Clinical trial NCT06310356: Continuous Glucose Monitoring for Women with Gestational Diabetes
Official title: Continuous Glucose Monitoring for Women with Gestational Diabetes: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Keywords: gestational diabetes
continuous glucose monitoring
early gestational diabetes
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
name: General Hospital Groeninge
name: Onze Lieve Vrouw Hospital
name: Ziekenhuis Netwerk Antwerpen (ZNA)
name: Vitaz
name: Centre Hospitalier Universitaire de Liege
name: Erasme University Hospital
name: Université Catholique de Louvain
name: University Hospital, Ghent
name: AZ Sint-Lucas Gent
name: AZ Sint-Lucas Brugge
name: AZ St Maarten Mechelen
name: Imelda Hospital, Bonheiden
name: AZ Oostende
First posted: 2024-03-15
Enrollment: 386
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 open-label multi-centric RCT with 14 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.

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

Primary outcomes:
measure: a composite of pregnancy outcomes
timeFrame: at delivery
Secondary outcomes:
measure: time in glucose range overnight between 70-95mg/dl
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: time in glucose range during the day between 70-95mg/dl
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: time in glucose range overnight between 63-140mg/dl
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks of gestation
measure: time in glucoserange during the day between 63-140mg/dl
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: time in glucose range during the day between 54-95mg/dl
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: time in glucose range overnight between 54-95mg/dl
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: time in glucose range overnight between 63-120mg/dl
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: time in glucose range during the day between 63-120mg/dl
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: hypoglycemia <54mg/dl
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: hypoglycemia <50mg/dl
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: hypoglycemia <63mg/dl
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: hypoglycemia <70mg/dl
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: standard deviation
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: Coefficient of Variance
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: mean amplitude of glycemic excursions
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: glucose time overnight >100mg/dl
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: glucose postprandial time >120mg/dl
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: glucose postprandial time >140mg/dl
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: glucose time >180mg/dl
timeFrame: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
measure: mean HbA1c
timeFrame: between 20.0-23.6 weeks, 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum
measure: Glucose management indicator
timeFrame: between 20.0-23.6 weeks, 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum
measure: timing of start insulin treatment
timeFrame: from GDM diagnosis till delivery
measure: mean insulin dose
timeFrame: from GDM diagnosis till delivery
measure: mean gestational weight gain
timeFrame: at delivery
measure: rate of postpartum hemorrhage
timeFrame: at delivery
measure: rate of macrosomia
timeFrame: at delivery
measure: rate of baby >4.5Kg
timeFrame: at delivery
measure: rate of Small-for-gestational age infant
timeFrame: at delivery
measure: rate of cesarean section
timeFrame: at delivery
measure: rate of instrumental delivery
timeFrame: at delivery
measure: rate of perineal inury
timeFrame: at delivery
measure: rate of labor inductions
timeFrame: at delivery
measure: rate of preeclamspia
timeFrame: at delivery
measure: rate of gestational hypertension
timeFrame: at delivery
measure: rate of fetal malformation
timeFrame: at delivery
measure: rate of miscarriage
timeFrame: at delivery
measure: rate of polycythemia
timeFrame: at delivery
measure: rate of neonatal hypoglycemia
timeFrame: at delivery
measure: Treatment satisfaction
timeFrame: between 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum
measure: Quality of life based on Short Form (SF-36) score
timeFrame: baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
measure: dietary intake
timeFrame: baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
measure: Physical activity
timeFrame: baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
measure: fear for hypoglycaemia
timeFrame: between 36.0-38.6 weeks
measure: fear for hyperglycaemia
timeFrame: between 36.0-38.6 weeks
measure: symptoms of depression
timeFrame: baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
measure: symptoms of anxiety
timeFrame: baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
measure: user-friendliness of CGM
timeFrame: between 36.0-38.6 weeks
measure: user-friendliness of CGM compared to oral glucose tolerance test (OGTT)
timeFrame: between 6-24 weeks postpartum
measure: duration of breastfeeding
timeFrame: postpartum between 6-24 weeks
measure: rate of hypercholesterolemia
timeFrame: postpartum between 6-24 weeks
measure: night glucose time in range between 70-180mg/dl
timeFrame: postpartum between 6-24 weeks
measure: day glucose time in range between 70-180mg/dl
timeFrame: postpartum between 6-24 weeks
measure: day glucose time in range <70mg/dl
timeFrame: postpartum between 6-24 weeks
measure: night glucose time in range <70mg/dl
timeFrame: postpartum between 6-24 weeks
measure: night glucose time in range >180mg/dl
timeFrame: postpartum between 6-24 weeks
measure: day glucose time in range >180mg/dl
timeFrame: postpartum between 6-24 weeks
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Aalst-Asse
state: Oost-Vlaanderen
city: Antwerp
country: Belgium
facility: UZA
city: Antwerp
country: Belgium
facility: ZNA Antwerpen
city: Bonheiden
country: Belgium
facility: Imelda Bonheiden
city: Brugge
country: Belgium
facility: AZ St Jan Brugge
city: Brussel
country: Belgium
facility: Erasme
city: Gent
country: Belgium
facility: UZ Gent
city: Gent
country: Belgium
facility: AZ St Lucas Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge Kortrijk
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHU de Liège
city: Mechelen
country: Belgium
facility: AZ St Maarten Mechelen
city: Oostende
country: Belgium
facility: AZ Oostende
city: Sint-Niklaas
country: Belgium
facility: Vitaz
Study officials:
References: