Continuous Glucose Monitoring in Pregnant Patients With Type 2 Diabetes, a Mixed Methods Approach
Phase: NA
Conditions: Type2Diabetes, Pregnancy in Diabetic
Sponsor: University of Wisconsin, Madison

AT GOAL: Adopting Technology for Glucose Optimization and 
Lifestyle in Pregnancy 
NCT05370612
Protocol Version date: 18 March 2024

Page i of 44
AT GOAL: Adopting Technology for Glucose 
Optimization and Lifestyle in Pregnancy 
Protocol Number: [IRB /Other Protocol Number 2022-028]
Principal Investigator: Jacquelyn Adams
IND/IDE Sponsor: Dexcom
University of Wisconsin Department of Obstetrics and Gynecology 
Research and Development Internal Funding 
This document is confidential.
No part of it may be transmitted, reproduced, published, or used by other persons 
without prior authorization from the Sponsor or Principal Investigator.
Protocol Version History
Protocol 
Version
Version Date
Summary of Revisions Made
1.0
10/2021
Initial version
1.1
03Nov2021
Incorporated into ICTR template
1.2
24Nov2021
Qualitative analysis to include all participants, stats info added
1.5
27Oct2022
Update to study risks
1.6
19Dec2022
Update to study calendar 
1.8
29Jan2023
Change to screening procedures
1.11
16Oct2023
Update to withdraw, exit interviewing, and delineating measures 
for early delivery
1.14
01Nov2023
1. clarification of study procedures when subjects self-withdraw
or are withdrawn by the PI
2. patient noncompliance description
3. description of subject final visit
4. description of mixed method study format
5. inclusion of communication with patients who speak Spanish
IRB NUMBER: 2022-028
IRB APPROVAL DATE: 03/28/2024

- i -
Table of Contents
1.0 STATEMENT OF COMPLIANCE ..........................................................................................1
2.0 LIST OF ABBREVIATIONS...................................................................................................2
3.0 STUDY SUMMARY................................................................................................................3
3.1
Synopsis .............................................................................................................3
3.2
Schematic of Study Design.................................................................................6
4.0 KEY ROLES...........................................................................................................................8
5.0 INTRODUCTION....................................................................................................................9
5.1
Type 2 Diabetes Background..............................................................................9
5.2
Current Standard of Care – Point of care glucose testing ..................................9
5.3
Continuous glucose monitors/glucose sensors.................................................10
5.4
Rationale...........................................................................................................10
6.0 STUDY OBJECTIVES AND ENDPOINTS...........................................................................10
7.0 STUDY DESIGN...................................................................................................................12
7.1
General Design.................................................................................................12
7.2
End of Study Definition .....................................................................................13
8.0 SUBJECT SELECTION .......................................................................................................13
8.1
Inclusion & Exclusion Criteria ...........................................................................13
8.2
Vulnerable Populations.....................................................................................13
8.3
Lifestyle Considerations....................................................................................13
8.4
Subject Identification and Recruitment .............................................................13
8.5
Remuneration and Retention Strategies...........................................................14
8.6
Early Termination and Withdrawal....................................................................14
9.0 STUDY AGENT (STUDY DRUG, DEVICE, BIOLOGIC, VACCINE, ETC.) AND/OR 
PROCEDURAL INTERVENTION AND/OR BEHAVIORAL OR SOCIAL INTERVENTION
............................................................................................................................................15
9.1
Study Agent and Control Description................................................................15
9.1.1
Source ............................................................................................................................15
9.1.2
Packaging and Labeling .................................................................................................15
9.1.3
Preparation .....................................................................................................................16
9.1.4
Storage and Stability.......................................................................................................16
9.1.5
Accountability..................................................................................................................16
9.1.6
Dosing and Administration..............................................................................................16
9.2
Method for Assigning to Treatment Groups......................................................16
9.3
Study Intervention Compliance.........................................................................16
9.4
Concomitant Therapy........................................................................................17
9.4.1
Permitted Concomitant Therapy.....................................................................................17
9.4.2
Prohibited Concomitant Therapy ....................................................................................17
10.0STUDY VISITS AND PROCEDURES..................................................................................17
IRB NUMBER: 2022-028
IRB APPROVAL DATE: 03/28/2024

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10.1
Study Calendar .................................................................................................17
10.2
Screening and Enrollment.................................................................................17
10.2.1
Pre-screening .................................................................................................................17
10.2.2
Informed Consent ...........................................................................................................18
10.2.3
Enrollment.......................................................................................................................18
10.2.4
Screen Failure and Re-enrollment..................................................................................18
10.3
On-Study/Follow-up Visits.................................................................................19
10.3.1
Visit 2..............................................................................................................................19
10.3.2
Visit 3..............................................................................................................................19
10.3.3
Visit 4..............................................................................................................................19
10.3.4
Final Study Visit..............................................................................................................19
10.4
Unscheduled Visits ...........................................................................................19
10.5
Early Termination/Withdrawal Visit ...................................................................19
10.6
Long-Term Follow-up | Re-contacting Subjects................................................19
11.0DATA HANDLING AND RECORD KEEPING.....................................................................19
11.1
Data Collection..................................................................................................19
11.1.1
Data Collection Forms ....................................................................................................19
11.1.2
Data Management Software System(s)..........................................................................20
11.2
Confidentiality and Privacy................................................................................20
11.3
Records Retention ............................................................................................21
11.4
Retention for Future Research: Data, Image, Audio- or Video-Recording & 
Biospecimen Banking .......................................................................................21
11.4.1
Purpose of Storage.........................................................................................................21
11.5
Protocol Deviations...........................................................................................21
11.6
Publication and Data Sharing Policies..............................................................22
12.0STUDY ANALYSIS ..............................................................................................................22
12.1
Statistical Hypotheses.......................................................................................22
12.2
Sample Size Justification..................................................................................22
12.3
Subject Population(s) for Analysis ....................................................................22
12.4
Statistical Methods............................................................................................23
12.5
Planned Interim Analysis ..................................................................................23
12.6
Handling of Missing Data..................................................................................23
13.0RISK/BENEFIT ASSESSMENT...........................................................................................23
13.1
Known Potential Benefits to the Subjects .........................................................23
13.2
Known Potential Risks ......................................................................................23
13.2.1
Known Interventional Risks ............................................................................................23
13.3
Risk/Benefit Analysis ........................................................................................23
14.0DATA AND SAFETY MONITORING ...................................................................................24
14.1
Adverse Event (AE) Definition ..........................................................................24
14.2
Serious Adverse Event (SAE) Definition...........................................................24
14.3
Classification of an Adverse Event ...................................................................24
14.3.1
Severity of Event.............................................................................................................24
14.3.2
Relationship to Study, Study Procedure and/or Study Intervention................................25
14.3.3
Expectedness for Study, Study Procedure and/or Study Intervention............................25
IRB NUMBER: 2022-028
IRB APPROVAL DATE: 03/28/2024

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14.4
Time Period and Frequency for Event Assessment and Follow-Up .................25
14.5
Reporting AEs and SAEs..................................................................................26
14.5.1
Reporting AEs.................................................................................................................26
14.5.2
Reporting SAEs ..............................................................................................................27
14.6
Unanticipated Problems....................................................................................27
14.7
Unanticipated Adverse Device Effect................................................................28
14.8
Incidental Findings............................................................................................28
14.9
Safety Oversight ...............................................................................................28
14.10 Study Monitoring...............................................................................................28
14.11 Study Stopping Rules .......................................................................................29
15.0STUDY FEASIBILITY ..........................................................................................................30
15.1
Economic Burden to Subjects...........................................................................30
15.2
Facilities and Locations.....................................................................................30
15.3
Feasibility of Recruiting the Required Number of Subjects...............................30
15.4
Principal Investigator Considerations................................................................30
15.4.1
Time Devoted to Conducting the Research....................................................................30
15.4.2
Process for Informing Study Teams ...............................................................................30
15.5
Availability of Medical or Psychological Resources ..........................................30
16.0REFERENCES.....................................................................................................................30
17.0APPENDICES ......................................................................................................................31
17.1
Patient Surveys.................................................................................................31
IRB NUMBER: 2022-028
IRB APPROVAL DATE: 03/28/2024

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Version Date:18Mar2024
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1.0
STATEMENT OF COMPLIANCE
I confirm that I have read this protocol. I will comply with the IRB-approved protocol, and applicable 
regulations, guidelines, laws, and institutional policies. 
I agree to ensure that all staff members involved in the conduct of this study are informed about their 
obligations in meeting the above commitment. 
Name
Signature
Date
Jacquelyn Adams
_______________________________
_________________________
____________
Principal investigator
_______________________________
_________________________
_____________
Sponsor
IRB NUMBER: 2022-028
IRB APPROVAL DATE: 03/28/2024

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2.0
LIST OF ABBREVIATIONS
AE
Adverse Event
CCC
Clinical Coordinating Center
CFR
Code of Federal Regulations
CGM
Continuous Glucose Monitor
CMP
Clinical Monitoring Plan
CRF
Case Report Form
CTCAE
Common Terminology Criteria for Adverse Events
CTMS
Clinical Trial Management Software
DCC
Data Coordinating Center
DHHS
Department of Health and Human Services
DMC
Data Monitoring Committee
DSMB
Data & Safety Monitoring Board 
DSMC
Data & Safety Monitoring Committee
DSMP
Data & Safety Monitoring Plan
eCRF
Electronic Case Report Forms
EDC
Electronic Data Capture
FDA
Food and Drug Administration
GCP
Good Clinical Practice
GWAS
Genome-Wide Association Studies
HIPAA
Health Insurance Portability and Accountability Act
IB
Investigator’s Brochure
IDE
Investigational Device Exemption
ICTR
Institute for Clinical and Translational Research
IND
Investigational New Drug Application
IRB
Institutional Review Board
MOP
Manual of Procedures
NIH
National Institutes of Health
OHRP
Office for Human Research Protections
PHI
Protected Health Information
PI
Principal Investigator
POC
Point of Contact
PRC
Pharmaceutical Research Center
REDCap
Research Electronic Data Capture
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
sIRB
single IRB
SMART IRB
Streamlined, Multisite, Accelerated Resources for Trials IRB
SMC
Safety Monitoring Committee
UP
Unanticipated Problem
IRB NUMBER: 2022-028
IRB APPROVAL DATE: 03/28/2024

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3.0
STUDY SUMMARY
3.1 Synopsis
Full Title
Continuous glucose monitoring in pregnant patients with Type 2 Diabetes, a mixed methods 
approach
Short Title
CGM for T2DM
Protocol Number
 UPH-Meriter IRB 2022-028
ClinicalTrials.gov 
Identifier & 
Summary
Clinicaltrials.gov identifier: NCT05370612
This is a randomized controlled, mixed methods pilot study on the use of continuous glucose 
monitors for the treatment of Type 2 diabetes in pregnant patients. Continuous glucose 
monitors (GGMs) will be compared to the standard of care point of care glucose testing 
(POCT). A qualitative component will consistent of patient surveys assessing satisfaction with 
treatment as well as semi-structured interviewing. 
Number of 
Site(s)
Single site study – Center for Perinatal Health at Meriter Hospital  
Main Inclusion 
Criteria

Age ≥18 years of age at enrollment

Ability to consent in English or Spanish

Gestational age ≤ 19 weeks 6 days at enrollment

Appropriate dating by certain LMP or ultrasound performed ≤ 19 weeks 6 day

Diagnosis of Type 2 Diabetes ≤ 19 weeks 6 days

Singleton gestation
Main Exclusion 
Criteria

Age <18 years of age at enrollment

Lack of appropriate dating

Multiple gestations

Use of concentrated insulin at enrollment (ie U500)

Preexisting CGM in place

Chronic use of medications known to cause hyperglycemia, such as HIV antiretrovirals 
and inhaled, injectable and oral corticosteroids

Be unwilling or unable to present to Center for Perinatal Care for visits
Objective(s)
Primary Objective 
To examine the feasibility of completing a study to assess for differences in patient 
preferences and glucose control between continuous glucose monitoring and standard 
glucose checks in pregnant patients with Type 2 Diabetes.
Secondary Objectives 

To estimate the effect of continuous glucose monitoring devices placed prior to 20 weeks 
in pregnancy in patients with Type 2 diabetes on time in range, as measured between 28-
32 weeks of pregnancy.

To assess patient satisfaction to continuous glucose monitoring during pregnancy

To estimate the effect of continuous glucose monitoring on the incidence of neonatal 
morbidity and mortality.
Endpoints
Primary Feasibility Endpoints
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
Completion of the study within the 26-month timeframe, including recruitment, 
randomization, retention, and completion of 36 out of 40 subjects
Primary Clinical Endpoint

The primary endpoint or primary objective is the total time within range (blood glucose 
level 70-140, min). All CGM data will be extracted from the Dexcom server for analysis.
Secondary Endpoints

Maternal End points 
1. Cesarean delivery rate in each group. 
2. Change in hemoglobin A1c (%) from initiation to third trimester.
3. Time spent in hyperglycemic range (>140 mg/dL)
4. Time spent in hypoglycemic range (<70 mg/dL)
5. Rates of gestational hypertension (systolic blood pressure 140 mm Hg or diastolic 
blood pressure 90 mg Hg on two occasions at least 4 hours apart)
6. Rates of preeclampsia (gestational hypertension plus either new-onset proteinuria [300 
mg/24 hours, protein:creatinine 0.3 mg/dL], thrombocytopenia [platelet 
count<100,000/uL], elevated Aspartate transaminase or alanine transaminase [>2 upper 
limit of normal], renal insufficiency [serum creatinine>1.1 mg/dL or an unexplained 
doubling of creatinine], pulmonary edema, or cerebral or visual symptoms)
7. Rates of polyhydramnios 

Neonatal Endpoints
1.
Incidence of neonatal hypoglycemia
2.
Rates of fetal macrosomia (actual birthweight >95% by Fenton growth curve for 
newborns)
3.
Rates of NICU Admission
4.
Rates of spontaneous preterm delivery (<37 weeks)
Study Design
This is a pilot prospective, randomized trial. Patients and investigators will not be blinded to 
assignment.
IND or IDE 
Number
IDE NSR
Study 
Intervention
Patients who are less than 20 weeks pregnant with Type 2 diabetes diagnosed prior to 
pregnancy will be randomized to receive a Dexcom G6 continuous glucose meter or standard 
point of care finger glucose monitoring with a Dexcom G6 Pro sensor placed for a ten day 
period at study enrollment and again at 28-32 weeks. Participants and investigators will be 
blinded to the Dexcom G6 Pro data throughout pregnancy. Questionnaires will be completed 
at study enrollment, 28-32 weeks gestation and postpartum or at the exit of the study if early 
withdrawal. Directed individual interviews will be conducted at the conclusion of the study.
Total Number of 
Subjects
A total of 40 subjects will be recruited from a single site. 
Study Population
A total of 40 gravid patients (age 18-45) who are less than 20 weeks’ gestation at time of 
consent with preexisting Type 2 diabetes who receive diabetes care from the Center for 
Perinatal Health at Meriter Hospital. 
Statistical 
Methodology
Subjects will be randomized 1:1 into the treatment or control group based on a random block 
size randomization scheme.  This will insure balance in both arms throughout the entirety of 
the study.  Estimation of treatment effect size will be the focus of the statistical analyses.  The 
primary clinical outcome will be time in range.  The effect size of treatment on time in range 
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will be estimated via longitudinal data analysis models with subject as a random effect.  
Effect size on secondary clinical outcomes will utilize similar models for continuous variables 
and mixed effects logistic regression for binary variables. Patients will be analyzed on the 
intention to treat principal. Additional per protocol analysis will also be performed.
Estimated 
Subject Duration
The duration of the study for each participant is expected to be approximately 26 weeks
Estimated 
Enrollment 
Period & Study 
Duration
Study enrollment and follow-up will occur over 20 months, from the date of first enrollment, 
with the total expected duration of the trial to be 26 months.
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3.2 Schematic of Study Design
*In the event of early withdrawal by patient or PI, patient will be eligible for exit interview following withdrawal from 
the study.
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IRB APPROVAL DATE: 03/28/2024

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Patient Anticipated Flow through Study
*In the event of early withdrawal by patient or PI, patient will be eligible for exit interview following withdrawal from 
the study. 
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4.0
KEY ROLES
The following is a list of all key personnel and roles:
Principal Investigator
Jacquelyn Adams, MD, Assistant Professor
University of Wisconsin
202 S Park St. Madison, WI 53715
608-417-6667
Jhadams3@wisc.edu
Participating Site(s)
University of Wisconsin
202 S. Park St., Madison WI 53715
Data Monitoring Committee 
ICTR Data Monitoring Committee
UW Madison
(608) 263-3804
asiedschlag@wisc.edu
Study Monitoring Contact
Kristen L. Mahaffey, MA, CCRP 
Central Monitoring Service Manager
Central Monitoring Service
FDA Regulated Research Oversight Program
UW School of Medicine and Public Health
750 Highland Avenue
Madison WI 53705
klmahaffey@wisc.edu
Funding Sponsor
UnityPoint Health - Meriter Foundation
202 S. Park Street
Madison, WI 53715
Phone: (608) 417-5300
Fax: (608) 417-5325
Email: msn_foundation@unitypoint.org
Biostatistician
Scott Hetzel, MS
UW
ICTR
Address
Phone Number
Email
5.0
INTRODUCTION
5.1 Type 2 Diabetes Background
Diabetes prevalence has been steadily increasing for the past several decades with increasing 
numbers of pregnant women affected by the disease. Estimates now suggest that up to 2% of all 
pregnancies are impacted by pregestational diabetes, with Type 2 significantly more common than 
Type 1.1,2 As rates of obesity increase, as do rates of insulin resistant Type 2 diabetes in younger, 
reproductive age women.3 The impacts on pregnancy are significant – both to mother and fetus. In 
the first trimester, elevated A1c is associated with increased rates of miscarriage and fetal 
anomalies, including complex cardiac defects. Later in pregnancy, rates of stillbirth, 
polyhydramnios, and macrosomia increase. After delivery, neonates of mothers with diabetes are 
more like to require neonatal intensive care admissions and prolonged hospital stays. In labor, rates 
of operative deliveries and cesarean sections are higher for mothers with diabetes. The maternal 
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impacts of diabetes in pregnancy are significant as well, and include increased rates of 
hypertensive disorders of pregnancy, diabetic retinopathy, diabetic nephropathy, as well as diabetic 
ketoacidosis. 
Improved blood sugar control throughout pregnancy has been demonstrated to decrease these 
risks; however, blood glucose control is recommended to be tighter in pregnancy as well, which can 
be challenging to manage and maintain.
5.2 Current Standard of Care – Point of care glucose testing
Historically, pregnant patients with Type 2 diabetes have been asked to check blood sugar using a 
home point of care glucose meter at least 5 times per day, although sometimes more frequently: 
fasting, 1-2 hours postprandial and prior to bed. It is not uncommon to ask patients to check a 2am 
blood sugar as well. This is a more onerous regimen than most patients adhere to prior to 
pregnancy and can be a difficult and stressful adjustment. 
Continuous glucose meters (CGM) are sensors that are placed on the body and test the interstitial 
glucose level every few minutes and transmit the data to a receiver where the output can either be 
uploaded to the cloud or a computer, or viewed in real time using a smart phone. Although CGMs 
are not approved for use in the pregnant population, several recent studies have demonstrated 
benefit in lowering blood glucose levels in Type 1 and gestational diabetic populations. To date, this 
research has not included patients with Type 2 diabetes. Furthermore, no data has been collected 
regarding patient perspective and satisfaction with CGMs, and therefore little is known about 
whether it actually improves patient quality of life and feelings of control and satisfaction with care 
during pregnancy. 
This study will utilize the Dexcom G6 CGM in the experimental group.  The CGM remains in place 
for 10 days. Patients will be provided with the same training and information that all patients 
receiving Dexcom CGMs receive. The protocol for wear will not differ compared to that of non-
pregnant patients and will follow standard of care. Patients will be provided with sufficient quantity 
of CGM so that they will have one in place for the duration of pregnancy. 
The control group will continue to utilize point of care finger sticks, using their preexisting 
glucometer. If a new glucometer is needed during the pregnancy, one will be prescribed in the 
same manner as a patient not involved in the study. At two time points during the study – 
enrollment and at 28-32 weeks, a Dexcom Pro G6 sensor will be placed and remain in place for 10 
days. Neither patients nor providers will have access to this data until after delivery, with the 
purpose being that it not be used to guide clinical decision making. 
Time in range is the primary outcome we are using for determine glucose levels. This is something 
that is only available through a CGM. Therefore to compare the control group to the experimental 
group, we need to have the control group wear a sensor that can provide time in range data. We 
are using two time points because the first time point is prior to starting the intervention and the 
second time point is after the experimental group will have worn the sensor for at least 8-12 weeks.
5.3 Continuous glucose monitors/glucose sensors
The device intervention to be used is a Dexcom 6 CGM, an FDA approved device. The device will 
be placed at time of enrollment and patients will be provided standardized instructional videos and 
information provided by Dexcom. Additionally, clinic staff will be available to ensure patients can 
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place sensors correctly. The patients will be instructed as to how to set up online accounts and user 
interfaces on their personal smart phones, as well as provided with instruction regarding viewing the 
data on their smartphone in real time. If a patient does not have a smart phone, she will be provided 
with one to use for the purpose of viewing glucose data for the duration of pregnancy. Additionally, 
patients will be instructed regarding timing and procedures for changing the CGM and transmitter. 
Controls will be asked to wear a blinded sensor, Dexcom G6 Pro, for two ten-day periods 
throughout the study – once at enrollment and once between 28-32 weeks. The sensor will be 
placed for them and the data uploaded to the cloud, which will be stored on a password protected 
Redcap server, by the clinical team. 
Several prior studies have examined similar sensors in pregnant women over the past 10 years.4–7 
5.4 Rationale
Several recent studies have demonstrated benefit in lowering blood glucose levels in Type 1 and 
gestational diabetic populations.5,6,8 To date, this research has not included patients with Type 2 
diabetes. Furthermore, no data has been collected regarding patient perspective and satisfaction 
with CGMs, and therefore little is known about whether it actually improves patient quality of life and 
feelings of control and satisfaction with care during pregnancy.
Mixed methods is the optimal format for this study given the dearth of knowledge around 
management of Type 2 diabetes in pregnancy using CGM. This comprehensive approach will allow 
for direct comparison of quantitative outcomes, hypothesis generation, and protocol development 
for larger clinical trials. The qualitative arm will identify themes for further exploration in diabetes 
management in pregnancy, CGM use in pregnancy, management satisfaction as well as explore 
patients’ experience with the protocol and study design. Interviewing patients that have been non-
compliant with assigned group or who choose to leave the study will allow accurate assessment of 
potential changes for a larger trial as well as improve methodology and experience.
6.0
STUDY OBJECTIVES AND ENDPOINTS
Quantitative Outcomes
Objectives
Endpoints
Primary
To examine the feasibility of completing a 
study to assess for differences in patient 
preferences and glucose control between 
continuous glucose monitoring and 
standard glucose checks in pregnant 
patients with Type 2 diabetes.

Completion of the study within the 26 month 
timeframe, including recruitment, 
randomization, retention, and completion of 
36 out of 40 subjects.
Secondary

To estimate the effect of continuous 
glucose monitoring devices placed 
prior to 20 weeks in pregnancy in 
patients with Type 2 diabetes on time 
in range, as measured between 28-32 
weeks of pregnancy.

The primary clinical endpoint is the total time 
within range (blood glucose level 70-140, 
min)
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
To estimate the effect of continuous 
glucose monitoring on the incidence of 
neonatal morbidity and mortality.

Incidence of neonatal hypoglycemia. 

Rate of fetal macrosomia (actual birthweight 
>95% by Fenton growth curve for newborns).

Rates of NICU admission

Rates of spontaneous preterm delivery (<37 
weeks

To estimate the effect of continuous 
glucose monitoring on the incidence of 
maternal morbidity

Cesarean delivery rate in each group. 

Change in hemoglobin A1c (%) from initiation 
to third trimester.

Time spent in hyperglycemic range (>140 
mg/dL)d. Time spent in hypoglycemic range 
(<70 mg/dL)

Rates of gestational hypertension (systolic 
blood pressure 140 mm Hg or diastolic blood 
pressure 90 mg Hg on two occasions at least 
4 hours apart)

Rates of preeclampsia ((gestational 
hypertension plus either new-onset 
proteinuria [300 mg/24 hours, 
protein:creatinine 0.3 mg/dL], 
thrombocytopenia [platelet 
count<100,000/uL], elevated Aspartate 
transaminase or alanine transaminase [>2 
upper limit of normal], renal insufficiency 
[serum creatinine>1.1 mg/dL or an 
unexplained doubling of creatinine], 
pulmonary edema, or cerebral or visual 
symptoms)

Rates of polyhydramnios

To assess patient satisfaction to 
continuous glucose monitoring during 
pregnancy

Satisfaction scores from quality of life and 
satisfaction survey administered at 3 time 
points: initial study enrolment, 28-32 weeks, 
2-4 weeks postpartum or at the conclusion of 
the study if the patient decides to withdraw or 
is withdrawn early.
Qualitative Outcomes
Objectives
Endpoints
Primary
Critically assess patients’ perceptions of 
diabetes control in pregnancy using 
standard testing versus continuous 
glucose monitoring
Gather information about patients’ thoughts and 
experiences in both arms of the trial about their 
ability to manage diabetes in pregnancy through 
surveys administered at study onset, 28 weeks 
and 32 weeks gestation, or at study completion
Secondary
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Explore how glucose monitoring affects 
patients’ thoughts and feelings about 
pregnancy and health.
Directed/semi-structured interviewing of patients 
at the end of the study period during the 
postpartum period. 
Explore if traditional management versus 
continuous glucose management has 
higher feelings of control over diabetes 
management.
Use of well validated tools in non-pregnant adults 
to discuss feelings about diabetes management 
with addition of pregnancy specific questions.
7.0
STUDY DESIGN
7.1 General Design 
This pilot single site randomized control trial will compare the blood glucose control and patient 
satisfaction scores of continuous glucose monitoring vs standard glucose checks in pregnant 
women with a prior diagnosis of Type 2 diabetes. 
The study population will consist of 40 women who are less than 20 weeks pregnant at time of 
enrollment who have a pre-pregnancy diagnosis of Type 2 diabetes.  Subjects will be randomized to 
one of two treatment arms.

Arm 1:  Placement of Dexcom G6 continuous glucose monitor for glucose monitoring for 
duration of pregnancy

Arm 2: Continuation of standard glucose finger sticks with placement of a blinded Dexcom Pro 
G6 continuous glucose sensor for two ten day periods (at enrollment and again at 28-32 weeks)
Subject accrual will occur over 20 months at 1 site. Subjects will complete 3 study visits, all of which 
will be in conjunction with previously scheduled prenatal or diabetes visits over the course of 
approximately 26 months. Surveys will be administered at each time point, as well as at the 
postpartum visit. At the final visit, patients will be asked for participate in a 10 minute semi 
structured interview.
7.2 End of Study Definition
The end of the study is defined as the date of completion of any final follow-up activity or data 
collection described in the protocol.
8.0
SUBJECT SELECTION
8.1 Inclusion & Exclusion Criteria  
Inclusion Criteria 
1.
Willing to provide informed consent.
2.
Willing to comply with all study procedures and be available for the duration of the study.
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3.
Must have a confirmed intrauterine pregnancy less than 20 weeks’ gestational age at time of 
enrollment
4.
Individuals at least 18 years of age.
5.
Verified Type 2 Diabetes prior to pregnancy
6.
Must have a singleton pregnancy
7.
Ability to consent in English or Spanish
Exclusion Criteria
1.
Age <18 years of age at enrollment
2.
Lack of appropriate dating
3.
Multiple gestations.
4.
Use of concentrated insulin at time of enrollment (ie U500)
5.
Preexisting CGM in place
6.
Chronic use of medications known to cause hyperglycemia, such as HIV antiretrovirals and 
inhaled, injectable and oral corticosteroids
7.
Unwilling or unable to present to Center for Perinatal Care for visits 
8.2 Vulnerable Populations
This study will enroll pregnant women because the intervention being studied has the potential to 
improve maternal health during pregnancy which will therefore benefit fetuses. There is minimal to 
no risk to fetuses. In fact, glucose control in early pregnancy is of paramount importance to 
preventing maternal and neonatal morbidity. 
8.3 Lifestyle Considerations
During this study, subjects are asked to: adhere to standard lifestyle pregnancy modifications, as 
well as those specific to any additional conditions they may have. No additional modifications will be 
asked of patients for the purpose of this study. 
8.4 Subject Identification and Recruitment
Subjects will be identified at their referring provider’s office, by the Diabetes in Pregnancy 
Program, or by maternal fetal medicine physician at the time of consultation. 
Location or 
scenario where 
approached
Obtain 
permission 
to contact
Consent 
and study 
discussed
Consent 
form 
signed
Randomization
Provider’s office 
at entry to 
prenatal care
YES
YES
NO – Will 
be done at 
referral
NO – Will be 
done at referral
Diabetes in 
Pregnancy 
Program – 
YES 
YES
YES
YES – 
Performed by 
study staff
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Center for 
Perinatal Care
Center for 
Perinatal Care – 
Maternal Fetal 
Medicine 
Consult 
YES
YES
YES
YES – 
Performed by 
study staff
Phone Call
NO
YES
NO – Will 
be done at 
referral
NO – Will be 
done at referral
All subjects who are enrolled in this study should be recorded on Enrollment Log. Enrollment 
should take place just prior to sampling, but after the subject has signed the IRB-approved 
consent form, undergone the screening process, and met all of the inclusion and none of the 
exclusion criteria.  Study staff will enter the subject’s Study ID as designated into REDCap. The 
patients will be screened, and all criteria will be collected in REDCap when the patient is given a 
study ID before they can be randomized.
Patient Phone Call
Study staff will be phoning subjects prior to their appointments at the Perinatal Clinic to 
introduce the study. Study staff will be getting consent and HIPAA authorization at either the 
clinic appointment or at another time.  Enrollment of the patient is a time consuming process. 
This extra step is necessary to limit the amount of time that the patient spends in clinic, 
reviewing the research study with staff. If the patient feels inconvenienced, this may lead to 
reduced enrollment.  This will be done once patient is identified as an appropriate candidate by the 
research team. 
Inclusion of Patients who speak Spanish
The study will enroll subjects who speak and read either English or Spanish. All documents, 
including the consent and HIPPA authorization form are translated into Spanish by a certified 
medical interpreter in the UW Hospital Interpreter Services Department.
An interpretation service, LanguageLine, will be used during the informed consent process. 
Interviews with patients who speak Spanish will be conducted by Dr. Iruretagoyena, who is a 
native Spanish speaker and a provider in the department of Ob/Gyn. The interviews will be 
transcribed into English.
First Approach
The coordinator may use LanguageLine or a certified hospital translator for first approach. The 
coordinator will call LanguageLine to go over the consent form with the patient. If there is no 
interpreter present, permission to approach will be delayed. The patient needs to be able to 
understand and communicate with the coordinator. Every effort will be made to approach 
Spanish-speaking subjects at the same locations/circumstances as non-Spanish speaking 
patients.
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8.5 Remuneration and Retention Strategies
Strategies for retention include: 

Phone call reminders from clinic staff regarding upcoming appointments

Email reminders with surveys before and after each time point with email surveys for patients to 
complete

Paper copies of surveys available in clinic appointments to complete if unable to do so 
electronically

Flexible study visit windows to accommodate subject schedules.  

Subjects will receive reimbursement for each completed study visit, a total of three payments for 
$50 each ($150 total). They will receive $10 dollars for completing a phone interview.  If they 
complete all study visits and the interview, they will receive $160 for participation in the study.
8.6 Early Termination and Withdrawal
Subjects are free to withdraw from participation in the study at any time upon request. 
The Principal Investigator (PI) may discontinue or withdraw a subject from the study for the 
following reasons at his/her discretion: 

Subject non-compliance with study requirements (e.g., study intervention non-compliance)  

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 
subject 

If the subject is no longer an appropriate candidate for participation   

There is evidence of progressive disease or unacceptable toxicity 

Subject unable to receive study intervention for 10 days 
 
Subjects who sign the informed consent form and are randomized but do not receive the study 
intervention will be replaced. Subjects who sign the informed consent form, are randomized and 
receive the study intervention, then subsequently withdraw, or are withdrawn or discontinued from 
the study, will not be replaced. 
The following actions must be taken if a subject withdraws, or fails to return for a required study 
visit: 

The site will attempt to contact the subject and reschedule the missed visit within the next 2 
weeks and counsel the subject on the importance of maintaining the assigned visit schedule 
and ascertain if the subject wishes to and/or should continue in the study. 
o
If a subject withdraws, study staff will clarify with the patient what they are withdrawing 
from
o
all study procedures and contact
o
participation with their randomized group
o
personal information/delivery outcome collection
o
study conclusion interview
o
survey materials  (if applicable)
o
research access and collection of data from their medical record

Study team will document in the electronic medical record the above findings
Before a subject is deemed lost to follow-up, the investigator or designee will make every effort to 
regain contact with the subject where possible, 3 telephone calls and, if necessary, a certified letter 
to the subject’s last known mailing address or local equivalent method>. These contact attempts 
shall be documented in the subject’s study file.  
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If the subject continues to be unreachable, they will be considered to have withdrawn from the study 
with a primary reason of lost to follow-up. The withdrawn date is the last day of attempted contact. 
9.0
STUDY AGENT (STUDY DRUG, DEVICE, BIOLOGIC, VACCINE, ETC.) AND/OR 
PROCEDURAL INTERVENTION AND/OR BEHAVIORAL OR SOCIAL INTERVENTION 
9.1 Study Agent and Control Description
Dexcom G6 Continuous Glucose Monitor
This device qualifies for an abbreviated IDE as it poses no significant risk.  
Active Control
Standard glucose finger sticks with blinded Dexcom G6 Pro sensors will be used at two time 
points 
Source
All study devices will be provided free of charge by Dexcom during the treatment phase.  
Packaging and Labeling

The G6 Dexcom system box contains the applicator and transmitter. The device will be 
packaged in its standard packaging provided by Dexcom. 
Preparation
Dexcom Sensor
See user guide Chapter 6 – Start your Sensor – page 71 for Commercial, and Page 10 – 
Inserting the Sensor, for the Pro products, included in the Addendum
Storage and Stability
Sensor
• Keep in its sterile packaging until you’re ready to use it.
•  Store at temperatures between 36° F and 77° F.
• Storing outside this range may cause inaccurate G6 readings.
• May store sensor in refrigerator if it’s within temperature range.
• Store sensors in a cool, dry place. Don’t store in parked car on a hot day or in freezer.
Transmitter
• Keep protected when not in use
• Store at temperatures between 32° F and 113° F
• Store between 10% and 95% relative humidity
Receiver
• Keep protected when not in use
• Fully charge the battery before storing for over 3 months
• Store at temperatures between 32° F and 104° F
• Store between 10% and 95% relative humidity
Accountability
Order forms will be provided by Dexcom to request products. Product will be shipped via FedEx. 
Products will be ordered in 3-month increments. 
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Dosing and Administration

Sensors are to be placed on the abdomen according to package instructions. 
9.2 Method for Assigning to Treatment Groups
Patients will be randomized at time of enrollment using random block randomization. There are no 
blinding procedures. The randomization table will be developed by the statistician and loaded into 
REDCap. Once the patient is entered into the REDCap system and informed consent is obtained, 
they can then be assigned to their study group through the randomize function. 
A separate paper and envelope randomization will be available in the event the REDCap server is 
unavailable. The instruments needed for enrollment and randomization will also be available on 
paper. These will be utilized until the REDCap server is available and then the patient will be 
entered into REDCap by the study team. 
9.3 Study Intervention Compliance
Compliance will be assessed by reviewing CGM glucose output or point of care glucose checks at 
each follow up visit, which is standardly performed by clinical staff. Unblinded participants will be 
able to upload their data to the study staff and Diabetes in Pregnancy program from their app at any 
point. 
If the patient utilizes management methods outside their assigned group, they will continue to be 
analyzed in the assigned group based on intention to treat basis and a protocol deviation will be 
entered. This will allow for unbiased analysis and conclusions regarding the effectiveness of the 
study intervention. Non compliance to study protocol and understanding patient motivation is a 
critical component of mixed methods research and key to future study design. In addition, the 
intention to treat analysis preserves the benefits of randomization and efficacy based on adherence 
to the protocol. 
Patients non-compliant with treatment will be noted in the electronic medical record and field notes. 
The patient will be asked to participate in surveys and a study completion interview to better 
understand their experience with the study and interventions.
9.4 Preterm Delivery
In the event of a preterm delivery prior to data collection at visits 1, 2, or 3, patients will have data 
collected and completed for all clinical outcomes. If delivery occurs before the 2nd survey 
administration and data collection point, the survey will be sent to the patient and notation made in 
the medical record and field notes. The postpartum survey instrument will be dispatched at the 
normal time frame. Data from surveys will be accepted up to 8 weeks post partum. Control patients 
will not be asked to wear the blinded sensor for the second time point. The patient will be offered an 
exit interview with study staff.  
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9.5 Concomitant Therapy
Permitted Concomitant Therapy
All additional medications and supplements, except those as listed below, will be reviewed and 
documented at each clinic visit. 
Prohibited Concomitant Therapy
Prohibited medications include those that are known to cause hyperglycemia, including HIV 
antiretrovirals, inhaled, oral and injectable corticosteroids when taken for chronic use. 
10.0
STUDY VISITS AND PROCEDURES
10.1
Study Calendar
The procedures performed at each study visit are listed in the table below.
Procedure
Baseline
Visit 1
Visit 2
Visit 3
Early 
Termination*
Postpartum
Visit Window
<20 weeks’ 
gestation
2-3 weeks after 
enrollment
28-32 week’s 
gestation
2-3 
weeks 
after visit 
2
2-4 weeks 
postpartum (up 
to 8 weeks 
postpartum)
Informed Consent
X
Demographics
X
Review Concomitant 
Medications
X
X
X
X
X
Obtain Medical 
History
X
Randomization
X
Administer Study 
Intervention
X
X
Adverse Event 
Review and 
Evaluation
X
X
X
X
X
X
Survey 
administration
X
X
X
X
Review glucometer 
data
X
X
X
Directed 
individualized 
interview
X
X
* “If early termination is before Visit 2, the Visit 2 survey will be sent out at early termination.  The exit 
interview will be conducted post the early termination. A postpartum survey will also be sent out 2-4 weeks 
post participant’s original due date.”
10.2
Screening and Enrollment
The Screening and Enrollment visits and procedures are described in detail below.
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Pre-screening
Pre-screening consists of examining a subject’s medical records by research staff who have 
completed HIPAA and human subjects training. All patients presenting for consults with at the 
Center for Perinatal Care at Meriter Hospital will be screened. In addition, physicians at outlying 
facilities can screen potential patients and offer patient facing brochures to assess interest. If 
the patient is willing to speak with study staff, the outlying facility may contact study staff by 
phone, email, or message in the electronic medical record. 
Informed Consent
Study staff will be phoning subjects prior to their appointments at the Perinatal Clinic to introduce the 
study. Study staff will be getting consent and HIPAA authorization either at the clinic appointment or 
at another time.
Preliminarily eligible subjects will be approached at initial appointment at Meriter Center for 
Perinatal Care for informed consent and formal screening. The informed consent process will be 
conducted following all federal and institutional regulations relating to informed consent. 
Informed consent will be obtained prior to conducting any study-related activities.
The informed consent process will be performed as follows:

Research coordinators or study staff will review the informed consent form and discuss the 
study in detail with the potential research subject.

Research coordinators or study staff will explain the study, its risks and benefits, what would 
be required of the research subject, and alternatives to participation.

The research subject will be given the opportunity to take the informed consent form home 
so that they may discuss it with family members, friends, clergy, or others when possible.  

The subject will have the opportunity to ask questions and have all questions answered by 
the Research coordinators or study staff and/or PI.

The informed consent document must be signed and dated by the research subject.

Research coordinators or study staff will review the informed consent document to ensure 
that all fields that require a response are complete (i.e., checkbox marked yes or no, etc.) as 
applicable.

The research subject will be given a copy of the signed and dated informed consent form. 
The original signed informed consent form is kept in a secure, locked cabinet in the OB/Gyn 
clinical research office. A copy will also be taken to patient registration to be scanned into 
the patient’s chart. 
Baseline
The baseline visit will be in conjunction with the patient’s first antenatal visit to the Center for 
Perinatal Care at Meriter Hospital. For some of these patients, it may be a consultation with 
maternal fetal medicine, an initial obstetrics visit, or an appointment with the diabetes in 
pregnancy program. At the time of the visit, the pre-screened patient will be approached 
regarding participation in the study. If interested, informed consent, enrolment, randomization, 
and a brief survey will be administered at that time. If randomized to the control group, a 
Dexcom G6 Pro sensor will be placed and participant will be scheduled to return to clinic in 10-
14 days to obtain data from the sensor. If randomized to the CGM placement, device education 
and placement will be performed at that time. Follow up on sensor data will be performed either 
remotely or in person, as guided by clinical necessity. 
Enrollment
Enrollment will be defined as the time of consent. The subject will not count toward the total “n” 
until they are consented and successfully randomized by the research staff. 
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Screen Failure and Re-enrollment
Individuals who do not meet the criteria for participation in this trial (screen failure) because of a 
misdiagnosis of Type 2 Diabetes or previously placed CGM may be rescreened. Rescreened 
subjects should be assigned a new subject ID number when they are re-screened.
10.3
On-Study/Follow-up Visits
After subjects have been enrolled, the On-Study/Follow-up visit and the procedures performed at 
each visit are described in detail below.
Visit 1
All controls will be scheduled for a visit 10-14 days after the baseline visit to collect the sensor 
data. Decision as to whether to collect CGM data from the experimental group in person or 
virtually will be at the discretion of the provider. 
Visit 2
Patients in the control group will have a second sensor placed at 28-32 weeks. This visit will be 
performed in conjunction with an already scheduled prenatal or diabetes visit. A survey will be 
administered at this visit. For experimental group participants, a survey will be administered at a 
previously scheduled prenatal or diabetes visit between 28-32 weeks. 
Visit 3
All controls will be scheduled for a visit 10-14 days after the baseline visit to collect the sensor 
data. Decision as to whether to collect CGM data from the experimental group in person or 
virtually will be at the discretion of the provider.
Final Study Visit
The final study visit will be defined as the final interaction with the study team. Patients may return 
unused materials if they desire for study team to dispose, however, returning unused equipment is 
not necessary given study supplies cannot be reused nor returned. 
All patients will be asked to participate in a 10-minute semi structured interview regarding their 
perceptions and thoughts regarding study participation. This visit may take place over the phone or 
in person per patient’s preference. Patients may decline interviewing with study staff and this will be 
documented in the medical record and placed as a protocol deviation.  
10.4
Unscheduled Visits
Unscheduled visits will not routinely occur for this study. Study procedures will be combined with 
clinically necessary visits to avoid undue burden on the patient. Exceptions may be made with 
patient’s permission if:

The patient misses a scheduled appointment

A new appointment is necessary to collect time-sensitive patient data such as professional 
sensor for control subjects

The patient prefers a separate appointment with study staff due to commute or schedule
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10.5
Early Termination/Withdrawal Visit
In the event of early withdrawal by a patient, patients will be asked their reason for early withdrawal 
from the study, and this will be documented in the electronic medical record as well as field notes in 
REDCap. The patient will be asked if they agree to participate in a semi-structured interview so that 
qualitative data can be collected. This will be scheduled following patients’ withdrawal from the 
study rather than postpartum to allow for adequate assessment. Patients will be considered 
withdrawn from the study following this final interaction with the study team, if agreeable.
10.6
Long-Term Follow-up | Re-contacting Subjects
Not Applicable. Study subjects will not be contacted following their final interview. 
11.0
DATA HANDLING AND RECORD KEEPING
11.1
Data Collection 
Data Collection Forms
Standardized data collection forms (e.g., source documents, case report forms, standardized 
assessment forms, etc.) are used to ensure data collected are consistent and compliant with the 
protocol and IRB application. 
Data collection is the responsibility of study team members under the supervision of the 
Principal Investigator (PI). The PI is responsible for ensuring the accuracy, completeness, 
legibility, and timeliness of the recorded and reported data.
All data collection forms must be completed in a legible manner; any missing data will be 
explained. Data entry errors will be corrected with a single line through the incorrect entry and 
the correct data is entered above/near the correction. All changes will be initialed and dated.
All interviews will be recorded using a recording device. The file will be stored in REDCap, as 
discussed below in section 11.1.2. Additionally, interviews will be transcribed using NVivo 12, 
text files from which will also be stored in REDCap. 
Data collection forms are maintained in the subject files and retained as described in Section 
11.3: Records Retention.
Data Management Software System(s)
Clinical data (including AEs, concomitant medications, and solicited events data) and clinical 
laboratory data will be entered into the following data management software system(s) to 
ensure consistent data entry and data quality. Clinical data will be entered directly from the 
source documents.
REDCap
The Obstetrics and Gynecology Research Electronic Data Capture (REDCap) system is used to 
manage the data for this study.
REDCap is a largely self-service, secure, web-based application for building and managing data 
collection forms. REDCap provides data management functionality by allowing the development 
of instrument and surveys to support data capture for research studies.
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11.2
Confidentiality and Privacy
Subject confidentiality and privacy are 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 subjects. 
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. 
All research activities will be conducted in as private a setting as possible.
All study staff engaged in the conduct of this project have completed training on the protection of 
human subjects and the Health Insurance Portability and Accountability (HIPAA) Privacy Rule. In 
addition, all key personnel (i.e., Principal Investigator, individuals involved in identifying/recruiting 
subjects, obtaining informed consent, or interacting and intervening with subjects) have undergone 
Good Clinical Practice (GCP) training.
Information about study subjects will be kept confidential and managed according to HIPAA 
requirements. All subjects will sign an informed consent document and a HIPAA authorization form 
or. Study data will be maintained per federal, state, and institutional data policies.
The investigator(s) will ensure that the identities of subjects are protected by using coded subject 
information. The log of subject identifying information that links subjects to their study-specific 
identification number will be maintained by the investigator. The log and all study records will be 
maintained in locked rooms and access will be limited to essential study personnel. Electronic study 
records/files will be stored on a department server and accessed via networked computers that are 
password-protected with access provided only to authorized study personnel. 
Authorized representatives of the following groups may need to review this research as part of their 
responsibilities to protect research subjects: the study monitor, other authorized representatives of 
the sponsor, representatives of the IRB, DSMB/DMC, DCC staff, regulatory agencies or 
pharmaceutical company supplying study product, and federal oversight agencies, such as the 
Food and Drug Administration (FDA). The clinical study site will permit access to such records.
Study staff may use e-mail to communicate with research subjects, if the subject has agreed to 
using email in the Informed Consent form. The information contained in emails will be limited to 
study visit time and date information, general questions, etc. All emails to subjects will be sent from 
UW/wisc.edu accounts; personal, home or Gmail email accounts will not be used.
11.3
Records Retention
It is the investigator’s responsibility to retain study essential documents for a minimum period of 7 
years following completion of the study per UW-Madison institutional policy, or at least 2 years after 
the last approval of a marketing application in their country and until there are no pending or 
contemplated marketing applications in their country or at least 2 years have elapsed since the 
formal discontinuation of clinical development of the investigational product, whichever comes last.
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11.4
Retention for Future Research: Data, Image, Audio- or Video-Recording & 
Biospecimen Banking 
Purpose of Storage
Not applicable
11.5
Protocol Deviations
A protocol deviation is any noncompliance with the clinical trial protocol or investigational plan 
requirements. The noncompliance may be either on the part of the subject, the investigator, or the 
study site staff. As a result of deviations, corrective actions are to be developed by the site and 
implemented promptly. 
It is the responsibility of the Principal Investigator/site investigator/study staff to use continuous 
vigilance to identify and report deviations. The Principal Investigator is responsible for assessing 
whether the deviation constitutes noncompliance as defined by the reviewing IRB and if so, 
reporting it within the required time frames. The site investigator is responsible for knowing and 
adhering to the reviewing IRB requirements.
11.6
Publication and Data Sharing Policies
This study will be conducted in accordance with the following publication and data sharing policies 
and regulations:
National Institutes of Health (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 
(https://www.ncbi.nlm.nih.gov/pmc/) upon acceptance for publication.
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-
Funded Clinical Trial Information and the Clinical Trials Registration and Results Information 
Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information 
from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to 
publish results in peer-reviewed journals.  
12.0
STUDY ANALYSIS
12.1
Statistical Hypotheses

Primary Efficacy Endpoint(s): 
As this is a pilot study we do not have a primary hypothesis test for efficacy.  Our main goal of 
the study is to demonstrate the ability to recruit, randomize, and retain at least 36 out of 40 
subjects throughout the 26 month duration of this pilot study.  In doing this we will learn barriers 
to recruitment and entry into the study.  We will also learn reasons why subjects drop-out from a 
study of this design.  This pilot study will also allow us to estimate the effect size (95% CI) of the 
continuous glucose monitoring on time in range.  All of this information will strengthen the 
design of a future fully powered efficacy study.

Secondary Efficacy Endpoint(s):
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There are no secondary efficacy hypothesis tests.  Effect size (95% CI) of continuous glucose 
monitoring will be estimated for secondary endpoints.
12.2
Sample Size Justification
Sample size justification is based on the precision of the 95% CI of the effect size of continuous 
glucose monitoring on time in range.  In this longitudinal randomized design the effect size will be 
the mean difference in change in time in range from baseline to 28-32 weeks of pregnancy.  With 
18 subjects in both groups our expected 95% CI around the effect size will be +/- 0.66*SD.  This 
would equate roughly to a Cohen’s D medium effect size, which will give us a good precision to 
make subsequent study sample size justification.  To account for planned 10% attrition rate we will 
recruit 20 subjects in both groups for a total of 40 subjects.
12.3
Subject Population(s) for Analysis
Estimation of effect sizes will be based on Intention-to-Treat.
12.4
Statistical Methods
Subjects will be randomized 1:1 into the treatment or control group based on a random block size 
randomization scheme.  This will insure balance in both arms throughout the entirety of the study.  
Estimation of treatment effect size will be the focus of the statistical analyses.  The primary clinical 
outcome will be time in range.  The effect size of treatment on time in range will be estimated via 
longitudinal data analysis models with subject as a random effect.  Effect size on secondary clinical 
outcomes will utilize similar models for continuous variables and mixed effects logistic regression 
for binary variables.  Patients will be analyzed in assigned groups in concordance with intention to 
treat analysis. Per protocol analysis will also be performed.
12.5
Planned Interim Analysis
There are no planned interim analyses for this pilot study.
12.6
Handling of Missing Data
All missing data will be considered missing at random for this pilot study.  To account for a possible 
10% attrition we have increased our needed sample size accordingly.
13.0
RISK/BENEFIT ASSESSMENT
13.1
Known Potential Benefits to the Subjects
The potential benefits to research subjects associated with this study include the possible 
improvement of blood glucose control as well as improved quality of life in pregnancy. 
If this study is able to show a therapeutic benefit of CGM in pregnant patients with Type 2 diabetes, 
the community at large would benefit by the availability of a superior treatment option.
13.2
Known Potential Risks
Known Interventional Risks
Detailed information on risks can be found in the IB
Dexcom G6 and G6 Pro
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The sensor used in this study is composed of medical grade plastic and unlikely to cause a 
reaction. Upon insertion of the device, there is a slight risk of bleeding at the insertion site. The 
integrity of the sensor may be impacted by bug spray, sunscreen and MRI machines, so 
glucometer should be used in the event that there is concern the sensor is no long accurate, 
until a replacement may be obtained. There are no obvious or foreseeable risks associated with 
the sensor itself. 
Survey
The survey, although brief, poses a theoretical risk of consuming additional participant time. No 
significant harm is expected to occur from this intervention. 
13.3
Risk/Benefit Analysis
There is no significant harm anticipated from either CGM placement or from survey or interview 
participation. Patients have the opportunity to potentially avoid glucometer finger sticks, which could 
be a significant advantage. Participants will also be compensated for all aspects of the study in 
which they participate. 
14.0
DATA AND SAFETY MONITORING 
14.1
Adverse Event (AE) Definition
An adverse event is defined as any untoward or unfavorable medical occurrence in a human 
subject including any abnormal sign, symptom, or disease temporally associated with the subject's 
participation in the research, whether or not considered related to the subject's participation in the 
research.
14.2
Serious Adverse Event (SAE) Definition
An adverse event is considered "serious" if, in the view of either the investigator or sponsor, it 
meets any of the following outcomes:

Death.

A life-threatening adverse event. 

Inpatient hospitalization or prolongation of existing hospitalization for > 24 hours. 
o
Does NOT include usual post-partum hospitalization of 2-4 days post-operative stay
o
Does NOT include antepartum admissions related solely to blood pressure monitoring or 
hypertensive disease of pregnancy
o
DOES include post-op stay >4 days
o
DOES include re-admissions after the usual postpartum hospitalization for indications 
other than blood pressure monitoring or hypertensive disease of pregnancy 

A persistent or significant incapacity or substantial disruption of the ability to conduct normal life 
functions. 

A congenital anomaly/birth defect.

Important Medical Events (IME) that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon medical judgment, they may 
jeopardize the patient or subject and may require medical or surgical intervention to prevent one 
of the outcomes listed in this definition (FDA, 21 CFR 312.32; ICH E2A and ICH E6).
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14.3
Classification of an Adverse Event
Severity of Event
All AEs will be assessed by the clinician using CTCAE v5.0, each event searchable using the 
Safety Profiler website (https://safetyprofiler-ctep.nci.nih.gov/CTC/CTC.aspx). For AEs not 
included in the protocol-defined grading system, the following guidelines will be used to describe 
severity. Specifically, hypo- and hyperglycemic events will only be an adverse event if additional 
medical treatment is sought for that event. 
Mild
(Grade 1)
Events require minimal or no treatment and do not interfere with the 
subject’s daily activities.
Moderate
(Grade 2)
Events result in a low level of inconvenience or concern with the 
therapeutic measures. Moderate events may cause some interference 
with functioning.
Severe
(Grade 3)
Events interrupt a subject’s usual daily activity and may require 
systemic drug therapy or other treatment. Severe events are usually 
potentially life-threatening or incapacitating.
Life Threatening 
(Grade 4)
The subject was at risk of death at the time of the event.
Fatal
(Grade 5)
The event caused death.
Relationship to Study, Study Procedure and/or Study Intervention
For all collected AEs, the clinician who examines and evaluates the subject 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
Clearly related to the study procedures/intervention and other 
possible contributing factors can be ruled out.
Probably Related
Likely related to the study procedures/intervention and the influence 
of other factors is unlikely.
Possibly Related
Possibly related to the study procedures/intervention and there are 
other factors that could be equally likely.
Unlikely to be related
Doubtfully related to the study procedures/intervention and there is 
another likely cause.
Unrelated
Clearly not related to the study procedures/intervention and/or 
evidence exists that the event is definitely related to another cause.
Expectedness for Study, Study Procedure and/or Study Intervention
The PI will be responsible for determining whether an AE is expected or unexpected in relation 
to the study procedures and intervention (as applicable). 
For investigational drug and device studies: An AE will be considered unexpected if the nature, 
severity, or frequency of the event is not consistent with the risk information previously 
described in the clinical protocol, device manual, investigator’s brochure, the package insert(s), 
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the IRB application, or the informed consent document. Expectedness is recorded for both study 
procedures and interventions.
14.4
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 subject 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 
appropriate CRF. Information to be collected includes event description, time of onset, clinician’s 
assessment of severity, relationship to study product (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 subject is screened will be considered as 
baseline and not reported as an AE. However, if the study subject’s condition deteriorates at any 
time during the study, it will be recorded as an AE.
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 the administration of 
the study drug and for up to 30 days after the date of the last dose of study drug. 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, stabilization, or completion of study participation.
14.5
Reporting AEs and SAEs 
Reporting AEs
The research coordinator and clinical research team will perform chart review during the patient’s 
hospitalization as well as following discharge. This information will be used to investigate our three 
specific aims and one developmental aim. Additional data will be obtained from patients via 
postpartum survey evaluations at two and six weeks postpartum. This will be collected and 
analyzed using REDCap. 
We plan to utilize the UW ICTR Data Monitoring Committee (DMC) to oversee the study. The UW 
ICTR DMC is comprised of experienced members (core plus ad hoc) with expertise required to 
oversee this study. The DMC members will review protocol-specific reports created by statisticians 
using data pulled from the Research Electronic Data Capture (REDCap) data management tool. 
These standard reports will include an overview of study objectives, a review of actual and 
projected accrual rates, an evaluation of patient demographics for balance of randomization, and a 
summary of the number and seriousness of adverse events. An interim analysis of study results 
may be performed and source documents may be reviewed to allow the DMC to independently 
judge whether the overall integrity and conduct of the protocol remain acceptable based on data 
provided and reported by the Principal Investigator. The DMC will make recommendations to the 
Principal Investigator that could include actions of continuation, modification, suspension, or 
termination.
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In providing oversight for the conduct of this study, the ICTR DMC will meet twice during the study 
to review all adverse events. Additional meetings may be scheduled as determined by the DMC or 
as requested by the PI. The predefined stopping points for this study will include excess rates of 
infection or reaction to the glucose monitors or uncontrolled blood glucoses in one arm requiring 
excess admissions. We will submit all reportable events to the DMC and the UnityPoint Health-
Meriter IRB in accordance with their reporting guidelines.
Adverse events will be identified by review of the EMR on week days while the subjects are 
admitted for delivery and for six weeks postpartum.  Any adverse events will be discussed at weekly 
research team meetings and will be reviewed to determine whether a change in protocol is 
necessary.  
AE/SAEs that meet the definition of an unanticipated problem will be reported to the IRB within 14 
business days.  Events that are immediately life threatening, severely debilitating to other current 
subjects or resulted in a death will be reported to the IRB Chair or IRB Director via telephone or 
email within 24 hours (1 business day) of site awareness.  
All AEs will also be reported to the ICTR DMC by completing the AE/SAE forms in REDCap and will 
be reported within the same timeframe as required by the IRB.   Once entered, an automatic 
notification of an SAE will be sent to the ICTR DMC.  The DMC co-chairs will review the SAE and if 
needed, schedule an ad hoc meeting of the full committee.  
Reporting SAEs
The investigator will immediately report to the sponsor any SAE, whether or not considered study 
intervention-related, including those listed in the protocol or investigator’s brochure and must 
include an assessment of whether there is a reasonable possibility that the study intervention 
caused the event. Study endpoints that are SAEs (e.g., all-cause mortality) must be reported in 
accordance with the protocol unless there is evidence suggesting a causal relationship between the 
study intervention and the event (e.g., death from anaphylaxis). In that case, the investigator must 
immediately report the event to the sponsor.
All SAEs will be followed until satisfactory resolution or until the site investigator deems the event to 
be chronic or the subject is stable. Other supporting documentation of the event may be requested 
by the Data Coordinating Center (DCC)/study sponsor and should be provided as soon as possible.
All AEs will also be reported to the ICTR DMC by completing the AE/SAE forms in REDCap and will 
be reported within the same timeframe as required by the IRB. The DMC co-chairs will review any 
reported SAE and if needed, schedule an ad hoc meeting of the full committee.
14.6
Unanticipated Problems
An unanticipated problem (UP), as defined by the DHHS Office for Human Research Protection 
(OHRP), is any incident, experience, or outcome that meets all of the following criteria: 

The incidence, experience, or outcome is unexpected given the research procedures described 
in protocol-related documents (e.g., the study protocol, the informed consent documents, the 
Investigator’s Drug Brochure) and the characteristics of the subject population being studied. An 
event may be considered unexpected if it exceeds the nature, severity, or frequency described 
in the study-related documents, Investigator’s Drug Brochure, product labeling, or package 
insert.
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
The incidence, experience, or outcome is related or probably related to participation in the 
research study. “Probably related” means the incidence, experience, or outcome is more likely 
than not to be caused by the research study procedures.

The occurrence of the incidence, experience, or outcome suggests that the research places 
subjects or others at a greater risk of harm (physical, psychological, economic, or social) than 
was previously known or recognized. 
The investigator will report UPs to the reviewing IRB and to the Data Coordinating Center 
(DCC)/lead Principal Investigator (PI). 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, informed consent documents, or other corrective 
actions that have been taken or are proposed in response to the UP.
Report UPs within the timeframe(s) specified by the IRB(s) of record.
14.7
Unanticipated Adverse Device Effect
An unanticipated adverse device effect (UADE) means any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or application), or any other 
unanticipated serious problem associated with a device that relates to the rights, safety, or welfare 
of subjects (21 CFR 812.3(s)).
An investigator shall submit to the sponsor and to the reviewing Institutional Review Board (IRB) a 
report of any UADE occurring during an investigation as soon as possible, but in no event later than 
10 working days after the investigator first learns of the effect (21 CFR 812.150(a)(1)). 
A sponsor who conducts an evaluation of an UADE shall report the results of such evaluation to the 
FDA and to all reviewing IRBs and participating investigators within 10 working days after the 
sponsor first receives notice of the effect. Thereafter the sponsor shall submit such additional 
reports concerning the effect as FDA requests (21 CFR 812.150(b)(1).
14.8
Incidental Findings
There are no anticipated incidental findings that will be discovered
14.9
Safety Oversight
Safety oversight will be performed under the DMS and DMC as described above.
We plan to utilize the UW ICTR Data Monitoring Committee (DMC) to oversee the study. The UW 
ICTR DMC is comprised of experienced members (core plus ad hoc) with expertise required to 
oversee this study. The DMC members will review protocol-specific reports created by statisticians 
using data pulled from the Research Electronic Data Capture (REDCap) data management tool. 
These standard reports will include an overview of study objectives, a review of actual and 
projected accrual rates, an evaluation of patient demographics for balance of randomization, and a 
summary of the number and seriousness of adverse events. An interim analysis of study results 
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may be performed and source documents may be reviewed to allow the DMC to independently 
judge whether the overall integrity and conduct of the protocol remain acceptable based on data 
provided and reported by the Principal Investigator. The DMC will make recommendations to the 
Principal Investigator that could include actions of continuation, modification, suspension, or 
termination
14.10
Study Monitoring
While many institutions involved in clinical research conduct various types of quality assurance 
reviews and audits, UW is one of the few institutions to offer independent Centralized Monitoring 
Services (CMS), a robust academic equivalent to the Industry Contract Research Organization 
(CRO) standards for ongoing study monitoring.
The Centralized Monitoring Services have been contracted for in the study and include the conduct 
and follow-up of monitoring visits throughout the life cycle of the study (e.g., Study Initiation Visit, 
Interim Monitoring Visits, and Close-Out Visit).  Study monitoring visits occur off-site (remotely) 
and/or on-site at a frequency necessitated by the protocol risk and complexity.  For this study, UW 
CMS personnel will conduct a Study Initiation Visit (SIV) with the University of Wisconsin’s research 
personnel in person after IRB approval was confirmed and before enrollment of any subjects into 
the study.  The SIV will included a detailed review of the protocol, good clinical practice guidelines, 
and data management expectations of the research team at the study site and CMS personnel.  
Following the Study Initiation Visit (SIV), CMS personnel will routinely conduct ongoing Interim 
Monitoring Visit (IMVs) for all data collection sites, either on-site, remotely or a combination of both, 
following enrollment of the first subject(s) and throughout the duration of the study.  During the 
IMVs, the monitor will review study materials, including but not limited to: regulatory files, consent 
forms, case report forms, and drug accountability logs.  CMS personnel will review compare the 
electronic data to that of the primary source documents and case report forms (described above). 
UW CMS personnel will conduct a Close-Out Visit (COV) upon completion of the study at the study 
site.
Monitoring consists of full or partial review of study records, depending on the risk level and 
observed compliance.  As such, during their monitoring activities, UW  CMS personnel plan to 
review all (100%) of the study-related subject records for at least 25% of the enrolled subjects.  
CMS personnel could increase the percentage of study or subject records to be reviewed if 
warranted by the ongoing monitoring findings.  The study monitor(s) work with the ICTR DMC 
statistician to conduct periodic central data reviews, with follow-up conducted by the study monitors 
for any data discrepancies identified.
The CMS conducts interim-monitoring visits (IMV) to ensure compliance and safety. The first IMV 
will be scheduled following the enrollment of the first 1-2 subjects. Subsequent IMVs will be 
scheduled to occur approximately quarterly or after the enrollment of the next 8-10 subjects. The 
schedule may vary based on study enrollment rate. Unscheduled visits may be conducted based on 
reports or evidence of potential noncompliance, significant increases in subject enrollment rates, or 
changes in protocol/personnel and training activities.
14.11
Study Stopping Rules
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 
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provided by the suspending or terminating party to investigator, funding agency, the IND/IDE 
sponsor and regulatory authorities. 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 subjects 

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 is addressed and 
satisfy the applicable federal and institutional regulatory authorities.
15.0
STUDY FEASIBILITY 
15.1
Economic Burden to Subjects
Subjects will not have to pay for study devices, such as CGMs. Subjects who are randomized to 
receive a CGM will be provided with sufficient quantity of sensors and transmitters for the duration 
of pregnancy. Phones will be provided to those who do not have access to a smart phone as well. 
The subject will not be billed by the healthcare system or their health insurance company for any 
costs related to a study procedure. 
Subjects will be responsible for any costs related to their diabetes follow-up as directed by their 
healthcare team, such as clinic visits and diabetes medication, including all out-of-pocket costs.
15.2
Facilities and Locations
Center for Perinatal Health at Meriter Hospital in Madison, WI. 
15.3
Feasibility of Recruiting the Required Number of Subjects
On review of previous records, our goal will be to recruit 40 subjects in 20 months. For the past 3 
years, our diabetes in pregnancy program has cared for 67, 84, and 87 patients with Type 2 
diabetes, respectively. With our numbers increasing each year and our hope to reach out to clinics 
such as Access Community Health and GHC, this timeline should be within reason. 
15.4
Principal Investigator Considerations
Time Devoted to Conducting the Research
The Principal Investigator time devoted to conducting the research. Dr. Erin Bailey will serve as 
co-investigator. She has 12 months dedicated research time in her fellowship. April Eddy works 
full time in the Diabetes in Pregnancy program and will serve as an important member of the 
study staff. In addition, we have the benefit of a research coordinator with 20% dedicated time 
over the next 20 months. 
Process for Informing Study Teams
The process for informing study teams of their respective roles will be recorded in the training 
log for this study. The PI will sign off on the training of all study staff. 
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15.5
Availability of Medical or Psychological Resources
Not applicable. 
16.0
REFERENCES
REFERENCES:
1. 
The American College of Obstetricians and Gynecologists. Pregestational diabetes mellitus. ACOG 
Practice Bulletin No. 60. Obstet Gynecol. 2005;105:675-685.
2. 
Ainuddin JA, Karim N, Zaheer S, Ali SS, Hasan AA. Metformin treatment in type 2 diabetes in pregnancy: 
An active controlled, parallel-group, randomized, open label study in patients with type 2 diabetes in 
pregnancy. J Diabetes Res. 2015;2015. doi:10.1155/2015/325851
3. 
Stuebe AM, Oken E, Gillman MW. Associations of diet and physical activity during pregnancy with risk for 
excessive gestational weight gain. Am J Obstet Gynecol. 2009;201(1):58.e1-58.e8. 
doi:10.1016/j.ajog.2009.02.025
4. 
Wilmot EG, Lumb A, Hammond P, et al. Time in range: A best practice guide for UK diabetes healthcare 
professionals in the context of the COVID-19 global pandemic. Diabet Med. 2021;38(1). 
doi:10.1111/dme.14433
5. 
Lane AS, Mlynarczyk MA, De Veciana M, Green LM, Baraki DI, Abuhamad AZ. Real-Time Continuous 
Glucose Monitoring in Gestational Diabetes: A Randomized Controlled Trial. Am J Perinatol. 
2019;36(9):891-897. doi:10.1055/s-0039-1678733
6. 
Murphy HR. Continuous glucose monitoring targets in type 1 diabetes pregnancy: every 5% time in range 
matters. Diabetologia. 2019;62(7):1123-1128. doi:10.1007/s00125-019-4904-3
7. 
Scott EM, Feig DS, Murphy HR, Law GR. Continuous glucose monitoring in pregnancy: Importance of 
analyzing temporal profiles to understand clinical outcomes. Diabetes Care. 2020;43(6):1178-1184. 
doi:10.2337/dc19-2527
8. 
Lane AS, Mlynarczyk MA, De Veciana M, Green LM, Baraki DI, Abuhamad AZ. Real-Time Continuous 
Glucose Monitoring in Gestational Diabetes: A Randomized Controlled Trial. Am J Perinatol. 
2019;36(9):891-897. doi:10.1055/s-0039-1678733
17.0
APPENDICES
17.1
Patient Surveys
Patient Survey on Entry into Trial
First, a few background questions
What year were you diagnosed with diabetes?
Where do you live the majority of the year:

Home or condo that you own

House or condo that you rent

A home or condo of a friend/family

Shelter

Other (please write in)
How many people live with you (drop down of number)?
How much schooling have you had?
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
8 grades or less

Some high school

Completed high school or GED

Some college or technical school

College graduate (bachelors degree)

Graduate degree
Which of the following describes your current employment status:

Full time (>35 hours per week)

Part time (<35 hours per week)

Unemployed or laid off and looking for work

Unemployed and not looking for work

Homemaker

In school

Disabled

Other (please write in)
Family History
This question pertains to your immediate family: mom, dad, siblings and children. Do you have any 
immediate family members with diabetes?

Yes or No

If yes,
o
Biological Mom
o
Biological Dad
o
Sibling 

If yes, how many?
o
Children 

If yes, how many?
Do you have extended family members with diabetes (aunts, uncles, grandparents, first cousins)?

Yes or No

If yes,
o
Aunt

If yes, how many?
o
Uncle

If yes, how many?
o
Cousin

If yes, how many?
Previous Pregnancy History
Now we will ask a few questions about your prior pregnancy history
Have you been pregnant before? (yes/no)
IF yes:
Did you have diabetes in your previous pregnancy or pregnancies?
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
Yes or No
o
If yes, how many?

Gestational (y/n)

Type 2 Diabetes (y/n)

Type 1 Diabetes (y/n)

Prediabetes (y/n)
For the following questions, please answer regarding your experience outside of pregnancy:
How many times did you check your blood sugar per day? (drop down)
Were you on medication (y/n)?
If yes, what type: 

Injectable insulin (y/n)

Oral medication (excluding metformin) (y/n)

Metformin only (y/n)

Diet/exercise (y/n)
Have you ever worn a continuous glucose meter in the past? (y/n)
Patient Survey to be Completed on entry and 28 – 32 weeks:  
Now we’re going to ask you a few questions about diabetes in this pregnancy. 
Reaction/Motivation questions
How comfortable were you in managing your diabetes prior to pregnancy? 

Extremely 

Very comfortable

Somewhat comfortable

Not comfortable or uncomfortable 

Uncomfortable

Very uncomfortable

Extremely uncomfortable
For the next questions, consider how you’ve felt over the previous 4 weeks. 
How comfortable do you feel managing your diabetes now that you are pregnant?

Extremely comfortable 

Very comfortable

Somewhat comfortable

Not comfortable or uncomfortable 

Uncomfortable

Very uncomfortable

Extremely uncomfortable
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How often do you feel overwhelmed managing your care in pregnancy?

Extremely comfortable

Very comfortable

Somewhat comfortable

Not comfortable or uncomfortable 

Uncomfortable

Very uncomfortable

Extremely uncomfortable
Social Support Questions
Do you have a main support person for this pregnancy? A support person can be your partner, spouse, 
friend, or family member that is helping you during your pregnancy

Yes or No

If yes -
o
Who?

Write in
Does your support person encourage you or care for you by helping with each of the following? (Each 
question y/n)

Helps with meal planning or prep

Assists with grocery shopping

Has switched diet to mimic mine

Makes an attempt to exercise with me

Reminds me to check my blood sugars

Attends appointments with me

Other
o
Please write in

How much are each of the following of concern to you? 

Changing my diet
o
Extremely concerning
o
Very concerning
o
Moderately concerning
o
Slightly concerning
o
Not at all concerning

Counting carbs
o
Extremely concerning
o
Very concerning
o
Moderately concerning
o
Slightly concerning
o
Not at all concerning

Taking medications (by mouth)
o
Extremely concerning
o
Very concerning
o
Moderately concerning
o
Slightly concerning
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o
Not at all concerning

Giving myself injections
o
Extremely concerning
o
Very concerning
o
Moderately concerning
o
Slightly concerning
o
Not at all concerning

Whether medications are safe for baby
o
Extremely concerning
o
Very concerning
o
Moderately concerning
o
Slightly concerning
o
Not at all concerning

Whether diagnosis will affect my baby
o
Extremely concerning
o
Very concerning
o
Moderately concerning
o
Slightly concerning
o
Not at all concerning

Will this affect my future health
o
Extremely concerning
o
Very concerning
o
Moderately concerning
o
Slightly concerning
o
Not at all concerning

Other
o
Please write in
How often do you worry about diabetes affecting your pregnancy?

Never

Very seldom

Sometimes

Often

All the time
How much do you think diabetes has affected your general pregnancy care?

Extremely affected

Very affected

Moderately affected

Slightly affected

Not at all affected
How satisfied are you with the additional burden pregnancy has placed on your diabetes management?

Extremely satisfied

Very satisfied
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
Moderately Satisfied

Neither

Moderately dissatisfied

Very dissatisfied

Extremely dissatisfied
Standardized Diabetes QOL Questions:
How satisfied are you with your current diabetes treatment? 

Extremely satisfied

Very satisfied

Moderately Satisfied

Neither satisfied nor dissatisfied 

Moderately dissatisfied

Very dissatisfied

Extremely dissatisfied
How satisfied are you currently with the amount of time it takes to manage your diabetes?

Extremely satisfied

Very satisfied

Moderately Satisfied

Neither satisfied nor dissatisfied 

Moderately dissatisfied

Very dissatisfied

Extremely dissatisfied
How satisfied are you with the time it takes to determine your sugar level?

Extremely satisfied

Very satisfied

Moderately Satisfied

Neither satisfied nor dissatisfied 

Moderately dissatisfied

Very dissatisfied

Extremely dissatisfied
How satisfied are you with the total time it has taken to manage your diabetes over the last 2 weeks?

Extremely satisfied

Very satisfied

Moderately Satisfied

Neither satisfied nor dissatisfied 

Moderately dissatisfied

Very dissatisfied

Extremely dissatisfied
How satisfied are you with the time you spend exercising in pregnancy?
IRB NUMBER: 2022-028
IRB APPROVAL DATE: 03/28/2024

Version #: 1.16
Version Date:18Mar2024
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
Extremely satisfied

Very satisfied

Moderately Satisfied

Neither satisfied nor dissatisfied 

Moderately dissatisfied

Very dissatisfied

Extremely dissatisfied
How satisfied are you with your sex life?

Extremely satisfied

Very satisfied

Moderately Satisfied

Neither satisfied nor dissatisfied 

Moderately dissatisfied

Very dissatisfied

Extremely dissatisfied
How satisfied are you with time spent getting checkups for your diabetes?

Extremely satisfied

Very satisfied

Moderately Satisfied

Neither satisfied nor dissatisfied 

Moderately dissatisfied

Very dissatisfied

Extremely dissatisfied
How often do you have a bad night’s sleep because of diabetes?

Never

Very seldom

Sometimes

Often

All the time
How often do you find that you eat something you shouldn’t rather than tell someone that you have 
diabetes?

Never

Very seldom

Sometimes

Often

All the time
Do you work outside the home? (y/n)
If yes:
How often do you worry about whether you will miss work?
IRB NUMBER: 2022-028
IRB APPROVAL DATE: 03/28/2024

Version #: 1.16
Version Date:18Mar2024
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
Never

Very seldom

Sometimes

Often

All the time
How often do you feel diabetes limits your career?

Never

Very seldom

Sometimes

Often

All the time
How often do you have pain because of the treatment for your diabetes?

Never

Very seldom

Sometimes

Often

All the time
How often do you feel your diabetes is a burden on your family?

Never

Very seldom

Sometimes

Often

All the time
How often do you feel physically ill?

Never

Very seldom

Sometimes

Often

All the time
How often do you worry about whether you will pass out?

Never

Very seldom

Sometimes

Often

All the time
How knowledgeable do you feel you are about your diabetes?

Extremely knowledgeable 

Very knowledgeable
IRB NUMBER: 2022-028
IRB APPROVAL DATE: 03/28/2024

Version #: 1.16
Version Date:18Mar2024
Page 40 of 40

Moderately knowledgeable

Neither knowledgeable or unknowledgeable 

Moderately unknowledgeable

Very unknowledgeable
IRB NUMBER: 2022-028
IRB APPROVAL DATE: 03/28/2024