A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With T1DM
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Sponsor: University of Illinois at Chicago

P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
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A Cognitive Behavioral Intervention to Reduce 
Fear of Hypoglycemia in Young Adults with Type 1 Diabetes  
Document Date: 5/12/2021 
NCT 03549104 
 
 
 
 
 
 
 

P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
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A Cognitive Behavioral Intervention to Reduce 
Fear of Hypoglycemia in Young Adults with Type 1 Diabetes  
ABSTRACT 
 
In persons with type 1 diabetes (T1DM), hypoglycemia is the major limiting factor in achieving optimal blood 
glycemic control. All persons with T1DM are at risk for hypoglycemia (blood glucose level < 70 mg/dl), which is 
life-threatening and accompanied by serious physical and psychological symptoms, resulting in a profound fear 
of hypoglycemia (FOH) and reduced quality of life. Young adults with T1DM are at greater risk for FOH and 
have worse glycemic control and self-management behavior than other age groups with T1DM. In our 
preliminary work, we found that 77% of young adults with T1DM reported FOH, and FOH resulted in increased 
glycemic variability. Glycemic variability (GV) is the minute-to-minute fluctuation in blood glucose that can be 
missed if looking only at A1C, a longer-term measure. Increased GV is dangerous because it is associated 
with cardiovascular events and diabetes complications. Cardiovascular disease remains the primary cause of 
mortality in T1DM; therefore, strategies to reduce it are necessary. A major gap exists in how to manage FOH 
as a component of diabetes self-management. Our overall objective is to reduce FOH and improve diabetes 
self-management, glycemic control, and GV in young adults with T1DM to reduce or delay diabetes 
complications and improve quality of life. We specifically aim to: (1) determine the feasibility and acceptability 
of a fear reduction program in young adults with T1DM, who experience FOH; and (2) determine the impact of 
an 8-week cognitive behavioral therapy (CBT)-based intervention on the outcomes: FOH, self-management 
behavior, glycemic control, and GV. To achieve these aims, we propose a randomized controlled trial in 50 
young adults aged 18 to 35 years with T1DM. Participants will be screened for FOH levels. Eligible subjects 
will be randomized to the intervention program (Fear Reduction Efficacy Evaluation [FREE]) or attention control 
group. A one-week run-in phase is planned, with baseline measures of FOH, self-management behavior, A1C, 
and 24-hour real-time continuous glucose monitoring recordings (RT-CGM) to calculate GV for both groups. 
The intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure 
treatment for specific fears. RT-CGM and a daily FOH diary will be used as feedback cues as part of the FREE 
program. The attention control group will participate in eight weekly individual one-hour diabetes self- 
management education (DSME) sessions and wear a 24-hour RT-CGM device (to measure GV only) during 
the same eight-week period. At completion, FOH will be measured, and RT-CGM recordings will be analyzed 
to determine differences between the FREE and control groups. Findings from this proposed pilot study will 
serve as the foundation for a larger clinical trial to reduce FOH and improve self-management, glycemic 
control, and GV. This program of research promises to reduce the development of diabetes complications and 
improve quality of life for young adults with T1DM. 

P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
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Specific Aims 
In persons with type 1 diabetes (T1DM), iatrogenic hypoglycemia is the major limiting factor in achieving 
optimal blood glucose control.1 All persons with T1DM are at risk for hypoglycemia (blood glucose level < 70 
mg/dl2), which is life-threatening3 and has serious physical and psychological sequelae, resulting in fear of 
hypoglycemia (FOH).4,5 FOH can be incapacitating, causing panic,4 anxiety,6 phobic disorders,7 and greatly 
diminished quality of life.8 FOH also results in greater glucose variability9,10 (GV; the intra-day fluctuations in 
blood glucose) and poor glycemic control due to under- or overcompensation of food intake, insulin dosing, or 
physical activity.11,12 Greater GV is associated with cardiovascular events,13-15 a greater risk of hypoglycemia16 
and diabetes complications.15 Despite improved insulin analogs, delivery systems, and glucose sensing 
technology, FOH persists.4 The proposed study will pilot test a program to decrease FOH and examine its 
association with GV. 
Our preliminary data using real-time measures demonstrated that 77% of young adults with T1DM reported 
FOH; FOH resulted in increased GV, with GV occurring after FOH.10 Young adults are particularly at risk 
because they report greater FOH than adolescents17 and have poorer glycemic control compared to middle- 
aged and older adults.18 Self-reported hypoglycemia occurs on average twice weekly, but for some individuals 
it may occur nearly daily.19 Fear management interventions using cognitive behavioral therapy (CBT) with 
exposure therapy and feedback have been effective in reducing anxiety in other populations,20 but have not 
been tested for persons with diabetes21 and are not a traditional part of diabetes self-management programs 
for T1DM. We have developed and manualized a CBT-based program tailored to FOH in young T1DM adults, 
developed with input from the target population. 
Responding to PA-15-176: Pilot and Feasibility Clinical Trials in Diabetes and Endocrine Metabolic 
Diseases, the main objective of this R21 is a pilot and feasibility clinical trial to test a CBT program for FOH on 
the outcomes: FOH, self-management, glycemic control (A1C), and GV in young adults with T1DM who 
experience FOH. Fifty young adults with T1DM will be randomized to an intervention or attention control group. 
The intervention group will participate in eight weekly, individual one-hour sessions using principles of CBT and 
exposure therapy, using real-time continuous glucose monitoring (RT-CGM) and a daily FOH diary as 
feedback cues. The attention control group will participate in eight weekly, individual one-hour diabetes self- 
management education (DSME) sessions and use RT-CGM. 
Specific aims for this pilot study are: 
In 50 young adults with T1DM (18-35 years)22 who experience FOH, we will: 
1. Determine the feasibility and acceptability of an eight-week CBT-based Fear Reduction Efficacy 
Evaluation (FREE). Feasibility will be determined through analysis of recruitment (number recruited, 
screened, eligible, and consented) and retention (% session attendance, program completion rates). 
Acceptability will be determined through participant evaluation (written evaluation and interview at 
program completion, and a convened advisory group of previous participants). 
2. Determine the impact of the FREE intervention, compared to an attention control group, on the 
outcomes: FOH (Hypoglycemia Fear Scale score), self-management (Self-Management Scale score), 
glycemic control (A1C), and glycemic variability (RT-CGM recordings). 
Primary hypothesis: Young adults with T1DM participating in the FREE program will demonstrate 
improvement in FOH compared to the attention control group. 
Secondary hypothesis: Young adults with T1DM participating in the FREE program will have improved 
self-management, glycemic control, and glycemic variability (GV) compared to the attention control 
group. 
This study will generate information for a larger clinical trial to test the effectiveness of the FREE 
intervention to reduce FOH, improve self-management behavior, and improve glycemic control and GV. If 
effective, this intervention will serve as an important adjunct to diabetes care in young adults with T1DM, 
reduce the development of diabetes complications, and improve quality of life. 

P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
4
Research Strategy 
1. Significance 
Why fear of hypoglycemia (FOH) in young adults? Young adulthood is the developmental period from 
age 18 to 35 years, when individuals transition to independent diabetes care as well as establish 
independence, careers, family, and parenthood.22 This is before the onset of long-term diabetes complications, 
when healthy behavior changes can have a critical impact on future health.23 Despite advances in insulin 
therapy and glucose-sensing technology, FOH remains a critical deterrent to type 1 diabetes (T1DM) self- 
management, psychological well-being, and quality of life (QOL).17 Fear is conceptualized as an emotion 
arising from a cognitive appraisal of a specific threat or danger.24 Normal fear is adaptive, stimulating more 
vigilance and improved performance; heightened fear leads to increased anxiety and may result in a delay to 
action or inappropriate action.21,24,25 Fear may mimic the symptoms of hypoglycemia and impair its detection, 
exacerbating the problem.5,26 At the extreme, fears can develop into anxiety disorders and phobias.7,21,27 
Previous negative experiences of hypoglycemia influence diabetes self-management behaviors.11,17,28-32 
Diabetes self-management is defined as the knowledge, skills, and behaviors needed for diabetes self-care.33 
Insulin doses may be inappropriately reduced and diet may be modified to avoid hypoglycemia. Dietary 
modifications may include excessive eating, particularly more carbohydrates12,34 or snacking at night.31,35 
These modifications lead to increased GV and poor glycemic control. Registry data from the T1D Exchange 
Clinic Registry revealed that only 13% of young adults achieved glycemic targets,36 and, in a survey of self- 
management practices, 45% of young adults reported they did not reach their glycemic goals due to FOH.37 
Over the past three decades, newer technologies have been designed to help patients with diabetes manage 
their treatment regimens, including continuous glucose monitoring (CGM) systems, insulin pumps, sensor- 
augmented pump therapy with insulin suspend features, and insulin bolus calculators. While these have 
improved glucose control (i.e., A1C), improved A1C has not consistently translated into reduced FOH.38-44 
What has been used to address FOH? Diabetes education programs typically discuss FOH but have no 
strategies to manage it.4 Glucose management and blood glucose awareness training have had variable 
effects on FOH.4,45-53 Outcomes demonstrated that, as glucose levels lower, worry levels do not consistently 
decrease.53 We hypothesize that the lack of consistent and sustainable reductions in FOH has occurred 
because the focus of these programs has been on glycemic control, not FOH. Any strategy that focuses on 
managing glucose to near-normal levels must include methods to cope with the fear that lower blood glucose 
levels could lead to hypoglycemia.54 A fear reduction program, informed by the proposed study, may provide a 
more comprehensive approach to diabetes care that reduces anxiety and improves glycemic control and GV. 
Why is glycemic variability (GV) important? GV has been associated with more frequent episodes of 
hypoglycemia16 and fluctuations between glucose extremes (i.e., hypo- to hyperglycemic), which may occur 
with overtreatment of a hypoglycemic episode. Evidence supports the role that GV (daily fluctuation) plays in 
generation of oxidative stress,14 endothelial dysfunction,55 and 
Figure 1. Glycemic Variability 
 
 
diabetes complications in T1DM.15 GV has also been associated with 
increased risk for cardiovascular events,56 and cardiovascular 
disease remains the major cause of mortality in T1DM.57 Though A1C 
provides a biomarker for average blood glucose over a 2- to 3-month 
period, it does not capture daily blood glucose fluctuations. As our 
previous research shows, individuals may have an optimal A1C yet 
high GV (Figure 1).10 GV is directly influenced by self-management 
behavior58 and amenable to change with appropriate intervention. 
This study will contribute new knowledge about the relationship of 
FOH and GV and its potential to impact diabetes self-management. 
Why a cognitive behavioral approach (FREE) to reduce FOH? 
Heightened fear develops from memories of previous negative 
hypoglycemic events that create a conditioned negative response to 
future fear triggers.21,59 CBT has been used to reduce fear in other populations.60 The FREE program will be 
based on the Beck Cognitive Behavioral Model.61 The conditioned fear response is reframed through cognitive 
restructuring of negative thoughts, regulation of emotions (FOH), and changing maladaptive behaviors (self- 

P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
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management behavior). Exposure therapy will be used to reduce FOH that is out-of-proportion to the threat 
through habituation to previously fearful situations (Figure 2).61 RT-CGM readings and fear diary review will be 
feedback cues to reinforce learning. The goal is not to replace 
standard diabetes therapy, but improve diabetes self- 
management62 through reducing fear. Our program is 
designed to reduce FOH and improve diabetes self- 
management, leading to improved glycemic control and GV. 
2. Innovation Most diabetes self-management research 
focuses on blood glucose management.48,50,53 A FOH 
reduction intervention represents a novel approach to 
addressing the role of FOH in glycemic control and GV. Most individuals with T1DM struggle with hypo- and 
hyperglycemia and develop a profound fear from these experiences. FOH does not resolve with education 
alone,4 and the magnitude of the problem is poorly understood and under-appreciated. As incidence of T1DM 
increases worldwide,63 the scope of the problem will rise. We have reported temporal associations between 
FOH and increased GV10 (see 3.1b), with strong justification for an intervention specifically targeting FOH. We 
will provide a CBT and exposure-based therapy intervention unique to diabetes care that has been effective in 
reducing fear and anxiety in other populations.64 Along with state-of-the-art real-time CGM technology, this will 
provide feedback on FOH reduction through weekly diary and RT-CGM cues. The combination of real-time 
feedback and CBT is innovative. Because exposure-based CBT has been effective for fear reduction in other 
disorders, success is likely. This intervention differs from programs developed to improve glycemic control 
because the emphasis is on FOH. NIH emphasizes treatment of young adults with T1DM; this innovative CBT 
program could facilitate prevention or delay of diabetes complications if it is found that GV is less by reducing 
FOH. If effective, this could be developed into a web-based application and tailored to other groups. 
3. Approach 
3.1. Preliminary Studies 
3.1a. Research Team Expertise. This application brings together an interdisciplinary team with shared 
(T1DM, FOH, CGM technology for GV measurement, chronic illness, and clinical practice) and complementary 
(CBT, feedback, intervention studies, and Certified Diabetes Educator [CDE®]) expertise. Collectively, the 
team’s research strengths span conceptual, methodological, clinical, statistical, and research abilities in the 
areas of self-management and chronic disease. 
3.1 b. Preliminary Work and Findings. This grant application builds on our previous studies. (1) First, we 
reported the association of GV with daily fear (using a prospective repeated-measures design) in 35 young 
adults with T1DM.10 The presence of FOH was not an inclusionary criterion; however, findings revealed: (a) 
FOH was highly prevalent, reported by 77% of the sample. (To our knowledge, there are no documented 
reports of FOH prevalence.) Daily diary comments related to FOH included: “I worry every day,” “It is a chronic 
fear,” “I live with it constantly, and it is never gone.” (b) FOH was linked to GV. Significant temporal 
relationships emerged: same-day fear levels were associated with same-day GV (r = .263, p < .001), and 
previous-day fear levels were associated with next-day GV (r = .218, p = .005). (3) A1C levels were not 
consistently associated with lower GV; 53% of those with optimal A1C levels (< 7% recommended target) had 
high GV (> 50 dL glucose standard deviation). (d) No significant sex differences were observed in the 
association of FOH and GV.10 (2) To examine the challenges of hypoglycemia and FOH further, focus groups 
were conducted. FOH emerged as a major stressor (unpublished data). As part of the study, participants 
provided suggestions on strategies to address FOH. They were very interested in a fear reduction program and 
favored individual, face-to-face meetings. (3) Lastly, based on this feedback, we developed, manualized, and 
carried out the FREE program in five young adults. All subjects completed the program. They provided 
feedback on program length, content, and approach, evaluating the program very positively. Stigma of 
participation in CBT therapy was not an issue. Participant suggestions have been incorporated. 
3.2. Design and Methods 
3.2 a. Overview. Young adults aged 18 to 35 years with T1DM (≥ 1 year) who experience FOH will be 
randomized to an intervention or attention control group. Following a one-week run-in phase, in which baseline 
RT-CGM recordings will be obtained and subjects adjust to wearing a RT-CGM, subjects will be randomized to 

P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
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the intervention or attention control group. Both groups will be blinded to the study hypothesis. The intervention 
group will participate in eight weekly individual one-hour sessions 
Figure 3. Study Design 
 
between-group differences (Figure 3). 
using a CBT-based approach (FREE), wear a RT-CGM device, 
and keep a daily fear diary. The attention control group will 
participate in eight weekly individual one-hour sessions on 
diabetes self-management education (DSME)62 and wear a RT- 
CGM device for eight weeks (for GV measurement only, no 
diary). Data is collected: (1) at the beginning of a one-week run- 
in period (Week 0); (2) at Week 4; (3) completion of the 
intervention (Week 8); and (4) post-program at (Week 12). FOH, 
self-management, and A1C will be measured, and RT-CGM 
recordings will be analyzed to determine within-group and 
3.2b. Setting and Sample. The study will take place remotely at the University of Illinois at Chicago (UIC) 
Medical Center and College of Nursing (CON) and in the participant’s living environment. Inclusion criteria: (1) 
18- 35 years old, (2) diagnosis of T1DM ≥ 1 year confirmed by self-report and insulin dependence since 
diagnosis, (3) receive medical care from an endocrinologist, (4) use insulin pump or multiple daily injection 
(MDI) therapy, (5) have FOH (screening questionnaire)65, and (6) attended a basic diabetes educational 
program to control for baseline knowledge, (6) has a mobile device, computer or phone to use to connect for 
weekly sessions, (7) has a private area for weekly sessions. Exclusion criteria: (1) pregnant or breastfeeding; 
(2) receiving psychotherapy for depression or anxiety disorders, (e.g., panic, obsessive compulsive disorder), 
or have received therapy specifically for FOH; (3) have a co-existing chronic illness or receiving medications 
(excluding insulin) that may influence diabetes self-management or GV. We anticipate few comorbidities that 
will influence diabetes management and GV, due to the age of the target population. Our preliminary data 
revealed no co-existing cardiovascular, pulmonary, or other major organ diseases. 
3.2c. Recruitment. Subjects will be recruited through the UIC medical center and diabetes websites and 
organizations, and Research Match using flyers, e-announcements, and recruitment letters and emails. We will 
identify potentially eligible subjects through the electronic medical record system and send recruitment letters 
and emails. The total number of annual clinic visits for young adult patients with T1DM was 832. The number of 
patients using insulin pumps is not available through the EMR classification system; however, we estimate 
56%-73% will use pumps, based on our preliminary data and data from the T1D Exchange Clinic Registry for 
this age group.18 There is a sufficient pool from which to recruit. We have been successful in recruiting using 
these methods for our previous studies. 
3.2d. Sample Size Determination. The sample size estimate will allow examination of within-group and 
between-group differences from beginning to end of the intervention and to calculate effect sizes to power a 
future larger study. To determine the sample size to meet these goals, the mean, SD, and mean/SD of FOH 
levels from our first study were used to re-estimate the expected effect size. The expected estimated effect 
size was 0.72. Twenty-five subjects will be required in each group (treatment and control; n = 50 total). A 20% 
attrition rate is expected, based on previous psychoeducational interventions in T1DM,49,51,53 Thus, we will 
accrue 30 subjects per group, to achieve a final sample size of 25 subjects per group (n = 50 total). 
3.2e. Procedures. 1.) Study staff will screen subjects for inclusion/exclusion criteria by phone. Worry item 
scores of 3 or 4 (4-point Likert), indicating that worry occurs often or very often, on any item on the worry scale 
of the Hypoglycemia Fear Scale-II (HFS-II)65 will be used to determine the presence of FOH. This method has 
been validated for this scale.66 2.) Those who meet study criteria will be invited to participate in the study. All 
study procedures will be explained and questions answered. If in agreement to participate, a link to complete 
the consent form in REDCap will be sent by email. 3.) Once the consent is completed, an appointment for a 
video-or telephone meeting will be scheduled and supplies and materials will be mailed to the participant’s 
home. At the first video- or telephone meeting study procedures will be reviewed and the study participant will 
be instructed on how to complete the baseline data collection tasks: one-time urine pregnancy (women to 
confirm eligibility), one-time waist circumference measure, questionnaires in REDCap through a URL link, 

P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
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perform the fingerstick test for A1C (average blood glucose), and how to place and care for the continuous 
glucose monitor. This will be the start of the one-week run-in period to obtain baseline measures (Week 0) and 
allow subjects to become familiar with wearing the RT-CGM sensor. Following the one-week run-in period, 
subjects will be randomly assigned to the FREE intervention or attention control group. Randomization will be 
computer-generated with permuted 
blocks in multiples of two. The use of 
permuted blocks preserves balance in 
the randomization over the course of 
the study (i.e., at any point in time, 
there will be approximately equal 
numbers of patients randomized to the 
FREE group or the attention control 
group). Randomization allocation will 
be concealed from the investigators by 
through REDCap as set up by the 
study statistician (Chang Park) who is 
not involved in performing the study 
protocol. During the study period, 
subjects will continue to receive their usual diabetes care with their health care provider and be encouraged to 
ask questions regarding blood glucose management of their diabetes health care provider. Subjects will 
continue to care for their diabetes as they normally would. 
3.2e1. FREE Intervention. Subjects randomized to the FREE intervention group will: (1) attend eight 
individual weekly remotely-delivered one-hour sessions based on principles of CBT and exposure treatment 
(Table 1). Program length was based on similar successful CBT programs.67 FREE sessions will be conducted 
by one consistent licensed clinical psychologist (Dr. Duffecy) who is a study co-investigator. The program 
curriculum is adapted from existing programs used for health-related anxiety using traditional CBT techniques. 
Treatment will target incorrect beliefs about hypoglycemia, hypervigilance to symptoms, fear of symptoms, and 
maladaptive behavioral responses in response to glucose levels. Participants will create a fear and avoidance 
hierarchy and be taught to begin 
approaching previously feared 
situations (e.g., spending time alone, 
reducing snacking, allowing glucose 
readings to reach lower safe levels, 
etc.) to experience habituation and the 
resulting decrease in anxiety 
(Appendix P1). Weekly homework will 
be assigned to reinforce the content. 
(2) FREE intervention subjects will 
continue to wear a RT-CGM for the 
eight weeks, and (3) complete a daily 
FOH diary (Appendix P3). RT-CGM 
readings and daily diaries will serve as 
feedback cues for glucose and FOH 
levels as part of the FREE program. 
(4) Participants will change their RT- 
CGM site as instructed by study staff 
member who is a registered nurse who will monitor remotely to assure proper placement and care. 
3.2e2. Attention Control Group. Subjects randomized to attention control: (1) attend eight weekly 
remotely-delivered individual one-hour sessions on diabetes self-management. Topics follow the American 
Diabetes Association DSME standards (Table 2; Appendix P2)68 and are led by a Certified Diabetes Educator 
(CDE®) and study co-investigator (Dr. Quinn). Weekly homework will be assigned. (2) Attention control 
subjects will continue to wear a RT-CGM for the eight-week session (for GV measurement only) and will not 
Table 1. Elements of the FREE Program 
Time 
Hypoglycemia and Its Causes 
Fear as a Normal Human Emotion 
Effect of Fear on Health and Health Behaviors 
Safety and Avoidance Behaviors 
Week 1 
Blood Glucose Cues 
Introduction to CBT 
Week 2 
Cognitive Restructuring, Safety Behaviors 
Introduction to Progressive Relaxation 
Week 3 
Exposure Therapy: Develop Fear Hierarchy 
Coping Strategies 
Week 4 
Exposure Practice, Coping, Relaxation and Cognitive Restructuring 
Weeks 5-7 
Review Techniques Learned, Develop a Plan to Maintain Gains 
Week 8 
Table 2. Elements of the Attention Control (DSME) Program 
Time 
Living with Diabetes 
Week 1 
Using Medications Safely for Therapeutic Effectiveness; Blood 
Glucose Monitoring 
Week 2 
Healthy Eating; Incorporating Nutritional Management into Lifestyle 
Self-Assessment: What is your Eating Style? 
Week 3 
Being Active: Incorporating Physical Activity into Lifestyle; Barriers 
and Strategies 
Self-Assessment: Activity Patterns/Preferences 
Week 4 
Healthy Sleep; Sleep Patterns; Challenges and Strategies for 
Success 
Self-Assessment: Sleep Quality 
Week 5 
Self-Management in the Workplace 
Balancing Work Stress 
Week 6 
Psychosocial Concerns 
Caring for Self 
Week 7 
Preventing Complications 
Review and Wrap-Up 
Week 8 

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keep a diary); and (3) will change their RT-CGM site as instructed by study staff (registered nurse) who will 
monitor remotely to assure proper placement and care of the glucose sensor. 
At the end of the data collection period, participants in both groups will return the supplies in a pre-paid 
envelope provided with the study maerials. 
3.2e3. Subject Retention Strategy. Both FREE intervention and attention control groups will (1) have 
weekly sessions scheduled at a time convenient for the participants; (2) wear a RT-CGM; (3) receive 
appointment reminders; (4) be compensated at Weeks 4, 8, and 12; and (5) receive a personalized folder with 
copies of their CGM recordings at study's end. Weekly sessions for both the FREE and attention control 
groups will include topics of interest and value to the study population. Use of RT-CGM technology is highly 
desirable for many young adults with T1DM and served as both an incentive and retention factor in our 
previous study. 
3.2e4. Treatment Fidelity Strategy. To maintain treatment fidelity, both FREE and attention control DSME 
sessions will follow a manualized protocol. 
3.2f. Measures. 
3.2f1. Baseline and Post-Intervention Measures. Self-report instruments will be used to obtain 
demographic, literacy and health information, previous history of hypoglycemia, diabetes self-management, 
(see Table 3 for a complete list of measures). The scales chosen have strong psychometric properties and 
have been validated in diabetes populations. The primary outcome, FOH, will be measured using the Worry 
Subscale of the Hypoglycemia Fear Scale. This 18-item, 5-point Likert scale measures situation-specific 
worries about hypoglycemia and provides one overall score for hypoglycemic worry. The scale has strong 
psychometric properties (Cronbach's alpha 0.95).65 Self-management will be measured with the Diabetes Self- 
Management Scale (Cronbach’s alpha 0.84).69 Convergent and construct validity are demonstrated for both 
scales.65,69 Glycemic control will be measured with a fingerstick for A1C using previously published methods 
(A1C Now®, Chek Diagnostics, Indianapolis, IN).70 
3.2f2. Glycemic Variability. Subcutaneous interstitial glucose levels will be monitored using a Dexcom G 
series (San Diego, CA) or Medtronic sensor (Annaheim, CA) Participants will be instructed on the placement 
of the glucose sensor and transmitter and how to change weekly. When CGM supplies are returned, glucose 
data will be downloaded for later analysis. To analyze GV, the raw data will be downloaded to an EXCEL 
spreadsheet. Research staff will be trained on cleaning data, confirming regular calibration, identifying errors, 
and reviewing missing data or time-points. The frequency and time spent in hypo- and hyperglycemia will be 
calculated (% and minutes; < 70 and > 180 mg/dL). GV will be determined by calculating the daily glucose 
standard deviation (GlucSD), continuous net glycemic action (CONGA), coefficient of variation (CV%), and 
interquartile range (IQR). These intra-day measures are recommended for comprehensive evaluation of 
GV.71,72 
 
Table 3. Measures 
Variables 
Measure 
Frequency 
Demographic, health, 
and literacy information 
Demographic, health questionnaire, self-reported height, weight, waist 
circumference, Hypoglycemia Patient Questionnaire2 
Health Literacy Screener (Newest Vital Sign)73 
Week 0 
Aim 1 
Recruitment 
Retention 
Acceptability 
Number recruited, screened, eligible, consented 
Attendance rate; Completion rate 
Participant evaluation survey and interview (Appendix P4) 
Advisory panel 
Weekly 
Weekly 
Week 8 
End of study 
Aim 2 
FOH 
Hypoglycemia Fear Scale-II (HFS-II65) 
Weeks 0, 4, 8,12 
Glycemic measures 
Glycemic control 
Glycemic variability 
A1C (A1C Now®) 
RT-CGM (Dexcom® or Medtronic®): daily glucose standard deviation (GlucSD), 
continuous net glycemic action (CONGA), coefficient of variation (CV%), 
interquartile range (IQR), time spent in hypo- and hyperglycemia (see 3.2f3) 
Weeks 0, 8, 12 
Weeks 0-8, and 
12 
Diabetes self- 
management 
Diabetes Self-Management Questionnaire69 
Weeks 0, 8, 12 

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9
3.2f3 Related Variables. Self-efficacy, anxiety, diabetes distress, depressive mood, and quality of life will 
be measured with validated instruments (Self-Efficacy for Diabetes Scale,74 General Anxiety Disorder-7 Item 
[GAD-7],75 Diabetes Distress Scale,76 Center for Epidemiological Studies Depression Scale [CES-D], and 
Diabetes Quality of Life Scale77 respectively, at Weeks 0, 8, and 12). Subjects who score 16 or greater on the 
CES-D will be offered a list of mental health resources (See Mood Score Script, Ver 1, 11-28-18 and Health 
Resource, Ver 1, 11-28-18). Subjects who withdraw from the study prior to weeks 8 and 12 will be asked to 
complete week 8 and/or week 12 data collection at the appropriate time. All questionnaire data will be collected 
remotely through REDCap by sending a link to the study participant for the appropriate week of data collection. 
3.2g. Data Analysis 
The statistical estimation method for this study is a mixed-effects model with repeated measures (SPSS 
24). This is superior to repeated-measures ANOVA because it avoids the limitations of strong assumptions 
such as sphericity and constant variance, and operates in a more general missing-at-random framework.78 
Participants who have a missing data point are not excluded, thus producing unbiased estimation of intent-to- 
treat (ITT) and reducing type 1 error.79 We have built-in procedures to minimize missing data, but missing data 
cannot be completely eliminated; thus, patterns will be examined, and longitudinal multiple imputation will be 
applied to compare any differences using Multiple Imputation for Chained Estimation (MICE).80 
Aim 1. Feasibility will be evaluated by assessing recruitment, retention, and participant evaluation. Records 
will be kept of the number of recruited, screened, eligible, and consented subjects. Retention will be evaluated 
by weekly attendance (% session attendance, program completion rates). Acceptability will be determined 
through participant evaluation (written evaluation and interview at program completion [Appendix P4]) and a 
convened advisory group of previous participants (Table 4). As part of feasibility, we will also track the number 
of RT-CGM sensor failures, placement sites, time to failure, and adverse sensor site problems. 
Aim 2. We will evaluate the effects of within-group and between-group differences from baseline (Week 0) 
to program completion (Week 8) and post program (Week 12) on the outcomes: FOH, self-management, 
glycemic control, and GV, using an intent-to-treat approach. To address sex as a biologic variable, sex 
differences in primary and secondary outcomes will be explored. Diabetes duration and depressive mood will 
also be statistically controlled. 
H1: FOH will be reduced. Within-group and between-group differences in HFS worry score from baseline to 
study completion and post program will be compared using a mixed-effects model. 
H2a: Diabetes self-management will be improved. Within- and between-group differences in the Diabetes 
Self-Management Scale score from baseline to study completion and post program will be compared using a 
mixed-effects model. 
H2b: Glycemic control. Within- and between-group differences in A1C from baseline to study completion 
and post program will be compared using a mixed-effects model. 
H2c: GV will decrease. GV will be determined through GlucSD, CONGA, CV%, and IQR, as well as daily 
time spent in hypo- or hyperglycemia. Within- and between-group differences will be calculated from daily RT- 
CGM recordings using a mixed-effects model. 
3.2 h. Table 4. Study Timeline 
Year 1 
July 
Aug 
Sept 
Oct 
Nov 
Dec 
Jan 
Feb 
Mar 
Apr 
May 
June 
Study set-up 
X 
X 
X 
FREE subjects 
4 
4 
4 
Control subjects 
4 
4 
4 
Total subjects 
8 
16 
24 
Year 2 
July 
Aug 
Sept 
Oct 
Nov 
Dec 
Jan 
Feb 
Mar 
Apr 
May 
--- 
FREE subjects 
6 
6 
6 
Control subjects 
6 
6 
6 
Total subjects 
36 
48 
60 
Convened advisory panel 
X 
Data analysis/report findings 
X 
X 
3.3 Strengths, Limitations, and Potential Problems with Alternative Solutions 
Strengths. (1) This study directly focuses on FOH reduction, lacking in previous interventions. (2)The RCT 
study design is a strength, as is use of RT-CGM monitoring to measure GV. (3) subjects using both insulin 

P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
10
pump and MDI will be eligible to evaluate FOH in this population, differences in GV from different insulin 
delivery methods will be controlled statistically using propensity score analysis. (4) We chose to conduct FREE 
sessions as individual sessions. Individual sessions will allow provision of a higher intervention dose by 
addressing each subject’s specific fears and was preferred by our population. (5) The eight-week time frame 
allows adequate time to measure FREE program effects. It is similar in length to other successful CBT 
programs.53,67 (6) The attention control group will receive a program equal in time and attention to the 
intervention group's. The content is distinct from the FREE program. (7) The post-program evaluation at Week 
12 allows evaluation of treatment sustainability. (8) The study team is a strength, bringing together expertise in 
T1DM management, intervention science, CBT strategies, and GV measurement. 
Limitations Potential Problems and Alternative Solutions. (1) We address recruitment concerns with 
strategies successful in previous studies. We established relationships with clinical sites (University of Illinois 
Health System, Loyola) that reports high volumes of accessible patients contactable for studies. (2) Our FREE 
pilot study had no attrition. We plan retention strategies outlined in 3.2e3. (3) To address fidelity concerns, a 
treatment manual and fidelity checklist will be used for both FREE and attention control sessions. All future 
videoconference sessions will be recorded and reviewed (telephone sessions will not be recorded). 
Participation for both groups will be reinforced at weekly meetings, weekly RT-CGM site changes by study 
staff, and follow-up reminders at mid-week (via text message). (4) Potential RT-CGM sensor failure is 
addressed by using a RT-CGM device that continuously displays glucose levels. This alerts subjects if the 
device stops recording to contact study staff. To further reduce the chance of missing data, sensors will be 
replaced weekly by the study participant. This process will be monitored by a trained registered nurse. (5) 
Because RT-CGM may affect GV, both groups will wear a RT-CGM during the eight-week intervention and 
able to view their real-time glucose levels. Changes in glycemic control from RT-CGM use are very small.81 
3.4 Future Directions. FREE's effectiveness could be studied in a larger, adequately powered clinical trial. 
FREE has potential for tailoring to other age groups and deploying as a web-based or smartphone app, 
allowing greater dissemination than traditional face-to-face. The long-term goal is the integration of fear- 
reducing strategies in mainstream diabetes education and care. 
3.5. Focus Group Meeting 
After the completion of the research, we will invite enrolled participants those who were in the FREE 
Intervention group and checked the box and provided their initials of the informed consent document indicating 
they are willing to be contacted for future research,  to a one-hour Zoom meeting to get their feedback on the 
study protocol. 
3.5.a. Recruitment. Subjects will be recruited through a recruitment email.  
3.5.b. Procedures. 1.) Subjects who consented to be contacted for future research as above will be recruited for 
the focus group meeting. 2.) If agreeable to participate, electronic consent will be obtained through a REDCap 
URL link, the focus group meeting informed consent (version 11, addendum, 5.12.21) will be obtained. 3.) There 
will be 2 focus group meetings; One focus group meeting is for the subjects who enrolled before COVID 
pandemic and participated in the FREE Intervention  face-to-face. A second focus group meeting is for the 
subjects who enrolled during the COVID pandemic and participated in the  FREE Intervention remotely. 4.) The 
size for each focus group on zoom is 5-6. Subjects and the principle investigator will meet through the Zoom link 
for approximately 1 hour. During the one-hour Zoom meeting the principle investigator will ask some questions 
(focus group script, version 1, 5.12.21). 5) The focus groups will be audio-recorded and a note-taker will be 
present.6. ) After the focus group meeting, compensation ($50) will be provided in cash. 
 
 
4.1 Protection of Human Subjects 
4.1.1 Risks to Human Subjects 
a. Human Subjects Involvement, Characteristics, and Design 
Human subjects will be involved in all aspects of this research because the purpose of the study is to test a 
fear reduction intervention in young adults with type 1 diabetes (T1DM). Fear of hypoglycemia (FOH) is a 
critical problem associated with poor glycemic control, greater glucose variability, and diminished quality of life 
(QOL). It affects most people with T1DM and is greater among young adults than adolescents. To our 
knowledge, there have been no programs developed to alleviate this problem in the exact way that we do. 

P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
11
Study population. We plan to recruit 60 subjects for an expected attrition rate of 20%. This will result in 
a final sample of 50 subjects. Inclusion criteria include: 18 to 35 years of age, diagnosed with T1DM > 1 
year, receive medical care from an endocrinologist, use insulin pump or multiple daily injection (MDI) therapy, 
experience FOH, and attended a basic diabetes education program (to control for baseline knowledge). 
Exclusion criteria include: pregnancy or breastfeeding; receiving psychotherapy for depression or anxiety 
disorders (e.g. panic, obsessive compulsive disorder); received therapy specifically for FOH; or have a 
coexisting chronic illness or receiving medications (excluding insulin) that may influence diabetes self- 
management or glycemic variability(GV). 
Sampling plan. Convenience sampling will be used to recruit subjects. Remote delivery will allow us to 
include study participants beyond the Chicago metropolitan area. 
Procedures. Subjects will be randomized to the intervention group or an attention control group to 
minimize bias. Randomization will be computer-generated with permuted blocks in multiples of two. All 
subjects in the intervention group will: (1) receive eight weekly individual remotely-delivered one-hour sessions 
based on principles of cognitive behavioral therapy (CBT) with exposure therapy, (2) complete a daily fear 
diary, (3) wear a real-time continuous glucose monitor (RT-CGM), (4) complete a post-program assessment of 
study outcomes at 8 weeks, and (5) be instructed on changing and caring for their RT-CGM site by a study 
staff member who is a registered nurse who will monitor placement and care. All subjects in the attention 
control group will: (1) receive eight weekly remotely-delivered one-hour individual diabetes self-management 
education (DSME) sessions, (2) wear a RT-CGM, (3) complete a post-program assessment of study outcomes 
at 8 weeks, and (4) be instructed on changing and caring for their RT-CGM site by study personnel (registered 
nurse) to assure proper placement and care of the device. Methods to maintain intervention fidelity in the 
intervention and attention control groups include: (1) treatment manual; (2) fidelity checklist; (3) having all 
FREE intervention sessions conducted by one licensed, trained clinical psychologist who is a member of the 
research team; (4) having all attention control group sessions conducted by one registered nurse who is a 
Certified Diabetes Educator® and a member of the research team; (5) videotaped sessions with review by 
study staff for consistency of treatment that will be reviewed by a member of the research team, who is not 
involved in carrying out the study protocol, for intervention fidelity; (6) weekly RT-CGM site changes; and (7) 
weekly reminders of next appointments. All study procedures will take place remotely (by phone, 
vidoconference, REDCap and by mail) by study personnel who are based out of the University of Illinois (UIC 
Medical Center. During the study period, subjects will continue to receive their usual diabetes care with their 
health care provider. Subjects will be encouraged to discuss any questions regarding blood glucose 
management with their diabetes health care provider. 
 
b. Sources of Materials 
Data will be collected from study subjects only for research purposes as follows: (1) self-reported data from 
questionnaires and daily diary (FREE intervention group only); (2) drop of blood from a finger prick for A1C; 
and (3) RT-CGM from a glucose sensor placed under the skin. 
1. Self-reported data will include information collected: (a) during recruitment to establish study eligibility; 
(b) demographic (sex, race, ethnicity, health literacy), health (diabetes duration, hypoglycemic experiences, 
comorbidities), and key study variables (fear of hypoglycemia, diabetes self-management; and related study 
variables (anxiety, depressive mood, diabetes distress, quality of life) collected from questionnaires; and (c) 
daily FOH diary (FREE intervention group only). 
2. A1C will be determined from a drop of blood from a finger prick. Study participants will be trained using 
standardized procedures by a member of the study personnel (registered nurse). The A1C result will be 
reported by the participant and entered into REDCap. 
3. Continuous interstitial glucose levels to calculate glycemic variability will be obtained from a RT-CGM 
sensor placed under the skin using standard procedures by trained study personnel (registered nurse). The 
sensor transmits the glucose levels to a receiver (the size of a quarter) that the subject wears. 
4. Program evaluation obtained from questionnaires and interview. At the end of the study, subjects will 
be invited to a convened advisory group (via videoconference) to provide additional suggestions and feedback. 
5. Data to evaluate program feasibility will include (1) recruitment (number recruited, screened, eligible, 
consented); (2) retention (attendance and completion rate records) maintained by study personnel. 

P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
12
 
c. Potential Risks 
The potential risks to subjects include: 
1. Bleeding, irritation, discomfort, or infection at the finger prick site (for A1C) and insertion site (for RT- 
CGM). The risk for these problems is very minor and is minimized by following standardized procedures using 
trained study personnel. Fingerstick procedures are familiar to all persons with type 1 diabetes as it is the 
standard of care is to test capillary glucose a minimum of four times per day. CGM is also becoming a standard 
of care with approximately 60% of patients with T1D having used a CGM. 
2. Loss of confidentiality. Standard procedures will be used to avoid breaches in confidentiality. We expect 
this risk to be low. We will require that participants have a private area for weekly intervention sessions. 
3. Individuals in the FREE group may feel emotional discomfort in discussing fears and memories of 
potentially sensitive thoughts and experiences related to hypoglycemia. We expect this risk to be low based on 
our experience in previous studies that examined experiences with hypoglycemia. 
4. It is possible that, in discussing fears and reframing thoughts about FOH, blood glucose levels may 
change (either increase or decrease). For example, if fear levels are reduced, it is possible that blood glucose 
may be lower at times, and the subject may experience hypoglycemia. 
5. Completing self-report measures on FOH, depressive mood, and diabetes distress may cause subjects 
some emotional distress. 

P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
13
4.1.2 Adequacy of Protection Against Risks 
a. Recruitment and Informed Consent 
Subjects (18-35 years) will be recruited from Chicago metropolitan area university medical centers, 
diabetes websites, and organizations and Research Match, using flyers, e-announcements, and recruitment 
letters. At the University of Illinois at Chicago (UIC), we will identify subjects through the electronic medical 
record systems and send recruitment letters. Potentially eligible interested subjects will be screened by study 
personnel for inclusion and exclusion criteria. Informed consent will be obtained prior to performing any 
research procedures. The informed consent process will begin when potential subjects are contacted. The 
researcher will explain the study purpose, procedures, benefits, risks, confidentiality, and research subject’s 
rights. After all questions have been answered and the subject verbally agrees to participate, e-consent will be 
obtained using REDCap. Study participants will be able to download a copy of the consent from REDCap 
and/or a copy will be mailed to them. 
 
b. Protections Against Risk 
Methods to minimize risk include: 
1. Minimization of bleeding, irritation, discomfort, or infection at the finger prick site (for A1C) and insertion 
site (for RT-CGM). The risk of for these problems is very minor and is minimized by following standardized 
procedures. RT-CGM placement and finger pricks will be done using sterile technique and standardized 
procedures. Participants will be trained on these procedures by a trained registered nurse. In addition, subjects 
will be instructed to observe their RT-CGM insertion site daily and contact the research personnel if there are 
signs of bleeding, irritation, redness, or pain. 
2. Loss of confidentiality. Strict procedures will be put into place to minimize the risk of breach of 
confidentiality. All study staff will be trained on methods of maintaining subject confidentiality. Subjects will be 
assigned a unique code number. A master list that links the subject identity to the data will be kept by the 
principal investigator (PI) and stored in a locked office separately from the data. Data storage: All data will be 
stored and analyzed by code number. This consists of coded questionnaires and A1C results in REDCap, 
diary, and RT-CGM recordings. The coded data will be entered into a password-protected computer with a 
secure server for analysis. Hard copy (paper copy) data (diary) will be stored in a locked office. No identifiers 
(except subject ID) will be included. Only members of the research team will be able to access these data. 
Procedures during data collection: Privacy will be provided during recruitment by screening potential 
subjects in a private setting. The screening data that contain personal identifiers will be kept separate from the 
coded study data and stored in REDCap or HIPAA-protected UIC Box folder. All data collection and study 
procedures will take place in a private location. To insure intervention fidelity, a fidelity checklist will be 
instituted. The first 25 FREE intervention and attention control program sessions will be audiotaped for review 
(this has been completed). These audiotapes will be stored by subject code number. Only the research staff 
will have access to the audiotapes. The tapes will be stored in a HIPAA-protected UIC Box folder and 
destroyed three years following data analysis. 
3. Individuals in the FREE group may feel emotional discomfort in discussing fears and memories of 
potentially sensitive thoughts and experiences related to hypoglycemia. CBT has not been shown to cause 
harm. The material discussed during the intervention will be thoughts, feelings, and experiences initiated by the 
subject for discussion. Subjects will not be probed to discuss anything that they are not comfortable discussing. 
The FREE sessions will be conducted by a licensed clinical psychologist with extensive experience using CBT 
and exposure interventions. If a subject has questions or concerns about his or her diabetes management, he 
or she will be encouraged to discuss these concerns with his or her diabetes health care provider. Should a 
subject identify that she or he would like to seek psychological counseling unrelated to their FOH, a list of 
counseling agencies will be provided. If the psychologist interventionist determines that continuation in the 
FREE program would not be appropriate due to confounding psychological issues that become evident during 
the study, continuation in the study may be stopped and a list of counseling agencies provided. 
4. It is possible that, in discussing fears and reframing thoughts about FOH, blood glucose levels may 
change (either higher or lower). For example, if fear levels are reduced, it is possible that blood glucose may 
be lower at times, and the subject may experience hypoglycemia. To reduce this risk, subjects will be reminded 

P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
14
to measure their capillary blood glucose at the usual times, as recommended by their diabetes care team, and 
at any time they feel they that their blood glucose is outside of their target range (high or low). Subjects will 
also be reminded to carry their glucose testing supplies and fast-acting carbohydrate (glucose) at all times to 
respond to low blood sugar. During the FREE sessions, subjects will be asked to check their capillary blood 
glucose at the beginning and end of each session. 
5. Because people with T1DM are always at risk for hypoglycemia, study staff will remind participants to 
have fast-acting carbohydrate available should a subject develop hypoglycemia during a meeting session 
(either FREE or attention control group). During the course of this study, subjects will have an additional 
measure of glucose through the RT-CGM; however, they will be instructed not to rely on the RT-CGM for blood 
glucose levels for treatment and to verify glucose readings with a capillary measure. Additionally, subjects will 
be under the care of an endocrinologist. This is an inclusionary criterion for study participation, which will 
ensure that subjects have resources to assist them with their diabetes care. 
6. Completing self-report measures on FOH, self-management, anxiety, depressive mood, diabetes 
distress and quality of life may cause subjects some emotional distress. The risk is minimal. In our previous 
studies with the same population, no subjects reported emotional distress with these measures. However, 
study staff will be aware of the possibility and address any concerns that are voiced. 
7. Should a subject require medical or other professional intervention due to an adverse event or illness, 
treatment may be obtained through the UIC Medical Center, the subject’s regular doctor, or the treatment 
center or clinic of their choice. Subjects will be provided contact information for the PI should they want to talk 
to her about their illness or injury. 
 
4.1.3. Potential Benefits of the Proposed Research to Human Subjects and Others 
There may be no direct benefits to participating in the study. However, subjects in the FREE intervention 
group may benefit from discussing their concerns about hypoglycemia and may experience a reduction in fear 
of hypoglycemia and improved glycemic control. The possible risks are no greater than those experienced in 
normal day-to-day life. Most persons with T1DM experience FOH and voice concerns of how it negatively 
influences their daily lives. 
 
4.1.4 Importance of Knowledge to be Gained. 
The risks to the study participants are minimal and no more than those encountered in daily life. 
Knowledge gained from this study may provide an important intervention for reducing fear of hypoglycemia and 
improving diabetes self-management and glycemic control in the future in young adults with T1DM. If effective, 
this intervention has important clinical implications for reducing diabetes complications and improve quality of 
life in this population. 
 
4.1.5 Data Safety Monitoring Plan for: A Cognitive Behavioral Intervention to Reduce Fear of 
Hypoglycemia in Young Adults with Type 1 Diabetes 
PI: Pamela Martyn-Nemeth 
This study will involve young adults (aged 18 to 35 years) with T1DM who experience fear of hypoglycemia 
(FOH). We plan to recruit 60 subjects for an expected attrition rate of 20%. This will result in a final sample 
of 50 subjects. Subjects will be enrolled and will complete a one-week run-in period to collect baseline data, 
including real-time continuous glucose monitoring (RT-CGM) to calculate baseline glycemic variability. 
Following the run-in period, subjects will be assigned to one of two groups. The attention control group = 8 
weeks of diabetes self-management education sessions and 8 weeks of RT-CGM. The FREE intervention 
group = 8 weeks of a fear reduction intervention using CBT and exposure therapy and 8 weeks of RT-CGM 
and a diary used as a feedback cue. Both groups will have their RT-CGM sites changed weekly (study 
participants will be trained and monitored by study staff). The risk associated with this study is minimal for the 
interventions and data collection methods employed by the study. The potential for a serious adverse event is 
very low. Pamela Martyn-Nemeth, PhD, RN, will be the primary monitor, and a Safety Monitoring Committee 
will share the responsibility of monitoring the data. 
 
Monitoring entity or who will monitor the study 

P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
15
The individuals responsible for data safety and monitoring will be the PI, Dr. Pamela Martyn-Nemeth, and a 
Study Monitoring Committee (SMC). A SMC will be appointed to provide oversight and monitoring of our data 
on an annual basis by individuals not directly associated with the study. The SMC will consist of: (1) Eileen 
Collins, PhD, RN, Professor, Department of Biobehavioral Health Science, College of Nursing; (2) Terry 
Unterman, MD, Professor of Medicine, Department of Medicine, Endocrinology, Diabetes and Metabolism; and 
(3) Lisa Sharp, PhD, Psychologist and Associate Professor, Pharmacy Systems, Outcomes and Policy, 
College of Pharmacy, and (4) Chang Park, PhD, study statistician—all at UIC. Drs. Collins, Unterman, and 
Sharp have expertise in reviewing the scientific design, conduct of study, intervention fidelity, evaluation of 
safety and risks to subjects, interpretation of data, and making recommendations concerning continuation, 
modification, suspension, or termination of the study. 
Dr. Martyn-Nemeth will meet with the SMC annually and provide a written and verbal progress report. The 
report will include a summary of cumulative recruitment, randomization, cumulative retention and attrition rate, 
study group demographics, adverse events, and data completeness and quality. The SMC will provide 
oversight of the study, as well as consider factors external to the study that may impact the safety of the 
participants or the ethics of the study. A written report of the meeting will be compiled that summarizes the 
review of data and outcomes, as well as any recommendations with respect to modification of the protocol. The 
report will be submitted to the UIC IRB and to the NIH. 
 
Procedures for monitoring study safety, minimizing research-associated risk, and protecting the 
confidentiality of subject data. 
Study Safety. Study procedures will take place remotely at private locations of research personnel and 
participants. All study personnel involved in conducting the research, including recruitment and screening for 
eligibility, data management, and provision of interventions, will receive training that will address: (1) overview 
of the study objectives and procedures, (2) background and training on collecting data free from bias, (3) 
protection of human subjects and confidentiality, (4) training and monitoring study participants in performing 
finger pricks for A1C and placing RT-CGM sensors using infection control procedures as well as procedures 
specific to measuring A1C and placing RT-CGM sensors (with verbal, written and video instruction with 
videoconference presence for the first time these procedures are performed and any time thereafter if needed. 
and (5) data and intervention monitoring. 
Dr. Martyn-Nemeth will assure that informed consent is obtained prior to performing any research activities, 
all subjects meet eligibility criteria, and the study is conducted according to the IRB-approved research plan. 
Compliance of regulatory documents and study data accuracy and completeness will be maintained 
through an internal quality assurance process. Quality control will include annual data verification and protocol 
compliance checks, as well as checks for missing data by Dr. Pamela Martyn-Nemeth and study personnel. 
Protocol adherence will be monitored by Dr. Martyn-Nemeth by auditing 50% of the cases for compliance with 
IRB requirements, informed consent requirements, verification of source documents, and compliance with the 
study protocol. To ensure reliability of data entry, a random sample of data entries will be reviewed and 
compared with the raw data by Dr. Martyn-Nemeth, and the results will be recorded. An acceptable error rate 
will be < 0.3%. Results of the audit will be documented. Monthly research meetings will be scheduled to assure 
quality of the conduct of the research and promote communication among study team members and good data 
management activities. 
 
Minimizing research-associated risk 
Potential subjects will be screened to ensure that they meet study inclusion criteria. 
Sources of materials: Data will be collected from study subjects only for research purposes as follows: (1) 
self-reported data from questionnaires; (2) daily diary (FREE intervention group only); (2) drop of blood from a 
finger prick for A1C; and (3) RT-CGM from a glucose sensor placed under the skin. 
 
Potential risks 
The potential risks to subjects include: 

P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
16
1. Bleeding, irritation, discomfort, or infection at the finger prick site (for A1C) or insertion site (for RT- 
CGM). The risk for these problems is very minor and is minimized by following standardized procedures and 
using trained study personnel. 
2. Loss of confidentiality. Standard procedures will be used to avoid breaches in confidentiality. We expect 
this risk to be low. 
3. Individuals in the FREE group may feel emotional discomfort in discussing fears and memories of 
potentially sensitive thoughts and experiences related to hypoglycemia. We expect this risk to be low based on 
our experience in previous studies that have examined experiences with hypoglycemia. 
4. It is possible that, in discussing fears and reframing thoughts about FOH, blood glucose levels may 
change (either increased or decreased). For example, if fear levels are reduced, it is possible that blood 
glucose may be lower at times, and the subject may experience hypoglycemia. 
5. Completing self-report measures on FOH, depressive mood, and diabetes distress may cause subjects 
some emotional distress. 
 
Protection against risk 
1. Minimization of bleeding, irritation, discomfort, or infection at the finger prick site (for A1C) and insertion 
site (for RT-CGM). The risk of for these problems is very minor and is minimized by following standardized 
procedures. Participants will be trained on RT-CGM placement and finger pricks using sterile technique and 
standardized procedures. Training and monitoring will be performed by a trained registered nurse. In addition, 
subjects will be instructed to observe their RT-CGM site daily and contact the research personnel if there are 
signs of bleeding, irritation, redness, or pain. 
2. Loss of confidentiality. Strict procedures will be put into place to minimize the risk of breach of 
confidentiality. All study staff will be trained on methods of maintaining subject confidentiality. Subjects will be 
assigned a unique code number. A master list that links the subject identity to the data will be kept by the 
principal investigator (PI) and stored separately from the data in a locked office. Data storage: All data will be 
stored and analyzed by code number. This consists of coded questionnaires and diaries, A1C finger prick 
results, and RT-CGM recordings. [RT-CGM data may be downloaded from a secure server over the internet 
(encrypted using AES-256 Encryption) using Dexcom Clarity data management software.  The RT-CGM data 
is de-identified at all times and only associated with the study code number from point of access through 
storage on the College of Nursing secure server.] The coded data will be entered into REDCap and a 
password-protected computer with a secure server for analysis. A1C results will be stored in REDCap. Hard 
copy (paper copy) data (diaries) will be stored in a locked office. No identifiers (except subject ID) will be 
included in the download. Only members of the research team will be able to access these data. Procedures 
during data collection: Privacy will be provided during recruitment by screening potential subjects in a private 
setting. The screening data that contain personal identifiers will be kept separate from the coded study data 
and stored in a locked office, REDCap or HIPAA-protected UIC Box folder. All data collection and study 
procedures will take place in a private location. To insure intervention fidelity, a fidelity checklist will be 
developed. The first 25 FREE intervention and attention control program sessions will be audiotaped for review 
(already completed). These audiotapes will be stored by subject code number. Only the research staff will have 
access to the audiotapes. The tapes will be stored in HIPAA-protected UIC Box folder and destroyed three 
years following data analysis. 
3. Individuals in the FREE group may feel emotional discomfort in discussing fears and memories of 
potentially sensitive thoughts and experiences related to hypoglycemia. CBT has not been shown to cause 
harm. The material discussed during the intervention will be thoughts, feelings, and experiences initiated by the 
subject for discussion. Subjects will not be probed to discuss anything that they are not comfortable discussing. 
The FREE sessions will be conducted by a licensed clinical psychologist who has extensive experience using 
CBT and exposure interventions. If a subject has questions or concerns about his or her diabetes 
management, he or she will be encouraged to discuss these concerns with his or her diabetes health care 
provider. Should a subject identify that she or he would like to seek psychological counseling unrelated to their 
FOH, a list of counseling agencies will be provided. If the psychologist interventionist determines that 
continuation in the FREE program would not be appropriate due to confounding psychological issues that 

P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
17
become evident during the study, continuation in the study may be stopped and a list of counseling agencies 
provided. 
4. It is possible that, in discussing fears and reframing thoughts about FOH, blood glucose levels may 
change (either higher or lower). For example, if fear levels are reduced, it is possible that blood glucose may 
be lower at times, and the subject may experience hypoglycemia. To reduce this risk, subjects will be reminded 
to measure their capillary blood glucose at the usual times, as recommended by their diabetes care team, and 
at any time they feel they that their blood glucose is outside of their target range (high or low). Subjects will 
also be reminded to carry their glucose testing supplies and fast-acting carbohydrate (glucose) at all times to 
respond to low blood sugar. During the FREE sessions, subjects will be asked to check their capillary blood 
glucose at the beginning and end of each session. 
5. Because people with T1DM are always at risk for hypoglycemia, study staff will remind participants to 
have fast-acting carbohydrate available should they develop hypoglycemia during a meeting session (either 
FREE or attention control group). During the course of this study, subjects will have an additional measure of 
glucose through the RT-CGM; however, they will be instructed not to rely on the RT-CGM for blood glucose 
levels for treatment and to verify glucose readings with a capillary measure. Additionally, subjects will be under 
the care of an endocrinologist. This is an inclusionary criterion for study participation, which will ensure that 
subjects have resources to assist them with their diabetes care. 
6. Completing self-report measures on FOH, self-management, anxiety, depressive mood, diabetes 
distress, and quality of life may cause subjects some emotional distress. The risk is minimal. In our previous 
studies with the same population, no subjects reported emotional distress with these measures. However, 
study staff will be aware of the possibility and address any concerns that are voiced. 
7. Should a subject require medical or other professional intervention due to an adverse event or illness, 
treatment may be obtained through the UIC Medical Center, the subject’s regular doctor, or the treatment 
center or clinic of their choice. Subjects will be provided contact information for the PI should they want to talk 
to her about their illness or injury. 
 
Procedures for identifying, reviewing, and reporting adverse events and unanticipated problems to the 
IRB and NIH. 
Throughout the study, Dr. Martyn-Nemeth will monitor the participants for adverse events (AEs). Dr. 
Martyn-Nemeth and study staff will review AEs individually in real time and in aggregate on a monthly basis 
and consult with co-investigators as needed. Dr. Martyn-Nemeth will review serious adverse events (SAEs) in 
real time. Dr. Martyn-Nemeth will ensure that all protocol deviations, AEs, and SAEs are reported to the UIC 
IRB according to applicable IRB requirements, and corrective actions will be taken as deemed necessary by 
the IRB. Events determined by the PI to be unanticipated problems that are SAEs involving risks to subjects or 
others will be reported by the PI to the UIC IRB per IRB policy or within 1 week. Unanticipated problems that 
are determined by the PI to be not serious will be reported per IRB policy or within 2 weeks. 
Unanticipated problems will be reported to appropriate UIC institutional officials and NIH as required by the 
reporting procedures of each institution. Dr. Martyn-Nemeth will provide a report to the NIH of (1) unanticipated 
problems or unexpected SAEs that may be related to the study protocol, (2) IRB-approved revisions to the 
study protocol that indicate a change in risk for participants, (3) a summary of recommendations made by the 
DSMB or other monitoring entity, (4) the action plan for response, and (5) notice of any actions taken by the 
IRB or regulatory bodies regarding the research and any responses to those actions. 
All study staff will be informed by Dr. Martyn-Nemeth about AEs. If any protocol changes are needed, the 
PI will submit a modification request to the UIC IRB. Protocol changes will not be implemented prior to IRB 
approval unless necessary to eliminate apparent immediate hazards to the research subjects. In such a case, 
the IRB will be promptly informed of the change following implementation, according to IRB policy. 

P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
18
References 
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Gonder-Frederick LA. Fear of hypoglycemia: A review. Diabetic Hypoglycemia. 2013;5(3):3-11. 
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28. 
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Goebel-Fabbri AE, Fikkan J, Franko DL, Pearson K, Anderson BJ, Weinger K. Insulin restriction and associated 
morbidity and mortality in women with type 1 diabetes. Diabetes Care. 2008;31(3):415-419. 
30. 
Hanna KM, Weaver MT, Stump TE, Slaven JE, Fortenberry JD, DiMeglio LA. Readiness for living independently 
among emerging adults with type 1 diabetes. The Diabetes educator. 2013;39(1):92-99. 
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32. 
Zander H, Beneke J, Veagedes D, Muller A, Zwaan M. Type 1 diabetes mellitus and bulimia nervosa: insulin 
restriction does not always represent purging of unwanted calories. Practical Diabetes International. 
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33. 
Gonzalez JS, Tanenbaum ML, Commissariat PV. Psychosocial factors in medication adherence and diabetes self- 
management: Implications for research and practice. The American psychologist. 2016;71(7):539-551. 
34. 
Anderbro T, Amsberg S, Adamson U, et al. Fear of hypoglycaemia in adults with Type 1 diabetes. Diabet Med. 
2010;27(10):1151-1158. 
35. 
Desjardins K, Brazeau AS, Strychar I, Rabasa-Lhoret R. Are bedtime nutritional strategies effective in preventing 
nocturnal hypoglycaemia in patients with type 1 diabetes? Diabetes, Obesity & metabolism. 2014;16(7):577-587. 
36. 
Miller KM, Foster NC, Beck RW, et al. Current state of type 1 diabetes treatment in the U.S.: updated data from 
the T1D Exchange clinic registry. Diabetes Care. 2015;38(6):971-978. 
37. 
Bohme P, Bertin E, Cosson E, Chevalier N. Fear of hypoglycaemia in patients with type 1 diabetes: do patients 
and diabetologists feel the same way? Diabetes & Metabolism. 2013;39:63-70. 
38. 
Barnard KD, Parkin C, Young A, Ashraf M. Use of an automated bolus calculator reduces fear of hypoglycemia 
and improves confidence in dosage accuracy in patients with type 1 diabetes mellitus treated with multiple daily 
insulin injections. Journal of diabetes science and technology. 2012;6(1):144-149. 
39. 
Barnard KD, Skinner TC. Cross-sectional study into quality of life issues surrounding insulin pump use in type 1 
diabetes. Practical Diabetes International. 2008;25(5):194-200. 
40. 
Davey RJ, Stevens K, Jones TW, Fournier PA. The effect of short-term use of the Guardian RT continuous glucose 
monitoring system on fear of hypoglycaemia in patients with type 1 diabetes mellitus. Primary care diabetes. 
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41. 
Hermanides J, Norgaard K, Bruttomesso D, et al. Sensor-augmented pump therapy lowers HbA(1c) in 
suboptimally controlled Type 1 diabetes; a randomized controlled trial. Diabet Med. 2011;28(10):1158-1167. 
42. 
Nicolucci A, Maione A, Franciosi M, et al. Quality of life and treatment satisfaction in adults with Type 1 
diabetes: a comparison between continuous subcutaneous insulin infusion and multiple daily injections. Diabet 
Med. 2008;25(2):213-220. 
43. 
Rubin RR, Peyrot M. Health-related quality of life and treatment satisfaction in the Sensor-Augmented Pump 
Therapy for A1C Reduction 3 (STAR 3) trial. Diabetes Technol Ther. 2012;14(2):143-151. 
44. 
Schmitz KH, Jacobs, D. R., Hong, C-P., Steinberger, J., Moran, A., Sinaikko, A. R. Association of physical activity 
with insulin sensitivity in children. International Journal of Obesity and Related Metabolic Disorders. 
2002;26(10):1310-1316. 

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45. 
Costea M, Ionescu-Tirgoviste C, Cheta D, Mincu I. Fear of hypoglycemia in type 1 (insulin-dependent) diabetic 
patients. Romanian Journal of internal Medicine = Revue roumaine de medecine interne. 1993;31(4):291-295. 
46. 
Cox D, Gonder-Frederick L, Polonsky W, Schlundt D, Julian D, Clarke W. A multicenter evaluation of blood 
glucose awareness training-II. Diabetes Care. 1995;18(4):523-528. 
47. 
Cox DJ, Gonder-Frederick L, Polonsky W, Schlundt D, Kovatchev B, Clarke W. Blood glucose awareness training 
(BGAT-2): long-term benefits. Diabetes Care. 2001;24(4):637-642. 
48. 
Cox DJ, Ritterband L, Magee J, Clarke W, Gonder-Frederick L. Blood glucose awareness training delivered over 
the internet. Diabetes Care. 2008;31(8):1527-1528. 
49. 
George JT, Valdovinos AP, Russell I, et al. Clinical effectiveness of a brief educational intervention in Type 1 
diabetes: results from the BITES (Brief Intervention in Type 1 diabetes, Education for Self-efficacy) trial. Diabet 
Med. 2008;25(12):1447-1453. 
50. 
Ismail K, Thomas SM, Maissi E, et al. Motivational enhancement therapy with and without cognitive behavior 
therapy to treat type 1 diabetes: a randomized trial. Annals of internal Medicine. 2008;149(10):708-719. 
51. 
Schachinger H, Hegar K, Hermanns N, et al. Randomized controlled clinical trial of Blood Glucose Awareness 
Training (BGAT III) in Switzerland and Germany. J Behav Med. 2005;28(6):587-594. 
52. 
Rondags SM, de Wit M, Twisk JW, Snoek FJ. Effectiveness of HypoAware, a Brief Partly Web-Based 
Psychoeducational Intervention for Adults With Type 1 and Insulin-Treated Type 2 Diabetes and Problematic 
Hypoglycemia: A Cluster Randomized Controlled Trial. Diabetes Care. 2016;39(12):2190-2196. 
53. 
Amsberg S, Anderbro T, Wredling R, et al. A cognitive behavior therapy-based intervention among poorly 
controlled adult type 1 diabetes patients--a randomized controlled trial. Patient Education and Counseling. 
2009;77(1):72-80. 
54. 
Vallis M, Jones A, Pouwer F. Managing hypoglycemia in diabetes may be more fear management than glucose 
management: a practical guide for diabetes care providers. Current diabetes reviews. 2014;10(6):364-370. 
55. 
Ceriello A, Novials A, Ortega E, et al. Evidence that hyperglycemia after recovery from hypoglycemia worsens 
endothelial function and increases oxidative stress and inflammation in healthy control subjects and subjects 
with type 1 diabetes. Diabetes. 2012;61(11):2993-2997. 
56. 
Yoon JE, Sunwoo JS, Kim JS, et al. Poststroke glycemic variability increased recurrent cardiovascular events in 
diabetic patients. J Diabetes Complications. 2016. 
57. 
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Mortality and Cardiovascular Disease Risk in Young Adults With Type 1 Diabetes: The Pittsburgh Epidemiology of 
Diabetes Complications Study. Diabetes Care. 2016;39(12):2296-2303. 
58. 
Kildegaard J, Christensen TF, Hejlesen OK. Sources of glycemic variability--what type of technology is needed? 
Journal of diabetes science and technology. 2009;3(4):986-991. 
59. 
Hartley CA, Phelps EA. Changing fear: the neurocircuitry of emotion regulation. Neuropsychopharmacology : 
official publication of the American College of Neuropsychopharmacology. 2010;35(1):136-146. 
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Wolitzky-Taylor KB, Horowitz JD, Powers MB, Telch MJ. Psychological approaches in the treatment of specific 
phobias: a meta-analysis. Clinical psychology review. 2008;28(6):1021-1037. 
61. 
Beck JS. Cognitive Behavior Therapy (2nd Ed.). New York: The Guilford Press; 2011. 
62. 
Beck J, Greenwood DA, Blanton L, et al. 2017 National Standards for Diabetes Self-Management Education and 
Support. Diabetes Care. 2017;40(10):1409-1419. 
63. 
Soltesz G, Patterson CC, Dahlquist G, Group ES. Worldwide childhood type 1 diabetes incidence--what can we 
learn from epidemiology? Pediatr Diabetes. 2007;8 Suppl 6:6-14. 
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Kaczkurkin AN, Foa EB. Cognitive-behavioral therapy for anxiety disorders: an update on the empirical evidence. 
Dialogues in clinical neuroscience. 2015;17(3):337-346. 
65. 
Gonder-Frederick LA, Schmidt KM, Vajda KA, et al. Psychometric properties of the hypoglycemia fear survey-ii 
for adults with type 1 diabetes. Diabetes Care. 2011;34(4):801-806. 
66. 
Hajos TR, Polonsky WH, Pouwer F, Gonder-Frederick L, Snoek FJ. Toward defining a cutoff score for elevated fear 
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67. 
Penckofer SM, Ferrans C, Mumby P, et al. A psychoeducational intervention (SWEEP) for depressed women with 
diabetes. Annals of behavioral Medicine : a publication of the Society of Behavioral Medicine. 2012;44(2):192- 
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68. 
Haas L, Maryniuk, M., Beck, J.,Cox,C. Duker, et al. National Standards for Diabetes Self-Management Education 
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69. 
Schmitt A, Gahr A, Hermanns N, Kulzer B, Huber J, Haak T. The Diabetes Self-Management Questionnaire 
(DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with 
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70. 
Martyn-Nemeth P, Quinn L, Penckofer S, Park C, Hofer V, Burke L. Fear of Hypoglycemia: Influence on Glycemic 
Variability and Self-Management Behavior in Young Adults with Type 1 Diabetes. Journal of Diabetes and its 
Complications. 
71. 
Rodbard D. New and improved methods to characterize glycemic variability using continuous glucose 
monitoring. Diabetes Technol Ther. 2009;11(9):551-565. 
72. 
Bergenstal RM, Ahmann AJ, Bailey T, et al. Recommendations for standardizing glucose reporting and analysis to 
optimize clinical decision making in diabetes: the Ambulatory Glucose Profile (AGP). Diabetes Technol Ther. 
2013;15(3):198-211. 
73. 
Weiss BD, Mays MZ, Martz W, et al. Quick assessment of literacy in primary care: the newest vital sign. Annals of 
family medicine. 2005;3(6):514-522. 
74. 
Lorig K. Self-Efficacy for Diabetes. http://patienteducation.stanford.edu/research/sediabetes.html. Accessed 
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76. 
Fisher L, Polonsky WH, Hessler DM, et al. Understanding the sources of diabetes distress in adults with type 1 
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77. 
Group DCaCTDR. Reliability and validity of a diabetes quality-of-life measure for the diabetes control and 
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Song T, Dong Q, Sankoh AJ, Molenberghs G. Evaluation of overall treatment effect in MMRM. Journal of 
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81. 
Pickup JC, Freeman SC, Sutton AJ. Glycaemic control in type 1 diabetes during real time continuous glucose 
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P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
22
APPENDIX: Trial Protocol 
P1. Outline of FREE Intervention 
 
The FREE intervention will consist of eight weekly individual one-hour sessions with a licensed clinical 
psychologist and will target incorrect beliefs about hypoglycemia, hypervigilance to symptoms, fear of 
symptoms, and maladaptive behavioral responses in response to glucose levels. As is typical in CBT 
interventions, each session will include a “homework assignment” for the participant to practice skills outside of 
the session. The RT-CGM site will be changed weekly. An outline of the session content is provided below. 
Week 1: Review of program goals, which are to reduce fear of hypoglycemia while improving awareness of 
blood glucose cues. Discuss hypoglycemia and its causes, including diet, exercise, stress, and insulin. Discuss 
fear as a normal human emotion to the perception of a threat. Identify how fear of hypoglycemia affects 
glucose control. Discuss safety and avoidance behaviors. Review the RT-CGM and fear diary instructions for 
use. 
Homework: Record fear levels and hypoglycemia events for the week. Get comfortable using RT-CGM for 
feedback. 
Week 2: Identify blood glucose cues. Present the cognitive behavioral model, including the role of 
thoughts, behaviors, and emotions. Discuss how memories of past hypoglycemic events influence diabetes 
care. 
Homework: Record daily emotions and emotions associated with hypoglycemia events. Monitor RT-CGM 
glucose levels. Remember to verify any RT-CGM sugars that are out-of-range with a capillary blood glucose. 
Also check capillary blood glucose anytime you think/feel your blood glucose may be out-of-range regardless 
of the RT-CGM reading. 
Week 3: Teach cognitive restructuring, including exploring realistic probabilities of hypoglycemic events, 
and identifying catastrophic thought patterns. Identify fear reduction strategies employed (safety behaviors) 
and examine behavioral responses to probable hypoglycemia. Introduce progressive relaxation. 
Homework: Describe safety behaviors employed over the week. Use RT-CGM readings as a cue to blood 
glucose awareness. Practice relaxation and cognitive restructuring. 
Week 4: Introduce exposure and the purpose of exposure. Discuss own safe ranges for blood glucose. 
Develop fear hierarchy. Begin graded exposure to items on hierarchy by starting with items low on the list and 
working up the list. Review RT-CGM data. 
Homework: Practice exposure. Practice relaxation. 
Week 5: Review previous week’s exposure practice. Troubleshoot any difficulties. Continue graded 
exposure to items on hierarchy. Review coping mechanisms, including relaxation and cognitive restructuring. 
Homework: Practice exposure. Practice relaxation. 
Week 6: Review previous week’s exposure practice. Troubleshoot any difficulties. Continue graded 
exposure to items on hierarchy while reinforcing appropriate use of coping. Review RT-CGM data. 
Homework: Practice exposure. Practice relaxation. 
Week 7: Review previous week’s exposure practice. Troubleshoot any difficulties. Continue graded 
exposure to items on hierarchy. 
Homework: Practice exposure. Practice relaxation. 
Week 8: Review previous week’s exposure practice. Review techniques learned and develop a plan to 
maintain gains. 

P.Martyn, CBT FOH Program, Ver 12, 5.12.21 
 
23
P2. Outline of Attention Control: Diabetes Self-Management Program 
 
The attention control condition will consist of eight weekly one-hour sessions. Sessions will be individual 
diabetes self-management education (DSME) sessions led by a CDE®, based on the National Standards for 
Diabetes Self-Management Education. To be similar in structure and time as the FREE intervention group, 
each session will include a homework assignment for the participant to complete outside of the session, which 
will be reviewed the following week. The RT-CGM site will be changed weekly. An outline of the session 
content is provided below. 
 
 
Week 1: Introduction to diabetes self-management education program. Living with T1DM, current self- 
management challenges, and understanding the disease process. 
Homework: Complete diabetes care self-assessments. 
Week 2: Using medications safely for therapeutic effectiveness. Insulin management and care. Challenges 
with pump and MDI use. Blood glucose awareness and monitoring. Assessment and treatment of hypo- and 
hyperglycemia. 
Homework: Blood glucose monitoring and glucose awareness self-assessments. 
Week 3: Healthy eating: Incorporating principles of a healthy diet into lifestyle. Review of major nutrients. 
Discuss how eating patterns and styles affect health and diabetes self-management. Diabetes and alcohol. 
Homework: Self-assessment of eating style. 
Week 4: Being active: Incorporating physical activity into lifestyle. Barriers encountered and strategies to 
meet activity goals. Blood glucose management with activity. Principles of healthy activity. 
Homework: Self-assessment of activity patterns and preferences. 
Week 5: Healthy sleep: Sleep patterns, challenges, and strategies for success. Sleep hygiene principles. 
Homework: Self-assessment of sleep quality. 
Week 6: Self-management in the workplace. Balancing work stress; leisure/work balance. Stress 
management strategies. Workplace disclosure. 
Homework: Self-assessment of workplace stressors. 
Week 7: Psychosocial concerns: Emotions and diabetes. Navigating relationships. Disclosure/non- 
disclosure. Setting limits. Developing personal success strategies. 
Homework: Self-assessment of stressors and coping style. 
Week 8: Preventing, detecting, and treating complications. 
Summary and Review: Plans to maintain behavior change. 

P.Martyn, CBT FOH Program, Ver 9, 6-2-2020 
 
P3. FREE Diary 
 
Fear of Hypoglycemia Level 
Hypoglycemia Events 
Morning 
 
Time   
 
Time   
 
Capillary blood glucose   
 
 
Low Fear 
High Fear 
Treatment: 
1 
2 
3 
4 
5 
6 
7 
8 
9 
 
Notes:   
 
  
 
 
 
 
 
Mid-day 
 
Time   
 
Time   
 
 
 
Treatment: 
Capillary blood glucose   
 
 
Low Fear 
High Fear 
1 
2 
3 
4 
5 
6 
7 
8 
9 
  
 
 
Notes:   
 
 
  
 
Time  
 
Capillary blood glucose:   
 
 
Treatment: 
 
Evening 
 
 
 
Time   
 
Low Fear 
High Fear 
1 
2 
3 
4 
5 
6 
7 
8 
9 
Time: 
Capillary blood glucose:   
 
 
Notes:  
 
Treatment: 
 
Directions: 
On the left side, circle one number your fear of hypoglycemia at the beginning of your day. Repeat at mid-day and evening but at these times, 
circle your fear level since the last report. Try to use the range, not just 1, 5, or 9. There is no right answer. Only you know how you feel each 

P.Martyn, CBT FOH Program, Ver 9, 6-2-2020 
 
time. On the right side, enter the time and capillary blood glucose level for any hypoglycemic events that occur each time and the treatment. If no 
hypoglycemic events occur, enter zero for that day. 

P.Martyn, CBT FOH Program, Ver 9, 6-2-2020 
 
P4. FREE PROGRAM EVALUATION 
 
We value your feedback! Circle one number for each item listed below with 1 being most helpful and 
7 least helpful. There is a space for comments at the end. Thank you! 
 
 
Not Helpful 
Very Helpful 
 
CONTENT 
Learning signs of anxiety 
& how it affects diabetes 
1 
2 
3 
4 
5 
6 
7 
Learning to recognize how 
memories influence thoughts 
1 
2 
3 
4 
5 
6 
7 
Learning to recognize emotions 
linked to hypoglycemia events 
1 
2 
3 
4 
5 
6 
7 
Learning fear reduction 
strategies 
1 
2 
3 
4 
5 
6 
7 
Using safety behaviors 
1 
2 
3 
4 
5 
6 
7 
Using healthy coping behaviors 
1 
2 
3 
4 
5 
6 
7 
 
 
 
 
EXERCISES 
Relaxation exercises 
1 
2 
3 
4 
5 
6 
7 
Identifying most unhelpful 
thoughts 
1 
2 
3 
4 
5 
6 
7 
Developing a fear hierarchy 
1 
2 
3 
4 
5 
6 
7 
Setting personal goals 
1 
2 
3 
4 
5 
6 
7 
Homework assignments 
1 
2 
3 
4 
5 
6 
7 
Wearing a RT-CGM 
1 
2 
3 
4 
5 
6 
7 
Keeping a daily log 
1 
2 
3 
4 
5 
6 
7 

P.Martyn, CBT FOH Program, Ver 9, 6-2-2020 
 
Go on to the next page . . . . 
 
 
FREE PROGRAM EVALUATION 
 
Not Helpful 
Very Helpful 
 
ENVIRONMENT 
Meeting location 
1 
2 
3 
4 
5 
6 
7 
Meeting time 
1 
2 
3 
4 
5 
6 
7 
Meeting room 
1 
2 
3 
4 
5 
6 
7 
 
 
 
 
 
FORMAT 
Initial orientation meeting 
1 
2 
3 
4 
5 
6 
7 
Individual meeting sessions 
1 
2 
3 
4 
5 
6 
7 
Length of each weekly session 
1 
2 
3 
4 
5 
6 
7 
Length of program 
1 
2 
3 
4 
5 
6 
7 
 
 
ADDITIONAL COMMENTS (use back side of paper if necessary): 
 
 
 
 
 
 
 
 
 
 
 
 
 
Thank you for your feedback! 

P.Martyn, CBT FOH Program, Ver 9, 6-2-2020 
 
OPEN-ENDED INTERVIEW QUESTIONS: 
 
1. Did you feel that the program was helpful to you? 
 
 
 
If so, in what way? 
 
 
 
 
 
 
 
2. What were the program strengths? 
 
 
 
 
 
 
 
 
3. What suggestions do you have for program improvement?