Autonomic Neuropathy and Hypoglycaemia in Type 1 Diabetes in Pregnancy
Research type
Research Study
Full title
A Feasibility Study Examining the Relationship between Autonomic Neuropathy and Severe Maternal Hypoglycaemia in Type 1 Diabetes during Pregnancy
IRAS ID
162872
Contact name
Dinesh Selvarajah
Contact email
Sponsor organisation
Sheffield Teaching Hospitals
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
It is still unclear, why early pregnancy is associated with a high rate of severe hypoglycaemia episodes. Since changes in autonomic function are present in pregnancy, we hypothesise that there is a potential interaction between autonomic dysfunction and risk of severe hypoglycaemia which warrants further investigation. In this feasibility study we aim to 1) provide ‘proof of concept’ for our hypothesis, 2) test our assessment strategies and 3) examine factors that would influence the design of a future larger study.
The study cohort will comprise 3 carefully characterised groups: pregnant healthy women (n=15) and women with type 1 diabetes [pregnant (n=15) and non-pregnant (n=15 already studied previously in another project)]. During each trimester of pregnancy and once postpartum; pregnant participants will undergo detailed autonomic function testing and assessments of hypoglycaemia awareness/symptoms with glucose monitoring in participants with diabetes (glucose self-monitoring, 7/day and/or continuous glucose monitoring). The same assessments have already been conducted once in non-pregnant participants in a previous study. All episodes of severe hypoglycaemia and pregnancy outcomes will be recorded. Pregnant diabetic study participants will be given information (sign posted to) on an ongoing study of foetal growth and brain development using in-utero magnetic resonance imaging (MRI) MERIDIAN ADD ON study. This is an optional component of this study.
Preliminary analyses will examine the associations between autonomic dysfunction, alterations in hypoglycaemic symptoms/awareness and frequency of hypoglycaemic episodes. We will also assess strategies for: 1) recruitment/retention, 2) utility/performance of different autonomic function tests and MRI in pregnancy and 3) monitoring glucose control and identifying hypoglycaemia.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
14/YH/1281
Date of REC Opinion
26 Jan 2015
REC opinion
Further Information Favourable Opinion