title: Trial protocol to compare the efficacy of a smartphone-based blood glucose management system with standard clinic care in the gestational diabetic population.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  NCT01916694; Pre-results.
authors.affiliation: Nuffield Department of Obstetrics & Gynaecology, Level 3, Women's Centre, John Radcliffe Hospital, Oxford, UK.
authors.forename: Lucy H
authors.initials: LH
authors.lastname: Mackillop
authors.affiliation: Women's Centre, Oxford University Hospitals NHS Trust, Oxford, UK.
authors.forename: Katy
authors.initials: K
authors.lastname: Bartlett
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Birks
authors.affiliation: Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Farmer
authors.affiliation: Department of Engineering Science, University of Oxford, Oxford, UK.
authors.forename: Oliver J
authors.initials: OJ
authors.lastname: Gibson
authors.affiliation: Department of Endocrinology, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia School of Public Health, Monash University, Melbourne, Australia.
authors.forename: Dev A
authors.initials: DA
authors.lastname: Kevat
authors.affiliation: Nuffield Department of Obstetrics & Gynaecology, Oxford University Hospitals NHS Trust, Oxford, UK.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Kenworthy
authors.affiliation: The Oxford Centre for Diabetes, Endocrinology and Metabolism, Oxford University Hospitals NHS Trust, Oxford, UK.
authors.forename: Jonathan C
authors.initials: JC
authors.lastname: Levy
authors.affiliation: Department of Engineering Science, University of Oxford, Oxford, UK.
authors.forename: Lise
authors.initials: L
authors.lastname: Loerup
authors.affiliation: Department of Engineering Science, University of Oxford, Oxford, UK.
authors.forename: Lionel
authors.initials: L
authors.lastname: Tarassenko
authors.affiliation: Department of Engineering Science, University of Oxford, Oxford, UK.
authors.forename: Carmelo
authors.initials: C
authors.lastname: Velardo
authors.affiliation: Nuffield Department of Obstetrics & Gynaecology, Oxford University Hospitals NHS Trust, Oxford, UK.
authors.forename: Jane E
authors.initials: JE
authors.lastname: Hirst
mesh_terms: D000293:Adolescent; D000328:Adult; D000554:Ambulatory Care Facilities; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring / Q000379:methods*; D002985:Clinical Protocols; D016640:Diabetes, Gestational / Q000097:blood*; D005260:Female; D006801:Humans; D017060:Patient Satisfaction; D011247:Pregnancy; D011248:Pregnancy Complications / Q000097:blood*; D016037:Single-Blind Method; D000068997:Smartphone / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires; D006113:United Kingdom; D055815:Young Adult
chemical_list: D001786:Blood Glucose