Diabetes Management Program for Hispanic/Latino
Phase: NA
Conditions: Type 2 Diabetes Mellitus, Type 2 Diabetes
Sponsor: Northwell Health

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RESEARCH PROTOCOL 
 
 
Protocol Title: 
Patient and Caregiver-Centered Diabetes Telemanagement 
Program for Hispanic/Latino Patients 
Principal Investigator: 
Renee Pekmezaris, PhD 
Vice President,  
Community Health & Health Services Research 
Division of Health Sercvices Research 
Department of Medicine 
Center of Health Innovations and Outcomes Research 
Northwell Health 
600 Community Drive 4th Floor 
Manhasset, NY 11030 
Voice (516) 600 – 1402 
Fax (516) 600 – 1508 
rpekmeza@northwell.edu 
Primary Contact Name: 
Myia Williams, PhD 
Primary Contact Phone: 
516-600-1485 
Primary Contact E-mail: 
Mwilliam26@northwell.edu 
IRB Number: 
19-0002 
Sponsor: 
Patient Centered Outcomes Research Institute (PCORI) 
 
 
Guidelines for Preparing a Research Protocol 
 
Instructions: 
 
• You do not need to complete this document if you are submitting an Application for 
Exemption or Application for a Chart Review.   
• Do not use this template if: 
o  Your study involves an FDA regulated product.  In this case, use the Clinical 
Trial Protocol Template. 
o Your study has a protocol from a sponsor or cooperative group.  In this case, use 
the Protocol Plus.   
o Your study is a registry or repository for data and/or samples,  In this case, use 
Protocol Template – Registry Studies.  .   
• If a section of this protocol is not applicable, please indicate such. 
• Do not delete any of the text contained within this document. 
• Please make sure to keep an electronic copy of this document.  You will need to use it, if 
you make modifications in the future.   
• Start by entering study information into the table above, according to these rules: 
o Protocol Title:  Include the full protocol title as listed on the application. 
o Investigator:  include the principal investigator’s name as listed on the application 
form 
 

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o Date Revised:  Indicate the date at which the protocol was last revised 
o IRB Number:  Indicate the assigned IRB number, when known.  At initial 
submission, this row will be left blank.   
• Once the table information in entered, proceed to page 2 and complete the rest of the 
form. 
 
 
 Continue to next page to begin entering information about this study  
 
 
1.  PREVIOUS STUDY HISTORY 
 
Has this study ever been reviewed and rejected/disapproved by another IRB prior to 
submission to this IRB? 
 
 No  
 Yes −  if yes, please explain:  
 
 
2. BRIEF SUMMARY OF RESEARCH 
• The summary should be written in language intelligible to a moderately educated, 
non-scientific layperson.  
• It should contain a clear statement of the rationale and hypothesis of your study, a 
concise description of the methodology, with an emphasis on what will happen to the 
subjects, and a discussion of the results.  
• This section should be ½ page 
 
 
Over half of Hispanic/Latino (H/L) patients will develop types 2 diabetes (T2D) 
during their lifetime.1 According to the Center of Disease Control (CDC), T2D is a 
leading cause of suffering and death due to cardiovascular disease, end-stage 
renal failure, blindness, non-traumatic lower limb amputations, hospitalizations, 
and poor QoL.2 The risk of dying for people with T2D is twice that of those without 
T2D.1  In the US, the prevalence in H/L males 65-74 is 31.1%; for H/L females, it is 
32.6%.3 Compared to non-H/L whites, the risk of diagnosed T2D is 66% higher 
among H/L.4 The National Academy of Medicine (NAM) indicates that H/L 
experience a 50–100% higher illness burden and mortality from T2D than non-H/L 
whites and that T2D remains poorly managed.4 The literature unequivocally shows 
that racial/ethnic minorities with T2D have poor access to healthcare and lower 
levels of T2D management.9–12 
Diabetes Telehealth Management (DTM) improves important outcomes, 
such as glycemic management (GM) and quality of life (QoL). It is yet unknown 
whether these results generalize to Hispanic/Latino (H/L) disadvantaged 
populations with Type 2 Diabetes (T2D), primarily when utilizing community-based 
participatory research (CBPR)26 approaches involving patients, caregivers, 
providers and other stakeholders in the process of adapting the intervention. The 

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proposed research has great potential to enhance evidence quality, empowering 
disadvantaged patients with T2D to make informed health decisions and improve 
outcomes. The study is designed to iteratively tailor DTM to the specific needs of 
the H/L patients, caregivers, and providers. It addresses several access issues 
consistently identified in disparities research and has the potential to improve 
adherence through increased engagement. Our goal is to compare DTM to 
comprehensive outpatient management (COM) on critical patient-centered 
outcomes. Both are based on 2018 American Diabetes Association (ADA) 
guidelinees.25 We propose a multiphase mixed method,27 CER RCT to: 
 
Specific Aim 1: Assess usability of an evidence-based DTM intervention 
utilizing a CBPR approach26 and adapt it to facilitate acceptability and 
feasibility in a population of H/L patients with T2D, and their caregivers and 
providers.  
 
Specific Aim 2: Assess whether H/L patients receiving DTM attain 
significantly improved patient-centered outcomes compared to COM, 
through a CER RCT. Expected outcomes include improved diabetes QoL, 
GM, blood pressure (BP), cholesterol, medication adherence, and diabetes 
self-efficacy (SE), and reduced diabetes distress, problem areas in diabetes 
(PAID), inpatient utilization, unscheduled T2D physician visits and sick days. 
 
 
 
3. INTRODUCTION/BACKGROUND MATERIAL/PRELIMINARY STUDIES AND 
SIGNIFICANCE 
• Describe and provide the results of previous work by yourself or others, including 
animal studies, laboratory studies, pilot studies, pre-clinical and/or clinical studies 
involving the compound or device to be studied.  
• Include information as to why you are conducting the study and how the study differs 
from what has been previously researched, including what the knowledge gaps are. 
• Describe the importance of the knowledge expected to result 
 
Over half of Hispanic/Latino (H/L) patients will develop types 2 diabetes (T2D) 
during their lifetime.1 According to the Center of Disease Control (CDC), T2D is a 
leading cause of suffering and death due to cardiovascular disease, end-stage 
renal failure, blindness, non-traumatic lower limb amputations, hospitalizations, 
and poor QoL.2 The risk of dying for people with T2D is twice that of those without 
T2D.1  In the US, the prevalence in H/L males 65-74 is 31.1%; for H/L females, it is 
32.6%.3 Compared to non-H/L whites, the risk of diagnosed T2D is 66% higher 
among H/L.4 The National Academy of Medicine (NAM) indicates that H/L 
experience a 50–100% higher illness burden and mortality from T2D than non-H/L 
whites and that T2D remains poorly managed.4 H/L patients with T2D have renal 
insufficiency rates 3 to 6 times greater than those of non-H/L white patients and 

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end-stage renal disease rates are 41% higher.5–8 For H/L, the prevalence of 
diabetic retinopathy is 84% higher than that of non-H/L whites.5,7 Compared to 
non-H/L whites, H/L Americans bear twice the risk of lower extremity amputation.8 
The literature unequivocally shows that racial/ethnic minorities with T2D have poor 
access to healthcare and lower levels of T2D management.9–12 
Two 2016 systematic reviews, one based on 111 RCTs and another on 55 
RCTs, both showed that DTM significantly improves GM; however, less than 25% 
of RCTs were conducted with ethnically diverse patients, which diminishes the 
external validity of the findings.13–15 Polisena et al.’s meta-analysis of 26 studies 
also showed a positive effect on GM, noting that more research of higher 
methodological quality is required, and recommends including patients from 
diverse backgrounds to increase external validity and assess technology 
adaptation to optimize use among different populations.16 Another meta-analysis 
which concluded that DTM improves GM, notes that studies should utilize CBPR 
approaches involving patients and caregivers to develop personalized 
interventions to enhance persistence in usage and treatment adherence.17 
Similarly, a 2017 overview of systematic reviews of mHealth T2D interventions 
found that they significantly reduce HbA1c when compared to COM.18 However, 
few studies have examined mHealth technologies in patients from disparity 
populations or specifically tailored them to fit the cultural, linguistic, and other 
needs of underserved groups.19 DTM programs have shown promise in improving 
GM in disparity populations.20,21 The ADA recommends patient-centered 
management strategies for T2D,22 but there has been no effort to date to 
specifically tailor a comprehensive, evidence-based DTM program to meet the 
needs of patients from H/L disparity populations. Interventions based on models 
that involve cultural, personal, caregiver and community factors and tailor care to 
patient preferences have been shown to have a higher probability of success.23 
Our research is germane to the NAM priority topics for CER, which recommends 
CER by comparing DTM and COM in managing chronic disease and enhancing 
medication adherence.24 Although effective in the general population, we do not 
know how DTM should be tailored to the needs of H/L disparity patients. Our study 
seeks to fill critical knowledge gaps identified by meta-analyses, systematic 
reviews and the NAM, by directly comparing DTM to COM, an existing best 
practice based on 2018 ADA Standards of Medical Care in Diabetes.25  
The proposed research has great potential to enhance evidence quality, 
empowering disadvantaged patients with T2D to make informed health decisions 
and improve outcomes. The study is designed to iteratively tailor DTM to the 
specific needs of the H/L patients, caregivers, and providers. It addresses several 
access issues consistently identified in disparities research and has the potential 
to improve adherence through increased engagement. 
 
 
 
4. OBJECTIVE(S)/SPECIFIC AIMS AND HYPOTHESES 

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• A concise statement of the goal(s) of the current study.  
• The rationale for and specific objectives of the study.  
• The goals and the hypothesis to be tested should be stated. 
 
Objectives: 
 
Diabetes Telehealth Management (DTM) improves important outcomes, such as 
glycemic management (GM) and quality of life (QoL). It is yet unknown whether 
these results generalize to Hispanic/Latino (H/L) disadvantaged populations with 
Type 2 Diabetes (T2D), primarily when utilizing community-based participatory 
research (CBPR)26 approaches involving patients, caregivers, providers and other 
stakeholders in the process of adapting the intervention. Our goal is to compare 
DTM to comprehensive outpatient management (COM) on critical patient-centered 
outcomes. Both are based on 2018 American Diabetes Association (ADA) 
guidelinees.25 We propose a multiphase mixed method,27 CER RCT to: 
 
Specific Aim 1: Assess usability of an evidence-based DTM intervention 
utilizing a CBPR approach26 and adapt it to facilitate acceptability and 
feasibility in a population of H/L patients with T2D, and their caregivers and 
providers.  
 
Specific Aim 2: Assess whether H/L patients receiving DTM attain 
significantly improved patient-centered outcomes compared to COM, 
through a CER RCT. Expected outcomes include improved diabetes QoL, 
GM, blood pressure (BP), cholesterol, medication adherence, and diabetes 
self-efficacy (SE), and reduced diabetes distress, problem areas in diabetes 
(PAID), inpatient utilization, unscheduled T2D physician visits and sick days. 
 
 
 
5.  RESOURCES AVAILABLE TO CONDUCT THE HUMAN RESEARCH 
• Explain the feasibility of meeting recruitment goals of this project and demonstrate a 
potential for recruiting the required number of suitable subjects within the agreed 
recruitment period 
o How many potential subjects do you have access to? 
• Describe your process to ensure that all persons assisting with the trial are 
adequately informed about the protocol and their trial related duties and functions 
 
The specific population affected by the research is underserved T2D patients. Our 
estimated sample size is 200 patients (240, assuming a 10% attrition rate). We 
propose to study H/L patients with T2D, recruited from the Ambulatory Care Unit at 
LIJMC and the Division of General Internal Medicine Practice located in Queens 
NY, one of the most diverse populations in the world. We also propose to recruit at 
Southside Hospital. NUMC and Glen Cove Hospital as well as the Dolan Family 

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Health Center. We selected these sites because 1) clinic patient statistics meet 
our enrollment criteria, with 4,092 adults H/L patients with T2D (well over the 200 
recruitment number required). 2) clinicians at these sites express enthusiasm 
for/commitment to the study and what it might mean for their H/L patients with 
T2D. These sites provide a real-world setting for implementation because LIJMC is 
where our target population of H/L disparity patients with T2D (many with limited 
English proficiency) receive their care (H/Ls comprise 27.5% of Queens' 
population).  
 
Staff have all reviewed and been trained on methods for the study outlined in the 
protocol. There will be an initial kick off meeting to discuss the protocol in further 
detail. They have all completed CITI training and compliance for HIPPA data. 
 
 
 
6.  RECRUITMENT METHODS 
• Describe the source of potential subjects 
• Describe the methods that will be used to identify potential subjects 
• Describe any materials that will be used to recruit subjects.  A copy of any 
advertisements (flyers, radio scripts, etc.) should be submitted along with the 
protocol.  
• If monetary compensation is to be offered, this should be indicated in the protocol 
 
To limit selection bias, and ensure true random selection, our Biostatistics Unit will 
randomly (using a random number generator) sample 400 patients from the 4,092 
total patients.  
 
Recruitment: The bilingual study RN, Multisite Patient Engagement Specialist or 
study coordinator will be responsible for recruitment at the various study sites. 
Given COVID-19 pandemic we will also be calling be patient over the phone to 
recruitment.  
 
Recruitment for Data Collection: Eligible patients will be approached and called 
for consent (consent form 1) to have longitudinal data collected, including surveys 
at specified time points over the 12 months of their participation. Patients who are 
called will be give verbal consent. Next, bilingual study RN, Multisite Patient 
Engagement Specialist or study coordinator will obtain the randomization number 
from the Biostatistics Unit for the patient to determine if they were allocated to the 
DTM arm or COM arm. If the patient is randomized into the DTM arm, the recruiter 
will approach to obtain a second consent (consent form 2) to receive DTM. Verbal 
consent will be given for patients who are called for recruitment. 
Informed consent will include a detailed but simple description, in patient’s 
preferred language, of study risks/benefits.  
Recruitment for DTM: Eligible patients will be approached or called for consent 
(consent 1) to have longitudinal data collected, including surveys at specified time 

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points over the 12 months from signing consent, in order to determine health 
outcomes. Next, the research coordinator will obtain the randomization number for 
the patient to determine if they were allocated to the DTM arm or COM arm. If the 
patient is randomized into the DTM arm, the coordinator will approach to obtain a 
second consent (consent 2) to receive DTM.  
 
Informed consent for DTM will include a detailed description, in English and 
Spanish, of the risks and benefits of the study with user-friendly images of the 
equipment. If the patients decline to participate in DTM, they will continue to 
receive standard of care and still have surveys administered and data collected 
over time (as agreed to in consent 1). Based on intention to treat (ITT), they 
nevertheless will be analyzed as part of the DTM group. 
 
For those patients randomized to DTM, the RN will explain to the patients that if 
they agree to participate, they will be asked to measure vital signs daily, receive 
weekly telehealth “visits” with the telehealth RN (with appropriate assurances 
regarding confidentiality), and receive reminders of their weekly visits. The 
experienced bilingual RN will be trained in the proper recruitment of patients to 
eliminate selection bias based on a standardized protocol. The research RN will 
also explain to the DTM patient that s/he will have a bilingual trainer meet them at 
their home and that they will receive training on how to properly use the 
equipment.  
 
For those patients randomized to COM, the research RN will have monthly phone 
contacts to determine how the patient is doing, how many days during the week 
they have been sick, and whether they have been to an unscheduled doctors visit, 
the ED or hospital during the last month and how many days they have been sick. 
Lastly, in both groups, the enroller will let patients know that they will be asked to 
complete pre and post surveys. The enroller will be trained on the proposed 
enrollment practices to ensure objective, unbiased and systematic selection and 
recruitment of participants.  
 
DTM patients will be asked if they prefer to involve their caregiver; if patients 
agree, caregivers will be provided with the caregiver app (Figure 3). The bilingual 
enroller will explain to DTM patients that they will provide DTM training at their 
home.  
 
 
We propose to study H/L patients with T2D, recruited from the Ambulatory Care 
Unit at LIJMC and the Division of General Internal Medicine Practice located in 
Queens NY, one of the most diverse populations in the world. We also propose to 
recruit at Southside Hospital. NUMC and Glen Cove Hospital as well as the Dolan 
Family Health Center. We selected these sites because 1) clinic patient statistics 
meet our enrollment criteria, with 4,092 adults H/L patients with T2D (well over the 

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200 recruitment number required). 2) clinicians at these sites express enthusiasm 
for/commitment to the study and what it might mean for their H/L patients with 
T2D. These sites provide a real-world setting for implementation because LIJMC is 
where our target population of H/L disparity patients with T2D (many with limited 
English proficiency) receive their care (H/Ls comprise 27.5% of Queens' 
population).  
 
Due to COVID-19 pandemic, we are also requesting patients be enrolled into the 
study via telephone by providing us with verbal consent. Surveys and 
questionnaires will be performed over the phone in the preferred language of the 
participant.  
 
For patients reaching 6 month or 12 month follow-up during this time, interviews 
and surveys/questionnaires will also be collected over the phone. 
 
 
7.  ELIGIBILITY CRITERIA 
• Describe the characteristics of the subject population, including their anticipated 
number, age, ranges, sex, ethnic background, and health status. Identify the criteria 
for inclusion or exclusion of any subpopulation.  
• Explain the rationale for the involvement of special classes of subjects, such as 
fetuses, pregnant women, children, prisoners or other institutionalized individuals, or 
others who are likely to be vulnerable.   You cannot include these populations in your 
research, unless you indicate such in the protocol 
• Similarly, detail exclusionary criteria: age limits, special populations (minors, 
pregnant women, decisionally impaired), use of concomitant medications, subjects 
with other diseases, severity of illness, etc. 
 
The specific population affected by the research is underserved T2D patients. Our 
research is designed to determine whether DTM improves important patient 
outcomes in H/L disparity patients.  
 
Participant subgroups. The selection of our caregiver status subgroups (Y/N) is 
based on potential impact of having vs. not having a caregiver participate and 
discussions with stakeholders. 
 
INCLUSION AND EXCLUSION CRITERIA 
 
Inclusion criteria: 1) H/L patients with a diagnosis of T2D alone or in combination 
with other chronic conditions (e.g., heart disease); 2) age > 18 speak English or 
Spanish. 
Caregivers age >18 taking care of a patient with T2D alone or in combination with 
other chronic conditions. 
Providers who treat patients with T2D alone or in a combination with other chronic 
conditions 
 

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Exclusion criteria: 1) patient is not a H/L with a diagnosis of T2D; 2) age <18. 
Identification of study participants: There are 4,092 H/L patients with T2D fitting 
our inclusion criteria.  
Caregivers age <18 who do not take care of a patient with T2D or in combination 
with other chronic conditions  
Providers who do not treat patients with T2D alone or in a combination with other 
chronic conditions.  
 
Our goal is to enroll 224 (240, assuming a 10% attrition rate) patients/20-months. 
With a 50% acceptance rate (estimated on our previous enrollment experience), 
we will need to approach 400 total patients (or 20/month) to enroll 12 patients per 
month, easily reaching our goal of 224 participants over the 20-month accrual 
period.  
 
 
 
8.  NUMBER OF SUBJECTS 
• Indicate the total number of subjects to be accrued locally.  If applicable, distinguish 
between the number of subjects who are expected to be pre-screened, enrolled 
(consent obtained), randomized and complete the research procedures. 
• If your study includes different cohorts, include the total number of subjects in each 
cohort. 
• If this is multisite study, include total number of subjects across all sites.   
 
For the pilot test in Aim 1, we will have 12 subjects. For the RCT in Aim 2, we will 
randomize 224 patients. We plan to consent 224 patients assuming there will be a 
10% attrition rate. 
 
 
9. STUDY TIMELINES 
• Describe the duration of an individuals participation in the study 
• Describe the duration anticipated to enroll all study subjects 
• The estimated date of study completion 
 
Participants in the pilot study will be involved for 2 months. For one month they 
will pilot the equipment and in the 2nd month they will be involved in a focus 
group or semi-structured interviews. Participants in the RCT will participate in the 
trial for 12 months. See page 11 of the protocol for study timeline 
 
 
10.  ENDPOINTS 
• Describe the primary and secondary study endpoints 
• Describe any primary or secondary safety endpoints  
 
 

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11.  RESEARCH PROCEDURES 
• Include a detailed description of all procedures to be performed on the research 
subject and the schedule for each procedure. 
• Include any screening procedures for eligibility and/or baseline diagnostic tests 
• Include procedures being performed to monitor subjects for safety or minimize risks 
• Include information about drug washout periods 
• If drugs or biologics are being administered provide information on dosing and route 
of administration 
• Clearly indicate which procedures are only being conducted for research purposes. 
• If any specimens will be used for this research, explain whether they are being 
collected specifically for research purposes.   
• Describe any source records that will be used to collect data about subjects 
• Indicate the data to be collected, including long term follow-up 
 
We propose a multiphase mixed method,27 CER RCT study to 1) assess DTM 
usability, focusing on patient/stakeholder input to adapt the intervention to facilitate 
acceptability and feasibility and 2) conduct a CER RCT to compare DTM to COM in 
H/L patients on critical patient-centered outcomes. DTM addresses many barriers 
facing T2D H/L disparity patients. DTM increases Access, as patients are seen at 
home, with less travel. Knowledge: T2D education, in English and Spanish, is a 
cornerstone of DTM, incorporating ADA educational modules to model successful T2D 
management behaviors and interactive quizzes to enhance education engagement 
(Figure 2 Bottom). The patient is actively involved in measuring vital signs daily and 
discussing how behavior affects results. Adherence: Culturally tailored DTM actively 
involves the patient in measuring vital signs and participating in tele-visits, resulting in 
higher treatment adherence. Our CAB discussions, focus groups, interviews, and 
previous literature strongly indicate that the proposed caregiver app (Figure 3) has 
real potential to increase patient engagement/adherence in a family-oriented 
population.28,29 Health literacy: Tailored educational videos, quizzes and frequent 
interaction with the DTM nurse provide many opportunities to improve T2D health 
literacy. Previous studies show that T2D patients with low health literacy receiving 
tailored messaging are more likely to reach their HbA1c goal.30 Theoretical 
Framework. Our methodology is well grounded in theory (Figure 1). The concept of 
self-efficacy (SE), stemming from social cognitive theory, is critical in chronic care 
management.31 SE beliefs are patient thought patterns that influence health behavior, 
including whether particular behaviors are initiated, effort used and sustained while 
experiencing impediments to progress. Health behavior requires confidence in the 
ability to self-regulate using strategies such as goal setting, planning, and self-
monitoring.31 There are 4 ways to increase SE:31,32 1) Mastery experiences, the 
strongest predictor of SE, relates to actual performance when successfully meeting a 
challenging task. Patients with T2D performing daily health behaviors and seeing 
progress experience mastery. 2) Vicarious modeling (seeing others facing similar 

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challenges and reaching their goals) will be achieved by showing patients ADA 
educational modules of similar H/L patients attaining GM. 3) Social persuasion 
(verbal encouragement) is provided by the RN and caregiver using DTM. 4) 
Physiological factors, such as anxiety and distress, are experienced by patients 
when they fail to manage symptoms; the RN/caregiver can interpret this as temporary-
not associated with overall success. The ADA recognizes SE as critical in improving 
T2D management and recommends SE assessment in interventions.33–36 SE predicts 
improved GM and is particularly important in disparity patients, who must overcome 
many barriers to T2D management.36–38 
 

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 Comparators:  1. Intervention: Diabetes Telehealth Management (DTM), based 
on the 2018 ADA Standards for T2D, uses smart devices to share information 
between patients, caregivers, and 
clinicians. DTM has 7 components that 
differentiate it from COM (Table 1): 1) 
real time informative clinician patient 
video interaction; 2) frequent vital 
signs discussion; 3) frequent 
diabetes management discussion; 4) 
timely vital signs/physiological data 
transmission/interpretation (e.g., GM, 
automatically transmitted and reviewed 
by the clinician daily); 5) a weekly 
“virtual” visit, wherein clinicians can 
“re-check” vitals, and discuss prior 
week’s data in relation to medication, 
nutrition, and exercise, further involving 
the patient in their care; 6) patient interactive educational videos 
and “teach back” quizzes, reinforcing self-management strategies 
involving diet, exercise, medication adherence, and stress 
management. Quiz results are transmitted to telehealth RN who can 
address knowledge gaps, and 7) a caregiver app with supportive 
capability (Figure 3). With patient permission, caregivers will be able 
to see vital signs data in real time remotely, enhancing engagement 
and treatment adherence. The caregiver app is based on interviews 
and focus groups with patients, caregivers, and our CAB and informed 
by the literature. As increasing numbers of patients with T2D live alone, 
integrating caregivers in DTM facilitates increased patient adherence to 
treatment.39,40 Patients receive a smartphone/tablet (Figure 2, Top), 
and Bluetooth enabled peripherals (calibrated BP cuff and scales) facilitating easy 
measurement and transmission of vital signs to clinicians. We propose to use patient-
centered management guidelines based on the 2018 ADA Standards25  (See 
Appendix 2). The ADA recommends that caregivers providing support for older adults 
with T2D should be included in management discussions35. The DTM nurse will work 
closely with the physician, particularly when readings are outside normal 
range/medications require adjustment. DTM can help clinicians address patient health 
from indicators (e.g., BG, hypertension and depression).41 
Process Evaluation for Complex Intervention. We will assess health literacy, as 
measured by the Short Assessment of Health Literacy–Spanish and English (SAHL–
S&E), at baseline and 6 months, and again at 12 months, to assess our hypothesized 
causal pathways. Participants who reach 6 months or 12 month follow up during 
the COVID-19 pandemic, will have data on secondary outcomes collected via 
phone for both groups. Participants will give verbal consent for outcomes to be 
• 
Figure 3. 
Caregiver 

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collected. Our proposed mediator is a continuous variable; we will conduct 
mediation analyses using PROC CAUSALMED in SAS.  
Comparator:  Comprehensive Outpatient Management (COM) is the most realistic 
evidence-based comparator, in that it is the most frequently recommended and used 
option for US T2D patients. COM, like DTM, is consistent with the 2018 ADA 
Standards which include, but are not limited to, past medical and family history, social 
history, medications, screening, physical examination, laboratory evaluation, etc.25,42 
We will measure adherence to these standards using a chart review checklist to 
assess issues of fidelity and differential adherence. Patients are instructed to monitor 
BG (within physician recommendations) BG monitoring will individualized throughout 
the study. Frequency of BG monitoring will vary depending on medication, A1c 
readings, sick days and stress levels, and have routine or “well” visits every 3 months. 
Patients can set appointments with a T2D educator. COM patients will receive monthly 
calls from the study RN to collect data. In the “real world,” COM patients would not 
receive such calls; however, to maximize retention, this will favor our outcomes toward 
the null hypothesis, thereby increasing our confidence in intervention effects of DTM 
relative to COM. Formal Study Protocol. We have initiated formal protocol 
development. It will include our research objectives, design, outcomes, and detailed 
analytical methods. We will provide internationally standardized data dictionaries, final 
study protocol documents, data sheets, study population descriptions, covariates used 
in analyses, discussion guides and qualitative research coding information and any 
other original materials that facilitate study replication along with the first 12-month 
progress report, and within 3 months of the end of the funding period. We understand 
that PCORI reserves the right to share our materials with other researchers. If funded, 
our work will be available for evidence synthesis, at 
http://www.crd.york.ac.ok/prospero/ and our clinical trial will be registered at 
www.clinicaltrials.gov. Stakeholder Engagement. Consistent with PCORI’s 
engagement rubric, there are five ways in which patient/stakeholder input has 
been and will continue to be critical (See Figure 5: Stakeholder Engagement)  1. 
Community Advisory Board will ensure that DTM and outcomes have relevance for 
patients and provide the study team with stakeholder perspectives, tailoring, 
implementation, and evaluating DTM. The CAB will lead the discussion on study 
outcomes, adaptation, usability, program satisfaction, and dissemination, and will 
review and approve the study protocol and resolve issues to ensure project success. 
For example, the CAB of our previous PCORI study identified a barrier (“fear of 
undocumented patient identification via weekly video visits”) and strongly 
recommended that the study team develop appropriate enrollment process protocols. 
We will use a similar strategy for this current proposal. Engagement will depend on the 
issue at hand; stakeholders bring different skills to the CAB (e.g., community 
dissemination of study results may be led by our H/L CBO representative, as she has 
expertise in this area, particularly with NY H/L media). See Research Team and 
Environment for details on CAB stakeholders and their expertise. Stakeholders 
bring different skills to the CAB (e.g., community dissemination of study results may 
be led by our community representatives and legislators, as they have expertise in this 

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area, particularly with NY H/L media). Regarding dissemination of study findings, we 
will have a discussion led by the policy and finance stakeholders toward the end of the 
project period to address methods to disseminate study results. CAB members will 
use the knowledge generated through the research to make informed decisions about 
policies, programs, and practices and contribute to dissemination discussions, with 
particular expertise in H/L communities in Queens, NY.  2. in-depth semi-structured 
interviews with patients have been a critical approach to shaping DTM thus far. 
Interviews with H/L disparity patients who have agreed to serve on our study team 
were conducted to identify and prioritize disease management barriers and facilitators 
encountered by H/L T2D disparity patients. Due to COVID-19 semi-structured 
interviews will be done over the phone. Phone interviews will last 45 minutes to an 
hour. Participants will give verbal consent to be audio recorded.  
 
 
Caregivers are a vital part of the patient care. Research has shown that patients with 
caregivers are more likely to adhere to disease management practices. Caregivers will 
play a vital role in the study in the following ways.  
 
a) Focus Groups: at the start of the study during our CAB meetings we will be 
inviting a few caregivers in to assist us with developing the intervention for the 
Hispanic/Latino population. At this point we will be consenting caregiver 
participants with the focus group consent forms (see attached) including audio 
consent forms (see attached).  
b) Usability – pilot study: We will also conduct a one month, in-home pilot study 
with 12 patient/caregiver dyads. Focus groups and structured interviews will 
be subsequently undertaken to obtain “in the home” user feedback regarding 
any barriers to implementation or usability suggestions to further adapt the 
intervention before the RCT commences.  
c) Use of the Caregiver App: With patient permission, caregivers will be able to 
see vital signs data in real time remotely, enhancing engagement and treatment 
adherence. In this case the patient will consent that the caregiver may see their 
data- however, the caregiver will not require consent. 
d) Exit quality interviews: Patients and caregivers in the DTM arm who complete 
the 6-month intervention or drop out of the CER RCT study will be asked to 
provide feedback on their experiences. The caregiver will not be consented to 
take part in the qualitative exit interviews, but will receive an information sheet 
that will detail what we will ask them.  
e) Caregiver usability app and engagement: We will assess engagement as 
number of minutes/day spent on the smart device and number of minutes/each 
component of the app (e.g., educational videos). 
 

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Our Community Advisory Board (CAB) consists of the study team, community 
members, health care practioners, health policy experts, subject matter experts, patient 
advisory committee and provider panel. Throughout this study, the CAB will be 
meeting 9 times, however, only three of those times we will be conducting focus groups. 
Our first CAB meeting will be a focus group (pre-pilot). During this time, the CAB will 
be broken down into three groups, each of which will participate in a focus group: 1. 
The Main CAB focus group, which will include all participants. After conducting the 
Main CAB focus group, the CAB will separate into two groups. 2. The  Patient 
Advisory Comittee (PAC) Focus Group and  3) The Provider Focus Group. This CAB 
meeting will be to discuss adaptation to outcomes, intervention and study design. 
Participants will be consented to be in the Focus Groups and then consented to be 
audio recorded.  
 
We will implement the recommendations from the CAB and then conduct a pilot study. 
After the pilot study, we will conduct our Third CAB meeting to discuss adaptations to 
outcomes, intervention and study design. See table below for further information:  
 
 
 
Name 
Description and Additional Information 
1. CAB Focus Group # 1 (preliminary 
pre-pilot) 
Focus groups with CAB to disucss adaptations to 
outcomes, intervention and study design.  
a. 
PAC Focus Group (pre-pilot) 
Focus group with PAC members to discuss 
adaptations to outcomes, intervention and study 
design 
b. Provider Focus Groups (pre-pilot) 
Provider focus group to tailor the intervention from 
the provider perspective 
2. CAB focus group  # 2 (pre-pilot) 
Preliminary Adaptions combining CAB & PAC 
guidance presented to CAB.  Provide summary of 
findings to PCORI. 
a. 
PAC Focus Group (pre-pilot) 
Focus group with PAC members to discuss 
adaptations to outcomes, intervention and study 
design 
b. Provider Focus Groups (pre-pilot) 
Provider focus group to tailor the intervention from 
the provider perspective 
Patient/Caregiver Pilot Study 
Recruit 12 patients and their caregivers to participate 
in pilot study, randomize to either DTM or COM 
c. 
CAB Focus Group (post – pilot)  
Conduct focus group with CAB to confirm 
adaptations to post-pilot  study 
a. 
Patient Focus Group (post – pilot)  
Conduct  focus group or structured interview with 
pilot patients PAC to confirm adaptations post-pilot  
b. Provider Focus Group (post –pilot)  
Conduct provider focus with providers to tailor the 
intervention from the provider perspective 
 
 
12.  STATISTICAL ANALYSIS 
• Describe how your data will be used to test the hypotheses.  
• State clearly what variables will be tested and what statistical tests will be used. 
• Include sample size calculations.  

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• If this is a pilot study, state which variables will be examined for hypothesis 
generation in later studies.  
 
Specific Aim 1: Assess usability of an evidence-based DTM intervention utilizing a CBPR approach26 
and adapt it to facilitate acceptability and feasibility in a population of H/L patients with T2D, and their 
caregivers and providers.  
• 
 
We will assess usability at Northwell’s Usability Lab through the examination of qualitative and 
quantitative usability indicators. The ADAPT-ITT framework, developed by Winwood and DiClemente, and 
previously used by the PI to tailor a CHF telehealth intervention for disparity patients, will be used to engage 
stakeholders in adapting DTM.43,44  
 
1a. Qualitative approach. We will assess indicators of usability to facilitate feasibility and acceptability in four 
stages. 1) We will analyze focus group sessions of crucial CAB stakeholders (patients, caregivers, 
community partners and patient advocates, CBOs, healthcare practitioners, and disparities experts) using 
qualitative analytic methods. 2) We will conduct theater testing of the evidence-based intervention (smart 
device, Bluetooth-enabled peripherals, and the caregiver app) with the CAB, provider panel, and PAC. 3) We 
will conduct a pilot and post-pilot focus groups or structured interviews with 12 pilot study 
patient/caregiver dyads receiving DTM and our PAC, CAB, and provider panel. 4) We will conduct semi-
structured exit interviews of patients and caregivers in the DTM arm. 
 
1ai. Pre-study acceptability/usability (stakeholder perspective). Qualitative methods (focus groups) will be 
used to tailor DTM to ensure patient and caregiver acceptability and feasibility from the CAB. The CAB will 
consist of individual patients with T2D, caregivers, and individual advocates within the community. Patient 
stakeholders in the CAB are demographically and geographically representative of the targeted outpatient 
population. We will conduct as many sessions as needed to reach data saturation. CAB members will be 
presented with the intervention (in English and Spanish) including its core components (non-adjustable 
components) as well as essential characteristics that can be adjusted. CAB members will be compensated $50 
for their time plus transportation costs. Focus groups will occur before theater testing and the pilot study to 
ensure that we have incorporated all feedback. Based on previous experience, we have addressed some 
adaptation issues (e.g., Spanish translation in various dialects; having a fluent in Spanish study RN). 
 
1aii.Theater testing. After the CAB completes the community needs assessment and reviews DTM 
components, DTM will be theater tested at Northwell’s Usability Lab with the PAC, patients, and caregivers. 
The PAC will intentionally meet separately from the CAB to remove any influence from stakeholders (e.g., 
clinicians) that might be intimidating to patients. The PAC will theater test every screen, all patient and 
caregiver engagement activities (e.g., educational modules/videos), and smart device configurations (e.g., 
speed of speech and language translation) to ensure usability. Similarly, a provider-only focus group will be 
held to ensure that DTM is tailored to facilitate usability for providers. 
 
1aiii. Usability (pilot patient/caregiver/provider perspectives). We will also conduct a one month, in-home 
pilot study with 12patient/caregiver dyads. Focus groups or structured interviews will be subsequently 
undertaken to obtain “in the home” user feedback regarding any barriers to implementation or usability 
suggestions to further adapt the intervention before the RCT commences. The pilot for COM patients will 
assess the feasibility of extracting all measures identified in Table 2. Similarly, provider usability will be 
evaluated to ensure DTM is acceptable and feasible. Participants will be compensated $50 for their time/travel 
plus pre/post-test completion ($100). Discussion topics include (but are not limited to) the following: 1) patient 
and caregiver perceptions of the ease of the study implementation; 2) patient and caregiver perceptions of 
intervention usefulness; 3) patient and caregiver input on barriers/challenges to DTM implementation, including 
the impact of DTM on the caregiver/patient relationship; and 4) suggestions for improvements/adjustments. 

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Table 2.  
Outcome 
Domain  
Scale name or 
measurement method   
Characteristics of scale/ 
test 
Psychometric properties  
Patient involvement in scale/test 
development 
Patient 
satisfaction 
with 
telehealth 
program 
Telehealth Satisfaction 
Questionnaire (TSQ) 
(modified from Yip et 
al)76  
15 questions to assess 
patient satisfaction 
with the receipt of health-
care via telemedicine. 
There were three components with 
eigenvalues over 1.0, which 
together explained 68% of the total 
variance. These were: quality of care 
provided, similarity to face-to-face 
encounter and perception of the 
interaction.The internal consistency 
of the TSQ was 0.93, indicating 
strong correlations between the 15 
items comprising the scale. Internal 
consistency above 0.7 
Validated in 38 patients 40-70 
yearswith . 
Caregiver 
support 
Rand modified Medical 
Outcomes Study 
(mMOS-SS) Social 
Support Survey scale 
(Short Form)95 
8Items: emotional/ 
informational, tangible and 
affectionate, social support 
Across populations, the internal 
reliability of the 
mMOS-SS measure was very good 
(Cronbach’s alpha: Boston 0.88, UCLA 
0.92, MOS 0.93, 
item-total correlations ≥0.67). 
A total of 3,241 women with 
complete mMOS-SS and MOS-SS 
data 
(complete cases) from three 
individual study populations in the 
United States: 
Diabetes QoL 
 Diabetes Quality of life 
Brief Clinical Inventory 
(Messina et al.,) 
15 items measuring 
diabetes care behaviors and 
satisfaction with diabetes 
control  
  internal consistency (r = 0.78–0.92), 
test retest reliability (r = 0.78–0.92), 
and convergent validity for all four 
subscales for people with type 1 and 
type 2 diabetes. 
 498 respondents, 32% had 
type 1 diabetes, and 68% had type 
2 diabetes, female (53%), and 
ages for respondents ranged from 
21 to more than 80 years, with a 
median of 51 years. 
HbA1c 
Laboratory testing 
 Glucose control over 3 
months 
N/A 
Standard laboratory test 
Medication 
adherence 
Adherence tp Refills 
and Medications Scale 
–Diabetes (ARMS-D) 
(Mayberry et al.,) 
11 items assessing 
medication adherence in 
patients with T2D 
Item-rest correlations ≥0.30 and 
Cronbach's α≥0.70  
 314 adult outpatients prescribed 
medications for type 2 diabetes 
and collected point-of-care HbA1C. 
Diabetes 
management 
self-efficacy  
Standford Diabetes 
Management Self-
Efficacy Scale80 
8 items measuring 
confidence in managing 
diabetes 
One main factor (.828) 
 186 patients with diabetes. (α= 
.85) and a test-retest validity of .80 
Hypoglycemia 
Episodes 
(blood glucose 
<70) 
Fingerstick, or reported 
symptoms  
Amount of glucose in the 
blood.  
N/A 
Standard laboratory test (In light 
of COVID-19, patients will have the 
option of LabFly or Point of Care 
testing (POC). 
Blood glucose 
testing 
adherence 
Number of times 
patient adheres to 
recommendations   
BG testing is compared to 
physician 
recommendations. 
N/A 
N/A 
Problem 
Areas in 
Diabetes  
Problem Areas in 
Diabetes 
Questionnaire82 
Problem areas that diabetics 
may experience. 
PC identified a large emotional 
adjustment factor for total score. 
256 volunteer diabetic outpatients 
Patient 
Engagement 
Patient Activation 
Measure77,78 
Patient skill and confidence 
in managing health/care 
Rasch person reliability .85 -.87. 
Cronbach’s alpha was .87. 
Validation study with a sample of 
1,515 patients with chronic 
illnesses 
Patient 
Distress  
  
Diabetes Distress Scale 
(DDS 17)45  
Problem areas/distress  
Internal reliability was α = 0.87;  
Validation with diverse patients 
Health 
Literacy 
 Validation of Self-
Reported Health 
Literacy Questions 
Among Diverse English 
and Spanish-Speaking 
Populations 
Health literacy 
 The “confident with forms” question 
performed best for detecting 
inadequate (C-index = 0.82, (0.77-
0.87)) and inadequate plus marginal 
HL (C index = 0.81, (0.76-0.86); 
p < 0.01 for differences from other 
Of 296 participants, 48% were 
Spanish-speaking; 9% were White, 
non-Hispanic; 47% had inadequate 
HL and 12% had marginal HL. 

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* The study team will inform the Labfly members to have proper precautions when they coming to subjects’ home to do the lab work. 
 
1aiv. Exit qualitative interviews. Patients and caregivers in the DTM arm who complete the 6-month 
intervention or drop out of the CER RCT study will be asked to provide feedback on their experiences. Through 
semi-structured phone interviews conducted by experienced qualitative researchers and recruitment specialists  
(in English and Spanish), we will assess patient/caregiver perceptions regarding intervention usefulness, 
feasibility/usability and identify particularly essential components.  
 
Qualitative procedure and analysis: Due to COVID_19 we will be conducting semi-structured phone 
interviews for each qualitative sub-aim, . Each focus group or structured interview will take about two hours 
and will be conducted in a private room at 600 Community Drive. All discussions will be guided by 
predetermined topics outlined in the interview guide (see Appendix 1), audio recorded (using two digital voice 
recorders) and professionally transcribed. Focus group and semi-structured interview transcripts will be 
analyzed according to Auerbach and Silverstein’s grounded theory approach.45 We will use NVivo software 
(QSR International, Inc.) for data storage/organization to improve procedure standardization and enhance 
completeness. Three researchers will conduct coding so that we can assess triangulation and achieve a 
broader and more complex understanding of the data. In the first phase, a team of coders (Dr. Williams, Dr. 
Kozikowski, and Dr. Patel) will independently read transcripts and highlight relevant text. They will describe 
their reasoning for coding a particular block of text by memo-ing to make explicit how they perceived, 
examined and developed their understanding of the data as well as its source in transcription. Concepts 
identified by at least two participants will be grouped into repeating ideas and categorized into themes to create 
an initial list of codes. In the second phase, the three coders will use this initial list to code each transcript and 
add new codes as needed. Coders will meet weekly discuss transcripts and resolve discrepancies between 
coded data. Codes will be compiled into themes and reviewed to ensure that quotations fit under the same 
code and to ensure accuracy. We will keep an audit trail throughout the coding process to document decision-
making and support trustworthiness and dependability of the data.46 Respondent validation will be 
implemented to improve accuracy, validity, and transferability. Participants will be shown an analysis summary 
and asked if it accurately represents their meanings/perspectives. Central themes will specify any necessary 
adaptation that should occur to increase the usability and acceptability of DTM.  
 
1b. Quantitative approach. This adaptation phase involves an ongoing formative process evaluation of 
usability using quantitative methods so that adjustments can be made as DTM is implemented. Below is how 
we will operationalize usability measures. The first two usability variables will be collected upon subject 
enrollment in the RCT:  
 
questions), and performed 
comparably to the summative scale. 
The “confident with forms” question 
and scale also performed best across 
language, race/ethnicity, educational 
attainment, and age 
Weight 
Weight scale 
Bluetooth enabled weight 
N/A 
N/A 
Blood 
Pressure 
Blood pressure cuff 
Bluetooth enabled BP cuff  
N/A 
N/A 
Lipid Profile 
Laboratory testing 
LDL, HDL, total cholesterol 
N/A 
Standard laboratory test  
Inpatient 
utilization  
Chart review and 
weekly/monthly phone 
calls  
 
Hospitalization (Y/N); 
number of hospitalizations; 
cumulative length-of-stay  
N/A 
Patient-reported (with EHR review 
verification) 
Unscheduled 
T2D sick visits 
and number 
of sick days n 
Weekly video visits 
(DTM) and monthly 
phone calls (COM) 
Patient ≤1 unscheduled sick 
visit; # of unscheduled T2D 
sick visits and days sick.  
N/A 
Patient-reported  

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1bi. Rate of acceptability. To simulate the rate of DTM acceptability in the real outpatient environment, we 
propose to determine, among those who DO NOT consent to be part of the study, the proportion who state that 
their reason is related to the technology (as opposed to those who simply do not want to be part of a study). 
This will allow us to compute the “acceptability rate” (as opposed to “acceptance rate” below). Data from other 
studies most similar to the intervention proposed herein indicate that telehealth acceptability in a general 
population may be as high as 96%.47 As acceptability may be different for the H/L disparity population, it is 
important to measure. Assuming the probability of acceptability in disparity populations is significantly lower 
(50% rather than 96%) and a total of 200 (240, assuming a 10% attrition rate) patients will need to be 
randomized (100 per arm) then, approximately 400 patients will need to be approached to yield 200 who 
consent to enroll. The actual acceptability rate will be calculated as X/200. Assuming the rate=50% and n=200, 
acceptability rate can be estimated to within +/- 7.1% using (95% CI for proportions). 
 
1bii. Rate of equipment acceptance: Of those randomized to DTM, the rate of “acceptance” will be the % of 
patients who accept the app and peripherals. We will randomize 200 patients (240, assuming a 10% attrition 
rate), to yield a maximum of 100 patients per arm/3 years, the maximum number that can be treated with DTM 
over 6 months. Assuming 90% of DTM patients will constitute the usability sample, DTM acceptance is 
estimated +/‐ 6% (95% CI for proportions). ITT analysis will include all patients randomized to DTM.  The 
following usability variables will be collected during and upon completion of RCT: 
 
1biii. Patient vital signs measurement adherence (BP, BG, weight). We propose 3 levels of adherence. 
“Minimal” is < 45 measurements/180 days; “Moderate”= 46-90 measurements/180 days, and “High”=91-
180/180 days. Only the first daily reading will count toward adherence. All measures will be prorated for 
patients who die/hospitalized during the study. With n=100, adherence rates can be estimated to, at worst, +/‐ 
10% (95% CI). 
 
1biv. Total number of telehealth visits completed: We will compute the proportion of scheduled visits kept; 
if a patient is followed for w weeks, there should be w scheduled visits. If the number of scheduled visits kept is 
denoted by v, then the proportion of scheduled visits kept = v/w. Visit participation rates will be averaged 
across patients; the mean rate will be computed, along with 95% CI. There is a maximum of 24 possible 
televisits over the 6-month study period. 
 
1bv. Patient and caregiver usability measure: Usability will be measured with the Telemedicine Satisfaction 
and Usefulness Questionnaire48 to elicit a total usability score dichotomized into satisfied/not satisfied. For 
satisfaction rates of 50%, 75%, and 90%, with a sample size of 100, the corresponding 95% CI will have 
precision of +/‐ 10%, 8.7%, and 6%.  
 
1bvi. Caregiver app utilization (for patients with caregivers participating): We propose two levels of app 
utilization: “Low” is, at most, once a week app utilization for any 12/24 weeks. “High” is at least once a week 
app utilization for > 13/24 weeks. We expect that at least 50% of patients will have caregivers that agree to 
participate; with this sample size, rates of adherence are estimated, at worst, +/‐ 14%, with a 95% CI. 
 
1bvii. Patient and caregiver engagement. We will assess engagement as number of minutes/day spent on 
the smart device and number of minutes/each component of the app (e.g., educational videos). Patient 
engagement in both groups will be measured using the 13-item Patient Activation Measure (PAM).49,50 With 
n=200, and an established SD=1051 the standard error of the mean = .71, resulting in a 95% CI for the mean 
with precision of +/‐ 1.4. 
 
Specific Aim 2: Assess whether H/L patients receiving DTM attain significantly improved patient-
centered outcomes compared to COM, through a CER RCT. Expected outcomes include: improved 

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diabetes QoL, GM, BP, cholesterol, medication adherence, and diabetes SE, and reduced diabetes 
distress, PAID, inpatient utilization, unscheduled T2D physician visits and sick days.  
 
Primary Analysis for Aim 2.  Our primary outcome, the basis of our sample size calculation, is change in 
HbA1c for DTM relative to COM from baseline to 180 days. We will use the modified Zelen RCF method. For 
this continuous data, we will use mixed models repeated measures analysis of covariance (ANCOVA) (SAS 
9.4; SAS Institute, Cary, NC) to compare the change in pre-post DTM HbA1c with the change in pre-post COM 
HbA1c, adjusting for caregiver status (Y,N). In keeping with ICH E9 statistical principles for clinical trials (V.7G) 
with a stratification variable, the interaction term for treatment x caregiver status will be included in the primary 
analysis, as well as main effects for treatment and caregiver status. Upon finding a significant treatment x 
caregiver interaction, treatment effects will be estimated separately for those with and without a caregiver 
(using ANCOVA for unequal slopes).  
 
Secondary Analyses for Aim 2.  Our secondary outcomes measure whether, relative to COM, the 
intervention: 1) Decreases HbA1c over time (baseline to 90 days to 180 days); 2) Decreases hypoglycemia 
episodes (BG<70) as measured by finger stick or reported symptoms; 3) Increases adherence, measured in 
3 ways: i. Number of finger stick tests performed/6 month study period relative to physician recommendation. 
COM patients will receive a ReliOn Ultima glucometer which saves in memory up to 450 tests; to capture all 
finger stick tests (i.e., beyond 450), the research RN will reset the monitor every 90 days to allow for continued 
monitoring. For DTM subjects, the smart device will collect this data daily; ii. ii. Adherence to Refills and 
Medication in Diabetes (ARMS-D), validated in diverse populations;52 4) Increases diabetes SE, or confidence 
in managing  39;75 6) Decreases distress related to T2D using the validated 7) Decreases problem areas in 
diabetes (PAID scale,76 a 5-item validated measure of emotional functioning in diabetes);  8) Decreases 
weight, if physician recommended, from baseline-180, captured by a Bluetooth weight scale; 9) Improves 
cholesterol (total cholesterol/HDL ratio (e.g., from baseline to 90 days to 180 days); 10) Decreases BP, using a 
calibrated Bluetooth enabled BP cuff. Outcome 1 will be analyzed with mixed models repeated measures 
ANCOVA corresponding to days 0, 90 and 180.  Outcome 2 will be analyzed using standard methods of 
Poisson regression (SAS PROC GENMOD, with corresponding to days 0, 90 and 180.  Outcome 2 will be 
analyzed using standard methods of Poisson regression (SAS PROC GENMOD, with caregiver status as 
covariate and, adjusted for over dispersion, if indicated). Outcome 3i will utilize ANCOVA.  Outcomes 3ii will 
utilize logistic regression. Outcomes 4-10 will be analyzed using ANCOVA models similar to the one used for 
the primary outcome. If necessary, appropriate data transformations will be made.  
 
Tertiary analyses for Aim 2. Finally, we will measure whether, relative to the COM, patients in the DTM arm: 
1) Experience less inpatient utilization defined by i. Hospitalization (Y/N): whether each patient had at least 
1 inpatient hospitalization; ii. The number of hospitalizations experienced by the patient; and iii. Cumulative 
length-of-stay (inpatient days) for each patient over the study period. 2) Experience less unscheduled T2D 
sick visits/days, defined as i. Whether a subject has at least 1 unscheduled T2D sick clinic visit; and ii. 
Number of T2D unscheduled sick visits. iii. T2D sick days will be assessed monthly through self-report. 
Utilization outcomes (1-2) will be analyzed using Poisson regression to compare group rates. Despite 
discreteness of many of the scales cited above, the relatively large proposed sample size (100 per group), 
higher than what is necessary to detect differences, allows for the use of ANCOVA. All measures have 
documented validity evidence. Subgroup analysis will be exploratory, as no existing literature would support a 
particular effect size hypothesis. There are no plans for interim analyses or early stopping of the trial. Data 

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transformations will be considered for all analyses. Subgroup analyses are outlined separately below. Assess 
data source adequacy. Given the RCT approach, it is unlikely that demographics will be misrepresented in 
treatment groups. Thus, confounding is highly unlikely. However, demographic variables such age, 
race/ethnicity, and insurance will be easy to measure through self-report, based on the success of an ongoing 
PCORI trial of telehealth-delivered CHF management (PI: Pekmezaris). These data will be a combination of 
self-report/medical record verification. The primary endpoint, HbA1c, is highly reliable as it is derived from a 
reputable, licensed laboratory. Planned sensitivity analyses to determine the impact of key assumptions. 
For all analyses, underlying assumptions will be evaluated using SAS diagnostic tools (PROC GENMOD, 
PROC MIXED, and PROC GLM). Address missing data. The best protection against missing data is to 
prevent it in the first place. To this end: 1) we have already partnered with the clinic directors to ensure that 
patient records will be available; 2) two separate team members, Patel and Williams, will track the completion 
of data weekly (checking each other’s data), which will be reported at weekly research meetings; and 3) each 
team member will have clearly defined tasks and will regularly report on progress. Prevention and monitoring 
of missing data on outcomes: Participants in both arms will be contacted (DTM through video visit; COM 
monthly by phone). This will be a “check-in” contact to assess how patients are doing and whether they have 
interacted with the healthcare system (i.e., ED visits). The RN will make all patient contact. If a patient does not 
continue with the study, we will ask for the reason for discontinuance. We will ask permission to collect 
outcome data as scheduled. We believe that this will help obtain outcome data in the spirit of ITT. In addition, 
we will use our pilot study and focus groups or structured interviews to identify potential challenges to data 
collection that we can address a priori.  During data collection researchers Dr (s) Patel and Williams will assess 
weekly capture of all outcomes. The database management system, managed by the Biostatistics Unit, 
includes features that report test and form completion. The study team will monitor data collection and 
troubleshoot during regular meetings. We will also minimize risk of incomplete data by making surveys as easy 
as possible for the patient, conducted in their home; we will also perform cognitive pretesting with our PAC and 
field test surveys with pilot patients. Statistical methods to handle missing data. We will use standard 
methods of multiple imputation. Since HbA1c will be measured 4 times (baseline, 3 months 6 months and 12 
months) pre-HbA1c data will necessarily be available and 3 or 6-month data (theoretically) will not. Therefore, 
a monotone missing data structure will be used. The missing data mechanism will be assumed to be missing at 
random (MAR). Similar approaches will be used for secondary outcomes-continuous and binary. Recording 
and reporting reasons for dropout and missing data, and account for all patients in reports. We will use 
the CONSORT diagram method to describe/account for subjects who drop out or for whom outcome variables 
are missing.53 Tables will reflect frequency/reasons for missing data. Sensitivity of inferences to missing 
data methods and assumptions, and incorporation into interpretation. A commonly used sensitivity 
analysis for the MAR assumption in multiple imputation is based on the pattern mixture model approach,54,55 
modeling distribution of responses as a mixture of observed responses and missing responses. Goals of 
planned HTE analyses. We will evaluate whether the treatment effect in H/L patients with a caregiver 
participating differs from those that do not by examining the treatment x caregiver status interaction term. 
Similarly, we will also evaluate whether the treatment effect in female H/L patients differs from male patients by 
examining the treatment x gender interaction term. It should be emphasized, however, given our resources, 
there may be insufficient power to detect such interactions. Therefore, these analyses will be exploratory.  If 
feasible, we will also evaluate the treatment x SE interaction. HTE analysis plan. In keeping with ICH E9 
statistical principles for clinical trials (V.7G), the interaction terms for treatment x caregiver status, and 
treatment x gender will be included in the primary analysis, as well as main effects for treatment, caregiver, 
and gender. We plan on exploratory subgroup analyses to explore differential effects of treatment on caregiver 

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and gender groups. Upon finding a significant treatment x caregiver interaction (or treatment x gender 
interaction), the effect of treatment on A1C will be estimated separately for caregiver status (Y/N) (likewise for 
gender). Estimate of treatment effects and their 95% CI will be constructed. The basis for all HTE claims 
based on appropriate statistical contrasts among groups being compared. The literature and discussions 
with our CAB indicate the importance of family in the H/L culture.28,29 Given the different social/familial roles of 
women, we will also explore potential gender differences. We will also look at type of caregiver (paid/family) 
and explore caregiver type in a post hoc analysis to better understand the effect of caregiving. HTE analysis 
plan to report all pre-specified analyses and, at minimum, the number of post-hoc analyses, including 
all subgroups and outcomes analyzed. With the rich data set expected from this study, we will examine data 
patterns in an exploratory post-hoc way to identify potential trends not specified a priori. While we will use both 
exploratory and standard statistical approaches, p values, and associated CIs will be interpreted cautiously, as 
firm conclusions cannot be drawn. Post-hoc analyses will be adjusted for multiple testing. Reporting plan to 
allow for assessments of the study’s internal and external validity. We will report trial results according to 
the CONSORT guidelines for reporting of RCTs, using the CONSORT 2010 checklist.53  We will report the 
progression of patients through the study using the CONSORT flow diagram, showing numbers of patients at 
each study point (enrollment, allocation, follow-up), and reasons for attrition at each point. For reporting 
qualitative results, we will use the COREQ a 32-item checklist for interviews/focus groups.56 
 
SECTION FIVE: SAMPLE SIZE JUSTIFICATION  
Our estimated sample size is 224 patients (240, assuming a 10% attrition rate): 112/group, yielding 80% power 
to detect a 0.5% difference in the pre-post change in HbA1c (two-tailed t-test with α =.05) over 6 months. Our 
power calculation is based on Polisena et al.’s meta-analysis.16 We computed a sample size-weighted median 
of the 12 standard deviations (SD) for HbA1c, yielding a value of 1.2%. If the SD of the pre-post 6-month 
change in HbA1c is 1.2% in each group, a 0.45% difference in this 6-month change yields a 0.42 effect size 
(ES). This ES is realistic, falling between 2 sets of reductions in the literature: the Diabetes Control and 
Complications Trial (1% decline in HbA1c reduced microvascular  complications by 30%57) and RCTs/meta-
analyses citing reductions of 0.3% as "clinically significant".1–4 Our reduction of 0.45% falls between those 
limits, is clinically significant/meaningful, as patients can see improvements in their scores. In a systematic 
review of 13 RCTs (n=4,207) telehealth was associated with a clinically significant mean HbA1c decline of 
−0.44% compared to COM.17 In medically underserved patients, telehealth led to a net improvement in HbA1c, 
cholesterol, and BP. Although our main power calculation refers to our primary outcome (HbA1c), power is still 
acceptably high for secondary variables (SE, distress or QoL) such that 112 patients/group will yield 80% 
power to detect an effect size of 0.4 SDs, using a simple t-test to sample size and power. 
 
3
4
5
6
9
10
11
12 13
14
15 16 17 18
19
20 21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
MAR
APR
MAY
JUN
SEP
OCT
NOV
DEC
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
NOV
DEC
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
NOV
DEC
JAN
FEB
MAR
APR
MAY
JUN
DTM
2
2
2
6
6
6
6
6
6
6
6
6
6
6
6
6
6
6
6
6
6
6
6
COM
2
2
2
6
6
6
6
6
6
6
6
6
6
6
6
6
6
6
6
6
6
6
6
Total
12
12
12
12 12
12
12 12 12 12
12
12
12
12
12
12
12
12
12
12
12 24 36 48
60
72
84
96
108
120 132 144 156 168 180 192 204 216 228 240
12
24
36
48
60
72
84
96
108 120 132 144 156 168 180 192 204 216 228 240
Meetings
CAB
PAC 
CAB
Pilot Focus 
Groups
PAC
CAB/PAC
CAB/PAC
CAB/PAC
CAB/PAC
CAB/PAC
CAB/PAC
CAB/PAC
CAB/PAC
CAB/PAC
Study Aims
6 MONTH FOLLOW UP
12 MONTH FOLLOW UP
12 Month Follow-Up
2022
Analysis
Manuscript Development 
& Dissemination
Specific Aim 2: Assess whether Hispanic/Latino patients receiving DTM attain significantly improved patient-centered outcomes compared to COM, 
through a CER RCT. Expected outcomes include: improved diabetes quality of life glycemic management, blood pressure, cholesterol, medication 
adherence, and diabetes self-efficacy, and reduced diabetes distress, problem areas in diabetes, inpatient utilization, unscheduled T2D physician 
visits and sick days. 
Month
1
2
 Figure 4. Study Plan: Following 240 Patients for 12 Months Randomized to Either DTM (n=100) or  COM (n=100) with 6 Month Intervention, Assuming 10% Attrition, Resulting in a Final Sample Size of 200
Year
2019
2020
2021
8
7
Pilot Analysis
CAB, PAC, Provider Focus
Group Analysis 
PAC Focus Group: Post-
Pilot Adaptions
CAB Finalizes Intervention
Adaption 
FEB
Pre-Pilot Adaptation 
Approval by the CAB
Specific Aim 1: Assess usability of an evidence-based DTM intervention utilizing a community based participatory research approach and 
adapt it to facilitate acceptability and feasibility in a population of Hispanic/Latino patients with T2D, and their caregivers and providers. 
PAC Focus Group: 
Confirm Outcomes, 
Preliminary Intervention 
& Study Design Adaption 
Recommendations
 
Enrollment
CAB Focus Group: 
Confirm Outcomes, 
Preliminary Intervention 
Adaptions & Study Design
Provider Focus Group Pre
Pilot Adaptation 
Recommendations
Pilot Study
JAN
Pilot
Pre-Pilot Adaptation 
Complete
JUL
Pilot Patient/Caregiver 
Focus Groups (2) 
Provider Focus Group: 
Post-Pilot Adaptions
AUG
CAB

Version Date:  7/13/2020  
 
Page 23 of 37 
 
 
 
 
 
 
 
13. SPECIMEN BANKING 
• If specimens will be banked for future research, describe where the specimens will be 
stored, how long they will be stored, how they will be accessed and who will have 
access to the specimens 
• List the information that will be stored with each specimen, including how specimens 
are labeled/coded 
• Describe the procedures to release the specimens, including:  the process to request 
release, approvals required for release, who can obtain the specimens, and the 
information to be provided with the specimens. 
 
N/A 
 
 
14.  DATA MANAGEMENT AND CONFIDENTIALITY 
• Describe the data and specimens to be sent out or received.  As applicable, describe: 
o What information will be included in that data or associated with the 
specimens? 
o Where and how data and specimens will be stored? 
o How long the data will be stored? 
o Who will have access to the data? 
o Who is responsible for receipt or transmission of data and specimens? 
• Describe the steps that will be taken to secure the data during storage, use and 
transmission. 
 
The investigators will use IRB-approved and HIPAA-compliant measures to 
maintain confidentiality, privacy and data security. Data privacy and security 
procedures will include: a) training staff on data sensitivity and protocols for 
safeguarding confidentiality; b) storing and processing sensitive hardcopy in a 
secured, centralized location; c) securing sensitive hardcopy in locked files when 
not in use; d) removing names, addresses, and other direct identifiers from 
hardcopy and computer-readable data when they are no longer necessary for 
patient tracking and then using encrypted codes for subsequent identification of 
participants; e) destroying all identifiable linkages to data after data accuracy has 
been verified and final analyses have been completed; f) using restricted logon 

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Page 24 of 37 
 
identification and password protection computer protocols for all computerized 
entry, retrieval, and analysis. 
 
RedCap and OneDrive are the only programs being used to restore research data 
 
 
 
15.  DATA AND SAFETY MONITORING PLAN 
 
A specific data and safety monitoring plan is only required for greater than minimal risk 
research.  For guidance on creating this plan, please see the Guidance Document on the 
HRPP website. 
 
Part I – this part should be completed for all studies that require a DSMP.   
Part II – This part should be completed when your study needs a Data and 
Safety Monitoring Board or Committee (DSMB/C) as part of your Data and 
Safety Monitoring Plan.   
 
Part I:  Elements of the Data and Safety Monitoring Plan 
•  Indicate who will perform the data and safety monitoring for this study.   
• Justify your choice of monitor, in terms of assessed risk to the research subject’s 
health and well being.  In studies where the monitor is independent of the study staff, 
indicate the individual’s credentials, relationship to the PI, and rationale for selection 
• List the specific items that will be monitored for safety (e.g. adverse events, protocol 
compliance, etc) 
• Indicate the frequency at which accumulated safety and data information (items listed 
in # above) will be reviewed by the monitor (s) or the DSMB/C.   
• Where applicable, describe rules which will guide interruption or alteration of the 
study design.   
• Where applicable, indicate dose selection procedures that will be used to minimize 
toxicity. 
• Should a temporary or permanent suspension of your study occur, in addition to the 
IRB, indicate to whom will you report the occurrence.   
 
Adverse Events and Data and Safety Monitoring Plan 
We do not expect any adverse events directly attributable to the intervention. 
Although discussions with our IRB indicate that the risk proposed by this 
intervention does not meet the requirements for establishing a Data Safety 
Monitoring Board (DSMB), we nonetheless will establish a DSMB to review 
aggregate data on a bi annually basis to review possible safety issues. Any 
adverse events will be reported immediately to the IRB. 
 
 
Part II:  Data and Safety Monitoring Board or Committee 
 
 
•  When appropriate, attach a description of the DSMB.   
• Provide the number of members and area of professional expertise.   
• Provide confirmation that the members of the board are all independent of the study. 
 

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16. WITHDRAWAL OF SUBJECTS 
• Describe anticipated circumstances under which subjects will be withdrawn from the 
research without their consent 
• Describe procedures for orderly termination 
• Describe procedures that will be followed when subjects withdraw from the research, 
including partial withdrawal from procedures with continued data collection.   
 
The patients and CAB members in the focus group or structured interviews may 
withdraw from the study at any time after giving consent. The study may 
discontinue at any time. Any actions that may follow such discontinuation of the 
study will have no impact upon patient care or employment.  
 
 
 
17. RISKS TO SUBJECTS 
• Describe any potential risks and discomforts to the subject (physical, psychological, 
social, legal, or other) and assess their likelihood and seriousness and whether side 
effects are reversible. Where appropriate, describe alternative treatments and 
procedures that might be advantageous to the subjects.  
• Include risks to others , like sexual partners (if appropriate) 
• Discuss why the risks to subjects are reasonable in relation to the anticipated benefits 
and in relation to the importance of the knowledge that may reasonably be expected 
to results 
• Describe the procedures for protecting against or minimizing any potential risks, 
including risks to confidentiality, and assess their likely effectiveness.   
 
We do not anticipate any significant physical, psychological, or social risk to the 
study patients. All risks and benefits of participation will be explained to 
participants and included in the written consent forms. Participants will be at 
minimal risk and will be informed of their right to withdraw from the study at any 
time. All identifiable information will be maintained with strict confidentiality 
measures by the investigators. 
 
 
 
 
18. RESEARCH RELATED HARM/INJURY 
• Describe the availability of medical or psychological resources that subjects might 
need as a result of anticipated problems that may be known to be associated with the 
research. 
• If the research is greater than minimal risk, explain any medical treatments that are 
available if research-related injury occurs, who will provide it, what will be provided, 
and who will pay for it.   
 

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We do not anticipate any significant physical, psychological, or social risk to the 
study patients. All risks and benefits of participation will be explained to 
participants and included in the written consent forms. Participants will be at 
minimal risk and will be informed of their right to withdraw from the study at any 
time. All identifiable information will be maintained with strict confidentiality 
measures by the investigators. 
 
 
19. POTENTIAL BENEFIT TO SUBJECTS 
 
• Explain what benefits might be derived from participation in the study, noting in 
particular the benefit over standard treatment (e.g. a once-a-day administration 
instead of four times a day, an oral formulation over an IV administration).  
• Also state if there are no known benefits to subjects, but detail the value of knowledge 
to be gained 
 
Potential benefits of participants include improved QoL, glucose management, 
medication adherence, and diabetes SE, BP and cholesterol and significantly 
reduced diabetes distress, problem areas in diabetes, inpatient utilization 
(hospitalization) and number of unscheduled physician visits and sick days. 
 
 
 
20. PROVISIONS TO PROTECT PRIVACY INTERESTS OF SUBJECTS 
 
• Describe the methods used to identify potential research subjects, obtain consent and 
gather information about subjects to ensure that their privacy is not invaded.  
• In addition consider privacy protections that may be needed due to communications 
with subjects (such as phone messages or mail).   
 
The study coordinator, Multisite Patient Engagement Specialist, or bilingual study 
RN will initially contact patients by phone from the various study sites randomly 
selected from the list of patients who fit our inclusion criteria and invite them to 
participate in our study. Informed consent will include a detailed but simple 
description, in English or Spanish (based on preferred patient language), of the 
risks and benefits of the study with user-friendly images of the equipment.  
 
Written, informed consent will be obtained prior to the participants taking part in 
any aspect of the study. Patients will be informed of the study’s risk and benefits, 
and that their choice to participate or not will have no effect on their medical care. 
The study coordinator, Multisite Patient Engagement Specialist, or bilingual study 
RN will obtain informed consent after thoroughly explaining all aspects of 
participation, including the use of audio recording where relevant, assessing 
understanding, and answering any questions from potential participants. 
Participants will receive written consent forms detailing the study, what 
participation entails, potential risks and benefits, the voluntary nature of their 
participation, and contact information for the PI, Co-Is and Northwell/Feinstein IRB.  
 

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Patient contact information will be collected in secure electronic documents only 
accessible to the PI and study team. For the focus groups or structured interviews, 
which will be audio recorded, participants will give informed consent for 
participation and separate consent to be audiotaped. 
 
We will also be obtaining the Certificate of Confidentiality from the NIH. Where 
necessary verbiage from this CoC is included in the consent forms.  
 
 
 
21.  COSTS TO SUBJECTS 
 
• Describe any foreseeable costs that subjects may incur through participation in the 
research 
• Indicate whether research procedures will be billed to insurance or paid for by the 
research study.   
 
We do not anticipate any foreseeable costs that subjects might incur. All research 
procedures will be paid for by the research study. We do not anticipate that 
participants will have an additional health procedures other than that which they 
are already used too. Any injuries which incurred and not part of the research 
study will be billed and paid for by the participant’s insurance. 
 
 
 
22. PAYMENT TO SUBJECTS  
 
• Describe the amount of payment to subjects, in what form payment will be received 
and the timing of the payments.   
 
CAB members will be compensated $50 for their time plus transportation costs. 
Participants will be compensated $50 for their time/travel plus pre/post-test 
completion ($100). 
 
 
23.  CONSENT PROCESS 
 
If obtaining consent for this study, describe: 
• Who will be obtaining consent 
• Where consent will be obtained 
• Any waiting period available between informing the prospective participant and 
obtaining consent 
• Steps that will be taken to assure the participants’ understanding 
• Any tools that will be utilized during the consent process 
•   Information about how the consent will be documented in writing.  If using a  
standard consent form, indicate such.   
• Procedures for maintaining informed consent.   
 

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The study coordinator, Multisite Patient Engagement Specialist, or bilingual 
study RN will initially contact patients by phone from the various study sites 
randomly selected from the list of patients who fit our inclusion criteria and 
invite them to participate in our study. Informed consent will include a detailed 
but simple description, in English or Spanish (based on preferred patient 
language), of the risks and benefits of the study with user-friendly images of 
the equipment.  
 
Written, informed consent will be obtained prior to the participants taking part 
in any aspect of the study. Patients will be informed of the study’s risk and 
benefits, and that their choice to participate or not will have no effect on their 
medical care. The study coordinator, Multisite Patient Engagement Specialist, 
or bilingual study RN will obtain informed consent after thoroughly explaining 
all aspects of participation, including the use of audio recording where relevant, 
assessing understanding, and answering any questions from potential 
participants. Participants will receive written consent forms detailing the study, 
what participation entails, potential risks and benefits, the voluntary nature of 
their participation, and contact information for the PI, Co-Is and 
Northwell/Feinstein IRB.  
 
Patient contact information will be collected in secure electronic documents 
only accessible to the PI and study team. For the focus groups, which will be 
audio recorded, participants will give informed consent for participation and 
separate consent to be audiotaped. Subjects who signed consent for the pilot 
study and focus group, but will now participate in a structured phone interview 
instead of focus group, we are seeking a waiver of documentation of consent 
and HIPAA authorization. We will read the script approved by IRB to get the 
subjects’ authorization. The subjects will be informed of the change over the 
phone and also asked for their authorization to be audio recorded before the 
interview begins. 
 
With current COVID_19 pandemic, the team also requests waiver of 
documentation of HIPAA authorization, as the interview is minimal risk, the 
interviewees are not readily available in person (and are not expected to be in 
the near future), and it would be reasonably expected that the response rate to 
a mailed HIPAA authorization would be so low that the research would be 
impracticable to perform.  The research could likewise not be performed 
without use of PHI, as the interviews will discuss patient health status and will 
be audio recorded.   
 
In our main RCT study, for patients in the telemonitoring arm, the patient will 
be consenting that we can contact their caregiver. We will ask the patient 
whether or not they have a caregiver and if they will give the caregiver 
permission to see their daily vital signs during the study. At this point there will 
be verbal consent on the part of the patient that we may contact the caregiver, 
and the team member, who is consenting, will be indicating on the enrollment 
note that verbal consent was given by the patient. Once consent is given by the 
patient, we will provide the caregiver with an information sheet outlining what 
our study entails (see information sheet attached).  

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Our Research Nurse and Recruitment specialist are both fluent in Spanish. 
During the recruitment and consenting process, our research team will ask the 
patient what is their preferred language (either English or Spanish) for which 
they would like to be consented. All consent forms will be translated into 
Spanish.  
 
 
 
In the state of NY, any participants under the age of 18 are considered children.  If your 
study involves children, additional information should be provided to describe: 
• How parental permission will be obtained 
• From how many parents will parental permission be obtained 
• Whether permission will be obtained from individuals other than parents, and if 
so, who will be allowed to provide permission.  The process used to determine 
these individual’s authority to consent for the child should be provided 
• Whether or not assent will be obtained from the child 
• How will assent be documented 
• Whether child subjects may be expected to attain legal age to consent to the 
procedures for research prior to the completion of their participation in the 
research.  If so, describe the process that will be used to obtain their legal 
consent to continue participation in the study.  Indicate what will occur if consent 
is not obtained from the now-adult subjects.   
 
 
 
 
If the study involves cognitively impaired adults, additional information should be 
provided to describe: 
• The process to determine whether an individual is capable of consent 
• Indicate who will make this assessment 
• The plan should indicate that documentation of the determination  and 
assessment will be placed in the medical record, when applicable, in addition to 
the research record. 
• If permission of a legally authorized representative will be obtained, 
o  list the individuals from who permission will be obtained in order of priority 
o Describe the process for assent of subjects; indicate whether assent will be 
required of all, some or none of the subjects.  If some, which subjects will be 
required to assent and which will not. 
o If assent will not be obtained from some or all subjects, provide an 
explanation as to why not 
o Describe whether assent will be documented and the process to document 
assent 
o Indicate if the subject could regain capacity and at what point you would 
obtain their consent for continued participation in the study 
 
 

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If the study will enroll non-English speaking subjects: 
• Indicate what language(s) other than English are understood by prospective 
subjects or representatives 
• Indicate whether or not consent forms will be translated into a language other 
than English 
• Describe the process to ensure that the oral and written information provided 
to those subjects will be in that language 
• If non-English speaking subjects will be excluded, provide a justification for 
doing so 
 
The consent form will be both in Spanish/English. The multisite recruitment 
specialists who are primarily recruiting for this study are both bilingual. 
Participants will be asked what is their preferred language of choice – 
Spanish or English. See recruitment procedures above. 
 
 
24.  WAIVER OR ALTERATION OF THE CONSENT PROCESS       
 N/A          
 
Complete this section if you are seeking an alteration or complete waiver of the consent   
process. 
• Describe the possible risks of harm to the subjects involved in this study and 
explain why the study involves no more than minimal risk to the subject:   
• Explain why the waiver/ alteration will not adversely affect the rights and welfare 
of subjects 
• Explain why it is impracticable to conduct this research if informed consent is 
required   
• Explain why it is not possible to conduct this research without using the 
information or biospecimens in an identifiable form 
• If appropriate, explain how the subjects will be provided with additional pertinent 
information after participation.   If not appropriate to do so, explain why.  
 
The caregiver will be provided with an information sheet. We are requesting a 
waiver of documented consent because the caregiver’s only role is to provide 
information about the patient’s care. The info sheet will have a phone number 
to answer questions about participation – see attached. 
 
We are also requesting a waiver of elements of the consent process/form for 
Consent 1.  We request that the first group of subjects are enrolled without a 
full description of the study procedures.  It is impracticable to conduct this 
research if elements (disclosing the full purpose of the study and the 
randomization procedure) of informed consent are required because we believe 
if we tell people which arm they are in, the people who are randomized to the 
non-telehealth arm will not want to participate because the telehealth arm has 
advanced technology and is more convenient for the patient. This creates a 

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Page 31 of 37 
 
major barrier for the successful completion of the intervention and therefore, 
the study would not be feasible to complete without the Zelen consent process.  
The telehealth intervention involves no more than minimal risk.  The waiver 
does not adversely affect the rights and welfare of the participants as they are 
still being asked to participate and being told the procedures that they will be 
involved in, at that point in the process.  
 
In addition, we are requesting a waiver of elements of the consent 
process/form for witness signature. We request that in situations when 
recruiters are performing at home consenting, that a witness signature not be 
required if no witness is available at the time of consenting. At home consent 
occurs when the patient agrees to participate in the study, but does not have the 
time in the clinic to answer the surveys, complete the enrollment process 
and/or drop off equipment for participants in the DTM group. We are asking 
for a waiver on witness signature as it is not always practical to have a witness 
available for at home consenting. This creates a major barrier for the 
successful completion of the consenting process. The telehealth intervention 
involves no more than minimal risk. Both recruiters for this study are bilingual 
and have thoroughly been trained in consenting procedures and conducting 
consenting in an ethical manner and based on protocol procedures. As such, 
the waiver does not adversely affect the rights and welfare of the participants 
as they are still being asked to participate and be told the procedures that they 
will be involved in at that point in the consenting process.     
 
Complete this section if you are obtaining informed consent but you are requesting a 
waiver of the documentation of consent (i.e., verbal consent will be obtained). To 
proceed with a waiver based on these criteria, each subject must be asked whether they 
wish to have documentation linking them to this study.  Only complete subsection 1 OR 
subsection 2.  
 
  SUBSECTION 1 
 
• Explain how the only record linking the subject to the research would be the 
consent document. 
• Explain how the principal risk of this study would be the potential harm resulting 
from a breach in the confidentiality 
• Indicate whether or not subjects will be provided with a written statement 
regarding the research. 
 
Participants will be giving verbal consent for this study. Verbal consent will be 
documented on the enrollment log. All staff who are recruiting participants 
are thoroughly trained in compliance and HIPAA rules and regulations for 
recruiting and ensuring participant confidentiality.  
 
 
 
SUBSECTION 2 

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•  Describe the possible risks of harm to the subjects involved in this study and 
explain why the study involves no more than minimal risk.   
• Confirm that the research only involves procedure for which consent is not 
normally required outside the research context.  
• Indicate whether or not subjects will be provided with a written statement 
regarding the research. 
 
 
 
. 
 
25. WAIVER OF HIPAA AUTHORIZATION  
 
 
 
 N/A       
 
Complete this section if you seek to obtain a full waiver of HIPAA authorization to use 
and/or disclose protected health information.  
• Describe the risks to privacy involved in this study and explain why the study 
involves no more than minimal risk to privacy:   
• Describe your plan to protect identifiers from improper use or disclosure and to 
destroy them at the earliest time. 
•  Indicate why it is not possible to seek subjects’ authorization for use or 
disclosure of PHI. 
• Indicate why it is not possible to conduct this research without use or disclosure 
of the PHI.   
• Indicate if PHI will be disclosed outside NSLIJ Health System, and if so, to whom.   
Note:  PHI disclosed outside NSLIJ Health System, without HIPAA authorization 
needs to be tracked. Please see guidance at www.nslij.com/irb for information 
about tracking disclosures. 
 
 
 
Complete this section if you seek to obtain a partial waiver of the patient’s 
authorization for screening/recruitment purposes (i.e., the researcher does not have 
access to patient records as s/he is not part of the covered entity) 
Note: Information collected through a partial waiver for recruitment cannot be shared 
or disclosed to any other person or entity. 
• Describe how data will be collected and used:  
• Indicate why you need the PHI (e.g.PHI is required to determine in, identifiers 
are necessary to contact the individual to discuss participation, other) 
• Indicate why  the research cannot practicably be conducted without the partial 
waiver (e.g. no access to medical records or contact information of the targeted 
population, no treating clinician to assist in recruitment of the study population, 
other) 
 
 
 

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Page 33 of 37 
 
26.  VULNERABLE POPULATIONS: 
 
Indicate whether you will include any of these vulnerable populations. If indicated, 
submit the appropriate appendix to the IRB for review: 
 
  Children or viable neonate 
  Cognitively impaired 
  Pregnant Women, Fetuses or neonates of uncertain viability or nonviable  
  Prisoners 
  NSLIJ Employees, residents, fellows, etc 
  poor/uninsured 
  Students 
  Minorities 
  Elderly 
  Healthy Controls 
 
If any of these populations are included in the study, describe additional safeguards that 
will be used to protect their rights and welfare. 
 
Minority populations: Individuals will be explained the full risks and benefits of taking 
part in the study. Additionally, participants will be told that all care will be taken to 
ensure their protection and confidentiality and only the Northwell Team will have 
access to their data. While results in the study will be published, all data is aggregated 
and their personal information will never be given out. The will not be asked any 
questions about their legal or immigrant status.  
 
We have obtained a Certificate of Confidentiality  
 
 
27.  MULTI-SITE HUMAN RESEARCH (COORDINATING CENTER) 
 
If this is a multi-site study where you are the lead investigator, describe the management 
of information (e.g. results, new information, unanticipated problems involving risks to 
subjects or others, or protocol modifications) among sites to protect subjects. 
For the Northwell sites, all study related files will be saved and shared between sites 
on a PHI drive on Northwell Health’s servers. For external site, all study related files 
will be shared between sites on OneDrive data storage (a secure cloud sharing 
system  provided by Northwell Health). 
 
 
 
28.  REFERENCES/BIBIOGRAPHY 
 
Provide a reasonable list of references directly related to the study. Any diagrams for 
new medical devices or brief reprints from journals might also prove useful. 
 
1.  
Gregg EW, Zhuo X, Cheng YJ, Albright AL, Narayan KMV, Thompson TJ. 

Version Date:  7/13/2020  
 
Page 34 of 37 
 
Trends in lifetime risk and years of life lost due to diabetes in the USA, 1985–
2011: a modelling study. Lancet Diabetes Endocrinol. 2014;2(11):867-874. 
doi:10.1016/S2213-8587(14)70161-5 
2.  
National diabetes fact sheet: national estimates and general information on 
diabetes and prediabetes in the United States, 2011. 2011. 
3.  
National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the 
United States, 2014. 2014. 
4.  
Nelson A. Unequal treatment: confronting racial and ethnic disparities in health 
care. J Natl Med Assoc. 2002;94(8):666-668. 
5.  
Harris MI, Klein R, Cowie CC, Rowland M, Byrd-Holt DD. Is the Risk of Diabetic 
Retinopathy Greater in Non-Hispanic Blacks and Mexican Americans Than in 
Non-Hispanic Whites With Type 2 Diabetes?: A U.S. population study. Diabetes 
Care. 1998;21(8):1230-1235. doi:10.2337/diacare.21.8.1230 
6.  
Cowie CC, Port FK, Wolfe RA, Savage PJ, Moll PP, Hawthorne VM. Disparities 
in Incidence of Diabetic End-Stage Renal Disease According to Race and Type 
of Diabetes. N Engl J Med. 1989;321(16):1074-1079. 
doi:10.1056/NEJM198910193211603 
7.  
Karter AJ, Ferrara A, Liu JY, Moffet HH, Ackerson LM, Selby J V. Ethnic 
Disparities in Diabetic Complications in an Insured Population. JAMA. 
2002;287(19):2519-2527. doi:10.1001/jama.287.19.2519 
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