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A randomised controlled trial to evaluate the role of the continuous glucose monitoring system (CGMS) in pregnancies complicated by pre-existing diabetes
ISRCTN ISRCTN84461581
DOI 10.1186/ISRCTN84461581
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial to evaluate the role of the continuous glucose monitoring system (CGMS) in pregnancies complicated by pre-existing diabetes
Scientific title
Acronym N/A
Serial number at source N0254145814
Study hypothesis The principal question is whether more detailed assessment of blood glucose levels using the CGMS system will improve glycaemic control throughout pregnancy without an excessive increase in rates of hyperglycaemia and thereby reduce both maternal and perinatal morbidity. In addition this will allow us to assess the relative contribution of different blood glucose parameters I.e. fasting Vs postprandial to measures of glycaemia (HbA1c) and foetal growth throughout gestation and neonatal hyperinsulinsemia. The effects of intensive monitoring on self-efficacy and quality of life will also be measured. We will also examine in more detail then hitherto possible the frequency, severity and management of hypoglycaemia in pregnancy. A detailed economic evaluation of the costs and benefits of the intervention will also be a vital component of this study.
Lay summary
Ethics approval Not provided at time of registration
Study design Collaborative, open-label, randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Nutritional, Metabolic, Endocrine: Diabetes
Participants - inclusion criteria Target total across all sites = 120.
Inclusion: All women with pre-existing diabetes attending Ipswich or Norwich antenatal diabetes centre.
Participants - exclusion criteria None other than serious medical or psychological co-morbidity which would interfere with the subjects ability to participate.
Anticipated start date 08/04/2004
Anticipated end date 31/12/2007
Status of trial Completed
Patient information material
Target number of participants 120 - closed to recruitment
Interventions A collaborative, open-label, randomised controlled trial with participants allocated to either standard antenatal care or CGMS which will be performed monthly in addition to standard care.

Primary outcome measure(s) Infants:
1. Perinatal outcome assessed will be gestational age
2. Body weight
3. Respiratory distress (1 and 5 minute apgar scores)
4. Admission to special care baby unit with hypoglycaemia or hyperbilirubinaemia
5. Cord blood measurements of adiposity and hyperinsulineamia

Mothers:
1. Glycaemic control
2. Frequency and severity of hypoglycaemia
3. Presence and /or progression of retinopathy
4. Mode of delivery
5. Delivery related complications
6. Diabetes related distress questionnaire
7. Individually generated index of quality of life measure
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Ipswich Hospital NHS Trust (UK) NHS R&D Support Funding
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/18818254
Contact name Dr  Helen  Murphy
  Address The Ipswich Hospital NHS Trust
Diabetes Centre
Heath Road
  City/town Ipswich
  Zip/Postcode IP4 5PD
  Country United Kingdom
  Tel +44 (0)1473 704759
  Fax +44 (0)1473 704750
  Email helen.murphy@ipswichhospital.nhs.uk
Sponsor Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
  Address The Department of Health
Richmond House
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Fax +44 (0)20 7307 2623
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.dh.gov.uk/Home/fs/en
Date applied 30/09/2005
Last edited 07/10/2008
Date ISRCTN assigned 30/09/2005
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