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 https://doi.org/10.1186/ISRCTN84461581
Secondary identifying numbers N0254145814
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
07/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Helen Murphy
Scientific

The Ipswich Hospital NHS Trust
Diabetes Centre
Heath Road
Ipswich
IP4 5PD
United Kingdom

Phone +44 (0)1473 704759
Email helen.murphy@ipswichhospital.nhs.uk

Study information

Study designCollaborative, open-label, randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesThe 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.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNutritional, Metabolic, Endocrine: Diabetes
InterventionA 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.
Intervention typeOther
Primary outcome measureInfants:
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 measuresNot provided at time of registration
Overall study start date08/04/2004
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants120 - closed to recruitment
Key inclusion criteriaTarget total across all sites = 120.
Inclusion: All women with pre-existing diabetes attending Ipswich or Norwich antenatal diabetes centre.
Key exclusion criteriaNone other than serious medical or psychological co-morbidity which would interfere with the subjects ability to participate.
Date of first enrolment08/04/2004
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Ipswich Hospital NHS Trust
Ipswich
IP4 5PD
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Ipswich Hospital NHS Trust (UK) NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 25/09/2008 Yes No