
Follow-up time: Baseline, 6 weeks, 12 weeks 
Date completed 
 
Note that IPAQ hours and IPAQ minutes should be automatically calculated from each other – if 
a respondent enters 1.5 hours, it should automatically input 90 minutes; and vice versa. 
 
We are interested in finding out about the kinds of physical activities that people do as part of 
their everyday lives. The questions will ask you about the time you spent being physically active 
in the last 7 days. Please answer each question even if you do not consider yourself to be an 
active person. Please think about the activities you do at work, as part of your house and yard 
work, to get from place to place, and in your spare time for recreation, exercise or sport.  
 
Think about all the vigorous activities that you did in the last 7 days. Vigorous physical activities 
refer to activities that take hard physical effort and make you breathe much harder than normal. 
Think only about those physical activities that you did for at least 10 minutes at a time. 
 
1. During the last 7 days, on how many days did you do vigorous physical activities like 
heavy lifting, digging, aerobics, or fast bicycling? 
_____ days per week (IPAQ1days) 
¨ No vigorous physical activities à Skip to question 3. (IPAQ1none; if checked, set 
IPAQ1days and IPAQ2mins to 0) 
 
2. How much time did you usual spend doing vigorous physical activities on one of those 
days? 
_____ hours per day (no specific variable name – auto-fills IPAQ2mins) 
_____ minutes per day (IPAQ2mins) 
¨ Don’t know / Not sure (IPAQ2dk; if checked, set IPAQ2mins to -9) 
 
Think about all the moderate activities that you did in the last 7 days. Moderate activities refer to 
activities that take moderate physical effort and make you breathe somewhat harder than normal. 
Think only about those physical activities that you did for at least 10 minutes at a time. 
 
3. During the last 7 days, on how many days did you do moderate physical activities like 
carrying light loads, bicycling at a regular pace, or doubles tennis? Do not include 
walking. 
_____ days per week (IPAQ3days) 
¨ No moderate activities à Skip to question 5. (IPAQ3none; if checked, set IPAQ3days 
and IPAQ4mins to 0) 
 
4. How much time did you usual spend doing moderate physical activities on one of those 
days? 
_____ hours per day (no specific variable name – auto-fills IPAQ4mins) 
_____ minutes per day (IPAQ4mins) 
¨ Don’t know / Not sure (IPAQ4dk; if checked, set IPAQ4mins to -9) 

42 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
 
Think about the time you spent walking in the last 7 days. This includes at work and at home, 
walking to travel from place to place, and any other walking that you have done solely for 
recreation, sport, exercise, or leisure. 
 
5. During the last 7 days, on how many days did you walk for at least 10 minutes at a time? 
_____ days per week (IPAQ5days) 
¨ No walking à Skip to question 7. (IPAQ5none; if checked, set IPAQ5days and 
IPAQ6mins to 0) 
 
6. How much time did you usually spend walking on one of those days? 
_____ hours per day (no specific variable name – auto-fills IPAQ6mins) 
_____ minutes per day (IPAQ6mins) 
¨ Don’t know / Not sure (IPAQ6dk; if checked, set IPAQ6min to -9) 
 
The last question is about the time you spent sitting on weekdays during the last 7 days. Include 
time spent at work, at home, while doing course work and during leisure time. This may include 
time spent sitting at a desk, visiting friends, reading, or sitting or lying down to watch television. 
 
7. During the last 7 days, how much time did you spend sitting on a week day? 
_____ hours per day (no specific variable name – auto-fills IPAQ7mins) 
_____ minutes per day (IPAQ7mins) 
¨ Don’t know / Not sure (IPAQ7dk; if checked, set IPAQ7mins to -9) 
 
Summary scores 
 
Treat responses of -9 as 0. 
Walking MET-minutes / week (metmin_walk) = 3.3 * IPAQ5days * IPAQ6mins  
Moderate MET-minutes / week (metmin_mod) = 4.0 * IPAQ3days * IPAQ4mins 
Vigorous MET-minutes / week (metmin_vig) = 8.0 * IPAQ1days * IPAQ2mins 
Total MET-mins / week (metmin_tot) = metmin_walk + metmin_mod + metmin_vig. 
 
Summary categories 
 
IPAQhepa = 1 if (IPAQ1days >= 3 & metmin_tot >= 1500) or ((IPAQ5days + IPAQ3days + 
IPAQ1days) >= 7 & metmin_tot >= 3000); else IPAQhepa = 0. 
 
IPAQminactive = 1 if (IPAQ1days >= 3 & IPAQ2mins >= 20) or (IPAQ3days >= 5 & 
IPAQ4mins >= 30) or ((IPAQ5days + IPAQ3days + IPAQ1days) >= 5 & metmin_tot >= 600); 
else IPAQminactive = 0. 
 
IPAQinactive = 1 if IPAQhepa = 0 & IPAQminactive = 0; else IPAQinactive = 0. 
 
 

43 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
Health-Related Quality of Life – EQ-5D-5L 
Follow-up time: Baseline, 6 weeks, 12 weeks 
Date completed 
Sample worksheet shown below. 
Items named MO, SC, UA, PD, AD, each taking a value between 1 and 5. 
 
 
 

44 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
 
 
Scoring 
Health utility value from EQ-5D-5L responses will be calculated by investigators using Canadian 
valuation data. Stata / SAS / excel code available at: https://apersu.ca/eq-5d-scoring-algorithms/. 
 
 
 

45 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
Appendix 5.5: HbA1c and Time in Range Form 
 
HbA1c Report Form 
Research assistant to complete 
Patient study ID 
Follow-up time: Baseline, 12 weeks 
HbA1c value 
Date of HbA1c 
 
isCGM Time-in-Range Report Form 
Research assistant to complete 
Patient study ID 
Follow-up time: 12 weeks 
For adults randomized to the isCGM group only 
 
Date of first sensor start: 
Date of second sensor start: 
Date of third sensor start: 
 
Referring to the first two weeks of isCGM sensor use: 
• Start date: 
• Time-in-range (3.9-10.0 mmol/L) (%): 
• Time-above-range (>10.0 mmol/L and <= 13.9 mmol/L): 
• Time-above-range – severe (> 13.9 mmol/L): 
• Time-below range (sum of < 3.9 mmol/L and < 3.0 mmol/L): 
• Glucose Management Indicator (GMI) (%): 
• Coefficient of variation (CV): 
 
Referring to the last two weeks of isCGM sensor use: 
• Start date: 
• Time-in-range (3.9-10.0 mmol/L) (%): 
• Time-above-range (>10.0 mmol/L and <= 13.9 mmol/L): 
• Time-above-range – severe (> 13.9 mmol/L): 
• Time-below range (sum of < 3.9 mmol/L and < 3.0 mmol/L): 
• Glucose Management Indicator (GMI) (%): 
• Coefficient of variation (CV): 
 
 
 
 
 

46 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
Appendix 5.6: Adverse events report form 
Patient study ID 
Adverse event 
• Diagnosis, if available 
• Patient-report 
Start date 
Setting: Managed in the community, required EMS, required ED, required hospital admission. 
Event details: 
• Enclose ED chart or discharge summary if ED or hospital admission required 
• Patient description of event 
Investigator Review: 
• Relationship to study treatment (definitely, possibly, not related) 
• Outcome (resolved, persistent, death) 
• Expected (yes, no) 
• Serious (yes, no) 
 
Definitions for adverse events form. 
 
An Adverse Event (AE) is defined as any untoward medical occurrence, including an 
exacerbation of a pre-existing condition, in a patient in a clinical investigation who received 
a pharmaceutical product. The event does not necessarily have to have a causal relationship 
with this treatment. 
 
A Serious Adverse Event (SAE) is defined as any AE which results in death, is immediately 
life-threatening, results in persistent or significant disability / incapacity, requires or prolongs 
patient hospitalization, is a congenital anomaly / birth defect, or is to be deemed serious for 
any other reason representing a significant hazard, which is comparable to the aforementioned 
criteria. 
 
Relationship to study treatment will be determined in the medical judgement of a study 
investigator. 
 
 
 
 

47 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
Appendix 6: Qualitative Sub-Study Interview Guides 
 
iCUDE Trial Qualitative Sub-Study 
 
Interview Guide 
Version (1): March 24, 2022 
1 
Interview Guide (Group 1: Trial Patients Randomized to Intervention) 
 
I would like to start by thanking you for participating in this interview. I am interested in your 
perspectives regarding the FreeStyle Libre 2 continuous glucose monitor and your visits with the 
diabetes educator. Before we start our interview, I would like to ask you not to use names of 
people or institutions that may identify them. We will also remove all identifying information 
from the transcripts. 
 
1. Did you have any thoughts or expectations about what using the FreeStyle Libre 2 would 
be like before you started it? 
 
2. Can you tell me about your experience using the Libre 2 for the first time? 
Probes: Was it easy or difficult to start using? What do you think about being able see 
your blood sugar on your cell phone? What did you think of your blood sugars the first 
day you measured them? How did they make you feel? Did you know what to make of 
them, or what to do about them? 
 
3. What changes did the Libre 2 lead to in terms of what you eat or what you do during the 
day? How difficult was it to make those changes?  
Probes: Can you think of anything that helped you make those changes? Anything that 
might have made it harder to make those changes? 
 
4. Has the Libre 2 changed how you think or feel about your diabetes?  
 
5. What kind of support or resources did you have to help with your diabetes before this 
trial? 
 
6. Can you tell me about the kind of impact meeting with the diabetes educator had on you?  
Probes: How long was the encounter? How did it feel talking to the diabetes educator? 
What did you learn during the encounter? Did you make a plan? What did you like best 
about the encounter? What would you like to be different? 
 
7. Can you tell me about the kind of impact meeting with the diabetes educator had on your 
ability to use the Libre 2? To look after your diabetes?  
Probes: How about in terms of changes to your diet and activity? 
 
8. Was the second educator encounter different from the first?  
Probes: Were there things you learnt that were different in the second encounter, from the 
first? What would the perfect number of encounters be? How far apart should they be? 
 
9. Is the FreeStyle Libre 2 something you’d consider using again in the future? Why or why 
not?  
 
10. Do you have goals for your diabetes moving forward?  
Probes: Can you describe your goals? What do you think about these goals? How 
optimistic are you that you will be able to follow through with your goals? 

48 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
iCUDE Trial Qualitative Sub-Study 
 
Interview Guide 
Version (1): March 24, 2022 
2 
 
11. Is there anything else you would like to share about using the Libre 2 or meeting the 
diabetes educator? 
 
Thank you very much for speaking with me. We would be pleased to offer you a small amount 
of money ($20) in appreciation for your time. You can expect it in the mail – please let us know 
if you don’t receive it. 
 
 
 

49 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
iCUDE Trial Qualitative Sub-Study 
 
Interview Guide 
Version (1): March 24, 2022 
3 
Interview Guide (Group 2: Trial Patient Randomized to Enhanced Usual Care) 
 
I would like to start by thanking you for participating in this interview. I am interested in your 
perspectives about looking after your diabetes and your visits with the diabetes educator. Before 
we start our interview, I would like to ask you not to use names of people or institutions that may 
identify them. We will also remove all identifying information from the transcripts. 
 
1. Do you know how well your diabetes was looked after before you met the educator? How 
did you feel about your diabetes before you met the educator?  
Probes: Were you doing anything in particular to make your diabetes better, or to keep it 
from getting worse? What kind of support or resources did you have to help with your 
diabetes? 
 
2. Can you tell me about the kind of impact meeting with the diabetes educator had on you?  
Probes: How long was the encounter? How did it feel talking to the diabetes educator? 
What did you learn during the encounter? Did you make a plan? What did you like best 
about the encounter? What would you like to be different? 
 
3. Was the second educator encounter different from the first?  
Probes: Were there things you learnt that were different in the second encounter, from the 
first? What would the perfect number of encounters be? How far apart should they be? 
 
4. Did you start measuring your blood sugars at any time during the trial? Do you feel that 
measuring your blood sugars could have been useful? 
 
5. Do you have goals for your diabetes moving forward?  
Probes: Can you describe your goals? What do you think about these goals? How 
optimistic are you that you will be able to follow through with your goals? 
 
6. Is there anything else you would like to share about meeting the diabetes educator? 
 
Thank you very much for speaking with me. We would be pleased to offer you a small amount 
of money ($20) in appreciation for your time. You can expect it in the mail – please let us know 
if you don’t receive it. 
 
 
 

50 
 
Intermittently Scanned CGM Versus Usual Care in Adults with Type 2 Diabetes Not on Insulin (iCUDE) 
Protocol # Pro00119503  
Version (2.3): September 12, 2022 
 
 
 
 
iCUDE Trial Qualitative Sub-Study 
 
Interview Guide 
Version (1): March 24, 2022 
4 
Interview Guide (Group 3: Providers) 
 
I would like to start by thanking you for participating in this interview. I am interested in your 
perspectives regarding looking after adults with early diabetes – those who are not on insulin, but 
who need additional blood sugar lowering to get to target. Specifically, I want to talk about using 
the FreeStyle Libre 2 continuous glucose monitor with these patients. Before we start our 
interview, I would like to ask you not to use names of people or institutions that may identify 
them. We will also remove all identifying information from the transcripts. 
 
1. What is your previous experience looking after patients using the Libre or Libre 2 CGM? 
 
2. What difference did the Libre 2 make for our trial patients who were not on insulin? 
Would you consider the Libre 2 useful or not useful, in this population? Why or why not? 
Probe: (If not useful, then what would the Libre 2 being useful look like?)  
 
3. Are there patient factors that determine whether the Libre 2 is useful for an individual or 
not? What are they? 
Probe: Are they related to knowledge? Skill? Motivation? Supports? Environment? Diet? 
Activity? Are there other factors you’d like to mention? 
 
4. Can you tell me about your encounters with patients using the CGM?  
Probes: How long was the encounter? How did it feel from your perspective? Is there 
anything you’d like to highlight as working particularly well? Anything you would think 
about doing differently during these encounters?  
 
5. Were you able to relate the Libre 2 results to things going on in the patients’ lives? Were 
you able to build plans of action with your patients using Libre 2 results? 
Probe: How challenging did you find this? What kind of plans did you typically leave 
with? Did patients need a lot of convincing to take these steps? 
 
6. Do you feel you have the right training or resources to help patients at this stage of their 
diabetes, to use the CGM and improve their diabetes? 
 
7. Is there anything else you would like to share about help adults with diabetes who are not 
on insulin use the Libre 2? 
 
Thank you very much for speaking with me. We would be pleased to offer you a small amount 
of money ($20) in appreciation for your time. You can expect it in the mail – please let us know 
if you don’t receive it. 
 
 

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