Practical Telemedicine to Improve Control and Engagement for Veterans With Clinic-Refractory Diabetes Mellitus (PRACTICE-DM)
Phase: NA
Conditions: Telemedicine
Sponsor: VA Office of Research and Development

Practical Telemedicine to Improve Control and Engagement for Veterans With 
Clinic-Refractory Diabetes Mellitus 
PI: Matthew Crowley, MD 
NCT03520413 
IIR 16-213 
Document Date: ƵŐƵƐƚϭϵ͕ϮϬϮϭ 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 1 of 25 
 
Purpose 
This randomized trial will evaluate the effectiveness of a novel telemedicine intervention, Practical Telemedicine 
to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM). Based on 
extensive pilot work,(1,2) this novel approach is designed for practical delivery within the Veterans health 
Administration (VHA). PRACTICE-DM bundles telemonitoring, self-management support, diet/activity support, 
medication management, and depression support – each of which targets a critical factor underlying persistently poor 
diabetes control – into a single, comprehensive telemedicine intervention specifically developed for practical delivery 
using existing VHA Home Telehealth (HT) workforce, infrastructure, and technical resources. We constructed PRACTICE-
DM to be: 1) potent enough to reduce HbA1c in clinic-refractory diabetes; and 2) suitable for practical delivery using 
existing VHA HT services. We will randomize 200 Veterans with persistently poor diabetes control from two VHA sites to 
receive one of two strategies over a 12-month period: 1) the comprehensive PRACTICE-DM telemedicine intervention; 
or 2) an active control, HT care coordination and telemonitoring (which is available as part of VHA standard care). All 
Veterans will continue to receive care from their primary clinicians during the study. This study has three Specific Aims:  
x 
Specific Aim 1: Determine PRACTICE-DM’s clinical effectiveness for Veterans with persistently poor diabetes 
control versus standard HT care coordination and telemonitoring  
x 
(H1ͿDĞĂŶ,ďϭĐŝŶƚŚĞŝŶƚĞƌǀĞŶƚŝŽŶŐƌŽƵƉǁŝůůďĞшϬ͘ϲйůŽǁĞƌĂƚϭϮŵŽŶƚŚƐƚŚĂŶŝŶƚŚĞĐŽŶƚƌŽůŐƌŽƵƉ 
x 
Specific Aim 2: Evaluate PRACTICE-DM’s acceptability and mechanisms of effect using a mixed-method process 
evaluation, in order to refine the intervention for future implementation  
x 
Specific Aim 3: Understand intervention and health care costs associated with PRACTICE-DM as compared to 
standard HT care coordination and telemonitoring  
 
Background and Significance 
Background 
For the Veterans Health Administration (VHA), diabetes is a daunting problem. Diabetes prevalence among 
sĞƚĞƌĂŶƐŝƐŚŝŐŚĞƌƚŚĂŶŝŶƚŚĞŐĞŶĞƌĂůƉŽƉƵůĂƚŝŽŶ;ΕϮϱйŽĨϮϯŵŝůůŝŽŶh^sĞƚĞƌĂŶƐͿ͕ĂŶĚŚĂƐƌŝƐĞŶƐŚĂƌƉůǇŝŶƌĞĐĞŶƚ
years.(ϯ͕ϰ) As in the general public, diabetes is the leading cause of kidney failure, non-traumatic lower limb 
amputations, and blindness in VHA. Veterans with diabetes have higher rates of heart attacks and strokes, along with a 
two-fold higher mortality ƌĂƚĞǀĞƌƐƵƐŽƚŚĞƌsĞƚĞƌĂŶƐ;ΕϱйǀƐ͘Ϯ͘ϲйͿ͘;5) As the fourth most expensive disease afflicting 
Veterans, diabetes is extremely costly to VHA.(ϲ͕ϳ)  
Both within and beyond VHA, the complications and costs of diabetes rise exponentially as hemoglobin A1c 
(HbA1c) increases.(8-10) Landmark research has shown that interruption of poor glycemic control reduces diabetes 
complications and costs,(11-ϭϯ) even when glycemic improvements are not sustained.(ϭϰ) While recent studies 
targeting near-normalization of HbA1c have suggested that overly tight glycemic control may be associated with 
increased mortality,(ϭϱ͕ϭϲͿĐŽŶƚŝŶƵŽƵƐŵĂŝŶƚĞŶĂŶĐĞŽĨĂŶ,ďϭĐшϴ͘ϱйĐŽŶĨĞƌƐĂĐůĞĂƌůǇĞůĞǀĂƚĞĚůĞǀĞůŽĨƌŝƐŬĨŽƌŵŽƐƚ
Veterans – a risk that would be reduced with improved glycemic control.(ϭϳ͕ϭϴ)  
While some patients with persistently poor diabetes control have not received regular healthcare, many 
maintain elevated HbA1c despite clinic-based diabetes management. We have operationalized this group as having 
persistent poorly-controlled diabetes mellitus (PPDM), which we define as the continuous maintenance of an HbA1c 
шϴ͘ϱйĨŽƌхϭǇĞĂƌĚĞƐƉŝƚĞĐůŝŶŝĐ-based management during this period by Primary Care or Endocrinology. Our work 
suggests that, within VHA, approximatelǇϭϮйŽĨĂůůsĞƚĞƌĂŶƐǁŝƚŚƚǇƉĞϮĚŝĂďĞƚĞƐŵĞĞƚŽƵƌĚĞĨŝŶŝƚŝŽŶĨŽƌWWD͘;19) 
Given their ongoing poor control in the face of clinic-based VHA care, Veterans with PPDM are likely to be the highest-
risk, highest-cost diabetes patients in the VHA system. Because diabetes control has a greater absolute impact 
preventing complications and costs in patients with high HbA1c,(ϭϯ͕ϮϬ) addressing PPDM should be a priority for VHA.  
By definition, patients with PPDM remain poorly-controlled despite receiving regular clinic-based diabetes care. 
Factors associated with poor diabetes control include unreliable or unavailable blood glucose data, self-management 
nonadherence, suboptimal diet, inadequate physical activity, complex insulin-based treatment regimens, and comorbid 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 2 of 25 
 
depression.(21-ϯϬ) These factors are particularly difficult to address 
with the infrequent patient-provider contact achievable in the clinic 
setting, leading to PPDM.(ϯϭ͕ϯϮ) Care delivery approaches are needed 
that can more effectively counter factors that lead to PPDM.  
Telemedicine, or use of electronic information for medical 
purposes,(ϯϯ) enhances outcomes versus clinic-based diabetes 
management. Telemedicine may utilize various technologies, such as 
telephone, smart phone-, and computer-based platforms, to facilitate 
synchronous (e.g., real-time voice or video contact) or asynchronous 
(e.g., store-and-forward data transmission) interactions.(ϯϰ) 
Telemedicine-based approaches are well-tolerated by patients and 
improve access, cost-efficiency, and quality.(ϯϯ͕ϯϱ)  
Telemonitoring, self-management support, diet/activity support, medication management, and treatment of 
comorbid depression are examples of telemedicine-based treatment strategies that address specific factors underlying 
poor diabetes control (Table 1). Though data are of variable quality, these approaches appear moderately effective 
versus clinic-based usual care (UC): 
x 
Telemonitoring: Facilitates blood glucose datĂĐŽůůĞĐƚŝŽŶ͕ůŽǁĞƌƐ,ďϭĐďǇϬ͘ϰϴйǀĞƌƐƵƐh;ϯϲ)  
x 
Self-management support: Fosters self-ŵĂŶĂŐĞŵĞŶƚĂĚŚĞƌĞŶĐĞ͕ůŽǁĞƌƐ,ďϭĐďǇϬ͘ϰϰйǀĞƌƐƵƐh;ϯϳ)  
x 
Diet/activity support͗ŽƵŶƚĞƌƐĞĨĨĞĐƚƐŽĨƉŽŽƌĚŝĞƚĂŶĚŝŶĂĐƚŝǀŝƚǇ͕ůŽǁĞƌƐ,ďϭĐďǇϬ͘ϲйǀĞƌƐƵƐh;ϯϴ)  
x 
Medication management͗ĚĚƌĞƐƐĞƐĐŽŵƉůĞǆƚƌĞĂƚŵĞŶƚƌĞŐŝŵĞŶƐ͕ůŽǁĞƌƐ,ďϭĐďǇϬ͘ϱϭйǀĞƌƐƵƐh;ϯϵ)  
x 
Depression support͗ZĞĚƵĐĞƐĚĞƉƌĞƐƐŝŽŶ͛ƐŝŵƉĂĐƚŽŶĚŝĂďĞƚĞƐ͕ůŽǁĞƌƐ,ďϭĐďǇϬ͘ϯϯйǀĞƌƐƵƐh;ϰϬ)  
Though effective versus clinic-based care, each of these strategies individually reduces HbA1c to a degree that is 
insufficient for most of the PPDM population. However, a comprehensive telemedicine intervention combining elements 
of each of these approaches could address multiple factors underlying PPDM and help these high-risk, clinic-refractory 
patients meet their HbA1c targets. In our recent pilot work, combining telemonitoring, self-management support, 
ŵĞĚŝĐĂƚŝŽŶŵĂŶĂŐĞŵĞŶƚ͕ĂŶĚĚĞƉƌĞƐƐŝŽŶƐƵƉƉŽƌƚŝŵƉƌŽǀĞĚ,ďϭĐďǇϭ͘ϬйŽŶĂǀĞƌĂŐĞǀĞƌƐƵƐĐůŝŶŝĐ-based UC and by 
ΕϮ͘ϬйĨŽƌŚŝŐŚůǇ-engaged patients.(1)  
 VHA currently utilizes telemonitoring for diabetes as part of its Home Telehealth (HT) program, as do some 
other health care organizations.(ϯϰ͕ϰϭ) However, neither VHA nor other systems have successfully combined 
telemedicine-based monitoring, self-management support, diet/activity support, medication management, and 
depression support in practice; this shortfall stems from the fact that comprehensive telemedicine-based diabetes care 
has not been designed for practical delivery under real-world conditions.(ϰϮ͕ϰϯ) The lack of practical alternatives to 
clinic-based care is particularly damaging to those clinic-refractory patients with PPDM.  
In order to maximize a telemedicine intervention’s eventual impact, early consideration should be given to its 
potential for practical use in the target context.(ϰϰ) To this end, key factors to consider during intervention development 
include the workforce requirements for intervention delivery, the organizational infrastructure required for 
implementation at scale, and the required technical resources.(ϰϯ) Because these key factors vary according to the 
health care context, designing an intervention around the target context’s available workforce, infrastructure, and 
technical resources could enhance prospects for eventual real-world use within that context.  
VHA’s unique HT program makes it a national leader in telemedicine. For diabetes, however, this capacity is 
used primarily for care coordination and telemonitoring, without integrated self-management support, diet/activity 
support, medication management, or depression support. Data regarding the effect of VHA HT care coordination and 
telemonitoring on HbA1c are limited;(ϰϱ-50) this effect is likely similar to that seen with telemonitoring in other settings 
;ΕϬ͘ϱйͿ͘ As currently configured, VHA’s HT services are therefore unlikely to achieve sufficient HbA1c-lowering for 
Veterans with PPDM. As such, VHA’s nation-leading HT program is currently underutilized for this high-risk population.  
Table 1. Telemedicine strategies for diabetes. 
Strategy 
Factor addressed 
Telemonitoring  
Unreliable/unavailable 
blood glucose data (21) 
Self-management 
support  
Self-management 
nonadherence (Ϯϰ) 
Diet/activity 
support 
Effects of poor diet and 
inactivity on control (25) 
Medication 
management 
Complex insulin-based 
treatment regimens (28) 
Depression 
support 
Impact of depression on 
diabetes self-care (29) 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 3 of 25 
 
If a comprehensive telemedicine intervention for PPDM could be delivered via existing HT workforce, infrastructure, and 
technical resources – which are ubiquitous at VHA centers nationwide – it could offer a practical, effective alternative for 
Veterans who are refractory to clinic-based diabetes care. VHA’s HT program provides a unique opportunity to develop 
comprehensive telemedicine for PPDM that can be used in real-world VHA practice. 
 
Current objective 
If telemedicine is to fulfill its potential to address VHA’s diabetes burden, it must be both effective enough for 
clinic-refractory Veterans with PPDM and explicitly designed for practical delivery using VHA workforce, infrastructure, 
and technical resources. Without such an intervention, clinicians and patients will continue without recourse when 
clinic-based care proves insufficient for PPDM.  
This randomized, controlled trial (RCT) will evaluate PRACTICE-DM, a comprehensive telemedicine intervention 
for Veterans with PPDM combines telemonitoring, self-management support, diet/activity support, medication 
management, and depression support – 5 evidence-based approaches that target factors underlying PPDM – and is 
designed for delivery using existing VHA HT workforce, infrastructure, and technical resources. We constructed this 
innovative intervention to be: 1) potent enough to meaningfully reduce HbA1c in PPDM; and 2) suitable for practical 
delivery using widely available VHA resources, enhancing its potential for real-world use within VHA. PRACTICE-DM will 
leverage VHA’s unique HT program to deliver effective, comprehensive, telemedicine-based management for PPDM in a 
practical manner, with the goal of improving outcomes in this high-risk, high cost population. 
 
Significance 
This study has high clinical and strategic significance for VHA. Clinically, PRACTICE-DM will reduce VHA’s diabetes 
burden by generating a practical management option for high-risk Veterans with PPDM. Strategically, this project aligns 
with key VHA and HSR&D priorities, as well as the goals of the VHA Office of Connected Care (OCC), which oversees the 
HT program nationally.  
 
Design 
In order to evaluate the effectiveness and feasibility of delivering PRACTICE-DM within two distinct VHA 
contexts, we will enroll from Veterans Affairs Medical Centers (VAMCs) in Durham, NC and Richmond, VA. We will 
enroll/consent ƵƉƚŽϯϬϬsĞƚĞƌĂŶƐper site in order to randomize 200 Veterans with PPDM (type 2 diabetes only) to 
receive: 1) PRACTICE-DM; or 2) an active control (HT care coordination and telemonitoring), which is available as part of 
standard VHA care. All participants will receive their assigned intervention for 12 months, during which time they will 
also continue to receive usual VHA care.  
 
Selection of Subjects 
Study sites 
The Durham, NC Center of Innovation (COIN) will be the organizing site for this study. Durham is an appropriate 
setting for this study because of our COIN’s extensive experience with research conduct, our racially and 
ƐŽĐŝŽĞĐŽŶŽŵŝĐĂůůǇĚŝǀĞƌƐĞƉĂƚŝĞŶƚƉŽƉƵůĂƚŝŽŶ͕ĂŶĚŽƵƌŚŝŐŚƉƌĞǀĂůĞŶĐĞŽĨWWD;ϭϱйŽĨsĞƚĞƌĂŶƐǁŝƚŚƚǇƉĞϮ
diabetes).(19) We have chosen the Hunter Holmes McGuire VAMC in Richmond as our second site for several reasons: 1) 
like Durham, RichmonĚŚĂƐĂĚŝǀĞƌƐĞƉŽƉƵůĂƚŝŽŶǁŝƚŚĂŚŝŐŚŝŶĐŝĚĞŶĐĞŽĨWWD;ϭϰйŽĨsĞterans with type 2 diabetes); 
2) Richmond’s strong HT program is keenly interested in adding comprehensive telemedicine for PPDM to its services 
(see Letter of Support from Richmond site PI Dr. Phillip Tarkington); ϯͿZŝĐŚŵŽŶĚ͕ƚŚŽƵŐŚŶŽƚĂK/E͕ŚĂƐƌĞƐĞĂƌĐŚ
ĞǆƉĞƌŝĞŶĐĞƚŚĂƚǁŝůůĂƐƐƵƌĞƚŚĞĨĞĂƐŝďŝůŝƚǇŽĨƚŚŝƐƐƚƵĚǇ͖ϰͿƵƌŚĂŵĂŶĚZŝĐŚŵŽŶĚŚĂǀĞĂŚŝƐƚŽƌǇŽĨƐƵĐĐĞƐƐĨƵůƌĞƐĞĂƌĐŚ
collaboration involving members of this team;(51) 5) Durham and Richmond are only 150 miles apart, which will 
facilitate collaboration and minimize travel costs.  
In developing this study, we have worked closely with the Durham and Richmond HT programs. Both are 
enthusiastic participants in this evaluation of PRACTICE-DM, and each program’s leadership endorses an adequate 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 4 of 25 
 
capacity to randomize the Veterans needed to conduct study activities at their site (see Letters of Support from Dr. 
Tarkington of Richmond and Brian Hayes/Oliver Massey of Durham).  
 
Population 
In order to assure a representative population, we will proactively recruit Veterans with type 2 diabetes 
ŵĂŶĂŐĞĚĨŽƌхϭǇĞĂƌĂƚĞĂĐŚsite, including Community-Based Outpatient Clinics (CBOCs). We will identify subjects with 
PPDM by reviewing the VHA electronic health record (EHR) and soliciting referrals. Inclusion criteria are: 
x 
Diagnosis of type 2 diabetes (diagnosis codes or prescription of diabetes medication)  
x 
ш1 ,ďϭĐǀĂůƵĞƐŽĨшϴ͘ϱйĚƵƌŝŶŐƚŚĞƉƌŝŽƌǇĞĂƌ͕ǁŝƚŚŶŽƌĞĂĚŝŶŐƐŽĨфϴ͘ϱй 
x 
ш1 appointments with a VHA Primary Care Provider (PCP) or Endocrinology during the prior year  
ĞĐĂƵƐĞƚŚĞƌĞĂƌĞхϭϬϬϬƉŽƚĞŶƚŝĂůůǇĞůŝŐŝďůĞsĞƚĞƌĂŶƐĂƚƵƌŚĂŵsDĂŶĚхϭϬϬϬĂƚDĐ'ƵŝƌĞsD͕ǁĞĂŶƚŝĐŝƉĂƚĞŶŽ
difficulty reaching our randomization goal of 200 Veterans. We will proactively identify and purposefully oversample 
women from our pool of elŝŐŝďůĞƉĂƚŝĞŶƚƐ͕ǁŝƚŚƚŚĞŐŽĂůŽĨĂĐŚŝĞǀŝŶŐĂƉŽƉƵůĂƚŝŽŶƚŚĂƚŝƐϮϬйĨĞŵĂůĞ͘tŝƚŚƌĞƐƉĞĐƚƚŽ
ŵŝŶŽƌŝƚǇsĞƚĞƌĂŶƐ͕ǁĞǁŝůůĐĂƌĞĨƵůůǇŵŽŶŝƚŽƌƌĞĐƌƵŝƚŵĞŶƚƚŽĂƐƐƵƌĞĂƉŽƉƵůĂƚŝŽŶƚŚĂƚŝƐĂƚůĞĂƐƚϱϬйĨƌŝĐĂŶ-American 
ĂŶĚϭϬй,ŝƐƉĂŶŝĐͬ>ĂƚŝŶŽ͕Ɛurpassing local demographics. No children or prisoners will be included in the proposed 
project. Current/prior use of VHA HT, Endocrinology, or other services will not exclude Veterans from participation. 
Exclusion criteria include:  
x 
ŐĞхϳ0͕ŽƌůŝĨĞĞǆƉĞĐƚĂŶĐǇфϱǇĞĂƌƐ  
x 
History of severe hypoglycemia documented in chart in the past 12 months 
x 
Inability to communicate by telephone  
x 
Dementia or psychosis  
x 
Active alcohol or substance disorder  
x 
Current pregnancy or report of new pregnancy during study  
x 
Prior hypoglycemic seizure or coma in the past 12 months 
x 
Refusal to perform self-monitored blood glucose (SMBG) at baseline evaluation  
x 
Use of continuous subcutaneous insulin infusion pumps 
x 
Hospitalized for stroke, heart attack or had surgery for blocked arteries in the past 12months 
x 
Receiving kidney dialysis 
x 
Diagnosed with metastatic cancer  
x 
Use of a continuous blood glucose monitor (due to HT equipment constraints) unless the subject is willing to 
perform standard finger stick blood glucose monitoring and submit blood glucose values per study protocol. 
x 
Primary provider requests patient not participate in the study 
x 
Primary medication management for diabetes is performed by a non-VAMC provider. 
 
Enrollment/Randomization         
Using a proactive process, eligible Veterans at each site will receive an invitation letter signed by the study PI, 
which will include instructions on opting out of further contact if desired. If a Veteran does not opt out within a week, 
study staff will initiate telephone contact to gauge interest in participation, explain the study, briefly screen for 
eligibility, and if appropriate, arrange an in-person appointment for further evaluation. Further screening and informed 
consent will be performed at this appointment by the site research assistant (RA) or project coordinator (PC). After 
consent, baseline assessment will include: 1) survey of demographics, clinical history, medications, and measures of 
relevant psychosocial constructs (Table 2Ϳ͖ϮͿŵĞĂƐƵƌĞŵĞŶƚŽĨWĂŶĚďŽĚǇŵĂƐƐŝŶĚĞǆ;D/Ϳ͖ĂŶĚϯͿůĂďŽƌĂtory HbA1c 
ƚĞƐƚŝŶŐ͘ĂƐĞůŝŶĞĂƐƐĞƐƐŵĞŶƚǁŝůůƚĂŬĞфϲϬŵŝŶƵƚĞƐ͘sĞƚĞƌĂŶƐǁŝůůƌĞĐĞŝǀĞĂƐƚƵĚǇƉĂĐŬĞƚĂŶĚĚĞƉĂƌƚƚŽĂǁĂŝƚĐŽŶƚĂĐƚ

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 5 of 25 
 
from HT. HT will enroll Veterans using local 
processes; all will receive standard HT equipment, for 
which all Veterans with PPDM qualify and which is 
similar across sites (Cardiocom®, Chanhassen, MN). 
Randomization will follow Veterans’ baseline 
appointment (Figure 1). Participants will receive 
information on both study arms during the consent 
process, we will not attempt to blind participants to 
randomization assignment. However, in order to 
assure blinding of our RAs, who manage outcome 
data collection, randomization will be managed by 
the PC. Using a computer-generated, blocked 
sequence, we will allocate Veterans into the two 
study arms in equal numbers. Randomization will be 
stratified by site, pre-enrollment use of HT services, 
and pre-enrollment receipt of Endocrinology care.  Notification of randomization assignment will occur within 1 week of 
enrollment and will be communicated with the veteran via telephone call from the study team.  Patients with a baseline 
HbA1c value below the study ŝŶĐůƵƐŝŽŶĐƌŝƚĞƌŝĂŽĨϴ͘ϱйǁŝůůŶŽƚďĞƌĂŶĚŽŵŝǌĞĚĨŽƌƐƚƵĚǇƉĂƌƚŝĐŝƉĂƚŝŽŶ͘ 
 
Study Procedures/Interventions 
Intervention group 
For Veterans randomized to PRACTICE-DM, each intervention component will be administered by HT nurses, as 
would be the case in real-world practice. Two HT nurses from each site will work with the intervention group. These 
nurses will be distinct from the HT nurses that work with the active control group. HT nurses conduct telemonitoring as 
part of their standard practice; based on our pilot work, HT can deliver PRACTICE-DM with minimal additional training. 
Intervention HT nurses at both sites will complete training during a single session, which will be led by the study PI, with 
follow-up/refresher sessions as needed. All HT nurses will receive a hardcopy PRACTICE-DM intervention manual 
containing study materials and procedures, and will use online software to 
track intervention activities (e.g., attempted/ completed phone calls, 
modules delivered, medication changes). PRACTICE-DM research staff will 
not participate in intervention delivery, but will manage only study-specific 
tasks like enrollment, randomization, and outcome assessment. Of note, 
while receiving PRACTICE-DM, intervention-group participants will 
continue to receive care from PCPs and other VHA providers.  
HT will deliver the 5 intervention components during telephone 
encounters (Figure 2) according to a schedule (see intervention schedule). 
Each encounter will be documented in an intervention database, as well as 
in the EHR. Based on feedback from our pilot work, we will allow a degree 
of flexibility in the encounter schedule for patients who achieve goal 
HbA1c. The standard encounter frequency will be every two weeks, but 
ŵĂǇďĞĞǆƚĞŶĚĞĚƚŽĞǀĞƌǇϰǁĞĞŬƐĨŽƌƉĂƌƚŝĐŝƉĂŶƚƐachieving their HbA1c 
goal. Per VA guidelines,(ϭϳ) HbA1c goals will be individualized based on 
age, comorbidities, and hypoglycemia risk; most Veterans’ goal will be 
ďĞƚǁĞĞŶфϳ͘ϬйĂŶĚфϴ͘Ϭй;ĂƐwill be the case in the control group). 
ĞĐĂƵƐĞ,ďϭĐǁŝůůďĞĂƐƐĞƐƐĞĚĞǀĞƌǇϯŵŽŶƚŚƐ͕ƚŚĞϯ-month outcome 
visit will be the first chance for participants to transition to every-ϰ-week 
encounters. Should Veterans relapse while receiving the lower encounter 
Figure 1. Patient flow through study. 
Table 2. Constructs/measures assessed at study baseline. 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 6 of 25 
 
frequency, HT will return to every-two-week encounters until 
the next HbA1c assessment. The 5 intervention components are 
described below:  
x 
Telemonitoring: Per HT policy, Veterans receive daily 
prompts to transmit data using their HT-issued 
equipment. FailƵƌĞƚŽƐƵďŵŝƚĚĂƚĂĨŽƌϯĚĂǇƐƚƌŝŐŐĞƌƐĂ
call from HT, followed by a letter at 5 days. Per ADA 
guidelines, and based on their medication regimen and 
corresponding allocation of glucometer supplies, 
participants are initially asked to perform SMBG up to 
four times per day before meals and at bedtime;(18) 
patients on stable medication doses at goal HbA1c may 
monitor less frequently at the discretion of the study 
clinician. At each intervention encounter, HT contacts 
participants by phone to review SMBG data, reconcile 
medications, and assess self-reported medication 
adherence. Following each encounter, HT compiles this 
information in a report documented in the HER (see report templates).  At each intervention encounter, HT 
contacts participants by phone to review SMBG data, reconcile medications, and assess self-reported 
medication adherence. Following each encounter, HT compiles this information in a report documented in the 
HER (see report templates).  
x 
Self-management support: PRACTICE-DM’s self-management support component utilizes behavioral strategies 
ƌŽŽƚĞĚŝŶƐŽĐŝĂůĐŽŐŶŝƚŝǀĞƚŚĞŽƌǇ͕ĂŶĚĐŽŶƚĞŶƚƌĞĨŝŶĞĚĚƵƌŝŶŐхϭϬƚƌŝĂůƐďǇĐŽ-investigator Hayden Bosworth, 
including recent trials in diabetes.(52-55) We have further adapted this evidence-based content for Veterans 
with PPDM through our pilot work.(1,2) This component builds patients’ self-management capacity by focusing 
on knowledge and self-efficacy, two key determinants of diabetes control.(ϱϲ) As PRACTICE-DM is delivered by 
existing VHA Home Telehealth (HT) nurses, our self-management support component addresses common issues 
underlying PPDM using a module-based approach appropriate for HT training. Our modules incorporate 
Veteran-centric strategies such as tailoring and goal setting; all material ŝƐĂƚчϴƚŚŐƌĂĚĞƌĞĂĚŝŶŐůĞǀĞů. At the 
first intervention encounter, HT nurses work with each participant on individualized goal setting. At subsequent 
encounters, HT delivers modules according to a schedule (see intervention schedule and modules). HT works 
with Veterans during some encounters to review and revise goal-setting.  
x 
Diet/activity support: PRACTICE-DM’s diet/activity support component is designed to help overweight/obese 
Veterans ;D/шϮϱͿ ĂĐŚŝĞǀĞхϱйǁĞŝŐŚƚůŽƐƐďǇƚĂƌŐĞƚŝŶŐ a 500-ϳϱϬĂůŽƌŝĞͬĚĂǇĚĞĨŝĐŝƚĂƐƉĞƌ
guidelines.(25) Because diets providing equivalent caloric restriction are equally effective in diabetes regardless 
of macronutrient composition͕;ϱϳ͕ϱ8) each Veteran’s diet plan is individualized based on personal preferences 
and likelihood of adherence. As per ADA guidelines,(59) our diet/activity support component encourages 
ƉĂƚŝĞŶƚƐƚŽŵĂŝŶƚĂŝŶшϭϱϬŵŝŶƵƚĞƐŽĨŵŽĚĞƌĂƚĞ-to-vigorous-intensity physical activity per week, spread over at 
ůĞĂƐƚϯĚĂǇƐǁŝƚŚŶŽŵŽƌĞƚŚĂŶ 2 consecutive days without activity. Diet and activity are addressed during each 
phone encounter throughout the intervention period. At the outset of the intervention, the PRACTICE-DM 
dietitian conducts a baseline call with each Veteran at both sites in order to develop the individualized diet plan. 
The dietitian also conducts a follow-up call at four weeks to discuss progress and adjust each participant’s plan 
as needed. HT documents each Veteran’s individualized diet plan, activity recommendations, and weight loss 
goals in every intervention encounter note. During each every-two-week PRACTICE-DM encounter, HT reviews 
participants’ goals, follows up progress with regard to diet and physical activity, and records self-reported 
weight data (a digital scale is standard HT equipment for all overweight/obese Veterans). For Veterans who are 
Figure 2. PRACTICE-DM intervention components. 
 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 7 of 25 
 
not progressing toward their weight loss goal, additional follow-up may be arranged with the PRACTICE-DM 
dietician.  
x 
Medication management: Our medication management approach has two key features associated with high 
impact; it facilitates frequent contact between Veterans and study staff, and allows study clinicians to modify 
diabetes medications.(ϯϵ) After each intervention encounter, HT generates an EHR report summarizing 
participants’ SMBG data, reconciled medications, self-reported medication adherence, and the delivered self-
management and diet/activity content. HT relays this report to the study clinician via EHR, who considers 
treatment changes based on our medication protocol. Our protocol targets fasting blood glucose 90-150 mg/dL 
ĂŶĚƉƌĞƉƌĂŶĚŝĂůďůŽŽĚŐůƵĐŽƐĞϭϰϬ-180 mg/dL; these liberal goals may be further tailored for individualized 
HbA1c goals or hypoglycemia. The study clinician notifies HT of any recommendations via addendum to the EHR 
report (see report templates), and HT contacts the Veteran by phone to implement the changes. PCPs are 
alerted to changes via EHR. We will use two study clinicians per site, each a doctor-level provider that is well-
versed in diabetes medication management. To assure homogeneity in management, we will utilize a 
medication protocol (see medication protocol) with regular case review meetings to assess protocol fidelity.  
x 
Depression support: Consistent with sͬKŐƵŝĚĞůŝŶĞƐ͕;ϲϬ) our depression support protocol offers both 
pharmacologic and non-pharmacologic options. Veterans without baseline depressive symptoms (including 
those without diagnosed depression AND those with well-controlled depression) do not enter the protocol, but 
receive screening with the Personal Health Questionnaire-8 (PHQ-8) by HT every 12 weeks.(ϲϭ) For all 
intervention subjects with PHQ-8 ш10, HT arranges an expedited appointment with the site’s study Psychiatrist 
or their existing MH provider, at which the Veteran reviews and chooses between pharmacotherapy and non-
pharmacologic options. For those choosing pharmacotherapy, the recommended first-line agent for 
antidepressant-ŶĂŢǀĞƉĂƚŝĞŶƚƐŝƐƐĞƌƚƌĂůŝŶĞ;ϱϬŵŐĚĂŝůǇĨŽƌϰǁĞĞŬƐ͕ƚŝƚƌĂƚĞto 100 mg for incomplete 
response),(ϲϮ) and the alternative is bupropion SR (150 mg daily for 2 weeks, titrate to 150 mg twice daily as 
needed).(ϲϯ) For Veterans with a baseline PHQ-8 ш10 already on an antidepressant, initial options are to 
increase the current agent, switch to sertraline, or add sertraline to current therapy (or bupropion SR if already 
on sertraline). For Veterans that opt for a non-pharmacologic approach, the study psychiatrist presents available 
therapy options and arranges appropriate referrals. The response to the therapeutic intervention will be assess 
by the study psychiatrist or existing MH provider who will determine whether the subject requires  an 
alternative medication (e.g., bupropion SR if no response to sertraline), combined pharmacotherapy, an 
alternative non-pharmacologic approach, or combined medication/non-pharmacologic treatment. Patients with 
symptom remission (PHQ-ϴфϭϬͿĂƌĞŵŽŶŝƚŽƌĞĚby HT for recurrence every 12 weeks. Emergency Psychiatric 
services (suicide hotline and VAMC emergency clinics) are available throughout the study. Please see the 
PRACTICE-DM Depression Support Algorithm for additional study practice guidelines. 
 
Control group 
Veterans randomized to the active control group at each site will receive standard HT services; the HT nurses 
assigned to these Veterans will be distinct from those working with the intervention group. As per the “Telemonitoring” 
subsection above, participants will be instructed to transmit SMBG data daily using their HT-issued equipment. Per HT 
ƉŽůŝĐǇĂƚďŽƚŚƐŝƚĞƐ͕sĞƚĞƌĂŶƐǁŝůůƌĞĐĞŝǀĞĚĂŝůǇƉƌŽŵƉƚƐĨŽƌĚĂƚĂƚƌĂŶƐŵŝƐƐŝŽŶ͕ĂŶĚĨĂŝůƵƌĞƚŽƐƵďŵŝƚĚĂƚĂĨŽƌϯĚĂǇƐǁŝůů
trigger a call from HT, followed by a letter at 5 days. Participants will not have study encounters, but will receive 
standard VA HT care coordination in addition to telemonitoring. Care coordination at both sites will include pre-
appointment compilation of SMBG data for review by PCPs or other providers, as well as communication with Veterans 
as needed between appointments. Control group participants will continue to receive care from PCPs and other 
providers.  
 
Study follow-up 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 8 of 25 
 
sĞƚĞƌĂŶƐǁŝůůƌĞĐĞŝǀĞƚŚĞŝƌĂƐƐŝŐŶĞĚŝŶƚĞƌǀĞŶƚŝŽŶĨŽƌϭϮŵŽŶƚŚƐ͘ƚϲĂŶĚϭϮŵŽŶƚŚƐ͕ĂůůǁŝůůĂƚƚĞŶĚŝŶ-person 
outcome assessment visits (Figure 1), at which they will complete a follow-up survey, BP/BMI measurement, and HbA1c 
testing. The estimated time required for these visits will be ϰϱŵŝŶƵƚĞƐ͘ƚϯĂŶĚϵŵŽŶƚŚƐ͕ĂůůsĞƚĞƌĂŶƐǁŝůůŚĂǀĞŝŶƚĞƌŝŵ
HbA1c assessment, which can be performed at the nearest CBOC or VAMC. At study completion, all participants at each 
site will continue routine HT management, with subsequent disposition per HT policy. Responsibility for diabetes care 
will return to PCPs and other providers.  
In order to further examine PRACTICE-DM’s acceptability and mechanisms of effect, we will also conduct phone-
based, semi-structured, qualitative interviews with 20-ϯϬ randomly chosen intervention arm subjects (approximately 10-
15 from each site) following their 12-month study visits.  Patients will be asked to provide consent to be contacted for 
these interviews at the time of study enrollment. 
 
Outcomes 
Effectiveness outcomes 
Our primary effectiveness outcome will be HbA1c difference between groups (baseline to 12 months).  
We will also examine multiple secondary outcomes. We will use the Self-Care Inventory-Revised (SCI-R) to examine 
Veteran engagement with PRACTICE-DM.(ϲϰ) We will examine diabetes burden as a marker for perceived workload 
using the Emotional Burden/Regimen Distress subscales of the Diabetes Distress Scale (DDS).(ϲϱ) We will use the 
Perceived Competence Scale (PCS) to examine patient capacity.(ϲϲ) We will examine weight and depressive symptoms 
as secondary clinical outcomes using BMI and PHQ-8.(ϲϭ)  
 
Process evaluation outcomes  
We will examine PRACTICE-DM’s acceptability and mechanisms of effect through a mixed-method process 
evaluation, which will help refine the intervention for future implementation. Using a qualitative approach, we will 
conduct phone-based, semi-structured interviews with approximately 20-ϯϬ intervention arm subjects (approximately 
10-15 from each site) following their 12-month study visits. Interview guide questions will probe patients’ explanatory 
models of diabetes, general perceptions of what did and did not work well with PRACTICE-DM, and impressions of the 5 
intervention components (see draft interview guide). We will also seek consent to conduct phone-based, semi-
structured qualitative interviews with the 2-ϯ HT nurses that participate in delivering PRACTICE-DM at each site, as well 
as with 2-ϯ administrators/medication managers at each site. As with the patient interviews, these interviews will help 
refine the intervention and will also provide data to guide future implementation. Along with this qualitative work, we 
will quantitatively examine possible moderators and mediators of PRACTICE-DM’s effect. In addition to guiding 
intervention refinement and implementation, these analyses will help us explore how the individual PRACTICE-DM 
components contribute to the overall intervention effect.  
In order to explore the need for possible refinements to the current PRACTICE-DM intervention design, we are 
interested in examining clinical information related to diabetes complications and comorbidities associated with PPDM, 
including retinopathy, nephropathy, neuropathy, dyslipidemia, hypertension, and nonalcoholic fatty liver disease. This 
clinical information will include only data that are available in the EHR and will not require prospective data collection or 
new patient contact. Specifically, we will examine medications, laboratory data (e.g., lipid profiles, gastrointestinal 
panels, kidney function and urine microalbumin), and data related to imaging and procedures associated with diabetes 
complications and comorbidities. 
 
Additionally, we will ask four program acceptability questions at the completion of the 12-month program with 
all participants receiving the PRACTICE-DM Intervention or Standard Home Telehealth programs.  The four questions 
were already approved as part of our quantitative evaluation but were not administered to all patients at the time of 
program completion.  In order to collect these acceptability data, we will query all study participants at either the 12-
month interview, on a brief follow-up telephone call (if the 12-month interview has passed), or via a mailed survey (if we 
ĂƌĞƵŶĂďůĞƚŽƌĞĂĐŚǀŝĂƚĞůĞƉŚŽŶĞĐĂůůĂĨƚĞƌϯĂƚƚĞŵƉƚƐͿ͘dŚĞƐĞƋƵĞƐƚŝŽŶƐǁŝůůďĞŽƉƚŝŽŶĂůĂŶĚǁŝůůƚĂŬĞůĞƐƐƚŚĂŶϱ
minutes to complete.  When telephone contact is made or when mailed materials are sent, we will remind the 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 9 of 25 
 
participants that their participation is optional. No additional compensation will be provided for responding to the 
questions.  The four survey questions can be found in the survey files. 
Cost outcomes 
We will assess intervention-related and VHA health care costs associated with delivering PRACTICE-DM and our 
active control. Labor and capital costs will both be captured in calculating intervention costs. Labor will include HT nurse 
and study clinician time as determined using daily logs documenting engagement in study tasks, with salaries based on 
VHA Human Resources salary data. For each arm, we will distinguish research-specific costs (e.g., staff time spent 
preparing regulatory documentation or in research meetings) from intervention costs (e.g., HT nurse time spent 
interacting with patients, HT time spent documenting reports and communicating with study clinicians, study clinician 
time). Capital costs will include HT telemedicine equipment, telephone service costs, overhead costs, and supplies.  
VHA health care costs will include costs for all health care utilization (clinic visits, Emergency Room visits, 
hospitalizations, procedures, laboratory, pharmacy, radiology, nursing, and all other clinical costs) that occurs in VHA 
facilities or facilities reimbursed by VHA (e.g., fee basis) during the 12-month intervention period. Along with tracking 
local utilization of services (e.g., different types of clinic visits, use of ancillary clinical services, Emergency Room visits, 
and hospitalizations), we will take a VHA payer perspective to this analysis, so we will obtain cost data from Managerial 
Cost Accounting National Data Extracts and fee basis files. 
 
Adverse Events 
All adverse events will be reported per Durham VAMC requirements. All Serious, Unanticipated and Related 
adverse events will be reported to IRB within 5 business days of hearing of the event. All other adverse events will be 
reported at continuing review.   
Expected adverse events associated with study participation in both arms may include hypoglycemia (as a result 
of glucose-lowering treatments) and reactions to commonly-used diabetes or depression medications (e.g., diarrhea 
with metformin or sertraline, injection site irritation from insulin). Because PRACTICE-DM utilizes approaches that are 
common in standard practice, we anticipate that adverse events will be similar to standard care in quality and rate. We 
will assess adverse events in both arms by structured self-report,(ϲϳ) and as hypoglycemia is the most common side 
effect of ĚŝĂďĞƚĞƐƚŚĞƌĂƉǇ͕ǁĞǁŝůůĞǆĂŵŝŶĞƚŚĞŝŶĐŝĚĞŶĐĞŽĨďůŽŽĚŐůƵĐŽƐĞфϳϬŝŶďŽƚŚŐƌŽƵƉƐďǇƌĞǀŝĞǁŝŶŐ^D'ĚĂƚĂ
transmitted to HT during the study. 
Due to the age and comorbidities of our study cohort (e.g., risk of vascular disease, existing depression), 
hospitalizations and other health events (e.g., development of new medical conditions, surgeries, ER visits, MI, stroke, 
falls and death) unrelated to the study are expected.  Any events that fall into one of these categories will be reported at 
continuing review/per the current SOP. Participants may miss study encounters or follow-up assessments during the 
conduct of the project. We will not consider such events to be protocol deviations, as they will not impact participants’ 
healthcare or impose any additional risks. 
At study outset, Veterans will be instructed to seek immediate emergency services for any adverse events that 
require urgent in-person evaluation. As some recruited patients may have diagnosed or undiagnosed depression, all 
patients will be given the national suicide hotline number at study outset for use as needed. 
 
Risk/Benefit Assessment 
Medical risks associated with study participation in both arms are similar to standard diabetes care, and include 
hypoglycemia and reactions to commonly-used diabetes/depression medications. PRACTICE-DM combines 5 strategies: 
1) telemonitoring, which is available as part of standard VHA care for Veterans with poor diabetes control; 2) self-
management support, which is central to effective diabetes care in any setting; ϯͿĚŝĞƚͬĂĐƚŝǀŝƚǇƐƵƉƉŽƌƚ͕ǁŚŝĐŚŝƐĂĨƌŽŶƚ-
line treatment approach for all patients with diabetes; ϰͿŵĞĚŝĐĂƚŝŽŶŵĂŶĂŐĞŵĞŶƚ͕ǁŚŝĐŚŝƐĂůƐŽĂƌĞƋƵŝƌĞŵĞŶƚĨŽƌ
effective diabetes management; and 5) depression support, which enhances patients’ ability to self-manage their 
diabetes. It is possible that combining these multiple standard diabetes management strategies into a single 
intervention may increase the risk of hypoglycemia versus standard care, but we have mitigated this possibility by 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 10 of 25 
 
utilizing relatively liberal blood glucose targets (fasting blood glucose 90-ϭϱϬŵŐͬĚ>͕ƉƌĞƉƌĂŶĚŝĂůďůŽŽĚŐůƵĐŽƐĞϭϰϬ-180 
mg/dL) and individualized HbA1c goals, which may be further relaxed for evidence of hypoglycemia. Further, all 
Veterans will be provided with detailed instructions for hypoglycemia management at study outset, and will also be 
prescribed a glucagon emergency kit for complicated hypoglycemia if deemed appropriate by study staff. Our active 
control, HT care coordination and telemonitoring, is available as part of routine VHA care, so risks will not exceed 
standard care.  
Of note, patients in both study arms will receive HT telemonitoring. Because HT nurses are uniquely suited to 
identifying and managing hypoglycemia and other therapeutic risks in Veterans with diabetes, overall detection and 
amelioration of medical risks could actually be enhanced relative to standard care. Further, all Veterans will continue to 
receive their regular VHA care with PCPs and other providers during the study, which will provide an added layer of risk 
protection. At study outset, Veterans will also be instructed to seek immediate emergency services for any adverse 
events that require urgent in-person evaluation. 
Risks specifically associated with study procedures, such as venipuncture, are minimal. As with any study, risk 
exists for breach of confidentiality and loss of protected health information (PHI), but steps will be taken to minimize 
this risk as per the “Privacy and Confidentiality/Information Security” section below. 
 
Direct benefits associated with study participation may include improved diabetes control (which is particularly 
elusive for Veterans with PPDM). Improved control could translate to reduced rates of future complications (which are 
particularly common for Veterans with PPDM). Veterans may also experience reduction in weight and improved control 
of depressive symptoms. Potential benefits to study subjects include improved glycemic control and avoidance of future 
diabetic complications. Benefits for Veterans not enrolled in this study may include the development of an effective, 
practical treatment option for Veterans with PPDM, which is currently not available within or beyond VHA. 
 
Costs and/or Payments to Subjects 
WĂƌƚŝĐŝƉĂƚŝŶŐsĞƚĞƌĂŶƐǁŝůůƌĞĐĞŝǀĞĐŽŵƉĞŶƐĂƚŝŽŶĨŽƌƚƌĂǀĞůĂŶĚƚŝŵĞĨŽƌĂůůŽƵƚĐŽŵĞǀŝƐŝƚƐ͘^ŝŶĐĞƚŚĞďĂƐĞůŝŶĞ͕ϲ-, 
and 12-month visits require travel to a VAMC, participants will receive ΨϱϬƉĞƌǀŝƐŝƚ͘dŚĞϯ- and 9-month assessments 
will require less time/travel, so Veterans will receive $25 per visit (maximum total compensation $200/Veteran). 
 
Data and Safety Monitoring 
Fidelity assessment 
We will conduct a fidelity assessment in order to assure the intervention is delivered in a manner consistent 
with our protocol across sites. Nurses will use a database to track all intervention activities, and this documentation will 
be reviewed weekly by the study coordinator in order to assure that intervention components due at each encounter 
were delivered. The overall study PI (Dr. Matthew Crowley) and overall project coordinator (Ms. Susanne Danus) will 
randomly tape record or listen to ĂƉƉƌŽǆŝŵĂƚĞůǇϭϬйŽĨĐĂůůƐĂƚĞĂĐŚƐŝƚĞŝŶŽƌĚĞƌƚŽĞŶƐƵƌĞĐŽnsistency in intervention 
delivery. Should we encounter interventionist-specific problems, we will work with local HT to enhance the quality of the 
nurse-patient interactions. Finally, we will assure fidelity to our medication management protocol through quarterly 
case review meetings, which all study clinicians will attend through VHA conferencing.  
 
Data monitoring committee 
We will also utilize a Data Monitoring Committee (DMC) for this study in order to monitor sample 
enrollment/randomization and safety issues at both sites. The DMC will consist of the overall PI (Dr. Matthew Crowley), 
the Richmond site PI (Dr. Phillip Tarkington), the other study clinicians, the study statistician, the overall project 
coordinator, and in order to provide an independent perspective, 2 Durham VAMC diabetes providers (e.g., 
Endocrinologist, PharmD) not affiliated with the study. The DMC will carry out the following functions:  
x 
The DMC will monitor enrollment/randomization at both sites to assure that the study adheres to the proposed 
timeline. Although we do not anticipate any difficulty meeting our enrollment/randomization goal in the time 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 11 of 25 
 
allotted, should slower-than-expected recruitment occur, the DMC will consider site-specific options to bolster 
enrollment/randomization, and if necessary, the replacement of an underperforming site.  
x 
The DMC will also review both individual adverse event reports and aggregated safety data to identify potential 
safety concerns in the intervention and control groups, meeting approximately every six months during the 
study period and as needed when concerns arise. The DMC will communicate any necessary information to 
other study staff as needed. Any findings or issues that require reporting to the IRB, participants, or PCP will be 
disseminated by the overall PI and project coordinator. The issue in question will determine the mode of 
information transmission (e.g., letter, secure e-mail, phone call).  
 
Integrity of study data 
Accuracy and integrity of study data will be ensured in two ways. First, the Durham VHA COIN conducts 
computer operations in a secure Centralized Computing Facility managed by VHA network and server administrators. 
Within this computing facility, all research data are stored on VHA-Administered servers, which are physically secured in 
the Durham VAMC computer room. VHA network access to research data is controlled in accordance with the COIN’s 
standard operating procedures and VHA policies. In addition, standard COIN procedures ensure that servers, 
workstations and portable computers are kept up-to-date with virus filters, security patches, software updates and 
firmware updates. 
 
Data management 
Study tracking data will be entered into an intervention database created by our COIN’s software development 
team (Microsoft .NET). Because this study’s recruitment, enrollment, and follow-up processes are similar to multiple 
previous studies that have used this database, we will be able to customize the database to meet our needs. This 
database will allow us to track: patient study status (i.e., eligible, enrolled, refused); the results of screening interviews; 
intervention tasks due for each participant; and encounter-specific data (e.g., attempted/completed phone calls, 
duration of phone encounters, modules delivered, medication changes). The randomization sequence and any necessary 
stratification variables can be imported and will allow our project coordinator to be able to randomize participants 
within the database. Screening and outcome measures will be entered directly into the study database using DatStat 
Illume™ or RedCAP, web-based survey tools. RedCAP will be hosted on the VINCI servers.  Data will be stored in a 
restricted folder on a secure VHA server. 
 
Future Use of Data 
We may want to run secondary data analyses related to the original aims of the grant (for example 
moderator/mediator analyses, analyses of baseline data, etc.).  It is also possible that data collection under this protocol 
might be used to inform future surveys, interviews, and/or intervention development among patients with diabetes.  
Data would only be used from patients who agreed that their data could be stored and used for future analysis on their 
complete Informed Consent and HIPAA Authorization forms. For these secondary analyses we would not use data from 
patients who provided written documentation of study withdrawal, as detailed in the section below.  To facilitate 
participation of investigators outside of our core study team in these study-related secondary analyses, we will create a 
de-identified PRACTICE-DM data set (see ‘De-identified dataset’ below). 
For any new projects unrelated to the original aims of the grant, a separate protocol, defining the new project(s) 
would be submitted to the Durham VA IRB. Such future studies would request either a waiver/ alteration to the 
ICF/HIPAA requirements or a consent form and updated HIPAA Authorization, as appropriate. 
 
Withdrawal of Participants 
 
Patients may be withdrawn from the research study without their consent under the following conditions (also 
previously listed as exclusion reasons): 
1. Inability to communicate by telephone  

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 12 of 25 
 
2. New diagnosis of dementia or psychosis  
ϯ͘ Active alcohol or substance disorder  
ϰ͘ Current report of new pregnancy during study  
5. New instance of hypoglycemic seizure or coma  
ϲ͘ Refusal to perform self-monitored blood glucose (SMBG)  
ϳ͘ Use of continuous subcutaneous insulin infusion pumps 
8. ,ďϭĐǀĂůƵĞфϴ͘ϱй at baseline study assessment 
Patients who choose to withdraw from the study after enrolling will be asked to provide written documentation of the 
request to the study team.  If a patient withdraws, no new data will be collected about him/her, other than a possible 
reason for withdrawal.  All data collected prior to the date of withdrawal will remain with the study files and may be 
used for analysis. 
  
Privacy and Confidentiality/Information Security 
Our experienced team has a strong understanding of research-associated risks and will take all necessary 
measures to protect patients at both study sites. Dr. Crowley (overall study PI) sits on the Durham VAMC IRB, and Dr. 
David Edelman (co-investigator) is the Chair of the Durham VAMC IRB. Data security for this project will be overseen by 
the VA OIT via use of security user groups that limit data access. The Durham COIN has developed standard operating 
procedures for data acquisition and data management, which are designed to protect against data loss and maintain 
patient confidentiality. These procedures have been used in many studies and we will adhere to these procedures at 
both sites for the proposed study.  
All participant information collected in the context of this research study, even the fact that an individual is 
participating in the study, will be considered confidential, and the study team will take steps to ensure the participant’s 
confidentiality is protected at each step of the research process:  
x 
Each participant will be assigned a study identification number (ID), which links all computerized research 
records; all research data files are organized by study ID, with no names or other identification attached.  
x 
All PHI will be housed on a secure server behind the Durham VAMC firewall at both sites, and access will be 
restricted. Computerized study data will be maintained on VHA network servers which are secured behind a 
firewall (as well as through controlled physical access). Server access is controlled by OIT, and staff members will 
only be allowed access to data pertinent and authorized for their role. All study forms and paper records that 
contain participant information will be kept in secured, locked areas when not in use, accessible only to 
appropriate personnel; when in use, these materials will be kept from public view.  
x 
All voice recordings will take place at Durham VAMC. Staff will use a VHA encrypted laptop in conjunction with 
VA approved software that has been installed and configured by VA OI&T personnel after sanctuary exemptions 
have been obtained.  Originally a “Sparky” USB-attached audio recording device and then the VA network 
WebEX program to record interviews, which will then in both methods be saved on the encrypted computer, 
immediately uploaded to a restricted folder on the VHA server network, and then removed from the laptop. We 
will remove identifiers from the file names and interview notes.  
x 
All study personnel will maintain IRB research certification, with special training in research ethics. This training 
includes detailed instruction on confidentiality.  
x 
Participants will not be identified by name in any reports or publications, nor will data be presented in such a 
way that the identity of individual participants can be inferred. All information obtained in the course of the 
ƐƚƵĚǇƚŚĂƚŝĚĞŶƚŝĨŝĞƐĂŶŝŶĚŝǀŝĚƵĂůǁŝůůďĞƚƌĞĂƚĞĚĂƐĐŽŶĨŝĚĞŶƚŝĂůŝŶĂĐĐŽƌĚĂŶĐĞǁŝƚŚƐĞĐƚŝŽŶϵϬϯŽĨƚŚĞWƵďůŝĐ
,ĞĂůƚŚ^ĞƌǀŝĐĞĐƚ;ϰϮh͘^͘͘ϮϵϵĂ-1). We will strip all identifiers from analytic data sets after data merging, and 
keep all personal identifiers in a separate location from the analytic data. Database files needed to generate 
mailing labels will contain no research data.  
 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 13 of 25 
 
Privacy, Confidentiality, and Information Security 
1. Lists of Data Reviewed and/or Collected for Screening/Recruitment and Conduction of Study:  
The Personal Health Information that will be obtained, used, and/or shared for this study includes: 
Identifier(s) 
Source(s) of Health Information 
 Names 
 Medical history & physical exam information 
 All geographic subdivisions smaller than a State, 
including street address, city, county, precinct, and zip 
code.  Describe: Full mailing address to include street, 
city, state and zip code 
 Photographs, videotapes, audiotapes, or digital 
or other images 
 All elements of dates (except year) for dates directly 
related to an individual, including birth date, admission 
date, discharge date, visit or treatment dates, etc.; and 
all ages over 89,  Describe: DOB, Dx dates, Visit, 
treatment, hospitalization and outpatient dates 
 Biologic specimens (e.g., blood, tissue, urine, 
saliva). Describe: blood samples to test HgA1c 
(applicable only when not using VA lab services for 
collection and testing) 
 Telephone numbers 
 Progress notes 
 Fax numbers 
 Diagnostic / Laboratory test results 
 Electronic mail addresses 
 Operative reports 
 Social Security Numbers 
 Imaging (x-ray, CT, MRI, etc.) 
 Medical record numbers 
 Discharge summaries 
 Health plan beneficiary numbers 
 Survey / Questionnaire responses 
 Account numbers 
 Billing records 
 Certificate and/or license numbers  
 HIV testing or infection records 
 Vehicle identifiers and serial numbers, including 
license plate numbers  
 Sickle cell anemia information 
 Device identifiers and serial numbers 
 Alcoholism or alcohol use information 
 Web Universal Resource Locators (URLs) 
 Drug abuse information 
 Internet Protocol (IP) address numbers 
 Mental health (not psychotherapy) notes 
 Biometric identifiers, including finger & voice prints 
 Psychological test results 
 Full-face photographic images and any comparable 
images 
 Genetic testing 
 Any other unique identifying number, linked study 
ID, characteristic, or code, describe:  Randomly assigned 
study ID number (for example: PRACTICE#####) 
 Other, describe:  Specialty consults related to DM care  
(such as Nephrology, Neurology/pain/anesthesia, Ophthalmology, Lipid 
clinic, Cardiology, and Hepatology/Gastroenterology)  
Although we will enroll non-Veterans in this study, we will not be collecting any personal health information on the non-
Veterans.  Therefore, we will not provide the VA Notice of Privacy Practices (NOPP) for signature.  Non-Veterans that will 
be enrolling in the study include the affiliated study staff members (HT nurses and administrators).  We acknowledge 
that these staff members may be also be Veterans.  We will obtain verbal consent from the study staff members so that 
we can gather their feedback in a qualitative interview related to the implementation of the study procedures and 
education provided to the patients.  
 
2. Data and/or Specimen Acquisition:   
Data for this study will be collected through (check all that apply): 
  Prospective data and/or specimen collection obtained from participants.  Provide description of processes:   
 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 14 of 25 
 
Participants will be contacted by a mailed recruitment letter followed by a telephone call, if they have not 
previously opted out, to assess interest in study participation. If the patient is interested, an in-person appointment will 
be arranged in which the patient will be asked to provide informed consent.  All data collection will occur during study 
contacts and visits in which we collect data using approved scripts and questionnaires.  Patients will also be asked to 
provide blood samples to the lab for HbA1c testing throughout the study ;ďĂƐĞůŝŶĞ͕ϯŵ͕ϲŵ͕ϵŵ͕ϭϮŵͿ.  We will also 
obtain biometric measures (height, weight, blood pressure) from the patients at each in-person study visit.  
Employee stakeholders will be contacted via telephone.  Those who are interested will be provided a verbal 
consent process and asked to respond to questions included in the corresponding semi-structured interview guide 
during a telephone interview. 
 
  Retrospective data collection and/or specimens obtained from medical chart review/data access.  Describe how 
data will be obtained (e.g., fileman, CDW, etc.):   
Once IRB approval has been obtained, we will initiate a DART request to identify the eligible patient sample, 
identify upcoming appointments and to obtain necessary information from the CDW as well as perform a chart review of 
the patient’s medical records as needed in either CPRS or VistaWeb/JLV. We may need to access the medical records 
throughout the study to monitor study progress, obtain lab values, pertinent health information, contact information 
changes, adverse events, etc. 
 
  Retrospective data collection and/or specimens obtained from an IRB-approved data and/or specimen repository.  
Indicate the repository source including name, VA location, and IRB number:       . 
Note:  for data and/or specimens obtained from a VA approved data repository, a Data Use Agreement (DUA) must be 
executed prior to obtaining data and/or specimens.  See VHA Handbook 1200.12 for further information. 
 
3. Level of Data:   
The following level(s) of data will be acquired/maintained for this study (check all that apply): 
  Identified (e.g., names, addresses or other identifiers included)  
  Coded (direct and/or all identifiers removed, but study code/ID included)  
  De-Identified (all HIPAA 18 and study ID/code removed): 
  Verified Statistically  
 
OR 
  Verified by Absence or Removal of HIPAA 18 and study ID  
  Limited Data Set 
  Other: Describe:        
 
4. Location of Data and/or Specimens, and Data Retention Plan:   
A. Data and/or Specimen Location:  
a. The Durham VAHCS OI&T staff has computer servers located at the Durham VAMC.  This center houses 
database servers, web servers, file servers, and the like that provide the computing infrastructure used 
by HSR&D. 
 
B. Data will be stored electronically in a secure folder located: R:\\[server name]Practice_DM  
a. Data that will be stored electronically include Data that will be stored on this server include: study 
sample identified from the CDW, study documents, reports, and all other electronic study files  
b. All study data will be backed up on a regular schedule. 
 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 15 of 25 
 
C. Paper records of data including any Durham project source documents will be stored in a locked file cabinet 
ůŽĐĂƚĞĚŝŶƚŚĞƐĞĐƵƌĞĚ,^ZΘƌĞƐĞĂƌĐŚƐƉĂĐĞŝŶ>ĞŐĂĐǇdŽǁĞƌŝŶŽĨĨŝĐĞϳ19 ĂŶĚͬŽƌϲϯϮ'͘ Paper records from 
the Richmond, VA will be scanned and stored on the Durham VA server and kept in locked file cabinets in the 
care of the local site PI.  Once all study related data collection activities have been completed, the Richmond 
paper forms may be returned to Durham for consolidated storage in accordance with VA record control 
requirements.  This process will be submitted to IRB prior to any file transport. 
 
D. Specimens include blood samples collected by the lab or certified study personnel to test HbA1c values and will 
be obtained and stored in accordance with local VA policy.  
 
E. 
  Data will be also be placed at the VA Informatics and Computing Interface (VINCI; 
http://vaww.vinci.med.va.gov/vincicentral/VINCIWorkspace.aspx). The VA Informatics and Computing 
Infrastructure is a partnership between the VA Office of Information Technology and the Veterans’ Health 
Administration Office of Research and Development.  Researchers and operations staff can use VINCI to access 
data and statistical analysis tools in a virtual working environment through a certified VHA network computer 
using the VA Intranet or Virtual Private Network (VPN).  
 
B. Data Retention Plan 
 Research records will be maintained and destroyed according to the National Archives and Records Administration, 
Records Schedule Number:  DAA-0015-2015-ϬϬϬϰ͘ZĞĐŽƌĚƐĚĞƐƚƌƵĐƚŝŽŶ͕ǁŚĞŶĂƵƚŚŽƌŝǌĞd, will be accomplished using 
the then current requirements for the secure disposal of paper and electronic records.  Currently, destruction of 
research records (see DAA-0015-2015-ϬϬϬϰ͕ƐĞĐƚŝŽŶϳ͘ϲ͞ZĞƐĞĂƌĐŚ/ŶǀĞƐƚŝŐĂƚŽƌ&ŝůĞƐ͟ĨŽƌŵĂƚĞƌŝĂůƐŝŶĐůƵĚĞĚŝŶƌĞsearch 
ƌĞĐŽƌĚƐͿŝƐƐĐŚĞĚƵůĞĚĨŽƌϲǇĞĂƌƐĂĨƚĞƌƚŚĞĐƵƚ-off (the cut-off is the completion of the research project) and may be 
retained longer if required by other federal agencies.  Records will not be destroyed without pre-notification to the 
facility records manager.   
  Other data retention plan, describe:        
 
5. Data Access and Data Recipients:   
 
a. Only those individuals listed on the project staff listing will be granted access to the data. 
i. Computerized study data and access to data will be user group protected, and staff members will be 
assigned individualized permissions that allow them access to only those elements of the data 
management system to which they are authorized. 
ii. The study tracking forms containing names and patient contact information will be protected using 
study user group policies and will only be accessible to study personnel who need access to patient 
identifiers.  
b. All data will be maintained on a password protected secure VA server behind the VA firewall and no data 
will transfer outside of the VHA system.  
c. All VA research personnel who have access to VHA records are instructed, in accordance with VA policy, on 
the requirements of Federal privacy and information laws and regulations, VA regulations and policies, and 
VHA policy. All study personnel who are VA employees working within the VA system have fulfilled all 
required HIPAA and other VA security and privacy policy training requirements and have agreed to follow 
guidelines pertaining to the protection of patient data. All research staff sign VA Rules of Behavior, and all 
study staff are up-to-date with VHA Privacy Policy Training and the VA Office of Cyber and Information 
Security Awareness Training Course. The data security and privacy procedures summarized in that course 
include logging off or locking the computer when walking away from it; no sharing of access codes, verify 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 16 of 25 
 
codes or passwords; not allowing anyone else to use the computer under one’s password; and disposing of 
sensitive information using VA-approved methods (e.g., shredder bins). 
d. The deidentified data set that contains A1c lab values, arm assignment, and timepoint in study participation 
will be shared with Frank Neelon, MD at  Duke University Medical Center. 
e. Access to study data will be removed for all study personnel when they are no longer part of the research 
team.  
 
 
6. Data and/or Specimen Transportation and/or Transmission for all data and/or specimens involved in the study:   
 
 
I. 
  Data and/or specimens will not be transported or transmitted outside of Durham VAMC environment. 
II. 
  Data and/or specimens will be transported BETWEEN sites that are under the auspices of the Durham VA 
Medical Center.  To meet the needs of Durham VAHCS patients, the possibility exists that patients may be seen 
at one of the affiliated CBOCs .  If patients are seen at one of the non DVAMC locations, all electronic data will be 
entered immediately using VA computers, paper source documents (signed consent forms, outcome measure 
forms, etc) will be immediately transported back to the HSR&D office space by the research staff that collected 
the information. Patients that enroll at the Richmond site will have information directly entered onto the 
Durham VA’s network (access will be granted to the study folder and study tracking system) and paper copies 
(signed consent forms, outcome measurement forms, etc) will be kept by Richmond study personnel and stored 
in locked file cabinets in accordance with local policy.  
 
III. 
   Data and/or specimens will be transmitted to other VA sites using the following method(s): 
A. Data 
  Data are de-identified and thus will be sent via unencrypted e-mail or unencrypted disk (encryption is 
optional). 
  Data are coded or contain identifiers and thus will be sent  
  Other, describe:  All study related data will remain on the Durham VAHCS servers.  Richmond and Salt 
Lake City study staff will be granted access to Durham’s study folder and all electronic study files will remain 
behind Durham’s firewall.  Blood samples obtained in Durham will remain in Durham, blood samples 
obtained in Richmond will remain in Richmond and will be stored/maintained in accordance with local 
policy.  Any paper records (source documents, consent forms, etc) will be stored/maintained in accordance 
with local VA policy.  The HT interventionist will conduct intervention interviews using the HSRD created 
tracking application and other hard copy scripts. If the HT nurses create source documents to record the 
intervention survey answers, these will be identified using a study ID number and will not contain PHI.  This 
method is being used to limit the burden on the home telehealth nurses and any hard copy responses will 
be transferred back to the patient’s research file located in Legacy Towers. The home telehealth nurses will 
utilize the study tracking database to document all contact and patient PHI. Since the study utilizes the 
clinical services of HT, the EHR will also be utilized for data collection and all data will be maintained in 
accordance with VA policy.   
B. Specimens 
  Specimens are de-identified and thus will be sent via standard carrier (tracking is optional). 
  Specimens are coded or contain identifiers and thus will be sent via VA-authorized carrier with tracking.   

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 17 of 25 
 
  Other, describe:        
IV. 
  Data and/or specimens will be transported to non-VA/VHA sites (e.g., academic affiliates, laboratories, etc.) 
using the following method(s): 
A. Data 
  Data are de-identified and thus will be sent via unencrypted e-mail or unencrypted CD. 
  Data are coded or contain identifiers and thus will be sent via фĐŚŽƐĞŵĞƚŚŽĚŽĨƚƌĂŶƐĨĞƌƐƵĐŚĂƐ&/W^
ϭϰϬ-ϮĞŶĐƌǇƉƚĞĚŽƌ&/W^ϭϰϬ-ϮĞŶĐƌǇƉƚĞĚŚĂƌĚĚƌŝǀĞͬĨůĂƐŚĚƌŝǀĞх using VA—approved carrier with 
tracking.   
  Data are coded or identified and will be uploaded to sponsor website using electronic case report form 
(eCRF)  
 Other, describe:       
B. Specimens 
  Specimens are de-identified and thus will be sent via standard carrier (tracking is optional) or will be 
hand-delivered by research study personnel.  Specify method of delivery:        
  Specimens are coded and thus will be sent via VA-approved carrier with tracking or will be hand-
delivered by research study personnel.  Specify method of delivery:        
In accordance with the HIPAA and the Privacy Act, for any coded or identifiable data or specimens released from 
the Durham VAMC (with the exception of Limited Data Sets), an Accounting of Disclosure (AOD) will be 
maintained (e.g., in a database or spreadsheet) that includes the participant’s name, date of the disclosure, 
description of the nature of the Individually Identifiable Information (III) disclosed, purpose of each disclosure, 
and the name and address of the person/agency to whom the disclosure was made. 
C.      
 Local DVAMC memorandum “Authorization to Use, Process, Store, or Transmit VA Sensitive 
Information Outside VA Owned or Managed Facilities” has been pre-filled out for each study team member who 
may transport the data and/or specimens off-site.  This (these) forms are included with the IRB materials.   
The memo referenced above is required to be fully signed for each study team member BEFORE any data can be 
transported by that individual. 
 
D. 
  Containers (e.g., briefcase, bin) are labeled with the following notice (label placed on the outside of 
ĐŽŶƚĂŝŶĞƌͿŝŶĂĐĐŽƌĚĂŶĐĞǁŝƚŚs,ŝƌĞĐƚŝǀĞϲϲϬϵ͗ 
NOTICE!!! 
Access to these records is limited to: AUTHORIZED PERSONS ONLY. 
Information may not be disclosed from this file unless permitted by all applicable legal authorities, which may 
ŝŶĐůƵĚĞƚŚĞWƌŝǀĂĐǇĐƚ͖ϯϴh͘^͘͘ΑΑϱϳϬϭ͕ϱϳϬϱ͕ϳϯϯϮ͖ƚŚĞ,ĞĂůƚŚ/ŶƐƵƌĂŶĐĞWŽƌƚĂďŝůŝƚǇĂŶĚĐĐŽƵŶƚĂďŝůŝƚǇĐƚ͖
ĂŶĚƌĞŐƵůĂƚŝŽŶƐŝŵƉůĞŵĞŶƚŝŶŐƚŚŽƐĞƉƌŽǀŝƐŝŽŶƐ͕Ăƚϯϴ͘&͘Z͘ΑΑϭ͘ϰϲϬ– ϭ͘ϱϵϵĂŶĚϰϱ͘&͘Z͘WĂƌƚƐϭϲϬĂŶĚϭϲϰ͘
Anyone who discloses information in violation of the above provisions may subject to civil and criminal 
penalties. 
 
7. Risk Mitigation Strategies:   
a. All study records that contain participant information will be kept in secured, locked areas located in the 
HSR&D research space in Legacy Tower, ŽĨĨŝĐĞϳϭϵĂŶĚͬŽƌϲϯϮ'ǁŚĞŶŶŽƚŝŶƵƐĞ. In addition, such materials, 
when in use, will be kept away from public scrutiny. 
b. Computerized study data and access to data will be user group protected, and staff members will be 
assigned individualized permissions that allow them access to only those elements of the data management 
system to which they are authorized. 
c. All electronic study materials will remain behind the VA firewall on the VA server in the project specific 
folder. 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 18 of 25 
 
d. Direct identifiers (patient name, address, etc) will be maintained separately in the study's tracking forms 
from data by using a study ID number to identify subjects. The separate tracking forms will be linked to 
identifying subject information and will be limited to only those who need access to patient identifiers. 
e. All research files are in the care of the Pl, Dr Matthew Crowley. 
f. All study personnel listed on the staff listing will maintain certification with the Durham VA IRB to ensure 
that they have completed training in research ethics and confidentiality. 
g. Study participants will not be identified by name in any reports or publications, nor will data be presented in 
such a way that the identity of individual participants can be inferred. 
 
  Data are fully de-identified (stripped of HIPAA 18 and study ID/code) before being shared outside of Durham VAMC. 
  Specimens are fully de-identified (stripped of HIPAA 18 and study ID/code before being shared outside of Durham 
VAMC. 
  Direct identifiers will be maintained separately from data and or specimens by using a code to “identify” subjects.  In 
a separate database (i.e., a “linking” or “cross-walk” database) this code will be linked to identifying subject information.   
  Other, specify:        
 
8. Suspected Loss of VA Information: 
Should any incident such as theft or loss of data, unauthorized access of sensitive data or non-compliance with security 
controls occur it will be immediately reported according to VA policy. All incidents regarding information 
security/privacy incidents will be reported to the ISO and PO within 1 hour of acknowledgement of issue and done so 
using the VHADUR Research Events Report e-mail group (VHADURResearchEventReport@va.gov). 
 
9. Reporting of Results:   
  Reporting of results, such as in scientific papers and presentations, will never identify individual subjects.  Data will 
be presented in aggregate and individual-level data will not be published. 
  Other results reporting plan, describe:       
 
10. Future Use of Data: 
  Data will be retained for future use.  This is described elsewhere in the protocol and is noted in the HIPAA 
authorization. 
 
  Future Use of data is optional (i.e., not required by the research subject). 
  Future Use of data is required for participation in the study. 
  No future use of data is currently planned. 
 
11. Use of Mail Merge Technology 
  Mail merge programs will be used to generate letters and/or address labels for mailings to potential or already 
enrolled research subjects.  The study team is aware that to reduce risk of mail merge related privacy incidents, use of 
ŵĂŝůŵĞƌŐĞƉƌŽŐƌĂŵƐƌĞƋƵŝƌĞƐĂϮϱйĂĐĐƵƌĂĐǇĐŚĞĐŬƚŽǀĞƌŝĨǇƚŚĂƚ;ƉŽƚĞŶƚŝĂůͿƌĞƐĞĂƌĐŚƐƵďũĞĐƚŶĂŵĞĂŶĚŵĂŝůŝŶŐĂĚĚƌĞƐƐ
ĂƌĞƉƌŽƉĞƌůǇ͞ŵĂƚĐŚĞĚ͘͟/ĨĚŝƐĐƌĞƉĂŶĐŝĞƐĂƌĞĨŽƵŶĚ͕ĂϭϬϬйĂĐĐƵƌĂĐǇĐŚĞĐŬŝƐƌĞƋƵŝƌĞĚďĞĨŽƌĞůĞƚƚĞƌƐŵĂǇ be mailed.   
 
12. Use of Non-Standard Software 
 I do NOT intend to use any new specialized software (i.e. Software that’s not already approved OR installed) in this 
study. 
 
We will be using DatStat Illume  or RedCAP for survey data collection, USB ‘Sparky’ audio recording pass through 
devices and or VA approved and installed audio recording programs (for example, WebEX), and HSR&D developed 
tracking databases during this study.  All have previously been used in other past and ongoing Durham studies. 
 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM)
PI: Matthew J. Crowley, MD
Protocol Version/Date: V10:08/19/2021
Page 19 of 25
I intend to use specialized software that has not already been installed and it has been approved for use by the VA 
Technical Reference Model (TRM) Group. 
(Note: All new software must be approved by TRM before it can be installed on VA systems.)
I intend to use previously installed software on my VA computer. 
13. Use of Cloud Computing Services
Cloud computing services will NOT be used in this study.
Cloud computing services WILL be used in this study as described below and have been approved nationally by the 
VA Chief Information Officer (CIO).  (Note: ONLY cloud computing services that have been approved nationally may be 
used.)
Data Analysis and Statistical Considerations
Primary analysis
HbA1ĐǁŝůůďĞĐŽůůĞĐƚĞĚĂƚϬ͕ϯ͕ϲ͕ϵĂŶĚϭϮŵŽŶƚŚƐ͘ĞĐĂƵƐĞ,ďϭĐŝƐĂĐŽŶƚŝŶƵŽƵƐŽƵƚĐŽŵĞ͕ǁĞǁŝůůƵƐĞůŝŶĞĂƌ
mixed-effects models (LMM) to examine between-arm differences over time.(ϲϴͿLMM will allow implicit accounting for 
the correlation between a patient’s repeated measures over time. The general mean structure of the LMM we will use 
to examine this hypothesis will be: 
Here, Yij represents HbA1c for patient i at time j. We will fit a common intercept, and arm reflects PRACTICE-DM vs. 
active control). Time is also classified; for example, I(month=12) is a dummy variable equal to 1 for the 12 month time 
point (baseline is the referent). Random intercepts will be included for each individual to account for correlation among 
repeated measures over time. The primary analytic model will adjust for stratification variables (study site, prior HT, 
prior Endocrinology). Mixed effects model parameters will be estimated and tested using SAS PROC MIXED (SAS 
Institute, Cary, NC). The hypothesis of between-arm differences over time will be tested using estimate statements 
within PROC MIXED. The estimated difference in HbA1c between HT and ST arms at 12 months (8) will be the primary 
effectiveness outcome.
Secondary analyses
Diabetes-related distress, diabetes self-care, self-efficacy, BMI, and depression will be fit using the same model 
ƐƚƌƵĐƚƵƌĞĂƐĨŽƌƚŚĞƉƌŝŵĂƌǇŽƵƚĐŽŵĞ͕ďƵƚǁŝƚŚƚŚĞϯ- and 9-ŵŽŶƚŚƚĞƌŵƐƌĞŵŽǀĞĚ;ĂƐƚŚĞǇĂƌĞŽŶůǇĐŽůůĞĐƚĞĚĂƚϬ͕ϲ͕
and 12 months). We will evaluate intervention engagement (SMBG transmission) and adverse events descriptively, 
examining mean occurrence in each group during the study. Additional secondary analyses of data relating to diabetes 
and complications and comorbidities will be conducted using standard statistical approaches, similar to above.
Missing data
Clinical outcome values may be missing due to dropout, incomplete follow-up, or item non-response. 
Mechanisms for missing data will be investigated by describing missingness by intervention group, identifying missing 
data patterns, and understanding which observed covariates predict missingness. Our main analysis technique, LMM, 
implicitly accommodates missingness when the response is Missing At Random (i.e., due either to treatment, to prior 
outcome, or to other baseline covariates in the LMM).(ϲϴ) In our study, we will also address missing data explicitly using 
multiple imputation procedures,(ϲϵ) which are useful when covariates have missing data, when time-varying covariates 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 20 of 25 
 
are predictive of future missingness, or when there is no scientific interest in conditioning on baseline covariates that 
are predictive of missingness in the final LMM. Once missing values have been multiply imputed, each dataset can be 
analyzed using standard complete-data methods, such as LMM. Final parameter estimates and standard errors will be 
calculated using Rubin’s formula for combining results from multiply imputed data sets.(ϳϬ) We will analyze our data 
and report final study results with and without multiple imputation, and carefully examine discrepancies.  
 
Intention-to-treat analysis 
Per the intention-to-treat principle, all participants must be included in the final data analysis once randomized, 
and all should be analyzed in the group to which they were randomized. Because HbA1c will be measured pre-
randomization, we do not expect missing baseline HbA1c or study arm indicator variables in the randomized sample, so 
our primary analytic technique fulfills both requirements.  
Power calculation 
tĞĚĞƌŝǀĞĚƉŽǁĞƌĞƐƚŝŵĂƚĞƐĞŵƉŝƌŝĐĂůůǇǀŝĂƐŝŵƵůĂƚŝŽŶ;^^ϵ͘ϰͿ. Based on our pilot work,(19) we assumed a 
ďĂƐĞůŝŶĞ,ďϭĐŽĨϭϬ͘ϯйĨŽƌďŽƚŚĂƌŵƐ͘tĞĂƐƐƵŵĞĚĂƌĞĚƵĐƚŝŽŶŝŶƚŚĞĐŽŶƚƌŽůĂƌŵŽĨϬ͘ϱйďǇϭϮŵŽŶƚŚƐ͖ŐŝǀĞŶ
uncertainty about the quality of existing telemedicine studies, this is a conservative estimate. For the PRACTICE-DM arm, 
ǁĞĂƐƐƵŵĞĚĂƌĞĚƵĐƚŝŽŶŽĨϭ͘ϭйĂƚϭϮŵŽŶƚŚƐ͖ƚŚŝƐƌĞĨůĞĐƚƐĂĐŽŶƐĞƌǀĂƚŝǀĞŚǇƉŽƚŚĞƐŝƐƚŚĂƚWZd/-DM will reduce our 
ƉƌŝŵĂƌǇŽƵƚĐŽŵĞ;,ďϭĐͿďǇϬ͘ϲйƌĞůĂƚŝǀĞƚŽĐŽŶƚƌŽůďǇϭϮŵŽŶƚŚƐ͘;1) Based on prior work,(1) we conservatively 
assumed ĂϮϬйĚƌŽƉŽƵƚďǇϭϮŵŽŶƚŚƐ͕ĂƐƚĂŶĚĂƌĚĚĞǀŝĂƚŝŽŶ;^ͿŽĨϭ͘ϲĂŶĚĂǁŝƚŚŝŶ-individual correlation of 0.55 for 
repeated HbA1c measurements. After generating 1,000 simulated datasets with these assumptions, we fit the LMM to 
each and assessed the effect of interest using two-sided tests with D=0.05. With 100 patients in each arm and our 
ĐŽŶƐĞƌǀĂƚŝǀĞǀĂƌŝĂŶĐĞĞƐƚŝŵĂƚĞƐ͕ƚŚĞƉŽǁĞƌĞƐƚŝŵĂƚĞŝƐϴϬ͘ϱйĨŽƌŽƵƌƉƌŝŵĂƌǇŽƵƚĐŽŵĞ͘tĞǁŝůůĂůƐŽďĞĂďůĞƚŽĚĞƚĞĐƚ
meaningful between-group differences in our secondary outcomes.  
 
Qualitative analysis 
All interviews will be recorded and transcribed verbatim. Approved staff from the VA Salt Lake City (VASLC) will 
transcribe the PRACTICE-DM audio files. The VASLC has a Professional Transcription Service available to VA sites and 
monitored by their own IRB. The PRACTICE-DM audio recordings to be transcribed by VASLC staff will be labeled by the 
subject’s unique alphanumeric code and saved behind the VA Firewall PRACTICE-DM’s secure shared project folder on 
the Durham HSR&D’s Project R drive ([server name]\PRACTICE_DM). The VASLC Transcriptionist staff will be given 
access to a sub-folder within PRACTICE-DM’s secure project folder ([server name]\PRACTICE_DM\Audio Recordings and 
Transcriptions). Approved Durham study staff will place a copy of the audio files in this folder for an approved VASLC 
transcriptionist to access for the purposes of transcription.  
The VASLC transcriptionist will transcribe each interview verbatim and save the completed transcript in the sub-
folder using the same alphanumeric code. No data (audio files, in-process transcripts, or completed transcripts) will 
leave the Durham VA’s secure research server. As completed transcripts become available, approved Durham study staff 
will move these files from the transcription sub-folder into another sub-folder that is only accessible to Durham study 
staff, where they will be stored and accessed for qualitative analyses. Transcription of the qualitative interviews will be 
conducted by the VASLC staff using the Express Scribe or Start-Stop Universal Transcription System.  
Transcripts will be analyzed with directed content analysis,(ϳϭ) in which existing knowledge is used to identify 
concepts. These concepts, along with any newly emergent themes from the transcripts, are used to develop descriptive 
‘codes’ to categorize text. All team members will review and agree upon the coding scheme, including labels and their 
definitions, by consensus. Content analysis involves reading and rereading transcripts to compare codes and develop 
higher-order themes by integrating related codes or retaining conceptually distinct codes. Higher-order themes are 
summarized with short phrases and example quotations. A qualitative codebook that includes code definitions, 
categorizations, and all coding decision rules will be developed as part of a qualitative audit trail. Qualitative data will be 
managed in Atlas.ti, which facilitates coding management and analysis of patterns.  
 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 21 of 25 
 
 
Cost analysis 
Since PRACTICE-DM is a 12-month intervention, between-arm differences in VHA health care costs will be 
analyzed by person-year units. Outpatient and total VHA costs will be estimated using generalized linear models with the 
distribution and link functions that best fit the data. VHA inpatient costs will be estimated using the cross-sectional 
marginalized two-part (MTP) model to account for the expected high proportion of zeros associated with lack of 
admission.(ϳϮ) The MTP model allows for inference to the entire study sample, not just the subset who have positive 
inpatient costs due to being admitted as in traditional two-part models. All stratification variables and the treatment 
indicator will be included as covariates in the model.  
 
De-identified dataset 
 
 
A deidentified dataset containing intervention arm and A1c data values during the course of the study will be 
created after all data collection has been completed.  A de-identified study ID will be created for the dataset, as well as a 
variable counting the number of days from randomization to be used instead of dates.  This dataset may be used for 
further study-related analysis and comparison of PRACTICE-DM to non-VA programs.  Patients who refused future use of 
data will not be included in this dataset, nor will patients who formally withdrew consent. 
 
 
 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 22 of 25 
 
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1. Crowley MJ, Edelman D, McAndrew AT, et al. Practical telemedicine for Veterans with persistently poor diabetes 
ĐŽŶƚƌŽů͗ĂƌĂŶĚŽŵŝǌĞĚƉŝůŽƚƚƌŝĂů͘dĞůĞŵĞĚ:,ĞĂůƚŚ͘ϮϬϭϲ͖ϮϮ;ϱͿ͗ϯϳϲ-ϴϰ͘ 
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ƚŽĂĚĚƌĞƐƐƉĞƌƐŝƐƚĞŶƚƉŽŽƌůǇĐŽŶƚƌŽůůĞĚĚŝĂďĞƚĞƐ;WWDͿ͘WĂƚŝĞŶƚWƌĞĨĞƌĚŚĞƌĞŶĐĞ͘ϮϬϭϳ͖ϱϴ͗ϭ-12. 
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December 5}  
ϰ͘ <Ğƌƌ͕<ƌĞŝŶ^>͕WŽŐĂĐŚ>D͕ĞƚĂů͘ŝĂďĞƚĞƐYhZ/ϮϬϭϭ^ƚƌĂƚĞŐŝĐWůĂŶ͘΀ŽŶůŝŶĞ΁;ϮϬϭϭͿ΂ĐŝƚĞĚϮϬϭϲ͕ĞĐĞŵďĞƌϱ΃ 
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ϳ͘ American Diabetes ƐƐŽĐŝĂƚŝŽŶ͘ĐŽŶŽŵŝĐŽƐƚƐŽĨŝĂďĞƚĞƐŝŶƚŚĞh͘^͘ŝŶϮϬϭϮ͘ŝĂďĞƚĞƐĂƌĞ͘ϮϬϭϯ͖ϯϲ;ϰͿ͗ϭϬϯϯ-
ϰϲ͘ 
8. Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular 
ĐŽŵƉůŝĐĂƚŝŽŶƐŽĨƚǇƉĞϮĚŝĂďĞƚĞƐ;h<W^ϯϱͿ͗ƉƌŽƐƉĞĐƚŝǀĞŽďƐĞƌǀĂƚŝŽŶĂůƐƚƵĚǇ͘D:͘ϮϬϬϬ͖ϯϮϭ͗ϰϬϱ-ϰϭϮ͘ 
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ĐŽŶƚƌŽůĂŶĚŬŝĚŶĞǇĨƵŶĐƚŝŽŶ͘ŝĂďĞƚĞƐĂƌĞ͘ϮϬϭϯ͖ϯϲ;ϱͿ͗ϭϭϳϮ-80.  
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11. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk 
ŽĨĐŽŵƉůŝĐĂƚŝŽŶƐŝŶƉĂƚŝĞŶƚƐǁŝƚŚƚǇƉĞϮĚŝĂďĞƚĞƐ;h<W^ϯϯͿ͘h<WƌŽƐƉĞĐƚŝǀĞŝĂďĞƚĞƐ^ƚƵĚǇ;h<W^Ϳ'ƌŽƵƉ͘
>ĂŶĐĞƚ͘ϭϵϵϴ͖ϯϱϮ;ϵϭϯϭͿ͗ϴϯϳ-ϱϯ͘ 
12. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on 
the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J 
DĞĚ͘ϭϵϵϯ͖ϯϮϵ͗ϵϳϳ-ϴϲ͘ 
ϭϯ͘ Baxter M, Hudson R, Mahon J, et al. Estimating the impact of better management of glycaemic control in adults 
with Type 1 and Type 2 diabetes on the number of clinical complications, and the associated financial benefit. 
ŝĂďĞƚDĞĚ͘ϮϬϭϲ:ĂŶϭϲ͘΀ƉƵďĂŚĞĂĚŽĨƉƌŝŶƚ΁ 
ϭϰ͘ Holman RR, Paul SK, Bethel MA, et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J 
DĞĚ͘ϮϬϬϴ͖ϯϱϵ;ϭϱͿ͗ϭϱϳϳ-89. 
15. Duckworth W, Abraira C, Moritz T, et al. Glucose control and vascular complications in veterans with type 2 
ĚŝĂďĞƚĞƐ͘EŶŐů:DĞĚ͘ϮϬϬϵ͖ϯϲϬ͗ϭϮϵ-ϯϵ͘ 
ϭϲ͘ Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 
ĚŝĂďĞƚĞƐ͘EŶŐů:DĞĚ͘ϮϬϬϴ͖ϯϱϴ͗Ϯϱϰϱ-59. 
ϭϳ͘ U.S. Department of Veterans Affairs. VA/DoD Clinical Practice Guidelines: Management of Type 2 Diabetes in 
WƌŝŵĂƌǇĂƌĞ͘΀ŽŶůŝŶĞ΁;ϮϬϭϳͿ΂ĐŝƚĞĚϮϬϭϳ͕DĂǇϯϬ΃ 
18. ŵĞƌŝĐĂŶŝĂďĞƚĞƐƐƐŽĐŝĂƚŝŽŶ͘^ƚĂŶĚĂƌĚƐŽĨŵĞĚŝĐĂůĐĂƌĞŝŶĚŝĂďĞƚĞƐ͘ŝĂďĞƚĞƐĂƌĞ͘ϮϬϭϳ͖ϰϬ͗^ϭ-Sϭϯϱ͘ 
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ϯϬ͕ϮϬϭϳ͘΀DĂŶƵƐĐƌŝƉƚŝŶƉƌĞƉĂƌĂƚŝŽŶ΁ 
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ĂƌĞ͘ϮϬϭϳƉƌϭϮ͘΀ƉƵďĂŚĞĂĚŽĨƉƌŝŶƚ΁ 
21. Davidson J. Strategies for improving glycemic control: effective use of glucose monitoring. Am J Med. 
2005;11ϴ;^ƵƉƉůϵͿ͗Ϯϳ^-ϯϮ^͘ 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 23 of 25 
 
22. Crowley MJ, Holleman R, Klamerus ML, et al. Factors associated with persistent poorly-controlled diabetes 
mellitus (PPDM): clues to improving management in patients with resistant poor control. Chronic Illn. 
ϮϬϭϰ͖ϭϬ͗Ϯϵϭ͘ 
Ϯϯ͘ Hill-Briggs F, Gary TL, Bone LR, et al. Medication adherence and diabetes control in urban African Americans with 
ƚǇƉĞϮĚŝĂďĞƚĞƐ͘,ĞĂůƚŚWƐǇĐŚŽů͘ϮϬϬϱ͖Ϯϰ͗ϯϰϵ-ϱϳ͘ 
Ϯϰ͘ Hartz A, Kent S, James P, et al. Factors that influence improvement for patients with poorly controlled type 2 
ĚŝĂďĞƚĞƐ͘ŝĂďĞƚĞƐZĞƐůŝŶWƌĂĐƚ͘ϮϬϬϲ͖ϳϰ͗ϮϮϳ-ϯϮ͘ 
25. American Diabetes Association. Obesity Management for the Treatment of Type 2 Diabetes. Diabetes Care 
ϮϬϭϳ͖ϰϬ;^ƵƉƉů͘ϭͿ͗^ϱϳ–^ϲϯ͘ 
Ϯϲ͘ Donnelly LA, Morris AD, Evans JM; DARTS/MEMO collaboration. Adherence to insulin and its association with 
ŐůǇĐĂĞŵŝĐĐŽŶƚƌŽůŝŶƉĂƚŝĞŶƚƐǁŝƚŚƚǇƉĞϮĚŝĂďĞƚĞƐ͘Y:D͘ϮϬϬϳ͖ϭϬϬ͗ϯϰϱ-50.  
Ϯϳ͘ Chiu CJ, Wray LA. Factors predicting glycemic control in middle-aged and older adults with type 2 diabetes. Prev 
ŚƌŽŶŝĐŝƐ͘ϮϬϭϬ͖ϳ͗Ϭϴ͘ 
28. Surwit RS, van Tilburg MA, Parekh PI, et al. Treatment regimen determines the relationship between depression 
ĂŶĚŐůǇĐĞŵŝĐĐŽŶƚƌŽů͘ŝĂďĞƚĞƐZĞƐůŝŶWƌĂĐƚ͘ϮϬϬϱ͖ϲϵ͗ϳϴ-80.  
29. Anderson RJ, Freedland KE, Clouse RE, et al. The prevalence of comorbid depression in adults with diabetes: a 
meta-ĂŶĂůǇƐŝƐ͘ŝĂďĞƚĞƐĂƌĞ͘ϮϬϬϭ͖Ϯϰ͗ϭϬϲϵ-ϳϴ͘ 
ϯϬ͘ de Groot M, Anderson R, Freedland KE, et al. Association of depression and diabetes complications: a meta-
ĂŶĂůǇƐŝƐ͘WƐǇĐŚŽƐŽŵDĞĚ͘ϮϬϬϭ͖ϲϯ͗ϲϭϵ-ϯϬ͘ 
ϯϭ͘ Morrison F, Shubina M, Turchin A. Encounter frequency and serum glucose level, blood pressure, and 
ĐŚŽůĞƐƚĞƌŽůůĞǀĞůĐŽŶƚƌŽůŝŶƉĂƚŝĞŶƚƐǁŝƚŚĚŝĂďĞƚĞƐŵĞůůŝƚƵƐ͘ƌĐŚ/ŶƚĞƌŶDĞĚ͘ϮϬϭϭ͖ϭϳϭ;ϭϳͿ͗ϭϱϰϮ-1550.  
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ĐŽŶƚƌŽů͘:ŝĂďĞƚĞƐŽŵƉůŝĐĂƚŝŽŶƐ͘ϮϬϭϭ͖Ϯϱ;ϱͿ͗Ϯϴϯ-8. 
ϯϯ͘ ŵĞƌŝĐĂŶdĞůĞŵĞĚŝĐŝŶĞƐƐŽĐŝĂƚŝŽŶ͘tŚĂƚ/ƐdĞůĞŵĞĚŝĐŝŶĞ͍΀ŽŶůŝŶĞ΁;ϮϬϭϮͿ΂ĐŝƚĞĚϮϬϭϲ͕ĞĐĞŵďĞƌϱ΃ 
ϯϰ͘ h͘^͘ĞƉĂƌƚŵĞŶƚŽĨsĞƚĞƌĂŶƐĨĨĂŝƌƐ͘sdĞůĞŚĞĂůƚŚ^ĞƌǀŝĐĞƐ͘΀ŽŶůŝŶĞ΁;ϮϬϭϱͿ΂ĐŝƚĞĚϮϬϭϲ͕Ğcember 5} 
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ϮϬϭϯ͖ϭϱ;ϳͿ͗ĞϭϱϬ͘ 
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ĚǀĂŶĐĞĚ^ƚĂŐĞƐŽĨdǇƉĞϮŝĂďĞƚĞƐ͗ZĂŶĚŽŵŝǌĞĚŽŶƚƌŽůůĞĚdƌŝĂů͘ŝĂďĞƚĞƐĂƌĞ͘ϮϬϭϳDĂǇϭϮ͘΀ƉƵďĂŚĞĂĚ
of print]  
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ϰϬ͘ Atlantis E, Fahey P, Foster J. Collaborative care for comorbid depression and diabetes: a systematic review and 
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ĂŶĚƌĞƐƵůƚƐĨƌŽŵĂƌĂŶĚŽŵŝǌĞĚĐůŝŶŝĐĂůƚƌŝĂů͘dĞůĞŵĞĚ:,ĞĂůƚŚ͘ϮϬϭϰ͖ϮϬ;ϮͿ͗ϭϬϵ-ϭϰ͘ 
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Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 24 of 25 
 
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veterans with diabetes: health services utilization and health-related quality of life. Eval Health Prof. 
ϮϬϬϱ͖Ϯϴ;ϰͿ͗ϰϲϰ-ϳϴ͘ 
ϰϲ͘ Barnett TE, Chumbler NR, Vogel WB, et al. The effectiveness of a care coordination home telehealth program for 
veterans with diabetes mellitus: a 2-year follow-up. Am J Manag ĂƌĞ͘ϮϬϬϲ͖ϭϮ;ϴͿ͗ϰϲϳ-ϳϰ͘ 
ϰϳ͘ Chumbler NR, Chuang HC, Wu SS, et al. Mortality risk for diabetes patients in a care coordination, home-
telehealth programme. J Telemed Telecare 2009;15:98-101.  
ϰϴ͘ Stone RA, Rao RH, Sevick MA, et al. Active care management supported by home telemonitoring in veterans 
ǁŝƚŚƚǇƉĞϮĚŝĂďĞƚĞƐ͗ƚŚĞŝĂdĞůƌĂŶĚŽŵŝǌĞĚĐŽŶƚƌŽůůĞĚƚƌŝĂů͘ŝĂďĞƚĞƐĂƌĞ͘ϮϬϭϬ͖ϯϯ;ϯͿ͗ϰϳϴ-ϴϰ͘ 
ϰϵ͘ Jia H, Feng H, Wang X, et al. A longitudinal study of health service utilization for diabetes patients in a care 
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50. Bashshur RL, Shannon GW, Smith BR, et al. The empirical evidence for the telemedicine intervention in diabetes 
ŵĂŶĂŐĞŵĞŶƚ͘dĞůĞŵĞĚ:,ĞĂůƚŚ͘ϮϬϭϱ͖Ϯϭ;ϱͿ͗ϯϮϭ-ϱϰ͘ 
51. Edelman D, Fredrickson SK, Melnyk SD, et al. Medical clinics versus usual care for patients with both diabetes 
ĂŶĚŚǇƉĞƌƚĞŶƐŝŽŶ͗ĂƌĂŶĚŽŵŝǌĞĚƚƌŝĂů͘ŶŶ/ŶƚĞƌŶDĞĚ͘ϮϬϭϬ͖ϭϱϮ͗ϲϴϵ-ϵϲ͘ 
52. Melnyk SD, Zullig LL, McCant F, et al. Telemedicine cardiovascular risk reduction in veterans. Am Heart J. 
ϮϬϭϯ͖ϭϲϱ;ϰͿ͗ϱϬϭ-8.  
ϱϯ͘ Crowley MJ, Powers BJ, Olsen MK, et al. The Cholesterol, Hypertension, and Glucose Education study: results 
ĨƌŽŵĂƌĂŶĚŽŵŝǌĞĚĐŽŶƚƌŽůůĞĚƚƌŝĂůŝŶĨƌŝĐĂŶŵĞƌŝĐĂŶƐǁŝƚŚĚŝĂďĞƚĞƐ͘ŵ,ĞĂƌƚ:͘ϮϬϭϯ͖ϭϲϲ͗ϭϳϵ-ϴϲ͘ 
ϱϰ͘ Crowley MJ, Bosworth HB, Coffman CJ, et al. Tailored case management for diabetes and hypertension (TEACH-
DM) in a community population: study design and baseline sample characteristics. Contemp Clin Trials. 
ϮϬϭϯ͖ϯϲ;ϭͿ͗Ϯϵϴ-ϯϬϲ͘ 
55. Edelman D, Dolor RJ, Coffman CJ, et al. Nurse-led behavioral management of diabetes and hypertension in 
ĐŽŵŵƵŶŝƚǇƉƌĂĐƚŝĐĞƐ͗ĂƌĂŶĚŽŵŝǌĞĚƚƌŝĂů͘:'ĞŶ/ŶƚĞƌŶDĞĚ͘ϮϬϭϱDĂǇ͖ϯϬ;ϱͿ͗ϲϮϲ-ϯϯ͘ 
ϱϲ͘ Brown SA, García AA, Brown A, et al. Biobehavioral determinants of glycemic control in type 2 diabetes: A 
systematic review and meta-ĂŶĂůǇƐŝƐ͘WĂƚŝĞŶƚĚƵĐŽƵŶƐ͘ϮϬϭϲ͖ϵϵ;ϭϬͿ͗ϭϱϱϴ-ϲϳ͘ 
ϱϳ͘ Sacks FM, Bray GA, Carey VJ, et al. Comparison of weight-loss diets with different compositions of fat, protein, 
ĂŶĚĐĂƌďŽŚǇĚƌĂƚĞƐ͘EŶŐů:DĞĚ͘ϮϬϬϵ͖ϯϲϬ͗ϴϱϵ-ϴϳϯ͘ 
58. Johnston BC, Kanters S, Bandayrel K, et al. Comparison of weight loss among named diet programs in overweight 
and obese adults: a meta-ĂŶĂůǇƐŝƐ͘:D͘ϮϬϭϰ͖ϯϭϮ͗ϵϮϯ-ϵϯϯ͘ 
59. ŵĞƌŝĐĂŶŝĂďĞƚĞƐƐƐŽĐŝĂƚŝŽŶ͘>ŝĨĞƐƚǇůĞŵĂŶĂŐĞŵĞŶƚ͘ŝĂďĞƚĞƐĂƌĞ͘ϮϬϭϳ͖ϰϬ;^ƵƉƉůϭͿ͗^ϯϯ-^ϰϯ͘ 
ϲϬ͘ U.S. Department of Veterans Affairs. VA/DoD Clinical Practice Guidelines: Management of Major Depressive 
ŝƐŽƌĚĞƌ͘΀ŽŶůŝŶĞ΁;ϮϬϭϲͿ΂ĐŝƚĞĚϮϬϭϳ͕DĂǇϯϬ΃ 
ϲϭ͘ Kroenke K, Strine TW, Spritzer RL, et al. The PHQ-8 as a measure of current depression in the general population. 
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ϲϮ͘ Lustman PJ, Clouse RE, Nix BD, et al. Sertraline for prevention of depression recurrence in diabetes mellitus: a 
randomized, double blind, placebo-ĐŽŶƚƌŽůůĞĚƚƌŝĂů͘ƌĐŚ'ĞŶWƐǇĐŚŝĂƚƌǇ͘ϮϬϬϲ͖ϲϯ͗ϱϮϭ-29.  
ϲϯ͘ Lustman PJ, Williams MM, Sayuk GS, et al. Factors influencing glycemic control in type 2 diabetes during acute- 
and maintenance-ƉŚĂƐĞƚƌĞĂƚŵĞŶƚŽĨŵĂũŽƌĚĞƉƌĞƐƐŝǀĞĚŝƐŽƌĚĞƌǁŝƚŚďƵƉƌŽƉŝŽŶ͘ŝĂďĞƚĞƐĂƌĞ͘ϮϬϬϳ͖ϯϬ͗ϰϱϵ-
ϲϲ͘ 
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Inventory-ZĞǀŝƐĞĚǁŝƚŚĂĚƵůƚƐ͘ŝĂďĞƚĞƐĂƌĞϮϬϬϱ͖Ϯϴ͗ϭϯϰϲ-ϭϯϱϮ͘ 
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ŝĂďĞƚĞƐĂƌĞ͘ϭϵϵϴ͖Ϯϭ͗ϭϲϰϰ-ϭϲϱϭ͘ 

Protocol Title: Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes 
Mellitus (PRACTICE-DM) 
PI: Matthew J. Crowley, MD 
Protocol Version/Date:  V10:08/19/2021 
Page 25 of 25 
 
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ŵĞĚŝĐŝŶĞ͘ϮϬϭϰ͖ϯϯ;ϮϴͿ͗ϰϴϵϭ-ϰϵϬϯ͘