Gestational Diabetes Clinical Trial
— CORDELIAOfficial title:
Continuous Glucose Monitoring for Women With Gestational Diabetes: a Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 386 |
Est. completion date | February 2027 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
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 | UCL | Brussel | |
Belgium | AZ St Lucas Gent | Gent | |
Belgium | UZ 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 | Vitaz | Sint-Niklaas |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven | AZ Oostende, AZ Sint-Lucas Gent, AZ St Maarten Mechelen, AZ St- Jan Brugge, Centre Hospitalier Universitaire de Liege, Erasme University Hospital, General Hospital Groeninge, Imelda Hospital, Bonheiden, Onze Lieve Vrouw Hospital, Université Catholique de Louvain, University Hospital, Antwerp, University Hospital, Ghent, Vitaz, Ziekenhuis Netwerk Antwerpen (ZNA) |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | a composite of pregnancy outcomes | 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 | at delivery | |
Secondary | time in glucose range overnight between 70-95mg/dl | time in range from 00 till 6am between 70-95mg/dl | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | time in glucose range during the day between 70-95mg/dl | time in range from 06 am til 00 between 70-95mg/dl | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | time in glucose range overnight between 63-140mg/dl | time in range from 00 till 6am 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 | |
Secondary | time in glucoserange during the day between 63-140mg/dl | time in range from 06 am til 00 between 63-140mg/dl | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | time in glucose range during the day between 54-95mg/dl | time in range from 06 am til 00 between 54-95mg/dl | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | time in glucose range overnight between 54-95mg/dl | time in range from 00 till 6am between 54-95mg/dl | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | time in glucose range overnight between 63-120mg/dl | time in range from 00 till 6am between 63-120mg/dl | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | time in glucose range during the day between 63-120mg/dl | time in range from 06 am til 00 between 63-120mg/dl | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | hypoglycemia <54mg/dl | time below 54mg/dl | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | hypoglycemia <50mg/dl | time below 50mg/dl | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | hypoglycemia <63mg/dl | time below 63mg/dl | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | hypoglycemia <70mg/dl | time below 70mg/dl | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | standard deviation | glycemic variability measured by standard deviation (SD) | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | Coefficient of Variance | glycemic variability measured by coefficient of variance (CV) | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | mean amplitude of glycemic excursions | glycemic variability measured by mean amplitude of glycemic excursions (MAGE) | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | glucose time overnight >100mg/dl | time in range from 00 till 6am >100mg/dl | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | glucose postprandial time >120mg/dl | postprandial time >120mg/dl 2hours after the meal | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | glucose postprandial time >140mg/dl | postprandial time >140mg/dl 1hour after the meal | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | glucose time >180mg/dl | time >180mg/dl | during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks | |
Secondary | mean HbA1c | glycated Hb | between 20.0-23.6 weeks, 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum | |
Secondary | Glucose management indicator | Glucose management indicator, GMI | between 20.0-23.6 weeks, 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum | |
Secondary | timing of start insulin treatment | gestational age at start insulin treatment | from GDM diagnosis till delivery | |
Secondary | mean insulin dose | dose of short and/or long)actinbg insulin | from GDM diagnosis till delivery | |
Secondary | mean gestational weight gain | weight gain in pregnancy | at delivery | |
Secondary | rate of postpartum hemorrhage | hemorrhage with delivery | at delivery | |
Secondary | rate of macrosomia | birth weight >4Kg | at delivery | |
Secondary | rate of baby >4.5Kg | birth weight >4.5Kg | at delivery | |
Secondary | rate of Small-for-gestational age infant | birth weight <10Th percentile | at delivery | |
Secondary | rate of cesarean section | total (planned and emergency) number of cesarean sections | at delivery | |
Secondary | rate of instrumental delivery | delivery with forceps or vacuum | at delivery | |
Secondary | rate of perineal inury | 3dr or 4th degree perineal laceration | at delivery | |
Secondary | rate of labor inductions | induction of labor | at delivery | |
Secondary | rate of preeclamspia | [=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 | at delivery | |
Secondary | rate of gestational hypertension | =20 weeks of gestation: blood pressure =140/90mmHg | at delivery | |
Secondary | rate of fetal malformation | congenital malformation | at delivery | |
Secondary | rate of miscarriage | fetal loss <20 weeks gestation | at delivery | |
Secondary | rate of polycythemia | increased hematocrite accoridng to local practice | at delivery | |
Secondary | rate of neonatal hypoglycemia | bypoglycemia at birth <40mg/dl | at delivery | |
Secondary | Treatment satisfaction | diabetes treatment satisfaction questionnaire score, the higher the score the more satisfied, max. score of 48 | between 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum | |
Secondary | Quality of life based on Short Form (SF-36) score | Short Form (SF-36) score, the higher the score the higher the Quality of life with a max score of 100 | baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum | |
Secondary | dietary intake | Frequyency Food Questionnaire | baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum | |
Secondary | Physical activity | International Physical Activity questionnaire score | baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum | |
Secondary | fear for hypoglycaemia | the Hypoglycaemia Fear Survey II | between 36.0-38.6 weeks | |
Secondary | fear for hyperglycaemia | self-designed questionnaire on fear for hyperglycaemia | between 36.0-38.6 weeks | |
Secondary | symptoms of depression | the 20-item Center for Epidemiologic Studies-Depression (CES-D) , questionnaire, max. score 60 (the higher the more symptoms of depression) | baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum | |
Secondary | symptoms of anxiety | validated six-item short-form STAI questionnaire on anxiety, max. score of 24 (the higher the more anxiety) | baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum | |
Secondary | user-friendliness of CGM | self-designed questionnaire on the user-friendliness of continuous glucose monitoring (CGM) | between 36.0-38.6 weeks | |
Secondary | user-friendliness of CGM compared to oral glucose tolerance test (OGTT) | self-designed questionnaire on the user-friendliness of continuous glucose monitoring (CGM) compared to OGTT | between 6-24 weeks postpartum | |
Secondary | duration of breastfeeding | breastfeeding duration (exclusive or half formula) duration in months | postpartum between 6-24 weeks | |
Secondary | rate of hypercholesterolemia | lipid profile with LDL-cholesterol and Triglycerides | postpartum between 6-24 weeks | |
Secondary | night glucose time in range between 70-180mg/dl | glucose time in range between 70-180mg/dl from 00 til 6am | postpartum between 6-24 weeks | |
Secondary | day glucose time in range between 70-180mg/dl | glucose time in range between 70-180mg/dl from 6am till 00 | postpartum between 6-24 weeks | |
Secondary | day glucose time in range <70mg/dl | glucose time below 70-mg/dl from 6am till 00 | postpartum between 6-24 weeks | |
Secondary | night glucose time in range <70mg/dl | glucose time below 70-mg/dl from 00 till 6am | postpartum between 6-24 weeks | |
Secondary | night glucose time in range >180mg/dl | glucose time above 180mg/dl from 00 till 6am | postpartum between 6-24 weeks | |
Secondary | day glucose time in range >180mg/dl | glucose time above 180mg/dl from 6am till 00 | postpartum between 6-24 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05081037 -
Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)
|
N/A | |
Active, not recruiting |
NCT03249896 -
Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes
|
N/A | |
Terminated |
NCT03749889 -
Low Carb vs Normal Carb in Pregnancy
|
N/A | |
Completed |
NCT03859193 -
Education Nutritional Video for Gestational Diabetics
|
N/A | |
Recruiting |
NCT05037526 -
Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes
|
N/A | |
Completed |
NCT06178250 -
Placenta, Fetal Liver, Sectional Ductus Venosus Volumes Examined by Three-dimensional Ultrasound in the Second Trimester
|
N/A | |
Not yet recruiting |
NCT06445530 -
Nutrition Optimization and Community Upliftment for Postpartum Recovery
|
N/A | |
Recruiting |
NCT02590016 -
Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial
|
Phase 4 | |
Not yet recruiting |
NCT00883259 -
Metformin and Gestational Diabetes in High-risk Patients: a RCTs
|
Phase 4 | |
Withdrawn |
NCT01947699 -
Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide
|
Phase 4 | |
Recruiting |
NCT03008824 -
Micronutrients in Pregnancy as a Risk Factor for Diabetes and Effects on Mother and Baby
|
N/A | |
Active, not recruiting |
NCT01340924 -
Relationship Between Gestational Diabetes and Type 2 Diabetes
|
||
Completed |
NCT00534105 -
Lipid Metabolism in Gestational Diabetes
|
N/A | |
Recruiting |
NCT00371306 -
Comparison of Glucovance to Insulin for Diabetes During Pregnancy
|
N/A | |
Completed |
NCT03388723 -
Intergenerational Programming of Diabesity in Offspring of Women With Gestational Diabetes Mellitus
|
||
Recruiting |
NCT04521712 -
Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia
|
N/A | |
Enrolling by invitation |
NCT03307486 -
Gestational Diabetes: a Cohort Study
|
N/A | |
Active, not recruiting |
NCT03301792 -
Group Versus Traditional Prenatal Care for Diabetes
|
N/A | |
Enrolling by invitation |
NCT05603793 -
YoUng Adolescents' behaViour, musculoskeletAl heAlth, Growth & Nutrition
|
||
Completed |
NCT03669887 -
Lifestyle Modification to Improve Diet in Women With GDM
|
N/A |