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 https://doi.org/10.1186/ISRCTN62568875
Secondary identifying numbers Version 1.3 Feb 9th 2009
Submission date
03/06/2009
Registration date
07/10/2009
Last edited
20/11/2012
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 R Murphy
Scientific

University of Cambridge Metabolic Research Laboratories
Level 4, Institute of Metabolic Science
Box 289, Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Phone +44 (0)1223 769079
Email hm386@medschl.cam.ac.uk

Study information

Study designProspective multicentre observational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Other
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvaluation 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
Study acronymCLIP - 01
Study objectivesWe 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(s)Cambridgeshire 1 Research Ethics Committee approved on the 16th December 2008 (ref: 08/H0304/128)
Health condition(s) or problem(s) studiedPregnant women with pre-existing type 1 diabetes
InterventionThe 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 typeOther
Primary outcome measureDocument 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 measuresMetrics 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 study start date20/03/2009
Completion date20/03/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants12
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment20/03/2009
Date of final enrolment20/03/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Cambridge Metabolic Research Laboratories
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge (UK)
Hospital/treatment centre

Box 277
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Phone +44 (0)1223 348491
Email louise.stockley@addenbrookes.nhs.uk
Website http://www.addenbrookes.org.uk
ROR logo "ROR" https://ror.org/04v54gj93

Funders

Funder type

Charity

Diabetes UK (UK) (ref: BDA 07/0003551)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
DIABETES UK LIMITED, British Diabetic Association
Location
United Kingdom
National Institute for Health Research (NIHR) (UK) - Post-Doctoral Fellowship (ref: PDF/08/01/036)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2012 Yes No
Results article results 01/10/2012 Yes No