Contact information
Type
Scientific
Primary contact
Dr Helen R Murphy
ORCID ID
Contact details
Level 4 Metabolic Research Laboratories
Institute of Metabolic Science
Box 289 Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 769079
hm386@medschl.cam.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1.2 Nov 11 2009
Study information
Scientific title
Evaluation of the safety and efficacy of closed loop glucose control during the activities of normal daily living in women with type 1 diabetes during pregnancy: an open label randomised cross-over study
Acronym
CLIP - 02
Study hypothesis
Null hypothesis:
The computer-based closed loop (CL) system provides glucose control which is as safe and efficacious as conventional insulin pump therapy during pregnancy in women with type 1 diabetes.
Alternative hypothesis:
The computer-based closed loop (CL) system provides better glucose control and reduced risk of hypoglycaemia than conventional insulin pump therapy during pregnancy in women with type 1 diabetes.
A pilot feasibility study of this trial was performed in 2009, registered with an ISRCTN under the title 'Closed Loop In Pregnancy: evaluation of the gut absorption rate of glucose during an evening meal and breakfast in women with type 1 diabetes throughout pregnancy (CLIP -01)', and this record can be found at http://www.controlled-trials.com/ISRCTN62568875.
Ethics approval
Essex 2 Research Ethics Committee approved on the 9th December 2009 (ref: 09/H0302/113)
Study design
Open label randomised cross-over study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type 1 diabetes
Intervention
Treatment arm: 24 hours closed loop insulin delivery (dose titration by computer algorithm)
Control arm: 24 hours of conventional insulin pump delivery (i.e dose titration according to fingerprick glucose levels)
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measure
Time spent with plasma glucose concentration in the target range (3.5 - 7.8 mmol/L) between 14.00 - 12.30 hours. Specific parameters will be the assessment of variability and frequency of mild and moderate hypoglycaemic events (plasma glucose less than 3.5 mmol/L and less than 2.8 mmol/L respectively), mild and moderate hyperglycaemic events (plasma glucose greater than 7.8 mmol/L and greater than 10.0 mmol/L respectively).
Secondary outcome measures
1. Total daily dose of insulin (TDD) on intervention versus control visit
2. Actiheart physical activity energy expenditure (PAEE) score during the 24 hour study visit and 24 hour free living
3. Continuous blood glucose monitored (CGM) glucose levels during the 24 hour study visit and 24 hour free living
Overall trial start date
01/03/2010
Overall trial end date
28/02/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Signed informed consent obtained before study-related activities. Study-related activities are any procedure that would not have been performed during standard medical care.
2. The participant is between 16 and 44 years of age (inclusive), female only
3. The participant has type 1 diabetes (T1DM), as defined by World Health Organisation (WHO) for at least 12 months and has had a viable singleton pregnancy confirmed by ultrasound
4. The participant has been commenced on insulin pump therapy during or prior to pregnancy
5. The participant is able and willing to use a real time continuous sensor
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
12
Participant exclusion criteria
1. Non-type 1 diabetes mellitus including those secondary to chronic disease
2. Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results such as coeliac disease or untreated hypothyroidism
3. Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and monoamine oxidase (MAO) inhibitors
4. Known or suspected allergy against insulin
5. Women with clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
6. Documented gastroparesis
7. Very poor glycaemic control i.e. HbA1c greater than or equal to 10%
8. Significant obesity, i.e., body mass index (BMI) at booking greater than 35 kg/m^2
9. Total daily insulin dose greater than 1.5 IU/kg at booking
10. Women who have conceived with in vitro fertilisation (IVF) or assisted reproductive techniques
Recruitment start date
01/03/2010
Recruitment end date
28/02/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Level 4 Metabolic Research Laboratories
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Organisation
Cambridge University Hospital NHS Foundation Trust (UK)
Sponsor details
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
stephen.kelleher@addenbrookes.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Diabetes UK (UK) (ref: BDA 07/0003551)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Funder name
National Institute for Health Research (NIHR) (UK) - Post-Doctoral Fellowship (ref: PDF/08/01/036)
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
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22011408
Publication citations
-
Results
Murphy HR, Kumareswaran K, Elleri D, Allen JM, Caldwell K, Biagioni M, Simmons D, Dunger DB, Nodale M, Wilinska ME, Amiel SA, Hovorka R, Safety and efficacy of 24-h closed-loop insulin delivery in well-controlled pregnant women with type 1 diabetes: a randomized crossover case series., Diabetes Care, 2011, 34, 12, 2527-2529, doi: 10.2337/dc11-1430.