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The prevalence of gestational diabetes mellitus (GDM) is rising in the UK. Good glycaemic control improves maternal and neonatal outcomes. Frequent clinical review of patients with GDM by healthcare professionals is required owing to the rapidly changing physiology of pregnancy and its unpredictable course. Novel technologies that allow home blood glucose (BG) monitoring with results transmitted in real time to a healthcare professional have the potential to deliver good-quality healthcare to women more conveniently and at a lower cost to the patient and the healthcare provider compared to the conventional face-to-face or telephone-based consultation. We have developed an integrated GDm-health management system and aim to test the impact of using this system on maternal glycaemic control, costs, patient satisfaction and maternal and neonatal outcomes compared to standard clinic care in a single large publicly funded (National Health Service (NHS)) maternity unit.Women with confirmed gestational diabetes in a current pregnancy are individually randomised to either the GDm-health system and half the normal clinic visits or normal clinic care. Primary outcome is mean BG in each group from recruitment to delivery calculated, with adjustments made for number of BG measurements, proportion of preprandial and postprandial readings and length of time in study, and compared between the groups. The secondary objective will be to compare the two groups for compliance to the allocated BG monitoring regime, maternal and neonatal outcomes, glycaemic control using glycated haemoglobin (HbA1c) and other BG metrics, and patient attitudes to care assessed using a questionnaire and resource use.Thresholds for treatment, dietary advice and clinical management are the same in both groups. The results of the study will be published in a peer-reviewed journal and disseminated electronically and in print.NCT01916694; Pre-results.

Original publication

DOI

10.1136/bmjopen-2015-009702

Type

Journal article

Journal

BMJ open

Publication Date

17/03/2016

Volume

6

Addresses

Nuffield Department of Obstetrics & Gynaecology, Level 3, Women's Centre, John Radcliffe Hospital, Oxford, UK.

Keywords

Humans, Pregnancy Complications, Diabetes, Gestational, Blood Glucose, Blood Glucose Self-Monitoring, Clinical Protocols, Single-Blind Method, Pregnancy, Adolescent, Adult, Ambulatory Care Facilities, Patient Satisfaction, Female, Young Adult, Smartphone, Surveys and Questionnaires, United Kingdom