Continuous Glucose Monitoring for Women with Gestational Diabetes
- Conditions
- Gestational Diabetes
- Interventions
- Device: Freestyle Libre 3Device: Glucometer
- Registration Number
- NCT06310356
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 386
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description continuous glucose monitoring Freestyle Libre 3 continuous use of realtime-continuous glucose monitoring with Freestyle Libre 3 self monitoring of blood glucose with glucometer Glucometer self monitoring of blood glucose with glucometer, at least 2 days per week if treated with lifestyle and daily if additional treatment with insulin is started
- Primary Outcome Measures
Name Time Method a composite of pregnancy outcomes at delivery Hence, the primary outcome is a binary variable, taking the value 1 if at least one of the adverse pregnancy outcomes occurs, or zero otherwise:preterm delivery \<37 weeks, large-for-gestational age infant, neonatal hypoglycaemia, (requiring intravenous dextrose), NICU admission (\>24h), respiratory distress (at least 4 hours of respiratory support with supplemental oxygen, CPAP, or intermittent positive-pressure ventilation during the first 24 hours after delivery), stillbirth or neonatal death, phototherapy for jaundice, birth trauma and shoulder dystocia
- Secondary Outcome Measures
Name Time Method day glucose time in range between 70-180mg/dl postpartum between 6-24 weeks glucose time in range between 70-180mg/dl from 6am till 00
fear for hypoglycaemia between 36.0-38.6 weeks the Hypoglycaemia Fear Survey II
rate of baby >4.5Kg at delivery birth weight \>4.5Kg
rate of polycythemia at delivery increased hematocrite accoridng to local practice
rate of gestational hypertension at delivery ≥20 weeks of gestation: blood pressure ≥140/90mmHg
Treatment satisfaction between 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum diabetes treatment satisfaction questionnaire score, the higher the score the more satisfied, max. score of 48
dietary intake baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum Frequyency Food Questionnaire
time in glucose range overnight between 70-95mg/dl during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks time in range from 00 till 6am between 70-95mg/dl
time in glucose range during the day between 70-95mg/dl during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks time in range from 06 am til 00 between 70-95mg/dl
time in glucoserange during the day between 63-140mg/dl during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks time in range from 06 am til 00 between 63-140mg/dl
hypoglycemia <54mg/dl during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks time below 54mg/dl
Coefficient of Variance during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks glycemic variability measured by coefficient of variance (CV)
glucose time overnight >100mg/dl during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks time in range from 00 till 6am \>100mg/dl
glucose postprandial time >140mg/dl during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks postprandial time \>140mg/dl 1hour after the meal
time in glucose range overnight between 63-140mg/dl during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks of gestation time in range from 00 till 6am between 63-140mg/dl
time in glucose range overnight between 54-95mg/dl during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks time in range from 00 till 6am between 54-95mg/dl
hypoglycemia <63mg/dl during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks time below 63mg/dl
hypoglycemia <70mg/dl during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks time below 70mg/dl
mean HbA1c between 20.0-23.6 weeks, 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum glycated Hb
rate of postpartum hemorrhage at delivery hemorrhage with delivery
rate of Small-for-gestational age infant at delivery birth weight \<10Th percentile
rate of cesarean section at delivery total (planned and emergency) number of cesarean sections
rate of instrumental delivery at delivery delivery with forceps or vacuum
rate of labor inductions at delivery induction of labor
Physical activity baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum International Physical Activity questionnaire score
symptoms of anxiety baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum validated six-item short-form STAI questionnaire on anxiety, max. score of 24 (the higher the more anxiety)
duration of breastfeeding postpartum between 6-24 weeks breastfeeding duration (exclusive or half formula) duration in months
rate of hypercholesterolemia postpartum between 6-24 weeks lipid profile with LDL-cholesterol and Triglycerides
night glucose time in range between 70-180mg/dl postpartum between 6-24 weeks glucose time in range between 70-180mg/dl from 00 til 6am
day glucose time in range <70mg/dl postpartum between 6-24 weeks glucose time below 70-mg/dl from 6am till 00
night glucose time in range <70mg/dl postpartum between 6-24 weeks glucose time below 70-mg/dl from 00 till 6am
hypoglycemia <50mg/dl during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks time below 50mg/dl
standard deviation during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks glycemic variability measured by standard deviation (SD)
glucose postprandial time >120mg/dl during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks postprandial time \>120mg/dl 2hours after the meal
glucose time >180mg/dl during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks time \>180mg/dl
Glucose management indicator between 20.0-23.6 weeks, 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum Glucose management indicator, GMI
rate of macrosomia at delivery birth weight \>4Kg
rate of perineal inury at delivery 3dr or 4th degree perineal laceration
rate of neonatal hypoglycemia at delivery bypoglycemia at birth \<40mg/dl
mean amplitude of glycemic excursions during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks glycemic variability measured by mean amplitude of glycemic excursions (MAGE)
mean insulin dose from GDM diagnosis till delivery dose of short and/or long)actinbg insulin
timing of start insulin treatment from GDM diagnosis till delivery gestational age at start insulin treatment
mean gestational weight gain at delivery weight gain in pregnancy
rate of preeclamspia at delivery \[≥20 weeks of gestation: new onset of hypertension and proteinuria or the new onset of hypertension and significant end-organ dysfunction with or without proteinuria (dipstick ≥ 2+, ≥0.3 g protein/24 hours or ≥30 mg/dL protein in spot urine or spot urine protein / creatinine ratio ≥30 mg protein/mmol creatinine
rate of fetal malformation at delivery congenital malformation
rate of miscarriage at delivery fetal loss \<20 weeks gestation
Quality of life based on Short Form (SF-36) score baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum Short Form (SF-36) score, the higher the score the higher the Quality of life with a max score of 100
fear for hyperglycaemia between 36.0-38.6 weeks self-designed questionnaire on fear for hyperglycaemia
symptoms of depression baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum the 20-item Center for Epidemiologic Studies-Depression (CES-D) , questionnaire, max. score 60 (the higher the more symptoms of depression)
user-friendliness of CGM between 36.0-38.6 weeks self-designed questionnaire on the user-friendliness of continuous glucose monitoring (CGM)
night glucose time in range >180mg/dl postpartum between 6-24 weeks glucose time above 180mg/dl from 00 till 6am
day glucose time in range >180mg/dl postpartum between 6-24 weeks glucose time above 180mg/dl from 6am till 00
time in glucose range during the day between 54-95mg/dl during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks time in range from 06 am til 00 between 54-95mg/dl
time in glucose range overnight between 63-120mg/dl during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks time in range from 00 till 6am between 63-120mg/dl
time in glucose range during the day between 63-120mg/dl during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks time in range from 06 am til 00 between 63-120mg/dl
user-friendliness of CGM compared to oral glucose tolerance test (OGTT) between 6-24 weeks postpartum self-designed questionnaire on the user-friendliness of continuous glucose monitoring (CGM) compared to OGTT
Trial Locations
- Locations (14)
Vitaz
🇧🇪Sint-Niklaas, Belgium
OLV Aalst-Asse
🇧🇪Aalst, Oost-Vlaanderen, Belgium
UZA
🇧🇪Antwerp, Belgium
ZNA Antwerpen
🇧🇪Antwerp, Belgium
Imelda Bonheiden
🇧🇪Bonheiden, Belgium
AZ St Jan Brugge
🇧🇪Brugge, Belgium
Erasme
🇧🇪Brussel, Belgium
UZ Gent
🇧🇪Gent, Belgium
AZ St Lucas Gent
🇧🇪Gent, Belgium
AZ Groeninge Kortrijk
🇧🇪Kortrijk, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
CHU de Liège
🇧🇪Liège, Belgium
AZ St Maarten Mechelen
🇧🇪Mechelen, Belgium
AZ Oostende
🇧🇪Oostende, Belgium