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| Name | Class |
|---|---|
| University Hospital, Antwerp | OTHER |
| General Hospital Groeninge | OTHER |
| Onze Lieve Vrouw Hospital | OTHER |
| Ziekenhuis Netwerk Antwerpen (ZNA) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| continuous glucose monitoring | Experimental | continuous use of realtime-continuous glucose monitoring with Freestyle Libre 3 |
|
| self monitoring of blood glucose with glucometer | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freestyle Libre 3 | Device | CGM |
| |
| Glucometer |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| time in glucose range during the day between 70-95mg/dl |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katrien Benhalima, MD PhD | Contact | +3216340614 | katrien.benhalima@uzleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campbelltown Hospital | Recruiting | Sydney | CAMPBELLTOWN NSW | 2560 | Australia |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| OTHER |
| Vitaz | OTHER |
| Centre Hospitalier Universitaire de Liege | OTHER |
| Erasme University Hospital | OTHER |
| Université Catholique de Louvain | OTHER |
| University Hospital, Ghent | OTHER |
| AZ Sint-Lucas Gent | OTHER |
| AZ Sint-Lucas Brugge | OTHER |
| AZ St Maarten Mechelen | UNKNOWN |
| Imelda Hospital, Bonheiden | OTHER |
| AZ Oostende | UNKNOWN |
| Royal Prince Alfred Hospital, Sydney, Australia | OTHER |
| Campbelltown Hospital/SWSLHD | UNKNOWN |
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| Device |
SMBG |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| timing of start insulin treatment | gestational age at start insulin treatment | from GDM diagnosis till delivery |
| mean insulin dose | dose of short and/or long)actinbg insulin | from GDM diagnosis till delivery |
| mean gestational weight gain | weight gain in pregnancy | at delivery |
| rate of postpartum hemorrhage | hemorrhage with delivery | at delivery |
| rate of macrosomia | birth weight >4Kg | at delivery |
| rate of baby >4.5Kg | birth weight >4.5Kg | at delivery |
| rate of Small-for-gestational age infant | birth weight <10Th percentile | at delivery |
| rate of cesarean section | total (planned and emergency) number of cesarean sections | at delivery |
| rate of instrumental delivery | delivery with forceps or vacuum | at delivery |
| rate of perineal inury | 3dr or 4th degree perineal laceration | at delivery |
| rate of labor inductions | induction of labor | at delivery |
| 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](streamdown:incomplete-link) | at delivery |
| rate of gestational hypertension | ≥20 weeks of gestation: blood pressure ≥140/90mmHg | at delivery |
| rate of fetal malformation | congenital malformation | at delivery |
| rate of miscarriage | fetal loss <20 weeks gestation | at delivery |
| rate of polycythemia | increased hematocrite accoridng to local practice | at delivery |
| rate of neonatal hypoglycemia | bypoglycemia at birth <40mg/dl | at delivery |
| 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 |
| 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 |
| dietary intake | Frequyency Food Questionnaire | baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum |
| Physical activity | International Physical Activity questionnaire score | baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum |
| fear for hypoglycaemia | the Hypoglycaemia Fear Survey II | between 36.0-38.6 weeks |
| fear for hyperglycaemia | self-designed questionnaire on fear for hyperglycaemia | between 36.0-38.6 weeks |
| 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 |
| 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 |
| user-friendliness of CGM | self-designed questionnaire on the user-friendliness of continuous glucose monitoring (CGM) | between 36.0-38.6 weeks |
| 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 |
| duration of breastfeeding | breastfeeding duration (exclusive or half formula) duration in months | postpartum between 6-24 weeks |
| rate of hypercholesterolemia | lipid profile with LDL-cholesterol and Triglycerides | postpartum between 6-24 weeks |
| 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 |
| 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 |
| day glucose time in range <70mg/dl | glucose time below 70-mg/dl from 6am till 00 | postpartum between 6-24 weeks |
| night glucose time in range <70mg/dl | glucose time below 70-mg/dl from 00 till 6am | postpartum between 6-24 weeks |
| night glucose time in range >180mg/dl | glucose time above 180mg/dl from 00 till 6am | postpartum between 6-24 weeks |
| day glucose time in range >180mg/dl | glucose time above 180mg/dl from 6am till 00 | postpartum between 6-24 weeks |
| Royal Prince Alfred Hospital | Recruiting | Sydney | Camperdown NSW | 2050 | Australia |
|
| OLV Aalst-Asse | Recruiting | Aalst | Oost-Vlaanderen | 9300 | Belgium |
|
| UZA | Recruiting | Antwerp | Belgium |
|
| ZNA Antwerpen | Recruiting | Antwerp | Belgium |
|
| Imelda Bonheiden | Recruiting | Bonheiden | 2820 | Belgium |
|
| AZ St Jan Brugge | Recruiting | Bruges | 8000 | Belgium |
|
| Erasme | Recruiting | Brussels | Belgium |
|
| UZ Gent | Recruiting | Ghent | 9000 | Belgium |
|
| AZ St Lucas Gent | Recruiting | Ghent | Belgium |
|
| AZ Groeninge Kortrijk | Recruiting | Kortrijk | 8510 | Belgium |
|
| UZ Leuven | Recruiting | Leuven | Belgium |
|
| CHU de Liège | Recruiting | Liège | Belgium |
|
| AZ St Maarten Mechelen | Recruiting | Mechelen | Belgium |
|
| AZ Oostende | Recruiting | Ostend | Belgium |
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| Vitaz | Recruiting | Sint-Niklaas | Belgium |
|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |