Can "Continuous Glucose Monitors" (CGMS) Improve Postpartum (PP) Gestational Diabetes (GDM) Screening for Diabetes?
Phase: NA
Conditions: Postpartum Gestational Diabetes Mellitus
Sponsor: Woman's

 
Woman's IRB Initial Approval Date: August 22, 2023 
 RP Number: RP-23-010-WH 
 
CAN “CONTINUOUS GLUCOSE MONITORS” (CGMS) IMPROVE 
POSTPARTUM (PP) GESTATIONAL DIABETES (GDM) 
SCREENING FOR DIABETES? THE PPCGMS INTERVENTION 
AFTER GDM TRIAL  
 
 
 
INVESTIGATOR-INITIATED STUDY PROPOSAL 
 
 
Principal Investigator:  
Karen Elkind-Hirsch, MSc., PHD 
 
Co-Investigator: 
 
Edward Veillon Jr. MD 
 
 
Woman’s Research Center 
Woman’s Maternal Fetal Medicine Department  
 
 
 
 
100 Woman’s Way 
 
 
 
 
Baton Rouge, LA  70817 
 
Sponsor: 
 
 
Woman’s Hospital 
 
 
Supported by an Investigator Initiated Trial Grant from Dexcom to KEH 
 
 
Correspondence to: 
Karen Elkind-Hirsch, MSc., PhD 
Director of Scientific Research 
100 Woman’s Way, Baton Rouge, Louisiana 70817 
225-231-5278 | Karen.Elkind-Hirsch@womans.org 

 
Woman's IRB Initial Approval Date: August 22, 2023 
 RP Number: RP-23-010-WH 
 
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Table of Contents 
 
BACKGROUND ..................................................................................................... 3 
STUDY OBJECTIVES ............................................................................................. 6 
STUDY DESIGN ..................................................................................................... 6 
Treatment Regimen ............................................................................................ 6 
Number of Participants ...................................................................................... 6 
Subject Population .............................................................................................. 6 
ELIGIBILITY CRITERIA ..........................................................................................  
Inclusion Criteria ................................................................................................ 7 
Exclusions Criteria:’ ............................................................................................ 7 
Timeline and Procedures ................................................................................... 7 
Duration of Study ............................................................................................... 7 
Outcome Measures ............................................................................................. 8 
Statistical Analyses ............................................................................................. 9 
REFERENCES…………………………………………………………………… ... 10  
 
 
 

 
Woman's IRB Initial Approval Date: August 22, 2023 
 RP Number: RP-23-010-WH 
 
Background 
Gestational diabetes mellitus (GDM), a complication of glucose 
intolerance with first recognition in pregnancy, is one of the most common 
medical problems in pregnancy and strongly linked with the development of 
type 2 diabetes (T2D) later in life (1–3).  Thirty percent of women with GDM 
will have persistent postpartum dysglycemia, and up to 70% ultimately receive 
the diagnosis of T2D within 10 years postpartum (4,5).  Therefore, postpartum 
blood glucose screening is important to detect prediabetes and T2D, allowing 
timely treatment (3-7).  For this reason, both the American Diabetes Association 
(ADA) and American College of Obstetrics & Gynecology (ACOG) 
recommend a 2-h 75-gram oral glucose tolerance test (OGTT) for all women 
who had GDM 6–12 weeks after delivery to detect persisting glucose 
intolerance or diabetes mellitus after pregnancy (8).  
Unlike other laboratory tests performed, the OGTT involves several 
phases, including the need to fast for several hours, to drink a concentrated 
glucose solution which can induce unpleasant gastrointestinal effects, the 
collection of three to four blood samples, and the need to remain seated in the 
laboratory for two to three hours (9).  Ingestion of the glucose solution is an 
important cause of discomfort for patients undergoing an OGTT.  Less than 
half of the women who had GDM comply to the recommendations of 
postpartum 75-gram OGTT diabetes screening and the majority do not attend 
any screening for T2D postpartum (10-12).  The average compliance rate for 
postpartum OGTT testing is 35%, largely related to women perceiving the test 
as inconvenient (13-15).  For example, in England, a study which examined 
postpartum glucose screening rates in women with a history of GDM, using a 
nationally representative sample from 127 urban and suburban primary care 
practices, found that just 18.5% of women had glucose screening within six 
months of birth [16].  Additional studies have identified reasons for non-
attendance or non-completion from the perspective of women (17-19); these 
reasons included: time pressures, lost laboratory forms, not knowing a test was 
necessary (15,19) feelings of emotional stress while adjusting to a new baby and 
fear of a T2D diagnosis [(17-19). 
The recommended diabetes screening test postpartum is the OGTT, as 
hemoglobin A1c  (HbA1c) is less sensitive to the rapid glycemic variations and 

 
Woman's IRB Initial Approval Date: August 22, 2023 
 RP Number: RP-23-010-WH 
 
blood volume changes expected after a recent GDM pregnancy.  HbA1c reflects 
average glycemic exposure over the preceding 2–3 months and is commonly 
used in people with diabetes to monitor long-term (∼3 months) glycemic 
control (20).  Even though the HbA1c is faster, easier, and less expensive to 
administer, it results in false negative findings 60–70% of the time when the 
OGTT detects diabetes (21,22).  While chronic blood glucose concentrations 
influence HbA1c levels, many other factors can increase or decrease HbA1c as 
well, which could lead to questionable HbA1c results and poor alignment with 
the OGTT.  HbA1c levels can be affected by genetic, hematologic, and illness-
related factors, especially anemia (23).  
Interestingly, the ADA has acknowledged that in patients in whom 
HbA1c is unreliable (especially those with hemoglobinopathies, altered red cell 
turnover or impaired renal function), the assessment of other indices of chronic 
glycemia may be advisable, although their relation with average glucose and 
prognosis remains uncertain (24).  HbA1c reflects the glucose concentration 
during the entire lifespan of the red blood cells but to the largest extent the 6–
8 weeks preceding the time of measurement (20).  Certain factors, e.g. red blood 
cell disorders, could potentially bias the measurement of HbA1c and therefore 
alternative markers could be useful (24, 25).   One such marker is fructosamine 
which relates to average levels of glucose during the preceding 1 to 3 weeks 
(24,25).  Fructosamine may give an earlier indication of poorly controlled 
glucose compared to HbA1c.  It is a simple, robust and inexpensive biomarker 
that could potentially be a useful tool in large epidemiological and clinical 
studies either as a stand-alone indicator of hyperglycemia or in combination 
with glucose and HbA1 (25).  Importantly, fructosamine may be reliably 
measured irrespective of fasting or non-fasting.  Glycated albumin is the 
percentage of serum albumin to which a glucose molecule has been 
nonenzymatically attached, while fructosamine refers to all ketoamine linkages 
resulting from serum protein glycation (26).  The term “fructosamine,” 
therefore, typically refers to all ketoamine linkages that result from glycation 
of serum proteins.  In non-pregnant populations, fructosamine has been shown 
to adequately identify individuals with diabetes, and to improve diabetes 
detection when used in combination with HbA1c or fasting glucose (27).  
Glycated serum proteins, such as fructosamine, may avoid issues related to 

 
Woman's IRB Initial Approval Date: August 22, 2023 
 RP Number: RP-23-010-WH 
 
RBC turnover and provide viable alternatives to HbA1c as a marker of 
glycemia.  In particular, these biomarkers are not based on hemoglobin and 
hence, do not depend on RBC turnover (26).  Since fructosamine reflects the 
average levels of blood glucose during the former 1 to 3 weeks, fructosamine 
also mirrors a poorly controlled glucose metabolism better than HbA1c (27).  
However, some physiological and pathological conditions can significantly 
influence the metabolism of fructosamine.  In brief, all those clinical conditions 
that affect protein metabolism potentially influence the concentrations of 
glycated proteins (28).  Thus, physiologic or pathologic conditions linked to 
hypo-proteinemia (i.e., pregnancy or malnutrition) are more likely to affect the 
concentration of fructosamine.  Another disadvantage of fructosamine is that 
its concentration is considerably influenced by the levels of immunoglobulins, 
especially IgA, which are present in abnormal concentration in a broad range 
of clinical conditions.(29).  
Among women who experience glucose abnormalities during 
pregnancy, screening during the postpartum period offers a window of 
opportunity for early identification of diabetes and prediabetes.  The rates of 
postpartum T2D screening with an OGTT for women with GDM are not 
optimal given the majority of women with GDM fail to return for postpartum 
glucose testing.   A new device called a continuous glucose monitor or “CGM” 
is a small disc that is placed on the arm and  can be easily placed and removed 
by the person wearing it.  It is worn for 10 days and can stay in place for 
activities such as sleeping and showering.  Over 10 days, over 1000 sugar 
measurements are taken without the person wearing the device having to do 
any testing (30).  Continuous glucose monitoring (CGM) systems have been 
recognized as an ideal method of monitoring glycemic control in diabetic 
patients (30,31).   The data of rigorous 24 h glucose profiles from CGM allow 
the 
calculation 
of 
glycemic 
variations, 
detection 
of 
asymptomatic 
hypoglycaemia and accurately depict the characteristics of blood glucose 
fluctuations (30,31).  In the past decade, CGM has been proven to have similar 
accuracy to self-monitoring of blood glucose (SMBG) and yet provides better 
therapy optimization and detects trends in glucose values due to higher 
frequency of testing.  Although CGM has been used successfully in T1D and 
T2D patients (31), the effectiveness of CGM in improving pregnancy outcomes 

 
Woman's IRB Initial Approval Date: August 22, 2023 
 RP Number: RP-23-010-WH 
 
complicated by GDM is still understudied (32).  Current updated evidence 
suggests that CGM is superior to SMBG among GDM pregnancies in terms of 
detecting hypoglycemic and hyperglycemic episodes, which might result in an 
improvement of maternal and fetal outcomes (33).  In addition, CGM is 
effective at capturing gestational glucose profiles and improving treatment 
effect among pregnant women with GDM (34,35). Further research is needed 
to explore the clinical utility such screening and predictive values of CGM for 
glucose impairment after having diabetes during pregnancy.  We need to 
improve diabetes testing after childbirth in women who experienced 
gestational diabetes.  This will allow us to target our efforts to improve the 
early diagnosis and treatment of diabetes following GDM.  No studies 
conducted to date have not comprehensively examined whether CGM after 
delivery can be used in women with a recent history to predict their risk of 
diabetes.  
 
STUDY OBJECTIVE 
Given the damaging effect of prolonged undetected hyperglycemia, 
prevention and early diagnosis of T2D is cost-saving and of public health 
importance.  This research study is being done to assess if using a glucose 
sensor (also known as a continuous glucose monitor or CGM) after childbirth 
can help identify women who are at risk of developing diabetes after having 
diabetes during pregnancy or gestational diabetes. Currently, screening for 
diabetes after childbirth is performed with an oral glucose tolerance test 4-16 
weeks after delivery, but this is burdensome and most patients are non-
compliant.  This study will use a CGM worn on the skin for 10 days. The data 
from the sensor will be compared to the standard oral glucose tolerance test as 
well as a HbA1c and fructosamine test.  This is a single site study from patients 
with recent GDM that attended the diabetes clinic at Woman’s Hospital. The 
research team plans to enroll 50 participants aged 18 years or older into the 
study. Participation in the study is expected to last up to 10 days during the 
postpartum interval.  Study procedures include;  1) consent and  screening; and 
2) sensor placement and download after 10 days of wear postpartum during 
which an OGTT, fructosamine and HbA1c test will be administered. 

 
Woman's IRB Initial Approval Date: August 22, 2023 
 RP Number: RP-23-010-WH 
 
 
STUDY PLANS AND PROCEDURES 
Participants and Treatment Regimen 
This is a prospective observational study of fifty postpartum women 
with a recent GDM pregnancy.  All participants will be requested to return at 
4-16 weeks postpartum for a 75 gm 2-hour OGTT as part of standard care after 
gestational diabetes.  Fifty women with a history of GDM will be enrolled to 
use a blinded continuous glucose monitor (Dexcom G7).  All CGM data will be 
masked and therefore not available to participants, clinicians, or researchers in 
real time.  Participants otherwise will receive standard clinical care.  All 
participants will be recruited from the Woman’s Hospital Diabetes Clinic or 
from the maternal fetal medicine practice referring to the clinic.  Those who 
wish to participate will provide written informed consent. The Woman’s 
Hospital Institutional Review Board (WHIRB) will have approved both the 
protocol and consent. 
All subjects will undergo a verbal screen, and if they are eligible and 
sign a medical release form, their medical records will be obtained to confirm 
their medical history. After consenting, demographic data, gravidity, parity, 
and body mass index (BMI) will obtained. The patient’s physician will be 
notified of participation in the study and have access to the laboratory results. 
Eligibility: 
Inclusion criteria: 
-include diagnosis of gestational diabetes during recent pregnancy (4-16 
weeks) 
-age 18 or older. 
-written informed consent 
Exclusion criteria: 
- pregestational diabetes (type 1 or type 2) 
- include known known skin adhesive allergy which would prevent subject 
from wearing a CGM, 
-history of bariatric surgery or other surgeries that induce malabsorption 
-long-term use (>2 weeks) of systemic steroids during the testing interval 
-inability or refusal to comply with protocol 
 

 
Woman's IRB Initial Approval Date: August 22, 2023 
 RP Number: RP-23-010-WH 
 
For study participants, a Dexcom G7 CGM (Dexcom, Inc., San Diego, 
CA, United States) in blinded mode (participant unable to see the glucose 
values) will be worn for 10 days.   Dexcom G7 CGM sensor measures interstitial 
glucose concentrations every 5 minutes.  Insertion of the sensor will require an 
additional hospital visit for DEXCOM placement and women will be offered 
flexibility in scheduling to assist compliance.  Trained research personnel will 
assist in implanting the sensors. Neither participants nor professionals will 
have access to the glucose measurements during sensor use.  The Dexcom G7 
sensors will be removed after 10 days and returned to study coordinator.  All 
participants will receive a $100 incentive for participation in the trial 
 
HbA1c, Fructosamine and OGTT data 
We will use the glucose levels and HbA1c values as defined by the 
American Diabetes Association (ADA) guidelines(8) for the diagnosis of 
normal, prediabetes, and type 2 diabetes.  Following the guidelines of ADA, a 
fasting blood glucose (FBG) below 126 or 2-h blood glucose (2hBG)< 140  mg/dl 
is considered normal glucose tolerance; FBG of 100-125 mg/dl or 2-h blood 
glucose (2hBG) ≥ 140- 199  mg/dl is classified as prediabetes, and FBG above or 
equal to 126 mg/dL or 2-h blood glucose (2hBG) ≥ 200 mg/dl in a standard oral 
glucose tolerance test (OGTT) as diabetic. The reference ranges for HbA1c 
results are: 
• 
No diabetes: below 5.7% 
• 
Borderline/prediabetes: 5.7% to 6.4% 
• 
Diabetes: 6.5% or higher (8) 
Fructosamine results may be considered alongside the HbA1c and other tests.  
• 
In non-diabetics with normal albumin, fructosamine levels normally 
range between 175-265umol/L (micromoles per liter).  For people with 
uncontrolled diabetes, the fructosamine range is 268-870 millimoles per 
liter (mmol/L).  The concentrations of fructosamine corresponding 
prediabetes and diabetes clinical cut-points of 5.7% and 6.5% for HbA1c, 
based on percentiles, were 241.4 umol/L (the 77.1 percentile) and 270.2 
umol/L (the 96.5 percentile), respectively  (36). 

 
Woman's IRB Initial Approval Date: August 22, 2023 
 RP Number: RP-23-010-WH 
 
 
Collection of glucose data The blinded glucose monitoring data on glycemia 
will be retrospectively assessed.  The participant data collected from the CGM 
(Dexcom G7) will be downloaded with the Dexcom G7 reader and uploaded 
to Dexcom CLARITY 
The percentage of time-in-target range, time hypoglycemia, and time 
hyperglycemia will be reported as either means with standard deviations (SD) 
or medians with interquartile ranges (IQR), depending on variable 
distribution.  For analyses assessing overnight glycemia, daytime is defined as 
5:00 AM to 11:59 PM and nighttime as 12:00 midnight to 4:59 AM 
 
. 
Statistical analysis 
Statistical analyses will be performed using SPSS version 15.1 for 
Windows (SPSS, Inc.; Chicago, IL).  Continuous variables will be tested for 
normality of distribution using the Kolmogorov-Smirov test.  When necessary, 
non-normally distributed data will be subjected to logarithmic or square-root 
transformation to obtain a normal distribution where necessary for subsequent 
analyses.  Continuous parameters will be given as means ± standard deviations 
or medians with interquartile ranges (IQR).  Results will be presented as mean 
± standard deviation for normally distributed continuous variables and as 
medians, with the 25th and 75th IQR for non-normally distributed variables.  
Categorical data will be presented as percentage.  Pearson correlation 
coefficient (r) and the significance for it (p) will be calculated between the 
variables.  The chi square test will be used to compare categorical variables. 
Chi-square test will be used to test differences in percentage proportionality 
Student t tests will be used to compare normally distributed groups; otherwise, 
Mann-Whitney rank sum tests will be used.  Multiple groups will be compared 
using Kruskal-Wallis one-way ANOVA with a Dunn’s test for pairwise 
comparisons when appropriate.  A two-sided P-value < 0.05 is considered 
statistically significant.  
 
 

 
Woman's IRB Initial Approval Date: August 22, 2023 
 RP Number: RP-23-010-WH 
 
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Woman's IRB Initial Approval Date: August 22, 2023 
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