My Dose Coach Titration and Maintenance in Patients With Type 2 Diabetes Mellitus on Basal Insulin
Phase: NA
Conditions: Diabetes Mellitus Type 2 - Insulin-Treated
Sponsor: Linda Siminerio

1 
 
PROTOCOL TITLE: 
MY DOSE COACH TITRATION & MAINTENANCE IN 
PATIENTS WITH TYPE 2 DIABETES MELLITUS ON 
BASAL INSULIN 
VERSION DATE: 
29 JULY 2021 
 
NCT04678661 
 
 
 
 

2 
 
TABLE OF CONTENTS 
 
ABBREVIATIONS………………………………………………………………………………………..4 
1 
OBJECTIVE, SPECIFIC AIMS, BACKGROUND, AND SIGNIFICANCE .......................... 6 
1.1 
Objective ....................................................................................................................................... 6 
1.2 
Specific Aims ................................................................................................................................. 6 
1.3 
Background ................................................................................................................................... 7 
1.4 
Significance ................................................................................................................................... 8 
2 
RESEARCH DESIGN AND METHODS ............................................................................ 8 
2.1 
Classification and Methodological Designs ................................................................................... 8 
2.2 
Detailed Description of Study Design ........................................................................................... 9 
2.3 
Insulin Management System ....................................................................................................... 12 
2.4 
Outcome Assessment ................................................................................................................. 13 
2.5 
Study Endpoints .......................................................................................................................... 15 
2.6 
Statistical Analysis ...................................................................................................................... 16 
3 
HUMAN SUBJECTS ........................................................................................................17 
3.1 
Subject Population ...................................................................................................................... 17 
3.2 
Inclusion Criteria ......................................................................................................................... 17 
3.3 
Exclusion Criteria ........................................................................................................................ 18 
4 
IRB APPROVAL ..............................................................................................................18 
5 
RECRUITMENT AND INFORMED CONSENT PROCEDURES .......................................18 
5.1 
Recruitment Methods .................................................................................................................. 18 
5.2 
Participant Informed Consent Procedures .................................................................................. 19 
6 
POTENTIAL RISKS AND BENEFITS ..............................................................................20 
6.1 
Potential Risks............................................................................................................................. 20 
6.2 
Alternative Treatments ................................................................................................................ 21 
6.3 
Potential Benefits ........................................................................................................................ 21 
7 
RISKS MANAGEMENT PROCEDURES..........................................................................21 
8 
REPORTABLE EVENTS .................................................................................................22 
8.1 
Definitions .................................................................................................................................... 22 
8.2 
Obligations and Responsibilities of the External Sponsor .......................................................... 24 
8.3 
Sanofi Pharmacovigilance Contact ............................................................................................. 25 
8.4 
Sanofi Product Technical Complaint Contact ............................................................................. 26 
9 
DATA SAFETY MONITORING ........................................................................................26 
9.1 
Data Safety Monitoring Plan ....................................................................................................... 26 
9.2 
Frequency of Monitoring ............................................................................................................. 26 
10 
WITHDRAWAL OF SUBJECTS ......................................................................................26 
11 
COSTS AND PAYMENTS ...............................................................................................27 
11.1 
Costs ........................................................................................................................................... 27 
11.2 
Payments .................................................................................................................................... 27 

3 
 
12 
REFERENCES .................................................................................................................27 
 
 
 

4 
 
ABBREVIATIONS 
ADR 
Adverse Drug Reaction 
AE 
Adverse Event 
AESI 
Adverse Event of Special Interest  
App 
Application 
BG 
Blood Glucose 
BGM 
Blood Glucose Monitor 
BMI 
Body Mass Index 
CFR 
Code of Federal Regulations 
CRF 
Clinical Research Form 
DDS17 
Diabetes Distress Scale  
DCES 
Diabetes Care and Education Specialist 
DM 
Diabetes Mellitus 
DMSRQ-SF 
Diabetes Medication System Rating Questionnaire-Short Form  
DSMP 
Data Safety Monitoring Plan 
EMR 
Electronic Medical Records 
Endo 
Endocrinologist 
FDA 
Food and Drug Administration 
FPG 
Fasting Plasma Glucose  
GCP 
Good Clinical Practice 
GEE 
Generalized Estimating Equations 
HbA1c 
Hemoglobin A, Glycated hemoglobin  
HCP 
Health Care Professional 
ICH 
International Conference on Harmonization 
ICSR 
Individual Case Safety Report  
IND 
Investigational New Drug 
iOs 
iPhone Operating System 
IRB 
Institutional Review Board 
LS 
Least Squares 
MDC 
MyDoseCoach App 
MDC-T 
MyDoseCoach App Titration Module 
MDC-M 
MyDoseCoach App Maintenance Module 
PC 
Primary Care 
PCP 
Primary Care Provider 
PI 
Principle Investigator 
SAE 
Serious Adverse Event 
SMBG 
Self-monitoring Blood Glucose  
SOC 
Standard of Care 
T2DM 
Type 2 Diabetes Mellitus 

5 
 
UPDI 
University of Pittsburgh Diabetes Institute 
UPMC 
University of Pittsburgh Medical Center 
US 
United States 
USPS 
United States Parcel Service 
 
 

6 
 
Note to Reviewers:  The health care professional portion of the study (related to the 
secondary objective and study aim 3) will be evaluated as a separate study submission. 
 
1 
OBJECTIVE, SPECIFIC AIMS, BACKGROUND, AND SIGNIFICANCE 
 
1.1 
Objective 
 
 Primary 
 
To demonstrate that patients who are trained on and use the MyDoseCoach titration (MDC-T) 
phone application (app) to titrate insulin will have greater improvements in hemoglobin A1c 
(HbA1c) and more likely to achieve glycemic control at 3 months as compared to usual care 
practice, and those who do attain glycemic goals, are able to maintain glycemic control for an 
additional 3 months using the MDC Maintenance (MDC-M) app. 
 
 Secondary 
 
To examine the feasibility of integrating digital solutions into clinical workflow and acceptability 
of MDC-T and MDC-M by health care professionals (HCPs) and patients. 
 
 Hypothesis 
 
Patients using MDC-T will reach individualized fasting plasma glucose (FPG) and HbA1c targets 
and MDC-M will help patients to maintain glycemic targets at 6 months from baseline. 
 
1.2 
Specific Aims 
 
 Aim 1 
 
To determine the effect of MDC-T on helping patients with T2DM, who are new to titrating 
insulin, to improve glycemic control and achieve target goals as compared to patients who titrate 
insulin with traditional usual care processes. 
 
 Aim 2 
 
To determine if patients with T2DM can maintain glycemic control when reaching target goals 
after using insulin titration guided by the MDC-T. 
 
 Aim 3 
 
To examine the feasibility of integrating digital solutions into clinical workflow and the 
acceptability of MDC (T and M) by HCPs and patients. 
 

7 
 
1.3 
Background 
 
 Type 2 Diabetes Mellitus and Challenges in Meeting Treatment Goals 
 
Despite the increasing body of knowledge of diabetes treatment strategies, a majority of 
patients with T2DM are still in a persistent state of poor glycemic control and unable to meet 
target goals [1]. Inertia surrounding insulin initiation and titration is a specific problem. 
Physicians may be reluctant to initiate and titrate insulin owing to a belief about patient risk, 
including associated concerns about patient competence, and resource issues [2,3]. 
 
Most patients with T2DM are seen in a primary care (PC) setting [4], which presents challenges 
in overcoming clinical inertia and facilitation of intensified therapies. A provider’s decision to 
delay therapy in many cases may be related to fears over inadequate time, educational 
resources and added workload [5-8]. A survey of physician attitudes found that they consider 
diabetes more difficult to treat than other chronic diseases as it requires more monitoring and 
medication adjustment to achieve treatment goals [7]. Physicians also report that there is 
inadequate support for the increased time and effort required for treating diabetes patients, and 
neither clinics nor patients can afford what it takes for comprehensive care [5-9].  
 
Various approaches have been proposed to help overcome clinical inertia, including support of 
patient self-management, and education for both physicians and people with diabetes [10-13]. It 
has been recommended that patient education should specifically target the concerns 
surrounding the intensification of therapy [14,15]. Our team conducted a 12-month cluster 
randomized controlled trial Practice Intensification via Office Transformation (PIVOT) to explore 
the feasibility and effectiveness of a diabetes care and education specialist (DCES)-led 
provider/patient intervention to support pharmacotherapy advancement in PC. Findings support 
the value of DCES-led education to reduce clinical inertia while highlighting the heterogeneity of 
practice models with recognition that clinical inertia in PC is a complex issue that requires 
continued exploration [13,16]. 
 
In an era of more tightly controlled health care resources, health systems and payers, including 
the University of Pittsburgh Medical Center (UPMC) and its’ integrated payer the UPMC Health 
Plan, have already begun to seek ways to examine approaches that shift roles and include non-
physician practitioners to address the problems. In partnership and supported by our own 
UPMC Health Plan, a Diabetes High Risk Program, was designed for diabetes patients at high 
risk for complications and unplanned care to receive DCES planned visits in underserved rural 
and urban practices. Two DCESs were introduced as members of PC teams, identified and 
provided individualized self-management education to DM patients considered at high risk (i.e., 
hemoglobin A1C >9%, DM-related emergency room visit or hospitalization, or reported barriers 
to care, e.g. medication adherence). Patients who participated in the program had significant 
improvements in glycemia that were sustained for one year [17].  
 
DCESs are well suited to support skills necessary to achieve glycemic target goals and 
considered experts in teaching patients medication taking skills [18,19]. Presently, paper-based 
guides are available in which clinicians/educators rely on to help their patients in determining 
and recording appropriate insulin doses. The paper-based titration tool is prepared as a 
worksheet with steps to determine the next insulin dose. Determining insulin doses in practice 

8 
 
today is often a matter of trial and error, as the dose is tailored to a patient’s individual 
therapeutic needs. A provider determines an appropriate dosage for the first time based on 
weight and blood glucose records. The patient is then expected to consult their provider and/or 
a DCES (if available) to teach him/her how to adjust the insulin dose, based on their BG levels 
and given a paper-based scale/algorithm to guide them on dose change doses. The patient is 
expected to assume the “lion’s share” of the effort to initiate and titrate insulin using their 
“worksheet” with limited or unpredictable follow up. Unfortunately, this process often sets the 
stage for reluctance and fear of insulin initiation and delays titration with implications for long-
term poor self-management and adherence. 
 
1.4 
Significance 
 
Appropriate titration of basal insulin and ensuring that patients adhere to health care 
professional (HCP) recommended therapeutic regimens is critical to the achievement and 
maintenance of glycemic targets in the management of T2DM. Therefore, Sanofi has developed 
the MDC (T&M) app for guiding titration  and supporting maintenance of therapy. 
 
 MyDoseCoach Application 
 
MDC is an FDA-approved digital solution comprising a smartphone app for people with T2DM 
and web portal for healthcare professionals (HCPs). The MDC Basal Titration Module (MDC-
T) provides a digital alternative to the manual titration model that is typically used for dose 
modification of longer-acting basal insulin for patients with T2DM. This allows the HCP to tailor 
the dosing instructions to the individual patient based on the HCP’s independent professional 
judgment. The HCP defines an individualized longer-acting basal insulin titration plan that is 
used in MDC to give dose recommendations to the user based on their FBG readings and 
hypoglycemic event data. MDC provides similar functionality as a paper-based tool, while 
automatically calculating the median FBG value and instructing the patient on the next 
appropriate insulin dose according to a dose plan and dose adjustment rules set by their HCP. 
 
The MDC app is also designed to support patients in maintaining proper insulin dosing to help 
ensure ongoing glycemic control. Like the titration module, the MDC Maintenance Module 
(MDC-M) is intended for use by HCP’s and patients to enable logging of insulin and non-insulin 
medication use and BG measurements and provide dosing and measurement reminders.  
 
2 
RESEARCH DESIGN AND METHODS 
 
2.1 
Classification and Methodological Designs 
 
This study is a 6-month open label non-randomized trial with a prospective intervention group 
and a retrospective usual care group that includes two phases: Phase 1 (titration) will be used to 
determine effectiveness of MDC-T during insulin titration after 3 months. This is followed by 
Phase 2 (maintenance), a 3-month observational period for patients from the intervention group 
who reach titration targets, to determine effectiveness of their use of the MDC-M in helping 
patients maintain their glycemic targets. An overview of the study design in shown in the 
following figure. 

9 
 
 
Figure 2.1. Study Design 
 
 
 
2.2 
Detailed Description of Study Design 
 
 Setting 
 
UPMC, headquartered in Pittsburgh, Pennsylvania, is one of the largest integrated health 
systems in the US, with more than 30 academic, community and specialty hospitals and 600 
outpatient sites serving diverse populations throughout the region and beyond. UPMC is closely 
affiliated with the University of Pittsburgh and together support training for medical residents, 
clinical trials and other academic research. UPMC’s reach and impact are extended through its 
Health Plan Insurer Services Division, which partners with UPMC and additional community 
network providers. UPMC is also a recognized innovator in health technology, including 
developing and applying data-driven approaches to provide patient-centered care. Central to 
these efforts is UPMC’s Clinical Data Warehouse that contains all data points documented 
within the EMR system for every patient entering a UPMC facility, including but not limited to 
office visits, hospitalizations, medications, labs, and geographical information. The Department 
of Clinical Analytics aims to empower UPMC’s health care professionals by providing access to 
interpretable visualizations of their own patient data. Such applications have facilitated both 
operational- and research-based endeavors, that ultimately improve patient care. For these 
reasons and more, UPMC provides an ideal “community laboratory” to examine methods that 
promote access and best practice to the patients it serves. 
 

10 
 
 Heath Care Providers 
 
HCPs who deliver diabetes care and education (e.g., endocrinologists, nurse practitioners, 
physician assistants and/or DCESs) at participating study sites will be invited to recruit/consent 
patients, train and support patients on use of the MDC, obtain study data as well as provide 
their own perspectives on the MDC app. Prior to initiating patient enrollment, participating HCPs 
will be fully trained on the MDC app and all study procedures, roles and responsibilities. 
 
 Intervention Group 
 
Phase 1 (Titration) 
Baseline Visit 
Patients assigned to the intervention group will meet with a DCES and receive insulin therapy 
education according to current standard of care procedures (e.g., how to use an insulin pen, 
when and where to administer insulin, etc.). Whereas DCESs typically provide patients with 
written titration instructions prepared by the physician provider, for the intervention, DCESs, 
another HCP and/or a trained clinical research coordinator will train patients to use MDC-T for 
titration guidance. The physician provider will prepare an individualized titration algorithm, 
including a dose plan and dose adjustment rules that will be embedded in MDC-T. The DCES, 
another HCP, and/or clinical research coordinator will demonstrate to the patient how to use the 
MDC Titration Module to determine and guide dosing adjustments. 
 
All patients will be asked to complete a baseline survey to assess behavioral and psycho-social 
factors that may influence diabetes self-management. In addition, patients will receive a three-
month supply of insulin pens (Lantus (U100) Solostar Pen or Toujeo (U300) Solostar Pen, as 
per treating Physician). 
 
Patients will be instructed to return for a three-month follow-up clinic visit, as is standard of care 
for patients new to insulin.  
 
Month 3 Visit 
At the three-month appointment, the DCES or another HCP will assess the patient’s 
experiences with titration and MDC-T, which will be documented using a study-specific survey. 
If the patient successfully reached their glycemic target, they will be invited to participate in 
Phase 2 of the study (maintenance).  
 
For those patients who do not reach target at 3 months, the DCES/HCP will partner with the 
patient (and physician provider, as needed) to assess the patient’s ability and interest in 
continued use of the MDC-T app and determine the best course of action (either return to usual 
care or continued participation in the study). If deemed eligible, the patient will continue to have 
access to the MDC-T app with continued guidance from their respective HCP, in regards to 
insulin therapy recommendations.  They will be asked to complete  follow-up surveys at months 
3 and 6, as well as permit access to pertinent medical record information (e.g., HbA1c values) 
for the duration of the study. Patients who stay in the study and continue to use the MDC-T app 
will receive another three-month supply of insulin pens (Lantus (U100) Solostar Pen or Toujeo 
(U300) Solostar Pen, as per treating Physician). 
 
 

11 
 
Phase 2 (Maintenance) 
Patients who are successful in reaching their glycemic target and agree to continue 
participation, will be transitioned into Phase 2 of the study at their three-month clinic visit. At this 
time, the HCP (endocrinology provider and/or DCES) will introduce and train patients how to 
use the MDC-M app to support glycemic control. Patients will receive another three-month 
supply of insulin pens (Lantus (U100) Solostar Pen or Toujeo (U300) Solostar Pen (as per 
treating Physician) and asked to return for the final follow-up visit at six months (routine clinic 
visit). They also will be asked to complete follow-up surveys at months 3 and 6 to assess 
changes in behavioral and psychosocial factors that influence diabetes self-management as 
well as their acceptability and satisfaction with their experience using the MDC app. When 
possible, surveys will be completed at clinic visits. However, surveys may also be made 
available electronically or via mail should visits occur remotely (e.g., via telemedicine) or a 
patient cannot complete at a face-to-face visit (e.g., time constraints). 
 
The DCES and endocrinology provider will be available throughout the course of the study to 
respond to any question or concerns that the patient may have regarding insulin titration, insulin 
dosing, and the MDC app specifically. 
 
 Usual Care Group 
 
A retrospective comparative group will be selected from eligible patients who previously were 
treated at the UPMC Diabetes Outpatient Clinics. This group was chosen for two reasons. First, 
patients seen at the UPMC Diabetes Specialty Outpatient Clinics have the most robust data 
available regarding insulin titration, including HbA1c and FBG and, for many patients, BG meter 
readings. Secondly, this particular group establishes a standard of specialty care against which 
to compare MDC and will uniquely inform the benefit of this digital tool. We postulate that if 
MDC produces outcomes, at the very least, equal to those of specialty practice, the likelihood of 
benefit to PC care is high. Patients in the usual care group will be identified using EMR data 
accessed through the UPMC Clinical Data Warehouse. As detailed in the Statistical Analysis 
Plan, propensity score matching will be used to pair intervention and usual care participants. 
 
 Study Calendar 
 
Study phase 
Phase 1 
(Titration) 
Phase 2 
(Maintenance) 
Visits 
1 
2 
3 
Time point Baseline 
3 Months 
6 Months 
Visit window 
 
±2 weeks 
±4 weeks 
Study Specific Procedures 
Informed Consent 
X 
 
 
Eligibility 
X 
 
 
MDC Installation and Education 
X 
X1 
 
 
 
 
 
Patient Surveys3 
X 
X 
X 
Health Care Provider Surveys4 
X 
X 
X 
Reports of Technical Issues 
 
X 
X 

12 
 
Clinical Care/EMR Data Abstraction 
Demographics5 
X 
 
 
Patient History6 
X 
 
 
Vital signs7 
X 
X 
X 
Lab work8 
X 
X 
X 
Self-monitoring blood glucose (SMBG) 
 
X 
X 
Provider visits (and Endocrinology 
escalation visits) 
 
X 
X 
Hypoglycemic events 
X 
X 
X 
Hospital stays 
X 
X 
X 
Adverse events 
X 
X 
X 
1. 
Education on MDC-M app only for those participants who were able to reach target FBG/A1c transition to 
maintenance. 
2. 
Diabetes Medication System Rating Questionnaire-Short Form (DMSRQ-SF), Diabetes Distress Scale 
(DDS17) at all time points; Usability and Satisfaction surveys as 3 and 6 months. 
3. 
Health care provider perspectives and experiences on insulin dosing survey at baseline and usability and 
satisfaction survey at 3 months and completion of the study. 
4. 
Participant name, age, gender, race, ethnicity, contact information, location, marital status, employment 
status, education level, health insurance information 
5. 
Diabetes duration, diabetes-related medication, diabetes-related hospitalizations, hypoglycemic events 
within the past year, co-morbidities 
6. 
Blood pressure, weight, BMI 
7. 
Fasting blood glucose, HbA1c, cholesterol, lipids (if available in clinical records); baseline values may have 
been collected and recorded up to nine months prior to study start (e.g., lipid panels are usually conducted 
once a year). 
2.3 
Insulin Management System 
 
Clinical and research components of clinical care are delineated in the table below. The 
information included in the “Routine Clinical Care (not on study)” column represents the routine 
care a patient with diabetes would undergo when starting an insulin regimen without being on a 
research study. The information in the “Routine Clinical Care (on study)” column represents the 
procedures the research participants will receive as routine clinical care while on this study and 
not related to the research component. The procedures in the “Study Research” column 
represents the investigational component of this research study being evaluated and would not 
be included as part of the patient’s routine clinical care. 
 
Table. Clinical and Research Components of Patient Visits 
 
Routine Clinical Care 
(not on study) 
Routine Clinical Care 
(on study) 
Study Research 
Phase 1 – 
Titration 
• 
Insulin pen (or 
syringe and 
needles) 
• 
Paper dosage 
algorithm 
• 
Blood glucose 
meter 
• 
Insulin pen (Lantus 
(U100) Solostar Pen 
or Toujeo (U300) 
Solostar Pen (as per 
treating Physician)) 
• 
Dosage algorithm 
• 
Blood glucose meter 
• 
Use of MDC-T app (to 
support insulin dosage 
algorithm) 
• 
 

13 
 
Phase 2 - 
Maintenance 
• 
Insulin pen 
• 
Blood glucose 
meter 
• 
Insulin pen (Lantus 
(U100) Solostar Pen 
or Toujeo (U300) 
Solostar Pen (as per 
treating 
Physician))Blood 
glucose meter 
• 
  
• 
Use of MDC-M app 
• 
 
 
 
 
 Phase 1 - Titration 
 
• 
Lantus (U100) Solostar Pen or Toujeo (U300) Solostar Pen (as per treating physician) 
• 
MyDoseCoach Titration App (MDC-T) 
• 
Blood Glucose Meter (any meter allowed) 
 
 Phase 2 - Maintenance 
 
• 
Lantus (U100) Solostar Pen or Toujeo (U300) Solostar Pen (as per treating physician) 
• 
MDC-M app 
• 
Blood Glucose Meter (any meter allowed) 
 
 
2.4 
Outcome Assessment 
 
The MDC app will be evaluated using a combination of clinical, behavioral, psychosocial, 
provider, patient and process measures, in addition to MDC analytics, as described in this 
section. 
 
 Clinical Data/EMR Abstraction 
 
Intervention Group 
Phase1 (Titration) Clinical: HbA1c will serve as the primary outcome and clinical measure to 
determine the impact of the MDC-T app on glycemic control from baseline to 3 months. Related 
measures to be collected will include: Change in FBG from baseline to 3 months, rate of 
patients who attained individualized titration target, the time it took to attain titration target and 
number and type of hypoglycemic events, which are defined as follows:  
 
• 
Mild/asymptomatic hypoglycemia – blood glucose <70 mg/dl and no symptoms; 
• 
Moderate/symptomatic hypoglycemia – blood glucose <70 mg/dl and symptoms; 
• 
Severe/symptomatic hypoglycemia – requires assistance of another person to 
resuscitate because blood glucoses are too low to maintain consciousness. 
 
Hypoglycemic data will be collected in the following ways:  
 
1) ask the patient to contact study team if/when it happens, 

14 
 
2) ask patient at each study visit, 
3) review of MDC information, 
4) review of EMR, 
 
Data will be collected on an AE form for each patient and reported if an SAE. In addition, blood 
pressure, cholesterol and BMI data will be retrieved from the patient’s EMR record. 
 
Phase 2 (Maintenance) Clinical: HbA1c will serve as the primary outcome to determine the  
longer term impact of MDC-M app on maintenance of glycemic control from 3 months to 6 
months for those patients achieving glycemic targets during the MDC-T titration phase. Related 
measures to be collected will include the number of patients who maintained individualized 
glycemic targets, change in FBG from 3 months to 6 months, and record of reported 
hypoglycemic events (following same definitions and data collection plan as described for 
Phase 1). Additionally, blood pressure, cholesterol and BMI data will be retrieved from the 
patient’s EMR record.  
 
All of the aforementioned data will be collected for the intervention group in accordance with the 
study calendar in section 2.2.5. 
 
Control Group 
A majority of the data is also expected to be available within the EMR for the control group. 
HbA1c, FBG, blood pressure, cholesterol, and BMI data should be recorded and accessible for 
patients. In addition, many patients also have BG meter readings. At a minimum, we will select 
patients who have HbA1c values that correspond to baseline [index date = date of insulin 
initiation] and follow-up time points/time frames that correspond with those described in the 
study calendar (section 2.2.5). EMR records, including notes, downloads, and related 
documented data will be reviewed to identify and classify hypoglycemic events according to 
already aformentioned definitions. 
 
 Health Care Provider/Clinical Workflow-Related Outcomes 
 
Clinician experiences and perspectives on insulin dosing previous to the study will be collected 
at baseline and the usability of and satisfaction with the MDC will be assessed through a study-
specific satisfaction survey (provider version). DCESs will keep logs detailing experiences 
(including triage/escalation to the need for an endocrinologist visit) and logistical issues, 
particularly those related to technology and disruption of workflow. In addition, at the end of the 
study, discussions s will be organized with UPMC HCPs and staff to review study findings and 
elicit additional perspectives on effective ways to integrate the app into clinical workflow in 
clinical practice. 
 
 Patient-Related Outcomes 
 
Patient usability of MDC to titrate insulin and maintain glycemic control will be tracked relying on 
the devices inherent data analytics. Patient satisfaction will be assessed using study specific 
acceptability and satisfaction surveys (patient version) and the validated Diabetes Medication 
System Rating Questionnaire-Short Form (DMSRQ-SF) [20]. Diabetes medication system refers 
to the medication taken as well as the devices and supplies required to administer the 
medication. The DMSRQ-SF includes 20 items to assess convenience, negative events, 

15 
 
interference, self-monitoring of blood glucose burden, efficacy, social burden, psychological 
well-being, treatment satisfaction and treatment preference [20]. 
 
Other patient data to be collected will include demographics, diabetes-related information (e.g., 
duration, medications, etc.), and their level of diabetes distress, which will be evaluated at 
baseline and follow-up with the 17-item Diabetes Distress Scale (DDS17). The DDS17 
assesses four dimensions of distress – emotional, regimen, interpersonal and physician [21], 
and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and 
physical activity in multiple samples of patients with T2DM [22]. 
 
 
2.5 
Study Endpoints 
 
 Primary Endpoint 
 
Change in HbA1c at 3 months as compared to patients using standard of care. 
 
 Secondary Endpoints 
 
2.5.2.1 Phase 1 (Titration) 
 
• 
Change in HbA1c from baseline to 3 months within and between groups 
• 
Proportion of patients reaching HbA1c <7% at 3 months as compared to patients using 
SOC 
• 
Change in FPG from baseline to 3 months within and between groups 
• 
Patient-reported changes in behavioral and psychosocial outcomes from baseline to 3 
months (survey) 
• 
Patient-reported acceptability of and satisfaction with MDC-T (survey) 
• 
Provider-reported acceptability of and satisfaction with MDC-T (survey) 
• 
Rate of escalation to Endo (Endocrine visits) for patients using MDC-T  
• 
Safety end points (including hypoglycemia, any untoward adverse events) 
• 
Number and type of technical complaints 
 
2.5.2.2 Phase 2 (Maintenance) 
 
• 
Proportion of patients maintaining their individualized HbA1c goal at 6 months as 
compared to the number of patients at target HbA1c at start of maintenance phase 
(month 3) 
• 
Proportion of patients maintaining HbA1c <7% at 6 months compared to number of 
patients at target HbA1c <7% at start of maintenance phase (month 3) 
• 
Change in HbA1c from baseline and 3 months to 6 months 
• 
Change in FPG from baseline and 3 months to 6 months, if available 
• 
Adherence to HCP recommended treatment plan 
• 
Patient-reported changes in behavioral and psychosocial outcomes from baseline or 3 
months to follow up time points (survey) 
• 
Safety end points (including hypoglycemia, AEs) 

16 
 
• 
Number and type of technical complaints 
 
2.6 
Statistical Analysis 
 
 Power and Sample Size Justification 
 
The primary objective of this study is to estimate the difference in HbA1c between the study 
treatment groups at 3 months. The sample size justification is based on precision estimate (i.e., 
confidence interval for the HbA1c difference between groups). The expected standard deviation 
for the 3-months change from baseline in HbA1c is 1.5. With 109 patients in the interventional 
arm and 109 patients in the retrospective control arm, the treatment effect, expressed as the LS 
means difference between arms, would be estimated with an expected precision of ± 0.40. 
Additionally, this sample size allows for a sufficient number of patients after drop-out, loss to 
follow-up and/or missing data to enter the maintenance phase (Phase 2) of the study. Based on 
previous research and experiences with insulin titration, an anticipated 70% of patients (n=76) 
will enter Phase 2 of the study. 
 
 Data Analysis 
 
Patients will be matched 1:1 on a propensity score based on baseline demographics and clinical 
characteristics to improve the comparability of the interventional and retrospective groups. A 
logistic regression model will be used to estimate the propensity score and those baseline 
variables that influence treatment assignment will be included in the model. In this analysis, the 
following variables will be used to calculate the propensity score: age, gender, baseline BMI and 
baseline HbA1c. Other factors that may be included are race and number of comorbid 
conditions. Once the propensity score is calculated, a greedy nearest neighbor algorithm will be 
used for matching to form pairs of subjects from intervention and control groups with similar 
propensity scores. This means that for a given treated subject, the closest untreated subject 
within the specified caliper distance is selected for matching to the treated subject. 
  
Descriptive statistics (e.g., demographics, duration of diabetes, etc.) will be used to describe the 
study groups. Baseline comparisons will be examined using standardized mean differences. A 
linear mixed model will be used to adjust the fixed effect of baseline FBG and the random effect 
of matched pairs, allowing to estimate the treatment effect with 95% CI.  .  Generalized 
estimating equations (GEE) for binary outcomes will be for binary outcomes to compare the 
change in slopes of outcomes of interest between the two groups and account for matched pairs 
. In addition, for the intervention group only, descriptive statistics will be used to summarize 
other data (e.g., patient and provider surveys, MDC metrics, etc.), and thematic analysis of any 
qualitative findings will be made.  
 
Phase 1 (Titration): For the intervention group only, using a descriptive statistical approach, a 
primary assessment of titration outcomes will be built into the study at 3 months to evaluate the 
MDC-T app using a combination of clinical data, provider and patient feedback and process 
data (including patient/provider study-specific efficiency and satisfaction surveys, DE logs, 
validated DMSRQ-SF and MDC analytics). 
 

17 
 
Phase 2 (Maintenance): For the intervention group only, using a descriptive statistical 
approach, an assessment of maintenance outcomes will occur to compare the percentage of 
patients at goal between the study treatment group at 6 months. Clinician and patient 
experiences and perspectives on the usability of and satisfaction with MDC-M will be assessed 
through various means including study-specific efficiency and satisfaction surveys. 
 
 
3 
HUMAN SUBJECTS 
 
3.1 
Subject Population 
 
Intervention participants will be identified in a consecutive manner at participating UPMC 
community-based PC practices, outpatient clinics and inpatient units. Study participants will 
include adult male and female T2DM patients, 18 to 75 years old, with T2DM and suboptimal 
glycemic control (HbA1c > 7.5%) who are recommended to start titrating basal insulin and 
willing and able to use the MDC app. 
 
The retrospective comparative group will be selected from eligible patients who previously were 
treated at the UPMC Diabetes Outpatient Clinics. This group will be chosen for two reasons. 
First, patients seen at the Diabetes Outpatient Clinic have the most robust data available 
regarding insulin titration, including HbA1c and FBG and, for many patients, BG meter readings. 
Secondly, this particular group establishes a standard of specialty care against which to 
compare MDC and will uniquely inform the benefit of MDC. Patients in the usual care group will 
be identified using EMR data accessed through the UPMC Clinical Data Warehouse. 
 
3.2 
Inclusion Criteria 
 
 Intervention Group 
 
• 
Patient receiving care at a UPMC Diabetes Outpatient and/or Inpatient settings 
• 
Adult male and female patients 18 to 75 years old 
• 
HbA1c > 7.5% 
• 
Recommended to start self titration of basal insulin 
• 
Access to and able to use an iOs or Android enabled device and have reliable internet 
access 
• 
Willing and able to use the MDC app 
• 
Able to comprehend basic diabetes survival skills, signs and symptoms of hypoglycemia 
and treatment of BG 
 
 Usual Care Group 
 
• 
Adult male and female patients 18 to 75 years old 
• 
HbA1c > 7.5% 
• 
Started on basal insulin in a UPMC Diabetes Outpatient facility within the past three 
years of study start  

18 
 
• 
Has blood glucose data available in EMR (At least two HbA1c measurements 
corresponding to baseline and a subsequent time point after insulin titration) FBG 
readings) 
 
3.3 
Exclusion Criteria 
 
• 
Pregnant or breastfeeding  
• 
Patients unwilling to use MDC app 
 
4 
IRB APPROVAL 
 
The Investigator will obtain, from the University of Pittsburgh Institutional Review Board (IRB), 
prospective approval of the clinical protocol and corresponding informed consent form(s); 
modifications to the clinical protocol and corresponding informed consent forms, and 
advertisements (i.e., directed at potential research subjects) for study recruitment. 
 
The only circumstance in which a deviation from the current IRB-approved clinical 
protocol/consent form(s) may be initiated in the absence of prospective IRB approval is to 
eliminate an apparent immediate hazard to the research subject(s). In such circumstances, the 
Investigator will promptly notify the University of Pittsburgh IRB of the deviation. The 
Investigator should also notify the sponsor of this event. 
 
The University of Pittsburgh IRB operates in compliance with FDA regulations at 21 CFR Parts 
50, 56 and 812, also in conformance with applicable International Conference on Harmonization 
(ICH) Guidelines on Good Clinical Practice (CGP). 
 
5 
RECRUITMENT AND INFORMED CONSENT PROCEDURES 
 
5.1 
Recruitment Methods 
 
 Intervention Group 
 
Intervention participants will be identified at participating UPMC community-based PC practices, 
outpatient clinics and inpatient units. A diabetes healthcare provider or staff member (e.g., 
endocrinologist, PCP, DCES) will identify patients who meet the following inclusion criteria – 
age, elevated HbA1c, and recommended to start basal insulin – and briefly introduce the patient 
to the study. The patient may be identified first from a clinic schedule or during the course of 
their visit. If the patient is interested in learning more about the study, a study investigator (who 
may also be a diabetes healthcare provider) will provide a more thorough description and a 
copy of the informed consent for review. 
 
 Health Care Group 
 
HCPs (provider participant) who already provide diabetes care and education as part of the 
patient’s routine clinical care will be involved in recruiting individuals for participation in this 
research study. The PI will formally invite HCPs to join the study, either in person or 
electronically (via email). A brief overview of the study, the risks and an explanation of their 

19 
 
involvement will be discussed with the potential provider participant. The PI, who is a nurse and 
DCES, works with and familiar with the HCPs that will be invited to be the provider participants 
for this study. If an HCP is interested in participating, they will be presented with the consent 
form. 
 
 
5.2 
Participant Informed Consent Procedures 
 
There are 3 options for obtaining consent: 
 
1) Consent process may take place within the diabetes outpatient or primary care setting 
(Diabetes endocrine satellite clinics or participating primary care sites) or during an 
inpatient stay. 
2) Consent process may take place by videoconferencing. 
3) Consent process may take place by telephone. 
 
Consent will be obtained prior to performing any of the research interventions/interactions. 
 
 Consenting in the Outpatient Practice or Inpatient Setting 
 
Potential participants will be presented with the research study and if interested will be 
presented with the informed consent form. If a potential participant is identified prior to an 
outpatient clinic visit, they may be presented with the research study by phone and if interested 
the consent may be sent to them by mail or email for them to review prior to their clinic visit. 
 
Potential participants are ensured that their decision to participate is totally voluntary and in no 
way will jeopardize their diabetes care or education services. Patients will be given sufficient 
time to come back to the study team regarding any questions that they may have and their 
decision. After reading/explaining the consent and study procedures, the study team member 
will ask the participant if they have any questions (general) and then re-review the study 
procedures one more time to ensure that they are fully understood. 
 
 Process for Videoconferencing Consenting 
 
• 
Study staff sends two copies (one to send back and one to keep) of the consent (via 
email or USPS) to the potential participant and schedules a video diabetes education 
visit to occur about a week later. In addition to the consent forms, they will also be 
provided a self-addressed, stamped envelope. 
• 
During the video visit, the participant must have a hard copy in front of them as the study 
staff reads it, and if they agree, will sign in front of the study staff by video. 
• 
The participant will hold up their signed signature page and study staff will take a “screen 
shot” – print it out to be attached to the study staff signed consent form. Another option 
is for the patient to take a picture of their signed signature page and upload into their 
MyUPMC account for the study staff to access. 
• 
The participant will be instructed to mail their original signed copy of the consent form to 
study staff using the self-addressed, stamped envelope. 

20 
 
• 
Research procedures can start via video visit after the study staff gets the screen shot of 
the participants signature page. 
 
Potential participants are ensured their decision to participate is totally voluntary and in no way 
will jeopardize their diabetes care or education services. Patients will be given sufficient time to 
come back to the study team regarding any questions that they may have and their decision. 
After reading/explaining the consent and study procedures, the study team member will ask the 
participant if they have any questions (general) and then re-review the study procedures one 
more time to ensure that they are fully understood. 
 
6 
POTENTIAL RISKS AND BENEFITS 
 
6.1 
Potential Risks 
 
The potential risks associated with participation in the study are of low frequency and of 
low/acceptable risk level. 
 
There is little likelihood of physical risk because of participation in this study. Patients will not 
undergo any clinical procedures beyond those used during usual diabetes care. Collection of 
clinical data will follow usual care procedures and be performed by trained clinical staff. As is 
usual, patients may experience some physical discomfort during clinical procedures. 
 
MDC is prescribed by the HCP with a therapy plan. A detailed risk analysis (user and product) 
has been conducted to evaluate all possible risks to the end user. An example of such a risk is 
how likely an overdose, attributed to an incorrect dose recommendation, will lead to serious 
hypoglycemia. 
 
All such risks have been mitigated in the design of all the products and/or via risk control 
measures to prove that the produce is safe for use. 
 
 
Within the context of this study, a favorable benefit-risk balance for the provided Sanofi 
medicinal products (Toujeo and Lantus) is already well established. The use of both drugs in 
this study is according to the approved National Product Label.  
 
Patients are at low risk for psychological harm as no research procedures are performed in 
addition to usual care except for the addition of technological support and the administration of 
questionnaires. The only potential risk is that patients may not fully understand the technology 
process or experience frustration. Clinical personnel will be asked questions that have low 
psychological risk and may refuse to provide answers to any questions they are not comfortable 
answering or if in any way they feel that answering questions may jeopardize their employment 
or practice communications. Clinical personnel also run the potential risk of frustration with the 
technology process or perceive additional burden or experience disappointment with any 
unintended technological challenges in the process. 
 
There is little social risk associated with this study. Patients are at low risk to social harm as no 
research procedures are performed in addition to usual care except for the addition of the 

21 
 
technology. For clinical personnel, questions will not go beyond the topic of healthcare delivery. 
HCP participants may perceive that feedback may be used to rate their performance; however, 
this is not the case and all responses will be kept anonymous. HCP participants may find the 
additional of technology to pose a potential disruption in office workflow. 
 
There is a small possibility of a breach of confidentiality. Procedures will be put in place to 
minimize this risk. All participant questionnaires will be de-identified and kept in a double locked 
environment (paper questionnaires) or a secure server (electronic questionnaires). 
 
6.2 
Alternative Treatments 
 
Patients who decline participation in this study will receive usual care for insulin dosing.   
 
6.3 
Potential Benefits 
 
This study may contribute to the participants’ ability to better self-manage their diabetes and 
provide valuable information on a process that has the potential to add evidence for broad best 
practice guidelines and policy. We are enthusiastic about the opportunity to implement a model 
MDC app that helps patients perform titration effectively to achieve their target goal and 
maintain improvement as compared to the current manual practice. 
 
7 
RISKS MANAGEMENT PROCEDURES 
The nature of this study places patients at low risk to physical, psychological or social harm. 
Patients will not undergo any procedures beyond usual care except for the addition of access to 
clinical, health, and self-management support delivered through technology. Patients and clinical 
personnel who participate will be free to refuse to respond to any survey questions. All responses 
will be kept anonymous and not linked to any identifying information. 
 
Only the minimum amount of data necessary for answering the proposed research questions will 
be extracted from the medical records. Patients will be assigned unique, study-specific identifiers. 
No clinical data will be linked to medical record numbers. A file linking patients to subject identifiers 
will be stored separately and securely from de-identified patient clinical data. Clinician participant 
data will be collected anonymously. Any identifying information will be eliminated from surveys. 
All research data will be stored on encrypted and password protected network drives. Access to 
patient-level data will be limited to members of the research team involved in data collection. All 
other members of the research team will review de-identified data. 
 
All research interventions/activities will be conducted in private. The collection of sensitive 
information about subjects is limited to the amount necessary to achieve the aims of the 
research, so that no unneeded sensitive information is being collected. 
 
Any paper records with patient identifying information will be store behind a double locked 
environment. An electronic password-guarded study database may be used under the 
supervision of the Investigator for this protocol with data being entered anonymously with a 
subject code behind a UPMC and/or University of Pittsburgh’s secure computer server. 
Information linking subject identifiers with the coded subject number will be stored under 
password protection on computers in locked areas, with access only to the database manager. 

22 
 
All staff will sign confidentiality statements. Access to the database will be limited to the data 
manager and staff under the supervision of the Investigator. 
 
All staff involved in this study are properly credentialed and instructed in the areas of testing, 
confidentiality, and safety.  
 
The PI will retain the data for the entire period of this study and will retain the specified records 
and reports for up to seven years at least seven years after final reporting or publication of the 
study. If the subject and/or legal representative decide to withdraw or be withdrawn from study 
participation, they may request that the study data and samples be destroyed. Subject names or 
other directly identifiable information will not appear on any reports, publications, or other 
disclosures of clinical study outcomes. 
 
8 
REPORTABLE EVENTS 
 
Each patient will be carefully monitored for adverse events by the investigator. 
 
8.1 
Definitions 
 
 Adverse Event (AE):  
 
Any untoward medical occurrence in a patient or clinical investigation subject administered a 
product and which does not necessarily have to have a causal relationship with this intervention. 
 
 Adverse Event of Special Interest (AESI) 
 
An adverse event of special interest (AESI) is an adverse event (serious or non-serious) of 
scientific and medical concern specific to the Sponsor’s product or program, for which ongoing 
monitoring and rapid communication by the Investigator to the Sponsor may be appropriate. Such 
events may require further investigation in order to characterize and understand them. AESIs may 
be added or removed during a study by protocol amendment. 
 
The AESIs are listed below: 
• 
Pregnancy of a female subject entered in a study as well as pregnancy occurring in a 
female partner of a male subject entered in a study with Sanofi medicinal products or 
devices; 
o Pregnancy occurring in a female participant entered in the clinical trial or in a 
female partner of a male participant entered in the clinical trial. It will be qualified 
as an SAE only if it fulfills one of the seriousness criteria. 
o In the event of pregnancy in a female participant, Sanofi medicinal products or 
devices should be discontinued. 
o Follow-up of the pregnancy in a female participant or in a female partner of a 
male participant is mandatory until the outcome has been determined 
• 
Symptomatic overdose (serious or non-serious) associated with Sanofi medicinal 
products or devices. An overdose (accidental or intentional) associated with the Sanofi 
medicinal product or devices is an event suspected by the Investigator or spontaneously 
notified by the participant (not based on systematic drug count) and defined as any dose 

23 
 
administration which, in the Investigators opinion based on clinical judgment, is 
considered significantly greater than the prescribed dose of insulin. 
 
Of note, asymptomatic overdose has to be reported as a standard AE. 
 
 New Safety Finding 
 
Any (other than reportable individual case safety report (ICSR)) safety issue that may require 
expedited reporting because providing information that may lead to a change in the known risk-
benefit balance for the product and as mentioned, but not limited to, in the following regulatory 
texts: Europe: Good Pharmacovigilance Practices, modules VI and VII; and US: FDA: 21 CFR 
Parts 312 Investigational New Drug Application- Section 312.32, (c) (1) IND safety reports. 
 
 Related Adverse Event, i.e. Adverse Drug Reaction (ADR) 
 
There is a reasonable possibility according to the External Sponsor that the product may have 
caused the event. 
 
 Serious adverse event (SAE) 
 
Any untoward medical occurrence that at any dose:  
• Results in death 
• Is life threatening, (Note: the term “life-threatening” refers to an event/reaction in which the 
patient was at risk of death at the time of the event/reaction; it does not refer to an event/ 
reaction which hypothetically might have caused death if it were more severe) 
• Requires inpatient hospitalization or results in prolongation of existing hospitalization 
• Results in persistent or significant disability/incapacity 
• Is a congenital anomaly/birth defect, or 
• Is a medically important event or reaction. Medical and scientific judgment should be 
exercised in deciding whether other situations should be considered serious, such as 
important medical events that might not be immediately life-threatening or result in death 
or hospitalization, but might jeopardize the patient or might require intervention to prevent 
one of the other outcomes listed in the definition above. 
 
 Unexpected related Adverse Event, i.e. Unexpected Adverse Drug Reaction (ADR) 
 
An adverse reaction, the nature or severity of which is not consistent with the applicable product 
information (e.g., Investigator's Brochure for an unapproved investigational medicinal product or 
package insert/summary of product characteristics for an approved product). An expected ADR 
with a fatal outcome should be considered unexpected unless the local/regional product labeling 
specifically states that the ADR might be associated with a fatal outcome. 
 
 Device Deficiencies 
 
All inadequacies related to the identity, quality, durability, reliability, safety or performance of the 
medical device including malfunctions, use errors, and inadequate labelling. 
 

24 
 
 Unanticipated Serious Adverse Device Effect 
 
Serious adverse device effect which by its nature, incidence, severity or outcome has not been 
identified in the current version of the risk analysis report, or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or welfare of subjects. 
 
 Medical Device Reporting reportable event 
 
• 
An event that user facilities become aware of that reasonably suggests that a device has 
or may have caused or contributed to a death or serious injury or 
• 
An event that manufacturers or importers become aware of that reasonably suggests 
that one of their marketed devices: 
• 
May have caused or contributed to a death or serious injury, or 
• 
Has malfunctioned and that the device or a similar device marketed by the 
manufacturer or importer would be likely to cause or contribute to a death or serious 
injury if the malfunction were to recur. 
 
8.2 
Obligations and Responsibilities of the External Sponsor 
 
The External Sponsor shall be responsible for transmitting to Sanofi all AE’s occurring with the 
use of Sanofi medicinal products. 
 
All complaints and adverse events will be managed and reported in compliance with all 
applicable regulations and included in the final clinical study report. 
 
For the intervention group: 
• 
All AEs, regardless of seriousness or relationship to Sanofi Medicinal product and study 
medical devices (e.g., MDC app), spanning from the signature of the informed consent 
form until the end of the study as defined by the protocol for that patient, are to be 
recorded on the corresponding page(s) or screen(s) of the CRF. 
• 
Any defect in the device or medical device complaint, with AE must be reported within 24 
hours in case of potential Adverse Event or Serious Adverse Event or without AEs must 
be reported within 5 days by the Investigator in order for a product technical complaint to 
be completed.  Appropriate information (e.g., samples, labels, or documents such as 
pictures or photocopies) related to product identification and product deficiencies may 
need to be gathered.  The investigator will assess whether or not the quality issue has to 
be reported together with an AE or SAE. 
• 
Whenever possible, diagnosis or single syndrome should be reported instead of 
symptoms. The Investigator should specify the date of onset, intensity, action taken with 
respect to Sanofi Medicinal product or Medical Device, corrective treatment/therapy 
given, additional investigations performed, outcome, and his/her opinion as to whether 
there is a reasonable possibility that the AE was caused by Sanofi Medicinal product(s), 
Medical Device or by the study procedure(s).  
• 
The Investigator should take appropriate measures to follow all AEs until clinical 
recovery is complete and laboratory results have returned to normal, or until progression 
has been stabilized, or until death, in order to ensure the safety of the patients. This may 
imply that observations will continue beyond the last planned visit per protocol, and that 

25 
 
additional investigations may be requested by the monitoring team up to as noticed by 
the Sponsor.  
• 
When treatment is prematurely discontinued, the patient’s observations will continue 
until the end of the study as defined by the protocol for that patient. 
• 
Laboratory, vital signs abnormalities are to be recorded as AEs only if:  
- 
Symptomatic and/or  
- 
Requiring either corrective treatment or consultation, and/or  
- 
Leading to Lantus (U100) or Toujeo (U300) discontinuation or modification of 
dosing, and/or  
- 
Fulfilling a seriousness criterion, and/or  
- 
Defined as an AESI 
For the retrospective control group: 
The Sponsor will transmit at the time of the analysis and at the latest the time of study report to 
Sanofi safety signals or conclusions with potential safety impact if any, based on data 
documented within the EMR. 
 
 Reporting Serious Adverse Events 
 
SAEs will be reported as follows: 
• 
SENDING (within 24 hours, preferably by fax or e-mail) the signed and dated 
corresponding page(s) from the CRF to the representative of the monitoring team 
whose name, fax number and e-mail address appear in the clinical trial protocol 
• 
ATTACHING a photocopy of all examinations carried out and the dates on which 
these examinations were performed. Care will be taken to ensure that the patient's 
identity is protected and the patient's identifiers in the clinical trial will be properly 
mentioned on any copy of a source document provided to the Sponsor. For 
laboratory results, the laboratory normal ranges will be included 
• 
All further documentation will be sent to the monitoring team within 24 hours of 
knowledge of the SAE. In addition, every effort will be made to further document any 
SAE that is fatal or life threatening within a week (7 days) of the initial notification. 
 
Any SAE brought to the attention of the Investigator at any time after the end of the study for the 
patient and considered by him/her to be caused by the Sanofi Medicinal product(s)/study 
medical devices with a reasonable possibility, will be reported to the monitoring team. 
 
 Reporting Adverse Events of Special Interest 
 
For AESIs, the Sponsor will inform Sanofi immediately (i.e., within 24 hours), as per SAE 
notification guidelines described previously 
 
8.3 
Sanofi Pharmacovigilance Contact 
 
Fax/emails to be adapted in the final contract:  
Email: CL-CPV-Receipt@sanofi.com 
Or  
Fax: to +33 1 60 49 70 70 

26 
 
 
8.4 
Sanofi Product Technical Complaint Contact 
 
Fax/emails to be adapted in the final contract: 
Email: customerservice@agamatrix.com 
Or  
Fax: to 1-866-906-4197 
 
9 
DATA SAFETY MONITORING 
 
9.1 
Data Safety Monitoring Plan 
 
A data and safety monitoring plan (DSMP) will be implemented by the PI to ensure that the 
confidentiality of the research data is maintained. The data and safety monitoring plan for the 
research information will involve quarterly monitoring by the PI of 1) the removal of direct 
identifiers from information contained within the electronic research database; 2) the security of 
the database linking the electronic research database linkage codes with subject identifiers; and 
3) any conditions that may negatively impact the confidentiality of information contained within 
the electronic research database. In addition to the DSMP meetings, the research team will hold 
meetings to discuss the study (e.g., study goals; progress in data collection, coding, and 
analysis; identification and documentation of adverse events or subject complaints; violations of 
confidentiality) and address any issues or concerns at that time. The research staff will also 
submit annual reports to the IRB at the time of annual renewals. 
 
Sharing of data generated by this project is an essential part of our proposed activities and will 
be carried out in several different ways. We would wish to make our results available both to the 
community of scientists and health care providers interested in diabetes and ways to support 
patients in successful diabetes self-management. Specifically, we intend to present at 
national/international scientific meetings (e.g., the American Diabetes Association’s Scientific 
Sessions), and in peer-reviewed journals (e.g., the DCES). In addition, we will also present our 
findings to local health care providers to inform best practices of diabetes care. 
 
Data confidentiality will be closely supervised. All paper-based files will be stored in a locked file 
cabinet with limited access. 
9.2 
Frequency of Monitoring 
 
The PI will review subject safety data as it is generated. The PI, sub-investigators, and the 
research staff will meet at least monthly to re-evaluate study goals, subject recruitment, data 
coding and retention, documentation and identification of adverse events, complaints and 
confidentiality of subjects. There will be an evaluation of the progress of the research study, 
including assessments of data quality, timelines, participant recruitment, accrual, and retention. 
The PI will also review the outcome and adverse event data to determine whether there is any 
change to the anticipated benefit-to-risk ratio of study participation and whether the study should 
continue as originally designed or should it be re-evaluated and changed. 
 
10 WITHDRAWAL OF SUBJECTS 

27 
 
 
Participation in this research is completely voluntary. An individual’s decision whether or not to 
participate in this research, or to later withdraw from it, will not affect his/her current or future 
medical care at UPMC or the relationship with the University of Pittsburgh. If a participant 
chooses to withdraw, any information collected about the participant up until the time of 
withdrawal will be kept, but no additional information will be collected. 
 
Study investigators may choose to remove participants from the study if a participant is advised 
by their health care provider to discontinue insulin therapy or if a participant is no longer able to 
act independently to follow study procedures due to such reasons as mental/cognitive 
incapacity or moved to assisted living. 
 
In addition, a subject may be considered “lost to follow” if they cannot be reached. Every 
attempt will be made to contact these participants and after 3 failed attempts a certified letter will 
be sent to the participant. 
 
11 COSTS AND PAYMENTS 
 
11.1 Costs 
 
Item 
Cost/Supplier 
MyDoseCoach App (Titration and Maintenance) 
Available free of charge from either the 
Google Play Store for android devices 
or App Store for iOS Apple devices 
Lantus (U100) Solostar Pen or Toujeo (U300) 
Solostar Pen 
Supplied free of charge by Sanofi 
 
 
 
11.2 Payments 
 
Patients will receive $20 for completing the baseline survey and $50 for each completed survey 
at 3 and 6 months. In addition, $100 per participant will be allotted for HCPs as remuneration for 
their time spent on study-related activities (e.g., consenting participants, survey administration, 
instructing patients on MDC, etc.). 
 
 
 
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