A randomised controlled trial to evaluate the role of the continuous glucose monitoring system (CGMS) in pregnancies complicated by pre-existing diabetes
ISRCTN | ISRCTN84461581 |
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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
Scientific
The Ipswich Hospital NHS Trust
Diabetes Centre
Heath Road
Ipswich
IP4 5PD
United Kingdom
Phone | +44 (0)1473 704759 |
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helen.murphy@ipswichhospital.nhs.uk |
Study information
Study design | Collaborative, open-label, randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
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 | 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 study start date | 08/04/2004 |
Completion date | 31/12/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 120 - closed to recruitment |
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
- England
- United Kingdom
Study participating centre
The Ipswich Hospital NHS Trust
Ipswich
IP4 5PD
United Kingdom
IP4 5PD
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | Results | 25/09/2008 | Yes | No |