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
Protocol serial number	N0254145814
Sponsor	Department of Health
Funder	Ipswich Hospital NHS Trust (UK) NHS R&D Support Funding

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

Primary study design	Interventional
Study design	Collaborative, open-label, randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	120
Key inclusion criteria	Target total across all sites = 120. Inclusion: All women with pre-existing diabetes attending Ipswich or Norwich antenatal diabetes centre.
Key exclusion criteria	None other than serious medical or psychological co-morbidity which would interfere with the subjects ability to participate.
Date of first enrolment	08/04/2004
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

The Ipswich Hospital NHS Trust

Ipswich
IP4 5PD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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