Individualised patieNt care and treatment FOR MatErnal Diabetes
Research type
Research Study
Full title
Understanding the glycaemic profile of maternal diabetes using continuous glucose monitoring: intensive glucose profiling to inform patient care and treatment(INFORMED)
IRAS ID
297276
Contact name
Michael A Zulyniak
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
0 years, 11 months, 19 days
Research summary
BACKGROUND. Women with pre-existing diabetes, struggle to control glucose levels during pregnancy and are at high risk of pregnancy complications, compared to women without diabetes. Previous studies suggest that control of glucose levels following mealtimes are key targets for improving overall glucose control but to date evidence is limited regarding (i) the role of diet and nutrition as mediators of glucose variability, and (ii) the generalizability of glycaemic response to diet across a diverse population. This study aims to investigate these points more closely in a clinical setting with pregnant women with pre-existing diabetes using routine clinical data obtained from continuous glucose monitors (CGM) and two meal interventions.
METHODS. Pregnant women (1st trimester) with pre-existing Type 1 diabetes (T1D) or Type 2 diabetes (T2D) (with or without medication) attending the Diabetes in Pregnancy Clinics at Leeds Teaching Hospitals NHS Trust (LTHT) will be recruited during their regular clinical visit (initially by the clinical care team). The study will involve (i) securely sharing medical details of their health, dysglycemia, pregnancy, and delivery with approved study researchers, (ii) completing questionnaires (via phone calls) to assess their lifestyle and 24h dietary recall diaries after clinical visits at approximately 10-12, 18-20, and 28-34 weeks gestation of the pregnancy; (iii) consuming two assigned meals in duplicate at ~18-20 and ~28-34 weeks of the pregnancy, (iv) permitting researchers to analyse urine they provide to the NHS for routine screening, and (v) providing 10 mL of blood on three occasions - at ~10-12 weeks, ~18-20 weeks, and ~28-34 weeks, for subsequent metabolomic and genetic analysis. The participant’s decision to participate in the study (or not) will have no effect on her clinical care.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
21/NE/0196
Date of REC Opinion
17 Dec 2021
REC opinion
Further Information Favourable Opinion