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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
ISRCTN ISRCTN62568875
DOI 10.1186/ISRCTN62568875
ClinicalTrials.gov identifier
EudraCT number
Public 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
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
Serial number at source Version 1.3 Feb 9th 2009
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.
Lay summary Not provided at time of registration
Ethics approval Cambridgeshire 1 Research Ethics Committee approved on the 16th December 2008 (ref: 08/H0304/128)
Study design Prospective multicentre observational cohort study
Countries of recruitment United Kingdom
Disease/condition/study domain Pregnant women with pre-existing type 1 diabetes
Participants - 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
Participants - 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
Anticipated start date 20/03/2009
Anticipated end date 20/03/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 12
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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
Sources of funding 1. Diabetes UK (UK) (ref: BDA 07/0003551)
2. National Institute for Health Research (NIHR) (UK) - Post-Doctoral Fellowship (ref: PDF/08/01/036)
Trial website
Publications 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22080230
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22804483
Contact name Dr  Helen R  Murphy
  Address University of Cambridge Metabolic Research Laboratories
Level 4, Institute of Metabolic Science
Box 289, Addenbrooke’s Hospital
Hills Road
  City/town Cambridge
  Zip/Postcode CB2 0QQ
  Country United Kingdom
  Tel +44 (0)1223 769079
  Fax +44 (0)1223 330 598
  Email hm386@medschl.cam.ac.uk
Sponsor Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge (UK)
  Address Box 277
Addenbrookes Hospital
Hills Road
  City/town Cambridge
  Zip/Postcode CB2 0QQ
  Country United Kingdom
  Tel +44 (0)1223 348491
  Email louise.stockley@addenbrookes.nhs.uk
  Sponsor website: http://www.addenbrookes.org.uk
Date applied 03/06/2009
Last edited 20/11/2012
Date ISRCTN assigned 07/10/2009
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