Online Diabetes Education Project: Virtual Diabetes Self-Management Education and Support Intervention
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Sponsor: University of Michigan

Study Title: Online Diabetes Education Project: Virtual Diabetes Self-
Management Education and Support 
NCT04743778 
Protocol Approved by University of Michigan IRB on 8/17/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Online Diabetes Education Project: Virtual Diabetes Self-Management 
Education and Support Intervention IRB Protocol 
1.0 PHASE II RESEARCH PLAN (Pilot Randomized Control Trial, 3 months) 
 
During Phase II we will be conducting a 3 month pilot randomized controlled trial 
(RCT) of Virtual Diabetes-Self Management Education and Support (DSME/S), the 
treatment adapted in Phase I, to evaluate participant recruitment and retention 
rates, treatment and intervention satisfaction and estimate intervention effect sizes 
on our primary outcome of glycemic control (HbA1c) as well as on secondary 
outcomes such as diabetes-related distress, self-management behaviors and 
diabetes social support at baseline and treatment termination. Data will be 
collected at baseline and three months (treatment termination) at a federally 
qualified health center, telephonically, or virtually. Participants will be randomized 
to the virtual empowerment-based DSMES or a control group. All virtual DSME 
intervention group sessions will be held on an online platform, Zoom Med. The 
baseline assessment and intervention period will consist of 14 weeks. In the first 2 
weeks participants will complete baseline questionnaires, interviews, and 
physiologic testing at a federally qualified health center, telephonically, or virtually. 
In weeks 3 to 10, participants will be simultaneously enrolled in 8 weekly virtual 
DSME classes. In weeks 13 and 14 of the intervention, participants will complete 
the post-treatment assessment battery (See Table 1). Patients who do not 
complete the intervention phase will also be invited to participate in the treatment 
termination assessment. The physiologic testing part of the assessment will be 
held at Detroit Community Health Connection, Inc. (DCHC) and other community-
based locations TBD, based on participant feedback, telephonically, or virtually. 
DCHC is a non-profit community-based primary care organization that provides 
medical and dental services to the insured, uninsured and underinsured at six 
federally qualified health centers in the city of Detroit. Data analyses and 
dissemination of study findings are anticipated to be completed in months 11-12 of 
the study funding period. In Phase III of this project, we will be conducting 
qualitative interviews to better understand the acceptability and sustainability of the 
intervention as routine practice in a community-based clinic.  
 
 
 
 

Table 1. Detailed timeline of Phase I and Phase II 
 
TIMELINE 
Q1 
Q2 
Q3 
Q4 
Study Activities 
Dec 
20 
Jan 
21 
Feb 
21 
Mar
21 
Apr 
21 
Jun 
21 
Jul 
21 
Aug 
21 
Sep 
21 
Oct 
21 
Nov 
21 
Dec 
21 
Phase I 
Focus Group 
Recruitment 
 
 
 
 
 
 
 
 
 
 
 
 
Hire & Train Research 
Staff 
 
 
 
 
 
 
 
 
 
 
 
 
Conduct Focus Groups  
 
 
 
 
 
 
 
 
 
 
 
Analyze Focus Group 
Data 
 
 
 
 
 
 
 
 
 
 
 
 
Adapt Intervention 
Materials 
 
 
 
 
 
 
 
 
 
 
 
 
Intervention Recruitment  
 
 
 
 
 
 
 
 
 
 
 
Phase II RCT 
Randomization 
 
 
 
 
 
 
 
 
 
 
 
 
T0 Baseline 
Assessment 
 
 
 
 
 
 
 
 
 
 
 
 
T1 Post-Intervention 
Assessment 
 
 
 
 
 
 
 
 
 
 
 
 
Phase III Data Analysis  
Interviews and Focus 
Groups (participants and 
practitioners) 
 
 
 
 
 
 
 
 
 
 
 
 
Analyze and 
disseminate data 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.0 BACKGROUND 
 
Diabetes is the 6th leading cause of death in Southeast Michigan.(15,16) One-third of people 
living in this area over the age of 50 have diabetes or pre-diabetes.(15,16) Michigan’s age-
adjusted diabetes death rates in 2009 were 26.6 for White males, 19.1 for non-Hispanic White 
females, 44.7 for Black males, and 33.6 for Black females (deaths per 100,000 
population).(15,16) Diabetes is highly prevalent in Black men and women and they are more 
likely to be diagnosed with diabetes compared to non-Hispanic Whites.(17) In addition, they are 
disproportionately more likely to have uncontrolled blood glucose levels than their non-Hispanic 
White counterparts.(17) 

Diabetes self-management education and support (DSME/S) is a cornerstone of 
successful diabetes management. Various methods have been used to reach the increasing 
numbers of patients with diabetes, including Internet-based education. A 2015 review found that 
DSME/S delivered via the Internet is effective at improving measures of glycemic control and 
diabetes knowledge compared with usual care. In addition, results demonstrate that improved 
eating habits and increased attendance at clinic appointments occur after the online DSME/S, 
although engagement and usage of Internet materials wane over time. Interventions that include 
an element of interaction with healthcare providers were seen as attractive to participants. 
Internet-delivered diabetes education has the added benefit of easier access for many 
individuals, and patients can self-pace themselves through materials. More research on the 
cost-benefits of Internet diabetes education and best methods to maintain patient engagement 
are needed, along with more studies assessing the long-term impact of Internet-delivered 
DSME/S. 
Based on our previous work, the long-term goal of our research is to determine the 
most effective, practical, and sustainable approaches to provide virtual diabetes self-
management education and support (DSME/S) to increase accessibility to DSME/S in clinical 
and non-clinical settings. The objective of this proposal is to examine the relative effectiveness, 
feasibility and acceptability of virtual DSME compared to a control group. To accomplish this 
objective, we will engage in a developmental phase and a validation phase [pilot randomized 
controlled trial (RCT)]. The RCT will be conducted with N=60 Black adult residents of Detroit, 
MI. Participants will be randomized to an enhanced usual care group or to the tailored virtual 
DSME/S. We hypothesize that 1) participants in the virtual diabetes approach will have 
improved outcomes over the control group, and 2) an evaluation of measures will confirm 
efficacy of the intervention. Measures will be collected at baseline and  3-months. The primary 
outcome will be change in A1c, depression, and self-management behaviors at baseline and 
post-intervention. Secondary outcomes include changes in weight, blood pressure, quality of 
life, and diabetes related distress. We hypothesize that 1) participants in virtual DSME/S 
approaches will have improved outcomes over the control group, and that 2) participants in the 
empowerment-based virtual DSME/S will achieve DSME/S skills at significantly higher levels 
than participants in the control group.  
 
3.0 AIMS 
Aim 1 (Phase I HUM00170437): Identify barriers and facilitators to mental health care 
utilization, diabetes self-management, and internet/computer accessibility and 
acceptability by: 
• 
Conducting 15 interviews with African American women and 15 interviews with African 
American men with diabetes 
• 
Conducting semi-structured stakeholder interviews including mental health care 
providers at a Detroit-based health clinic. 
 
Specific Aim 2: Develop a virtual empowerment-based Diabetes Self-Management 
Education and Support (DSME/S) intervention to work in a community-based clinic based 
on what we learn in Aim 1. Development, adaptation and refinement will involve: 
• 
Developing an empowerment-based DSME/S based on our interviews and previous 
research. 

 
Specific Aim 3: Assess the impact intervention strategies developed in Aim 1 by:  
• 
conducting a pilot study of our DSME/S to evaluate participant recruitment and retention 
rates, treatment and intervention satisfaction and estimate intervention effect sizes on 
our primary outcome of glycemic control (HbA1c) as well as on secondary outcomes 
such as self-management behaviors, depression and diabetes social support at baseline 
and 3 months. Data from the pilot trial will help refine recruitment strategies, training 
materials, and protocol to be used in a larger clinical trial.  
• 
conducting qualitative interviews to better understand the acceptability and sustainability 
of the intervention as routine practice in a community-based clinic.  
 
Overall Impact: Data from the pilot RCT will help refine recruitment strategies, training 
materials, and the study protocol to be used in a larger cluster RCT. Our study will also identify 
strategies to increase patient participation in intervention research and improve dropout rates. 
This goal is in line with the mission of NIDDK to disseminate science-based information on 
diabetes, to improve people’s health and quality of life. 
 
4.0 PARTICIPANTS AND RECRUITMENT 
Participants will be 60 Black men and women that are 18 years or older and meet 
the inclusion criteria listed below. During the Phase II pilot we will individually 
randomize each participant with a 50/50 randomization scheme to either virtual 
empowerment based DSME/S or a control group.  
Inclusion: Inclusion criteria for the Phase II (intervention) will include participants 
with all of the following identities: age 18 or older, Black, a diagnosis of T2D for six 
months duration or longer, ambulatory status, and currently under a physician’s care. 
Eligibility will be determined using a telephone screening (administered by a 
research assistant or project coordinator). Respondents who meet eligibility criteria 
will be invited to participate in the baseline screening assessment. 
 
Exclusion For Phase II (intervention) we considered restricting eligibility to a higher-risk 
population of participants with A1c ≥ 8%. Preliminary data suggest that over 50% of the 
proposed study sample will have an A1c ≥ 8%. Focusing on all Black/African American 
men and women with type 2 diabetes allows us to cast a wide net for secondary 
prevention and public health impact. Persons who meet eligibility criteria will be invited 
to participate in the baseline screening assessment. While we have chosen the above 
eligibility criteria based on previous work, we will make adjustments to the future, larger 
trial, based on results and feedback from our proposed pilot. 
Recruitment We plan to utilize the following strategies to enhance and maintain 
participation in the proposed study: Patients currently at the DCHC clinic and eligible 
for the study will be identified via electronic medical record (EMR) by DCHC facility 

staff and provide the UM study team with names, phone numbers, and emails of 
eligible patients. The UM study team will then contact the potential subjects via email 
and by phone. The UM study team will not have access to patient EMRs. Flyers 
describing the study will be posted at each of the 6 DCHC clinics and in community-
based locations. Interested participants will call the UM study team’s central office 
phone number where they will be scheduled for screening. We also plan to recruit 
from the Michigan Center for Urban African American Aging Research Participant 
Resource Pool (MCUAAAR PRP). Flyers describing the study will be posted at the 
MCUAARP center, including the central phone number for participants to reach the 
research staff. The research staff will be given a list of eligible male and female 
candidates from the research pool who have a Type 2 diabetes diagnosis; and a 
self-identified Black/African American identity from the MCUAAAR PRP will be 
invited to participate in the intervention. The MCUAAAR PRP is a research volunteer 
registry can be accessed by scholars conducting research of Black makes, 55 years 
of age and older who meet their study criteria. Dr. Hawkins has previously conducted 
studies using older Black males with T2D recruited from the PRP. There are 
currently a total of 1424 active PRP members and 60.1% of male PRP members 
have T2D. 
5.0 PROCEDURES 
Screening Individuals that are interested in participating in the study will be asked to 
complete a phone screen with a study team member. During the phone screen, the 
research staff will read a brief recruitment script and ask if the participant is interested in 
participating. If the individual is interested and willing, they are asked to complete a 
phone screen. The phone screen can be scheduled for immediately following the 
recruitment script or at a time convenient for the potential participant. 
  
The phone screen will assess the following: basic demographic information, and self-
identified T2D diagnosis. Individuals will be eligible for a baseline interview if they meet 
demographic criteria (self identified as African American/black, and over eighteen years 
old), and self-report having Type 2 Diabetes. 
 
Upon completion of the phone screen, the study team member will inform the individual 
if they are eligible to complete the baseline interview. If the individual is eligible, a 
baseline assessment will be scheduled and details will be given to the individual. The 
purpose of this initial screen is to invite research candidates to additional eligibility 
screening (Baseline Assessment) having met initial criteria and for the research 
candidates to provide consent to answering questions at the in-person Baseline 
Assessment which involve Private Health Information, to be used for determining 
eligibility. 

 
Baseline Assessment (Assessment Battery) All individuals that meet initial phone 
screening criteria and agree to participate will complete a baseline assessment. 
Baseline assessment will be held in person at Detroit Community Health Center 
(DCHC), by phone or virtually with a study team member. During the assessment the 
participant will be asked to complete the informed consent (with electronic signature 
using SignNow), questionnaires, interviews, and physiologic testing to determine if the 
participant is eligible to participate based on inclusion and exclusion criteria. Baseline 
assessments will last about sixty minutes. The PI will train all research staff in 
standardized data collection. Participants will be paid $20 for completing the 
assessment and the same assessments at T0 (baseline) and T2 (treatment 
termination). 
 
Randomization Participants will be randomized to the virtual empowerment based 
DSME/S or a control group using a 50/50 randomization scheme. Participants will be 
aware if they are in the intervention group or the control group.  
 
Intervention (virtual empowerment-based DSME/S n=30) Participants randomized 
into the virtual empowerment-based DSME/S group will receive 10 hours of DSME/S 
delivered by a Certified Diabetes Care and Education Specialist (CDCES) over 8 weeks 
delivered via the Zoom for Health at U-M service may be used for Protected Health 
Information (PHI, regulated by HIPAA). To ensure treatment fidelity, three DSME/S 
sessions will be selected at random and recorded and rated for fidelity to the above 
content by our research team. 
 
Control Group (Control n=30) Participants randomized to enhanced usual care will 
receive referrals to community mental health providers, pedometers, gym memberships 
to a community-based venue, and intervention patient manuals. Based on several years 
of experience in Detroit, providing all participants with referrals, pedometers, and 
educational materials minimizes ethical concerns regarding assignment of underserved 
populations to receive a no-treatment control. 
Follow-Ups Follow up assessments for both the virtual empowerment-based 
DSME/S group and control group will occur at three months (post-treatment 
assessment). Participants will return to the DCHC for follow-up assessments, 
telephonically, or virtually and the same measurements and surveys will be 
completed. Participants will be compensated $20 for completing each assessment. 
Data will be stored in REDCap, a secure, web-based application hosted at UM. 
Maintenance of Samples Strategies will be used to encourage attendance of group 
sessions and to complete follow up interviews. Reminder emails, texts and/or calls 

will be sent before each session to remind participants by the study team. In 
addition, the study team will collect participant contact information from baseline 
through the follow up phase. The study team will also ask participants to provide 
additional contact person(s) that the study team can contact if they cannot reach the 
participant. 
Participant Retention The following procedures will be used to minimize participant 
attrition: 1) Data collection sessions will be completed at the DCHC site in order to 
maximize the convenience of data collection for subjects, and 2) multiple techniques 
are used to increase the likelihood that participants will keep their data collection 
appointments, including advanced scheduling, multiple reminder letters, and phone 
reminders. Participants who withdraw will still be asked to participate in study data.  
Data Collection & Data Safety For Phase II (intervention), research data will be 
collected through the following methods: finger stick capillary blood samples, blood 
pressure measurements, weight, height, exit interviews regarding treatment 
satisfaction, surveys, audio recorded interviews and treatment sessions, and 
transcribed interviews and treatment session recordings. All data will be obtained 
specifically for research purposes and will be collected only with informed consent 
over the course of the award period. 
 
At the time of study enrollment, participants will be assigned a study identification 
number to be used in all study materials and data for the duration of the study. All 
identifying information will be separated from the data and laboratory values. A master 
list that contains participants names and study identification number will be kept in a 
locked filing cabinet within a locked office in the School of Social Work at the University 
of Michigan. Audiotapes of interviews and treatment sessions will be stored securely on 
a password protected computer only accessible to study personnel and will be 
destroyed upon study completion. We will use DropBox, a secure platform to share 
these recordings, transcriptions, and other study data between study team members.  
 
The principal investigator (Dr. Hawkins) and the research assistants will be the only 
persons who have access to the file linking study participant identification number to 
each subject, and this will be stored separately from study data. Participants will be 
assured that all data they provide to the study will be confidential to this study, unless it 
is necessary to “alert” the patient and possibly also their physician because of a 
laboratory value outside of the normal ranges that reflects a risk requiring immediate 
medical attention. All reports will use aggregate data. Subject names or other identifiers 
will not be reported. All quotes shared collected from the interviews will be de-identified 
for privacy. No persons from the recruitment sites will handle or have access to 
personal health information or participant survey data. 

 
Data will be stored in REDCap, a secure, web-based application hosted at the 
University of Michigan. Analyses will be conducted using Atlas.ti. This data will be used 
to conduct a final refinement of treatment content as needed. 
 
To ensure the proper monitoring of the safety of all participants and the quality of data 
collected, a Data Safety and Monitoring Board (DSMB) will be established that will 
follow techniques suggested in the literature (Damocles, et al, 2005). The board will 
consist of Drs. Hawkins, Piatt, and Alexander. In addition, five outside members, who 
are not involved with the study, will serve on the DSMB as voting members and will be 
identified at a later date. Voting members will consist of University professors with 
experience and expertise in clinical diabetes intervention research to ensure 
consistency and quality of input. 
6.0 GROUP LEADERS & TRAINING 
To ensure staff participation in data safety and monitoring activities, all members of the 
project team (research assistants and staff) will be trained on the specifics of the data 
safety and monitoring plan. Field staff will be trained on what constitutes an adverse 
event to a participant and instructed to report any adverse events immediately to the 
principal investigator, Dr. Jaclynn Hawkins.   
 
All questionnaires and instrumentations are standardized measures that have been 
used in our own trials and in other diabetes research and there are no significant risks 
anticipated related to the completion of them. However, breaks will be given as needed 
to reduce fatigue, or measures read to adolescents, and research assistants will be 
appropriately trained to obtain personal information in a sensitive fashion. Research 
staff will be trained in research ethics, confidentiality protection, and HIPAA prior to and 
throughout the study period.  All CDCESs in this study are either a Registered Dietitian 
Nutritionist RDN) or Registered Nurse (RN) and are certified through the Certification Board for 
Diabetes Care and Education. The extensive CDCES certification process ensures health care 
professionals possess comprehensive knowledge and experience in prediabetes, diabetes 
prevention, and diabetes management. Katherine Kloss, RDN, CDCES has been working with 
people with diabetes for 6 years and a CDCES for 2 years. Robin Nwankwo, MPH, RDN, 
CDCES has been working with people with diabetes for 28 years and a CDCES for 24 years. 
 
The PI will monitor adverse events throughout the clinical trial period. To ensure staff 
participation in data safety and monitoring activities, all members of the project team 
(research assistants and staff) will be trained on the specifics of the data safety and 
monitoring plan.  Field staff will be trained on what constitutes an adverse event to a 
participant and instructed to report any adverse events immediately to the principal 
investigator, Dr. Jaclynn Hawkins.   

 
The principal and co-investigators on the proposed study make up a trans-disciplinary, 
accomplished and collaborative team of community-based behavioral and clinical 
researchers. Together, our research team has a strong history of successfully 
implementing and publishing our work regarding diabetes interventions in high-risk 
communities. Most notably, Drs. Piatt and Herman of the Michigan Center for Diabetes 
Translational Research (MCDTR), collaborated on Praise I and II, T2D randomized 
controlled trials of the effectiveness of church-based diabetes self-management support 
being conducted with Black adults in Toledo, Flint, and Metro Detroit of which Dr. Piatt 
is PI. Dr. Hawkins is currently a co-investigator on Praise 2 (R01DK104733-02). Also, 
as part of the MCDTR, Dr. Hawkins is an early career trainee and Dr. Piatt served as 
Dr. Hawkins’ primary mentor for the last 3 years. All are members of BRIDGE. 
7.0 MEASURES 
Primary Outcome Measures 
Metabolic Control will be measured via hemoglobin A1c (HbA1c). HbA1c will be 
collected using the DCA 2000 point-of-care testing instrument.  
Depression will be measured using the PHQ-9 (score >=10) and The BDI-II, a 21-
item self-administered questionnaire used to assess symptoms of depression. 
Depression will be measured using the Beck Depression Inventory (BDI-II). BDI-II 
items have been designed to correspond with DSM-IVTR diagnostic criteria. The 
BDI-II has been shown to have excellent test-retest reliability and validity when used 
in general populations as well for use with diabetes samples. 
Regimen adherence will be measured using the Perceived Diabetes Self-
Management Scale, a self-report questionnaire used to measure a broad range of 
management behaviors, such as insulin management, dietary management, blood 
glucose monitoring, symptom response, and parent assistance/supervision.  
Secondary Outcome Measures 
BMI will be calculated using height and weight. Height will be measured using a 
stadiometer. Weight will be measured on a high quality, calibrated digital scale. BP 
will be measured using the auscultatory method. 
Diabetes Social Support will be measured using the Diabetes Social Support 
Questionnaire. Diabetes-related Distress will be measured using Diabetes Distress 
Scale (SF-12) and lastly, a validated Diabetes Quality of Life will be used to measure 
quality of life. Participants will also complete questionnaires that assess socio-
demographic, behavioral, psychosocial, and health services utilization and are 

validated in diverse populations with diabetes. 
 Specific Aim 1: Qualitative analyses will be conducted during the development 
phase and on the post-intervention focus groups and interviews.  First, we will 
develop codes utilizing a grounded theory approach and will start with the formulation 
of categories and definitions developed directly from the text. Content from transcripts 
will be coded for themes and patterns. Through this process a coding manual and 
definitions will be finalized. The refined manual will be used to guide ongoing coding 
and pairs of coders will read subsequent transcripts keeping codes that achieve 80% 
agreement on code application. Analyses will be conducted using Dedoose. This data 
will be used to conduct a final refinement of treatment content as needed. 
 
Specific Aim 2: The proposed study includes a sample size of 60 Black men and 
women, 30 in the intervention arm and 30 in the control arm. We will assess the impact 
of the intervention on HbA1c (primary outcome) and diabetes management (secondary 
outcomes) using multilevel modeling, with intervention group as a between-subjects 
factor (2 levels) and time as a within subjects factor (3 levels). HbA1c, depression 
symptoms, diabetes self-management, and social support at baseline and 3 months will 
be used as the dependent variables. Independent variables include intervention group, 
time of assessment, and interaction between time and intervention group. Random 
effects will be allowed for the intercept (to allow differences in baseline measurements) 
and the slope (to allow differences in the trajectories of change). Covariates e.g. length 
of time since diabetes diagnosis, age will be tested as predictors of the outcome and 
retained if significant at p < .10.  
 
Power Analysis: Assuming 20% attrition, we expect a final sample size of 48, 
approximately 12 per group (with 2 groups in the treatment arm). If we assume 
correlations of 0.25 between successive measurements of HbA1c, then this sample size 
will yield power of 0.8 to detect a difference of 0.6 standard deviation between average 
values of HbA1c in treatment and control groups. 
8.0 PROTECTION OF HUMAN PARTICIPANTS 
The protocol for this study will meet approval by the University of Michigan Institutional 
Review Board prior to initiating any of the described study activities. 
 
D 1. Human Participants Involvement And Characteristics Removing Participants From 
The Protocol.  
 
Respondents who meet eligibility criteria will be invited to participate in the baseline 
screening assessment. While we have chosen the above eligibility criteria based on 

previous work, we will make adjustments to the future, larger trial, based on the results 
and feedback from our proposed pilot. 
 
D 2. Sources Of Materials 
For Phase II (intervention), data will be collected through the following methods:  
finger stick capillary blood samples, blood pressure measurements, weight, and 
height. Data that are obtained specifically for research purposes will be collected 
only with informed consent. All data will be collected over the course of the award 
period. 
 
D 3. Potential Risks 
 
Participation in this study involves minimal foreseeable risks. Participants will be asked 
to provide finger stick capillary blood samples during assessments. Risks associated 
with finger stick capillary blood draws include: minor discomfort from obtaining the blood 
sample, minor pain, bruising, or bleeding at the puncture site similar to any other routine 
blood sample collections. With self-report surveys, there is also the small risk that 
prompting patients to review their diabetes care practices and providing them with 
feedback about their diabetes-related health outcomes (e.g., A1C, blood pressure) 
could cause some emotional discomfort or anxiety. Such discomfort would likely prime 
patients and their primary care physician or group facilitator to address any problems 
identified. Other risks include breach of confidentiality of study data. 
 
Protection Against Risk 
All questionnaires and instrumentations are standardized measures that have been 
used in our own trials and in other diabetes research and there are no significant risks 
anticipated related to the completion of them.  However, breaks will be given as needed 
to reduce fatigue, or measures read to adolescents, and research assistants will be 
appropriately trained to obtain personal information in a sensitive fashion.  Research 
staff will be trained in research ethics, confidentiality protection, and HIPAA prior to and 
throughout the study period.   
 
At the time of study enrollment, participants will be assigned a study identification 
number to be used in all study materials and data for the duration of the study. All 
identifying information will be separated from the data and laboratory values.   A master 
list that contains participants names and study identification number will be kept in a 
locked filing cabinet in the School of Social Work. The principal investigator (Dr. 
Hawkins) and the research assistant will be the only persons who have access to the 
file linking study ID# to each subject.  Participants will be assured that all data they 
provide to the study will be confidential, unless it is necessary to “alert” both the patient 

and their physician because of a laboratory value outside of the normal ranges that 
reflects a risk requiring immediate attention.  All reports will use aggregate data.  
Subject names or other identifiers will not be reported. No persons from the DCHC or 
other community based location will handle or have access to personal health 
information or participant survey data. 
 
D 6. Potential Benefits Of The Proposed Research To The Participant And Others 
Participants will have the potential to benefit from the study by receiving free diabetes 
self-management education and support from the intervention and also an opportunity 
to discuss barriers and facilitators to recruitment and retention of men and women in a 
large-scale intervention. There are also benefits to society from the research through its 
potential to improve diabetes self-management interventions for persons with Type 2 
diabetes. We feel the benefits of participating in this study significantly outweigh the 
risks. 
 
9. DATA AND SAFETY MONITORING PLAN 
Adverse Events:  The PI will monitor adverse events throughout the clinical trial period. 
To ensure staff participation in data safety and monitoring activities, all members of the 
project team (research assistants and staff) will be trained on the specifics of the data 
safety and monitoring plan.  Field staff will be trained on what constitutes an adverse 
event to a participant and instructed to report any adverse events immediately to the 
principal investigator, Dr. Jaclynn Hawkins.   
 
For the purposes of this study, adverse events will be considered any undesirable sign, 
symptom, or medical condition occurring during the study, whether or not related to the 
intervention. Adverse events include new events not present during the training period 
or events that were present during the training period but increased in severity over 
time. Each adverse event will be recorded and assessed for its date of onset, duration, 
severity, seriousness, and relationship to study treatment, and any action/treatment that 
is required. All adverse events will be collected, analyzed, and monitored using an 
adverse event form. Furthermore, the committee will establish “alert” values for A1C 
and blood pressure.  The PI will notify the subject and the subject’s physician whenever 
there are laboratory results above these values because of the clinical implications of a 
value substantially out of normal range.   
 
All serious medical events will be reported within one business day of their identification. 
All serious, fatal or life-threatening adverse events will be reported to UM IRB and the 
NIH within 24 hours of its identification. All causes of death are considered to be serious 
medical events. Unexpected moderate or severe adverse events will be reported in 
writing to the IRB and NIH. Serious medical events will be collected throughout the 

intervention phase of the study. The PI, along with the study psychologist Dr. Mary de 
Groot will adjudicate whether or not each serious adverse event may be attributable to 
study participation. Events that involve an unexpected adverse event and are possibly 
or probably related to participation in the study will be reported to the IRB at University 
of Michigan within one business day.  Annual reporting of aggregate adverse events to 
the IRB and NIH will be performed. All research project personnel will complete training 
in the protection of human research participants. The PI and research assistant will 
verify appropriate reporting of adverse events, quality of data collection, and adherence 
to the study protocol. Participant dropout rate will also be monitored and reviewed for 
needs or trends based on specific participant characteristics. 
 
Data Safety & Monitoring Board: The DSMB will hold a minimum of two conference 
calls over the award period (approximately two hours per call) to discuss the progress of 
the intervention and review research results, if applicable.  At the first meeting, the 
board will elect a chair of the DSMB. To facilitate these conference calls, the principal 
investigator will prepare a report on the progress of the project to date. This report will 
be circulated well in advance of the conference call to allow all members ample time to 
read it. These calls will be scheduled and organized by the study coordinator and will be 
held at a time convenient for all members.  
 
The DSMB is responsible for assuring that study participants are not exposed to 
unnecessary or unreasonable risks and that the study is being conducted according to 
high scientific and ethical standards. Specifically, the DSMB will:  
 
1. Assess the performance of the study with respect to subject recruitment, retention 
and follow-up, protocol adherence, and data quality and completeness, in order to 
ensure the likelihood of successful and timely milestone completion.  
 
2. Monitor interim data regarding the safety of the study, including adverse events. The 
DSMB may, at its discretion, examine effectiveness data as well.  
 
3. Review abstract and publications of main findings prior to submission to ensure the 
study is being reported appropriately.  
 
4. Review and consider any protocol modifications or ancillary studies proposed by the 
study investigators after the main study begins to ensure that these do not negatively 
impact on the main trial.  
 
5. Advise the NIA and the study investigators as to whether a protocol should continue 
as scheduled or undergo a modification due to a finding from the monitoring process.  

 
6. Make recommendations to the NIA and principal investigator concerning continuation 
or conclusion of the trial. 
10.0 STUDY SITES 
Virtual empowerment-based DSME/S sessions: All DSME/S sessions will be held 
virtually via HIPPA compliant Zoom med. Baseline and post-treatment assessments 
will take place telephonically, virtually or at DCHC is a non-profit community-based 
primary care organization that provides medical and dental services to the insured, 
uninsured and underinsured at six federally qualified health centers in the city of 
Detroit. 
Elements Unique to this Site In each location, rooms with doors and telephones 
will be available to facilitate privacy, confidentiality, and safety of assessments.