Keeping in Touch (KiT) With Youth as They Transition to Adult Type 1 Diabetes Care: a Randomized Control Trial Testing the Effectiveness of an eHealth Text Message-based Intervention to Improve Diabetes Self-efficacy
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Sponsor: The Hospital for Sick Children

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STUDY PROTOCOL 
 
Title:  Keeping in Touch (KiT) with Youth as they Transition Through Type 1 Diabetes Care:  a 
randomized control trial comparing the effectiveness of an eHealth text message-based 
intervention in conjunction with usual T1D care compared to usual care alone on diabetes self-
efficacy 
 
Study Nickname:  KiT 
 
Principal Investigator: Dr. Rayzel Shulman 
 
Sponsor: Dr. Rayzel Shulman and The Hospital for Sick Children. 
 
Funded by:  CIHR 
 
Version Date:  02 JULY 2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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STATEMENT OF COMPLIANCE 
 
 
 
The trial will be conducted in accordance with this protocol, International Council on 
Harmonisation Good Clinical Practice (ICH GCP) and applicable regulatory requirements.  The 
Principal Investigator (PI) will assure that no deviation from, or changes to the protocol will take 
place without prior agreement from the Sponsor and documented approval from the Research 
Ethics Board (REB), except where necessary to eliminate (an) immediate hazard(s) to the trial 
participants.  
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the REB for review and approval.  Approval of both the protocol and the consent 
form(s) must be obtained before any participant is enrolled.  Any amendment to the protocol will 
require review and approval by the REB before the changes are implemented to the study.  All 
changes to the consent form will be REB approved; a determination will be made regarding 
whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form. 
 
Name of Principal Investigator (Print):  _________________________________  
 
 
Signature of Principal Investigator: _____________________________ 
  Date:  ______________ 
 
<DD Month YYYY> 
 
 
Site Address  
____________________________________________ 
____________________________________________  
____________________________________________  
____________________________________________ 
 
 

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PROTOCOL SUMMARY 
1.1 
SCHEMA 
 
Prior to  
Enrollment 
(21 month  
Recruitment  
Period) 
 
 
 
 
 
 
 
 
 
 
 
Baseline 
 
 
 
 
 
 
 
 
 
Intervention  
Start 
 
 
 
6-Month 
 
 
 
 
 
 
 
 
 
 
12-Month 
 
 
 
Local coordinator:  securely transfer Memotext Study ID, Randomization arm and phone number of 
newly randomized participant. Memotext to activate enrollment by sending start-text to participants 
in both arms 
Local coordinators: Collect HbA1c lab-reported value no later than 6 months prior to enrolment 
date, emergency department and hospitalization data, and OHIP/RAMQ numbers to link to admin 
data 
Follow-up assessments:  Memotext sends SMS of 6-month questionnaires as 
URLs that linkout to REDCap: KiT Survey, READDY, BDA Stigma Subscale, 
SEDM to both arms. Interim Process Evaluation with intervention arm 
Total 234:  Screen potential participants by inclusion and exclusion criteria, obtain 
informed consent, Assign Study ID number 
 
Memotext:  based on READDY tool responses, sends SMS of T1D-related 
questions, support, and management to only intervention arm for 12 months.  
Both groups receive usual medical care during intervention period. 
Randomize on REDCap (done by local 
coordinator) 
Final Follow-up assessments:  Memotext sends SMS of 12-month questionnaires 
as URLs that linkout to REDCap: KiT Survey,READDY, BDA Stigma Subscale, 
and SEDM to both arms.  Process Evaluation, Health System utilization and Cost 
of implementation analysis performed at end of intervention.   
KiT intervention modification:  based on results of process evaluation; 
adjustments or modification to KiT algorithm will be made to improve message 
and content delivery, and improve user engagement and satisfaction  
Memotext:  sends SMS of baseline questionnaires as URLs that linkout to 
REDCap for: KiT demographic Survey ,READDY, BDA Stigma Subscale, and 
SEDM  to both arms 
Control arm 
(117 participants) 
KiT intervention arm 
(117 participants) 

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1.2 
SCHEDULE OF ACTIVITIES (SOA) 
Table 1:  Schedule of activities for KiT intervention  
 
Time Point 
Enrolment/ 
Randomization 
(21 month 
randomization period) 
 
Intervention 
Period 
(12 months) 
 
End of 
intervention 
-1 week 
0 
3 
months 
6 
months 
12 
months 
12 
months 
ENROLMENT 
Eligibility screen 
X 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
Randomization 
X 
 
 
 
 
 
INTERVENTION* 
Active arm 
 
X 
X 
X 
X 
 
Control arm 
 
 
 
 
 
 
ASSESSMENTS 
KiT 
Demographics 
survey 
 
X 
 
X 
X 
 
READDY 
 
X 
 
X 
X 
 
SEDM 
 
X 
 
X 
X 
 
Barriers to 
Diabetes 
Adherence (BDA) 
in Adolescence 
Stigma subscale 
 
X 
 
X 
X 
 
T1D-related 
hospitalization 
(OHIP/RAMQ) 
 
 
 
 
X 
 
T1D-related ED 
visits 
(OHIP/RAMQ) 
 
 
 
 
X 
 
Process 
Evaluation 
 
 
X 
X 
X 
 
KiT 
modifications** 
 
 
X 
X 
 
 
Cost of 
implementation 
analysis 
 
 
X 
X 
X 
 
*only participants in the active arm will receive the KiT intervention during the 12-month intervention period.  Both study arms 
will receive usual medical care during 12-month intervention period.  
 
**will occur in real-time and only if results of process evaluation reveal modifications or adjustments are required to improve 
user engagement and satisfaction  
 
 
 
 
 
 
 

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2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
During the transition to adult diabetes care, young adults with type 1 diabetes (T1D) are at risk for 
deterioration of their diabetes management, having a gap in establishing adult care, and of acute life-
threatening complications such as diabetic ketoacidosis. We have shown that there are persistent gaps in 
transition care services, poor uptake of existing transition resources, and gaps in collaboration and 
linkages between pediatric and adult diabetes providers. Most digital transition interventions do not offer 
personalized educational content or resources to support patients based on their stage of transition 
readiness and they require additional human resources. As a result, existing digital interventions do not 
adequately engage patients across the transition continuum or demonstrate scalability. Our study proposes 
to implement and evaluate a pragmatic digital tool that delivers just-in-time personalized transition 
education, to improve patient-reported diabetes outcomes and gaps in diabetes care.  
 
2.2 
BACKGROUND  
 
Type 1 diabetes (T1D) is one of the most common chronic diseases of childhood with significant 
morbidity and mortality(1). A particularly challenging period for people living with type 1 diabetes (T1D) 
is emerging adulthood (18-30 years) when parental involvement in diabetes care is decreasing and 
emerging adults are undergoing emotional, physical, financial, occupational, and social changes within a 
short period of time(2–4). Prevention of T1D-related complications is vital for patient health. 
Randomized trials have demonstrated the importance of optimizing blood sugar control (glycemic 
control) in preventing chronic complication(5,6). However, data from a large U.S. type 1 diabetes registry 
demonstrated that glycemic control deteriorates in adolescence and remains suboptimal throughout the 
early to mid-20s(7). This is particularly worrisome because glycemic control early in life has a lasting 
effect on the future risk of developing long-term diabetes complications(5,6). Further, nearly one in three 
U.S. adolescents and emerging adults with T1D already have diabetes complications (retinopathy, 
neuropathy, and nephropathy)(8,9). Prevention of acute diabetes-related complications are equally 
important. Shulman et al. found that emerging adults with diabetes in Ontario have a 4.27 times higher 
risk of death compared with those without diabetes (95% CI 3.37 to 5.41)(10). 
 
From pediatric to adult diabetes care: The incidence of type 1 diabetes (T1D) in Canada is amongst the 
highest in the world (1). In 2012, there were 6,676 children under 18 years of age living with T1D in 
Ontario alone(11). As these children enter emerging adulthood, they face challenges that complicate the 
transition to adult diabetes care. One single-centre study in the United States found that 34% of T1D 
patients transitioning to adult programs reported a gap of more than 6 months in establishing adult 
care(12). Using data from Ontario, we showed that almost half of emerging adults with T1D had a gap 
exceeding 12 months between their last pediatric appointment and the time they saw their eventual adult 
diabetes care physician(13). This may be due to a number of recognized barriers for emerging adults, 
including making a connection with the new adult team, difficulties communicating with the new clinic 
regarding scheduling appointments, and lack of perceived value in the clinic visit(14). Many emerging 
adults arrive at adult clinics feeling inadequately prepared for transition and are often not counselled on 
topics relevant to their specific needs. Feeling unprepared for adult care has been associated with an 
increased risk of having a gap of more than 6 months between pediatric and adult care(15). Further, we 
have shown that the struggles that transitioning T1D patients experience in taking on multiple new 
responsibilities and adult providers’ lack of appreciation of these struggles are key barriers to successful 
transition. We have also found that upon the transfer to adult care there was often no sharing of a formal 
medical summary(16). These studies have identified the need for improved transition preparation, care 
coordination, and communication between pediatric and adult providers(15). We have shown that there is 

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variability in transition practices across Ontario pediatric diabetes centres(13). There is an urgent need to 
develop a system-level innovative approach to help emerging adults remain engaged in their care during 
this vulnerable period.   
 
To reduce complications, the medical care of emerging adults with T1D requires regular access to 
specialized healthcare services. However, during the transfer to adult care emerging adults are at high risk 
of dropping out of medical care altogether(17–19), only to resurface with life-threatening diabetes-related 
complications such as diabetic ketoacidosis (DKA)(20–22). The goal of transition care is to provide care 
that is uninterrupted and developmentally appropriate while developing adolescents’ and emerging adults’ 
skills in decision-making and self-care(20). However, we have documented significant variability and 
deficiencies in transition care services. In Ontario, pediatric diabetes centres reported challenges related to 
transition preparation, communication with adult teams, adult programs’ ability to meet the needs of 
emerging young adults, and loss to follow-up(13). We have also found a lack of transition care services in 
pediatric diabetes centres across Quebec. Adult diabetes care providers in Quebec perceive an absence of 
transition care preparation for adult care as a major barrier to successful transition(16,23). A few studies 
have addressed this lack of transition care services using digital resources, but they did not offer 
personalized educational content or resources to support patients based on their stage of readiness to 
transition and they required additional human resources. They also failed to fully address the range of 
factors influencing transition, including the complex psychosocial issues that determine ongoing 
engagement and glycemic control in this age-group. As a result, existing digital interventions do not 
adequately engage patients across the transition continuum or demonstrate scalability(24). 
 
Interventions: A variety of interventions targeting the transition from pediatric to adult T1D care have 
been evaluated, including those directed at patients (educational programs, skills training), clinic staff 
(transition coordinators, joint clinics run by pediatric and adult physicians), and services (separate young 
adult clinics, out of hours phone support, enhanced follow-up)(25–33). However, these models tended to 
be institution-specific with limited access (i.e. location within academic hospital-based sub-specialty 
centres or targeted ‘young adult’ clinics), particularly for those living away from home attending post-
secondary school or those living outside urban centres. Although these interventions show promise, they 
are limited by their cost, scalability, and generalizability.  
 
Digital Tools for Transitioning Youth: Most digital interventions for supporting T1D self-management 
do not focus on providing personalized transition support resources, and do not facilitate content delivery 
that is specific to the individual’s stage of transition readiness or on expressed topics of interest, and 
require additional human resources (24). As a result, existing digital interventions have not demonstrated 
cost effectiveness, scalability, or the ability to adequately engage patients across the transition 
continuum(24).  
 
For example, the Maestro Project in Manitoba demonstrated that a system navigator model that connected 
transitioning patients to adult care improved the drop-out rate of adult medical care(29). However, this 
program did not see any improvements in short term outcomes or evaluate the scalability and economic 
impact of the program. Another study testing a system navigator approach found that clinic visits were 
maintained, diabetes control improved, and DKA rates reduced. This study infers that the navigator had a 
significant role in improving outcomes, however, it does not address the relationship between the patient 
and their pediatric and adult providers over the transition period(32). Our digital tool will help youth with 
T1D learn more information about the adult diabetes center they’ve been referred to as we will be 
providing a link via a text message to KiT, that will take participants to a landing page that is specific to 
their adult referral site and will have information about the clinic’s healthcare providers, clinic address 
and contact information, and who to contact to schedule or change appointments, and information on any 
special programs offered to this patient population.   
 

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While telemedicine is being explored as a modality for improving communication and accessibility across 
the transition period, it remains limited by the lack of interoperability with health records, the 
personalization of technology used, and reimbursement for the services delivered(24). Recognizing these 
implementation challenges, the use of text messaging or SMS is being explored as an engaging, 
acceptable, accessible, and cost-effective way of reaching patients(34). Interestingly, all text message 
studies to date have relied on a health care provider to deliver the content to patients, or they default to 
simple reminders for self-care(34,35). To our knowledge, our proposed intervention will be the first to 
explore how to develop a text message-based algorithm designed to assess the patient’s diabetes status, 
and provide personalized resources associated to that status.  Recognizing that most adolescents with poor 
glycemic control turn to technology in a reactive manner, we hypothesize that pushing support content 
based on quick and simple assessments via SMS, over time, may improve engagement with support 
content and self-management(24).  
 
While we have strong evidence of the short and long-term benefits of intensive glycemic control, most 
adolescents and emerging adults living with T1D are unable to achieve glycemic targets. There are many 
barriers to optimal T1D transition care, involving a range of patient, provider, and health system factors. 
Patient-related barriers include limited knowledge and skills for diabetes self-management, competing 
priorities (e.g. family/school/social relationships), and difficulty making a connection with the adult team. 
There are also a number of provider- and system-related barriers, such as incomplete transfer of patient 
information between pediatric and adult providers and poor uptake of available structured tools into 
practice(36).  
 
2.3 
RISK/BENEFIT ASSESSMENT   
 
The value of the information to be gained from this study outweighs the risks of participation in the study 
as we do not expect the KiT intervention to cause any negative effects on participants, and previous 
research has already demonstrated that personalized support and data collection must result in meaningful 
feedback or provide support to the patient(37).  The KiT intervention can deliver all of these features and 
will be delivered through a medium that is used by adolescents on a daily basis, mobile phones and text 
messaging.  This makes this intervention more likely to be acceptable to users.  There is a potential risk of 
users finding the KiT text messages intrusive or bothersome.  To minimize this risk, we will be offering 
user options to customize frequency and time of delivery of texts.  In addition, there is a potential risk of 
personal data being revealed due to the nature of how this intervention is delivered – via text-messaging.  
However, Memotext will never ask participants any personal identifying information, nor will Memotext 
receive any personal identifying information from the study team, apart from the participant phone 
number and Study ID number; both needed to onboard and activate the participant with the KiT 
intervention. Participants will also be briefed during the consent and enrollment process to ensure that 
their mobile device is their own personal device and is not shared with anyone else (friend or family), and 
that they should not text KiT any personal identifying information so as to minimize the risk of loss of 
confidentiality and privacy.  Furthermore, KiT will be hosted on a secure sever at Memotext offices in 
Toronto; these servers will be encrypted and will not be accessed by any members outside of the 
Memotext research team, increasing protection of privacy and confidentiality.  Overall, this intervention 
has the potential to offer the missing support and resources needed for young adults as they prepare to 
transition from pediatric to adult diabetes care, and this support will be offered in a private and 
confidential manner.  
 
 
 
 
 

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3 
OBJECTIVES AND ENDPOINTS 
The primary objective of this study is to compare the effectiveness of a text message-based T1D 
transition intervention that will personalize transition education and support, as an adjunct to usual T1D 
transition care versus usual transition care alone on a patient-reported outcome measures (PROM) called 
the Self-Efficacy for Diabetes Management (SEDM) scale, measured at baseline, 6 months, and 12 
months after enrollment in the study.  
The secondary objectives of this study are to evaluate the impact of this text-messaging based 
intervention on: 
• 
other patient reported experiences and outcomes (PREMs/PROMs) including the READDY tool, a 
transition readiness assessment for emerging adults with diabetes diagnosed in youth; and the Barriers 
to Diabetes Adherence in Adolescence (BDA) questionnaire Stigma Subscale for assessing perceived 
stigma  
• 
self-reported time between final pediatric diabetes visit and first adult diabetes visit 
• 
self-reported and/or lab reported A1c at baseline and at 12 months after enrollment to study 
(depending on data availability) 
• 
diabetes-related ED visits (measured using self-reported, medical chart and health administrative 
data) 
• 
diabetes-related hospitalizations (measured using self-reported, medical chart and health 
administrative data) 
• 
Aggregate and direct medical costs associated with the intervention and its implementation study data 
and administrative data) 
• 
Exploring how the KiT large language model (LLM) chatbot is used in a real-world setting for more 
natural conversations and opportunities for us to improve its performance over time. The LLM 
chatbot is not a learning model and will only utilize existing resources gathered for the KiT study. 
An additional secondary, exploratory objective is to conduct an embedded process evaluation. The 
process evaluation will occur during the delivery of the intervention, real-time engagement metrics will 
be analyzed to evaluate participant engagement and will allow for intervention modification to increase 
and improve user engagement and content delivery. The objectives of the process evaluation are to 
evaluate how and why the intervention achieved (or failed to achieve) the desired effects in order to gain 
an in-depth understanding of whether the intervention was received as intended, the mechanisms of 
action, and the conditions and factors associated with initial engagement and sustained use of the 
intervention. Additionally, we would like to identify the different paths of engagement (i.e., combinations 
of KiT components) that produce a positive effect on trial outcomes. Overall, the embedded process 
evaluation will optimize the engagement with the intervention and assess the feasibility of implementing 
this intervention in the real-world. 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 
Compare the 
effectiveness of a digital 
T1D transition platform 
that will personalize 
transition education and 
support, as an adjunct to 
usual T1D transition 
Self-efficacy for diabetes management measured 
by the Stanford self-efficacy for Diabetes 
Management scale (SEDM) at baseline, 6 
months, and 12 months. The SEDM is an 8-item 
measure answered on a Likert scale from 1 (not 
at all confident) to 10 (totally confident), how 
confident they feel that they can carry out the 
listed tasks regularly at the present time.  The 
Validated and reliable (α = 
0.90); shown to have good 
internal consistency and 
test-retest validity; 
measure used in adolescents 
with type 1 diabetes(38,39); 
measure of self-efficacy 
related to core elements of 
diabetes self-management in 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
care versus usual 
transition care alone on 
diabetes self-efficacy 
score is calculated using the mean of the eight 
items with higher scores indicating self-efficacy. 
 
Minimal clinically important difference is 10% 
adolescents with type 1 
diabetes  
Secondary 
 
 
evaluate the impact of 
this text message-based 
intervention on the 
following, compared to 
the usual transition care 
alone: 
• 
Transition readiness 
• 
perceived stigma of 
living with T1D 
• 
self-reported time 
between final 
pediatric diabetes 
visit and first adult 
diabetes visit 
• 
self-reported and/or 
lab reported A1c at 
baseline and at 12 
months after 
enrollment to study 
(depending on data 
availability) 
• 
diabetes related ED 
visits  
• 
diabetes related 
hospitalization 
• 
Cost of 
implementation 
• 
Explore how the 
KiT LLM chatbot is 
used in a real-world 
setting for more 
natural 
conversations and 
opportunities for us 
to improve its 
performance over 
time. The LLM 
chatbot is not a 
learning model and 
will only utilize 
• 
transition readiness measured by the 
READDY tool at baseline, 6 and 12 months; 
READDY is a transition readiness 
assessment for emerging adults with diabetes 
diagnosed in youth.  The READDY tool 
assesses diabetes-related knowledge or skill 
items by querying respondents on 42 total 
items split into 5 domains: knowledge, 
navigation, health behaviors, and insulin 
pump skills.  Respondents answer on a Likert 
scale from “yes, I can do this” to “Haven’t 
thought about it”; confidence level is 
evaluated in each domain  
• 
the Barriers to Diabetes Adherence in 
Adolescence questionnaire (BDA) Stigma 
Subscale; in our study, stigma will be defined 
as an affirmative response to at least one of 
three key items on this subscale 
• 
A1c collected at baseline and 12 months after 
enrollment to study will be self-reported 
and/or lab-reported (depending on data 
availability) 
• 
Diabetes related ED visits, hospitalizations,  
will be measured for the 12 months prior to 
and 12 months during the intervention using 
self-reported, medical chart, and health 
administrative data from ICES. 
• 
Costs of implementation  
• 
LLM chatbot data 
 
• 
The READDY tool has 
been validated during its 
development by 
examining its 
correlation with existing 
validated transition 
readiness tools such as 
TRAQ(40); the 
READDY tool was 
favored by the KiT 
subcommittee that 
included a patient 
partner.  The KiT 
subcommittee felt that 
compared to other 
transition readiness 
scales specific to 
diabetes, the READDY 
tool was specific and 
relevant to what is being 
evaluated and it is 
patient-reported 
• 
the Barriers to Diabetes 
Adherence in 
Adolescence 
questionnaire was 
developed to measure 
psychosocial barriers to 
adherence in adolescents 
with T1D; the stigma 
subscale has previously 
shown to be useful in 
research and clinical 
settings(41) 
• 
HbA1c: From long-term 
follow up of the 
landmark Diabetes 
Control and 
Complications Trial 
(DCCT) participants, 
early metabolic control 
has a lasting legacy. 
Individuals randomized 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
existing resources 
gathered for the KiT 
study. 
 
to intensive therapy 
experienced a reduced 
risk of retinopathy up to 
10 years after the study 
ended despite the 
convergence of mean 
HbA1c values to similar 
levels in both groups 
(~8%)(42). This 
underscores the 
importance of good 
metabolic control in 
early adulthood to 
prevent future diabetes 
complications. Further, 
HbA1c is at its highest 
(indicating poorest 
control) in the 18-24 
year age group(7), even 
stabilizing HbA1c 
during this time would 
indicate a clinical 
improvement from the 
current state. 
• 
Cost of implementation 
will be collected to 
ascertain the cost of 
developing and using 
this intervention in a 
hospital setting in 
Ontario and Quebec; 
variables that will be 
collected for this 
analysis will include:  
salaries for staff 
working on the design, 
development and 
management of the 
intervention for the 
entire intervention 
duration; salary of 
research coordinators 
working to onboard 
participants to the 
intervention; cost of 
digital services and 
office equipment needed 
to develop and manage 
the intervention 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
(computers, hosting 
service, servers); cost of 
REDcap servers and 
hospital IT support for 
REDCap integration 
with MEMOTEXT 
platform 
 
Exploratory  
 
 
Evaluation of participant 
engagement and 
intervention fidelity  
Embedded process evaluation using real-time 
engagement metrics (i.e. number of participants 
who are engaging with intervention messages on 
and which types of messages are the most and 
least engaged with, identify the different paths of 
engagement (i.e., combinations of KiT 
components) that produce a positive effect on 
trial outcomes). 
Concurrent process 
evaluation allows for real-
time intervention 
modification to increase and 
improve user engagement 
and content delivery 
 
3.1 
SYNOPSIS  
Title: 
Keeping in Touch with Youth as they Transition Through Type 1 Diabetes 
Care:  A randomized control trial comparing the effectiveness of an eHealth 
text message-based intervention in conjunction with usual T1D care 
compared to usual care alone on diabetes self-efficacy 
Study Description: 
A multi-center, 1:1 randomized control trial with 6 sites (4 in Ontario and 2 
in Quebec) 
Objectives: 
 
Primary Objective:  Diabetes self-efficacy (SEDM) 
Secondary Objectives: Transition readiness (READDY), Barriers to 
Diabetes Adherence (BDA) Stigma subscale, HbA1c, healthcare utilization 
and cost of implementation 
Exploratory Objectives: embedded process evaluation  
Endpoints: 
Primary Endpoint:  SEDM at 12 months  
Secondary Endpoints:  READDY, BDA Stigma subscale, diabetes-related 
admissions and emergency department visits,  HbA1c, cost of 
implementation data and LLM chatbot data.  
Exploratory Endpoints: qualitative and quantitative data from embedded 
process evaluation 
Study Population: 
234 (117 in each arm) adolescents with T1D preparing to transition to adult 
diabetes care and receiving care for T1D at participating pediatric centres in 
Ontario or Quebec; English or French speaking and possess their own 
mobile device that can send and receive SMS messages 
Description of Study 
Intervention: 
Text-message based algorithm that operates similar to a chatbot and will 
send SMS messages for T1D personalized support, education, resources 
and collection of outcome measures.  
Study Duration: 
21 months of recruitment and 12-month intervention period 
Participant Duration: 
12 months for each participant to complete the study 
 

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4 
STUDY DESIGN  
 
4.1 
OVERALL DESIGN 
 
First, we hypothesize that the intervention will improve diabetes self-efficacy. 
 
We will conduct a multi-site randomized control trial to evaluate the effectiveness of an eHealth 
solution for T1D transition care. The study sample size is 234 adolescents with T1D from 6 pediatric 
diabetes centres (4 in Ontario and 2 in Quebec) and allocate them 1:1 to the intervention or control arm 
stratified by site. Participants will be recruited at their pediatric centre within 3-4 months of either their 
planned final pediatric visit or 18th birthday. We opted for individual randomization the target of the 
intervention is diabetes self-efficacy during the time between pediatric and adult care and relates to the 
individual rather than provider or clinic-based practices.   
Intervention: both intervention and control groups will receive usual diabetes care including all medical 
visits and tests.  In addition, the intervention group will receive the text messages for diabetes support and 
resources tailored according to their needs and interest.  Both intervention and control groups will also 
complete PREMs and PROMs at baseline, 6 and 12 months. 
 
Process Evaluation: the embedded process evaluation involves a mixed-methods approach using 
individual semi-structured interviews alongside user engagement metrics and quantitative outcome data to 
evaluate how and why the intervention achieved (or failed to achieve) the desired effects and identifying 
the different paths of engagement (i.e., combinations of KiT components) that produce a positive effect 
on trial outcomes. Using an embedded single case design with cross case synthesis, the objective of the 
process evaluation is to gain an in-depth understanding of whether the intervention was received as 
intended (intervention fidelity), the mechanisms of action, and the conditions and factors associated with 
initial engagement and sustained use of the intervention.  
Health system impact: We will examine health care utilization of patients with T1D using de-identified 
administrative and, self-reported health data for at least 12 months after study enrolment. We will 
securely link patients’ health card number to provincial administrative databases housed at ICES in 
Ontario and Med-Echo and Régie de l'assurance maladie du Québec (RAMQ) databases in Quebec.  
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
We chose to conduct a multi-site randomized control trial in both Ontario and Quebec in order to ensure 
representation across the two main sizes of pediatric diabetes centers (tertiary and community); our 
intervention will also be available in both English and French; participants in both provinces will be able 
to select their preferred language of intervention delivery at study enrollment.  We opted to do 1:1, 
individual level randomization because the target of the intervention is individual level diabetes self-
efficacy during the time between pediatric and adult diabetes care and not pediatric provider or clinic-
based transition care.  The treatment allocation not being blinded to the research team will not pose any 
bias or contamination as randomization to control or intervention group will be completed via an 
automated computer program on REDCap; the randomization sequence will be generated by a 
biostatistician who is not involved in recruitment or enrollment and has no contact with study 
participants. The research team does not know the randomization sequence which will be in blocks of 2 or 
4, thus making it difficult to pre-determine treatment allocation during the recruitment or consent process. 
This study is not blinded and therefore the research team, Memotext and participant will know which arm 
they have been randomized to. Also, the control group not having access to the tailored support or 
diabetes resource messages will not pose any potential problems or issues as the control group and 

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intervention group will both be receiving the regular standard of care for diabetes and will not be 
restricted access to their usual diabetes resources and supports. Both the control and intervention group 
will receive the same incentives to complete the outcome measures at baseline, 6 months, and 12 months. 
The Intervention group participants may receive compensation for participation in the process evaluation 
upon completion of the interview. 
 
 
4.3 
END OF STUDY DEFINITION 
 
The end of the study is defined as completion of the 12-months in the intervention period and completion 
of at least the SEDM at 12-months.It is estimated that it will take 30 months from when the study opens 
to enrollment until the end of the study. 
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
 
To be eligible to participate in this study, an individual must meet all of the following criteria: 
1. Diagnosed with type 1 diabetes, ascertained from patient’s medical chart 
2. Receiving out-patient care for T1D at a pediatric diabetes center participating in this study 
3. Is within 6 months of either planned transfer or 18th birthday so research coordinator can 
approach patient and inform them about the study, and then can be re-approached for consenting 
and enrollment only within 3-4 months of either: planned transfer to adult diabetes care OR 18th 
birthday 
4. Proficient in written and spoken English or French 
5. Possession of their own personal mobile device that can support SMS with capacity to send and 
receive SMS/texts 
6. Valid and working mobile phone number  
7. Valid email address 
 
5.2 
EXCLUSION CRITERIA 
 
An individual who meets any of the following criteria will be excluded from participation in this study: 
 
1. Unable to carry out their diabetes care independently due to an intellectual or neurocognitive 
disability; discerned from medical chart during pre-screening  
2. Non-resident of Ontario or Quebec  
3. Planning to move out of either province in the next 6-12 months and after moving, will not be 
receiving diabetes care in either province and/or will not have a valid and working mobile number 
4. Currently enrolled in any other clinical research trial with an SMS-based intervention 
5. Currently enrolled in another diabetes intervention trial that will continue beyond the final 
pediatric diabetes visit 
 
5.3 
SCREEN FAILURES 
 
Screen fails are defined as participants who consent to participate in the clinical trial but are not 
subsequently randomly assigned to the study intervention or entered in the study. A minimal set of screen 

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failure information is required to ensure transparent reporting of screen failure participants. Minimal 
information includes demography, screen failure details and eligibility criteria. 
 
5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Sample size: The total target sample size for this trial is 234 adolescents with T1D, with 117participants 
in each arm (intervention and control arm). Participants will be recruited from participating pediatric 
diabetes centers in Ontario and Quebec: four pediatric diabetes clinics in Ontario and two in Quebec. 
Recruitment will occur for 21 months while the intervention will occur for a 12-month period.   
 
• 
Ontario (4 sites total):  Two sites will be tertiary hospitals - The Hospital for Sick Children and 
the Children’s Hospital of Eastern Ontario (CHEO), and the other two sites will be community 
hospitals – Oak Valley Health  previously Markham Stouffville Hospital and Trillium Health 
Partners.   
• 
Quebec (2 sites total): Two tertiary sites: Montreal Children’s Hospital and CHU Saint Justine.   
 
Recruitment, consenting and onboarding process: At each participating site in Ontario and Quebec, 
the following recruitment process will occur: 
1) Local coordinator will identify eligible patients by pre-screening daily or weekly diabetes clinic lists 
and medical charts for inclusion and exclusion criteria. The local coordinator will obtain prior 
permission to access diabetes clinic lists from REB and site-specific institutional approval. 
2) Initial contact with eligible patients:   
a. Where applicable, a study introductory letter from the local diabetes team (circle of care) will 
be sent (via email or post-mail) to potentially eligible patients after pre-screening.  The 
introductory letter will inform the patient of the research study (study objective and purpose, 
study tasks and duration of study), and will inform participant that they are eligible to 
participate. The study information letter will ask the participant to reach out to their local 
study coordinator via telephone or email if they are interested in participating.  The letter will 
also allow an opt-out feature where patients can opt-out of being contacted about the study by 
calling, writing or emailing the contact provided to let the research team know. The letter will 
also indicate that if there is no response to the letter within 2 weeks of receipt, a member of 
the study team will reach-out to the patient via phone, email or in-person at their next 
diabetes clinic visit to explain the study and gauge interest in participation. If via telephone or 
email, the study team will attempt to contact the eligible patient up to a maximum of 3 times 
with 1-week in between each contact attempt.  
b. If (a) is not feasible or permissible at a local site, the local diabetes team (circle of care) will 
send an opt-in letter (via email or post-mail) to all potentially eligible patients at their site. 
The opt-in letter will also provide the same details about the study as the Study Introduction 
letter in (a) but in (b), patients will be required to respond to the opt-in letter to express their 
consent to being contacted about this study by the local research coordinator either by phone, 
email, or in-person at their next diabetes clinic visit.  
3) Other methods of advertising for this study: study flyers and digital advertisements will be posted on 
diabetes clinic waiting areas and waiting areas digital screens, with the contact information for the 
local research coordinator; we will also distribute study flyers in newsletters, communication boards, 
websites, and social media feeds. 
4) Two weeks after initial contact from the circle of care, eligible patients (who have expressed interest 
from (2a) or did not respond to the letter from (2a) or opted-in from (2b) will be approached by the 
local research coordinator at their diabetes clinic visit or via telephone, video visit, or email to 
introduce the study again, provide a study information either in hard copy or electronically and 
discuss interest in participating in the study. The local research coordinator will explain study details 

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including purpose, study tasks, duration of study, responsibilities of participating in the study, risks, 
and benefits of participating in the study, study confidentiality, types of data that will be collected and 
what data elements will be shared with other members of the research team (and who these team 
members are), and planed use of participant data and data analysis.  Sufficient time will be provided 
to answer any questions from the potential participant. 
5) After reviewing the informed consent form, if a patient expresses interest in participating in the trial, 
the local research coordinator will email them a link to a site-specific informed consent form on 
REDCap, or will provide a hard copy version of the consent form. Local coordinators will explain all 
sections of the informed consent form to the patient and allow time for questions. When the patient is 
ready to provide consent, they will be instructed on checking off appropriate sections of the consent 
form electronically or on hard copy, and on providing their electronic signature on the electronic 
consent form or wet signature on hard copy of consent form.   
6) Once a completed electronic or hard copy consent form is returned, the local coordinator will obtain 
relevant demographic and PHI information from the participant and confirm this information with 
participant, including:  First and Last Name, DOB, OHIP # or RAMQ #, mobile phone number, 
mailing address including 6-digit postal code, and email address. This information will be kept on a 
site-specific enrollment log that is not stored on REDCap and will not be shared with other members 
of the study team. 
7) The local coordinator will assign a site-specific study ID number to consented participant.   
8) The local coordinator will randomize the participant using REDcap’s automatic randomization 
feature. Both the local coordinator and participant will be aware of what study arm they were 
assigned to as local coordinator will need to explain next steps to the participant depending on study 
arm and participant will be aware of whether they will receive texts from the KiT intervention. 
9) Upon randomization, the local coordinator will enter the randomized participant study ID number, 
randomization arm, mobile phone number, and preferred language in the Research Assistant 
Participant Enrolment form via Memotext.   
10) Memotext will send an initial SMS to the participant’s mobile phone number, letting them know they 
are now enrolled in KiT.  
i. The following SMS will include the first URL link to a REDCap survey that first 
prompts to participant to complete the baseline KiT survey (demographic information 
and information about the participant’s diabetes care and self-management). When 
this questionnaire is completed and submitted, the survey will automatically produce 
the next surveys for participant completion, one at a time: READDY tool 
questionnaire, SEDM, and BDA Stigma subscale 
1. Some of the content and sequence of the messages and resources sent to the 
intervention participants will be personalized, based on confidence ratings as 
measured by the “Readiness of Emerging Adults with Diabetes Diagnosed in 
Youth” (READDY) tool. 
2. For all participants, if theydo not complete the  questionnaires within 1 week 
of receipt, KiT intervention will send a follow-up reminder SMS asking them 
to complete the questionnaire. This reminder will be sent a maximum of two 
times (1 week apart). At week three,, the local research coordinator will be 
notified via email by Memotext that the participant has not yet completed 
their questionnaires and will then follow up with the participant via 
telephone, SMS or email asking them to complete the questionnaires. 
3. Once the participant completes the questionnaires, they will be sent their $20 
Amazon gift-card via SMS. 
ii. If the participant is in the intervention arm, after they complete the baseline 
questionnaires, they will then be sent an SMS with a link to a short enrolment survey 
where they will learn how to use KiT, access the settings, set up their frequency 
preferences to receive the content, and set up appointment reminders. 

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iii. Once the enrolment survey is completed, the intervention will begin for those 
participants. 
11) KiT will continue to send SMS messages throughout the duration of the study (12-month intervention 
period) to individuals in the intervention arm. In addition to personalized SMS about T1D care and 
management that will be sent to intervention group, both study groups will receive SMS messages of 
URLs that will link to REDCap for the PREMs and PROMs at 6 months and 12 months from the date 
of enrolment.  
 
 
6 
STUDY INTERVENTION 
 
6.1 
STUDY INTERVENTION(S) ADMINISTRATION 
 
6.1.1 STUDY INTERVENTION DESCRIPTION 
 
The KiT intervention is a text messaging algorithm that will operate like a chatbot, querying adolescents 
with T1D about their confidence with different aspects of T1D self-management as they are preparing to 
transition to adult diabetes care. The KiT intervention has five components of messaging (see below); if 
enrolled in the intervention group, participants will receive all four types of messages while the control 
group will only receive messages pertaining to the fourth category: 
1) Personalized Educational Content (referred to as “push content”): KiT will send some 
personalized educational content to participants based on self-reported confidence ratings as 
measured by the “Readiness of Emerging Adults with Diabetes Diagnosed in Youth” 
(READDY) tool and participants self-reported interest in particular topics. The KiT 
intervention will send a combination of young-adult friendly educational text messages and 
links to existing trusted online resources about topics such as driving and diabetes, alcohol 
and diabetes, managing diabetes-related stressors; and diabetes and sexual health and 
function. 
a. With respect to managing stressors related to living with type 1 diabetes, KiT will 
initiate a series of support-based text-messages offering suggestions to improve 
behavioral health using suggested coping strategies.  These behavioral health text 
messages will be created by an expert group that includes: a pediatric psychologist 
(JK) who specializes in working with chronically medically ill children and youth 
and is a certified diabetes educator (CDE); a pediatric endocrinologist who 
specializes in diabetes (RS); and our study’s patient partner (MG) 
2) Standard Educational Curriculum: deliver messages and reminders related to transition to 
adult diabetes care that are relevant to all adolescents with T1D preparing to transition to 
adult care.  These messages will support participants as they navigate adult diabetes care. 
Messages will cover topics such as preparing for an upcoming clinic appointment,  
reminders about booking appointments, refilling and paying for diabetes medication and 
supplies.  
3) Provide participant compensation for filling out questionnaires about clinic attendance, 
information about diabetes care and self-management such as diabetes device use and 
measures of glycemia, and patient reported outcome measures (READDY, BDA Stigma 
subscale, and SEDM; all at baseline, 6 months and 12 months). All participants (in both the 
control and experimental groups), will be provided the same compensation at the same time-
points once all outcome measures at each time-point (baseline, 6 months and 12 months) have 

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been completed: a $20 Amazon gift-card for completion of outcome measures at each time-
point for a maximum total value of $60 in Amazon gift-cards per participant. This 
compensation amount was determined based on the total estimated time to complete all 
outcome measures (total of 4 outcome measures plus initial survey) at each time-point – 
approximately 15-20 minutes.  This compensation amount per time-point is further justified 
as other similar studies in the same population offered $20 for completion of 8-10 outcome 
measures that took approximately 45 minutes to complete.  When KiT sends messages with 
links to the REDcap-based outcome measures, KiT will also remind participants that they 
will only receive an automatic e-gift card via KiT text-message once they complete all 
questionnaires at each time-point.  
4) Question and Answer (Q&A) feature:  participants in the intervention arm can message the 
KiT intervention with their T1D related questions and the intervention will send links (where 
available) via text-message, to relevant resources from the validated resources collected in the 
environmental scan. 
5) LLM Chatbot feature: in addition to the Question and Answer (Q&A) feature, participants in 
the intervention arm can also access a LLM chatbot via a link KiT shares that is outside of the 
SMS-based intervention. Participants can ask the LLM chatbot their T1D related questions 
and the LLM chatbot will send answers in a natural language format and links (when 
available) from the same validated resources collected in the environmental scan. If no 
resource relevant to the question is found, a message stating this is presented to participants. 
Personalized Educational Content:  After considering over 20 available transition readiness tools and 
questionnaires used in the diabetes population, the KiT subcommittee (consisting of our patient partner, 
and four pediatric diabetes endocrinologists), selected the READDY tool as the preferred diabetes-
transition tool to help guide the intervention topics list, content creation and messages. Alongside the KiT 
subcommittee, an environmental scan was conducted to find what online resources related to T1D 
transition were provided by organizations, hospitals, institutions and governmental groups across Canada.  
These resources were categorized based on relevance to T1D transition, availability in French and 
English, production quality, accessibility, web-site screen resolution adjusting on mobile device, and 
licensing.  Furthermore, these resources were itemized as “topic areas” and mapped to the relevant 
domain of the READDY tool in an effort to distinguish which items on the READDY tool that the KiT 
intervention could provide education and resources on. Therefore, the results of the environmental scan 
that mapped to the READDY tool serves as the knowledge base for the KiT algorithm to deliver 
educational content and resources. The environmental scan included only Canadian sources, however, we 
may opt to include non-Canadian educational resources if they are deemed by the research team to be 
credible.  
 
Also, during Phase 1 of the KiT study, we conducted one-on-one semi-structured interviews and co-
design sessions in Ontario and Quebec with pediatric and young adult patients with T1D, as well as 
pediatric and young adult diabetes providers, asking to help design a digital tool for youth to keep in 
touch with their diabetes team during transition to adult care. The interviews and co-design sessions 
revealed what topics, gaps and challenges patients and providers felt were important to address with youth 
transitioning to adult diabetes care. The most salient topics from these interviews and co-design sessions 
were then mapped to topic areas within the domains of the READDY tool. Taken together, this revealed 
the most important topic areas that the KiT intervention would address and provide resources on.  The 
interviews and co-design sessions also revealed additional topics that patients and providers felt were 
important but did not map to the READDY tool domains or topic areas. See Appendix, Table 2: KiT 

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Educational Topics and see Appendix, Table 3:  KiT Intervention – Feature Category and Sample 
Dialogue; KiT Sample Messages in Appendix Page 37-40 
 
Educational Content: We included only topics that were identified to be important to patients based on 
data from the interviews and co-design sessions and in the literature. We also only included topics for 
which there are credible resources available. Topics that will be relevant to all participants will be 
delivered to all participants as part of the “core educational curriculum” and topics that may not be 
relevant to all, will be delivered only to those who self-report low confidence or interest in those topics. 
The content of these messages will be developed by the research team and the tone and style of the 
messages will be developed by the eHealth innovation team with input from patients and providers in the 
co-design sessions.  
 
Reminders: delivery of messages to help participants navigate diabetes care (e.g. reminders about 
booking appointments, refilling and paying for medication and supplies).  See Appendix, Table 3:  KiT 
Intervention – Feature Category and Sample Dialogue, under section “Care Coordination”); KiT 
Sample Messages in Appendix Page 37-40 
 
Questionnaires and PREMs/PROMs:  At baseline, a text message will be sent containing a URL 
linkout to a REDCap survey  including the KiT survey (questionnaire about demographics and diabetes 
care and self-management) the READDY tool, SEDM, and BDA Stigma subscale.  At 6 and 12-months 
after baseline, URLs will be sent via SMS to linkouts to REDCap surveys of the KiT survey (diabetes 
care and self-management) READDY tool,  SEDM, and the BDA Stigma subscale. .  
 
Other aspects of the KiT intervention messages: Participants in the intervention group will be sent 
messages at set intervals, however, they will have the option of increasing or decreasing the frequency of 
messages within a range of options and opt for messages to be sent on their preferred days of the week 
and time of day. Participants can also pause their messages at any time for a discrete period by texting the 
word “PAUSE”. The tone of the messages sent by the KiT intervention was developed by the eHealth 
innovation team and reviewed for acceptability with the help of our patient partner and adolescents who 
are of similar age to those who would be typically transitioning from pediatric to adult diabetes care.   
 
KiT Intervention Technology and Development: the intervention algorithm will be built and managed 
by our third-party collaborator, Memotext, based in Toronto. Memotext is a digital patient engagement 
platform that uses health data and analytics to optimize digital communications. Memotext will be 
designing, developing, deploying and managing our study intervention in partnership with our study 
collaborators at UHN, the eHealth Innovation team. Memotext will work with SickKids REDCap 
administrators to ensure that REDCap API (Application Programming Interface) integration is enabled 
with SickKids REDCap servers in order to deploy chatbot link-outs to REDCap for PREMs and PROMs 
data collection. Memotext will only be receiving PHI in the form of participant phone number in order to 
enact registration between participant’s personal mobile devise (via SMS) and the chatbot; every 
participant will have their own Study ID number and Memotext will not be privy to the patients’ names or 
any other personal identifying information. During the consent process, participants will be made aware 
of all the information collected by the intervention, how this information will be used and who will have 
access to this information (Memotext and members of the research team); participants will be asked to 
provide their consent to collect this information within the KiT intervention during the e-consent process. 
Participants with any type of mobile device that is registered to any mobile network will be able to enroll 
in this study as text-messaging capabilities are universal for all mobile devices. Participants will be 
informed that only text-messages via SMS will be sent to their phones and will be advised to be 
connected to a wifi network when they are accessing links provided by KiT and when completing the 
outcome measures; this is to ensure that the participant does not incur extra out-of-pocket costs for data 
usage while not connected to a wifi network. Memotext’s system will maintain logs of all outgoing and 

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incoming messages, and this de-identified data (only linked to Study ID number), will be compiled into a 
feedback report that will be reviewed and evaluated by the research team on a periodic basis.    
LLM Chatbot feature Technology and Development:  
 
The LLM version of KiT is built using 3 components: 1) a web app with a prototype created with the 
Streamlit Python framework, which will provide the user interface; 2) an instance of AnythingLLM, an 
open-source application that turns documents into context that the LLM can use for reference during 
conversations; and 3) a Microsoft Azure OpenAI instance which runs the GPT-4 LLM.  
  
The Streamlit app enables the user to send a query (Fig. 1). The app makes a call to the AnythingLLM 
API, sending the prompt to a workspace in the AnythingLLM instance. This instance is configured with 
the required documents that users need to chat with KiT. It is also connected to Microsoft Azure which is 
running the LLM. Azure returns the answer to the user query to AnythingLLM, which in turn returns the 
answer to the Streamlit app (Fig. 2).  
 
A knowledge-base of diabetes-related documents comprised of the same resources used in the Q&A 
feature is used to create the LLM version of KiT. A research associate, research analyst and post-doctoral 
researcher at the Centre for Digital Therapeutics extracted the content from each resource to create the 
knowledge base. Each resulting document was then uploaded to AnythingLLM, which turns it into 
embeddings using OpenAI’s text-embedding-ada-002 model (of note, these documents do not contain 
sensitive data; rather, they have information on diabetes-related topics freely available on the web). When 
a user makes a query, the embeddings are used by AnythingLLM to return the more relevant documents, 
which are then sent to the LLM running on Azure as context to create its answer. This minimizes the 
possibility of incorrect responses while ensuring answers are based on the curated knowledge-base. In 
addition, answers from the LLM also provide URL links to users (Fig. 1). If no relevant document is 
found by AnythingLLM, a standard reply is given: “There is no relevant information in this workspace to 
answer your query”. 
 
The Streamlit app and AnythingLLM instance will run on a server set up by MEMOTEXT. Users will be 
sent an URL to the Streamlit app as an SMS through MEMOTEXT, which will contain their study user 
ID as a parameter – for example <https://llmbotlink.ca/?username=1>. This username parameter in the 
URL (in this case representing study ID 1) is essential as it will allow us to log conversation history for 
each user.  
 
Intervention arm: both intervention and control groups will continue with their usual diabetes care. In 
addition, the intervention group will receive the automated text messages for diabetes support and 
resources tailored according to their level of confidence and interest in transition topics, for 12 months.  
At baseline, individuals in the intervention group will receive a link via text-message that will take them 
to a questionnaire about their demographics and diabetes care and self-management, the READDY tool 
questionnaire, BDA Stigma Subscale, and SEDM on REDCap. Responses to the READDY tool will 
guide the personalized content of the educational text-messages. During the 12-month intervention period, 
participants in the intervention group will all receive messages to support participants to navigate diabetes 
care (e.g. reminders about upcoming appointments, refilling and paying for medication and supplies). At 
6 and 12 months after enrollment in this study, all participants (intervention and control arms) will receive 
links via text messages that link-out to REDCap surveys for completion of: a questionnaire about diabetes 
care and self-management, SEDM, BDA Stigma subscale, and the READDY tool. Financial 
compensation will be provided for participant time to complete these outcome measures at baseline, 6, 
and 12 months. 

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Control arm: Participants randomized to the control arm will also be offered the same incentives to 
complete questionnaires (outcome measures) but will not receive any other components of the 
intervention – no personalized/customized support or diabetes resource messages and no reminders.  
Control arm participants will continue with their usual T1D transition care. They will be sent prompts via 
SMS asking them to complete the same questionnaire about diabetes appointments and care, 
PROMs/PREMs as the intervention group, at the same time-points of baseline, 6 months, and 12 months.  
The same financial incentive will be offered to both intervention and control groups to encourage 
participants to respond to these prompts.  
 
6.2 
RANDOMIZATION AND BLINDING 
 
Eligible participants will be randomised to either intervention or control group in a 1:1 ratio stratified by 
site. The randomization sequence will be generated by a computer program using random block sizes of 2 
or 4 and overseen by the biostatistician at The Hospital for Sick Children. The treatment allocation will be 
concealed until the point of randomization. Randomization will be done by the local coordinator after 
informed consent has been obtained. The local coordinator will use REDCap’s automatic randomization 
feature that has been enabled for this project. Due to the nature of the intervention, participants and the 
local coordinator will be aware of their treatment allocation. Research staff (local and Memotext) will not 
be blinded to the treatment allocation as they will need to be aware of group assignments for the purposes 
of onboarding participants to the application and querying any technical questions if participants reach out 
for assistance.    
 
6.3 
STUDY INTERVENTION COMPLIANCE 
 
Compliance to the KiT intervention will be defined as responding to questions posed by the intervention 
messages and completing questionnaires and PREMs and PROMs at study-specific time-points. If a 
participant does not reply to the first three intervention messages/questions and/or does not complete the 
PREMs/PROMs sent by the intervention, two reminders to answer the message and/or PREMs/PROMs 
will be sent by the intervention, one week apart. If there is still no engagement from the participant, the 
local coordinator will contact the participant via telephone, SMS or email. The local coordinator will 
inquire why the participant has not engaged with the intervention and/or why they have not completed the 
PREMs/PROMs sent to them and ask if they are still interested in participating in this study. Furthermore, 
as part of the embedded process evaluation, user engagement will be tracked and analyzed to see who is 
not engaging with the intervention and possible reasons for why. As part of the process evaluation, those 
who enroll in the study but engage with the intervention only once or not at all or have very sporadic 
engagement will be invited to participate in a virtual one-on-one interview.  These candidates will be 
contacted by a member of the research team to discuss what could be done to improve their experience. 
Those who have provided their consent to participate in the process evaluation will be contacted by a 
member of the research team who will schedule an interview to gather feedback on why they are not 
engaging with the KiT intervention and what could be improved.   
7 
DISCONTINUATION AND WITHDRAWAL 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION 
 
Discontinuation from KiT intervention does not mean discontinuation from the study, and remaining 
study procedures should be completed as indicated by the study protocol.   
 
The data to be collected at the time of study intervention discontinuation will include the following: 

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• 
The 6-month or 12-month follow-up questionnaires (dependent on which questionnaire was most 
recently completed), PROMS (SEDM, READDY, BDA) 
• 
Self or lab- reported A1c at baseline and at 12 months after enrollment to study  
• 
diabetes related ED visits and hospitalizations (measured using health administrative data) 
• 
Aggregate and direct medical costs associated with the intervention and its implementation study data 
and administrative data) 
 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants are free to withdraw from participation in the study at any time upon request. 
An Investigator may discontinue or withdraw a participant from the study for the following reasons: 
 
• 
Withdrawal of informed consent (participant withdrew for any reason) 
• 
Significant study intervention non-compliance  
• 
If the participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
Participants who sign the informed consent form, and are randomized and receive the study intervention, 
and subsequently withdraw, or are withdrawn or discontinued from the study, will be attempted to be 
replaced if there at least 12 months remaining in the study so new replacements would receive the full 
intervention. The data from participants who are withdrawn or discontinued from the study will be used in 
the analysis unless the participant requests otherwise. 
7.3 
LOST TO FOLLOW-UP 
 
A participant will be considered lost to follow-up if they fail to complete at baseline, or 12 months, the 
SEDM, and is unable to be contacted by the study site staff after the maximum number of reminders and 
contact attempts. 
Before a participant is deemed lost to follow-up, the Principal Investigator or designee will make every 
effort to regain contact with the participant (where possible, 2 reminders via KiT intervention and email, 
SMS,or telephone follow-ups and, if necessary, a certified letter to the participant’s last known mailing 
address or local equivalent methods). These contact attempts will be documented in the participant’s 
medical record or study file. Should the participant continue to be unreachable, they will be considered to 
have withdrawn from the study with a primary reason of lost to follow-up. 
 
 
 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
ASSESSMENTS 
 
• 
Questionnaires and patient-reported outcomes: all the following will be sent as a URLs via KiT 
intervention SMS that will link-out to web-based REDCap surveys: 
o KiT Demographic survey (diabetes care and self-management),  

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o READDY tool: transition readiness assessment for emerging adults with diabetes diagnosed 
in youth, administered at baseline, and 6 and 12 months after baseline 
o SEDM: self-efficacy with diabetes self-management, administered at baseline, 6 and 12 
months after baseline  
o BDA Stigma subscale: type 1 diabetes stigma assessment subscale, administered at baseline, 
6 and 12 months after baseline 
 
• 
Administrative data via OHIP or RAMQ number collection: the following data will be collected 
via linking to administrative datasets via ICES in Ontario and Med-Echo and Régie de l'assurance 
maladie du Québec (RAMQ) databases in Quebec 
o Deprivation quintile 
o diabetes related ED visits and hospitalizations  
o HbA1c (in Ontario only) 
 
• 
Cost of implementation: we will measure all relevant costs associated with the intervention and its 
implementation using study data. More specifically, costs will be collected in five broad categories: 
staff (e.g. salaries, fee for services), equipment (e.g. equipment/technology platform and depreciation 
costs, software costs, installation costs, and maintenance costs), communication (e.g. data 
transmission costs), administration (e.g. administration costs, supplies) 
 
• 
Process Evaluation: The embedded three-step process evaluation will occur between 3 and 12 
months after the intervention launch, contingent on sufficient participant enrollment and data 
collection. In Step 1, we will develop a theoretical model depicting the predictors of the initial 
engagement and sustained use of the KiT intervention (includes personalized educational content, Q 
& A, and standard educational curriculum) according to extant literature on the e-health interventions. 
This program theory builds on the tenants of the Health Action Process Approach (HAPA) and the 
Technology Acceptance Model (TAM) to generate candidate hypotheses, which have been framed 
using the Context-Mechanism-Outcome (CMO) configurations that are typical of realist evaluation. 
In Step 2, we will test the hypothesized pathways using semi-structured interviews. We will 
purposively sample participants across two categories: (1) participants with little to no engagement 
(bottom 50% of activity) and (2) participants with high levels of engagement (top 50% of activity) 
according to the user engagement data (e.g., # of texts that users sent per month, % of external link 
clicks) at month 3 of the RCT. We will plan to invite all participants with little to no engagement in 
an interview who have consented to being contacted to participate in the process evaluation. Semi-
structured interviews will be informed by the HAPA and TAM and will explore how context 
influences intervention uptake and adherence among participants (please see Interview Guide 1). 
Specifically, we will explore the technological aspects (perceived usefulness, perceived ease of use), 
treatment aspects (perceived needs, outcome expectation, self-efficacy, etc.), and social aspects 
(social support, competing priorities, etc.) of the KiT intervention. For those who have high levels of 
engagement at three months, we will explicitly explore the interventions’ mechanism of action as 
hypothesized in Step 1 (please see Interview Guide 2). Participants who complete the process 
evaluation interview, 45-60 minutes, will be compensated with a $25 gift card for their time. In Step 
3, we will identify the potential paths and corresponding combination of factors that are associated 
with trial outcomes using Coincidence Analysis. 
 

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Data to be transferred to THP for process evaluation: 
1. Participant sampling  
• Participant-level engagement data at months 1-3 of the RCT  
• Demographic data  
2.  Participant recruitment  
• Contact information (including name, phone number, and email address)  
3.  Data triangulation and analysis  
• Study ID  
• Participant-level engagement data at months 4-6 of the RCT  
• RCT health outcome data (including SEDM, READDY, stigma, and HbA1c) 
 
Data transfer for Process evaluation: 
Sites will identify participants who consented to be contacted for an interview for the process evaluation. 
Sites will send study id, name and contact information (phone/email) to SickKids. SickKids will send 
study id, contact information (from sites) and engagement data (from Memotext) to THP via SickKids 
secure data transfer portal. THP research staff recruit and schedule interviews for those participants for 
the process evaluation. 
  
9 STATISTICAL CONSIDERATIONS 
 
8.2 
STATISTICAL HYPOTHESES 
 
• 
Primary Endpoint(s): Diabetes self-efficacy measured by SEDM at baseline, 6 and 12 months 
after baseline. We hypothesize that the intervention will improve engagement with support 
content and improve self-management of diabetes among the intervention group compared to 
control group at 12 months compared to baseline.   
 
• 
Secondary Endpoint(s):  transition readiness measured by the READDY tool; perceived stigma 
measured by the Barriers to Diabetes Adherence (BDA) stigma subscale, and time from final 
pediatric to first adult diabetes appointment;  HbA1c; diabetes-related ED visits and 
hospitalizations at 12 months. We hypothesize that the intervention, may improve transition 
readiness and improve glycemic management, decrease the time from last pediatric to first adult 
diabetes appointment, and decrease the frequency of diabetes-related ED visits and 
hospitalizations in the intervention group compared to the control group at 12 months compared 
to baseline.   
 
• 
Exploratory Endpoint(s):   
o Within the embedded process evaluation, we will investigate the pragmatic nature of this 
trial and study whether making real-time adjustments will improve user interaction and 
experience will increase user uptake and satisfaction. We will also identify the different 
paths of engagement (i.e., combinations of KiT components) that produce a positive 
effect on trial outcomes. 
o We will measure the cost of implementing this intervention to inform the feasibility of 
scaling this intervention.  
o We will explore if socioeconomic status as measured by material deprivation quintile is 
related to the use, engagement and effectiveness of the KiT intervention on diabetes self-

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efficacy and/or the readiness to transition to adult diabetes care, and/or barriers to 
diabetes adherence stigma subscale.   
 
8.3 
SAMPLE SIZE DETERMINATION 
 
The total sample size of 234 (117 per arm) was determined based on the number of adolescents with T1D 
who are annually transferred to adult diabetes care at each participating site: 
 
• 
Ontario (4 sites total): The Hospital for Sick Children, Children’s Hospital of Eastern Ontario 
(CHEO), Markham Stouffville Oaklands and Trillium Health Partners. The total number of 
patients annually transferred from these Ontario pediatric diabetes centers to adult diabetes 
centers is approximately 202. Thus, over an 21-month period, there will be approximately 303 
patients transferred to adult diabetes care who are eligible to participate in this trial. We estimate, 
based on prior experience of the investigators involved in transition research, that we would be 
able to make contact, recruit, consent and enroll approximately half (152) of the eligible patients 
(303), and account for 20% (30) being lost to follow-up, we will have approximately 120 
participants from Ontario sites enrolled in this trial. 
 
• 
Quebec (2 sites total): Montreal Children’s Hospital and CHU Saint Justine. The total number of 
patients annually transferred from both pediatric diabetes centers to adult diabetes centers is 
approximately 152.  Thus, over an 21-month period, there will be approximately 228 patients 
transferred to adult diabetes care who are eligible to participate in this trial. We estimate, based 
on prior experience of the investigators involved in transition research, that we would be able to 
make contact, recruit and enroll approximately half (114) of the eligible patients (228), and 
account for 20% (23) being lost to follow-up, we will have approximately 90 participants from 
Quebec sites enrolled in this trial. 
 
We have a conservative sample size of 234 (117 per arm) that will provide more than 80% power of 
detecting a between-group change in mean score for self-efficacy with diabetes management (SEDM) of 
0.75, this accounts for 20% loss to follow-up at the 5% significance level (alpha) using a two-sample 
equal-variance t-test.   
 
 
8.4 
POPULATIONS FOR ANALYSES 
 
The conventional frequentist analyses are often interpreted in a dichotomous matter, based on the p-value 
chosen as threshold for ‘statistical significance’ and ‘no evidence of effect’ is confounded with ‘evidence 
of no effect’. A Bayesian analysis will be conducted to provide the probability of any benefit or harm. An 
intention-to-treat analysis will be conducted by blinded analysts. We will evaluate the extent of missing 
data to determine if values are missing at random or not and will consider imputation to account for 
missing values. 
 
 
8.5 
STATISTICAL ANALYSES 
 
8.5.1 GENERAL APPROACH 
 
Demographics and baseline characteristics will be summarised using descriptive statistics. Continuous 
data will be reported as means with SDs.   

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8.5.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
 
We will compare the mean SEDM score at 12 months between those in the intervention (regardless of 
original or modified) versus control arms. This will be done using linear regression to estimate the effect 
of the KiT intervention on self-efficacy of diabetes management, controlling for baseline SEDM. The 
linear model will be estimated using Bayesian linear mixed effect model accounting for the clustering of 
patients at their pediatric diabetes clinic using integrated nested Laplace approximation (INLA). We will 
adjust our analysis by sex and gender. The results will be presented as posterior mean with 95% creditable 
interval, probability of any benefit or any harm, and the probability of clinical important benefit. Any 
benefit is defined as the difference between two arms is greater than zero. Any harm is defined as the 
difference is smaller than zero. The threshold for clinical important benefit is chosen at 0.75. A significant 
probability of benefit or harm (clinical important benefit) will be declared above 95%.  
 
 
Sensitivity analysis 
 
Clinicians were uncertain about whether they would expected differences between the modified 
intervention and the original intervention. Therefore, we will also investigate the potential impact of the 
modified intervention compared to the original intervention. To determine this, we will perform a 
sensitivity analysis by examining the interaction effects between the original intervention and the number 
of months under the modified intervention. We use the same model as our primary analysis, adjusting for 
atreatment indicator (under the original intervention) and the interaction between being on treatment and 
the number of months exposed under the modified intervention. This analysis will allow us to understand 
the impact of the duration of exposure to the modified intervention. Our goal is to compare individuals 
who received the 12-month modified intervention and those who received the 12-month original 
intervention by leveraging the partially exposed data. The sensitivity analysis will involve the following 
steps: 
 
(1) Calculate the posterior probability of the difference between the estimated effect of recieving  12 
–months of the modified intervention and 12months of the original intervention being greater 
than zero. This will determine whether  there is any evidence to support the idea that the modified 
intervention is more effective than the original intervention. If the probability is less than 90%, 
we can conclude that there is no significant evidence to prove the difference between the two 
interventions. 
(2) If the posterior probability calculated in step (1) is greater than 90%. We then use our interaction 
effect model to calculate the posterior probability of any benefit/harm and probability of clinical 
important benefit of receiving the 12-month original and 12-month modified interventions 
separately as a supplement to the primary analysis.  
 
 
8.5.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
For secondary outcomes, continuous data will be reported as means with SDs and between-arm 
differences in means will be calculated using Student’s t-tests or non-parametric statistics. To account for 
repeated measures, secondary analysis will be conducted to calculate within (baseline, 6 months, 12 
months) and between arm-differences to evaluate changes.    

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We will compare baseline adjusted self-reported mean HbA1c at 12 months between those in the 
intervention versus control arms. This will be done using linear regression to estimate the effect of the 
intervention on HbA1c.. The same Bayesian model as the primary analysis will be used. We will adjust 
for by sex and gender.  
 
From the process evaluation, we will report metrics of user engagement by # of interested topics chosen 
by the participant, type of specific topics, proactive use of chatbot, response rate (%) to messages that 
query participants with a question or prompt requiring a SMS response, and proportion (%) of participant 
clicks on resource and educational links.  Furthermore, qualitative observations made during the one-on-
one interviews and surveys administered during the process evaluation will be analyzed using thematic 
analysis strategies guided by HAPA and the TAM, identifying key themes that demonstrate important 
contextual influences and practices related to the implementation and evaluation of the e-Health 
technologies in actual contexts of health care delivery. The findings of the qualitative data will be used to 
develop statements of the relationships between (a) key contextual factors (e.g., perceived needs, outcome 
expectancies, self-efficacy), (b) the mechanisms by which they affect the implementation of the e-Health 
interventions, and (c) the impact on the outcomes of the KiT intervention themselves (in Realist 
Evaluation these statements are referred to as “Context-Mechanism-Outcome Configurations” (43). 
 
For the Coincidence Analysis, we will create individual case constructions for all trial participants that 
will triangulate intervention engagement data by intervention component with outcome data, using 
pathways informed by the semi-structured interviews. Where required, variable values will be converted 
to have categorical properties according to the definitions and criteria developed by the research team. 
CNA package in R will be used for data analysis.   
 
The descriptive cost analysis of the aggregate and direct medical costs associated with the KiT 
intervention will be conducted from the perspective of the Ontario MOHLTC and adopted over a life of 
the intervention period. We will assume a 1.5% discount rate for costs and consequences going beyond 1 
year as per the Canadian Agency for Drugs and Technology in Health (CADTH) guidelines for economic 
evaluations (44). All costs will be reported in 2023 Canadian dollars using the Bank of Canada Consumer 
Price Index calculator to adjust for inflation to a given base year (45). We will utilize a bottom-up 
approach when tallying the healthcare resource utilization costs for individuals over the study duration. 
Healthcare resource utilization costs will consist of the ED visits, hospitalizations, and physician visits, 
and diabetes drug and devices claims, as well as other relevant services as decided with the study 
stakeholders during follow-up. Costs related to hospitalizations and emergency room visits will be 
estimated using the resource intensity weight (RIW) methodology, whereby the cost is the product of the 
R1W associated with a particular case and the average cost per weighted case for Ontario and Québec 
(44).  Furthermore, we will simulate the scaling of the program and its impact on the program and health 
system costs.  
 
Analyses for the preliminary safety and performance KiT LLM chatbot testing will include descriptively 
describing whether the LLM Evaluator acts more conservatively than human raters when scoring answers, 
and if the answers generated by KiT LLM are acceptable based on the graded criteria (see section 9). 
After the trial is completed, CDTx (UHN) will analyze conversation logs between participants and KiT 
LLM to derive effective engagement with the bot. This will include analyzing the conversation between 
participants and KiT LLM (eg, duration, breadth, and depth of bot usage). The performance of the LLM 
Evaluator will also be assessed by evaluating conversations flagged and any potentially sensitive 
conversations missed. This evaluation will provide insights into how KiT LLM was used in a real-world 
setting and opportunities to improve its performance over time. 
 
8.5.4 BASELINE DESCRIPTIVE STATISTICS 

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Summary statistics will be used to describe baseline characteristics and other outcomes of interest. 
Categorical endpoints will be summarized using proportions and frequencies. Continuous endpoints will 
be summarized using the mean, median, range or standard deviations. Subgroup summarization based on 
KiT intervention message frequency or other criteria will also be conducted. 
 
 
8.5.5 PLANNED INTERIM ANALYSES  
 
An interim analysis within the process evaluation is planned to be performed on user engagement and 
participant satisfaction with the KiT intervention 3 or 6 months after the start of the intervention; timing is 
contingent on having enough participants enrolled. The interim analysis will be performed by the process 
evaluation research team, unblinded to the treatment allocation. The results of the interim analysis will be 
used as feedback information to the research team to make adjustments to the KiT intervention in real-
time. These adjustments could be in the form changing the tone of messaging, changing the wording of 
messages or switching out topics that had the least user engagement, updating or replacing resources or 
educational content that had the least user engagement or changing the frequency or sequencing of 
messaging.   
 
8.5.6 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
 
Individual de-identified participant data will be listed by time point of response to every message and 
resource sent by the KiT intervention and engagement via clicks on resource and educational links. This 
individual-level data is required to conduct the process evaluation (interim and full-analysis) to determine 
on an individual and aggregate scale, what messages and resources participants find the most engaging 
and useful. This participant data will then enable modifications to the KiT intervention in real-time, 
improving user uptake and effectiveness. All de-identified participant data will be listed in the data table 
by study ID number and no PHI information will be listed. 
 
9 
PARTICIPANT SAFETY 
 
Due to the nature of the KiT intervention, we do not expect adverse or serious adverse events related to 
the intervention to occur. If a participant texts KiT any messages signalling a crisis situation (see table 4  
for list of crisis key words that will be recognized by KiT), support messages will be delivered by KiT, 
encouraging the participant to reach out to medical professionals and will offer key contact information 
for appropriate assistance.  The LLM chatbot also has instructions to send the same support messages in 
case any topic related to suicidal ideation is identified in the more natural language conversation. 
Participants will have the option to pause the KiT messages at any time if they feel that the intervention 
messages are causing them to feel uncomfortable or distressed  until and if they feel ready to resume the 
messages again. Any elevated harm, discomfort or distress caused by the KiT messages, communicated to 
the research team by the participant, will be immediately reported to the Principal Investigator, and the 
Research Ethics Board, and entered the study database as a note to file. 
 
English Safety Testing 
We would like to use a new LLM (using GPT-4) chatbot feature to enhance the participant’s experience 
for a more natural conversation. Prior to implementation, we will conduct a safety evaluation and are 
requesting access to the question data that enrolled participants have asked using the current question and 
answer feature. Please note, that the LLM chatbot feature will not be turned on until the English safety 
testing and analysis are completed. To do this safety evaluation, we will ask the patient questions (in 
addition to synthetically generated questions) to the KiT LLM and have human raters (investigators and 

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patient partners) to score the answers from 1-5 based on accuracy, safety and a metric known as the 
global quality score. The validity and reliability of these metrics were established during several rounds of 
testing with the raters in addition to literature evidence. The LLM chatbot is not a learning model and will 
only utilize existing resources gathered for the KiT study. Although, since LLMs are stochastic in nature 
– i.e., may generate different answers to the same question at different times – we will ask each question 3 
times. In addition, we want to test the use of LLMs as evaluators of the quality of answers. In order to do 
this, we will ask an LLM evaluator to also grade the answer to questions based on the aforementioned 
criteria, and compare this rating to the human raters. If successful, we plan to have the LLM evaluator 
continuously assess the questions asked by participants for any sensitive information (e.g., pertaining to 
suicidal ideation) and the quality of answers given, and flag any potentially harmful case for human 
review during the study.  
 
It should also be noted we have previously assessed a prototype version of the KiT LLM and an LLM 
Evaluator (using GPT-4 accessed through UHN’s Microsoft Azure subscription) on a set of synthetic 
questions, with promising results. We are in the process of improving these applications based on 
feedback from this initial assessment. Examples of these updates include stronger language on 
recommending visits to the emergency department in certain cases and explicit instructions to consider 
suicidal ideation when flagging potentially sensitive questions. We plan to test updated versions of the 
KiT and Evaluator LLMs with the questions already asked by participants during the study.  
 
The English safety testing has been completed and the results are below. Once this amendment is 
approved them the LLM chatbot will be incorporated in Ontario sites. 
 
English safety testing conclusions (please see accompanying PowerPoint presentation in CTO 
application) 
 
Common questions to all raters (39 participant questions +12 synthetic questions) 
- 
When considering the full set of questions (39 participant, 12 synthetic), the KiT LLM seems to 
perform well, with high scores in most metrics, particularly Safety.  
- 
Overall the LLM Evaluator seems to act as, or more, conservative than most human raters (the 
exception being Patient Partner 2, which was slightly more conservative in general). 
○ There is some subjectivity in how clinicians and patient partners perceive the quality of the 
KiT LLM answers. For example, while PP2 indicated (few) major safety concerns, PP1 did 
not indicate any safety concerns. No major safety concerns were also indicated by clinicians. 
- 
GQS metric, which is largely a measure of practicality, was scored lower by human raters (although 
still with high scores. This is not a major concern to us, as Accuracy and specially Safety scores were 
high, indicating the answers are factual and, most importantly, do not do major harm to 
participants. 
 
Participant questions – subset of common questions (39 participant questions) 
- 
When only looking at the common subset of participant questions, KiT LLM still maintains scores in 
the high-end for all metrics. 
- 
Human raters seem to be more conservative than the LLM Evaluator for most metrics, but not by 
much.  
○ As before, there is some variability between raters. For example, the LLM Evaluator tends to 
be more conservative than PP1 for all metrics, and slightly less for PP2. Overall scores for all 
metrics are still high. 
- 
In particular, the LLM Evaluator seems well calibrated for the Safety metric, being as conservative as 
the human raters in most cases. 

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- 
In general, metric scores show promising results by the human raters – again, in particular with the 
Safety metric.  
 
Participant questions - all questions, inclusion unique ones per rater (45 questions) 
- 
When considering the entire set of participant questions (including unique questions asked to each 
rater), the conclusions are similar to when considering the common set of participant questions – 
which is expected, since the common set is a subset of the questions asked in these analyses. 
In general, the human raters are slightly more conservative than the LLM Evaluator, but not by much. The 
LLM Evaluator seems to be well-calibrated for the Safety metric in particular, being close to the human 
raters in the scoring.  
 
LLM Evaluator (using GPT-4 accessed through UHN’s Microsoft Azure subscription) 
 
-Shows to be well-calibrated to flag answers to humans, especially pertaining to Safety. 
-Participant answers, will be flagged if they score an Accuracy/GQS score >=3, and with a Safety score 
>=2 (any minor or major concerns).  
-Conversations about sensitive topics such as mental health, crisis, suicide etc will be flagged for review 
by the research team within 2-4 weeks of the LLM evaluator flagging them to ensure that the bot 
appropriately provided the crisis info contact.  
-Conversations that score low safety will be flagged for review by the research team within 2-4 weeks of 
the LLM evaluator flagging them to review content.  
-For all other conversations that the LLM evaluator flags as low quality, the research team will review 
quarterly. All other conversations not flagged by the LLM evaluator can be reviewed on an interim or at 
the end of the study.  
-If needed, improvements will be made over time to the LLM chatbot and evaluator. 
 
French Safety Testing 
As our study is in English and French, it is important for us to complete the safety testing in French as 
well. The French safety testing methods will be similar to the English. 
 
Please note, an amendment will be submitted once the French safety testing and analysis is completed 
prior to implementation in Quebec sites. Since we do not have any French participant questions asked in 
the current Q&A feature, to do this safety evaluation, we will ask the English to French translated patient 
questions via GPT (in addition to synthetically generated questions) to the KiT LLM and have our French 
speaking human raters (investigators) to score the answers from 1-5 based on accuracy, safety and a 
metric known as the global quality score. The validity and reliability of these metrics were established 
during several rounds of testing with the raters in addition to literature evidence. The LLM chatbot is not 
a learning model and will only utilize existing resources gathered for the KiT study. Although, since 
LLMs are stochastic in nature – i.e., may generate different answers to the same question at different 
times – we will ask each question 3 times. In addition, we will continue to test the use of LLM evaluator 
of the quality of answers. In order to do this, we will ask an LLM evaluator to also grade the answer to 
questions based on the aforementioned criteria, and compare this rating to the human raters. 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 STUDY DISCONTINUATION AND CLOSURE 
 

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This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to study participants, Investigator, funding agency, and regulatory 
authorities.  If the study is prematurely terminated or suspended, the PI will promptly inform study 
participants, and the REB and will provide the reason(s) for the termination or suspension.  Study 
participants will be contacted, as applicable, and be informed of changes to study timelines. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, and 
satisfy the REB.   
 
10.1.2 CONFIDENTIALITY AND PRIVACY  
 
Participant confidentiality and privacy is strictly held in trust by the participating Investigators, their staff, 
and Collaborators. This confidentiality is extended to cover the clinical information relating to 
participants. Therefore, the study protocol, documentation, data, and all other information generated will 
be held in strict confidence.  
 
Any research information obtained about the patient in this study will be kept confidential. A patient will 
not be identified by name, only by unique study ID number. The patient’s name or any identifying 
information will not appear in any reports published as a result of this study. All identifying information 
will be kept behind 2 security measures or as per equivalent institutional policy, under the supervision of 
the study/site PI and will not be transferred outside of the hospital. 
 
The representatives of the Research Ethics Board (REB) may inspect all documents and records required 
to be maintained by the Investigator, including but not limited to, medical records of the participants in 
this study. The clinical study site will permit access to such records. 
 
Eligible participants will be told about all types of data that will be collected for this study that include 
PHI, including self-reported characteristics and diabetes care measures, text messages exchanged with the 
KiT intervention, and OHIP/RAMQ number collection which will be linked to administrative data before 
they enroll in the study. This information will be presented to them in the informed consent form so they 
are fully aware of what the study entails and what information the intervention will collect, store and 
analyze.  Participants will also be informed during the consenting process about the collection and use of 
their cell phone number by the research coordinator and Memotext.  Participants will be asked to provide 
their consent to share their telephone number with Memotext team, which is needed to onboard and 
activate them into the KiT study.  Participants will be provided information on Memotext’s secure 
systems and platforms and ensured that their phone number will not be shared with any members outside 
of their local coordinator who recruited them for the study and Memotext team working on the KiT 
intervention, and participants will not be contacted by cell phone (call or text) or email or in any other 
manner by any members of the research team or Memotext, except for study purposes as outlined by our 
study objectives.  Furthermore, participants will be allowed to provide consent to different aspects of the 
KiT intervention, should they not be interested in participating in every component of the study.  For 
example, the informed consent form will ask interested participants to provide their consent individually 
main study intervention (receiving KiT intervention text messages and engaging with the text messages if 

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enrolled in the intervention arm) or participation in the process evaluation if enrolled in the intervention 
arm.   
 
De-identification of all study participants: All participants who have provided informed consent and 
who have been enrolled in the study, will be assigned a site-specific study ID number, which will be 
recorded in the enrollment log kept at each site. The study ID number will be used to track all participants 
while they receive the study intervention and during analysis of study results. The Enrolment and Master 
Linking Log containing the Study ID, first and last name, DOB, sex, MRN, phone number, address 
including 6 digit postal code, and email address of the participant will be kept separately from all other 
study data and will be stored at each respective site. The Master Linking log will not be shared with any 
members of the research team outside of the local site and will be secured as an encrypted file on a 
password protected computer. 
 
Study data from the KiT intervention: User engagement data from the KiT intervention will be stored 
on the secure servers of our collaborator, Memotext, located in Toronto. Memotext will operate and 
manage the administration of the KiT intervention. Memotext collects and uses data in accordance with 
all applicable laws and PPEDA and HIPAA. There will be a data sharing agreement in place between 
Memotext and all participants sites, to facilitate secure data transfer of de-identified study data from 
Memotext to SickKids, UHN and Trillium Health Partner for data analysis of the main study outcomes, 
process evaluation and cost of implementation analysis. The data sharing agreements between all study 
sites and Memotext will enable secure data transfer of enrolled participant’s Study ID numbers and linked 
mobile numbers. This is necessary to allow Memotext to activate enrolled participants into the KiT 
intervention to either the intervention or the control arm, depending on the randomization assigned to 
each enrolled participant. All data transfer will be performed under secure transfer conditions and only 
accessible by Memotext research team members working on the KiT study. Memotext agrees not to 
attempt to re-identify de-identified information and not to transfer deidentified information to any party. 
 
OHIP and RAMQ numbers:  All participants provide consent to collect and use their OHIP and/or 
RAMQ number in accordance with protocol-specified outcomes and analysis, this PHI information will 
be securely stored in a file separate to the Master Linking Log and separate to the enrollment log of the 
study. This file will be encrypted and stored on a password-protected computer at each study site. At the 
time of analysis, this file will be securely transferred from each Ontario study site to SickKids via 
SickKids Secure File Transfer Portal System that requires a password protected account for each sender 
and receiver of data. All study sites will have a data sharing agreement in place with SickKids to facilitate 
this data transfer. Once SickKids receives files from all Ontario study sites, SickKids will initiate a secure 
file transfer to the ICES, where individual data linkage to administrative datasets for analysis of 
secondary outcomes will be performed. Quebec sites will securely transfer the RAMQ numbers to McGill 
who will then securely transfer to RAMQ for linkage. Files containing OHIP and RAMQ numbers will 
not be shared with Memotext as their scope of work does not require access to this data.   
 
Chatbot feature: Please note, this is not a training model and no patient data will be stored and used for 
training purposes. A log of every user interaction and bot answer, with respective timestamps, will be 
created and stored by Memotext (using study IDs for privacy as previously described). Microsoft Azure 
does not share data with third parties and can be configured to be compliant with Canadian privacy 
regulations (e.g., PHIPA). Although we can also run the same deployment using open-source, local 
models through a software called LMStudio, testing of the two solutions showed that GPT-4 through 
Microsoft Azure has much better accuracy and performance. 
10.1.3 FUTURE USE OF DATA  
 
Data collected for this study will be analyzed and stored at SickKids for primary and secondary outcome 
analysis, and at Trillium Health Partners for the analysis of the process evaluation. After the study is 

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completed, the de-identified, archived data will be transmitted to and stored at The Hospital for Sick 
Children for use by other researchers including those outside of the study. 
When the study is completed, access to study data will be provided through the principal investigator: Dr. 
Rayzel Shulman. 
 
Participants coded study data may be used or shared with other researchers (inside and outside of Canada) 
for future studies.  “Coded” means that directly identifying information (such as name and date of birth) 
will be replaced by a study ID, which will be applied to the study data.   This may include storing the 
coded study data in controlled-access databases, for which access is limited to researcher(s) who submit a 
study plan and who sign an agreement to use the coded study data only for that research. The goal of 
sharing is to make more research possible. However, the code matching study data with participant name 
and other directly identifying study data will not be shared. 
Participant will not be asked if they agree to take part in future research studies using their study data. 
Participant or their study doctor will not be told what type of research will be done. Participant will not be 
given reports or other information about any research that is done with their study data. 
The study teams that use data collected through this study database will acknowledge this study and study 
team in future publications and/or presentations. 
 
 
10.1.4 KEY ROLES AND STUDY GOVERNANCE 
 
Principal Investigator 
Dr. Rayzel Shulman, MD, PhD  
The Hospital for Sick Children  
555 University Avenue, Toronto, 
Ontario, Canada, M5G 1X8 
Phone:  416-813-6218 
rayzel.shulman@sickkids.ca 
 
 
10.1.5 QUALITY ASSURANCE AND QUALITY CONTROL 
 
Each clinical site will perform internal quality management of study conduct, data collection, 
documentation, and completion. 
 
Data entry for enrollment and randomization, and online questionnaires will be entered through a web 
browser (on computer or mobile device for participants completing online questionnaires) in real time 
into a secure central database using REDCap, hosted at SickKids. Data will be systematically checked for 
completeness and consistency by routine data-pulls of de-identified data from Memotext and SickKids 
research staff. Queries from these routine checks will be transmitted to the research coordinators at local 
sites for resolution. 
 
Data entry into the enrollment log, master linking log and OHIP/RAMQ log will be all be done on 
separate secure files, not entered on REDCap and all stored separately on encrypted files in password-
protected computers, at each local site.  
 
 
10.1.6 DATA HANDLING AND RECORD KEEPING  
 
10.1.6.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  

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Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site 
Investigator. The Investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
 
Study data will be entered into REDCap (Research Electronic Data Capture), a secure, web-based 
application designed exclusively to support data capture for research studies. REDCap is developed and 
maintained by a team at Vanderbilt University and licensed free of charge by the Research Institute at The 
Hospital for Sick Children. The application and data are housed on servers provided by The Hospital for 
Sick Children. These servers are located within SickKids secure data center. Local support for REDcap is 
provided by SickKids Research IT. 
 
Research coordinators at each study site will have an External REDCap account that requires a secure 
login and password.  Local coordinators will use their individual REDCap accounts to access the KiT 
Intervention REDCap project and will be able to enroll and randomize participants via REDCap 
automatic randomization, and enter enrollment data (date of enrollment, study site and Study ID number).  
Local coordinators will also be able to track completion of baseline, 6-month and 12-month outcome 
measures for participants at their site. This is necessary in case the local coordinator needs to make 
contact with participants who are not engaging with the intervention and/or not completing their outcome 
measures at the specified time-points. 
 
Data collection on REDCap: Enrollment data, and all outcome measures at baseline, 6 and 12 months 
will be entered in real-time by local coordinators and participants directly into REDCap. REDcap will 
house these data on secure servers at SickKids. 
 
 
Data Collection from medical charts: 
1) From Medical Charts: first and last name, telephone number and email in order for local research 
coordinator to establish contact with eligible participants during recruitment phase, either in clinic 
or virtually via telephone or email.  Participant’s HbA1c value within 6 months prior to 
enrollment, mailing address including 6-digit postal code will also be obtained from their medical 
chart.  The full mailing address is needed to send study information letters and/or baseline, 6 
month or 12 month reminder letters (if preferred by participant versus email communication).  
Additionally, the full 6-digit postal code is needed for ICES verification during linkage of 
participant OHIP number to administrative data sets, and for socioeconomic analysis using the 
deprivation index , which requires the use of 6-digit postal codes. Diabetes related ED visits, and 
hospitalizations will be measured for the 12 months prior to enrolment to evaluate the impact of 
this text message-based intervention, compared to the usual transition care alone. Only local 
research coordinators will access information from patient medical charts after obtaining local 
REB approval and institutional approval for this study. PHI data from participant medical charts 
will be stored on the enrollment log (encrypted and on password-protected computer).    
2) Provincial Health Card Number: All participant consent forms will indicate that we are collecting 
OHIP (in Ontario) and RAMQ (in Quebec) numbers in order to perform linkage to provincial 
administrative data . We will be recording and storing the OHIP and/or RAMQ numbers on a log 
separate from all other data collection documents and will not enter this information into 
REDCap or the KiT intervention algorithm, or the enrollment log or Master Linking log. 
Memotext will not have access to participants’ OHIP and/or RAMQ number. Upon study data 
collection completion, all participating sites will upload their participant OHIP/RAMQ number to 
a secure file portal in order to enable administrative data linkage via ICES in Ontario and Med-
Echo and Régie de l'assurance maladie du Québec (RAMQ) databases in Quebec. To enable  

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verification of provincial health card number for linkage to administrative datasets, ICES and 
RAMQ will receive participant full first and last name, Study ID number, OHIP or RAMQ 
number, full date of birth, sex and full 6-digit postal code. 
 
Data collection from KiT algorithm: Data collected from the KiT algorithm via text messages will 
include responses to text queries including but not limited to: the date of upcoming medical visits in order 
to send reminders in advance of the appointment date, responses about what educational content 
participants’ would like to receive, and the number of times participants’ click on links provided to online 
resources, and any questions texted from the participant to KiT as part of KiT’s Q&A feature. Memotext 
will store all responses and engagement metrics to/with KiT algorithm on their secure severs in Toronto. 
All data collected by KiT algorithm will be de-identified; no PHI or personal identifying information will 
be collected by the KiT algorithm via text. Memotext will routinely monitor and check the data output 
from the KiT algorithm and will also track user engagement. 
Memotext protects personal information by security safeguards appropriate to the sensitivity of 
information. They are committed to keeping personal information secure, and have appropriate technical, 
administrative, and physical procedures in place to protect personal information against loss or theft, as 
well as authorized access, disclosure, copying, use, modification, disposal or destruction. In addition, 
methods of protection and safeguards include, but are not limited to, locked filing cabinets, restricted 
access to offices, security clearances, need-to-know access and technological measures including the use 
of passwords, encryption and firewalls. 
 
Data collection from LLM chatbot: Data collected from the chatbot will include questions asked by 
participants and responses to questions related to T1D, as well as respective timestamps. Memotext will 
store all responses and engagement metrics on their secure servers in Toronto. All data collected will be 
de-identified; no PHI or personal identifying information will be collected by the chatbot. As mentioned, 
participants will be asked not to shared any identifying information during their conversation with the 
chatbot. 
 
Memotext protects personal information by security safeguards appropriate to the sensitivity of 
information. They are committed to keeping personal information secure, and have appropriate technical, 
administrative, and physical procedures in place to protect personal information against loss or theft, as 
well as authorized access, disclosure, copying, use, modification, disposal or destruction. In addition, 
methods of protection and safeguards include, but are not limited to, locked filing cabinets, restricted 
access to offices, security clearances, need-to-know access and technological measures including the use 
of passwords, encryption and firewalls. 
Data collection for secondary outcomes measured using administrative data:  We will securely link 
patients’ health card number to provincial administrative databases housed at ICES in Ontario and Med-
Echo and Régie de l'assurance maladie du Québec (RAMQ) databases in Quebec. The study investigators 
will be permitted to access de-sensitized information only for analysis (i.e., any information that can 
directly identify a person like health card number or name will be removed or replaced with a code that is 
not known to the study investigators). We will measure all diabetes-related hospitalizations, emergency 
department visits, and HbA1c results (Ontario only from the Ontario Lab Information System (OLIS)), in 
the 12 months prior to enrollment in the study and for 12 months after enrollment. In Ontario we will also 
collect information on hospitalizations for DKA or hypoglycemia from the Canadian Institute of Health 
Information (CIHI) discharge abstract database (DAD) and emergency department visits for 
hyper/hypoglycemia will be ascertained using the National Ambulatory Clinic Reporting System 
(NACRs). In Quebec we will measure hospitalizations from Med-Echo (hospitalizations) and RAMQ 
databases (physician billings from hospitalizations) and emergency department visits for 
hypo/hyperglycemia will be identified from the RAMQ databases. A data sharing agreement will be in 
place for this transfer, between ICES and SickKids.   

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Data collection for the cost of implementation analysis: Cost of implementation will be collected to 
ascertain the cost of developing and using this intervention in a hospital setting in Ontario and Quebec; 
variables that will be collected for this analysis will include:  salaries for staff working on the design, 
development and management of the intervention for the entire intervention duration; salary of research 
coordinators working to onboard participants to the intervention; cost of digital services and office 
equipment needed to develop and manage the intervention (computers, hosting service, servers); cost of 
REDcap servers and hospital IT support for REDCap integration with MEMOTEXT platform. 
   
 
10.1.6.2 STUDY RECORDS RETENTION  
 
To enable evaluations and/or audits from Regulatory Authorities, the Sponsor, the Principal Investigator 
agrees to keep records, including the identity of all participating patients (sufficient information to link 
records, CRFs and hospital records), all original signed informed consent forms, copies of all data entry 
records on REDCap and output data from KiT algorithm, for a minimum of 7 years in accordance with 
SickKids policy. At the end of the study, all records will continue to be kept in a secure location. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX 
 
Table 2:  KiT Educational Topics 
 
 
 
Topic Areas from Environmental Scan 
Topics from Interviews and Co-Design 
Sessions (prominent topics have two 
x’s) 
READDY 
Tool 
Knowledge 
What is diabetes 
 
What is A1C and my target 
X 
Hyperglycemic/high blood glucose 
complications 
X 
Hypoglycemic/low blood glucose signs 
XX 
Hypoglycemic/low blood glucose treatments 
(e.g. glucagon) 
XX 
Alcohol & glucose 
X 
Tobacco & heart health & diabetes 
 
Diabetes & sexual health/function 
XX 
Glucose control before and during pregnancy 
 
Tests done in routine visits to prevent 
complications 
X 
Navigation 
What to ask during a clinic appointment 
XX 
Contact information of your healthcare team, 
where to look for advice and help 
XX 
 
Medical insurance 
XX 
Emotional, family, peer, and community 
support 
XX 
Refilling prescriptions 
XX 
Find a family doctor 
 
Disability accommodations  
X 
Find trustworthy resources 
X 
Insulin 
Management 
Insulin & syringe, pen, and pump 
X 
Insulin dose & blood glucose 
 
Insulin dose & food intake 
 
Insulin adjustments & glucose patterns 
XX 
Health Behaviours 
Understanding carbohydrates & carb 
counting 
X 
When to test glucose 
 
Taking insulin and checking glucose in public 
X 
Weight change 
 
Sick day management 
XX 
What to do with positive ketones 
XX 
Preventing highs and lows during exercise 
XX 
Diabetes & driving, treating highs and lows 
XX 
Safe sex practices 
X 

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Insulin Pump 
Pump setup 
X 
Pump programming (basal and bolus) 
XX 
Test basal rate 
X 
Pump troubleshooting 
X 
Insulin injections 
 
Non-READDY topics 
How to use a glucometer 
X 
Diabetes & mental health (eating disorders, 
navigating stigma, diabetes burnout, 
managing stress) 
XX 
Continuous Glucose Monitoring 
X 
Flash glucose monitoring 
X 
Travel 
X 
Nutrition & healthy eating, fats and protein, 
eating out 
XX 
Diabetes and other health conditions 
 
Diabetes and holidays 
 
Managing T1D at school and work (not from 
scan) 
XX 
Proper foot care (not from scan) 
X 
 
 
 
Table 3: KiT Intervention - Feature Category and Sample Dialogue  
 
Feature 
Category 
Intervention Feature 
Sample Dialogue 
Care 
Coordination 
Asking patient for 
information about the 
adult T1D clinic they are 
going to and providing a 
clinic welcome package 
KiT: Could you tell me the name of the adult clinic that you’re 
going to be attending? 
User: Women’s College Hospital 
KiT: Wonderful, you can click on this link for more information 
about the clinic, the providers who work there, and the 
different services they provide [insert link] 
Asking patient for their 
scheduled appointments 
and sending appointment 
reminders 
 
KiT: Hello! Do you know when your next appointment is? 
User: It is on Sept 27th 2022 at 2 pm 
KiT: Perfect, I’ll send you a reminder the week before so you 
don’t forget! 
Asking patient for the tests 
they are required to 
complete before their 
appointments and sending 
reminders 
KIT: Were there any tests, like bloodwork, that your healthcare 
team asked you to complete before your next appointment? 
User: My doctor wanted me to check my A1C 
KiT: That’s definitely important! I’ll send you a reminder 2 weeks 
before your appointment to get your A1C bloodwork done, so 
you can be prepared. 
Reminding patients about 
their medication and 
device refills 
KiT: Just a reminder to check for the number of refills on your 
diabetes medication and supplies, so you don’t run out!  
 
Reminding patients to 
upload CGM data 
KiT: Did your healthcare team ask you to upload your CGM data 
before your next appointment? 
User: Yes 
KiT: Ok, I’ll send you a reminder to do that before your next 
scheduled appointment 

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Education and 
self-advocacy  
 
Sending patient checklists 
and information on how to 
prepare for their first adult 
visit 
KiT: Your first appointment with your new adult clinic is coming 
up soon! I wanted to share some ideas on how to best prepare 
for it, because I know it can be overwhelming. Click on this link 
for some helpful tips [insert link] 
Sending patient reflection 
prompts to support them 
in self advocating during 
healthcare visits 
KiT: Now that you’ve had your first visit with your new adult 
healthcare team, I encourage you to think about how it went. 
How did your new clinic and team make you feel? What are 
some things you liked about the visit, and what were some 
things you wish went differently? Remember that it can take 
time to build this new relationship, but that there are also other 
clinics you can try out if this one wasn’t a good fit.  
Receiving T1D-related 
questions from the patient 
and sending answers from 
a validated bank of 
resources 
User: How do I talk about T1D with my employer? 
KiT: Thanks for the question. This is something a lot of people 
have questions about. [Insert quote and link of validated 
content resource] 
Prompting patient with 
T1D information from a 
validated bank of 
resources 
KiT: Hi, I wanted to send you some information about 
government assistance programs for people living with T1D. The 
Assistive Devices Program (or ADP) is a government program 
that may support you with the costs of your diabetes devices. It 
is something that needs to be renewed each year with the 
support from your physician. To learn more go to [link] or ask 
your physician about it at your next appointment.  
Storing patient’s questions 
and notes that they want 
to bring up in their clinic 
visits 
User: #NOTE: Remember to ask doctor about controlling my 
blood sugars when exercising 
User: #NOTE: How to apply for ADP 
User: #NOTE: Mental health resources at clinic?? 
KiT: Your next appointment is coming up soon, and I wanted to 
send you the notes you made so you can discuss them with your 
team: “Remember to ask doctor about controlling my blood 
sugars when exercising, How to apply for ADP, Mental health 
resources at clinic??”  
PREMs/PROMs 
Administering baseline and 
end of study questionnaire 
to patient 
KiT: Please click on this link to complete the baseline and follow-
up (6 months and 12 months) questionnaires for the study 
[insert REDCap link] 
 
Table 4: Mental health crisis keywords 
 
Standard response message (to be sent after receipt of flagged keyword) 
 
ONTARIO: “It sounds like you might be going through something difficult right now. If you feel like you 
are at immediate risk, please call 911. If not, you can always reach out to your healthcare team for 
support. Or to talk to someone right away, you can text HOME/ PARLER to 686868 anytime, anywhere 
in Canada to speak with a trained Crisis Responder through the Crisis Text Line.”  
 
- 
Other Ontario mental health supports: https://ontario.cmha.ca/provincial-mental-health-supports/  
 
QUEBEC: “It sounds like you might be going through something difficult right now. If you feel like you 
are at immediate risk, please call 911 or 811. If not, you can always reach out to your healthcare team for 
support. Or to talk to someone right away, you can text HOME/ PARLER to 686868 anytime, anywhere 
in Canada to speak with a trained Crisis Responder through the Crisis Text Line.”  
 

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- 
Other Quebec mental health supports: https://amiquebec.org/crisis/  
 
Standard response message (French) 
 
ONTARIO : « On dirait que tu vis des moments difficiles. Si tu sens que tu es en danger immédiat, 
appelle le 911. Sinon, tu peux toujours communiquer avec ton équipe de soins de santé pour obtenir du 
soutien. Pour parler avec quelqu’un tout de suite, tu peux en tout temps texter HOME / PARLER au 
numéro 686868, peu importe où tu te trouves au Canada. Tu pourras alors parler avec un intervenant en 
situation de crise formé par l’intermédiaire de Crisis Text Line ».   
-    Autres ressources de soutien en santé mentale en Ontario : https://ontario.cmha.ca/fr/soutien-
en-sante-mentale-au-niveau-provincial/ 
  
QUÉBEC : « On dirait que tu vis des moments difficiles. Si tu sens que tu es en danger immédiat, appelle 
le 911 ou le 811. Sinon, tu peux toujours communiquer avec ton équipe de soins de santé pour obtenir du 
soutien. Pour parler avec quelqu’un tout de suite, tu peux en tout temps texter HOME / PARLER au 
numéro 686868, peu importe où tu te trouves au Canada. Tu pourras alors parler avec un intervenant en 
situation de crise formé par l’intermédiaire de Crisis Text Line ».   
  
-    Autres ressources de soutien en santé mentale au Québec : https://amiquebec.org/crisis/ 
https://www.quebec.ca/sante/conseils-et-prevention/sante-mentale/obtenir-aide-en-sante-
mentale/ressources-aide-et-soutien-en-sante-mentale 
Mental health crisis keywords (https://www.stateofmentalhealth.org/lethal-words) 
● Excedrin/aspirin 
● 800 mg 
● Ibuprofen/ Advil 
● Acetaminophen/ Tylenol 
● Nightstand 
● Vampire 
● Railroad 
● 💊💊 (U+1F48A) 
● 😭😭 (U+1F62D) 
● Looney 
● 11:11 
● Kill myself 
● Die 
● Antifreeze 
● Safe 
● Tablets/ pills  
● Bathtub / bath tub / bath 
● Electrocution / electrocute 
● Bridge 
● Noose / rope  
● Syringe / needle  
● Suicide / suicidal 
● Train 
● Midnight  
● Cop / police  
● Hopeless/ no hope  
● No purpose 
● Trapped 

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● Pain  
● Burden  
● Pills 
● Overdose 
● Vomit/ throw up/ puke 
● Cut/ cutting  
● Binge  
 
 
Mental health crisis keywords (French) 
 
·   Excedrin/aspirine 
·   800 mg 
·   Ibuprofène/ Advil 
·   Acétaminophène/ Tylenol 
·   Table de nuit 
·   Vampire / veines 
·   Rails / tracks / chemin de fer 
·    ߚ
ߛ
ߜ (U+1F48A) 
·    ☥
☦
☧
☨
☩
☪ (U+1F62D) 
·   Looney 
·   11:11 / 11 h 11 / 11h11 
·   Me tuer / me suicider / finir mes jours / mettre fin / mettre fin à ma vie / en finir / arrêter de 
souffrir / passer à l’acte / souffrance / souffrances / soufrance / vie / vi / vivre  
·   Seul au monde / seule au monde / solitude 
·   Mourir 
·   Antigel 
·   Sécurité 
·   Comprimés/ pilules / cachets / médicament / médicaments 
·   Bain / baignoire 
·   Électrocution / électrocuter / électrocuté / électrocutée 
·   Pont 
·   Rhum / rum / fort 
·   Revolver / gun / fusil / arme / arme à feu 
·   Nœud coulant / corde / pendre / pendu / pendue 
·   Seringue / aiguille / seryngue 
·   Suicide / suicidaire / idées suicidaires / pensées suicidaires / idées noires / tendance 
·   Train 
·   Minuit 
·   Policier / police / agent / officier / forces de l’ordre 
·   Désespoir / désespéré / désespérée / sans espoir / pas d’espoir / plus d’espoir / pus d’espoir / vide 
·   Aucun but / sers à rien / sert à rien 
·   Pris / enfermé / emprisonné / emprisonnée / en prison / étouffer / étouffé / étouffée / piège 
·   Douleur / mal 
·   Fardeau / lourd / poids / peser / pèse / épaules    
·   Somnifère / somnifères 
·   Overdose / surdose / surdosage 
·   Vomi / vomissement / vomir / dégueuler / dégueule / gerber / dégobiller 
·   Couper / découper / coupe 
·   Beuverie / binge / brosse / boire / coup / prendre un coup 

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KiT – Sample Messages: 
 
Care Navigation 
 
*CARE TEAM* Your diabetes care team can be made up of a bunch of different healthcare 
professionals, such as a nurse, endocrinologist, dietician, social worker, and more!  
 
If you’re not sure who is a part of your care team, ask your clinic and check out this handy form from 
Diabetes Canada which lists out all the different healthcare providers who might be: 
https://www.diabetes.ca/DiabetesCanadaWebsite/media/Managing-My-
Diabetes/Tools%20and%20Resources/know-your-team.pdf?ext=.pdf    
  
*CONTACTS* It’s important to know how to contact your diabetes care team outside of appointments in 
case you have questions or need their support. Do you know if your clinic has an on-call or urgent number 
that you can reach them at?? Try saving your care team as contacts in your phone 📱📱  
 
*PRIMARY CARE* A family doctor or nurse practitioner is a really important member of your diabetes 
care team. They might not be an expert in T1D, but they can support you with all kinds of questions - you 
can go to them for things like mental health, sexual health, and other physical health concerns (stomach 
aches, rashes, stuff like that).  
 
If you don’t have a family doctor or nurse practitioner, Health Care Connect can help you find one: 
https://www.ontario.ca/page/find-family-doctor-or-nurse-
practitioner?_ga=2.87075160.154570205.1644426680-1166791615.1644426680   
  
 
Ketones and DKA 
 
*KETONES* I'm sure you've heard the term "ketones" a lot so I wanted to give you a quick refresher on 
what they are! When your body doesn't have enough insulin to use glucose for energy, it starts using fat 
as a source of energy - when this happens, your body makes ketones, and high levels of ketones can be 
harmful.  
 
So, like your car (your body) uses gas (fat) to run, there is a by-product of exhaust (ketones). Too much 
smoke in the air (ketones in the blood) is toxic! 🚗🚗  
 
*DKA* Since we're on the topic of ketones, it’s important to chat about Diabetic Ketoacidosis (DKA). 
High levels of ketones in the blood can lead to DKA which is a medical emergency 🚨🚨  
 
In most cases, you can bring your ketone levels back to normal with the proper insulin dose. This link 
shows you how to calculate the right insulin dose based on your blood ketone levels, and what to do if 
your ketone levels are too high: https://type1better.com/wp-content/uploads/2020/07/How-to-
Manage-Ketone-Bodies.pdf  
  
*PREVENTING DKA* Obviously, no one wants DKA! So to avoid it, make sure to:  
- Measure your blood sugar regularly  
- Always take your insulin (even when you’re sick!)  

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- Check your blood or urine for ketones if you have any symptoms of DKA so that you can act quickly!  
 
Check out this short video for more info on DKA symptoms and prevention: 
https://www.youtube.com/watch?v=NwBzGfKY_gE   
  
 
Sick Day Management 
 
*SICK DAY CARE* Getting sick is probably going to happen, and during these times your blood sugars 
may fluctuate and become unpredictable SO it’s really important to keep track of your body when you’re 
not feeling well!  
 
When you're sick, make sure to check your blood sugar and ketones every 2 to 4 hours - set an alarm to 
wake you up when you’re sleeping ⏰ For more info, check out 
https://waltzingthedragon.ca/diabetes/illness/home-alone-and-sick/    
 
*DEHYDRATION* When you’re sick with vomiting, diarrhea, or a fever, you’re at risk of dehydration, 
and who wants to be dehydrated (not you, I’m sure)!? So, make sure to drink plenty of sugar-free fluids, 
avoid caffeine since that can make dehydration worse, and try eating a ½ cup of applesauce, Jell-O, or a 
popsicle to prevent low blood sugar.  
 
See this Diabetes Canada resource for suggestions of what to drink and eat to prevent dehydration: 
https://www.diabetes.ca/diabetescanadawebsite/media/managing-my-
diabetes/tools%20and%20resources/stay-safe-when-you-have-diabetes-and-sick-or-at-
risk-of-dehydration.pdf?ext=.pdf  
 
*TELL A FRIEND* If you’re not feeling well, make sure to let someone know! That way, you can get 
rest without worry, knowing you have a friend or family member who can check in on you and help you 
out if you need it  
 
Hypoglycemia 
 
*LOW BLOOD SUGAR* Do you know what your symptoms of low blood sugar are? These symptoms 
can show up in different ways for different people! So when you’re feeling like you have low BG, check 
your sugars and treat your symptoms as quickly as possible!  
 
For a refresher on the signs of low blood sugar, check out this link: 
https://www.diabetes.ca/DiabetesCanadaWebsite/media/Managing-My-
Diabetes/Tools%20and%20Resources/hypoglycemia-low-blood-sugar-in-
adults.pdf?ext=.pdf   
 
*FEAR OF HYPO* It’s totally normal to be afraid of having low blood sugar - especially at night. As 
with many complex situations, remember that there are things you can do to prevent low blood sugar and 
manage it when it happens! If you’re feeling stressed about your lows and want to make a plan to support 
you, reach out to your diabetes care team - they’re there to help! 
 
Drugs and Alcohol 
 

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*DRINKING SAFELY* Remember not to drink alcohol on an empty stomach! Make sure to eat 
something with slow-acting carbs before drinking to prevent low blood sugar, and have a snack before 
bed. http://www.bcchildrens.ca/endocrinology-diabetes-site/documents/alcohol.pdf    
 
*DRINKING SAFELY* When you’re drinking, make sure to carry diabetes identification and tell at least 
1 person who is drinking with you about your diabetes and how they can help if your blood sugar goes 
low #teamwork  
 
*ALCOHOL LOWS* Alcohol induced lows can be different from other lows. Some funky stuff that 
happens when drinking is that low BG can happen right away, or up to 12 hours after drinking. Your 
symptoms might be different (it may just feel like you’re drunk) and glucagon might not work as well.  
 
SO it’s important to check your blood sugar not only while you drink but after you drink, before you go to 
sleep, and in the morning too! And make sure to have your glucose meter, glucose tabs, and a snack for 
lows handy.  
 
Travel 
 
*TIME ZONES* When travelling, stick to your original time zone while in transit, and change your 
clocks to the time of your destination when you arrive.  
 
If you’re travelling through more than 5 time zones, you’ll probably have to adjust your insulin (you’ll 
usually need more if travelling west ⬅ and less if travelling east ➡ so it’s a good idea to chat with your 
doctor about making changes to your medication dosage or schedule before you leave for your trip! 
 
*TRAVELLING* To make sure you can enjoy a stress-free trip, pack lots of extra supplies! It’s good to 
have extra glucose meters, batteries, pumps and infusions sets, insulin and syringes (in case your pump 
malfunctions), and medications on hand, just in case.  
 
You might even want to split your supplies between two bags, in case one gets lost or stolen!  
 
*SECURITY* Don’t worry - people living with T1D are allowed to carry medical supplies (including 
emergency juice above the liquid limit) with them when travelling through security! Pumps and CGMs 
should NOT go through an x-ray machine or body scanner, so you can ask to walk through a regular 
metal detector or get a pat-down instead.  
 
You can get your doctor to provide you with a letter like this one to make the process of getting through 
security with your diabetes supplies smoother: https://www.diabete.qc.ca/wp-
content/uploads/2019/04/Voyage-lettreMD-Anglaisdocx-5.pdf      
 
Chatbot Link Appended to the End of Sample Message  
 
Sample Q&A Answer: Thanks for asking! Hopefully this resource about food labels from Diabetes 
Quebec answers your question mtxt.io/cyhn5t 
 
Appended to end of message: If you have more questions, ask our KiT Q&A chatbot at 
mtxt.io/qachat?sid=12312 
 

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Appended to the end of messages not recognized: Hmm, looks like we don’t have a good answer – 
sorry about that! Try our new KiT Q&A chatbot at mtxt.io/qachat?sid=12312 to see if you can find 
an answer there! 
 
Figure 1: Streamlit prototype app interface 
 
 
 
 
 
 
 
 
 
 

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Figure 2: Chat Flow diagram