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Glucose Monitoring Met Sensor.


- candidate number10162
- NTR NumberNTR2996
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jul-2011
- Secondary IDs80-82310-97-11157 ZonMW
- Public TitleGlucose Monitoring Met Sensor.
- Scientific TitleEffectiveness of continuous glucose monitoring in pregnancy in women with type 1 and type 2 diabetes.
- ACRONYMGlucoMOMS
- hypothesisGlucose assessment by means of continuous monitoring in addition to standard glucose assessments, and subsequent therapeutic addaptations, will lower the incidence of macrosomia.
- Healt Condition(s) or Problem(s) studiedPregnancy, Diabetes Mellitus
- Inclusion criteria1. Pregnant women with either diabetes type 1 or 2;
2. On insuline therapy;
3. Singelton pregnancies.
- Exclusion criteria1. Multiple pregnancies;
2. Severe medical or psychological comorbidity.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2011
- planned closingdate1-jul-2014
- Target number of participants300
- InterventionsPatients in the intervention group will receive in addition to regular glucose assessments a continuous glucose monitoring. This will be placed every 6 weeks for 5-7 days. After every monitor cycle, the measurements will be retrospectively evaluated and subsequently the insulin therapy will be adjusted.
Patients in the control group will have regular glucose assessments: HbA1c every 6 weeks and self measured day curves.
- Primary outcomeMacrosomia: Birth weight above 90th percentile. Measured directly after birth.
- Secondary outcome1. HbA1c: Regular measurements every 6 weeks;
2. Birth weight;
3. Maternal and neonatal morbidity: Information on labour and following few days will be collected;
4. Cost-effectiveness.
- TimepointsN/A
- Trial web sitewww.studies-obsgyn.nl/glucomoms
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. D. Munster, van
- CONTACT for SCIENTIFIC QUERIESDrs. D. Munster, van
- Sponsor/Initiator ZonMw: The Netherlands Organization for Health Research and Development
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThe GlucoMOMS trial is a multicentre randomised controlled trial that investigates the additional value of continuous glucose assessments at 5 timepoints during pregnancy in women with typ 1 and tye 2 diabetes in order to reduce the incidence of macrosomia.
- Main changes (audit trail)
- RECORD15-jul-2011 - 31-aug-2011


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