Gestational Diabetes (GDM) is associated with higher than normal blood sugar levels in
pregnant women which has the potential to harm the baby and mother. The condition
resolves with delivery of the baby, but during the pregnancy there is a limited time
window for diagnosis and treatment before harm may be caused.
GDM is thought to affect up to 32% of pregnancies and is becoming more common due to
rising rates of obesity and maternal age. The current recommended practice in the UK for
the diagnosis of GDM is to use the oral glucose tolerance test (OGTT), which is two
plasma blood glucose tests (one at baseline and one 2 hours after a glucose load)
performed on expectant mothers who have at least one risk factor for GDM at 28 weeks
gestation. This method is not standard internationally, with some countries using the
test on all woman who fall pregnant, others adhering to different diagnostic thresholds,
and others performing the test in a different way. Furthermore, there is no international
consensus on the best way to diagnoses GDM. The challenge in diagnosing the condition
arises because the results of the OGTT relies upon only two glucose measurements and
therefore are not always accurate, meaning that some expectant mothers with GDM are
missed, and others who do not have GDM are incorrectly told they have the condition.
Pregnant women who develop GDM but are not identified by the OGTT may suffer
complications which could have been avoided with glucose lowering therapy, whilst woman
who are incorrectly diagnosed with the condition may have their pregnancies unnecessarily
medicalised, both of which places extra burden on the healthcare system. Therefore,
improving the accuracy of the diagnosis of GDM has the potential to improve outcomes in
pregnancies worldwide (and significantly impact upon current practice).
Recent technological advances in the field of diabetes care have seen the emergence of
continuous glucose monitoring (CGM) - digital sensors placed on a patient's skin which
constantly read the blood sugar level and communicate with their smart phone. Data from
the CGM sensor is sent via Bluetooth to the smart phone, and using software downloaded in
an app, is converted into a graphical summary illustration called an 'ambulatory glucose
profile' (AGP) allowing for better treatment decisions to be made.
CGM devices are revolutionising the monitoring and treatment of diabetes, including GDM,
however they are not utilised for diagnostic purposes. This study examines the
challenging task of accurately diagnosing GDM by comparing the CGM data of patients with
GDM with the CGM data of individuals at high risk of GDM (who are OGTT negative) to
determine if the OGTT result is predictive of high blood glucose.
The glucose data from CGM devices in woman who test positive on the OGTT will be compared
with women who are high risk for GDM but test negative, whilst also correlating with
pregnancy outcomes such as need for treatment or complications. The study aims to test
the hypothesis that a positive OGTT may not predict hyperglycaemia in pregnancy. If the
hypothesis is proven correct, it may suggest that CGM/AGP has the potential to improve
the current methodology of testing for GDM and that further studies examining this would
be recommended.
The study will be undertaken in the Academic department of Diabetes and Endocrinology and
the Joint diabetes antenatal clinic at Queen Alexandra Hospital, Portsmouth Hospitals
University NHS trust. Participants will be pregnant women who have been identified
according to established NICE criteria as being suitable for screening for GDM. Woman
with any of the following risk factors are offered a screening test (OGTT) for GDM as per
standard NHS care: BMI above 30kg/m², previous macrosomic baby weighing 4.5kg or more,
previous GDM, family history of diabetes (first-degree relative with diabetes), an
ethnicity with a high prevalence of diabetes. Patients with the risk factor 'previous
GDM' will be excluded from the study as this prior diagnosis may influence behaviour in
the current pregnancy. The risk assessment is undertaken during their booking appointment
at 12 weeks gestation.
Participants will be identified using the hospital's electronic maternity records system,
contacted at the earliest opportunity and given the participant information sheet (PIS).
Patients will be given sufficient time to read the PIS (at least 24 hours) after which
eligibility criteria will be checked and informed consent taken. This will take place
during 12-26 weeks gestation. All participants will continue to receive antenatal care.
The investigators will recruit 400 participants onto the study.
Study visit 1: (26-27 weeks gestation) This will be an in person visit at our site which
is in addition to standard antenatal care. This is the only visit that is additional to
standard NHS care for the majority of the study cohort. The study process will be
discussed in full and any questions answered. A CGM device (freestyle Libre sensor) will
be applied to the patient. It collects data automatically and is blinded.
Study visit 2: (28 weeks Gestation - OGTT date) When the participants attend for their
OGTT they will have further opportunity to interact with the study team (all of whom are
involved in the routine delivery of NHS maternity diabetes care) and any issues will be
addressed. Their CGM devices will be removed at the end of the data capture period. The
data from their OGTT test will be compared with their CGM data.
Sub-Group Study visit 3: 32 weeks gestation Of the 400 patients, 60 will be randomly
selected (to include 30 OGTT positive and 30 OGTT negative patients) to form a sub-group.
Patients in this sub-group will be invited prior to their standard NHS 32 week maternity
visit to receive a further CGM device which will be applied on the day of the visit. The
sub-group analysis is to assess for progression of glycaemia in both OGTT positive and
negative groups.
Further study visits (up until end of gestation) Participants who tested positive on
their OGTT are diagnosed with GDM and are usually followed up fortnightly in the JDANC
clinic as part of routine NHS care. The study team will use information from these visits
to inform the previously stated secondary objectives.
Follow up:
Patients will not be required to fill in questionnaires or attend further study visits in
the follow up period. Electronic data will be collected on birth outcome; including mode
of delivery, birth weight, premature delivery, any adverse fetal outcomes or neonatal
hypoglycaemia. Data will be collected on the participants' 3 month post-partum HbA1c test
that assess for resolution of GDM. This is a routine test that will not be undertaken by
the study team but will be easily accessible on the electronic hospital record.