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
Scientific
University of Cambridge Metabolic Research Laboratories
Level 4, Institute of Metabolic Science
Box 289, Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223 769079 |
|---|---|
| hm386@medschl.cam.ac.uk |
Study information
| Study design | Prospective multicentre observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | CLIP - 01 |
| Study objectives | 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(s) | Cambridgeshire 1 Research Ethics Committee approved on the 16th December 2008 (ref: 08/H0304/128) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 20/03/2009 |
| Completion date | 20/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 12 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 20/03/2009 |
| Date of final enrolment | 20/03/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Cambridge Metabolic Research Laboratories
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge (UK)
Hospital/treatment centre
Hospital/treatment centre
Box 277
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| Phone | +44 (0)1223 348491 |
|---|---|
| louise.stockley@addenbrookes.nhs.uk | |
| Website | http://www.addenbrookes.org.uk |
"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)
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 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? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2012 | Yes | No | |
| Results article | results | 01/10/2012 | Yes | No |
