Contact information
Type
Scientific
Primary contact
Dr Helen R Murphy
ORCID ID
Contact details
University of Cambridge Metabolic Research Laboratories
Level 4
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 1.3 Feb 9th 2009
Study information
Scientific title
Evaluation of the gut absorption rate of glucose during an evening meal and breakfast: a prospective three-centre observational cohort study in pregnant women with type 1 diabetes
Acronym
CLIP - 01
Study hypothesis
We aim to evaluate whether estimates of glucose absorption rates differ according to the meal type and composition (i.e., breakfast versus evening meal) and according to gestational age during pregnancy. This evaluation will inform the future development of insulin dose adjustment algorithms for use in closed loop systems during pregnancy in women with type 1 diabetes.
Ethics approval
Cambridgeshire 1 Research Ethics Committee approved on the 16th December 2008 (ref: 08/H0304/128)
Study design
Prospective multicentre observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pregnant women with pre-existing type 1 diabetes
Intervention
The same study protocol will be performed on two occasions during early (12 - 16 weeks gestation) and late (28 - 32 weeks gestation) pregnancy. On each occasion participants will eat a tracer-enriched, more slowly-absorbed evening meal, followed by an overnight stay with a tracer enriched, more rapidly absorbed breakfast meal the next morning. A variable subcutaneous (SC) insulin infusion will continue throughout using algorithm control aiming to maintain plasma glucose between 3.5 - 7.8 mmol/L.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Document the changes in gut absorption of a more slowly absorbed medium sized evening meal and a more rapidly absorbed medium sized breakfast meal during pregnancy by the model-based analysis of the data using computational approach previously described by Hovorka et al. The gut absorption rates will be compared using the root mean square error (RMSE).
Secondary outcome measures
Metrics obtained by modelling of tracer glucose:
1. BIOmod*: meal bioavailability
2. Tmax, mod*: time-to-maximum of the model-derived gut absorption
3. T25%, mod*, T50%, mod*, T75%, mod*: time to 25%, 50%, and 75% of the model-derived gut absorption
4. AUC0-420, mod*: the area-under-curve of the model-derived gut absorption
Analysis of plasma glucose:
5. Cmax,PG, tmax, PG: the concentration-time profile of plasma glucose concentration following meal digestion/start of glucose infusion
Analysis of plasma insulin:
6. AUCPI(0-240), Cmax, PI, tmax, PI for the concentration-time profiles of plasma insulin
Overall trial start date
20/03/2009
Overall trial end date
20/03/2010
Reason abandoned
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)
3. The participant has type 1 diabetes, as defined by World Health Organization (WHO) for at least 12 months and has had a viable singleton pregnancy confirmed by ultrasound
4. The participant has been on insulin pump or multiple daily injection (MDI) therapy for at least 6 months
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
20/03/2009
Recruitment end date
20/03/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Cambridge Metabolic Research Laboratories
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge (UK)
Sponsor details
Box 277
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 348491
louise.stockley@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
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
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22080230
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22804483
Publication citations
-
Results
Murphy HR, Elleri D, Allen JM, Harris J, Simmons D, Rayman G, Temple RC, Umpleby AM, Dunger DB, Haidar A, Nodale M, Wilinska ME, Hovorka R, Pathophysiology of postprandial hyperglycaemia in women with type 1 diabetes during pregnancy., Diabetologia, 2012, 55, 2, 282-293, doi: 10.1007/s00125-011-2363-6.
-
Results
Murphy HR, Elleri D, Allen JM, Simmons D, Nodale M, Hovorka R, Plasma C-peptide concentration in women with Type 1 diabetes during early and late pregnancy., Diabet. Med., 2012, 29, 10, e361-4, doi: 10.1111/j.1464-5491.2012.03747.x.