Personalizing Sleep Interventions to Prevent Type 2 Diabetes in Community Dwelling Adults With Pre-Diabetes
Phase: NA
Conditions: PreDiabetes
Sponsor: New York University

 
 
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PERSONALIZING SLEEP INTERVENTIONS TO PREVENT TYPE 2 
DIABETES IN COMMUNITY DWELLING ADULTS WITH PREDIABETES: 
A PHASE 1 SINGLE-CENTER RANDOMIZED CLINICAL TRIAL OF THE 
EFFECTS OF IMPROVING SLEEP ON GLYCEMIC CONTROL IN 
PARTICIPANTS WITH PREDIABETES 
  
 
Principal Investigator: 
 
Susan Kohl Malone PhD, RN 
NYU Rory Meyers College of Nursing 
433 First Avenue 
New York, NY 10010 
sm7760@nyu.edu 
212-992-7047 
Additional Investigators: 
 
Gail D’Eramo Melkus, EdD 
NYU Rory Meyers College of Nursing 
433 First Avenue 
New York, NY 10010 
gdm3@nyu.edu 
212-998-5356 
 
David Lee, MD 
NYU Langone Health, Ronald O. Perelman Department of 
Emergency Medicine 
550 First Avenue 
New York, NY 10016 
David.Lee@nyulangone.org 
212-263-3293 
NYULMC Study Number: 
19-01745 
Funding Sponsor:  
National Institute of Nursing Research 
31 Center Drive, Room 5B03 
Bethesda, MD 20892-2178 
301-496-0207 
ClinicalTrials.gov 
Number                 
03398902 
 
Initial version: 01/07/2020 
Amended: 
April, 7, 2021 
Amended: 
June, 11, 2021 
Amended: 
July, 8, 2021 
 
 
 

Study number: 19-01745 
 
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Statement of Compliance 
 
This study will be conducted in accordance with the Code of Federal Regulations on the Protection of 
Human Subjects (45 CFR Part 46), any other applicable US government research regulations, and 
institutional research policies and procedures. The Principal Investigator will assure that no deviation from, 
or changes to the protocol will take place without prior agreement from the sponsor and documented 
approval from the Institutional Review Board (IRB), except where necessary to eliminate an immediate 
hazard(s) to the trial participants. All personnel involved in the conduct of this study have completed Human 
Subjects Protection Training. 
 
 

Study number: 19-01745 
 
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Table of Contents 
 
PROTOCOL SUMMARY .............................................................................................................................. 1 
SCHEMATIC OF STUDY DESIGN ............................................................................................................... 3 
1 
KEY ROLES ......................................................................................................................................... 4 
2 
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ....................... 5 
2.1 
BACKGROUND INFORMATION AND RELEVANT LITERATURE ................................................................ 5 
2.2 
RATIONALE .................................................................................................................................... 6 
2.3 
POTENTIAL RISKS & BENEFITS ........................................................................................................ 7 
2.3.1 
Known Potential Risks ............................................................................................................. 7 
2.3.2 
Known Potential Benefits ........................................................................................................ 8 
3 
OBJECTIVES AND PURPOSE ........................................................................................................... 8 
3.1 
PRIMARY OBJECTIVE ...................................................................................................................... 9 
3.2 
SECONDARY OBJECTIVES (IF APPLICABLE) ...................................................................................... 9 
4 
STUDY DESIGN AND ENDPOINTS .................................................................................................... 9 
4.1 
DESCRIPTION OF STUDY DESIGN .................................................................................................... 9 
4.2 
STUDY ENDPOINTS......................................................................................................................... 9 
4.2.1 
Primary Study Endpoints ......................................................................................................... 9 
4.2.2 
Secondary Study Endpoints .................................................................................................... 9 
4.2.3 
Exploratory Endpoints ............................................................................................................. 9 
5 
STUDY ENROLLMENT AND WITHDRAWAL .................................................................................... 9 
5.1 
INCLUSION CRITERIA ...................................................................................................................... 9 
5.2 
EXCLUSION CRITERIA ................................................................................................................... 10 
5.3 
VULNERABLE SUBJECTS ............................................................................................................... 10 
5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION .......................................................................... 11 
5.4.1 
Use of DataCore/Epic Information for Recruitment Purposes .............................................. 12 
5.5 
DURATION OF STUDY PARTICIPATION ............................................................................................ 13 
5.6 
TOTAL NUMBER OF PARTICIPANTS AND SITES ................................................................................ 13 
5.7 
PARTICIPANT WITHDRAWAL OR TERMINATION ................................................................................ 13 
5.7.1 
Reasons for Withdrawal or Termination ................................................................................ 13 
5.7.2 
Handling of Participant Withdrawals or Termination ............................................................. 13 
5.7.3 
Premature Termination or Suspension of Study ................................................................... 14 
6 
BEHAVIORAL/SOCIAL INTERVENTION ......................................................................................... 14 
6.1 
STUDY BEHAVIORAL OR SOCIAL INTERVENTION(S) DESCRIPTION .................................................... 14 
6.1.1 
Administration of Intervention ................................................................................................ 14 
6.1.2 
Procedures for Training Interventionalists and Monitoring Intervention Fidelity ................... 15 
6.1.3 
Assessment of Subject Compliance with Study Intervention ................................................ 15 
7 
STUDY PROCEDURES AND SCHEDULE ....................................................................................... 15 
7.1 
STUDY PROCEDURES/EVALUATIONS ............................................................................................. 15 
7.1.1 
Study Specific Procedures .................................................................................................... 15 
7.1.2 
Standard of Care Study Procedures ..................................................................................... 16 
7.2 
LABORATORY PROCEDURES/EVALUATIONS ................................................................................... 16 
7.2.1 
Clinical Laboratory Evaluations ............................................................................................. 16 
7.2.2 
Other Assays or Procedures ................................................................................................. 17 
7.2.3 
Specimen Preparation, Handling, and Storage ..................................................................... 17 
7.2.4 
Specimen Shipment .............................................................................................................. 17 
7.3 
STUDY SCHEDULE ........................................................................................................................ 17 
7.3.1 
Screening .............................................................................................................................. 17 
7.3.2 
Enrollment/Baseline .............................................................................................................. 17 

Study number: 19-01745 
 
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7.3.3 
Intermediate Visits ................................................................................................................. 18 
7.3.4 
Final Study Visits ................................................................................................................... 18 
7.3.5 
Withdrawal Visit ..................................................................................................................... 19 
7.3.6 
Unscheduled Visit .................................................................................................................. 19 
7.4 
CONCOMITANT MEDICATIONS, TREATMENTS, AND PROCEDURES .................................................... 19 
7.5 
JUSTIFICATION FOR SENSITIVE PROCEDURES ................................................................................ 19 
7.5.1 
Precautionary Medications, Treatments, and Procedures .................................................... 19 
7.6 
PROHIBITED MEDICATIONS, TREATMENTS, AND PROCEDURES ........................................................ 19 
7.7 
PROPHYLACTIC MEDICATIONS, TREATMENTS, AND PROCEDURES ................................................... 19 
7.8 
PARTICIPANT ACCESS TO STUDY INTERVENTION AT STUDY CLOSURE ............................................. 19 
8 
ASSESSMENT OF SAFETY ............................................................................................................. 20 
8.1 
SPECIFICATION OF SAFETY PARAMETERS ...................................................................................... 20 
8.1.1 
Definition of Adverse Events (AE) ......................................................................................... 20 
8.1.2 
Definition of Serious Adverse Events (SAE) ......................................................................... 20 
8.1.3 
Definition of Unanticipated Problems (UP) ............................................................................ 20 
8.2 
CLASSIFICATION OF AN ADVERSE EVENT ....................................................................................... 21 
8.2.1 
Severity of Event ................................................................................................................... 21 
8.2.2 
Relationship to Study Intervention......................................................................................... 21 
8.2.3 
Expectedness ........................................................................................................................ 21 
8.3 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP .................................... 21 
8.4 
REPORTING PROCEDURES – NOTIFYING THE IRB .......................................................................... 22 
8.4.1 
Adverse Event Reporting ...................................................................................................... 22 
8.4.2 
Serious Adverse Event Reporting ......................................................................................... 22 
8.4.3 
Unanticipated Problem Reporting ......................................................................................... 23 
8.4.4 
Reporting of Pregnancy ......................................................................................................... 23 
8.5 
REPORTING PROCEDURES – NOTIFYING THE STUDY SPONSOR ...................................................... 23 
8.6 
REPORTING PROCEDURES – PARTICIPATING INVESTIGATORS ......................................................... 23 
8.7 
STUDY HALTING RULES ................................................................................................................ 24 
8.8 
SAFETY OVERSIGHT ..................................................................................................................... 24 
PROTECTING PARTICIPANT CONFIDENTIALITY. ............................................................................................ 25 
9 
CLINICAL MONITORING .................................................................................................................. 26 
10 
STATISTICAL CONSIDERATIONS .................................................................................................. 26 
10.1 
STATISTICAL AND ANALYTICAL PLANS ........................................................................................... 26 
10.2 
STATISTICAL HYPOTHESES ........................................................................................................... 26 
10.3 
ANALYSIS DATASETS .................................................................................................................... 26 
10.4 
DESCRIPTION OF STATISTICAL METHODS ...................................................................................... 26 
10.4.1 
General Approach ............................................................................................................. 26 
10.4.2 
Analysis of the Primary Efficacy Endpoint(s) .................................................................... 27 
10.4.3 
Analysis of the Secondary Endpoint(s) ............................................................................. 27 
10.4.4 
Safety Analyses ................................................................................................................ 27 
10.4.5 
Adherence and Retention Analyses .................................................................................. 27 
10.4.6 
Baseline Descriptive Statistics .......................................................................................... 27 
10.4.7 
Planned Interim Analysis .................................................................................................. 27 
10.4.8 
Additional Sub-Group Analyses ........................................................................................ 27 
10.4.9 
Multiple Comparison/Multiplicity ........................................................................................ 28 
10.4.10 
Tabulation of Individual Response Data ........................................................................... 28 
10.4.11 
Exploratory Analyses ........................................................................................................ 28 
10.5 
SAMPLE SIZE ............................................................................................................................... 28 
10.6 
MEASURES TO MINIMIZE BIAS ....................................................................................................... 28 
10.6.1 
Enrollment/Randomization/Masking Procedures .............................................................. 28 
10.6.2 
Evaluation of Success of Blinding ..................................................................................... 29 
10.6.3 
Breaking the Study Blind/Participant Code ....................................................................... 29 
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ................................. 29 

Study number: 19-01745 
 
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12 
QUALITY ASSURANCE AND QUALITY CONTROL ....................................................................... 29 
13 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................................. 30 
13.1 
ETHICAL STANDARD ..................................................................................................................... 30 
13.2 
INSTITUTIONAL REVIEW BOARD ..................................................................................................... 30 
13.3 
INFORMED CONSENT PROCESS .................................................................................................... 30 
13.3.1 
Consent/Assent and Other Informational Documents Provided to Participants ............... 30 
13.3.2 
Consent Procedures and Documentation ......................................................................... 30 
13.4 
POSTING OF CLINICAL TRIAL CONSENT FORM ................................................................................ 30 
13.5 
PARTICIPANT AND DATA CONFIDENTIALITY .................................................................................... 31 
13.5.1 
Research Use of Stored Human Samples, Specimens, or Data ...................................... 31 
13.6 
FUTURE USE OF STORED SPECIMENS ........................................................................................... 32 
14 
DATA HANDLING AND RECORD KEEPING ................................................................................... 32 
14.1 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES .............................................................. 32 
14.2 
STUDY RECORDS RETENTION ....................................................................................................... 32 
14.3 
PROTOCOL DEVIATIONS ............................................................................................................... 33 
14.4 
PUBLICATION AND DATA SHARING POLICY ..................................................................................... 33 
15 
STUDY FINANCES ............................................................................................................................ 34 
15.1 
FUNDING SOURCE ........................................................................................................................ 34 
15.2 
COSTS TO THE PARTICIPANT ......................................................................................................... 34 
15.3 
PARTICIPANT REIMBURSEMENTS OR PAYMENTS ............................................................................ 34 
16 
STUDY ADMINISTRATION ............................................................................................................... 34 
16.1 
STUDY LEADERSHIP ..................................................................................................................... 34 
17 
CONFLICT OF INTEREST POLICY .................................................................................................. 34 
18 
REFERENCES ................................................................................................................................... 35 
19 
ATTACHMENTS ................................................................................................................................ 40 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study number: 19-01745 
 
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List of Abbreviations 
AE 
Adverse Event/Adverse Experience 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CSOC 
Clinical Study Oversight Committee 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data and Safety Monitoring Board 
FFR 
Federal Financial Report 
FWA 
Federal-wide Assurance 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
MOP 
Manual of Procedures 
N 
Number (typically refers to participants) 
NIH 
National Institutes of Health 
OHRP 
Office for Human Research Protections 
OHSR 
Office of Human Subjects Research 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SOP 
Standard Operating Procedure 
US 
United States 
 
CGM 
 
        Continuous glucose monitoring 
 
CSM 
 
        Composite Score of Morningness 
 
PSQI 
 
        Pittsburgh Sleep Quality Index 
 
T2DM  
        Type 2 diabetes mellitus 
 
AHI 
 
        Apnea hypopnea index 
 
NYULH  
        New York University Langone Health 
 
CTSI 
 
        Clinical Translational Science Institute 
 
CLIA 
 
        Clinical Laboratory Amendments 
IPAQ 
 
     International Physical Activity Questionnaire 

Study number: 19-01745 
 
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CHO 
 
     Carbohydrate 
 
RCT 
 
     Randomized clinical trial 
 
HbA1c  
     Hemoglobin A1c or glycated hemoglobin 
 
OSA 
 
     Obstructive sleep apnea 
 
CBT-I  
     Cognitive behavioral therapy for insomnia 
 
ADA 
 
     American Diabetes Association 
 
PHI 
 
     Protected health information 
 
PHQ-9  
     Patient Health Questionnaire -9 
 
PP 
 
     Per protocol 
 
ITT 
 
     Intent to treat 
 
PCP 
 
     Primary care provider 
 
BHS 
  
     Bellevue Hospital System 
 
CRC 
 
     Clinical Research Coordination 
 
EMR  
 
     Electronic Medical Record 
 
CRNP  
     Certified Register Nurse Practitioner 
 
SRM-5  
     Social Rhythms Metric 
 
 
 
 
 
 
 
 

 
STOP T2 
 
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writing by the study sponsor 
Drug/Device Template Version: 11 Jan 2019 
Protocol Summary 
Title 
Personalizing sleep interventions to prevent type 2 diabetes in community 
dwelling adults with prediabetes: A phase 1 single center randomized clinical 
trial of the effects of improving sleep on glycemic control in participants with 
prediabetes 
Short Title 
STOP T2 
Brief Summary 
A two-armed, parallel-design randomized trial of the effect of a sleep 
intervention on glycemic control in adults with prediabetes. The two arms will 
include the intervention arm (n = 94) and the attention matched control arm (n 
=94) for a total sample of N=188. Both arms will attend one clinic visit at 
baseline, a 2-week at home assessment for baseline sleep and glycemic 
control, 8 weekly individual intervention sessions, and a 2-week at home 
assessment for end of treatment sleep and glycemic control.  Linear 
regression models will be used to assess the effect of the sleep intervention 
versus the control intervention on the percent time glucose is greater than or 
equal to 140 mg/dL. 
Phase 
Phase 1 
Objectives 
Primary objective: to determine the effect of a personalized sleep intervention 
on glycemic control.  
Methodology 
A single blind parallel-design randomized trial of the effect of a sleep 
intervention on glycemic control in adults with prediabetes. 
Endpoint 
Primary endpoint: percent time glucose is greater than or equal to 140 mg/dL  
Study Duration 
5 years 
Participant Duration 
15 weeks 
Duration of behavioral 
intervention 
8 weeks 
Population 
We will screen 1,000 participants in order to enroll and retain 188 adults 
greater than or equal to 21 years of age and less than 65 years of age 
diagnosed with prediabetes. 
Study Sites 
New York University 
Number of participants 
We will screen 1,000 participants in order to enroll and retain188 participants 
at New York University 
Description of Study 
Intervention/Procedure 
The sleep intervention arm will receive a personalized sleep intervention that 
is based on Cognitive Behavioral Therapy for Insomnia (CBT-I). Like CBT-I, 
the sleep intervention extends sleep based on sleep efficiency. Bedtimes and 
wake times will be prescribed each week for each participant and allow for 
gradual adjustments in sleep opportunity. Bedtimes will be set 15 minutes 
earlier each week provided sleep efficiency remains greater than 90%. Earlier 
bedtimes will extend sleep duration by increasing the opportunity for sleep. 
2019 American Diabetes Association (ADA) Standards of Medical Care 
recommendations for physical activity and nutrition in adults with prediabetes 
will also be included. 
Reference Therapy 
The control arm will receive lifestyle intervention recommendations according 
to ADA Standard of Medical Care for physical activity and nutrition. Generic 
sleep recommendations will also be included. 

Study number: 19-01745 
 
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Key Procedures 
Baseline and end-of-treatment surveys 
Daily sleep diaries 
Weekly sleepiness surveys 
14 days of continuous wrist accelerometer wear time at baseline and end-of-
treatment 
7 days of continuous glucose monitoring wear time at baseline and end-of-
treatment 
Statistical Analysis 
Linear regression models will be used to assess the effect of the sleep 
intervention versus the control intervention on the percent time glucose is 
greater than or equal to 140 mg/dL. The outcome variable will be the percent 
time glucose is greater than or equal to 140 mg/dL. The dichotomous 
predictor variable will be the intervention arm (0 = control, 1 = sleep 
intervention). 
 
 
 

Study number: 19-01745 
 
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Schematic of Study Design 
 
Visit 1/Day 0 CTSI visit 1 Screening  
• 
Total n= 800 to retain 400 for at home screening  
• 
Obtain informed consent  
• 
Screen potential subjects by inclusion and exclusion criteria 
• 
Complete the following screening surveys (AUDIT, ARES, Insomnia Severity Index, selected 
questions from the Sleep Disorder Symptom Checklist (SDS-CL 25), PHQ-9, NINR 
Demographics) 
• 
Obtain targeted health and medication history and brief physical (height, weight, waist, neck 
circumference, blood pressure, Hemoglobin A1c point of care test, optional blood draw)  
 
Weeks 1-2/Days 1 - 14 At-home screening and baseline assessments 
• 
Total n= 400 to retain 188 for intervention 
• 
Wrist accelerometer (24/7 for 14 nights); Continuous glucose monitor (CGM) (24/7 for 7 days); 
Pulse oximeter (for 1 night, as needed); Sleep Diaries (daily); Social Rhythms Metrics (SRM-5), 
Epworth Sleepiness Scale (weekly); ASA24 hour dietary recall; Composite Scale of Morningness; 
International Physical Activity Questionnaire; Pittsburgh Sleep Quality Index; PROMIS-
Depression 6a; Sleep Environment Survey 
 
Week 3/Days 15 - 21  Randomization  
• 
Sleep intervention group (n=94 enrolled to retain n=75)  
• 
Attention control group (n=94 enrolled to retain n=75) 
 
Weeks 4-11/Days 22 - 77  Study Intervention  
• 
Administer study intervention (weekly) 
• 
Sleep Diaries (daily); Epworth Sleepiness Scale (weekly) 
 
Visit 2/Days 78-84 CTSI visit 2. 
• 
ASA24 hour dietary recall; International Physical Activity Questionnaire; Pittsburgh Sleep Quality 
Index; PROMIS-Depression 6a 
• 
Weight, waist, and blood pressure measurements 
 
 
Weeks 12-13/Days 78 - 91 End of Study Assessments  
• 
Wrist accelerometer to be worn 24/7 for 14 nights. Continuous glucose monitor (CGM) to be worn 
24/7 for 7 days. 
• 
Sleep Diaries (daily); Social Rhythms Metrics (SRM-5), Epworth Sleepiness Scale (weekly) 
• 
Final visit (optional) 

Study number: 19-01745 
 
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1 Key Roles 
Susan Kohl Malone, PhD, Assistant Professor 
NYU Rory Meyers College of Nursing 
433 First Avenue New York, NY 10010 
212-992-7047 
sm7760@nyu.edu  
 
Gail D’Eramo Melkus, EdD Professor with Chair, Academic Vice Dean 
NYU Rory Meyers College of Nursing 
433 First Avenue 
New York, NY 10010 
212-998-5356 
gdm3@nyu.edu 
 
David Lee, MD 
NYU Langone Health, Ronald O. Perelman Department of Emergency Medicine 
550 First Avenue 
New York, NY 10016 
David.Lee@nyulangone.org 
212-263-3293 
 
Victoria Vaughan Dickson, PhD, CRNP, Associate Professor, Academic Director 
NYU Rory Meyers College of Nursing 
433 First Avenue 
New York, NY 10010 
212-992-9426 
vdickson@nyu.edu 
 
Clinical and Translational Science Institute, Bellevue Hospital 
462 1st Avenue, C/D Building, 4th floor 
New York, NY 10016  
212-263-7900 
ctsi@nyumc.org 
 
National Institutes of Health, National Institute of Nursing Research 
31 Center Drive, Room 5B03 
Bethesda, MD 20892-2178 
Dr. Augi Diana, Program Official 
301-402-6423 
augusto.diana@nih.gov 
Dr. David Banks, Program Official 
301-496-9558 
banksdh@mail.nih.gov 
 
 
 
 

Study number: 19-01745 
 
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2 Introduction, Background Information and Scientific Rationale 
2.1 Background Information and Relevant Literature 
Global rates of prediabetes, a strong risk factor for T2DM, are rising1 particularly among racial/ethnic 
minorities, young and middle aged adults, those living in poverty, and those with a normal BMI2. This 
trend bodes poorly for reducing T2DM incidence and its comorbidities, such as blindness and 
amputations3,4. The impact on quality of life5-7, coupled with the economic burden for national health care 
budgets and for families, mandates intensified efforts to prevent and reverse prediabetes.  
Prediabetes can be reversed and T2DM progression delayed through intensive lifestyle modification 
programs that promote weight loss by diet and exercise8-12. Lifestyle modification interventions are more 
effective in the long-term prevention of T2DM than pharmacological interventions in adults with 
prediabetes13. Disappointingly, 25 people with prediabetes need to be treated to prevent one T2DM case 
using lifestyle modification interventions13. Wide ranges in T2DM risk reduction have been reported when 
translating lifestyle modification programs into community settings using less intense, more affordable 
interventions14-16. Moreover, only 50% of Americans with prediabetes attempt lifestyle modifications17. 
Collectively, this evidence suggests that diet and exercise approaches are only effective for a sub-set of 
adults18. Expanding success for resistant groups and optimizing long term maintenance requires 
approaches beyond diet and exercise. The sleep intervention in this proposed study represents such an 
approach. This proposed study is significant because it will test the effect of improving sleep on glucose 
in high risk groups and inform interventions for 
prediabetes.  
Associations between sleep duration19-21, sleep 
timing22-24, sleep regularity25, and glycemic control in 
healthy adults summarized below suggest that 
interventions targeting these sleep dimensions will 
improve glycemic control. The conceptual model, 
adapted from Reutrakul and Knutson26, illustrates 
these relationships and accounts for demographic 
(age, sex, race/ethnicity)27,28, socio-economic 
(employment, income, education)29-32, chronotype28 
factors, and depressive symptoms33 that are known to 
influence sleep. See Figure 1. 
Glycemic control is influenced by sleep duration via 
glucose counter-regulatory hormones, appetite 
regulatory hormones, food reward pathway activation, 
diet quality, and physical activity. Hormones that 
counteract insulin action34 increase during sleep restriction (e.g., growth hormone, cortisol, 
catecholamines)20,21,35. Restricting sleep alters appetite regulatory hormones52,53, increases neuronal 
activation in brain regions associated with food reward36,37, increases carbohydrate (CHO)-rich/energy-
dense food intake38-41 and is associated with reduced physical activity42,43. These factors contribute to 
weight gain and subsequent insulin resistance over time. Reduced physical activity also reduces non-
insulin dependent glucose uptake by skeletal muscles44,45. In sum, acutely restricting sleep in healthy 
adults during controlled laboratory conditions worsens glycemic control by increasing insulin resistance in 
most19-21,35,46, but not all47,48, studies. 
Disrupting behavioral and biological rhythms nearly doubles the effect of restricted sleep on insulin 
resistance49. Disrupted rhythms, such as altered meal and gluco-regulatory hormone alignment, stem 
from irregular sleep patterns and late sleep times. For example, irregular sleep patterns and late sleep 
times give rise to later eating opportunities that coincide with peak insulin resistance50-52. Eating later 
versus earlier meals leads to higher postprandial glucose levels53-55, impedes weight loss efforts56,57 and 
contributes to weight gain58,59. Weight gain and subsequent insulin resistance also stems from altered 
appetite regulatory hormones, increased CHO-rich/energy-dense food intake60-63, and reduced energy 
expenditure (via reduced thermic response to meals)63. Irregular eating habits (time and frequency) that 
are associated with irregular sleep patterns64 also associate with insulin resistance and postprandial 

Study number: 19-01745 
 
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hyperglycemia64-66. In sum, irregular sleep patterns, caused by shifting the main sleep episode 8-12 
hours, worsen glycemic control49,50,67,68 even to prediabetic levels67 independent of sleep duration49 in lab 
studies. Some22-24, but not all69, studies report that habitual irregular sleep patterns of smaller magnitudes, 
such as 1-2 hour differences in the time of the main sleep episode between work and free days, worsens 
glycemic control in healthy adults. Evidence that poor glycemic control persists, even after prolonged 
exposure to irregular sleep patterns, is supported by the increased risk for T2DM in shift workers70-74.  
Sleep interventions studies to improve glycemic control are limited despite this collective evidence that 
restricted sleep and irregular sleep patterns worsen glycemic control. One lab-based crossover study 
reported reduced insulin resistance following 3 nights of regularizing sleep patterns and extending sleep 
duration compared to restricting sleep in 19 short sleeping healthy young men75. Another community-
based study reported reduced insulin resistance following a 6-week sleep extension intervention in 16 
healthy young adults76. Our proposed study is a randomized clinical trial (RCT) that will use wearable 
sensor technologies (actigraphs and continuous glucose monitors). See device table below. This will 
make it possible to assess temporal patterns of glycemic control across the 24-hour day in relation to 
sleep in adults with prediabetes, a group at greatest risk for T2DM onset and heretofore unexamined. 
This proposed study is significant because it will improve sleep dimensions that are relevant to glycemic 
control, specifically short sleep duration and irregular sleep patterns 
Our study will complement the well-controlled lab studies linking sleep to glycemic control and 
determine if these findings are relevant to the everyday lives of people. Transferring lab findings to the 
community is hindered by the short duration of lab-based studies. Sleep, restricted to ~4-5 hours/night in 
the lab, is not sustainable over time in everyday life77. Short term lab studies prevent observing possible 
changes in response to prolonged conditions. This shortcoming is underscored by findings of transient 
insulin resistance to sleep restriction in a community based study78. Insulin resistance worsened during 
the first week of sleep restriction, corroborating laboratory evidence. However, insulin resistance declined 
afterwards and for the duration of the 3-week study suggesting adaptations to changes in sleep in the 
home environment that were not detectable in the lab. This shortcoming can have profound implications 
for interventions. Also, adherence to sleep interventions hinges on tailoring sleep to accommodate 
individual lifestyles (e.g., work demands). This study is significant because it will identify sleep 
interventions most sustainable for persons in the context of their daily routines.  
Continuous glucose monitoring (CGM) and actigraphy will allow us to see how glucose fluctuates over 
the day in relation to sleep patterns, without disturbing sleep79,80. Several days of monitoring will detect 
delayed effects of sleep patterns on glucose79. Our primary outcome measure is the percent time glucose 
is ≥140 mg/dL (% time≥140) , one of the earliest indicators of T2DM risk81. High glucose variability and % 
time≥140 presage fasting hyperglycemia82,83 and HbA1c elevations84. Postprandial hyperglycemia and 
glucose variability uniquely predict oxidative stress85-87, macro and micro-vascular complications88,89, and 
greater T2DM risk90 in adults with prediabetes. CGM will estimate glucose every 5 minutes over several 
days and thereby detect the % time≥140 and glucose variability that may go undetected  by HbA1c 
alone79. 
 
Device 
Name 
Manufacturer 
FDA 510K 
clearance number 
FDA approval 
status 
Actigraph 
Actiwatch Spectrum 
Philips Respironics 
K983533 
n/a 
Continuous 
glucose monitor 
Freestyle Libre Pro 
Abbott Medical 
n/a 
P150021 
Pulse oximeter 
WatchPat 
Itamar 
K081982 
n/a 
 
2.2 Rationale 
Diet and exercise interventions have made great strides in preventing and delaying type 2 diabetes 
(T2DM) onset: benefits that surpass pharmacological interventions. Yet, variable responses from less 
intense, more affordable interventions and waning benefits over time are significant limitations. Identifying 
additional modifiable factors that can expand intervention options, beyond diet and exercise, are needed 
to sustain metabolic benefits and to reach heretofore resistant groups. One viable option is improving 
sleep. Multiple dimensions of sleep have been independently associated with T2DM risk and poor 

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glucose control in persons with T2DM. Improved insulin sensitivity has been reported in a small 
community based daily sleep extension study (N= 16), as well as in a 2-day lab based sleep extension 
study using a personalized “catch up” sleep intervention in healthy adults (N = 19,). Yet, the role of sleep 
in mitigating T2DM risk remains uncertain because of the small sample sizes, controlled lab conditions, 
and the exclusion of persons at greatest risk for T2DM in existing studies. An important but unanswered 
question is whether improving sleep reduces T2DM risk in high risk subgroups, such as adults with 
prediabetes. This study will test the effects of a sleep intervention versus a control intervention on the 
percentage of time glucose is  140 mg/dL in short sleeping, community-dwelling adults with pre-
diabetes. Specifically, the sleep intervention aims to achieve adequate sleep duration (7-8 hours) and 
regular sleep patterns among enrolled participants. Wearable sensor technologies (continuous glucose 
monitoring and accelerometry) will be used. This study will inform personalized sleep interventions that 
improve glycemic responses, thus providing treatment for the prediabetic state. 
 
2.3 Potential Risks & Benefits 
2.3.1 Known Potential Risks 
• Immediate risks 
The immediate risks associated with this study are loss of confidentiality, embarrassment, local discomfort, 
and sleep complaints. Participants are free to refuse any procedure and to withdraw from the study at any 
time without repercussions. All risks will be explained to the participant. 
Surveys. The main concern with the surveys relates to confidentiality and embarrassment. Loss of 
confidentiality will be minimized by collecting and storing all data according to standards approved by the 
NYULH IRB and HIPPA. Embarrassment will be minimized by allowing participants to omit any survey 
questions. Clinicians, sensitive to emotional responses to these surveys, will assist with administering the 
surveys as needed. Additionally, the survey questions used in this study have been established and used 
in other research studies. Participants who are psychologically distressed will be referred for appropriate 
treatment.  
Height, waist, and weight measurements may be embarrassing or lead to a psychological reaction for 
participants. To minimize embarrassment or a psychological reaction, height, waist, and weights will be 
measured in a private area at the CTSI during visit 1. Clinicians, sensitive to emotional or physical 
responses to these procedures will conduct these measurements. Participants who are psychologically 
distressed will be referred for appropriate treatment. 
Blood draws and HbA1c fingerstick for point of care testing may lead to discomfort, bruising, bleeding, 
or fainting. These risks will be minimized by using skilled and trained personnel to perform the fingerstick 
or the blood collection to minimize discomfort and potential for infection. If blood is drawn, standard 
procedures and analysis according to Clinical Laboratory Improvement Amendment (CLIA) standards will 
be followed. 
Home sleep apnea monitoring may cause local discomfort while wearing the device. Participants will 
be given written, illustrated instructions for using the device. A 24-hour contact number to call for any 
problems will be provided. Participants diagnosed for the first time with moderate to severe OSA (apnea 
hypopnea (AHI) greater than or equal to 10) will be provided referrals to sleep clinics in the New York 
area for further evaluation and treatment. 
Actigraphy monitoring may lead to local discomfort including skin irritation beneath the band. 
Wearing the accelerometer may also be inconvenient or uncomfortable. Participants will be free to remove 
the actigraph as needed. We will request that they note this in their sleep diary. 
Inserting the continuous glucose monitor sensor into the back of a participant’s upper arm may 
cause redness, pain, bruising, bleeding, or infection at the insertion site. Wearing the sensor may also be 
inconvenient, uncomfortable, and cause other more serious skin problems. The sensor is water-resistant 
and can be worn for bathing, showering or swimming. However, sensors cannot be taken  in water deeper 
than 3 feet or for longer than 30 minutes. Sensors must be removed prior to MRI, CT scan, X-ray or 
diathermy treatment. Some airport full-body scanners include x-ray or millimeter radio-wave and will require 
the sensor to be removed if participants choose to go through these full body scanners. Also, sensors may 
lose adherence and fall off requiring the study team to insert another continuous glucose monitor sensor. 
Broken sensor probes are considered a minor risk and, although rare, are possible. To protect against a 

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broken sensor probe under the skin, a trained study team member will insert sensors for participants and 
participants will be required to verify that sensors have been removed at the end to the 7-day period. 
 
Sleep interventions. Extending sleep may be associated with sleep complaints as well as insomnia. 
These risks will be protected against by personalizing sleep intervention strategies designed from the 
participant’s habitual sleep patterns and based on an existing sleep intervention protocol. If sleep is 
restricted due to low sleep efficiency, participants may experience sleepiness. To protect against 
excessive sleepiness, participants will be monitored weekly with the Excessive Sleepiness Survey. 
Strategies for managing sleepiness and modifications to the sleep intervention (e.g. napping, flexible 
sleep schedules) will be implemented. 
 
• Rationale for the necessity of exposing human participants to such risks 
The rationale for the proposed research is that determining the effect of sleep on glycemic control may 
provide the basis for developing a T2DM lifestyle modification approach that includes sleep. This 
approach may improve the quality of life in adults with prediabetes and be cost effective. There is a 
critical need to develop personalized strategies to prevent T2DM in adults with prediabetes because they 
are at high risk for T2DM. Expanding success for resistant groups and optimizing long term maintenance 
requires approaches beyond diet and exercise. The sleep intervention in this proposed study represents 
such an approach.  
 
• 
Why the value of the information to be gained outweighs the risks involved 
If effective, this intervention will thwart the development of T2DM in a group at high risk for T2DM, expand 
treatment options to resistant groups, and optimize long term maintenance to existing lifestyle 
management interventions. In sum, the risks of participating in the study are outweighed by the potential 
benefit of thwarting the development of T2DM and improving sleep health. 
 
• If risk is related to proposed procedures included in protocol, any alternative procedures that have 
been considered and explanation on why alternative procedures not included 
The only alternative to study participation is non-participation. Non-participation will in no way affect the 
potential participant’s medical care. 
2.3.2 Known Potential Benefits 
Immediate benefits for participants in the intervention arm are that participants may advance their 
understanding of the benefits of sleep and their metabolic risk and sleep health profile may improve.  
We have preliminary evidence demonstrating the effectiveness of this sleep intervention for improving 
sleep health (unpublished data). Others have demonstrated improvements in insulin sensitivity in 
normoglycemic adults following a sleep extension intervention76. At the end of their participation in the 
study, participants in the intervention and the control arms will receive a study report from the research 
team that will include the results from their continuous glucose monitoring and sleep assessments with an 
explanation of the results and recommendations for improvement. 
 
Long range potential benefits are that participants may gain some satisfaction that their participation will 
advance our understanding of the relationship between sleep and T2DM risk that may someday improve 
preventative efforts. Improving sleep in short sleeping adults may contribute to improved health in the 
long run. 
 
3 Objectives and Purpose 
 
The overall objective of this application is to test and compare the effects of a sleep intervention versus a 
control condition on blood glucose in short sleeping adults with prediabetes in a randomized clinical trial. 
The effect on changes in blood glucose relative to baseline will be established and compared across 
arms. The central hypothesis is that the sleep intervention will significantly improve glycemic control 
compared to the control intervention.  

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3.1 Primary Objective 
The primary objective is to determine the effect of a personalized sleep intervention on glycemic control. 
Our hypothesis is that the sleep intervention participants will have a lower percentage of time glucose is ≥ 
140mg/dL compared to the control intervention participants after 8-weeks of treatment. 
3.2 Secondary Objectives (if applicable) 
The secondary objective it to determine the effect of a personalized sleep intervention on glycemic 
variability. Our hypothesis is that the sleep intervention participants will have a less glycemic variability 
compared to the control intervention participants after 8-weeks of treatment. 
 
4 Study Design and Endpoints 
4.1 Description of Study Design 
This study is a phase 1, single center, single blind, parallel design randomized clinical trial. There will be 
two arms: 1) the sleep intervention arm and 2) the control arm. The sleep intervention arm will receive a 
personalized sleep intervention based on CBT-I that aims to extend sleep duration, improve sleep 
regularity, sleep efficiency, and sleep quality, as well as advance sleep timing. The sleep intervention arm 
will also receive 2019 American Diabetes Association (ADA) Standards of Medical Care 
recommendations for physical activity and nutrition in adults with prediabetes. The control arm will receive 
a time and attention matched lifestyle intervention recommendations according to ADA Standard of 
Medical Care for physical activity and nutrition. Generic sleep recommendations will also be included. 
4.2 Study Endpoints 
4.2.1 Primary Study Endpoints 
The primary outcome will be the percent time glucose is ≥ 140mg/dL, estimated from 7 days of 
continuous glucose monitoring. The percent time glucose is ≥ 140mg/dL was chosen as the primary 
endpoint because this variable is linked to postprandial glucose levels which when elevated uniquely 
predict oxidative stress85-87, macro and micro-vascular complications88,89, and greater T2DM risk90 in 
adults with prediabetes. Moreover the percent time glucose is ≥ 140mg/dL, has been identified as one of 
the earliest indicators of T2DM risk81 and significant differences in the percent time glucose is ≥ 140 
mg/dL have been reported between people with and without prediabetes91. Continuous glucose 
monitoring results are validated measures to estimate glycemic control because continuous glucose 
monitoring data have been validated with blood glucose lab analyses (r =0.95)92. 
4.2.2 Secondary Study Endpoints 
Glucose variability estimated from continuous glucose monitoring will be a secondary study endpoint 
because this variable has also been associated with oxidative stress85-87, macro and micro-vascular 
complications88,89. 
4.2.3 Exploratory Endpoints 
Exploratory endpoints will be diet quality, specifically percent carbohydrate and percent fat intake 
estimated from the ASA 24 diet recall, as well as physical activity estimated from the International 
Physical Activity Questionnaire (short form). 
5 Study Enrollment and Withdrawal 
5.1 Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
1. ≥ 21 years old and < 65 years old. 

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2. HbA1c  5.7% and < 6.5% or taking Metformin or Glucophage. Individuals with a HbA1c in this 
range have been identified as being at greatest risk for progressing to T2DM and for developing 
microvasculature complications. This will also ensure that those recruited have prediabetes. 
3.  6.0 hours actigraphy-estimated sleep. 
4. English speaking. Participants will need to demonstrate adequate English comprehension 
(assessed during informed consent). This is because the Sleep Environment Survey (used at 
baseline) has not been validated in other languages. 
5.2 Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this study: 
1. Diagnosis of T2DM or taking insulin or oral hypoglycemic medications (other than Metformin or 
Glucophage). The diagnosis of T2DM and treatment with anti-diabetic agents will confound 
continuous glucose monitoring assessments. Individuals taking metformin alone will not be 
excluded as metformin is frequently prescribed for prediabetes. 
2. Pregnancy/lactation. Pregnancy and lactation can disrupt habitual sleep patterns and our primary 
interest is in recruiting individuals with habitual short sleep. Additionally, hormonal changes during 
pregnancy increase insulin resistance and may confound continuous glucose monitoring results93. 
3. Current chemotherapy treatments. Current chemotherapy treatments may contribute to fatigue 
and alter habitual sleep patterns94.  
4. Alcohol abuse/dependence may interfere with habitual sleep and limit the individual’s ability to 
adhere to the sleep interventions. Alcohol abuse will be assessed with the Alcohol Use Disorders 
Identification Test (a measure that has demonstrated good reliability and validity). Individuals with 
scores > 15 (men) or > 13 (women) will be excluded95. 
5. Recent or planned night shift work (previous 2 months or during the intervention period) or trans-
meridian travel >1 hour time zone difference during theRECR previous 4 weeks or during the 
intervention period. Shift work and trans-meridian travel of > 1 hour may disrupt habitual sleep 
and limit the individual’s ability to adhere to the sleep interventions. 
6. Sleep disorders (other than OSA discussed above and insomnia symptoms). Specific sleep 
disorders will be assessed with selected questions from the Sleep Disorders Symptom Checklist- 
(SDS-CL-25) that screens for narcolepsy in questions 18-20 (summed average score ≥3), 
restless legs syndrome in questions 15-17 (summed average score ≥3), and parasomnias in 
question 23 because these sleep disorders may interfere with the individual’s ability to adhere to 
the sleep intervention. 
7. Chronic use of sleep-promoting medications (self-reported) defined as taking a sleep-promoting 
medication ≥ 3 nights per week. Chronic use of sleep medication may interfere with sleep 
patterns and limit the participant’s ability to take part in the sleep interventions. 
8. Unstable medical illness or health condition that may interfere with habitual sleep and limit the 
individual’s ability to adhere to the sleep interventions. 
9. Unstable psychiatric illness, including the current or past diagnosis of psychotic or bipolar 
disorder assessed by self-report and/or medical record.  
10. Moderate/severe or severe depression. Moderate-severe or severe depression will be assessed 
with the Patient Health Questionnaire (PHQ-9). Moderate-severe depression or severe 
depression may contribute to sleep disturbances and interfere with the participant’s ability to 
adhere to the sleep interventions. Therefore, individuals with PHQ-9 scores ≥ 15 will be excluded. 
11. Any condition that, in opinion of the PI, will interfere with the safe completion of the study.  
5.3 Vulnerable Subjects 
Children, pregnant women, fetuses, neonates, the elderly, persons with decisional incapacity, or 
prisoners are not included in this research study. 
 
Employees and students may be enrolled. They will be informed that their decision to participate will not 
affect their academic or employment standing. No students who are under the supervisory oversight of 
the study team members will be enrolled. 

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5.4 Strategies for Recruitment and Retention 
We plan to telephone screen 1,000 potential participants to enroll 800 community-dwelling, short sleeping 
adults (≥ 21 years and < 65) with prediabetes (defined as Hemoglobin A1c ≥ 5.7% and < 6.5%) in order to 
retain 188 participants who will complete the intervention. Short sleep will be defined as ≤ 6.0 hours of 
actigraphy-estimated sleep. Based on patients seen at New York University Langone Health (NYULH) 
diagnosed with prediabetes during the last year (HbA1c ≥ 5.7% and < 6.5%), we anticipate recruiting a 
sample consisting of 57% females, 43% males, 46% Whites, 24% Blacks, and 30% other 
races/ethnicities. 
 
Prior to recruitment, IRB approval will be obtained from the New York University School of Medicine. We 
will recruit participants from the community by 1) electronically posting study flyers, 2) advertising in the 
community and via social media 3) posting flyers in clinics, 4) distributing flyers at NYULH facilities, 5) 
contacting past study participants who agreed to be contacted for future research studies, 6) using Epic to 
identify and contact potential participants, 7) using research registries such as Research Match, and 8) 
using a peer recruitment strategy. 
 
All inquiries will be subjected to a structured telephone interview conducted by the project coordinator or 
research assistant to determine potential eligibility. If the telephone interview indicates that the potential 
participant may be eligible, s/he will be contacted by the project coordinator to schedule the CTSI visit 1. 
 
1) Electronically-posted flyers: IRB-approved electronic flyers will be posted at selected sites with 
permission from the site. Potential sites include NYULH, Bellevue Hospital, NYU College of Dentistry, 
NYU College of Nursing, commuter ferries and ferry terminals, and metro terminals. Interested persons 
responding to the flyers will be contacted by the project coordinator or research assistant and provided 
with the option of proceeding with the IRB-approved telephone screening.  
 2) Advertising in the community: Community members may learn of the study through electronically-
posted flyers or other methods, such as radio talk shows (e.g., NYU Langone Nurse Radio, sleep apnea 
support groups). Interested community members may contact the study team for more information about 
the study. After contacting the study team, the project coordinator or research assistant will provide 
individuals with the option of proceeding with the IRB-approved telephone screening. 
3) Posted/distributed flyers: Flyers promoting the study will be available to individuals who visit the 
participating NYULH and Bellevue Hospital health facilities. Flyers will also be distributed at community 
sites so that interested individuals can contact the study team. Those responding to the distributed flyer 
will be contacted by the project coordinator or research assistant and provided with the option of 
proceeding with the IRB-approved telephone screening.  
4) NYULH recruitment. This study will recruit individuals from settings affiliated with NYULH, such as 
employee health, occupational medicine, cardiology, endocrinology, emergency medicine, and college of 
nursing faculty practices. Flyers promoting this study will be available to individuals who visit the 
participating health facilities or attend employee health events (e.g. flu shot clinics, health fairs). Clinical 
staff informed of the study protocol and provided with the IRB-approved study information may also inform 
individuals about the study and refer them to the study team to contact if interested in participating in the 
study. With approval of the clinical site, the research staff will also be available at the clinical site during 
specific hours to facilitate recruitment. However, given the current limitations for being onsite for 
recruitment, this study will expand recruitment to include telephone or email recruitment of patients seeking 
care at all NYULH Family Health Centers and other NYULH settings.  Working with the Family Health 
Centers and NYULH staff and scheduling personnel and NYU Langone DataCore personnel, the PI will 
obtain a list of patients with appointments in the NYU Langone Family Health Centers and other NYULH 
settings during the next month. This may include viewing the upcoming schedule in Epic. The PI will email 
the list of potential participants to their providers telling them their patient will be contacted about this study 
(the patients will be contacted via phone or email). The PI will ask the provider in this email if they have any 
objections to their patient’s participation in the study. If there are no objections, the PI will contact the patient 

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telling them about the study. Patient’s that do not have a primary care provider or other health care provider 
identified will be contacted via phone or email.   
5) Past study participants. Only past study participants from the PI’s and Co-I’s previous studies who agreed 
to be contacted for future studies will be contacted by the project coordinator or research assistant. 
Contacted individuals expressing interest in the study will be provided with the option of proceeding with 
the IRB-approved telephone screening.  
 
6) DataCore/Epic. See below. 
7) Research Match. We will also utilize Research Match (ResearchMatch.org), a national, electronic, web-
based recruitment tool that was created through the Clinical and Translational Science Awards 
Consortium in 2009 and iConnect to send study recruitment messages to potential study participants. 
This study’s recruitment content will be inserted into the standard Research Match electronic notification 
that informs possible matched participants that they have been identified as a potential match for this 
study. The secure Research Match clearinghouse will route an IRB approved Research Match notification 
to each of these Research Match participants. These potentially matching participants will have the option 
of replying “yes”, “no”, or “not respond” through a set of quick links available in this notification of the 
study announcement. The contact information of the “yes” responding participants will be made available 
on the PI’s “Manage my Study” dashboard. A member of the research team will contact the individual who 
expresses interest. If a subject requests information regarding opting out of further recruitment for all 
research, subjects will be directed to contact the study coordinator or have subjects contact research-
contact-optout@nyumc.org or 1-855-777- 7858. 
 
8) Peer recruitment strategy. This study will employ a hybrid sampling strategy involving targeted 
sampling from recruitment venues and peer recruitment. Initial seeds who are selected by study staff to 
recruit peers to the study, and individuals who were recruited by peers. They will be asked to recruit peers 
who they know by name or face, and are living with pre-diabetes. They will receive $10 for each peer who 
completes the CTSI screening visit.  
 
Written informed consent will take place during the first clinic visit at the CTSI prior to any study related 
procedures. At the CTSI visit 1, the study details and procedures will be discussed with the project 
coordinator. The potential participant will be given adequate time to ask questions and review the 
informed consent document. Once satisfied that all questions have been answered, the potential 
participant will either decline to participate or sign the informed consent document. The consent form will 
be signed in the presence of the project coordinator. All participants must read, sign, and date a consent 
form before entering the study, undergoing physical examination, or undergoing any testing.  
 
Participation retention will be enhanced by scheduling and reminding participants about weekly 
intervention visits, tracking the completion of daily sleep diaries, and sending email reminders if the daily 
sleep diary has not been completed. The study team will reach out to participants as needed to problem 
solve for missed sessions or missing sleep diaries. 
 
 
5.4.1 
Use of DataCore/Epic Information for Recruitment Purposes 
This study will utilize EPIC to identify subjects. A study team member will submit a request to DataCore to 
identify potential participants. Data points to be searched will include age, diagnosis of prediabetes, 
HbA1c in the prediabetic range over the previous year provided there is no diagnosis of T2DM or record 
of taking antidiabetic medication other than metformin (HbA1c: ≥ 5.7% and <6.5%), no diagnosis of 
bipolar disorder, and active MyChart participation.  DataCore queries will be run at the start of the study 
and monthly after the study starts depending on recruitment rates. DataCore will request a report from 
EPIC for these patients with identifiable protected health information (name, email address) for research 
related purposes. Only the PI and project coordinator will have access to the search results. The Epic 
team will set up an IRB approved recruitment message in MyChart and work with the PI and project 

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coordinator to send it out. The message will include a description of the study, inclusion and exclusion 
criteria, and contact information for the PI (phone number and email). Participants responding that they 
are interested in the study will be sent a MyChart message to arrange for a convenient date and time for 
the telephone screen. The recruitment message may be repeated two times at one-month intervals if 
needed for subject recruitment (total 3 MyChart messages). These data will be used solely for participant 
identification in order to determine patients who are initially eligible and for chart review. If any recruitment 
information does need to be sent by email, the SendSafe Secure email method will be used. The study 
team will discard information from those who do not wish to participate in the study.  
 
If a subject requests information regarding opting out of further recruitment for all research, subjects will 
be directed to contact research-contact-optout@nyumc.org or 1-855-777-7858. 
5.5 Duration of Study Participation 
Study participants’ participation will involve a 3-4 week baseline phase that will include the CTSI visit 1, a 
2 week at-home baseline assessment for sleep and glycemic control, using accelerometers (14 nights), 
continuous glucose monitors (7 days), and pulse oximetry (1 night, if needed). These 2 weeks will be 
followed by a 1-week review of the at-home data by the PI to assess continued eligibility (e.g., objectively 
confirmed short sleep). The at-home baseline assessment will be followed by the 8-week intervention. 
After the 8-week intervention, participants will return to the CTSI for the wrist accelerometer and 
continuous glucose monitor for the 2-week at-home end of treatment assessment. Thus, participants can 
anticipate involvement in the study for approximately a 15 week period. 
5.6 Total Number of Participants and Sites  
This is a single site study being conducted at NYULH. Recruitment will end when approximately 800 
participants are enrolled. It is expected that approximately 800 participants will be enrolled in order to 
produce 188 evaluable participants. 
5.7 Participant Withdrawal or Termination 
5.7.1 Reasons for Withdrawal or Termination 
Participants are free to withdraw from participation in the study at any time upon request. An investigator 
may terminate participation in the study if: 
• 
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation 
occurs such that continued participation in the study would not be in the best interest of the 
participant. 
• 
The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation. 
• 
At the discretion of the PI for lack of adherence to the intervention or study procedures or visit 
schedules (e.g., target 80% of weekly daily diary completion and 80% attendance at 
intervention sessions). Reasons for less adherence will be assessed, and if addressable will 
be re-evaluated at the next scheduled intervention session. 
• 
The participant does not respond to weekly phone calls/emails for 4 weeks during the 
intervention. 
5.7.2 Handling of Participant Withdrawals or Termination 
Participants will be considered withdrawn if they cannot be contacted for 4 weeks during the intervention 
using all of the contact information collected. No further efforts will be made to contact the participant and 
that participant will be considered lost to follow-up. Abrupt termination of participation in the study 
intervention poses no safety risk to participants. As this study is minimal risk, efforts will not be made to 
collect safety and efficacy data after withdrawal. If a participant withdraws or is withdrawn from the study, 
no further study visits or procedures will be completed. It will be documented whether or not each subject 
completes the clinical study. 
 

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Any data collected before withdrawal from the study will be retained for analysis, and no new data will be 
collected. If the participant requests that data be destroyed, all paper records will be shredded, and any 
data already processed into computer files will be removed. However, if results based on the participant's 
data have been submitted for publication or presentation before the request is made, the results cannot be 
removed from the publication or presentation. 
5.7.3 Premature Termination or Suspension of Study 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to the PI, appropriate funding agency, and New York University 
IRB. If the study is prematurely terminated or suspended, the PI will promptly inform the IRB and will 
provide the reason(s) for the termination or suspension. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping 
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, data quality are addressed and 
satisfy the sponsor and/or IRB. 
6 Behavioral/Social Intervention 
6.1 Study Behavioral or Social Intervention(s) Description 
Sleep Intervention Arm: The sleep intervention is based on Cognitive Behavioral Therapy for Insomnia 
(CBT-I). Participants may not require the initial sleep restriction that characterizes the first step of CBT-I if 
their sleep efficiency is > 90%. However, the sleep intervention will employ CBT-I’s gradual approach for 
increasing sleep time and applying it to short sleepers. The 8-week intervention period of gradually 
increasing sleep duration by advancing bedtimes 15 minutes per week (or 1 hour per month) will provide 
the time needed to increase sleep duration in habitual 5 hour sleepers to the recommended 7 to 8 hour 
sleep duration. Like CBT-I, the sleep intervention extends sleep duration based on sleep efficiency (the 
proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed 
each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 
15 minutes earlier each week provided sleep efficiency remains >90%. Earlier betimes will extend sleep 
duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are 
often determined by external demands, such as work schedules. Participants in the sleep intervention 
arm will receive generic nutrition, physical activity, and psycho-social self-management  
recommendations as per the ADA lifestyle management guidelines for adults with prediabetes.  
Control Arm: The control arm will receive a time and attention matched intervention that is based on the 
ADA lifestyle management guidelines for adults with prediabetes. Content covered will include nutrition 
therapy, physical activity, and psycho-social education. Participants in the control arm will receive generic 
sleep hygiene recommendations. 
6.1.1 Administration of Intervention 
This intervention will be delivered by a trained study team member. It will consist of 8 weekly sessions. 
Sessions 1-8 for the intervention and control arms will consist of 45-60 minute HIPPA compliant Zoom 
videoconference or phone call sessions. An optional final study visit (30-minute HIPPA compliant Zoom 
videoconference or phone call session) will be scheduled for interested participants after all end of 
treatment measurements are completed and wearable technology returned (wrist accelerometer and 
continuous glucose monitor) 

Study number: 19-01745 
 
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At this final visit, a study team will review the participant’s baseline and end of treatment continuous 
glucose monitoring reports, wrist accelerometer, weight measurements, and ASA24 reports with 
participants.  
 
If participants do not have access to a laptop, computer, tablet, or telephone for these sessions several 
alternatives will be offered to ensure that low income individuals are not excluded. A tablet will be offered 
to participants as needed for the duration of the intervention. Participants will return the tablets at their 
second CTSI visit. Alternatively, sessions may take place in-person and participants will be compensated 
for their travel to and from these sessions.  
6.1.2 Procedures for Training Interventionalists and Monitoring Intervention Fidelity 
The PI and trained study team members will be responsible for administering the intervention. We will use 
recommendations of the Treatment Fidelity Workgroup of the NIH Behavior Change Consortium98 to 
enhance the intervention fidelity. The treatment fidelity plan includes audiotaping each session and 
reviewing content against an a priori performance checklist to ensure consistency in the intervention 
delivery. Participants and staff will be told not to state the participant’s name or any identifying information 
during these sessions to ensure participant confidentiality with respect to the stored audio recordings. 
Treatment fidelity will be monitored by the PI and research team. Barriers to implementing the intervention 
will be identified and resolved. 
6.1.3 Assessment of Subject Compliance with Study Intervention 
The study team will track participant compliance by monitoring daily sleep diary completion, baseline and 
end of treatment survey completion, and weekly intervention session attendance. Retention rates for both 
arms will be monitored by the study team. Daily texts or email reminders will be sent to participants to 
remind them to complete the sleep diaries each evening as needed.  
7 Study Procedures and Schedule 
7.1 Study Procedures/Evaluations 
7.1.1 Study Specific Procedures 
Participants meeting the telephone screen eligibility criteria will be invited to the CTSI. CTSI visit 1 will be 
scheduled within 4 weeks of the telephone screen. At the CTSI visit 1, participants will provide written 
informed consent prior to the study specific procedures listed below. All surveys at the CTSI will be 
completed using REDCap.  
 
• 
Medical history will be obtained by completing specific surveys at the CTSI visit 1. Surveys will 
include: Alcohol Use Disorders Identification Test (AUDIT), ARES, Insomnia Severity Index, 
selected questions from the Sleep Disorder Symptom Checklist -25 , the NINR BRICS with race 
clarifying questions, Patient Health Questionnaire (PHQ-9), Primary care provider contact 
information, and a targeted health survey. Prediabetes (HbA1c  5.7% and < 6.5%) will be 
confirmed from the NYULH medical records (for NYULH participants) or from a HbA1c point of 
care fingerstick test (for non-NYULH participants). 
• 
Medication history will be obtained by completing specific surveys at the CTSI visit 1. Surveys will 
include self-reported prescription and over-the counter medications. Specific permitted and 
prohibited medications will also be queried. Prohibited medications include prescribed 
medications for T2DM with the exception of Metformin and chronic use of prescribed or over the 
counter sleep medications (greater than or equal to three times per week). 
• 
Physical examination performed at the CTSI visit will be targeted and include a measured height, 
waist, and weight, neck circumference, and blood pressure.  

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• 
Radiographic or other imaging assessments. Not applicable.  
• 
Biological specimen collection and laboratory evaluations. Participants who do not have the 
results of a HbA1c within the previous 3 months of the CTSI visit 1 will have a Hemoglobin A1c 
point of care fingerstick to confirm high risk prediabetes. Participants may also be offered the 
option to provide a blood sample that will be de-identified for future analysis of biomarkers for 
metabolic disorders, sleep or circadian health, or other health conditions See Section 7.2. All 
blood draws will take place during the CTSI visit 1. 
• 
A discussion of the results of any study specific procedures that will be provided to the participant 
include results from the 1) ARES indicating high risk for sleep apnea ( 6), 2) PHQ-9 indicating 
moderate/severe depression (>15), or 3) HbA1c test results from the CTSI visit 1 in the T2DM 
range ( 6.5%). Participants with a high-risk ARES score or previously diagnosed and currently 
treated OSA will complete 1 night of pulse oximetry measurements during the 2-week at home 
baseline assessment to confirm absence of moderate to severe OSA or the effectiveness of the 
current OSA treatment regime (AHI  10). Participants not previously diagnosed and treating 
OSA will be provided with a list of sleep clinics and encouraged to follow up with a provider for 
further testing and evaluation. Participants with ineffectively treated OSA will be encouraged to 
follow up with their health care provider managing their OSA. Participants responding “several 
days”, “more than half the days” or “nearly every day” to the PHQ-9 question: “Over the past 2 
weeks, how often have you been bothered by any of the following problems?....Thoughts that you 
would be better off dead or of hurting yourself” will be screened further at the CTSI visit 1 by the 
project coordinator as per the Depression Safety and Referral Protocol.  
• 
Participants with HbA1c point of care fingerstick test results from in the T2DM range of  6.5% 
will be provided their test results as outlined in the protocol. 
• 
Counseling procedures. Not applicable. 
• 
Assessment of study intervention adherence will be monitored by the completion of daily sleep 
diaries and by the attendance at the weekly intervention sessions. 
• 
Administration of questionnaires or other instruments for participant outcomes, include Sleep 
Diaries (daily); Epworth Sleepiness Scale (weekly); and SRM-5 (daily for the 2-week baseline and 
2-week end of treatment study period), ASA24 hour dietary recall (baseline and end of treatment); 
Composite Scale of Morningness (baseline); International Physical Activity Questionnaire 
(baseline and end of treatment); Pittsburgh Sleep Quality Index (baseline and end of treatment); 
PROMIS-Depression 6a (baseline and end of treatment); and Sleep Environment Survey 
(baseline) will be administered through the Assessment Center Application Programming 
Interface in REDCap (Research Electronic Data Capture) and during CTSI visit 2 (end of 
treatment surveys). 
Wearable sensor technology assessments will be as follows: pulse oximeter (baseline for 1 night, 
as needed); Wrist accelerometer (baseline and end of treatment 24/7 for 14 nights); Continuous 
glucose monitor (baseline and end of treatment 24/7 for 7 days). 
7.1.2 Standard of Care Study Procedures 
All participants will receive lifestyle management information for the prevention of T2DM focused on 
nutrition and physical activity during the intervention as per the 2019 ADA Standards of Care99. 
7.2 Laboratory Procedures/Evaluations 
7.2.1 Clinical Laboratory Evaluations 
Participants without evidence of a HbA1c within the previous 3 months or from outside the NYULH 
system will have a HbA1c point of care fingerstick test after enrollment (5L). This approach is consistent 
with other studies examining the relationship between sleep and metabolic outcomes whereby most 
recent bloodwork from subject’s medical records were used69. Participants recruited from outside the 
NYULH system will have a HbA1c point of care fingerstick test after enrollment. Participants providing 
consent for the optional blood draw may have the blood specimen collected by peripheral vein 
venipuncture at the NYULH CTSI Clinical Research Center (CRC) at Bellevue Hospital C/D Building, 4th 
floor by the Clinical Research Coordinators. The estimated total volume of blood drawn is 20 ml.  

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Table 1: Blood collection  
 
 
Volume 
required 
Specimen type 
Collection tube 
Hemoglobin A1c point of 
care fingerstick 
5L 
Whole blood 
Not applicable 
Optional Blood draw 
20 ml 
Whole blood 
EDTA 
 
7.2.2 Other Assays or Procedures 
Not applicable. 
7.2.3 Specimen Preparation, Handling, and Storage 
All vacutainer tubes for the optional blood draw will be labeled with participants’ unique study ID without 
PHI.  
7.2.4 Specimen Shipment 
Not applicable. 
7.3 Study Schedule 
7.3.1 Screening 
 
Telephone Screening Visit (Day -30 to -1)  
• 
Obtain verbal consent from potential participant to continue with the scripted telephone screen. 
• 
Provide participants with general information about the study as per the scripted telephone 
screen. 
• 
If interested, continue with the scripted telephone screen to determine potential eligibility for CTSI 
visit 1. 
• 
If eligible based on telephone screen, schedule the CTSI visit 1 within 30 days of the telephone 
screening date. 
7.3.2 Enrollment/Baseline 
 
Enrollment/Baseline CTSI Visit 1 (Visit 1, Day 0) 
• 
Obtain written informed consent and written audio consent of the potential participant verified by 
signature on study informed consent form. 
• 
Verify inclusion/exclusion criteria. 
• 
Review medical history to determine eligibility based on inclusion/exclusion criteria (prediabetes 
diagnosis, most recent HbA1c  5.7% and < 6.5%, no diagnosis of current or previous bipolar 
disorder). 
• 
Obtain demographic information, medical history, medication history, and alcohol use history. 
• 
Record vital signs, results of examinations, other assessments. 
• 
HbA1c point of care fingerstick (if needed) and blood draw for future analyses (optional). 
• 
Provide eligible participants with instructions for the at-home assessments with wrist 
accelerometry, continuous glucose monitoring, pulse oximetry (if needed), and baseline surveys 
via REDCAp including daily sleep diaries. 

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7.3.3 Intermediate Visits 
7.3.3.1 
At-home visits 
 
Week 1 (Days 1 - 7)  
• 
Record adverse events as reported by participant or observed by investigator. 
• 
Participant will wear the continuous glucose monitor for 7 days 24/7. Return the continuous 
glucose monitor to the study team in the prepaid package after day 14. 
• 
If needed, participant will wear the pulse oximeter for 1 night. Return the pulse oximeter to the 
study team in the prepaid package after 1 night of wear time. 
• 
Record results of continuous glucose monitor and pulse oximeter. 
• 
Participant will wear wrist accelerometer (24/7). 
• 
Complete Sleep Diaries (daily), SRM-5 (daily), and Epworth Sleepiness Scale (day 6) 
• 
Complete baseline surveys: ASA24 hour dietary recall; Composite Scale of Morningness; 
International Physical Activity Questionnaire; Pittsburgh Sleep Quality Index; PROMIS-
Depression 6a; Sleep Environment Survey. 
• 
Record participant’s adherence to intervention program. 
 
Week 2 (Days 8 - 14)  
• 
Record adverse events as reported by participant or observed by investigator. 
• 
Record results of wrist accelerometer. 
• 
Complete Sleep Diaries (daily), SRM-5 (daily) and Epworth Sleepiness Scale (day 13). 
• 
Record participant’s adherence to intervention program. 
 
Week 3 (Days 15-21)  
• 
Participant to ship wrist accelerometer back to the study team in the prepaid package after 14 
nights of wear time (day 15). 
• 
Record adverse events as reported by participant or observed by investigator. 
• 
Determine eligibility for intervention based on wrist accelerometry and pulse oximetry data. 
• 
Randomize eligible participants to sleep intervention or control arm. 
• 
Notify participant of eligibility and arrange for weekly videoconference intervention sessions. 
 
Weeks 4-11 (Days 22 – 77)  
• 
Record adverse events as reported by participant or observed by investigator. 
• 
Record results of daily Sleep Diary and weekly Epworth Sleepiness Scale results. 
• 
Administer the study intervention to the participant in accordance with the intervention manual for 
the sleep intervention arm or the control arm. 
• 
Record participant’s adherence to intervention program. 
7.3.4 Final Study Visits 
 
CTSI visit 2 (Days 78-84)  
• 
Record adverse events as reported by participant or observed by investigator. 
• 
Measure weight, waist, and blood pressure 
• 
Complete end of treatment surveys: ASA24 hour dietary recall; International Physical Activity 
Questionnaire; Pittsburgh Sleep Quality Index; PROMIS-Depression 6a, medical history update, 
and medication history update. 
• 
Provide participants with instructions for the at-home assessments including wrist accelerometry 
and continuous glucose monitoring. 
 
Week 12 (Days 78-84) 
• 
Record adverse events as reported by participant or observed by investigator. 

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• 
Partiipant will wear the continuous glucose monitor for 7 days 24/7. Return the continuous 
glucose monitor to the study team in the prepaid package after day 92. 
• 
Record results of continuous glucose monitor. 
• 
Participant will wear wrist accelerometer (24/7). 
• 
Complete Sleep Diaries (daily), SRM-5 (daily), and Epworth Sleepiness Scale (day 83) 
 
Week 13 (Days 85-91) 
• 
Record adverse events as reported by participant or observed by investigator. 
• 
Complete Sleep Diaries (daily), SRM-5 (daily),  and Epworth Sleepiness Scale (day 90) 
• 
Participant to ship wrist accelerometer back to the study team in the prepaid package after 14 
nights of wear time (day 92). 
• 
Record results of wrist accelerometer. 
 
Final Visit (optional) 
 
Study team will review baseline and end of treatment continuous glucose monitoring reports, wrist 
accelerometer, weight measurements, and ASA24 reports with participants who are interested in this 
optional final visit.  
7.3.5 Withdrawal Visit 
If a participant withdraws or is withdrawn from the study, no further study visits or procedures will be 
completed. 
7.3.6 Unscheduled Visit 
If a participant needs an unscheduled visit for replacing the continuous glucose monitor, this visit will be 
arranged by the project coordinator and documented in REDCap. 
 
7.4 Concomitant Medications, Treatments, and Procedures 
All concomitant prescription medications taken during study participation will be recorded on the case 
report forms (CRFs). For this protocol, a prescription medication is defined as a medication that can be 
prescribed only by a properly authorized/licensed clinician. Medications to be reported in the CRF are 
concomitant prescription medications, over-the-counter medications and non-prescription medications. 
7.5 Justification for Sensitive Procedures 
Not applicable. 
7.5.1 Precautionary Medications, Treatments, and Procedures 
Not applicable. 
 
7.6 Prohibited Medications, Treatments, and Procedures 
Not applicable. 
7.7 Prophylactic Medications, Treatments, and Procedures 
Not applicable. 
7.8 Participant Access to Study Intervention at Study Closure 
Not applicable. 

Study number: 19-01745 
 
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8 Assessment of Safety 
8.1 Specification of Safety Parameters 
The study will involve no more than minimal risk to research participants. The probability and magnitude 
of harm or discomfort anticipated for this research are not greater than what this same population 
encounters in daily life or during the performance of physical or psychological examinations or tests. The 
only alternative to study participation is non-participation. 
8.1.1 Definition of Adverse Events (AE) 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity 
during the course of the study.  Intercurrent illnesses or injuries should be regarded as adverse events.  
Abnormal results of diagnostic procedures are considered to be adverse events if the abnormality: 
• results in study withdrawal 
• is associated with a serious adverse event 
• is associated with clinical signs or symptoms 
• leads to additional treatment or to further diagnostic tests 
• is considered by the investigator to be of clinical significance 
8.1.2 Definition of Serious Adverse Events (SAE) 
 
Serious Adverse Event 
Adverse events are classified as serious or non-serious.  A serious adverse event is any AE that is:  
• fatal 
• life-threatening 
• requires or prolongs hospital stay 
• results in persistent or significant disability or incapacity 
• a congenital anomaly or birth defect 
• an important medical event 
 
Important medical events are those that may not be immediately life threatening, but are clearly of major 
clinical significance. They may jeopardize the subject, and may require intervention to prevent one of the 
other serious outcomes noted above.  For example, drug overdose or abuse, a seizure that did not result 
in in-patient hospitalization, or intensive treatment of bronchospasm in an emergency department would 
typically be considered serious.  
 
All adverse events that do not meet any of the criteria for serious should be regarded as non-serious 
adverse events.  
8.1.3 Definition of Unanticipated Problems (UP) 
 
Unanticipated Problems Involving Risk to Subjects or Others 
Any incident, experience, or outcome that meets all of the following criteria:  
• Unexpected in nature, severity, or frequency  (i.e. not described in study-related documents such 
as the IRB-approved protocol or consent form, the investigators brochure, etc) 
• Related or possibly related to participation in the research (i.e. possibly related means there is a 
reasonable possibility that the incident experience, or outcome may have been caused by the 
procedures involved in the research) 
• Suggests that the research places subjects or others at greater risk of harm (including physical, 
psychological, economic, or social harm). 

Study number: 19-01745 
 
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8.2 Classification of an Adverse Event 
8.2.1 Severity of Event 
For AEs not included in the protocol defined grading system, the following guidelines will be used to 
describe severity. 
 
• Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities. 
• Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating. 
 
8.2.2 Relationship to Study Intervention 
For all collected AEs, the clinician who examines and evaluates the participant will determine the AE’s 
causality based on temporal relationship and his/her clinical judgment. The degree of certainty about 
causality will be graded using the categories below. 
• Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, including an abnormal laboratory test 
result, occurs in a plausible time relationship to intervention administration and cannot be 
explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the 
intervention (dechallenge) should be clinically plausible.  
• Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. The clinical event, including an abnormal laboratory test result, occurs within a 
reasonable time after administration of the intervention, is unlikely to be attributed to concurrent 
disease or other drugs or chemicals, and follows a clinically reasonable response on withdrawal 
(dechallenge). Rechallenge information is not required to fulfill this definition. 
• Possibly Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of the trial intervention). However, other 
factors may have contributed to the event (e.g., the participant’s clinical condition, other 
concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it 
can be flagged as requiring more information and later be upgraded to “probably related” or 
“definitely related,” as appropriate. 
• Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to intervention administration makes a causal relationship improbable (e.g., 
the event did not occur within a reasonable time after administration of the trial intervention) and in 
which other drugs or chemicals or underlying disease provides plausible explanations (e.g., the 
participant’s clinical condition, other concomitant treatments). 
• Not Related – The AE is completely independent of study intervention administration, and/or 
evidence exists that the event is definitely related to another etiology. There must be an 
alternative, definitive etiology documented by the clinician. 
 
8.2.3 Expectedness 
Dr. Susan Malone, PI will be responsible for determining whether an AE is expected or unexpected. An 
AE will be considered unexpected if the nature, severity, or frequency of the event is not consistent with 
the risk information previously described for the study intervention. 
8.3 Time Period and Frequency for Event Assessment and Follow-Up 
The occurrence of an AE or SAE may come to the attention of study personnel during study visits and 
interviews of a study participant presenting for medical care, or upon review by a study monitor. All AEs 
including local and systemic reactions not meeting the criteria for SAEs will be captured on the 

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appropriate RF. Information to be collected includes event description, time of onset, clinician’s 
assessment of severity, relationship to study intervention (assessed only by those with the training and 
authority to make a diagnosis), and time of resolution/stabilization of the event. All AEs occurring while on 
study must be documented appropriately regardless of relationship. All AEs will be followed to adequate 
resolution. 
 
Any medical condition that is present at the time that the participant is screened will be considered as 
baseline and not reported as an AE. However, if the study participant’s condition deteriorates at any time 
during the study, it will be recorded as an AE. UPs will be recorded in the data collection system 
throughout the study. 
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. AEs characterized as intermittent require documentation of 
onset and duration of each episode. 
 
The PI will record all reportable events with start dates occurring any time after informed consent is 
obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At 
each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events 
will be followed for outcome information until resolution or stabilization.  
 
All unresolved adverse events should be followed by the investigator until the events are resolved, the 
subject is lost to follow-up, or the adverse event is otherwise explained.  At the last scheduled visit, the 
investigator should instruct each subject to report any subsequent event(s) that the subject, or the 
subject’s personal physician, believes might reasonably be related to participation in this study.  The 
investigator should notify the study sponsor of any death or adverse event occurring at any time after a 
subject has discontinued or terminated study participation that may reasonably be related to this study. 
8.4 Reporting Procedures – Notifying the IRB  
8.4.1 
Adverse Event Reporting 
AEs are not expected due to participation in this minimal risk study. However, AE forms will be completed 
at each of the study assessments as well as any AEs reported during the weekly intervention sessions. 
Study participants will be encouraged to contact study staff immediately should any AEs occur during 
study participation. Periodic adverse event reporting will include any AE that occurs while a participant is 
on the research protocol, regardless of whether it is considered related to study participation. The PI will 
submit as part of annual progress reports to the IRB a summary of monitoring that took place; cumulative 
adverse event data; assessments that were performed to evaluate external factors or relevant information 
that may have an impact on the safety of study participants or ethics of the research study; outcomes of 
procedural reviews conducted to ensure participant privacy and confidentiality; and final conclusions 
regarding changes to the anticipated risk-to-benefit ratio of study participants and recommendations 
related to continuing, changing, or terminating the study. 
8.4.2 
Serious Adverse Event Reporting 
SAEs are not expected due to participation in this minimal risk study. The procedure for AE reporting will 
be followed for SAEs. In addition, if a serious adverse event occurs, it will be reported in a timely fashion 
after adjudication: All SAE reports will be made to the IRB within 5 working days; any participant deaths 
will be reported to the NINR Program Officer within 24 hours of realization, and all other serious adverse 
events will be reported to NINR within 72 hours of realization. 

Study number: 19-01745 
 
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8.4.3 
Unanticipated Problem Reporting 
Incidents or events that meet the OHRP criteria for UPs require the creation and completion of an UP 
report form. It is the site investigator’s responsibility to report UPs to their IRB and to the DCC/study 
sponsor. The UP report will include the following information: 
 
• Protocol identifying information: protocol title and number, PI’s name, and the IRB project number; 
• A detailed description of the event, incident, experience, or outcome; 
• An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP; 
• A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline: 
 
• UPs that are SAEs will be reported to the IRB and to the study sponsor within the timeframe 
described in 8.4.2 of the investigator becoming aware of the event. 
• Any other UP will be reported to the IRB and to the study sponsor within the timeframe described 
in 8.4.1 for AEs  of the investigator becoming aware of the problem. 
• All UPs should be reported to appropriate institutional officials (as required by an institution’s 
written reporting procedures), the supporting agency head (or designee), and OHRP within the 
time frame described for AEs or SAEs, as appropriate, of the IR’s receipt of the report of the 
problem from the investigator. 
8.4.4 
Reporting of Pregnancy 
Pregnant or breastfeeding participants will not be able participate in the study because pregnancy and 
lactation can disrupt habitual sleep patterns, and hormonal changes during pregnancy increase insulin 
resistance93. Female participants of child bearing potential will be asked to use a medically accepted 
method of birth control while in the study. If participants become pregnant during the course of the study, 
their data will not be used in the analyses. 
8.5 Reporting Procedures – Notifying the Study Sponsor 
The study clinician will complete a SAE Form within the following timelines: 
 
• All deaths and immediately life-threatening events, whether related or unrelated, will be recorded 
on the SAE Form and submitted to the DCC/study sponsor within 24 hours of site awareness. See 
Section 1, Key Roles for contact information. 
• Other SAEs regardless of relationship will be submitted to the DCC/study sponsor within 72 hours 
of site awareness. 
 
All SAEs will be followed until satisfactory resolution or until the site investigator deems the event to be 
chronic or the adherence to be stable. Other supporting documentation of the event may be requested by 
the DCC/study sponsor and should be provided as soon as possible.  
 
As a follow-up to the initial report, within the following 48 hours of awareness of the event, the investigator 
shall provide further information, as applicable, on the unanticipated event or the unanticipated problem in 
the form of a written narrative.  This should include a copy of the completed Unanticipated Problem form, 
and any other diagnostic information that will assist the understanding of the event.  Significant new 
information on ongoing unanticipated adverse effects shall be provided promptly to the study sponsor. 
8.6 Reporting Procedures – Participating Investigators  
Not applicable. 

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8.7 Study Halting Rules 
As this study is minimal risk, it is not anticipated that the study may be halted. However, if there is a 
determination of unexpected, significant, or unacceptable risk to participants, the study may be 
temporarily suspended or prematurely terminated as described in section 6.7 
8.8 Safety Oversight 
It is the responsibility of the Principal Investigator to oversee the safety of the study at his/her site.  This 
safety monitoring will include careful assessment and appropriate reporting of adverse events as noted 
above, as well as the construction and implementation of a site data and safety-monitoring plan. Dr. 
Victoria Dickson, CRNP, will be the medical monitor of the study and will review participant safety data 
including adverse event on a monthly basis as described in this section. Dr. Dickson is a certified 
registered nurse practitioner (CRNP) and is qualified to oversee the safety of participants in this study. It 
is within the scope of practice for nurse practitioners to care for patients throughout their lifespan. This 
may include the diagnosis of illness and physical conditions and the performance of therapeutic and 
corrective measures. 
 
Medical monitoring will include a regular assessment of the number and type of serious adverse events.  
 
The following are plans for data and safety monitoring during this R00 study: 
Monitoring entity. This study will be monitored by the PI, the project coordinator, the bio-statistician, 
and the IRB. The PI will ensure that the project coordinator undergoes training in the study protocol. The 
project coordinator will be trained in the safety protocol for depression. The PI will oversee adherence to 
the study protocol to ensure the safety, reliability, and validity of data collection. The PI will be responsible 
for submitting all necessary reports to the study sponsor and the IRB. The project coordinator will prepare 
monthly reports on participant demographics, recruitment, attrition, data collection, data entry updates, 
and any other issues or concerns since the last research team meeting. These reports will also contain a 
summary of monthly accrual and cumulative accrual, a summary of key characteristics of the study 
participants, and a summary of the completeness and quality of data. The statistician will prepare reports 
about missing, invalid, or inconsistent data on selected key variables as needed.  
 
Monitoring Study Safety. Once enrollment is initiated, the PI will arrange monthly meetings with the 
project coordinator and research assistant. These meetings will consist of retrospective and concurrent 
evaluation of all research procedures, including participant screening for inclusion/exclusion criteria, the 
informed consent process, and participant study instructions, as well as any necessary staff training in the 
IRB approved study protocol. The PI and Co-I will meet quarterly to review the study progress. Meetings 
will also be arranged by the PI if an adverse event occurs. 
 
Minimizing research-associated risk. We do not believe that there are any major risks associated with 
the proposed study, although a subject may be identified with OSA risk, T2DM, or moderate/severe or 
severe depression. This is not a research-associated risks but may be detected during screening or 
participation in the study. The sleep intervention and accelerometry monitoring have minimal risk. Trained 
research personnel will perform all testing and will be monitored by the PI. Throughout the study, the PI 
and the research coordinator will monitor participants for adverse events and for adherence to the study 
protocols. We have developed the following medical alert and reporting policies: 
1. ARES questionnaire  6 
a. For participants not eligible for the at-home assessment, refer the participant to a 
nearby sleep disorders center for further evaluation. 
b. For participants that are eligible for the at-home assessment, complete 1 night of at-
home pulse oximetry. 
2. Pulse oximetry AHI > 10 
a. Refer diagnosed and treated OSA participants to their health care provider. 

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b. For undiagnosed OSA participants, refer the participant to a nearby sleep disorders 
center for further evaluation. 
3. PHQ-9 response to question 9 
a. Participants responding “several days”, “more than half the days” or “nearly every 
day” to the PHQ-9 question: “Over the past 2 weeks, how often have you been 
bothered by any of the following problems?....Thoughts that you would be better 
off dead or of hurting yourself” will be screened further at the CTSI visit 1 by the 
project coordinator as per the Depression Safety and Referral Protocol. 
 
b. See the Depression Safety and Referral Protocol. 
4. HbA1c point of care fingerstick results  6.5% 
a.  Participants will be notified of HbA1c point of care fingerstick results  6.5% at the 
CTSI visit.  
b. Participants will be instructed to share the results with their PCP. If the participant 
does not identify a PCP, the authorized prescribing provider (Dr. Dickson) is 
notified and a referral made to the NYU Faculty practice health care providers. 
 
Protecting Participant Confidentiality. 
Participant Screening and Enrollment. When individuals are contacted to determine their interest in 
participating in the study, no language will be used that will indicate any study opportunity/eligibility or 
personal health information unless research personnel are speaking directly with the party of interest. All 
data from participants screened for the study will be entered into the Research Electronic Data Capture 
(REDCap). The collected data will be helpful in examining the patient population and feasibility of enrollment 
criteria and will include gender, age, race, and reason for exclusion. For retained participants, the research 
staff will collect and enter required data (written informed consent and demographics) onto study data forms 
in REDCap. Individuals will be assigned a unique study ID number. 
Only the PI and the study team will have access to the linkage between the participant identity and the 
study identification number. This linkage will be password protected and stored on a secure NYU server.. 
This linking file will be destroyed at closure of the study, and the study will remain open with the IRB until 
these identifiers are destroyed. The unique study identification number will be used on all data forms. 
Paper records, such as the informed consent documents, will be kept in a locked file cabinet in a locked 
office. All data will be reported in aggregate. 
Binders. A regulatory file will also be maintained to include the IRB- approved protocol, original informed 
consent documents, and other study-related regulatory documents. All paper research records and case 
record files will be maintained in a locked file cabinet in a secure facility within the College of Nursing. 
Access to the research records, study database and PHI’s will be restricted to study personnel as 
approved by the PI and IRB. 
Data entry, processing, monitoring. This study will use REDCap for data capture and management. Data 
exports will be limited to the PI, the project coordinator, and the statistician for generating reports and 
conducting statistical data analysis. Monthly meetings will include reports on participant recruitment and 
retention, adverse events, and protocol deviations, as well as summaries of monthly accrual and 
cumulative accrual, key characteristics of the study participants, and the completeness and quality of 
data. Information on missing, invalid, and inconsistent data on selected key variables will be reviewed. 
Data Security. All data will be saved in an electronic database on a secure NYU server. All system logins, 
data entries, and data updates are recorded, enabling efficient data tracking. Access to the server is 
available only to authorized users with passwords; overall data security is ensured by a firewall. 
Additional security is provided by database software requiring a password for data entry and allowing for 
password protection at the record level within a database. Patient confidentiality will be ensured by 
eliminating from the design of the data systems any information that could be used to identify individual 
participants. Each participant will be identified in the database by a project-specific ID number. Identifiable 

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information (e.g., name, birthdate, home address, or other personal information) will not be stored on any 
of the devices used in this study. For mobile devices and software such as the tablets or cell phones that 
will be used to gather survey data, guidelines established by NYU IRB will be followed including 
documentation of security controls, incident response program, compliance certifications, privacy 
practices, physical data security, and subcontractors. The packages that are shipped to and from study 
participants will not have any information on the exterior of the box indicating that they are a research 
participant. 
External factors. The PI will monitor developments in the literature as the study progresses. Should it 
become clear that the intervention would be in any way harmful to participants, would increase risk, or 
would be unethical to continue, the IRB and study sponsor will be notified and the study will be stopped. 
Futility analysis. As this randomized clinical trial will also be used to provide preliminary data (e.g., 
effect sizes) for a future well-powered R01 application, we will not do a futility analysis. 
9 Clinical Monitoring 
Clinical site monitoring is conducted to ensure that the rights and well-being of human subjects are 
protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct of the 
trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable 
regulatory requirement(s). 
 
• The PI or project coordinator will audit one case per quarter, selected at random, to confirm 
compliance with IRB requirements, including conformance with informed consent requirements, 
verification of source documents, and investigator compliance. 
• Authorized representatives of the IRB and the NINR may review de-identified information, as 
well as participants' identifiable information, for the purposes of assuring proper conduct of the 
research, addressing a specific reported incident, or verifying appropriate use of funds. The 
Quality Assurance and Quality Improvement Division of NYU’s Research and Regulatory 
Services may audit the study to confirm compliance. Access of any protected health information 
will be done in the offices of the PI in his presence. No identifiable information may be copied or 
taken off-site. 
10 Statistical Considerations 
10.1 Statistical and Analytical Plans 
A formal SAP will be developed for this study in consultation with the study biostatistician. Only a general 
overview of study statistics is included in this protocol. 
10.2 Statistical Hypotheses 
Sleep intervention participants will have a lower percentage of time glucose is ≥ 140mg/dL compared to 
control intervention participants after 8-weeks of treatment. 
10.3 Analysis Datasets 
Primary analyses will be performed within an intent-to-treat (ITT) sample, including all participants that are 
randomized to either the Sleep Intervention or Control Intervention.  
10.4 Description of Statistical Methods 
10.4.1 General Approach 
The goal of this single site, parallel arm randomized clinical trial is to assess the impact of improved sleep 
on glycemic control (percent time glucose is  ≥ 140) when compared to habitual sleep. Using descriptive 

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analyses, the investigators will describe each variable using measures of central tendency (means, 
medians) and variability (standard deviations, interquartile ranges) for continuous variables; counts and 
percentages for categorical variables. Data will be evaluated for anomalies (e.g., nonrandom missing 
data, erroneous outliers, multicollinearity, possible confounding) that may invalidate planned analyses. 
Data transformations, imputation, and/or robust and tailored analysis approaches will be used for non-
normally distributed variables. 
10.4.2 Analysis of the Primary Efficacy Endpoint(s) 
Linear regression models will be used to assess the effect of the sleep intervention with the subject 
specific change in the percent time glucose is ≥ 140 from baseline as the continuous outcome variable 
and intervention arm (0=Control Intervention, 1=Sleep Intervention) as a dichotomous predictor. Effect 
sizes will be presented as beta coefficients and associated 95% confidence intervals, equal to the 
expected difference between the SI and CI. Important covariates that will be controlled for in these 
analyses include demographic characteristics including age, sex, race/ethnicity and behaviors 
characteristics including diet quality and physical activity. The rationale for including these covariates is 
because of their associations with both sleep and glycemic control. Statistical significance will be 
determined with a p-value < 0.05 using a two-tailed test for significance. 
10.4.3 Analysis of the Secondary Endpoint(s) 
The same analytic approach described in Section 10.4.2 will be used to assess the effect of the sleep 
intervention with the subject specific change in glucose variability. 
10.4.4 Safety Analyses 
As this study is minimal risk, it is not anticipated that the study may be halted. However, if there is a 
determination of unexpected, significant, or unacceptable risk to participants, the study may be 
temporarily suspended or prematurely terminated. 
10.4.5 Adherence and Retention Analyses 
Intervention compliance will be defined by 80% completion rate of daily sleep diaries and 80% attendance 
at the intervention sessions.  
10.4.6 Baseline Descriptive Statistics 
Demographic and other measures will be compared between the sleep intervention and control 
intervention arms at baseline using T-tests or Wilcoxon rank sum tests for continuous measures and chi-
squared or Fisher’s exact tests for categorical variables. Given the randomized nature of the study 
design, the two arms are expected to be balanced with respect to all baseline characteristics; in the 
unlikely case that there is imbalance in important covariates, these measures will be adjusted for in 
statistical models.  
10.4.7 Planned Interim Analysis 
Not applicable. 
 
10.4.7.1 Safety Review 
Not applicable. 
10.4.7.2 Efficacy Review 
Not applicable. 
10.4.8 Additional Sub-Group Analyses 
To obtain a robust estimate of the treatment effect, we will perform secondary analyses within a per-
protocol (PP) sample, defined in the Sleep Intervention arm as obtaining at least 1 hour/night longer in 

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sleep by the end of the 8-week protocol. Controls that show over a 1 hour/night increase in their habitual 
sleep durations, such that they meet the above definition for investigational patients, will also be excluded 
from the PP sample. In our preliminary data utilizing the proposed intervention, 4 of 5 (80%) individuals 
met this criteria; the remaining participant almost achieved this threshold, with 57.7 minutes increased 
sleep; thus, we expect at least 80% of the sample to be retained in PP analyses. 
 
Primary or secondary endpoints may be analyzed for descriptive purposes by age, race/ethnicity, or any 
other participant characteristic as described in detail in the SAP. 
10.4.9 Multiple Comparison/Multiplicity 
Not applicable.  
10.4.10 
Tabulation of Individual Response Data 
For these analyses, the investigators will generally not control for multiple comparisons. 
10.4.11 
Exploratory Analyses 
The same analytic approach described in Section 10.4.2 will be used to assess the effect of the sleep 
intervention with the subject specific change in diet quality and physical activity. 
10.5 Sample Size 
The primary analyses will involve comparing the mean change in the percent time glucose is ≥ 140 from 
baseline between the sleep intervention and control intervention arms. The study by Leproult et al76 
(N=16) reported no significant changes in insulin or glucose with sleep extension, but did not provide 
effect sizes for determining power; they did report large significant correlations (rho>0.6) between 
increased sleep time and insulin. Thus, for powering the current study, effect size assumptions come from 
previous research examining effects of weekend sleep extension on improvement in the calculated area 
under the glucose curve (Glucose AUC), which is similar to the primary endpoint we are studying here. 
Specifically, Killick et al75 observed a mean improvement in Glucose AUC of 69.2 mmol min.L-1 (SD = 
57.7) associated with weekend sleep extension; this corresponds to an effect size of ~1.2 standard 
deviations. If we observe this large effect, we would need 20 subjects per arm to have 95% power in the 
current study, at an α=0.05. To protect against over-estimates in this observed effect, which was 
conducted in a study with <20 individuals and relied on a different sleep intervention than proposed here, 
we note that 74 individuals per arm would be required to maintain 95% power in the ITT analysis set for a 
50% reduction in this effect (i.e., 0.6 SDs) at an alpha of 0.05; thus, we will recruit 75 subjects per arm in 
the current study. Under our expectation that at least 80% will achieve our PP definition (n=60 per arm), 
we would maintain power of at least 90% for this effect size in the PP analysis set. To maintain power for 
up to 20% loss to follow-up or non-adherence during the 8-week intervention, we will plan to enroll a total 
of 188 participants in the two arms. 
10.6 Measures to Minimize Bias 
10.6.1 Enrollment/Randomization/Masking Procedures 
After the 2-week at-home sleep assessment and baseline data collection, eligible participants will be 
randomly assigned to the sleep intervention group or to the time and attention matched control 
intervention group using a block randomization method. Selection bias will be reduced by using random 
block sizes and keeping the PI blind to the size of each block. Participants will be blinded to the group 
assignment. It will not be possible to blind the interventionists to the intervention. The study 
biostatistician will have no direct contact with study participants and will not be blinded to group 
assignment. The biostatistician will produce and maintain the randomization codes for the blocks. 
Randomization may only be unmasked by the biostatistician at the completion of analysis of the primary 
outcome, or for reporting of SAEs or UPs for which it will be essential to provide information to the PI on 
group assignment. 

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10.6.2 Evaluation of Success of Blinding 
Blinding will be considered successful if participants remain unaware of group assignment. 
10.6.3 Breaking the Study Blind/Participant Code 
Participant blinding will be broken before completion of the study only for reporting of SAEs or UPs. For 
SAEs or UPs that could affect other participants, the entire group will be unblinded so that the PI and 
study staff can discuss with these participants whether it is safe for them to continue in the study. 
 
While every effort will be made to remind interventionists not to unblind the participant, it is possible that 
the interventionist  may unintentionally unblind the participant during the intervention. If a blind is 
unintentionally broken, it will be reported to the study biostatistician and discussed by the data and 
safety monitoring team. Any unintentional unblindings will be reported to the IRB as a deviation from 
protocol. The participant will be allowed to continue in the study and data will be analyzed. 
11 Source Documents and Access to Source Data/Documents 
Source data is all information, original records of clinical findings, observations, or other activities in a 
clinical trial necessary for the reconstruction and evaluation of the trial.  Source data are contained in 
source documents.  Examples of these original documents, and data records include: hospital records, 
clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, 
pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions 
certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm 
or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at 
medico-technical departments involved in the clinical trial.  
 
The study case report form (CRF) is the primary data collection instrument for the study.  All data 
requested on the CRF must be recorded.  All missing data must be explained.  If a space on the CRF is 
left blank because the procedure was not done or the question was not asked, write “N/D”.  If the item is 
not applicable to the individual case, write “N/A”.  All entries should be printed legibly in black ink.  If any 
entry error has been made, to correct such an error, draw a single straight line through the incorrect entry 
and enter the correct data above it.  All such changes must be initialed and dated.  DO NOT ERASE OR 
WHITE OUT ERRORS.  For clarification of illegible or uncertain entries, print the clarification above the 
item, then initial and date it. 
 
Access to study records will be limited to IRB-approved members of the study team. The investigator will 
permit study-related monitoring, audits, and inspections by the IRB/EC, the sponsor, government 
regulatory bodies, and University compliance and quality assurance groups of all study related 
documents (e.g. source documents, regulatory documents, data collection instruments, study data etc.).  
The investigator will ensure the capability for inspections of applicable study-related facilities (e.g. 
pharmacy, diagnostic laboratory, etc.). 
 
Participation as an investigator in this study implies acceptance of potential inspection by government 
regulatory authorities and applicable University compliance and quality assurance offices. 
12 Quality Assurance and Quality Control 
QC procedures will be implemented beginning with the data entry system and data QC checks that will be 
run on the database will be generated. Any missing data or data anomalies will be communicated to the 
site(s) for clarification/resolution. 
 
Following written SOPs, the monitors will verify that the clinical trial is conducted and data are generated, 
documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory 
requirements (e.g., Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)). 
 

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The investigational site will provide direct access to all trial related sites, source data/documents, and 
reports for the purpose of monitoring and auditing by the sponsor, and inspection by local and regulatory 
authorities. 
13 Ethics/Protection of Human Subjects 
13.1 Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with Regulations for the 
Protection of Human Subjects of Research codified in 45 CFR Part 46. 
13.2 Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form must be 
obtained before any participant is enrolled. Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study. All changes to the consent form 
will be IRB approved; a determination will be made regarding whether previously consented participants 
need to be re-consented. 
13.3 Informed Consent Process 
13.3.1 Consent/Assent and Other Informational Documents Provided to Participants 
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
participant and written documentation of informed consent is required prior to starting intervention. The 
following consent materials are submitted with this protocol: Informed Consent (reviewed and signed at 
CTSI visit 1) and Audio Consent for intervention fidelity checking (reviewed and signed at CTSI visit 1). 
13.3.2 Consent Procedures and Documentation 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study 
and continues throughout the individual’s study participation. Extensive discussion of risks and possible 
benefits of participation will be provided to the participants and their families. Consent forms will be IRB-
approved and the participant will be asked to read and review the document. The investigator will explain 
the research study to the participant and answer any questions that may arise. All participants will receive 
a verbal explanation in terms suited to their comprehension of the purposes, procedures, and potential 
risks of the study and of their rights as research participants. Participants will have the opportunity to 
carefully review the written consent form and ask questions prior to signing. The participants should have 
the opportunity to discuss the study with their surrogates or think about it prior to agreeing to participate. 
The participant will sign the informed consent document prior to any procedures being done specifically 
for the study. The participants may withdraw consent at any time throughout the course of the trial. A 
copy of the signed informed consent document will be given to the participants for their records. The 
rights and welfare of the participants will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study. 
 
A copy of the signed informed consent document will be stored in the subject’s research record. The 
consent process, including the name of the individual obtaining consent, will be thoroughly documented in 
the subject’s research record. Any alteration to the standard consent process (e.g. use of a translator, 
consent from a legally authorized representative, consent document presented orally, etc.) and the 
justification for such alteration will likewise be documented.  
 
13.4 Posting of Clinical Trial Consent Form 
The informed consent form will be posted on the Federal website after the clinical trial is closed to 
recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.  

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13.5 Participant and Data Confidentiality 
Information about study subjects will be kept confidential and managed according to the requirements of 
the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Medical records of non-NYU 
patients will not be obtained. All non-NYU patients will be required to have a fingerstick for HbA1c. Those 
regulations require a signed subject authorization informing the subject of the following:  
• What protected health information (PHI) will be collected from subjects in this study 
• Who will have access to that information and why 
• Who will use or disclose that information  
• The rights of a research subject to revoke their authorization for use of their PHI.  
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, 
retains the ability to use all information collected prior to the revocation of subject authorization.  For 
subjects that have revoked authorization to collect or use PHI, attempts should be made to obtain 
permission to collect at least vital status (i.e. that the subject is alive) at the end of their scheduled study 
period. 
 
Participant confidentiality is strictly held in trust by the participating investigators, their staff, and the 
sponsor(s) and their agents. This confidentiality is extended to cover testing of biological samples and 
genetic tests in addition to the clinical information relating to participants. Therefore, the study protocol, 
documentation, data, and all other information generated will be held in strict confidence. No information 
concerning the study or the data will be released to any unauthorized third party without prior written 
approval of the sponsor. 
 
The study monitor, other authorized representatives of the sponsor, or representatives of the IRB may 
inspect all documents and records required to be maintained by the investigator, including but not limited 
to, medical records (office, clinic, or hospital) and pharmacy records for the participants in this study. The 
clinical study site will permit access to such records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by local IRB and Institutional regulations. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted to and stored in the research offices of the PI at the NYU Meyers College of Nursing. This 
will not include the participant’s contact or identifying information. Rather, individual participants and their 
research data will be identified by a unique study identification number. The study data entry and study 
management systems used by clinical sites and by NYU Meyers College of Nursing research staff will be 
secured and password protected. At the end of the study, all study databases will be de-identified and 
archived at the NYU Meyers College of Nursing. 
 
To further protect the privacy of study participants, a Certificate of Confidentiality will be obtained from the 
NIH. This certificate protects identifiable research information from forced disclosure. It allows the 
investigator and others who have access to research records to refuse to disclose identifying information 
on research participation in any civil, criminal, administrative, legislative, or other proceeding, whether at 
the federal, state, or local level. By protecting researchers and institutions from being compelled to 
disclose information that would identify research participants, Certificates of Confidentiality help achieve 
the research objectives and promote participation in studies by helping assure confidentiality and privacy 
to participants. 
13.5.1 Research Use of Stored Human Samples, Specimens, or Data 
Existing or stored samples will not be used for this study. 

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13.6 Future Use of Stored Specimens 
Data collected for this study will be analyzed and stored at the Bluestone Center for Clinical Research. 
After the study is completed, the de-identified, archived data will be transmitted to and stored at the 
Meyers Biological Laboratory under the supervision of Dr. Susan Malone, for use by other researchers 
including those outside of the study. Permission to transmit data to the Meyers Biological Laboratory will 
be included in the informed consent. These samples could be used for research into the causes of 
metabolic disorders and multiple chronic conditions, its complications and other conditions for which 
individuals with the metabolic syndrome are at increased risk, and to improve treatment. The Meyers 
Biological Laboratory will also be provided with a code-link that will allow linking the biological specimens 
with the phenotypic data from each participant, maintaining the masking of the identity of the participant. 
 
Samples will be stored indefinitely in the Meyer’s Biological Laboratory located on the 10th floor of 433 1st  
Avenue (Room 1068). Samples will be stored consistent with the ICF. Samples will be coded and only the 
NYU PI will have access to the linking key between the participant ID and the participant identity. Only 
researchers authorized by the PI will have access to the banked samples. Samples will be coded with 
freezer safe labels and stored in freezers with emergency backup power. No genetic testing will be 
performed in the future use of samples. Samples will be stored until they are all used up. 
  
During the conduct of the study, an individual participant can choose to withdraw consent to have 
biological specimens stored for future research. However, withdrawal of consent with regard to 
biosamples storage will not be possible after the samples have been used. 
 
When the study is completed, access to study data and/or samples will be provided through the Meyers 
Biological Laboratory. 
14 Data Handling and Record Keeping 
14.1 Data Collection and Management Responsibilities 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site PI. 
The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the 
data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation of 
data. Black ink is required to ensure clarity of reproduced copies. When making changes or corrections, 
cross out the original entry with a single line, and initial and date the change. DO NOT ERASE, 
OVERWRITE, OR USE CORRECTION FLUID OR TAPE ON THE ORIGINAL. 
 
Copies of the electronic CRF (eCRF) will be provided for use as source documents and maintained for 
recording data for each participant enrolled in the study. Data reported in the eCRF derived from source 
documents should be consistent with the source documents or the discrepancies should be explained 
and captured in a progress note and maintained in the participant’s official electronic study record. 
 
Clinical data (including AEs, concomitant medications, and expected adverse reactions data) and clinical 
laboratory data will be entered into REDCap, a data capture system provided by the NYULH. The data 
system includes password protection and internal quality checks, such as automatic range checks, to 
identify data that appear inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from 
the source documents. 
14.2 Study Records Retention 
Study documents will be retained for the longer of 3 years after close out or 5 years after final 
reporting/publication. These documents should be retained for a longer period, however, if required by 
local regulations. No records will be destroyed without the written consent of the sponsor, if applicable. It 
is the responsibility of the sponsor to inform the investigator when these documents no longer need to be 
retained. 

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14.3 Protocol Deviations 
A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or MOP requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly. 
 
These practices are consistent with ICH E6: 
• 4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3 
• 5.1 Quality Assurance and Quality Control, section 5.1.1 
• 5.20 Noncompliance, sections 5.20.1, and 5.20.2. 
 
It is the responsibility of the site to use continuous vigilance to identify and report deviations within 3 
working days of identification of the protocol deviation, or within 3 working days of the scheduled protocol-
required activity. All deviations must be addressed in study source documents, reported to NYU IRB. 
Protocol deviations must be reported to the local IRB per their guidelines. The site PI/study staff is 
responsible for knowing and adhering to their IRB requirements. Further details about the handling of 
protocol deviations will be included in the MOP. 
14.4 Publication and Data Sharing Policy 
This study will comply with the NIH Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
The International Committee of Medical Journal Editors (ICMJE) member journals have adopted a clinical 
trials registration policy as a condition for publication. The ICMJE defines a clinical trial as any research 
project that prospectively assigns human subjects to intervention or concurrent comparison or control 
groups to study the cause-and-effect relationship between a medical intervention and a health outcome. 
Medical interventions include drugs, surgical procedures, devices, behavioral treatments, process-of-care 
changes, and the like. Health outcomes include any biomedical or health-related measures obtained in 
patients or participants, including pharmacokinetic measures and adverse events. The ICMJE policy, and 
the Section 801 of the Food and Drug Administration Amendments Act of 2007, requires that all clinical 
trials be registered in a public trials registry such as ClinicalTrials.gov, which is sponsored by the National 
Library of Medicine. Other biomedical journals are considering adopting similar policies. For interventional 
clinical trials performed under NIH IC grants and cooperative agreements, it is the grantee’s responsibility 
to register the trial in an acceptable registry, so the research results may be considered for publication in 
ICMJE member journals. The ICMJE does not review specific studies to determine whether registration is 
necessary; instead, the committee recommends that researchers who have questions about the need to 
register err on the side of registration or consult the editorial office of the journal in which they wish to 
publish. 
 
FDAAA mandates that a "responsible party" (i.e., the sponsor or designated principal investigator) register 
and report results of certain "applicable clinical trials": 
 
• Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I investigations 
of a product subject to FDA regulation; 
• Trials of Devices: Controlled trials with health outcomes of a product subject to FDA regulation 
(other than small feasibility studies) and pediatric postmarket surveillance studies. 
• NIH grantees must take specific steps to ensure compliance with NIH implementation of FDAAA. 

Study number: 19-01745 
 
Page 34 
Version: July 8, 2021 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and NYU Langone Health.  Do not disclose or use except as authorized 
in writing by the study sponsor 
Behavioral Intervention Template Version: 11 January 2019 
15 Study Finances 
15.1 Funding Source 
This study is funded through a grant from the National Institutes of Health, National Institute of Nursing 
Research R00NR017416. 
15.2 Costs to the Participant 
Participants will not be charged for any procedures of this study. 
15.3 Participant Reimbursements or Payments 
This payment system reflects the significant commitment and effort that data collection is anticipated to 
require on the part of participants. Therefore, the guidelines for the market model of payment from Dickert 
and Grady will be used for the remuneration plan100. The function of payment in the market model is that 
of an incentive rather than a reward. Using this model, participants will receive a $25 gift card at 
enrollment, a $25 gift card after 4-weeks of the sleep intervention is complete, and a $50 when they 
complete the study, for a total remuneration of $100 per participant in the form of gift cards for the 15-
week commitment. Transportation cost incurred by the participant for required CTSI visits will be 
reimbursed. $10 for recruitment of each peer who completes CTSI screening visit.  
16 Study Administration 
16.1 Study Leadership 
The study team will govern the conduct of the study. The study team will be composed of the PI, a co-
investigator, two key collaborators, a biostatistician, and a project coordinator, as listed in section 1. With 
the exception of NINR personnel, who will meet with the study team when required, the PI will schedule 
monthly study team meetings. In addition, the PI will meet individually with study team members as 
needed. 
 
17 Conflict of Interest Policy 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a 
way that is appropriate to their participation in the trial. The study leadership in conjunction with the NIH 
has established policies and procedures for all study group members to disclose all conflicts of interest 
and will establish a mechanism for the management of all reported dualities of interest.  
 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial gain 
greater than the minimum allowable by their institution, etc.) must have the conflict reviewed by the NYU 
Langone Conflict of Interest Committee with a Committee-sanctioned conflict management plan that has 
been reviewed and approved by the study sponsor prior to participation in this study.  All NYULMC 
investigators will follow the applicable conflict of interest policies. 
 
 
 
 

Study number: 19-01745 
 
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in writing by the study sponsor 
Behavioral Intervention Template Version: 11 January 2019 
18 References 
1. 
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in writing by the study sponsor 
Behavioral Intervention Template Version: 11 January 2019 
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Version: July 8, 2021 
 
 
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in writing by the study sponsor 
Behavioral Intervention Template Version: 11 January 2019 
49. 
Leproult R, Holmback U, Van Cauter E. Circadian Misalignment Augments Markers of Insulin 
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McHill AW, Melanson EL, Higgins J, et al. Impact of circadian misalignment on energy 
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64. 
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67. 
Scheer FA, Hilton MF, Mantzoros CS, Shea SA. Adverse metabolic and cardiovascular 
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69. 
Reutrakul S, Siwasaranond N, Nimitphong H, et al. Relationships among sleep timing, sleep 
duration and glycemic control in Type 2 diabetes in Thailand. Chronobiol Int 2015;32:1469-76. 
70. 
Pan A, Schernhammer ES, Sun Q, Hu FB. Rotating night shift work and risk of type 2 diabetes: 
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71. 
Morikawa Y, Nakagawa H, Miura K, et al. Shift work and the risk of diabetes mellitus among 
Japanese male factory workers. Scandinavian journal of work, environment & health 2005;31:179-83. 

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CONFIDENTIAL 
This material is the property of the NYU School of Medicine and NYU Langone Health.  Do not disclose or use except as authorized 
in writing by the study sponsor 
Behavioral Intervention Template Version: 11 January 2019 
72. 
Suwazono Y, Sakata K, Okubo Y, et al. Long-term longitudinal study on the relationship between 
alternating shift work and the onset of diabetes mellitus in male Japanese workers. Journal of 
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Suwazono Y, Dochi M, Oishi M, Tanaka K, Kobayashi E, Sakata K. Shiftwork and impaired 
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Kang X, Wang C, Lifang L, et al. Effects of Different Proportion of Carbohydrate in Breakfast on 
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Soliman A, DeSanctis V, Yassin M, Elalaily R, Eldarsy N. Continuous glucose monitoring system 
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90. 
Wang C, Lv L, Yang Y, et al. Glucose fluctuations in subjects with normal glucose tolerance, 
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Study number: 19-01745 
 
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in writing by the study sponsor 
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94. 
Rha SY, Lee J. Symptom clusters during palliative chemotherapy and their influence on 
functioning and quality of life. Supportive care in cancer : official journal of the Multinational Association of 
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95. 
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Sleep from Inpatient Alcohol Rehabilitation Treatment to the Community. PLoS One 2016;11:e0161725. 
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Punjabi NM. Sleep disordered breathing and cardiovascular disease: An outcome-based 
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PAYMENT FOR RESEARCH PARTICIPATION. New England Journal of Medicine 1999:198-203. 
 
 
 

Study number: 19-01745 
 
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in writing by the study sponsor 
Behavioral Intervention Template Version: 11 January 2019 
19 Attachments 
These documents are relevant to the protocol, but they are not considered part of the protocol.  They are 
stored and modified separately. As such, modifications to these documents do not require protocol 
amendments. 
• 
Attachment A: Schedule of Events 
 
 

 
STOP T2 
 
page 1 
Version: July 8, 2021 
CONFIDENTIAL 
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Drug/Device Template Version: 11 Jan 2019 
Attachment A 
Schedule of Events 
 
 
Activity 
Telephone 
Screen 
[-30 to -1 day] 
CTSI Visit 1 
[Day 0] 
Week 1 
[Days 1-7] 
Week 2 
[Days 8-15] 
 
Week 3 
[Days 16-23] 
Week 4-11 
[Days 24-80] 
CTSI Visit 2 
[Days 81-87] 
 
Week 13 
[Days 88-95] 
 
Week 14 
[Days 96-103] 
Study team 
procedures 
  
  
  
  
 
  
  
 
 
Telephone 
Screen 
X 
 
 
 
 
 
 
 
 
Schedule CTSI 
Visit  
X 
 
 
 
 
X (week 8) 
 
 
 
Study consent 
 
X 
 
 
 
 
 
 
 
Anthropometric 
measurements & 
blood pressure 
 
X 
 
 
 
 
x 
 
 
Randomization 
 
 
 
 
X 
 
 
 
 
Study 
intervention 
provided 
 
 
 
 
 
X 
 
 
 
Participant 
intervention 
compliance 
check 
 
 
X 
X 
 
X 
 
 
X 
 
X 
Subject Survey 
 
X 
X 
X 
 
X 
X 
X 
X 
Continuous 
glucose 
monitoring 
 
 
X 
 
 
 
 
 
X 
 
Wrist 
accelerometer 
 
 
X 
X 
 
 
 
X 
X 
Pulse oximetry 
 
 
X (1 night, 
if needed) 
 
 
 
 
 
 
Final visit  
 
 
 
 
 
 
 
 
optional 
Laboratory 
Assessments 
 
 
 
 
 
 
 
 
 
HbA1c point of 
care fingerstick 
 
X  
(if needed) 
 
 
 
 
 
 
 
Optional blood 
draw 
 
X