Gestational Diabetes
Conditions
Keywords
gestational diabetes, continuous glucose monitoring, early gestational diabetes
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-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
DEVICEFreestyle Libre 3
CGM
DEVICEGlucometer
SMBG
Sponsors
Universitaire Ziekenhuizen KU Leuven
University Hospital, Antwerp
General Hospital Groeninge
Onze Lieve Vrouw Hospital
Ziekenhuis Netwerk Antwerpen (ZNA)
Vitaz
Centre Hospitalier Universitaire de Liege
Erasme University Hospital
Université Catholique de Louvain
University Hospital, Ghent
AZ Sint-Lucas Gent
AZ Sint-Lucas Brugge
AZ St Maarten Mechelen
Imelda Hospital, Bonheiden
AZ Oostende
Royal Prince Alfred Hospital, Sydney, Australia
Campbelltown Hospital/SWSLHD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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) |
| 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) |
| 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 >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 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 |
| 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 |
| 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 |
| 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 |
| timing of start insulin treatment | from GDM diagnosis till delivery | gestational age at start insulin treatment |
| mean insulin dose | from GDM diagnosis till delivery | dose of short and/or long)actinbg insulin |
| mean gestational weight gain | at delivery | weight gain in pregnancy |
| rate of postpartum hemorrhage | at delivery | hemorrhage with delivery |
| rate of macrosomia | at delivery | birth weight \>4Kg |
| rate of baby >4.5Kg | at delivery | birth weight \>4.5Kg |
| 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 perineal inury | at delivery | 3dr or 4th degree perineal laceration |
| rate of labor inductions | at delivery | induction of labor |
| 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 gestational hypertension | at delivery | ≥20 weeks of gestation: blood pressure ≥140/90mmHg |
| rate of fetal malformation | at delivery | congenital malformation |
| rate of miscarriage | at delivery | fetal loss \<20 weeks gestation |
| rate of polycythemia | at delivery | increased hematocrite accoridng to local practice |
| rate of neonatal hypoglycemia | at delivery | bypoglycemia at birth \<40mg/dl |
| 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 |
| 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 |
| dietary intake | baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum | Frequyency Food Questionnaire |
| Physical activity | baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum | International Physical Activity questionnaire score |
| fear for hypoglycaemia | between 36.0-38.6 weeks | the Hypoglycaemia Fear Survey II |
| 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) |
| 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) |
| user-friendliness of CGM | between 36.0-38.6 weeks | self-designed questionnaire on the user-friendliness of continuous glucose monitoring (CGM) |
| 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 |
| 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 between 70-180mg/dl | postpartum between 6-24 weeks | glucose time in range between 70-180mg/dl from 6am till 00 |
| 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 |
| 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 |
Countries
Australia, Belgium
Contacts
CONTACTKatrien Benhalima, MD PhD
Outcome results
None listed