A Single-center, Prospective, 'Open-label,' Investigator-initiated Pilot Study Evaluating the Role of Continuous Glucose Monitor (CGM) Use Either Alone or With Remote Monitoring Capabilities in Pregnancy Associated With Type 1 Diabetes
Phase: NA
Conditions: Diabetes Mellitus, Type I
Sponsor: University of Colorado, Denver

 
CGM T1DM Pregnancy QI Study 
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Cover Page 
 
Official Title of the Study:  Investigator-initiated Pilot Prospective CGM Quality Improvement (QI) Project 
Investigator Initiated Study Protocol 
 
NCT number:  
 
02556554 
 
Date of the Document:  
March 17, 2016 

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Investigator-initiated Pilot Prospective CGM Quality Improvement (QI) Project 
Investigator Initiated Study Protocol 
Protocol #: 
 
 
WIRB # 20151413, COMIRB #15-1006  
 
Principal Investigator: 
Sarit Polsky, MD, MPH 
 
 
 
 
Assistant Professor of Medicine and Pediatrics 
 
Co-Investigators: 
 
Satish Garg, MD 
 
 
 
 
Professor of Medicine and Pediatrics 
 
Rachel Garcetti, PA  
 
 
 
 
Instructor of Pediatrics and Medicine 
 
 
 
 
 
Mary Voelmle, NP, CDE  
 
 
 
 
Instructor of Pediatrics and Medicine 
 
Chief Coordinators: 
Mara Schwartz RN, Daniel Ruck, CDE, Lisa Meyers, CDE, Terra Thompson, 
RN 
 
Co-Coordinators: 
Dominique Giordano, PRA, Ashleigh Downs, PRA, Scott Brackett, PRA 
 
Primary Institution:   
Barbara Davis Center for Diabetes 
University of Colorado Denver 
 
 
 
 
1775 Aurora Court, Mail Stop A140  
Aurora, CO 80045 
 
Sponsor: 
 
 
DexCom, Inc. 
 

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Abbreviations: 
A1C 
 
 
Hemoglobin A1C 
ADA 
 
 
American Diabetes Association 
AE 
 
 
Adverse Event 
ATTD  
 
Advanced Technologies and Treatments for Diabetes 
CDE 
 
 
Certified Diabetes Educator 
CGM  
 
Continuous Glucose Monitoring 
CSII 
 
 
Continuous Subcutaneous Insulin Infusion 
DKA 
 
 
Diabetic Ketoacidosis 
FDA 
 
 
Food and Drug Administration 
HBGI  
 
High Blood Glucose Index 
LBGI  
 
Low Blood Glucose Index 
MAGE  
 
Mean Amplitude of Glycemic Excursions 
MDI 
 
 
Multiple Daily Injections 
SAE 
 
 
Serious Adverse Event 
SMBG  
 
Self-Monitoring of Blood Glucose 
T1DM  
 
Type 1 Diabetes 
 

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Project Overview/Summary: 
This is a single-center, prospective, ‘open-label,’ investigator-initiated pilot study evaluating the role of 
continuous glucose monitor (CGM) use either alone or with remote monitoring capabilities that enable 
subjects to share CGM data with family and friends (whom we will call “followers” in this protocol) among 
women with T1DM associated with pregnancy.  We hypothesize that CGM use will decrease percentage of 
glucose values below the target range, decrease frequency of severe hypoglycemic episodes, and 
increase post-prandial glucose values into the target range, with a possible reduction in A1C compared to 
not using CGM during pregnancy. We hypothesize that the use of remote technology (Share™ 
technology) with subject’s designated follower will decrease hypoglycemia fear and the frequency of 
severe hypoglycemic episodes compared to CGM use alone in pregnancy or not using CGM use in 
pregnancy. This study aims to improve maternal glucose management among women with T1DM with a 
hope to also improve health outcomes during pregnancy. 
The study will enroll up to 40 patients from the Barbara Davis Center for Childhood Diabetes (BDC) Adult 
clinic over the age of 18 years who are pregnant (13 weeks gestation or less) or plan to become pregnant 
within the following 6 months. The study will also attempt to enroll up to 40 followers (one per pregnant 
subject) who are family members or friends of the pregnant subjects and over the age of 18 years. All 
subjects meeting these criteria will be invited to sign informed consent and participate in the study. All 
pregnant subjects will be stratified into one of three groups: (1) CGM use alone, (2) CGM use with Share™, 
(3) no CGM use. CGM use will be offered to all subjects, but individuals who do not want to wear a CGM 
will be stratified to Group 3. Stratification for Groups 1 and 2 will depend on the following: subjects and 
followers who have iPhones, iPads, and/or iPod touches will be placed into Group 2 which requires one of 
these devices to function, while all others will be placed in Group 1. All subjects will be followed for study 
visits with similar frequency during the pregnancy, and subjects in Groups 1 and 2 will wear the Dexcom 
G4 Platinum® CGM system from the first pregnancy visit until delivery. All subjects in Group 2 will also use 
the Share™ technology from the first pregnancy visit until delivery. 
CGM data will be analyzed for mean blood glucose values, time spent in hyperglycemic (>240, >300mg/dl) 
and hypoglycemic (<50, <70, <80 mg/dl) ranges and various indices of glycemic variability. Laboratory 
analysis for A1C will be performed at baseline, monthly thereafter during the pregnancy, and post-partum.   
Routine blood tests will be performed in all subjects in each trimester (see Table 1). 
Primary outcomes will be: 
1) Glucose variability as measured by glucose excursions from self-monitoring blood glucose (SMBG) data 
through log books and downloads as well as CGM downloads and various indices [J-index, mean 
amplitude of glycemic excursion (MAGE), high blood glucose index (HBGI), low blood glucose index 
(LBGI)] from CGM downloads.  
2) Changes detected by the hypoglycemia fear questionnaire. 
. 
Secondary outcomes will be:  
1) How CGM alone and CGM with Share™ usage affect A1C compared to no CGM use, 
2) Progression of diabetes complications (retinopathy, nephropathy), 
3) Maternal and fetal outcomes (eclampsia/pre-eclampsia, live birth rates, birth weight, neonatal 
hypoglycemia, and other similar measures). 
 
Introduction: 
Among the US population, 29.1 million people (9.3%) have diabetes (1). Pre-existing diabetes has to be 
managed very carefully throughout pregnancy to optimize maternal and fetal outcomes (2). Among women 

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with T1DM who are pregnant, the tools that we have to regulate maternal glucose control include multiple 
daily injections (MDI), continuous subcutaneous insulin infusion therapy (CSII) also known as insulin pump 
therapy, and for high-risk individuals continuous glucose monitoring (CGM) (2). CGM use in pregnancy has 
been shown to be safe, to reduce the frequency of severe hypoglycemia, and to improve A1C values (3-6). 
Sensor-augmented pump therapy with CGM use continuously was shown to lower A1C more than 
intermittent use in pregnant women with T1DM (7). However, few studies have measured changes in 
glucose variability that occur with CGM use during pregnancy and no studies have evaluated how tools that 
allow family and friends (followers) to access glucose trends affect outcomes during pregnancy. 
The goal of this prospective, non-randomized, pilot quality improvement study is to evaluate how CGM 
usage with and without remote monitoring capabilities affects glucose variability, A1C control, and patient-
related outcomes compared to non-CGM use in pregnancy among women with T1DM. This study may lead 
to further investigations about the role of mobile phones and handheld devices (such as iPod touch) for 
T1DM self-care in pregnancy. 
The Barbara Davis Center (BDC) Adult Clinic follows ~3,000 patients with T1DM. Sarit Polsky, MD, MPH is 
this study’s Principal Investigator and the director of the Pregnancy and Women’s Health Clinic at the BDC, 
which includes an extensive multidisciplinary team (physician’s assistant, nurse practitioner, registered 
nurses, certified diabetes educators, registered dieticians, and a social worker). The BDC Pregnancy and 
Women’s Health Clinic has all the necessary resources to perform such a trial.  Moreover, the investigators 
have extensive experience conducting clinical trials, including trials during pregnancy.   
Primary Objectives: 
The primary objectives of this pilot study are to improve maternal glucose management, to assess the role 
of CGM usage either alone or with remote monitoring capabilities (Share™) and changes detected by the 
hypoglycemia fear questionnaire among women with T1DM associated with pregnancy.   
Secondary objectives: 
1. Assessment of remote monitoring capabilities of followers (Share™ usage) that lead to 
interventions for hypoglycemia and hyperglycemia that affect subjects wearing CGM. 
2. Reduction in A1C from baseline to 3 months with maintained control at 6 and 9 months. 
3. Assess progression or stability of diabetes complications (retinopathy, nephropathy). 
4. Assess effects of CGM usage on maternal and fetal health outcomes (eclampsia/pre-eclampsia, 
live birth rates, birth weight, neonatal hypoglycemia, and other similar measures). 
Research Design:  
What do we intend to do? 
We intend to execute a single-center, prospective, non-randomized, ‘open-label,’ investigator initiated pilot 
study evaluating the effect of CGM usage with or without remote monitoring capabilities on women with 
T1D throughout pregnancy and compare outcomes to women who do not use a CGM during pregnancy. 
We also intend to ask a main follower for each woman about his/her knowledge of extreme glucose values 
among subjects and interventions on a subject’s behalf. See Figure 1 for study design. 
 
 

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How are we going to do the work? 
 
The BDC is primarily a T1DM clinical and research center and follows large numbers of patients with 
T1DM. Pregnant women are followed in the Pregnancy and Women’s Health clinic at the BDC. All site 
personnel will attend an investigator’s meeting, which will be organized and conducted before trial initiation.  
All subjects prospectively enrolled will sign an informed consent form approved by the Western Institutional 
Review Board (WIRB) through the Colorado Multiple Institutional Review Board (COMIRB).  A follower, 
designated by each subject, will also be asked to sign an informed consent form approved by the Western 
Institutional Review Board (WIRB) through the Colorado Multiple Institutional Review Board (COMIRB), 
however follower consent will not obligatory for a pregnant subject to participate in the study. Subjects 
identified through the retrospective chart review of existing data who are no longer pregnant, may have 
irregular visits to the Barbara Davis Center and in some cases only return to clinic once per year. As such, 
these subjects will be contacted by phone or e-mail to see if they are interested in participating in the study. 
Interested post-partum women will be sent the consent form approved by WIRB through the COMIRB prior 
to the informed consent discussion. We will undergo consenting procedures with subjects in person, when 
possible, or by phone and will have subjects sign the consent form and send it back to us. After our staff 
signs the consent form, subjects will receive a copy of the completed, signed consent form. 
Communications with the consent form with subjects in the retrospective chart review will take place via e-
mail, United States Postal Service, or fax (to be determined by availability, security of devices, and subject 
preference). 
What is the study population? 
The primary study population will consist of women at the BDC in the pre-conception and early gestational 
periods that are eligible for this pilot investigator-initiated CGM QI Project.  Subjects will be women 
intending to become pregnant or within the first 13 weeks of gestation, 18 years of age or older, using MDI 
or CSII therapy, with any A1C level, and willing to participate in the study. There is also a no CGM 
comparison group of women who were pregnant around the time study enrollment began and earlier who 
were patients at the BDC and whose data are available retrospectively through the electronic medical 
record system. The secondary study population will be designated followers of pregnant patients at the 
BDC. Followers will be family members or friends of pregnant subjects who are willing to participate in the 
study. 
How are subjects being recruited into the study? 
Subjects will be recruited from the BDC Pregnancy and Women’s Health clinic for screening, as well as the 
BDC Adult Clinic. During pre-conception counseling visits, women will be approached about participating in 
the study (if eligible). We will maintain a list of women intending to conceive within the next 6 months, ask 
women to come in for a pregnancy visit as soon as pregnancy is confirmed, and stratify women into 1 of 3 
groups described below. If after 6 months a woman on the list has not yet come in for a pregnancy visit, we 
will contact her to inquire if she still plans to conceive (keep subject on the list) or not (remove from list). 
 
Women who have their first pregnancy visit at the BDC at 13 weeks of gestation or less will be screened for 
the study. If eligible and interested in participating, after signing the informed consent, women will be 
stratified to either CGM use alone (Group 1) or CGM use with Share™ (Group 2). As Share™ requires 
specific device use, Group 1 subjects will be women who do not have an iPhone, iPad, or iPod touch or 
whose main follower does not have an iPhone, iPad, or iPod touch. Group 2 subjects will be women who 
have an iPhone, iPad, or iPod touch and whose main follower also has an iPhone, iPad, iPod touch, or 
other compatible device for downloading the Follower app. If eligible to participate but not interested in 
using a Dexcom CGM, women will be invited to sign informed consent so that we may follow their 

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outcomes over the course of the pregnancy while diabetes control is managed per usual care (Group 1 for 
women using a non-Dexcom CGM such as Medtronic Enlite CGM or Group 3 for no CGM use). A PRA will 
maintain an active list of individuals and will update the list continuously as women are assigned into 
groups. All subjects will have similar clinical visits throughout the pregnancy. 
 
Subjects stratified to Group 2, CGM use with Share™, will be asked to designate followers who will be able 
to view glucose trends and receive alerts for high or low sensor glucose values on an iPhone, iPad, iPod 
touch, and/or other compatible device. While multiple followers are allowed, one will be the main follower 
and will be invited to sign informed consent at the screening visit or within the first two months of each 
subject’s study participation. Subjects stratified into Groups 1 and 3 will be asked to designate a main 
follower who may be aware of a subject’s extreme glucose values (lows or highs) through contact with her 
and who may intervene on her behalf in such cases and will be invited to sign informed consent at the 
screening visit or within the first two months of each subject’s study participation. 
What are the treatment groups? 
There will be three ‘open-label’ treatment arms consisting of routine care in the Pregnancy and Women’s 
Health clinic at the BDC (no CGM use), an intervention arm using the Dexcom G4 or G5 Platinum® CGM 
system during pregnancy, and an additional treatment arm using the Dexcom G4 or G5 Platinum® CGM 
system with Share™ remote monitoring capabilities during pregnancy. As this is a non-randomized study 
and most women will opt to be in the Dexcom alone or Dexcom Share groups, we will include pregnant no 
CGM users identified through a retrospective chart review into the no CGM arm of the study. 
How many subjects per treatment arm? 
A total of up to 40 pregnant women will be prospectively recruited into the study. As this is an ‘open-label’ 
study whose group stratification is based on subject characteristics (willingness to wear CGM, subject 
possession of iPhone, iPad, or iPod touch, follower possession of iPhone, iPad, or iPod touch), we cannot 
predict the number of subjects per treatment arm. Based on our current pregnant population’s willingness 
to use CGM and device usage, we anticipate that 10 subjects will be in Group 1, 20 subjects in Group 2, 
and 10 subjects in Group 3. We will include up to 30 additional women in Group 3 identified through a 
retrospective chart review who were pregnant around the time of study enrollment and before the study 
began. 
In addition, there will one main follower for each prospectively enrolled pregnant subject (up to 40 adults) 
who will be asked questions once per month about knowledge of the subject’s glucose trends and 
interventions that s/he may have done on her behalf over the last month. 
What is the schedule of events for the treatment groups? 
After screening, when pregnancy is confirmed subjects will be stratified to Group 1, 2, or 3. Subjects in all 
groups will have similar study/clinic visits for data acquisition at the screening, pregnancy visits (which 
occur a minimum of monthly throughout gestation), and post-partum clinic visit. All subjects will be required 
to test blood glucoses at least 7 times a day throughout pregnancy. All subjects will be asked to log the 
SMBG values 7 times a day with insulin doses for meals for 1 week every trimester of the pregnancy. 
Subjects stratified to CGM wear will be provided with a Dexcom G4 CGM, transmitter, and sensors (4 per 
month). Subjects stratified to CGM wear who want to use their personal Dexcom G5 devices will be asked 
to provider Dexcom mobile usernames (if they use G5 with an iPhone) and will be provided with sensors (4 

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per month). Subjects already using a Dexcom G4 or G5 CGM will be provided only with the sensors. 
Replacement transmitters will be provided on an as needed basis during the study. A designated CDE or 
nurse will train each subject in the use of CGM at Visit 2, including how to use the sensor data (rate of 
change of glucose, to cross-check with fingerstick blood glucose as per FDA label before action is taken). 
Subjects in Group 2 will be additionally instructed on how to use the Platinum System with Share™ and will 
set up contact lists with family and friends at that visit. Subjects will be asked to wear the CGM for the 
duration of the pregnancy and to change sensor sites every 7 days. All subjects will be encouraged to 
check the blood glucose level (SMBG) before taking action on the CGM glucose values (as per the FDA 
label). Subjects in Groups 1 through 3 will be asked to designate a main follower who is willing to sign 
informed consent and fill out a questionnaire once a month. 
Subjects will be asked to return to clinic a minimum of once per month for pregnancy care with a BDC 
provider and to receive the next month’s sensors from a designated PRA. There are women whom we ask 
to return to clinic based on their clinical needs every week or every 2 weeks for pregnancy care who will be 
allowed to pick up sensors on a biweekly basis rather than monthly, if preferred. If a patient misses an 
appointment and needs to pick up sensors, she will be asked to reschedule her pregnancy visit and will be 
allowed to pick up sensors from the PRA for one more month. All subjects will be allowed to keep the 
devices used in the study upon completion. 
The final study visit will occur in conjunction with the post-partum visit.  
What is the schedule of events for the follower group? 
After screening, subjects assigned to Group 2 will be asked to designate a main follower and up to 4 other 
followers who will be allowed access to view glucose trends, to receive low sensor glucose alerts, and to 
receive high sensor glucose alerts for the subject. After screening, subjects assigned to Groups 1 or 3 will 
be asked to designate a main follower with whom she shares time and/or information about her diabetes 
care and who may intervene on her behalf should a need arise (e.g., provide glucagon for severe 
hypoglycemia, or suggest going to the hospital for extreme hyperglycemia). Main followers who sign 
informed consent, which will be obtained in person or by phone, will be asked to fill out a brief 
questionnaire once per month inquiring about the frequency of viewing information about glucose trends, 
receiving alerts or information about extreme low and high glucose values, and acting upon 
aforementioned data to assist the subject. The main follower can fill out the Follower Questionnaire on 
paper or s/he can receive the follower questionnaire electronically through REDCap is s/he has a working 
e-mail address (see Data Collection Tools section for details).  
Description of Mobile Technology:  
Subjects in Group 2 will be trained on the use of Dexcom G4 Platinum® CGM system with Share™.  This 
is a bluetooth low energy secure wireless communication system that allows remote viewing of sensor 
glucose levels, trends, and data between the person with diabetes wearing the CGM and her designated 
family members or friends. The followers can additionally receive alerts (alarms) for pre-specified low 
sensor glucose and high sensor glucose values. The person with diabetes can also designate herself as a 
follower to allow access to data through the approved devices. This technology is currently only available 
for use with Apple iPhone®, iPad, or iPod touch®. Followers have to have access to a device (smart phone) 
that allows download of the Dexcom Follower app. We will not provide iPhones, iPads, or iPods to subjects 
or followers for this study. 
Visit Descriptions:  

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Screening, Visit 1 (Week 0): 
The study will begin with a screening visit either during a pre-conception counseling visit or within the first 
13 weeks of gestation: Visit 1, (Week - 0).  All subjects meeting inclusion/exclusion criteria will be invited to 
sign informed consent, which will be obtained at this study visit.   
During this visit, pregnant subjects will receive a physical exam, vitals, medical history, demographics, and 
concomitant medications. Laboratory tests will be performed to assess for A1C. SMBG values will be 
downloaded. If applicable CGM units and insulin pumps will be downloaded.  
Stratification, Visit 2 (Week 1): 
 
Subjects enrolled in the study from pre-conception will be asked to come to clinic as soon as a home 
pregnancy test or serum blood test confirms pregnancy, during which time routine clinical care will be 
provided and subjects will be stratified to 1 of 3 study arms based on subject characteristics. Subjects who 
did not have a pre-conception counseling visit who come to clinic for routine clinical care before 13 weeks 
of gestation will combine Visit 1 (screening) with Visit 2 (stratification with CGM start). A urine pregnancy 
test will be administered to confirm pregnancy. Per routine clinical care, we will screen for diabetic 
neuropathy on physical exam, thyroid disease (TSH blood draw), and kidney disease (24-hour urine protein 
with creatinine). These tests will be repeated once each trimester. Also per routine clinical care, women will 
be asked to get a dilated retinal eye exam each trimester and to provide the BDC with a copy of the 
provider’s report of each exam. 
Women stratified to Groups 1 and 2 who own a Dexcom G4 or G5 Platinum CGM® will be given 4 sensors. 
Women stratified to Groups 1 and 2 who do not own a Dexcom G4 or G5 Platinum CGM® will be given 
Dexcom G4 CGM units, transmitters, and 4 sensors. They will also receive training in the insertion of 
sensors and CGM use. A Dexcom G4 Platinum® CGM sensor will be inserted that day and will be worn in 7 
day periods throughout the study. Although subjects will be asked to wear the device 7 days/week, 
satisfactory data capture rate is regarded as 5 days of successful CGM readings. The CGM data will be 
unblinded (real-time use) such that subjects will be able to view glucose values and trends, as well as 
receive alerts for low and high sensor glucose values. Women will be asked to check SMBG at least 7 
times daily (fasting, before meals, 2 hours after a meals, and at bedtime) for the duration of the study.  
Women in Group 2 will be trained in the use of the Share™ technology. They will be asked to designate a 
main follower and up to 4 additional followers who will receive access to sensor glucose data remotely 
through the secure, wireless communication system. Recommendations will be made for low and high 
glucose sensor alerts that will be individualized to each subject’s needs (for example a low glucose alert 
with a higher glucose value for subjects with hypoglycemia unawareness compared to those without it). 
The main follower for each subject will be approached and asked to sign informed consent at Visit 2 or 
within 2 months of the subject’s first pregnancy visit. Study participation of a main follower will be 
encouraged but not obligatory. 
Women unwilling to wear a CGM but willing to participate in the study (Group 3) will be asked to check 
SMBG at least 7 times daily (fasting, before each meal, and 2 hours after meals, and at bedtime), per 
standard of care, for the duration of the study. All 3 groups will receive education about diabetes during 
pregnancy. 
Women in Groups 1 and 3 will be asked to designate a main follower who will not receive data through a 
device, but rather through contact with the subject. The main follower for each subject (Groups 1 through 3) 

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will be approached and asked to sign informed consent at Visit 2 or within 2 months of the subject’s first 
pregnancy visit. Study participation of a main follower will be encouraged but not obligatory. 
Data on all subjects for medical history, existing diabetes complications, medications, vital signs, 
height/weight, A1C (current and most-immediately pre-conception), insulin doses, glucometer downloads, 
insulin pump downloads (if applicable), CGM downloads (if applicable), and adverse events (AEs) will be 
collected. If the woman was seen at the Barbara Davis Center prior to the consent visit, we will do a 
retrospective chart review for medications, vital signs, height/weight, A1C, insulin doses, glucometer 
downloads, insulin pump downloads (if applicable), and CGM downloads (if applicable) for the most-
immediate pre-conception clinic visit and for visits during the current pregnancy. Each subject will be given 
a hypoglycemic fear questionnaire. We will ask women about interventions that have taken place over the 
last month for extremely low and high glucose values, directed by patient or a third party, and keep the 
information on research source documents. 
Visits 3 through 13 (Weeks 5 to 40): 
Subjects will come to the BDC for routine clinical care at least once per month for the duration of the 
pregnancy (through gestational week 40, though some women deliver up to 42 weeks gestation) and for 
continued study participation. Per routine clinical care, we will screen for diabetic neuropathy on physical 
exam, thyroid disease (TSH blood draw), and kidney disease (24-hour urine protein with creatinine) at least 
once each trimester. Also per routine clinical care, women will be asked to get a dilated retinal eye exam 
each trimester and to provide the BDC with a copy of the provider’s report of each exam. 
Subjects in Groups 1 and 2 will receive 4 new sensors per month, but may choose to get 2 sensors twice a 
month instead, at study visits. Use of acetaminophen-containing medications like Tylenol® during sensor 
wear may affect device performance, therefore we will ask subjects to keep a log of each time these 
medications are used. We will ask subjects at each monthly visit whether she used acetaminophen-
containing medications during the previous month and when. Followers will be administered a brief 
questionnaire at the beginning of every month inquiring on the frequency of low alerts, high alerts, viewing 
glucose trends, and actions they may have taken on behalf of the subjects because of the above (see 
Table 2 and Follower Questionnaire for details). On source documents, we will also record how often 
subjects required an intervention for low or high glucose values within the previous month, and the nature 
of the interventions. If in Group 2, we will keep source documentation about interventions resulting from a 
Share™ alert within the previous month. 
Data on all pregnant subjects for medications, vital signs, height/weight, insulin doses, glucometer 
downloads, insulin pump downloads (if applicable), and CGM downloads (if applicable) will be collected at 
least once per month and as often as every week. All subjects will be asked to collect a 7-point profile for 
SMBG measurements (blood glucose measurements before meals, 2 hours after meals, and at bedtime) 
along with meal insulin dosing for 1 week once per trimester (see SMBG Questionnaire). A1C will be 
measured once per month. Subjects will be asked about updated concomitant drugs and any AEs that may 
have occurred. Each subject will be given a hypoglycemic fear questionnaire.  
Visit 14 (Weeks 44 to 52): 
All subjects will have routine post-partum clinical care between 4 and 6 weeks post-partum. However, a 
post-partum visit up to 12 weeks post-partum will be accepted as a final study visit. Data on all subjects for 
medications, vital signs, height/weight, insulin doses, SMBG values, glucometer downloads, insulin pump 
downloads (if applicable), and CGM downloads (if applicable) will be collected. All subjects will be asked to 

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collect a 7-point profile for SMBG measurements (blood glucose measurements before meals, 2 hours 
after meals, and at bedtime) along with meal insulin dosing for 1 week in the post-partum period (see 
SMBG Questionnaire). A1C will be measured. Subjects will be asked about updated concomitant drugs 
and any AEs that may have occurred. Subjects in Groups 1 and 2 may have had a Dexcom G4 Platinum 
CGM® for personal use prior to study participation and may thereafter still wear the device after labor and 
delivery. In such cases, CGM downloads will be included in study data. On source documents, we will 
record how often subjects required an intervention for low or high glucose values within the previous 
month, and the nature of the interventions. Subjects will be administered a questionnaire inquiring about 
the labor and delivery process, maternal and fetal complications before and after delivery, baby’s 
anthropometrics at birth (weight and length), baby’s current age, breastfeeding, and other measures (see 
BDC Pregnancy CGM Post-Partum Questionnaire for details). If the pregnancy ended early (for example, 
spontaneous abortion or stillbirth) or resulted in fetal or neonatal death (for example, stillbirth) we will obtain 
data about these outcomes. Each subject will be given a hypoglycemic fear questionnaire. Followers will be 
asked to fill out their last Follower Questionnaire during the post-partum period. 
Control Arm: 
As outlined in the proposal, the subjects prospectively enrolled in this arm (Group 3) will receive the same 
care as in the intervention arms (Groups 1 and 2)  with the exception of not having access to the Dexcom 
G4 Platinum CGM® with or without Share™ technology.  
There will also be a control arm of pregnant patients at the BDC identified through a retrospective chart 
review who were pregnant around the time of study enrollment or before and who did not use a CGM 
device throughout their pregnancies. The retrospective chart review will collect data on a subject’s medical 
history, diabetes complications, medications, vital signs, height/weight, A1C, insulin doses, glucose meter 
downloads, insulin pump downloads (if applicable), and CGM downloads (if applicable) for the most 
immediate pre-conception visit, all pregnancy visits, and the post-partum visit. Subjects identified through 
the retrospective chart review will not have filled out any of our questionnaires (baseline, hypoglycemic 
fear, and postpartum questionnaires), nor will they have had followers who filled out questionnaires. They 
will not be asked to fill out these questionnaires.  
Inclusion Criteria:  
Subjects that meet the following criteria will be considered for admission to the study: 
1. Signed informed consent before any study-related activities 
2. Female aged 18 years and older with T1D duration >1 year 
3. Pregnancy with confirmation of gestational age 13 weeks or less 
4. Willingness to routinely practice at least 3-7 blood glucose measurements per day 
5. Using MDI or CSII therapy 
6. Any A1C level 
7. Ability and willingness to adhere to the protocol including scheduled study visits for the duration of 
the pregnancy 
8. Able to speak, read, and write English 
Exclusion Criteria: 
Subjects will be excluded from the study if any of the following apply: 

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1. Unwilling to sign informed consent and participate in the study 
2. Female age 17 years or younger 
3. T1D duration <1 year 
4. Pregnancy in gestational week 14 or higher 
5. Extensive skin changes/diseases that inhibit wearing a sensor on normal skin 
6. Severe known allergy to adhesives within the last 3 months 
7. Any other condition, as determined by the investigator, which could make the subject unsuitable for 
the trial, impairs the subject’s suitability for the trial, or impairs the validity of the informed consent 
Risks and Justification of Procedures: 
CGM: Continuous glucose monitoring is an FDA approved technology that offers a unique and practical 
way of identifying and differentiating clinical benefits of intensive diabetes care. The American Diabetes 
Association currently recommends CGM use during pregnancy for high-risk individuals (2).  We currently 
have hundreds of patients, which include many pregnant patients, in the Adult Clinic at The BDC using 
CGM on a regular basis as part of usual medical management of their diabetes. Subjects may experience 
pain at the site of sensor insertion. The adhesive pads for the sensor may cause skin erythema for 1 to 2 
days or more. An allergic reaction to 1 or more parts of CGM devices may occur which can be mild, 
moderate, or severe (rare). In rare cases, an infection at the sensor site may occur. In rare cases, the 
sensor or needle may break inside the body and would require a minor surgical procedure to remove it. 
Data Collection Tools: 
A confidential subject database will be established to maintain study data. Data will be entered into 
REDCap (Research Electronic Data Capture). REDCap is an internal secure, computerized database 
system at the University of Colorado Denver. This system allows data entry, survey/questionnaire building, 
data exportation to statistical packages, and is HIPAA compliant. Each subject will be assigned an 
identification number, which will be used to code and identify all of that subject’s records. This will avoid the 
continual use of subject names. REDCap surveys can be sent to study participants via e-mail for direct 
input into the database. The electronic medical record system at the Barbara Davis Center will be used to 
conduct a retrospective chart review to identify BDC patients not using a CGM device who were pregnant 
around the time of study enrollment and before. Their data will be put into REDCap and will be de-
indentified for data analyses. All study data will be locked in PI’s office and all relevant computer study files 
will be input on staff computers, which are password protected and contain encryption software. Data 
storage will be take place on a secured server maintained by the University of Colorado. The server is 
backed up nightly and a copy of the back-up file is kept off site in a secure facility. Data access will be 
limited to study personnel. Study results may be presented in the form of posters, abstracts, oral 
presentations, or publications at academic meetings or in journals. In all forms of study result reporting, 
subject identification will not be disclosed. A study subject may access his/her protected health information 
at any time by requesting said information in writing of the investigator. The investigative team has been 
trained in IRB and HIPAA compliance issues and will maintain confidentiality and protect health 
information. The above-stated procedures have been highly effective in preventing breaches of patient 
confidentiality for the prior and current research studies in which the PI has been and continues to be 
involved at the University of Colorado Denver. 
Safety Measures: 

Polsky, et al. 
           13 
A data safety monitoring board (DSMB) consisting of Drs. Janet Snell-Bergeon (Epidemiologist and 
Statistician), Peter Gottlieb, and Viral Shah will oversee safety data throughout the study via reporting of 
hypoglycemic events, adverse events (AE), and severe adverse events (SAEs) if any.   
All AEs, reported spontaneously by the subject, as well as those noted by the investigator or study staff, 
regardless of seriousness, severity or expectedness will be recorded on source documents from the time of 
obtaining the informed consent.   
Severe hypoglycemia as defined as a hypoglycemic episode requiring assistance or hospitalization with or 
without an SMBG is to be reported as an SAE.  A hypoglycemic event “requiring assistance” is determined 
when the subject is unable to treat the event on her own.  Any untoward event resulting in hospitalization, 
extension of hospitalization, death, or threat of death will also be considered an SAE.  SAEs will be 
reported to the DSMB.  The endpoints of A1C and mean glucose readings will be excluded from SAE 
reporting.  
Weakness of the Study 
This is not a randomized clinical trial, as the Dexcom remote monitoring technology is not available for 
other types of handheld devices besides the iPhone, iPad, and iPod Touch.  This is a pilot study as no one 
has previously evaluated the role of this mobile technology in diabetes care complicated by pregnancy.  
Our goal is to learn from this study and plan for a much larger study where handheld devices are also 
provided and thus randomization can occur in the future after implementing changes that will be learned 
from this pilot study. 
Statistical Analysis Plan: 
Statistical analysis is expected to be completed within 6 months of the last study visit of the last enrolled 
subject.  Analysis will be conducted with an intention to treat approach.  We will aim to recruit up to 40 
pregnant subjects and plan for a 20% drop-out rate (n=8) to have 32 subjects complete the study. We aim 
to enroll up to 40 followers, but as their participation will be not be obligatory outcomes will not depend on 
their enrollment. As this is a pilot-study and has no formal power, calculations will be performed for the 
primary or secondary endpoints.  
The primary endpoints are glucose variability and changes detected by hypoglycemic fear survey. We will 
measure indices of glucose variability (mean glucose ± SD, % of glucose within/above/below target ranges, 
J Index , High Blood Glucose Index [HBGI], Low Blood Glucose Index [LBGI], Mean Amplitude of Glycemic 
Excursions [MAGE], CONGAn) throughout pregnancy using the SMBG 7-point profiles for one week taken 
once per trimester. Hypoglycemic fear survey results will be assessed once monthly over the pregnancy. 
We will compare outcomes within individuals over time and between individuals of the different study arms. 
We will test whether outcomes differ between women using Dexcom alone and women using Dexcom with 
Share™ using interaction terms, and will stratify analyses if differences by group are greater than 10 mg/dL 
in mean glucose levels are detected. Since SMBG logs will be taken at multiple time points over the 
pregnancy and since CGMs will be worn continuously for the duration of each pregnancy, linear mixed 
models will be used to assess changes in outcome measures (GV, time spent in target below or above 
target) over time in each trimester of pregnancy. We will use linear mixed models to assess changes in the 
hypoglycemic fear survey in each month of the pregnancy. Secondary endpoints include A1C differences 
among study arms. Improvement in glycemic variability parameters with a possible reduction of A1C by 
0.3%, measured as the difference of the mean A1C laboratory values of the arms of the study between 
baseline (0-3 months, first trimester), second trimester (3-6 months), and third trimester (6 to 9 months).  
Mixed models account for missing data, allow for an unstructured covariance matrix for repeated 
measures, and account for inter-subjects correlation of measurements. Secondary outcomes will be used 

Polsky, et al. 
           14 
in the same mixed models.  Differences in frequency of low alert glucose rates, high alert glucose rates, 
and interventions for low or high glucose values among the followers for each study arm will be analyzed 
with student t-tests. A p-value < 0.05 will be considered significant, and we will perform statistical analyses 
with SAS software (version 9.3, SAS Institute, Cary NC). 
 
Publication Strategy: 
The BDC is a leading clinical T1DM clinical and research center.  All study personnel will attend an 
investigator’s meeting, which will be organized and conducted before trial initiation.  All subjects will sign an 
informed consent form approved by Western Institutional Review Board (WIRB) and the Colorado Multiple 
Institutional Review Board (COMIRB).   
Study results will be presented at national and international conferences including the Scientific Sessions 
of the American Diabetes Association (ADA), EASD, ATTD, etc.  The Principal Investigator may submit 
study results for publishing to peer reviewed scientific journals, particularly within the fields of diabetes and 
endocrinology.   

Polsky, et al. 
           15 
Table 1: Study Procedures for Subjects 
Visit 
1 
2 
3 - 13 
14 
Study Week 
0 
1 
5-40 
44-52 
Informed Consent and Eligibility Criteria 
X 
 
 
 
Demographic Data, Medical History 
X 
 
 
 
Concomitant Medications 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
Physical Exam 
X 
X 
X* 
X 
Urine Pregnancy Test  
 
X 
 
 
A1C 
X 
X 
X 
X 
Vital Signs, Height, Weight 
X 
X 
X 
X 
Record Basal, Bolus, Total Insulin 
Dose** 
X 
X 
X 
X 
SMBG Questionnaire 
 
X 
X* 
X 
Glucose Meter Download 
X 
X 
X 
X 
Insulin Pump Download (if applicable) 
X 
X 
X 
X 
DexcomTM CGM Training and 
Education (if needed, Groups 1 & 2) 
 
X 
 
 
CGM sensor insertion  
 
X 
X 
 
CGM Removal/ Download 
 
X 
X 
X 
Record interventions of a 3rd party for a 
subject’s high or low glucose levels 
 
X 
X 
X 
Hypoglycemic Fear Questionnaire 
 
X 
X* 
X 
BDC Pregnancy CGM Post-Partum 
Questionnaire 
 
 
 
X 
* Once per trimester. 
** From insulin pump download or record of patient’s MDI insulin use. 
 
Table 2: Study Procedures for Followers 
Visit 
1 
2 
3 - 13 
14 
Study Week 
0 
1 
5-40 
44-52 
Informed Consent and Eligibility Criteria 
X 
 
 
 
Follower Questionnaire 
 
 
X* 
X 
* Once per month. 
 

Polsky, et al. 
           16 
Figure 1 Study design: 
 
 
 
 
 
 
 
Visit 3 onwards** 
 
Post-partum 
 
 
 
 
 
 
 
1st to 3rd Trimesters 
 
Post-partum 
 
 
 
 
 
 
 
CGM use (patient use) 
follow-up 
 
 
 
 
Visit 2 (Groups 1,2)*  
 
Group 1: CGM Use Alone 
 
 
 
1st Trimester 
 
 
 
Randomization, 
 
 
 
CGM training 
 
 
 
and insertion  
 
 
Group 2: CGM Use with Share™ 
 
 
 
 
 
 
 
 
Visit 1* 
 
 
 
 
 
Visit 3 onwards** 
 
Post-partum 
Screening, 
 
 
 
 
 
1st to 3rd Trimesters 
 
Post-partum 
Baseline Visit  
 
 
 
 
CGM use (patient, 
 
follow-up 
n=40  
 
 
 
 
 
family, and friend use) 
 
 
 
 
 
 
Consent 
 
 
 
 
 
 
 
Group 3: No CGM Use 
 
 
 
 
 
 
 
 
Visit 2 (Group 3)* 
 
Visit 3 onwards ** 
 
Post-partum 
 
 
 
1st Trimester  
 
1st to 3rd Trimesters 
 
Post-partum 
 
 
 
No CGM 
 
 
No CGM 
 
 
follow-up 
 
*Visit 1 will apply for women screened at a pre-conception counseling visit. Women screened in the 1st 
trimester may combine visits 1 and 2. 
**Visits 3 through 13 for pregnancy care and study follow-up. 
 
 
 
 
 

 
CGM T1DM Pregnancy QI Study 
                    17 
Appendix A 
The Dexcom G4 Platinum® CGM system 
should be used: 
 For measuring interstitial glucose levels 
from the sensor tip which is inserted into 
the skin of the abdomen or forearm. 
 With calibration with measurements of 
blood sugar levels from fresh capillary 
whole blood samples taken from the 
fingertip, palm (at the base of the thumb), 
or forearm. 
For use at home by persons with diabetes, or in 
a clinical setting by healthcare professionals, as 
an aid to monitor the effectiveness of diabetes 
control.  
About the Share™ technology 
 Remote monitoring capacity: Bluetooth® Low 
Energy technology. 
 Compatibility with: iPhone versions 4S through 6 
Plus, iPod touch 5th Gen, iPad versions 3 and 4, 
iPad Air and Air 2, iPad Mini versions 1 through 3. 
 Apps: Dexcom Share and Dexcom Follow both 
require internet connectivity 
 Number of followers allowed: 5. 
 Information sharing: Applies when the app is 
running in the foreground or background, as long 
as the app is open.  
 Access to trend graph and notification 
settings: Applies when the Sharer sets access to 
the follower, Sharer can change access to the 
trend graph, Follower can modify the notification 
settings. 
 

 
CGM T1DM Pregnancy QI Study 
                    1 
Appendix B 
 
Baseline Participant Questionnaire 
 
Subject ID: ________________________________  Study Visit: (dd/mmm/yyyy) :             /            /           . 
 
DEMOGRAPHIC INFORMATION 
 
 
Date of Birth ______________ 
 
 
   (dd/mmm/yyyy) 
 
   Ethnicity  
 
 
 
 
 
 
 
 
 
 Asian/Oriental 
 
 
 
 African American  
 
 
 Caucasian 
 Hispanic or Latino 
 
 Other                    If other, specify ______________ 
  
Education 
 
 Grade school 
 
 
 
 High School/GED  
 
 
 Some College 
 
 Associates degree 
 
 Bachelor’s Degree 
 
 
 
 
 Master’s degree 
 
 
 Other  
 
If other, specify ______________ 
Marital Status 
 Single 
 Married 
 Widowed 
 Other  
 
If other, specify ______________ 
 
DIABETES HISTORY 
Duration of Diabetes: _____________________  
 
 
Immediate family history of diabetes?      Yes 
   No 
   
 
 
Method of Insulin delivery: 
 
 MDI   
 Pump Therapy 
 VGO Insulin Therapy 
 
Type and Average Dose of Insulin Used: 
Basal: ______________________  Dose______ 
Bolus:______________________   Dose______ 
 
Other Diabetes medications? __________ 
If yes, specify  ______________________________________________________ 
 

CGM T1DM Pregnancy QI Study 
                   2 
CGM Use: 
 Current CGM user  
If yes, duration of previous use ____________ 
 
 
 Past CGM user 
 
 
 Never used CGM 
 
DIABETIC COMPLICATIONS 
         
Diabetic Retinopathy? 
 
 
 
 
Yes 
   No 
  Unknown 
 
 
 
Diabetic sensory or motor neuropathy?  
 
 
Yes 
   No 
  Unknown 
 
 
Diabetic autonomic neuropathy?  
 
 
 
Yes 
   No 
  Unknown 
 
 
Diabetic nephropathy? (including micro-albuminuria) 
Yes 
   No 
  Unknown 
 
If yes, please specify the most recent event diagnosed at the time of patient inclusion: 
 
 
Impaired renal function (estimated GFR by MDRD below 60mL/min)   
 
 
 
Micro-albuminuria (30-299mcg per mg creatinine) 
 
 
 
 
 
 
Overt proteinuria (equal to or above 300 mcg per mg creatinine) 
 
 
 
High Cholesterol?  
 
 
 
 
 
Yes 
   No 
  Unknown 
 
 
 
 
 
High Blood Pressure?   
 
 
 
 
Yes 
   No 
  Unknown 
 
 
 
PRE-EXISTING CONDITIONS 
 
Does the subject have any pre-existing conditions?              
 
            Yes 
   No 
 
 
If yes, list below 
________________________________________________________________________________________________________
________________________________________________________________________________________________________
________________________________________________________________________________________________________
________________________________________________________________________________________________________ 
 
CONCOMITANT THERAPY 
 
Is the subject taking any medications other than insulin?   
 
            Yes 
   No 
If yes, list 
below 
________________________________________________________________________________________________________
________________________________________________________________________________________________________
________________________________________________________________________________________________________
________________________________________________________________________________________________________
________________________________________________________________________________________________________ 
 
PREVIOUS OBSTETRIC HISTORY 
 
Past pregnancy?               
              
 
             
 
            Yes 
   No 
  
          If no, skip to next section. 
 
Fill out information for each pregnancy. If there are more than 4 pregnancies, continue on another sheet. 
 
 

CGM T1DM Pregnancy QI Study 
                   3 
First Pregnancy 
Outcome Date  ____________ 
                            (dd/mmm/yyyy) 
Delivery type:  
                 Vaginal 
         If yes: Spontaneous 
 Induced 
 Breech 
 Vacuum 
 Forceps  
                     VBAC 
        If yes: Spontaneous 
 Induced 
 
Cesarean Section 
        If yes: Low Transverse 
 Low Vertical 
 Classical 
 Unspecified 
 
               Abortion 
        If yes: Spontaneous 
 Therapeutic 
 
      Tubal/ectopic 
 
 
 
 
 
 
 
Gestational Age ____________  
Birth Weight  ____________ 
 
Preterm labor during pregnancy?               
        
Yes 
   No 
 
 
 
Child is still living?               
              
 
Yes 
   No 
 
 
 
Pregnancy complications?                    
 
Yes 
   No 
 
 
      If yes, check all that apply: 
      Pregnancy-induced hypertension  
 
 
                               Hypoglycemic seizure 
 
                    Eclampsia/Pre-eclampsia  
                                                    Diabetic Ketoacidosis 
 
            Large for gestational age baby 
                    Progression of diabetic complication(s) 
 
            Small for gestational age baby 
                    Other  
 Specify _____________________ 
 
Labor complications?       
              
 
             
 
            Yes 
   No 
  
       If yes, check all that apply: 
                          Fetal Intolerance  
  
                                     Anesthetic Complications 
 
            Eclampsia/Pre-eclampsia  
                                                              Dysfunctional Labor 
 
                   Seizures during Labor 
                                               Cephalopelvic Disproportion 
 
                         Aburptio Placenta 
                                                                       Placenta Previa 
 
                         Shoulder Dystocia 
                                                                 Excessive Bleeding 
 
Failure to Progress in First State 
                                     Failure to Progress in Second State 
 
               Neonatal Hypoglycemia 
                    Other  
 Specify _________________________ 
 
Second Pregnancy 
Outcome Date  ____________ 
                            (dd/mmm/yyyy) 
Delivery type:  
                 Vaginal 
         If yes: Spontaneous 
 Induced 
 Breech 
 Vacuum 
 Forceps  
                     VBAC 
        If yes: Spontaneous 
 Induced 
 
Cesarean Section 
        If yes: Low Transverse 
 Low Vertical 
 Classical 
 Unspecified 
 
               Abortion 
        If yes: Spontaneous 
 Therapeutic 
 
      Tubal/ectopic 
 
 
 
 
 
 
 
Gestational Age ____________  
Birth Weight  ____________ 
 
Preterm labor during pregnancy?               
        
Yes 
   No 
 
 
 
Child is still living?               
              
 
Yes 
   No 
 
 

CGM T1DM Pregnancy QI Study 
                   4 
Pregnancy complications?                    
 
Yes 
   No 
 
 
      If yes, check all that apply: 
      Pregnancy-induced hypertension  
 
 
                               Hypoglycemic seizure 
 
                    Eclampsia/Pre-eclampsia  
                                                    Diabetic Ketoacidosis 
 
            Large for gestational age baby 
                    Progression of diabetic complication(s) 
 
            Small for gestational age baby 
                    Other  
 Specify _____________________ 
 
Labor complications?       
              
 
             
 
            Yes 
   No 
  
       If yes, check all that apply: 
                          Fetal Intolerance  
  
                                     Anesthetic Complications 
 
            Eclampsia/Pre-eclampsia  
                                                              Dysfunctional Labor 
 
                   Seizures during Labor 
                                               Cephalopelvic Disproportion 
 
                         Aburptio Placenta 
                                                                       Placenta Previa 
 
                         Shoulder Dystocia 
                                                                 Excessive Bleeding 
 
Failure to Progress in First State 
                                     Failure to Progress in Second State 
 
               Neonatal Hypoglycemia 
                    Other  
 Specify _________________________ 
 
Third Pregnancy 
Outcome Date  ____________ 
                            (dd/mmm/yyyy) 
Delivery type:  
                 Vaginal 
         If yes: Spontaneous 
 Induced 
 Breech 
 Vacuum 
 Forceps  
                     VBAC 
        If yes: Spontaneous 
 Induced 
 
Cesarean Section 
        If yes: Low Transverse 
 Low Vertical 
 Classical 
 Unspecified 
 
               Abortion 
        If yes: Spontaneous 
 Therapeutic 
 
      Tubal/ectopic 
 
 
 
 
 
 
 
Gestational Age ____________  
Birth Weight  ____________ 
 
Preterm labor during pregnancy?               
        
Yes 
   No 
 
 
 
Child is still living?               
              
 
Yes 
   No 
 
 
 
Pregnancy complications?                    
 
Yes 
   No 
 
 
      If yes, check all that apply: 
      Pregnancy-induced hypertension  
 
 
                               Hypoglycemic seizure 
 
                    Eclampsia/Pre-eclampsia  
                                                    Diabetic Ketoacidosis 
 
            Large for gestational age baby 
                    Progression of diabetic complication(s) 
 
            Small for gestational age baby 
                    Other  
 Specify _____________________ 
 
Labor complications?       
              
 
             
 
            Yes 
   No 
  
       If yes, check all that apply: 
                          Fetal Intolerance  
  
                                     Anesthetic Complications 
 
            Eclampsia/Pre-eclampsia  
                                                              Dysfunctional Labor 
 
                   Seizures during Labor 
                                               Cephalopelvic Disproportion 
 
                         Aburptio Placenta 
                                                                       Placenta Previa 
 
                         Shoulder Dystocia 
                                                                 Excessive Bleeding 
 
Failure to Progress in First State 
                                     Failure to Progress in Second State 
 
               Neonatal Hypoglycemia 
                    Other  
 Specify _________________________ 

CGM T1DM Pregnancy QI Study 
                   5 
Fourth Pregnancy 
Outcome Date  ____________ 
                            (dd/mmm/yyyy) 
Delivery type:  
                 Vaginal 
         If yes: Spontaneous 
 Induced 
 Breech 
 Vacuum 
 Forceps  
                     VBAC 
        If yes: Spontaneous 
 Induced 
 
Cesarean Section 
        If yes: Low Transverse 
 Low Vertical 
 Classical 
 Unspecified 
 
               Abortion 
        If yes: Spontaneous 
 Therapeutic 
 
      Tubal/ectopic 
 
 
 
 
 
 
 
Gestational Age ____________  
Birth Weight  ____________ 
 
Preterm labor during pregnancy?               
        
Yes 
   No 
 
 
 
Child is still living?               
              
 
Yes 
   No 
 
 
 
Pregnancy complications?                    
 
Yes 
   No 
 
 
      If yes, check all that apply: 
      Pregnancy-induced hypertension  
 
 
                               Hypoglycemic seizure 
 
                    Eclampsia/Pre-eclampsia  
                                                    Diabetic Ketoacidosis 
 
            Large for gestational age baby 
                    Progression of diabetic complication(s) 
 
            Small for gestational age baby 
                    Other  
 Specify _____________________ 
 
Labor complications?       
              
 
             
 
            Yes 
   No 
  
       If yes, check all that apply: 
                          Fetal Intolerance  
  
                                     Anesthetic Complications 
 
            Eclampsia/Pre-eclampsia  
                                                              Dysfunctional Labor 
 
                   Seizures during Labor 
                                               Cephalopelvic Disproportion 
 
                         Aburptio Placenta 
                                                                       Placenta Previa 
 
                         Shoulder Dystocia 
                                                                 Excessive Bleeding 
 
Failure to Progress in First State 
                                     Failure to Progress in Second State 
 
               Neonatal Hypoglycemia 
                    Other  
 Specify _________________________ 
 
ALCOHOL AND TOBACCO CONSUMPTION HABITS 
 
Past cigarette use?               
              
Yes 
   No 
 
 
 
Current cigarette use? 
              
Yes 
   No 
 
 
If yes, usage duration ____________ 
 
 
 
  
 
         
 
         
Alcohol use:    
 
 
      Never    
 
 
                   At least weekly 
  
 
  
Occasionally (less than monthly)   
                                                  At least daily 
 
               At least monthly   
 
      
How many standard drinks* containing alcohol does subject have on a typical day when drinking? 
          1 or 2 
                                              Greater than 2 
 
 
*standard drink: 1 pint/bottle of beer, 1 glass of wine, 1 shot of hard liquor

CGM T1DM Pregnancy QI Study 
                    
Appendix C  
Hypoglycemic Fear Survey 
Subject ID: _____________________        
Clinic Visit: (dd/mmm/yyyy) :             /            /           . 
Visit (check one): _   Baseline      First Trimester      Second Trimester      Third Trimester      Post-Partum 
 
 
This survey is intended to find out more about how low blood sugar makes people feel  Please answer the following questions as 
frankly as possible. 
 
 
I. 
Behavior. Below is a list of things people with diabetes sometimes do in order to avoid low blood sugar. Read each item 
carefully. Circle one of the numbers to the right that best describes what you do during your daily routine to avoid low blood sugar. 
 
 
Never 
Rarely 
Sometimes 
Often 
Very often 
 1. Eat large snacks at bedtime 
1 
2 
3 
4 
5 
 2. Avoid being alone when my sugar is likely to be low 
1 
2 
3 
4 
5 
 3. If test urine, spill a little sugar to be on the safe side. If test 
blood glucose, run a little high to be on the safe side 
1 
2 
3 
4 
5 
 4. Keep my sugar higher when I will be alone for a while 
1 
2 
3 
4 
5 
 5. Eat something as soon as I feel the first sign of low blood 
sugar 
1 
2 
3 
4 
5 
 6. Reduce my medication (insulin/pills) when I think my sugar is 
too low 
1 
2 
3 
4 
5 
 7. Keep my blood sugar higher when I plan to be in a long 
meeting or at a party 
1 
2 
3 
4 
5 
 8. Carry fast-acting sugar with me 
1 
2 
3 
4 
5 
 9. Avoid a lot of exercise when I think my sugar is low 
1 
2 
3 
4 
5 
10. Check my sugar often when I plan to be in a long meeting or 
go out to a party 
1 
2 
3 
4 
5 
 
 
 
 
 

CGM T1DM Pregnancy QI Study 
                    
II. 
Worry. Below is a list of concerns people with diabetes sometimes have. Please read each item carefully (do not skip 
any). Circle one of the numbers to the right that best describes how often you worry about each item because of low blood sugar. 
 
 
Never 
Rarely 
Sometimes 
Often 
Very often 
11. Not recognizing/realizing I am having a reaction 
1 
2 
3 
4 
5 
12. Not having food, fruit, or juice with me 
1 
2 
3 
4 
5 
13. Feeling dizzy or passing out in public 
1 
2 
3 
4 
5 
14. Having a reaction while asleep 
1 
2 
3 
4 
5 
15. Embarrassing myself or my friends/family in a social 
situation 
1 
2 
3 
4 
5 
16. Having a reaction while alone 
1 
2 
3 
4 
5 
17. Appearing stupid or drunk 
1 
2 
3 
4 
5 
18. Losing control 
1 
2 
3 
4 
5 
19. No one being around to help me during a reaction 
1 
2 
3 
4 
5 
20. Having a reaction while driving 
1 
2 
3 
4 
5 
21. Making a mistake or having an accident at work 
1 
2 
3 
4 
5 
22. Getting a bad evaluation at work because of something 
that happens when my sugar is low 
1 
2 
3 
4 
5 
23. Having seizures or convulsions 
1 
2 
3 
4 
5 
24. Difficulty thinking clearly when responsible for others 
(children, elderly, etc.) 
1 
2 
3 
4 
5 
25. Developing long-term complications from frequent low 
blood sugar 
1 
2 
3 
4 
5 
26. Feeling lightheaded or faint 
1 
2 
3 
4 
5 
27. Having an insulin reaction 
1 
2 
3 
4 
5 
 
 

CGM T1DM Pregnancy QI Study 
                    
Appendix D 
 
SMBG (Self-Monitoring Blood Glucose) Questionnaire 
 
Subject ID: _____________________        
Clinic Visit: (dd/mmm/yyyy) :             /            /           . 
 
Gestational Age:       8 to 12 weeks         20 to 24 weeks         32 to 36 weeks    __Post-Partum 
 
DAY 
DATE 
TIME POINT 
BLOOD GLUCOSE 
BEFORE MEAL (OR 
BEDTIME) 
SHORT-ACTING 
INSULIN DOSE 
(UNITS) 
BLOOD GLUCOSE 2 
HOURS AFTER MEAL 
1 
 
Breakfast 
 
 
 
Lunch 
 
 
 
Dinner 
 
 
 
Bedtime 
 
 
 
2 
 
Breakfast 
 
 
 
Lunch 
 
 
 
Dinner 
 
 
 
Bedtime 
 
 
 
3 
 
Breakfast 
 
 
 
Lunch 
 
 
 
Dinner 
 
 
 
Bedtime 
 
 
 
4 
 
Breakfast 
 
 
 
Lunch 
 
 
 
Dinner 
 
 
 
Bedtime 
 
 
 
5 
 
Breakfast 
 
 
 
Lunch 
 
 
 
Dinner 
 
 
 
Bedtime 
 
 
 
6 
 
Breakfast 
 
 
 
Lunch 
 
 
 
Dinner 
 
 
 
Bedtime 
 
 
 
7 
 
Breakfast 
 
 
 
Lunch 
 
 
 
Dinner 
 
 
 
Bedtime 
 
 
 

CGM T1DM Pregnancy QI Study 
                    
Appendix E 
Follower Questionnaire 
Subject ID: _____________________        
Clinic Visit: (dd/mmm/yyyy) :             /            /           . 
Gestational Age of Pregnant Participant:  
_   4 to 8 weeks             8 to 12 weeks         12 to 16 weeks        16 to 20 weeks        20 to 24 weeks  
     24 to 28 weeks        28 to 32 weeks        32 to 36 weeks        36 to 40 weeks        40 to 42 weeks  
__4 to 12 weeks post-partum 
LOW GLUCOSE QUESTIONS 
 
How many times were you alerted to low glucose levels this month? 
 Never 
 1-5x mo 
 1-5 x weekly 
 Daily 
 More than 1 x daily 
 N/A 
Did you intervene to help your pregnant partner with low glucose levels this month?  
 Yes 
 No 
 
If yes, how often?  
 
 Never 
 1-5x mo 
 1-5 x weekly 
 Daily 
 More than 1 x daily 
 N/A 
If yes, what was the nature of the intervention? Check all that apply. 
 Gave glucose tablets/gel   
 
 Gave glucagon injection 
 Gave food or drink with carbohydrates 
 Called health care provider 
 Checked blood glucose level 
 
 Called emergency services (like 911) 
 Other (Please describe: ______________________________________________) 
How many times did your pregnant partner’s low glucose levels interfere with her daily activities this 
month? 
 Never 
 1-5x mo 
 1-5 x weekly 
 Daily 
 More than 1 x daily 
 N/A 

CGM T1DM Pregnancy QI Study 
                    
HIGH GLUCOSE QUESTIONS 
 
How many times were you alerted to high glucose levels this month? 
 Never 
 1-5x mo 
 1-5 x weekly 
 Daily 
 More than 1 x daily 
 N/A 
Did you intervene to help your pregnant partner with high glucose levels this month?  
 Yes 
 No 
 
If yes, how often?  
 
 Never 
 1-5x mo 
 1-5 x weekly 
 Daily 
 More than 1 x daily 
 N/A 
If yes, what was the nature of the intervention? Check all that apply. 
 Gave insulin shot   
 
 
 Checked ketone level 
 Gave insulin through an insulin pump 
 Called health care provider 
 Checked blood glucose level 
 
 Called emergency services (like 911) 
 Other (Please describe: ______________________________________________) 
How many times did your pregnant partner’s high glucose levels interfere with her daily activities this 
month? 
 Never 
 1-5x mo 
 1-5 x weekly 
 Daily 
 More than 1 x daily 
 N/A 
 

CGM T1DM Pregnancy QI Study 
    1                   
Appendix F 
BDC Pregnancy CGM Post-Partum Questionnaire 
Subject ID: _____________________        
Clinic Visit: (dd/mmm/yyyy) :             /            /           . 
Post-Partum Week: _   4 to 6 weeks             6 to 8 weeks         8 to 10 weeks        10 to 12 weeks    
Pregnancy Outcome Date __________ 
                                              (dd/mmm/yyyy) 
 
Gestational Age __________ Birth Weight __________ Birth Length __________ 
 
Child is still living?  
 Yes 
 No 
 
Baby’s Sex 
 Male 
 Female 
 
Preterm labor during pregnancy?  
 Yes 
 No   
If yes, please describe, including dates of hospital admissions: _____________________ 
________________________________________________________________________ 
 
Delivery type: 
                 Vaginal 
         If yes: Spontaneous 
 Induced 
 Breech 
 Vacuum 
 Forceps  
                     VBAC 
        If yes: Spontaneous 
 Induced 
 
Cesarean Section 
        If yes: Low Transverse 
 Low Vertical 
 Classical 
 Unspecified 
 
 
Pregnancy complications?  
 Yes 
 No 
 
 
If yes, check all that apply: 
 
 Placenta previa                                
 Placenta accreta            
 Incompetent cervix  
 Hyperemesis gravidarum               
 Proteinuria                     
 Hypoglycemic seizure 
 Pregnancy-induced hypertension 
 Oligohydramnios          
 Polyhydramnios   
 
 Pre-eclampsia                                   
 Eclampsia                       
 Diabetic ketoacidosis   
 HELLP syndrome                              
 Progression of diabetic complications   
 Small for gestational age baby      
 Large for gestational age baby   
 Other ________________________________________________________________ 
 
Labor complications?  
 Yes 
 No 
 
If yes, check all that apply: 
 
 Fetal intolerance                        
 Anesthetic complications  
 Pre-eclampsia      
 Eclampsia  
 
        
 Dysfunctional labor            
 Seizures during labor           
 Cephalopelvic disproportion    
 Placental abruption            
 Placenta previa       
 Shoulder dystocia                       
 Breech delivery                   
 Nuchal cord 
 
 Excessive bleeding                      
 Failure to progress in first state  
 Failure to progress in second state  
 Other ________________________________ 
 
Neonatal complications?  
 Yes  
 No 
 
If yes, check all that apply: 
 
 Birth trauma/injury                    
 Hypoglycemia                       
 Asphyxia    
 Jaundice                                       
 Congenital anomalies _______________________ 

CGM T1DM Pregnancy QI Study 
2 
 Other ________________________________________________________________ 
 
Was the baby admitted to the Neonatal Intensive Care Unit (NICU) for any length of time during your 
hospital stay?  
 Yes 
 No 
 
If yes, please describe: _____________________________________________________ 
 
________________________________________________________________________ 
 
________________________________________________________________________  
 
________________________________________________________________________ 
 
 
Are you or did you ever breastfeed after your baby was delivered? 
 Yes 
 No 
 
If yes, check all that apply: 
 
 Breastfed within the first week of baby’s birth and not afterwards 
 
 Breastfed within the first month of baby’s birth and not afterwards 
 
 Breastfed for the first 2 months after baby’s birth and not afterwards 
 
 Breastfed for the first 3 months after baby’s birth and not afterwards 
 
 Breastfed for the first 3 months after baby’s birth and still breastfeeding 
 
 Breastfed exclusively 
 
 Breastfed and formula-fed the baby 
 
Questions about glucose variability: 
Have you had any glucose values below 50 within the last month? 
 Yes 
 No 
 
If yes, how often on average? 
 
 Every day 
 
 A few times per week 
 
 A few times per month 
 
 Once 
 
Over the last month did you have to do something to correct a low glucose (<50 mg/dL) or did someone 
else have to intervene for a low glucose on your behalf? 
 Yes 
 No 
 
If yes, check all that apply: 
 
 Consume glucose tablets or glucose gel 
 
 Eat or drink something with carbohydrates 
 
 Call health care provider for help 
 
 Receive an injection of glucagon 
 
 Receive an infusion of dextrose (glucose through a vein) 
 
 Call to emergency services (like 911) 
 
 Stay in the hospital for observation and/or treatment 
 
 
If yes, when? _____________   For how long? ______________ 
 
Have you had any glucose values above 300 within the last month? 
 Yes 
 No 
 
If yes, how often on average? 
 
 Every day 
 
 A few times per week 
 
 A few times per month 
 
 Once 

CGM T1DM Pregnancy QI Study 
3 
Over the last month did you have to do something unusual (besides taking extra insulin) for a very high 
glucose (<300 mg/dL) or did someone else have to intervene for a very high glucose on your behalf? 
 
Yes 
 No 
 
If yes, check all that apply: 
 
 Take multiple insulin boluses within 6 hours to bring the glucose down 
 
 Change an infusion set earlier than anticipated 
 
 Drink extra amounts of fluids 
 
 Call health care provider for help 
 
 Call to emergency services (like 911) 
 
 Receive insulin and/or fluids through a vein 
 
 Stay in the hospital for observation and/or treatment 
 
 
If yes, when? _____________   For how long? ______________ 

CGM T1DM Pregnancy QI Study 
                 
References: 
 
1. 
Center for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its 
Burden in the United States, 2014. Atlanta, GA: U.S. Department of Health and Human Services, 2014. 
2. 
Kitzmiller JL, Block JM, Brown FM, Catalano PM, Conway DL, Coustan DR, et al. Managing preexisting 
diabetes for pregnancy: summary of evidence and consensus recommendations for care. Diabetes care. 
2008;31(5):1060-79. 
3. 
Kerssen A, de Valk HW, Visser GH. The Continuous Glucose Monitoring System during pregnancy of women 
with type 1 diabetes mellitus: accuracy assessment. Diabetes technology & therapeutics. 2004;6(5):645-51. 
4. 
Secher AL, Stage E, Ringholm L, Barfred C, Damm P, Mathiesen ER. Real-time continuous glucose monitoring 
as a tool to prevent severe hypoglycaemia in selected pregnant women with Type 1 diabetes - an observational 
study. Diabetic medicine : a journal of the British Diabetic Association. 2014;31(3):352-6. 
5. 
Murphy HR, Rayman G, Lewis K, Kelly S, Johal B, Duffield K, et al. Effectiveness of continuous glucose 
monitoring in pregnant women with diabetes: randomised clinical trial. Bmj. 2008;337:a1680. 
6. 
Murphy HR. Integrating educational and technological interventions to improve pregnancy outcomes in 
women with diabetes. Diabetes, obesity & metabolism. 2010;12(2):97-104. 
7. 
Petrovski G, Dimitrovski C, Bogoev M, Milenkovic T, Ahmeti I, Bitovska I. Is there a difference in pregnancy 
and glycemic outcome in patients with type 1 diabetes on insulin pump with constant or intermittent glucose 
monitoring? A pilot study. Diabetes technology & therapeutics. 2011;13(11):1109-13.