MyDiaText: Texting the Way to Better Diabetes Control
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Sponsor: Children's Hospital of Philadelphia

 
 
PROTOCOL TEMPLATE: INTERVENTION STUDY (CLINICAL TRIALS)  
 
Title: 
MyDiaText: Texting the Way to Better Diabetes Control 
Short Title 
MyDiaText Intervention for Diabetic Adolescents 
Sponsor: 
The Children’s Hospital of Philadelphia 
The National Institutes of Health (NIH) 
eIRB Number 
NCT Number 
16-013222 
02927639 
Protocol Date: 
 
Version: 
October 6th, 2016 
 
7.0, Last Revised April 22, 2019 
 
Study Principal Investigator 
Terri Lipman, PhD, CRNP 
University of Pennsylvania School of Nursing 
The Children’s Hospital of Philadelphia 
Philadelphia, PA, 19104 
Phone: 215-590-3174 
email: lipman@nursing.upenn.edu 
 
 
 
 

  
 
 
 
ii 
TABLE OF CONTENTS 
Table of Contents ................................................................................................................... ii 
Abstract .................................................................................................................................. v 
Protocol Synopsis .................................................................................................................. vi 
Table 1: Schedule of Study Procedures ............................................................................ viii 
Figure 1: Study Diagram .................................................................................................... ixx 
1 
BACKGROUND INFORMATION AND RATIONALE ....................................................................... 1 
1.1 
INTRODUCTION ..................................................................................................................................... 1 
1.2 
NAME AND DESCRIPTION OF INTERVENTION ........................................................................................ 1 
1.3 
RELEVANT LITERATURE AND DATA ..................................................................................................... 1 
1.4 
COMPLIANCE STATEMENT .................................................................................................................... 2 
2 
STUDY OBJECTIVES ............................................................................................................................... 3 
2.1 
PRIMARY OBJECTIVE (OR AIM) ............................................................................................................. 3 
2.2 
SECONDARY OBJECTIVES (OR AIM) ...................................................................................................... 3 
3 
INVESTIGATIONAL PLAN .................................................................................................................... 3 
3.1 
GENERAL SCHEMA OF STUDY DESIGN .................................................................................................. 3 
3.1.1 
Focus Groups .................................................................................................................................. 3 
3.1.2 
Inclusion Criteria for Focus Groups ............................................................................................... 4 
3.1.3 
Exclusion Criteria for Focus Groups .............................................................................................. 4 
3. 2 General Schema for Intervention Study .......................................................................................... 4 
3.2.1 Screening Phase ................................................................................................................................... 4 
3.2.2 Phase 1 ................................................................................................................................................. 4 
3.2.3 Phase 2 ................................................................................................................................................. 5 
3.2.4 Follow-up Phase .................................................................................................................................. 5 
3.3 ALLOCATION TO TREATMENT GROUPS AND BLINDING ................................................................................ 5 
3.4 STUDY DURATION, ENROLLMENT AND NUMBER OF SITES .......................................................................... 5 
3.4.1 Duration of Study Participation .......................................................................................................... 5 
3.4.2 Total Number of Study Sites/Total Number of Subjects Projected ...................................................... 5 
3.5 STUDY POPULATION ..................................................................................................................................... 6 
3.5.1 Inclusion Criteria ................................................................................................................................. 6 
3.5.2 Exclusion Criteria ................................................................................................................................ 5 
4 
STUDY PROCEDURES ............................................................................................................................ 6 
4.1 
PRE-INTERVENTION PHASE: FOCUS GROUPS ........................................................................................ 6 
4.2 
SCREENING VISIT (VISIT 1) ................................................................................................................... 6 
4.3 
STUDY TREATMENT PHASE ................................................................................................................... 6 
4.3.1 
Visit 1 is also the screening visit as mentioned above ..................................................................... 6 
4.3.2 
Visit 2 ............................................................................................................................................... 7 
4.3.3 
Visit 3 ............................................................................................................................................... 6 
4.4 
UNSCHEDULED VISITS .......................................................................................................................... 6 
4.5 
SUBJECT COMPLETION/WITHDRAWAL ................................................................................................. 7 
4.5.1 
Early Termination Study Visit ......................................................................................................... 8 
5 
STUDY EVALUATIONS AND MEASUREMENTS .............................................................................. 9 
5.1 
FOCUS GROUP EVALUATION ................................................................................................................. 9 
5.2 
SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS .................................................. 9 
5.2.1 
Medical Record Review ................................................................................................................... 9 
5.2.2 
Laboratory Evaluations ................................................................................................................... 9 
5.2.3 
Other Evaluations, Measures .......................................................................................................... 9 
5.3 
EFFICACY EVALUATIONS ...................................................................................................................... 9 

 
 
 
 
iii 
5.3.1 
Diagnostic Tests, Scales, Measures, etc. ......................................................................................... 9 
5.4 
SAFETY EVALUATION ........................................................................................................................... 9 
6 
STATISTICAL CONSIDERATIONS .................................................................................................... 10 
6.1 
PRIMARY ENDPOINT ........................................................................................................................... 10 
6.2 
SECONDARY ENDPOINTS ..................................................................................................................... 10 
6.3 
STATISTICAL METHODS ...................................................................................................................... 10 
6.3.1 
Baseline Data ................................................................................................................................ 10 
6.3.2 
Efficacy Analysis ............................................................................................................................ 10 
6.4 
SAMPLE SIZE AND POWER .................................................................................................................. 10 
7 
STUDY INTERVENTION ....................................................................................................................... 12 
7.1 
DESCRIPTION ...................................................................................................................................... 12 
7.1.1 
Treatment Compliance and Adherence ......................................................................................... 12 
8 
SAFETY MANAGEMENT ..................................................................................................................... 13 
8.1 
CLINICAL ADVERSE EVENTS ............................................................................................................... 13 
8.2 
ADVERSE EVENT REPORTING ............................................................................................................. 13 
9 
STUDY ADMINISTRATION ................................................................................................................. 14 
9.1 
TREATMENT ASSIGNMENT METHODS ................................................................................................. 14 
9.1.1 
Randomization ............................................................................................................................... 14 
9.1.2 
Blinding ......................................................................................................................................... 14 
9.1.3 
Unblinding ..................................................................................................................................... 14 
9.2 
DATA COLLECTION AND MANAGEMENT ............................................................................................ 14 
9.3 
CONFIDENTIALITY .............................................................................................................................. 14 
9.4 
REGULATORY AND ETHICAL CONSIDERATIONS .................................................................................. 15 
9.4.1 
Data and Safety Monitoring Plan .................................................................................................. 15 
9.4.2 
Risk Assessment ............................................................................................................................. 15 
9.4.3 
Potential Benefits of Trial Participation ....................................................................................... 15 
9.4.4 
Risk-Benefit Assessment ................................................................................................................ 15 
9.5 
RECRUITMENT STRATEGY .................................................................................................................. 15 
9.6 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION ............................................................ 16 
9.6.1 
Focus Group .................................................................................................................................. 16 
9.6.2 
Intervention .................................................................................................................................... 16 
9.7 
PAYMENT TO SUBJECTS/FAMILIES ...................................................................................................... 16 
9.7.1 
Payments to subject for time, effort and inconvenience (i.e. compensation) ................................ 16 
10 
PUBLICATION ........................................................................................................................................ 15 
11 
REFERENCES .......................................................................................................................................... 17 

  
 
 
 
iv 
ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
 
 
CHOP 
 
Children’s Hospital of Philadelphia 
T1DM 
 
Type 1 diabetes mellitus 
HbA1c 
 
Hemoglobin A1c 
SCI 
 
Self-Care Inventory 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
 
 
v 
ABSTRACT 
Context: 
Type 1 diabetes mellitus is one of the most common chronic diseases in childhood in the 
United States and its incidence continues to rise. Glycemic control during adolescence can 
be extremely difficult to achieve due to various biological, social, behavioral, and 
psychological factors. Development of effective and sustainable interventions to improve 
diabetes control and diabetes self-management during adolescence is of utmost importance 
to prevent short- and long-term complications and improve the quality of life of adolescents 
with type 1 diabetes mellitus. 
Objectives: 
The primary objective of this study is to test a text messaging intervention using MyDiaText 
and to determine whether such an intervention will decrease HbA1c in children 12 to 18 
years with type I diabetes mellitus.   
The secondary objectives is to determine if a text messaging intervention using MyDiaText 
will improve diabetes self-management skills as measured by the Self-Care Inventory (SCI) 
in children 12 to 18 years. 
Study Design:  
Randomized trial  
Setting/Subjects: 
This study will take place at the Children’s Hospital of Philadelphia. 
It will include 200 adolescents aged 12-18 with T1DM. 
Study Interventions and Measures:  
This study will use MyDiaText text messaging program as an intervention. 
The main outcome measure will be change HbA1c. The secondary outcome measure will be 
change in scores of the Self-Care Inventory questionnaire. 

  
 
 
 
vi 
PROTOCOL SYNOPSIS 
Study Title 
MyDiaText: Texting the Way to Better Diabetes Control 
Funder 
NIH T32 Grant-Pediatric Endocrinology Division of CHOP 
Clinical Phase 
intervention 
Study Rationale 
Optimal control of type 1 diabetes may prevent, or at least decrease 
the risk of, diabetes complications. Adolescents with diabetes often 
have difficulty adhering to a diabetes management plan such a 
monitoring of blood glucose levels, administering insulin, and 
eating healthy. There is a need for an intervention that will resonate 
with youth and support adolescents with type 1 diabetes to improve 
their self-management practices in order to improve their glycemic 
control and prevent or reduce the risk of short- and long-term 
complications. 
Study Objective(s) 
Primary  
• 
To develop a text messaging intervention using MyDiaText and 
to determine whether such an intervention will decrease HbA1c 
in children 12 to 18 years 
Secondary 
• 
To determine if a text messaging intervention using MyDiaText 
will improve diabetes self-management skills as measured by 
the Self-Care Inventory (SCI) in children 12 to 18 years 
Test Article(s) 
The intervention will consist of daily text messages sent to the 
subject’s personal mobile device. Previously developed text 
messages and quiz questions based on the ADA behavior goals will 
be used for this intervention.  
Study Design 
Randomized trial  
Subject Population 
key criteria for 
Inclusion and 
Exclusion: 
Inclusion Criteria 
1. Subjects age 12 to 18 year of age. 
2. Have a diagnosis of T1DM for more than 1 year. 
3. HbA1c ≥ 8% but < 14%. 
4. Have been seen in the diabetes clinic in the last 6 months. 
5. Own a personal mobile device with unlimited text 
messaging plan. 
6. Parental/guardian permission (informed consent) and, if 
appropriate, child assent. 
Exclusion Criteria 
1. Non-English speaking. 
2. Significant cognitive disability or major organ illness. 
3. Hemolytic anemia. 

 
 
 
 
 
vii 
4. Ongoing oral steroid use 
Number Of Subjects  
 
200 subjects will be recruited from Diabetes Clinics affiliated with 
the Children’s Hospital of Philadelphia 
Study Duration 
Each subject’s participation will last for approximately 180 days 
Study Phases 
Screening 
Study Treatment 
Follow-Up   
(1) Pre-screening: focus groups to determine details of the 
intervention 
(2) Screening: screening for eligibility and obtaining consent, 
review medical record for HbA1C, obtain baseline Self-Care 
Inventory score 
(3) Intervention: review medical record for HbA1C, obtain Self-
Care Inventory score 
(4) Follow-up: review medical record for HbA1C, obtain Self-Care 
Inventory score, complete satisfaction survey 
Efficacy Evaluations 
The primary efficacy endpoint will have two parts:  the change in 
HbA1c between control and intervention groups between visit 1, 2 
and 3. 
Safety Evaluations 
Adverse events are not anticipated in this study. 
Statistical And 
Analytic Plan 
Descriptive data analysis will include estimating means and 
standard deviations for continuous variables and counts and 
proportions of categorical variables for all aims. Two sample t-tests 
will be used to evaluate changes in HbA1c and SCI scores between 
the control and intervention groups and paired t-tests (or 
nonparametric methods if data is not normally distributed) will be 
used to compares the above changes within each group. 
Data and Safety 
Monitoring Plan 
The PI will monitor study progress, ensure the accuracy and security 
of the data, and ensure subject safety. 

 
viii  
 
 
 
 
 
TABLE 1: SCHEDULE OF STUDY PROCEDURES  
Study Phase 
Screening 
Control 
Intervention 
Follow-Up 
 
Visit Number 
1 
2 
3 
Study Days 
 
90 (+/- 30 days) 
90 (+/- 30 days) 
1 
Informed Consent/Assent 
X 
 
 
 
Review Inclusion/Exclusion 
Criteria 
X 
 
 
 
Randomization 
X 
 
 
 
Intake Questionnaire 
X 
 
 
Height and Weight 
X 
X 
X 
HbA1c  
X 
X 
X 
SCI Questionnaire 
X 
X 
X 
Exit Questionnaire (Subjective 
Assessment of Intervention) 
 
 
X 

 
ix 
  
 
FIGURE 1: STUDY DIAGRAM 
 
 
 
Visit 1: 
Screening 
Randomize 
Visit 3: 
Final 
Assessment 
Visit 2 
Intervention 
Control 
Visit 2 
Visit 3: 
Final 
Assessment 
Intervention 

1 
 
 
1 
BACKGROUND INFORMATION AND RATIONALE 
1.1 Introduction 
Type 1 diabetes mellitus (T1DM) is one of the most common chronic diseases in 
pediatrics in the United States with more than 18,000 children diagnosed every year. 
Management of T1DM in adolescence is challenging because pubertal hormonal changes 
result in insulin resistance and accelerated growth changes insulin requirements. 
Adolescence is also a time when diabetes care is being transferred from parent to child 
resulting in more diabetes self-management, which often leads to sporadic blood glucose 
monitoring and insulin administration resulting in poor diabetes control evidenced by 
elevated HbA1c. As a result, it is of utmost importance to develop effective interventions for 
adolescents that optimize their diabetes control. The use of technology has been shown to be 
a successful intervention in adolescents with chronic diseases and seems to be a promising 
intervention for adolescents with T1DM as well. 
A recent review on the use of technology for adolescents with T1DM showed some 
improvements in HbA1c as high as a 1% decrease as well as improvement in diabetes self-
management. These interventions included text messaging communication, phone and video 
communication, and smartphone applications. However, most studies have been small, 
interventions have been cumbersome, and most did not include a diverse sample of 
adolescents. A larger study using a feasible intervention in a diverse population is necessary 
to develop and evaluate an intervention that would be effective in improving diabetes 
control in adolescents. 
1.2 Name and Description of Intervention 
MyDiaText is an SMS texting program and website mydiatext.com developed by an 
interdisciplinary team of students, faculty, and clinicians from University of Pennsylvania 
School of Nursing and School of Engineering and Applied Sciences and the Children’s 
Hospital of Philadelphia that follows the National Standards for Diabetes Self-Management 
Education established by the American Diabetes Association. It was developed to support 
behavior change in children aged 10-17 years with T1DM. A feasibility study was done with 
20 adolescents (10 of whom identified as non-White) involving daily text messages for a 1 
month period. This study showed the use of this application to be feasible and well received 
in this population. 
1.3 Relevant Literature and Data 
Each year, more than 18,000 children under the age of 20 are diagnosed with T1DM 
[1]. Management of T1DM is very demanding as it requires lifelong frequent blood sugar 
checks, frequent insulin administration, and many lifestyle changes or modifications to 
maintain good diabetes control. This is particularly challenging in adolescence for a number 
of reasons. Hormonal changes during puberty can result in insulin resistance necessitating 
increased insulin doses [2]. Adolescence is also a period of rapid growth which also 
increases the insulin requirement. Most importantly, parental involvement in the diabetes 
management generally decreases with increasing age of the child resulting in medical 
independence. This often occurs prematurely and leads to decreased blood glucose 

2 
 
 
monitoring and insulin administration, which results in poor diabetes control and can lead to 
significant morbidity and mortality. 
  
Technology, in particular the use of text messaging, appears to be a good vehicle for 
interventions in adolescents because of its pervasive use in this population. About 3 in every 
4 children aged 12-17 own a cell phone. Studies have shown that 75% of teenagers text, 
with 63% of them sending text messages on a daily basis [3]. This is also true in low 
income, urban, and minority adolescents. Some studies have shown high access to 
technology in this population with estimates of 94% sending text messages on a daily basis 
[4,5]. 
 
Interventions using text messages in adolescents with T1DM have been carried out 
previously with high levels of satisfaction, but variable improvements in diabetes control 
measured by HbA1c [6,7]. One intervention involved weekly text messages of 
encouragement based on self-identified barriers to diabetes self-management [8]. This 
intervention did not result in a change from baseline HbA1c after 3 months of intervention, 
but a matched historical control group had significant worsening of glycemic control. 
Another intervention involved automated text or email messages on blood glucose 
monitoring sent on a self-selected schedule [9]. This intervention showed a slight but not 
significant improvement in HbA1c after 3 months. Another intervention involved regular 
text messages based on diabetes goals compared to the same intervention in addition to an 
intensive insulin regimen [10]. This intervention lasted 12 months and at its conclusion there 
was a significant improvement in those adolescents receiving the intervention plus intensive 
insulin regimen, but no significant improvement in those receiving the intervention alone. 
All of these studies were rather small, with only 18-33 subjects per group. Of these 
interventions, only the third study reported race/ethnicity information and only included 4% 
non-White population. 
 
While studies around text messages have been promising, they have not been 
conclusive.  A systematic review of text messaging studies in T1D concluded that while text 
message interventions are likely a valuable behavioral change tool, that further research 
should be grounded in behavioral theory[14].  A study in the adolescent T1D population 
showed that financial incentives for adherence to blood glucose monitoring showed 
increased monitoring during the incentive period but not in follow up [15].  A study showing 
the effect of reward for engagement in diabetes education via text message does not exist.  
1.4 Compliance Statement 
This study will be conducted in full accordance with all applicable Children’s Hospital of 
Philadelphia Research Policies and Procedures and all applicable Federal and state laws and 
regulations including 45 CFR 46, 21 CFR Parts 50, 54, 56, 312, 314 and 812. All episodes 
of noncompliance will be documented. 
The investigators will perform the study in accordance with this protocol, will obtain 
consent and assent, and will report unanticipated problems involving risks to subjects or 
others in accordance with The Children’s Hospital of Philadelphia IRB Policies and 
Procedures and all federal requirements. Collection, recording, and reporting of data will be 

3 
 
 
accurate and will ensure the privacy, health, and welfare of research subjects during and 
after the study.  
2 
STUDY OBJECTIVES 
The purpose of the study is to determine if an intervention using MyDiaText for adolescents 
with T1DM will improve their glycemic control and self-management skills. 
2.1 Primary Objective (or Aim) 
The primary objective of this study is to develop a text messaging intervention using 
MyDiaText and to determine whether such an intervention will decrease HbA1c in children 
12 to 18 years. This will be divided into 2 parts: 
• To determine whether this intervention will decrease HbA1c in children 12 to 18 
years after 3 months +/- 1 month. 
• To determine whether the effect of the intervention persists after an additional 3 
months +/- 1 month of intervention. 
2.2 Secondary Objectives (or Aim) 
The secondary objectives are to: 
• Determine if a text messaging intervention using MyDiaText will improve diabetes self-
management skills as measured by the Self-Care Inventory (SCI) in children 12 to 18 
years. 
• Analyze the response rate to educational text messages when a reward paradigm, in 
which children are intermittently rewarded for engaging in the application for multiple 
days in a row, is administered. 
 
3 
INVESTIGATIONAL PLAN 
3.1 General Schema of Study Design 
3.1.1 Focus Groups 
Up to 5 focus groups of 10 adolescents with type 1 diabetes will be carried out to develop 
the text messaging intervention. Text messages previously developed for the feasibility 
study will be used for this intervention. These text messages will be presented to the focus 
group subjects to determine whether changes need to be made. The focus groups subjects 
will also have input on other details of the intervention such as frequency and timing of the 
text messages. Subjects for these focus groups will be recruited from the CHOP 
Endocrinology and Diabetes outpatient clinic. Focus groups will last about one hour. They 
will be held in a private location at a time that is convenient to the subjects. Focus groups 
will be digitally recorded and transcribed. Subjects of these focus groups will be excluded 
from participation in the intervention phase. 

4 
 
 
3.1.2 Inclusion Criteria for Focus Groups 
1) Males or females age 12 to 18 years.   
2) Have a diagnosis of T1DM for more than 1 year. 
3) Own a personal mobile device.  
4) Parental/guardian permission (informed consent) and, if appropriate, child assent. 
3.1.3 Exclusion Criteria for Focus Groups 
1) Subject is non-English speaking. 
2) Subject has a significant cognitive disability. 
3) Subject does not have insurance approval for point-of-care A1C measurement  
3. 2 General Schema for Intervention Study 
3.2.1 Screening Phase 
Potential subjects will be recruited from the CHOP Endocrinology and Diabetes outpatient 
clinic. Clinic schedules will be reviewed for determination of potential subjects as per the 
inclusion criteria above. Some subjects will be pre-screened for interest only, without 
eliciting PHHI, by telephone prior to their clinic visit.  Subjects will be approached during 
their clinic visit and informed about the current study.  If the subject agrees to participate, 
informed consent (from caregiver if subject is < 18 y/o and from subject if he/she is >18 y/o) 
as well as assent if subject is < 18 y/o will be obtained. HbA1c and diabetes treatment plan 
will be collected from the medical record.  
3.2.2 Phase 1 
This phase will start enrollment. Subjects will be registered into the MyDiaText website by 
research staff.  At registration, MyDiaText will randomize half of the subjects to the 
intervention group and the other half to the control group.  At this time, SCI will be 
administered via a text message link to the MyDiaText website; this will serve also to ensure 
the phone number for the patient was entered correctly and that account is active for log-in. 
All subjects will get $5 upon completion of baseline self-care inventory. All subjects, 
control and intervention, will create a profile in the MyDiaText system.  This profile will 
consist of his/her name, birthday, gender, ethnicity, phone number, and email. All subjects 
will be following their diabetes care plan as dictated by their primary diabetes provider. The 
subjects in the intervention group will start receiving the text messaging intervention as 
described in the intervention section (section 7).  Subjects in the intervention group will be 
instructed to respond to each text as a proxy for having read it. Previously, a point system 
reflected scoring on quizzes and educational activities.  To update the text messages based 
on current technology, all quizzes have been transitioned into text messages.  To address 
gaps in research, a specific reward paradigm was created based on the concept of “streaks,” 
or reward for consecutive days of engagement in the application. Those with the longest 
“streak” will be placed in a drawing for an extra cash prize of $10 every two weeks. 

5 
 
 
3.2.3 Phase 2 
This phase will start at their next visit with their diabetes provider, which usually occurs 
after 3 months +/- 1 month. During this phase, control group will continue to not receive text 
messages, and intervention group will continue to receive text messages. HbA1c and 
diabetes treatment plan will be collected from the medical record. SCI will be completed at 
this time.  All subjects will get $10 for completing the second SCI.  Invitation to fill out 
second SCI will be administered via text message.  If second SCI is not filled out 7 days 
after this invitation, a reminder text message will be sent.  If not filled out 7 days after 
reminder text message, a second reminder text message will be sent.  No further reminders 
for that SCI will be sent.  
3.2.4 Follow-up Phase 
This phase will start and end at their next visit with their diabetes provider (second from 
randomization). This phase will only entail data collection on that day. HbA1c and diabetes 
treatment plan will be collected from the medical record. SCI will be completed at this time 
as well as a questionnaire assessing the intervention.  Invitation to fill out third SCI and 
intervention assessment will be administered via text message.  If third SCI and intervention 
assessment are not filled out 7 days after this invitation, a reminder text message will be 
sent.  If not filled out 7 days after reminder text message, a second reminder text message 
will be sent.  No further reminders for survey completion will be sent after this point. All 
subjects will get $15 for completing the third SCI and intervention assessment. This phase 
will conclude the study. 
3.3 Allocation to Treatment Groups and Blinding 
Half of the subjects will be randomized to the intervention and the other half will serve as 
controls. MyDiaText will randomly assign patients to treatment or control upon registration. 
Given the nature of the intervention, subjects will not be blinded. All study personnel and 
diabetes providers will not blinded to current subject phase during the study, since 
unblinding should not result in bias in this study and it would difficult to ensure that subjects 
do not tell their providers whether or not they are receiving text messages. 
3.4 Study Duration, Enrollment and Number of Sites 
3.4.1 Duration of Study Participation 
The study duration per subject will be about 180 days, with up to 1 day for screening (which 
coincides with the first day of phase 1), about 90 days for Phase 1, about 90 days for Phase 
2, and 1 day for follow-up (which coincides with the last day of phase 2). 
3.4.2 Total Number of Study Sites/Total Number of Subjects Projected 
The study will be conducted at up to 6 investigative sites in the United States, the main 
CHOP Diabetes and Endocrinology outpatient clinic at the Buerger Center in Philadelphia 
PA; CHOP Specialty Care in Princeton, NJ;  CHOP Specialty Care & Surgery Center in 
Chalfont, PA; CHOP Specialty Care & Surgery Center in King of Prussia, PA; CHOP 
Specialty Care & Surgery Center in Voorhees, NJ; and CHOP Specialty Care in Lancaster, 
PA.  

6 
 
 
Recruitment for randomized controlled trial will stop when 200 subjects are enrolled.  
Recruitment for focus groups will stop when 50 subjects are enrolled.  
3.5 Study Population 
3.5.1 Inclusion Criteria 
1) Males or females age 12 to 18 years. 
2) Have a diagnosis of T1DM for more than 1 year. 
3) HbA1c ≥ 8% but < 14%. 
4) Have been in seen in the diabetes clinic in the last 6 months. 
5) Own a personal mobile device with unlimited text messaging plan. 
6) Parental/guardian permission (informed consent) and, if appropriate, child assent. 
3.5.2 Exclusion Criteria 
1) Subject is non-English speaking. 
2) Subject has a significant cognitive disability or major organ illness. 
3) Subject has hemolytic anemia. 
4) Participation in the focus groups. 
5) Ongoing steroid use 
Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations 
of these criteria must be reported in accordance with IRB Policies and Procedures.  
4 
STUDY PROCEDURES 
4.1 Pre-Intervention Phase: Focus Groups 
Focus group will be recorded and transcribed. No identifying information will be collected. 
4.2 Screening Visit (Visit 1) 
Screening will take place just prior to Phase 1.  It will consist of explaining the study and 
screening for eligibility.  Subjects that qualify and are interested will move on to Phase 1 
4.3 Study Treatment Phase 
4.3.1 Visit 1  
• Informed Consent and/or Subject Assent 
• Medical Record Review 
• Lab: hemoglobin A1c 

7 
 
 
• Registration on MyDiaText website by study staff 
• SCI questionnaire 
4.3.2 Visit 2 
• Medical Record Review 
• Lab: hemoglobin A1c 
• SCI questionnaire 
4.3.3 Visit 3 
• Medical Record Review 
• Lab: hemoglobin A1c 
• SCI questionnaire 
• Exit questionnaire 
4.3.4 Assessment of adherence to program (Ongoing) 
• Every two weeks, MyDiaText will report consecutive response to text message by 
subject number.  If one subject has the longest streak, they will be rewarded with $10 
placed on their bank card.  If more than one subject has the longest streak, 
MyDiaText will pick one subject at random to receive this reward.  They will be 
informed if they received this reward via text message.  
 
4.4 Unscheduled Visits 
Since study visits will coincide with visits with primary diabetes provider, no unscheduled 
visits will take place. If a subject is seen by their diabetes provider or care team less than 2 
months from the previous visit, then the study team will not approach the subject at that 
time. 
4.5 Subject Completion/Withdrawal 
Subjects may withdraw from the study at any time without prejudice to their care.  They 
may also be discontinued from the study at the discretion of the Investigator for lack of 
adherence to study treatment or visit schedules. The Investigator may also withdraw subjects 
who violate the study plan, or to protect the subject for reasons of safety or for 
administrative reasons.  It will be documented whether or not each subject completes the 
clinical study. 

8 
 
 
4.5.1 Early Termination Study Visit 
Subjects who withdraw from the study will have all procedures enumerated for Visit 3 as the 
early termination visit.  Should they withdraw by sending a text message to the text message 
carrier “STOP,” a one-time e-mail will be sent from study personnel to the address provided 
at registration with visit 3 procedures.  

9 
 
 
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 Focus Group Evaluation 
Notes and transcripts from the focus groups will be read and analyzed by two different 
investigators. Common themes will be extracted and appropriate changes made to text 
message content and delivery. 
5.2 Screening and Monitoring Evaluations and Measurements 
5.2.1 Medical Record Review 
• Weight 
• Height 
• BMI 
• Most recent HbA1c value 
• Current diabetes treatment plan 
• Number of DKA admissions 
5.2.2 Laboratory Evaluations 
• Hemoglobin A1c 
5.2.3 Other Evaluations, Measures 
• Self-Care Inventory 
 
5.3 Efficacy Evaluations 
5.3.1 Diagnostic Tests, Scales, Measures, etc. 
The efficacy of this intervention in improving glycemic control will be determined using 
HbA1c values. HbA1c is checked every 3 months as part of the diabetes treatment plan. 
These values will be collected as a research lab at each visit. 
The efficacy of this intervention in improving diabetes self-management skills will be 
determined by the SCI questionnaire. This will be completed at each study visit. 
5.4 Safety Evaluation 
Given the nature of the intervention, no adverse events that will require intervention or 
monitoring will occur. 

10 
 
 
6 
STATISTICAL CONSIDERATIONS 
6.1 Primary Endpoint 
The primary endpoint will be the change in SCI score between Visit 1 and Visit 2 in control 
group as compared to intervention group  
6.2 Secondary Endpoints 
Secondary endpoints will include the following: 
• The change in HbA1C score during the intervention phase. 
• Measure the response rate to text messages in the context of the incentivized reward 
program 
• Responses to the intervention assessment questionnaire. 
• Durability analysis of adherence to text message intervention from visit 2 to 3.  
• Mean SCI score and HbA1C changes from visit 1 to visit 3 and visit 2 to visit 3.  
 
6.3 Statistical Methods 
6.3.1 Baseline Data  
Baseline and demographic characteristics will be summarized by standard descriptive 
summaries (e.g. means and standard deviations for continuous variables such as age and 
percentages for categorical variables such as gender). 
6.3.2 Efficacy Analysis 
The primary analysis will include all subjects randomized at Visit 1 who have gotten HbA1c 
measurements at visit 2. The primary efficacy endpoint will be the change in SCI Score. 
The first analysis will be change in SCI score from visit 1 to visit 2 comparing treatment and 
control groups. For this analysis we will use paired t-tests to test the null hypothesis of no 
difference in change in SCI scores at the two-sided alpha = 0.05 level. 
The secondary analysis will be the change in HbA1c between the intervention and control 
group from visit 1 to visit 2. For this analysis we will use two sample t-test to test the null 
hypothesis of no difference in the change in HbA1c at the two-sided alpha = 0.05 level. 
An additional secondary analysis will be the durability of the text messaging intervention 
from visit 2 to 3.  SCI score and HbA1C will continue to be tracked to compare visit 1 to 
visit 3 and visit 2 to visit 3 at study conclusions. 
6.4 Sample Size and Power 
The average HbA1c in adolescents at the CHOP Endocrinology and Diabetes clinic 
is 9.11% with a SD of 2.26%. Given this average HbA1c and its SD, a sample size of 164 
subjects would be needed to observe a difference of 1% in mean HbA1c between groups at a 

11 
 
 
0.05 level of significance with 80% power in a cross-over study. We will aim to recruit up to 
200 subjects out of over 1400 adolescents with T1DM seen at the CHOP Diabetes clinics for 
their routine care on a yearly basis. 
 

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7 
STUDY INTERVENTION 
7.1 Description 
The intervention will consist of daily text messages sent to the subject’s personal 
mobile device. Previously developed text messages based on the ADA behavior goals in 
addition to multiple-choice questions formerly used as quizzes on the MyDiaText website 
will be used for this intervention. These will be adapted with input from the focus groups 
that will be carried out with adolescents with T1DM. The details of the intervention, such as 
frequency and timing of text messages, will be determined from input obtained from the 
focus groups. The management of the website and SMS system is CHOP IT who will man 
the server as problems arise. 
7.1.1 Treatment Compliance and Adherence 
Compliance for the intervention arm will be measures on a bi-weekly basis. Once every two 
weeks, the MyDiaText website will create a report showing which subjects answered text 
messages for the most days in a row, and randomly pick one to win a cash prize. Subjects 
who do not answer any text messages will not be eligible for the bi-weekly cash prize, but 
will still be able to be reimbursed for completion of SCI.  

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8 
SAFETY MANAGEMENT 
8.1 Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study.  
8.2 Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any 
unanticipated problems related to the research involving risks to subjects or others happen 
during the course of this study (including SAEs) they will be reported to the IRB in 
accordance with CHOP IRB SOP 408: Unanticipated Problems Involving Risks to Subjects. 
AEs that are not serious but that are notable and could involve risks to subjects will be 
summarized in narrative or other format and submitted to the IRB at the time of continuing 
review.  

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9 
STUDY ADMINISTRATION 
9.1 Treatment Assignment Methods 
9.1.1 Randomization 
MyDiaText will randomize subjects to control or intervention arm.  The number of subjects 
in each arm will be monitored to ensure they are equal. 
9.1.2 Blinding 
Given the nature of the intervention, subjects will not be blinded. All study personnel and 
diabetes providers will not blinded to current subject phase during the study. 
9.1.3 Unblinding 
No unblinding protocol needs to be established since no one is blinded in this study. 
9.2 Data Collection and Management 
Consistent with CHOP Policy A-3-6: Acceptable Use of Technology Resources that defines 
the requirements for encryption and security of computer systems.  The MyDiaText 
application is hosted on a secure CHOP server.  The application uses an external service, 
Twilio, to send and receive text messages through one secure port in the CHOP firewall.  
Databases are protected by CHOP’s firewall.  
Digital recordings from the focus group will be kept in a locked cabinet until they are 
uploaded to a private desktop computer. After the recordings are uploaded, the recordings 
will be deleted from the recording device. Recordings will be transcribed and transcriptions 
will be stored on a private desktop computer. Recordings and transcriptions will be retained 
for three years. 
• PHHI and subject ID number will be stored in the MyDiaText Application.  Only 
IRB-approved study personnel will have access to subject PHHI.  Each subject will 
have access to their own PHHI.   
• MyDiaText has the ability to export data without PHHI . For this reason, we will not 
require a separate master list to store PHHI. Data exports for analysis purposes will 
include subject number, age, and study data but not name, date of birth, phone 
number, address, or email.  
• Profile history data will be purged within 6 months of study completion or when a 
subject opts to delete account. 
• All consent forms will be kept in locked filing cabinets that only the study team has 
access to. 
• The identifiers will be destroyed after publication. The other data will be retained for 
three years. 
9.3 Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
Institutional policies and HIPAA on subject privacy and the Investigator and other study 

15 
 
 
personnel will not use such data and records for any purpose other than conducting the 
study. All data and records will be kept confidential by using password-protected files.  
No identifiable data will be used for future study without first obtaining IRB approval. The 
investigator will obtain a data use agreement between the provider (the PI) of the data and 
any recipient researchers (including others at CHOP) before sharing a limited dataset (PHI 
limited to dates and zip codes).  
9.4 Regulatory and Ethical Considerations 
9.4.1 Data and Safety Monitoring Plan 
The PI and lead investigator will monitor study progress, ensure the accuracy and security of 
the data, and ensure subject safety. The PI and lead investigator will also follow the adverse 
event reporting plan. 
9.4.2 Risk Assessment 
There is minimal risk of loss of confidentiality.  
There is a potential risk of cost of text messaging incurred on the subject. However, this will 
be addressed by only recruiting subjects that own a mobile device with an unlimited texting 
plan.  
 
There is a potential risk that subjects will use this platform for health questions or problems 
that should be handled by a healthcare professional. This will be addressed by installing a 
’check’ so that subjects are not under the impression that someone is reading their texts. If a 
subjects responds or sends an unprompted text, a reply will be sent saying “MyDiaText does 
not recognize that message. Please only respond when asked. If you have any medical 
questions or concerns contact your healthcare provider”. 
9.4.3 Potential Benefits of Trial Participation 
Participation in this study can provide multiple benefits to the subjects. It could help 
improve the subjects’ diabetes control. The subjects can also develop better self-
management skills to treat his/her diabetes. This study can also provide indirect benefits to 
the subjects and other children with diabetes. Individuals can accrue the necessary skills to 
improve diabetes control that could prevent long-term complications of diabetes. If 
effective, this intervention could be implemented to improve the diabetes control of all 
children with diabetes. 
9.4.4 Risk-Benefit Assessment 
Since the risks are small and theoretical and the benefits are great in the short term and 
possibly in the long term, the benefits outweigh the risk. 
9.5 Recruitment Strategy 
Subjects for the focus groups will be recruited from the CHOP Diabetes and Endocrinology 
outpatient clinics. Clinic schedules of all diabetes providers will be screened for prospective 
subjects. These subjects will be approached in person by the research team. 

16 
 
 
Subjects for the intervention will be recruited from the main CHOP Diabetes and 
Endocrinology outpatient clinic. Occasionally, and for the intervention only, subjects may 
be screened for interest in the study by telephone prior to their clinic visit. PHHI will not be 
elicited to assess for eligibility during this conversation; only interest in learning more about 
the study will be assessed.  Clinic schedules of all diabetes providers will be screened for 
prospective subjects based on the inclusion criteria mentioned above. These subjects will be 
approached in person by the research team.   
9.6 Informed Consent/Assent and HIPAA Authorization 
9.6.1 Focus Group 
Upon recruitment for participation in the focus groups, subjects (if 18 years of age) or 
parents will be provided with written consent forms that must be signed for participation. 
Assent will also be obtained from the subject if he/she is < 18 years old. It will be made 
clear to subjects that all information will be kept confidential, their participation is entirely 
voluntary and they are allowed to leave or withdraw consent at any time. 
9.6.2 Intervention 
After a subject agrees to participate in this research study, written consent from the subject (if 
≥ 18 years old) or parent (if subject is < 18 years old) as well as assent from the subject if 
he/she is < 18 years old will be obtained and documented by the study coordinator/study 
investigator. This will take place in a private patient room at the CHOP Diabetes and 
Endocrinology outpatient clinic. A description of the procedures involved in the study, as well 
as the risks/benefits will be provided verbally and written as part of this process. Additionally, 
it will be stressed that any questions are appropriate and that all aspects of the study are 
voluntary. 
Consent documents will be maintained in the subject’s study file and documented. The 
subject will receive a copy of the signed document(s). A combined consent-authorization 
document will be used.  
9.7 Payment to Subjects/Families 
9.7.1 Payments to subject for time, effort and inconvenience (i.e. compensation) 
The payment for participation in the focus groups will be $10 per subject, which will be 
given in the form of a pre-paid bank card obtained from the CHOP Participant Research 
Card program). 
The payment for participation in the intervention will be variable.  All patients will get $5 to 
fill out the initial SCI, and $10 for the second SCI, and $15 for the third (total of 
$30/subject).  Subjects in the intervention group will have additional opportunities for a $10 
cash prize every other week.  These will be given in the form of a pre-paid bank card 
obtained from the CHOP Participant Research Card program. 
 

17 
 
 
10 PUBLICATION 
The results of this study may be submitted for consideration for presentations at national 
meetings and/or publication in academic journals. At no time will any PHI from this study be 
disclosed for any presentation(s) or journal article(s). 
 
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