Postprandial Walks for Glucose Control in Type 2 Diabetes in Pregnancy
Phase: NA
Conditions: Pregestational Diabetes, Type 2 Diabetes
Sponsor: Eastern Virginia Medical School

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Project title: Glucose Control in Type 2 Diabetes in Pregnancy 
 
Principal investigator:  
Marwan Ma’ayeh, MD  
825 Fairfax Avenue, Suite 520, Norfolk, VA 23507 
E-mail: MaayehMG@evms.edu 
 
Co-Investigators: Morgan Scaglione, MD, MA; George Saade, MD 
 
Institution: Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, Virginia 
 
1. Background: 
Pregestational diabetes mellitus affects 1-2% of all pregnancies in the United States each year, and the 
incidence continues to increase at an accelerated rate. From 2016-2021, there was a 27% rate increase in 
women giving birth with pregestational diabetes
1. In addition, there are racial disparities associated with 
pregestational diabetes, with the lowest rates in Caucasian women and the highest rates in Black, Native 
American, and Hispanic women
2.  
Pregestational diabetes is also comprised of both Type 1 and Type 2 diabetes mellitus; however, these 
are the result of vastly different mechanisms. Similar to the pathophysiology of gestational diabetes in 
pregnancy, Type 2 diabetes is related to insulin resistance (as opposed to insulin deficiency in Type 1) and is 
closely associated with obesity and sedentary lifestyle. Because of the characteristics, Type 2 diabetes is likely 
to respond to lifestyle interventions for improvement. 
Lifestyle modification is an important part of blood glucose management in pregnancy. Although the 
primary focus is typically diet modification, physical activity is also associated with improved glucose 
control
4−5. Andersen et al. followed 14 women with diet-controlled gestational diabetes in Denmark and 
found reduced mean glucose in patients with 20 minutes of walking after each meal
6. In addition, short 
periods of post-prandial walking were found to have similar effect on glucose concentrations compared to 
longer strenuous activity 
7. Outside of pregnancy, postprandial walking was found to be superior to pre-meal 
exercise for management of Type 2 diabetes
8. 
Optimization of glucose levels in pregnancy can reduce the risk of several adverse outcomes, which 
include miscarriage, congenital birth defects, macrosomia, intrauterine fetal demise, and neonatal morbidity
2. 
Traditionally in pregnancy, patients with diabetes would monitor blood glucose levels four times daily: fasting 
and then 1- or 2-hours postprandial. However, more recently, continuous glucose monitoring (CGM) has 
become more popular and readily available. In a cohort of patients using CGM, Bartal et al. found that the 
proportion of the time glucose levels where within what is considered acceptable range, referred to as time in 
range was associated with neonatal outcomes
3. Specifically, patients whose time in range was below 70% 
had worse neonatal outcomes than those with time in range at or above 70%. 
We hypothesize that post-prandial walking will improve time in range on continuous glucose monitoring, 
as well as maternal and neonatal outcomes in pregnant patients with Type 2 diabetes. As an initial step in 
testing this hypothesis, we will conduct a randomized controlled trial to limit bias in evaluating these 
hypotheses. A FitBit will be provided to both groups to assess adherence to the walking regimen. 
Each year, approximately 400 pregnant women with Type 2 diabetes are followed at Eastern Virginia 
Medical School Maternal Fetal Medicine. This would be the first randomized-controlled trial focusing on post-
prandial walking utilizing continuous glucose monitoring and FitBit data in this US patient population. 
 
2. Specific aims:  
Aim 1. To examine the effect of post-prandial walking on time in range on CGM in pregnant patients with Type 
2 diabetes  
 
3. Study design:  
We propose a randomized controlled trial of women with singleton pregnancies who present with a 
diagnosis of pre-gestational Type 2 diabetes. The participants will be randomized to the intervention group 
(post-prandial walks + standard care) or control group (standard care alone which includes the usual 
counseling regarding activity) in a 1:1 ratio. The participant will be randomized by a number-generating 

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computer software after recruitment at the gestational diabetes education class. All participants will receive a 
continuous glucose monitor and basic model FitBit for use and data collection. 
 
Inclusion criteria 
- 
Singleton gestation 
- 
Known diagnosis of Type 2 diabetes OR meets new diagnosis of Type 2 diabetes in the first trimester 
(up through 13 weeks and 6 days)
9 
- 
Age ≥18 and <50 years 
- 
Gestational age <32 weeks 0 days gestation 
 
Exclusion criteria 
- 
Non-English as primary language. 
- 
Inability to participate in 20 minutes of walking at a time 
- 
Known or suspected fetal anomaly or aneuploidy 
- 
Prisoners 
- 
Management of diabetes outside of Eastern Virginia Medical School Maternal Fetal Medicine 
 
Because we are a tertiary care center, some individuals may be seen at several different time points in the 
pregnancy at time of recruitment. All of these participants can be included for recruitment until 32 weeks 0 days 
gestation. 
 
3.1 Postprandial walking: 
Post-prandial walking group 
Participants will be instructed to walk specifically for 20 minutes after each meal (breakfast, lunch, and dinner).   
 
Control group 
Participants will receive the usual counseling regarding physical activity, which does not include post-prandial 
walking.   
 
Both groups 
All participants will be encouraged to continue exercise per the U.S. Department of Health and Human 
Services Physical Activity Guidelines for Americans and the American College of Obstetricians and 
Gynecologists recommendations, which includes at least 150 minutes of moderate intensity aerobic activity per 
week during pregnancy. Given these recommendations, post-prandial walking is minimal risk to the patient and 
is an activity that patients may choose to do even outside of this study. 
Both groups will have a fasting blood draw and urine sample at enrollment and between 34-36 weeks gestation 
in the outpatient setting, typically less than 25cc blood, to test for metabolomics. 
Both groups will also have an estimation of body composition at enrollment and between 34-36 weeks 
gestation using bioelectrical impedance analysis (BIA), which introduces (non-invasively) a current into the 
body passing through a source electrode and a detector electrode, located on both hands and feet. BIA 
measures Resistance and Reactance and their vector relationship Impedance. Based on predictive equation, 
BIA estimates fat mass, fat-free mass, lean soft tissue, total body, intracellular, extracellular water, and phase 
angle. There are no known risks or discomforts related to the BIA. Minor discomfort is associated with the 
placement and removal of the electrodes on the skin. 
 
4. Procedures: 
4.1 Recruitment and Screening: 
Subjects will be screened and offered recruitment if they meet inclusion and exclusion criteria. This will occur 
at the EVMS Maternal Fetal Medicine Diabetes Program Clinic. The length of active participation will be 
variable depending on when they enter our care, and our intervention will continue throughout pregnancy. Our 
primary outcome length will last 2 weeks, but from randomization to postpartum, it can be up to 37 weeks 
(almost the entire pregnancy). No direct involvement is needed from the patient after delivery. However, data 
collection for secondary outcomes via chart review will continue to be collected through 2 weeks postpartum. 
 
4.2 Consenting process: 

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Patients will be approached at the EVMS Maternal Fetal Medicine Diabetes Program. The patients will be 
informed that the purpose of the study is to evaluate the effect of physical activity on glucose control and that 
all participants will receive a FitBit Inspire 3 and continuous glucose monitor (Dexcom G7). The patients will be 
informed that the groups will receive two different types of counseling regarding physical activity. A patient may 
be withdrawn from the study if a provider outside of the research team no longer deems that participation is in 
the best interest of the patient. Participation in this research study will not affect any other aspect of the 
patient’s care. The patient may withdraw from the study at any point without affecting her care. No 
inducements will be offered to terminate a pregnancy. Those engaged in this study will not take any part in 
decisions regarding termination of pregnancy and if the patient desires termination or questions the viability of 
the pregnancy, the patient will be referred to a non-investigator for appropriate care. 
 
Due to the risk of introducing bias when divulging the details of the intervention group procedures to the control 
group, authorized deception will be utilized during the consent process. A general overview of the study that 
focuses on standard of care will be provided to the patients initially. If the patient is randomized to the 
intervention group, they will be provided with a second consent form outlining the randomization to 20 minute 
postprandial walks. Two separate consent forms will therefore be used: one for all participants prior to 
randomization, and another for the intervention group only outlining the specifics of the postprandial walk 
intervention. 
 
5. Randomization: 
This will be a randomized-controlled trial 1:1. Randomization to each group will be conducted via the REDCap 
randomization module.  
 
6. Outcomes: 
Our primary outcome is the time in range (via CGM data) during the management of Type 2 diabetes in 
pregnancy between 34 and 36 weeks gestation. We chose this primary outcome because it is at the time of 
peak insulin resistance and time in range is more closely associated with pregnancy outcomes as compared to 
other means of monitoring glucose control.  
 
Secondary outcomes include FitBit data (duration of postprandial walk (in minutes), sleep duration, baseline 
heart rate, maximal heart rate during walks, frequency of aerobic exercise per week), CGM data (mean 
glucose level, glucose excursions, fasting blood sugar), total daily insulin dose, fetal demise, fetal growth 
restriction, preeclampsia, placental abruption, mode of delivery (cesarean or vaginal delivery), indication of 
cesarean delivery, presence of shoulder dystocia (for vaginal deliveries), quantitative blood loss (QBL mL), 
postpartum hemorrhage (QBL > 1000 mL), infection (either chorioamnionitis or postpartum endometritis prior 
to discharge), birth weight (gram), APGAR scores, neonatal infection (defined as sepsis, fever, positive 
cultures, or a suspicious clinical course that warranted antibiotics treatment), respiratory distress syndrome, 
necrotizing enterocolitis, and neonatal intensive care unit admission (NICU), and days in NICU. Other 
secondary outcomes will include metabolomic markers collected from the urine and blood, as well as body 
composition data. 
 
We will also collect demographic and clinical characteristics including maternal age, gestational age at 
delivery, race, ethnicity, insurance, marital status, history of preterm birth, parity, and number of previous 
cesarean or vaginal delivery. 
 
Chart review for secondary outcomes and demographic/clinical characteristics will be completed through 
Allscripts, EPIC, and Powerchart. 
 
7. Data Gathering and Safety: 
The FitBits, continuous glucose monitors, and all supplies for the patient will be paid for with no cost to the 
patient or the patient’s insurance company. The Marwan Ma’ayeh Discretionary Research Fund is covering the 
cost of the FitBits and CGMs. For the Dexcom G7, it is recommended that the sensor be changed every 7 
days, which will be performed by the patient. Therefore, the sensor will need to be changed between 8 and 37 
times throughout the study period, dependent upon what gestational age the patient was enrolled. 

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The research team will gather the data from the continuous glucose monitors via the share function, similar to 
how the data is shared to the clinical team. 
The primary outcome will focus on the 34 through 36 week gestation data. However, the data from the rest of 
the subject’s participation will be included in the secondary outcomes.  
There will be two blood draws: at enrollment and again between 34 and 36 weeks gestation. A urine collection 
will also be performed at these times. These will be collected at an already scheduled clinic appointment. 
Therefore, no additional appointment will be needed for this. It will be drawn by phlebotomy staff or research 
nurses. It will be kept refrigerated, processed within 24 hours, and kept in -70 degree freezer in a secured 
area. After collection, samples will be run and kept in a separate repository for potential future use. This will be 
paid by the Marwan Ma’ayeh Discretionary Research Fund. There will be no cost to the patient. 
 
The study dataset and ID key will be stored in REDCap in separate projects due to inclusion of data from the 
EMR. 
 
8. Sample size calculation: Time in range in pregnant patients with pre-gestational diabetes is 66.3% with a 
standard deviation of 21.3%
3. We assume that 20 minutes of postprandial walking after each meal will 
decrease the mean glucose by 30%. Therefore, assuming a 30% improvement in time in range, with a power 
of 80% and alpha of 0.05, 18 mother/neonate pairs per group would be needed to reach statistical significance. 
Assuming a 10% loss to follow up rate, a total of 40 mother/neonate pairs will be included in the study.  
 
9. Statistical analysis: Descriptive statistics will be provided first for describing the subjects’ demographic and 
clinical characteristics. Fisher’s exact or Chi Squared test will be used to compare categorical variables and the 
Student t-test or Man-Whitney U test will be used to compare numerical variables.  
 
 
 

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References: 
1. Gregory ECW, Ely DM. Trends and Characteristics in Prepregnancy Diabetes: United States, 2016–2021. 
Natl Vital Stat Rep. 2023;72(6):1-13. 
2. American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins-Obstetrics. ACOG 
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Doi:10.1097/AOG.0000000000002960 
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9279 
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doi:10.1139/apnm-2021-0619 
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dinner than pre-dinner exercise in type 2 diabetic individuals. J Am Med Dir Assoc. 2009;10(6):394-397. 
doi:10.1016/j.jamda.2009.03.015 
9. American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care. 
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