Contact information
Type
Scientific
Primary contact
Dr Helen Murphy
ORCID ID
Contact details
The Ipswich Hospital NHS Trust
Diabetes Centre
Heath Road
Ipswich
IP4 5PD
United Kingdom
+44 (0)1473 704759
helen.murphy@ipswichhospital.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0254145814
Study information
Scientific title
Acronym
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.
Ethics approval
Not provided at time of registration
Study design
Collaborative, open-label, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Diabetes
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
Not provided at time of registration
Overall trial start date
08/04/2004
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Target total across all sites = 120.
Inclusion: All women with pre-existing diabetes attending Ipswich or Norwich antenatal diabetes centre.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
120 - closed to recruitment
Participant exclusion criteria
None other than serious medical or psychological co-morbidity which would interfere with the subjects ability to participate.
Recruitment start date
08/04/2004
Recruitment end date
31/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Ipswich Hospital NHS Trust
Ipswich
IP4 5PD
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ipswich Hospital NHS Trust (UK) NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/18818254
Publication citations
-
Results
Murphy HR, Rayman G, Lewis K, Kelly S, Johal B, Duffield K, Fowler D, Campbell PJ, Temple RC, Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial., BMJ, 2008, 337, a1680.