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

Completed

• Conditions: Pregnant women with pre-existing type 1 diabetes; Nutritional, Metabolic, Endocrine; Insulin-dependent diabetes mellitus

• Registration Number: ISRCTN62568875
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-07
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 12

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Metrics obtained by modelling of tracer glucose:<br>1. BIOmod*: meal bioavailability<br>2. Tmax, mod*: time-to-maximum of the model-derived gut absorption<br>3. T25%, mod*, T50%, mod*, T75%, mod*: time to 25%, 50%, and 75% of the model-derived gut absorption<br>4. AUC0-420, mod*: the area-under-curve of the model-derived gut absorption<br><br>Analysis of plasma glucose:<br>5. Cmax,PG, tmax, PG: the concentration-time profile of plasma glucose concentration following meal digestion/start of glucose infusion<br><br>Analysis of plasma insulin:<br>6. AUCPI(0-240), Cmax, PI, tmax, PI for the concentration-time profiles of plasma insulin