Continuous Glucose Monitoring for Women With Gestational Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Freestyle Libre 3, Glucometer.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Continuous Glucose Monitoring for Women With Gestational Diabetes: a Randomized Controlled Trial
Overview
There are a few ongoing large randomized controlled trials (RCT's) on continuous glucose monitoring (CGM) in women with gestational diabetes (GDM) powered for pregnancy outcomes. However, none of these studies included women diagnosed with early GDM. The CORDELIA trial is a Belgian-Australian open-label multi-centric RCT with 16 centers in women with GDM (including both early and late GDM). Women will be randomized 1/1 to either treatment with CGM (intervention group, Freestyle Libre 3 +) or continue with self-monitoring of blood glucose (SMBG) with glucometer in line with normal routine (control arm). The study ends at the postpartum oral glucose tolerance test (OGTT 6-24 weeks postpartum) to screen for glucose intolerance.
Detailed description
At diagnosis of GDM, women will receive education on the management of GDM with lifestyle and need to monitor glucose with SMBG. Within one week of GDM diagnosis, all participants will be asked to use a blinded CGM (Freestyle Libre Pro IQ,) during a run-phase. Women randomized to the control arm, will be asked to intermittently wear a blinded CGM sensor (Freestyle Libre Pro IQ) during 14 days at least two time points in pregnancy (at 31.0-33.6 weeks and between 36.0-38.6 weeks). For women diagnosed with early GDM (\<20 weeks), blinded CGM will be needed 3 times in pregnancy with a first time at 20.0-23.9 weeks. Women randomized to the intervention arm will be recommended tu use the rt-CGM (Freestyle Libre 3) till the delivery. In line with normal routine, a 75g OGTT will be performed between 6-24 weeks postpartum to screen for glucose intolerance. Participants will be asked to also wear a blinded CGM (Freestyle Libre Pro IQ) at this last study visit.
Interventions
- Device Freestyle Libre 3
CGM - Device Glucometer
SMBG
Primary outcome measures
- a composite of pregnancy outcomes [Time frame: at delivery]
Secondary outcome measures (12)
- time in glucose range overnight between 70-95mg/dl [Time frame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- time in glucose range during the day between 70-95mg/dl [Time frame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- time in glucose range overnight between 63-140mg/dl [Time frame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks of gestation]
- time in glucoserange during the day between 63-140mg/dl [Time frame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- time in glucose range during the day between 54-95mg/dl [Time frame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- time in glucose range overnight between 54-95mg/dl [Time frame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- time in glucose range overnight between 63-120mg/dl [Time frame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- time in glucose range during the day between 63-120mg/dl [Time frame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- hypoglycemia <54mg/dl [Time frame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- hypoglycemia <50mg/dl [Time frame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- hypoglycemia <63mg/dl [Time frame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- hypoglycemia <70mg/dl [Time frame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
Eligibility criteria
Inclusion criteria
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- Singleton pregnancy
- Diagnosed with gestational diabetes before 29.6 weeks of pregnancy
- Needs to be able to understand and speak Dutch, French or English.
- Have email access
Exclusion criteria
- Patient has a history of type 2 or type 1 diabetes, or presence of auto-immune antibodies for type 1 diabetes
- A physical or psychological disease likely to interfere with the conduct of the study (based on the evaluation by the treating physician).
- Use of medication with significant impact on glycemia (such as high dose glucocorticoids and diabetes medication such as metformin)
- Participation in an interventional Trial with an investigational medicinal product or device
- Multiple pregnancy
- History of bariatric surgery
- Known allergy to the adhesives used with the continuous glucose monitoring
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 14 centers
- OLV Aalst-Asse — Aalst
- UZA — Antwerp
- ZNA Antwerpen — Antwerp
- Imelda Bonheiden — Bonheiden
- AZ St Jan Brugge — Bruges
- Erasme — Brussels
- UZ Gent — Ghent
- AZ St Lucas Gent — Ghent
- … and 6 more centers
Australia · 2 centers
- Campbelltown Hospital — Sydney
- Royal Prince Alfred Hospital — Sydney
Identifiers
NCT: NCT06310356 · CORDELIA