Open Access Protocol BMJ Open: first published as 10.1136/bmjopen-2016-013117 on 27 March 2017. Downloaded from Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial Iren Borgen,1 Lisa Maria Garnweidner-Holme,1 Anne Flem Jacobsen,2 Kirsti Bjerkan,3 Seraj Fayyad,4 Pål Joranger,1 Anne Marie Lilleengen,1 Annhild Mosdøl,5 Josef Noll,4 Milada Cvancarova Småstuen,1 Laura Terragni,1 Liv Elin Torheim,1 Mirjam Lukasse1 To cite: Borgen I, ABSTRACT Strengths and limitations of this study Garnweidner-Holme LM, Introduction: The promotion of a healthy diet, Jacobsen AF, et al. physical activity and measurement of blood glucose ▪ Smartphone application for Tailored health information through the Pregnant levels are essential components in the care for women women with gestational + app in Norwegian, Urdu or Somali for women diabetes mellitus: a study with gestational diabetes mellitus (GDM). Smartphones with gestational diabetes mellitus. protocol for a multicentre offer a new way to promote health behaviour. The main ▪ Automatic transfer of blood glucose levels from randomised controlled trial. aim is to investigate if the use of the Pregnant+ app, in the glucometer to the app via Bluetooth Low BMJ Open 2017;7:e013117. addition to standard care, results in better blood Energy. doi:10.1136/bmjopen-2016- glucose levels compared with current standard care ▪ Privacy protection of participants’ information 013117 only, for women with GDM. through local storage instead of cloud service. Methods and analysis: This randomised controlled ▪ No blinding of participants, staff and researchers ▸ Prepublication history and trial will include 230 pregnant women with GDM but blinding of those analysing samples and the additional material is followed up at 5 outpatient departments (OPD) in the statistician. available. To view please visit greater Oslo Region. Women with a 2-hour oral the journal (http://dx.doi.org/ glucose tolerance test (OGTT) ≥9 mmol/L, who own a 10.1136/bmjopen-2016- smartphone, understand Norwegian, Urdu or Somali INTRODUCTION http://bmjopen.bmj.com/ 013117). and are <33 weeks pregnant, are invited. The Gestational diabetes mellitus (GDM), intervention group receives the Pregnant+ app and defined as glucose intolerance first identified standard care. The control group receives standard Received 23 June 2016 in pregnancy, is an increasing problem care only. Block randomisation is performed 1 Revised 30 November 2016 among pregnant women worldwide. The electronically. Data are collected using self-reported Accepted 17 January 2017 prevalence is ranging from 1.7% to 20% questionnaires and hospital records. Data will be depending on diagnosis criteria and popula- analysed according to the intention-to-treat principle. 1 Groups will be compared using linear regression for tion characteristics. On the basis of cases the main outcome and χ2 test for categorical data and reported to the Norwegian Medical Birth on September 30, 2021 by guest. Protected copyright. Student’s t-test or Mann-Whitney-Wilcoxon test for Registry (NMBR), the prevalence of GDM in skewed distribution. The main outcome is the glucose Norway is ∼2%.2 However, in a cohort study level measured at the 2-hour OGTT 3 months where all pregnant women were screened for postpartum. Secondary outcomes are a change in GDM, the prevalence was 13% overall, with health behaviour and knowledge about GDM, quality of 11% in ethnic Norwegians and 14.6% in life, birth weight, mode of delivery and complications groups of non-European origin.3 It is there- for mother and child. fore likely that GDM is underdiagnosed in Ethics and dissemination: The study is exempt the general population. from regional ethics review due to its nature of quality The majority of pregnant women with improvement in patient care. Our study has been approved by the Norwegian Social Science Data GDM recover from their glucose intolerance once the pregnancy is over.4 However, For numbered affiliations see Services and the patient privacy protections boards end of article. governing over the recruitment sites. Findings will be research suggests that a history of GDM presented in peer-reviewed journals and at increases the risk for developing type 2 dia- 56 Correspondence to conferences. betes mellitus (T2DM) later in life. Iren Borgen; Trial registration number: NCT02588729, Well-known risk factors for GDM include [email protected] Post-results. maternal obesity, advanced maternal age, Borgen I, et al. BMJ Open 2017;7:e013117. doi:10.1136/bmjopen-2016-013117 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2016-013117 on 27 March 2017. Downloaded from ethnicity, family history of diabetes and a previous to the smartphone and provides a graphic overview indi- history of GDM.578Women with GDM have an cating if the levels are satisfactory. Additionally, the app increased risk for pre-eclampsia, induction of labour, provides information about a healthy diet and physical birth injuries, postpartum haemorrhage and caesarean activity. Our Pregnant+ app is meant for daily use by section.9 GDM increases the infant’s risk of macrosomia, women, and not solely during consultation with health birth injuries, neonatal hypoglycaemia and stillbirth.89 professionals. In addition, the Hyperglycaemia and Adverse The main aim of the study is to assess whether the use Pregnancy Outcome study (HAPO) suggests an of the Pregnancy+ app in addition to standard care increased risk of adverse maternal and infant outcomes results in better glucose levels at routine OGTT, with increasing levels of hyperglycaemia.10 3 months postpartum, compared with standard care In Norway, pregnant women with a 2-hour oral only. Secondary outcomes are birth weight, mode of glucose tolerance test (OGTT) ≥9 mmol/L receive add- delivery and complications for mother and child. itional healthcare at a specialised Outpatient Department (OPD).11 New national Norwegian diabetic METHODS guidelines are being developed and expected to be Study design implemented by 2017. Current care in Norway includes giving information about a healthy diet, physical activity We will perform a multicentre RCT. This protocol and monitoring of blood glucose levels and observing includes the elements elaborated in the SPIRIT (Standard Protocol Items: Recommendations for the fetus through cardiotocography (CTG) and ultra- 22 sound.12 Health information is commonly given verbally, Interventional Trials) checklist. We recruit women often accompanied by leaflets. Anecdotal evidence indi- attending the diabetic OPD at the Oslo University cates that information on non-western food items in dif- Hospital, Vestre Viken Hospital Trust and Akershus University Hospital. Study design and data collection are ferent languages is limited. fl fi During the restricted time of clinic visits, information shown in the ow chart ( gure 1). about healthy eating and physical activity competes with other components of care and other information. Participants, recruitment and blinding Health information via an app is easily and constantly Midwives and general practitioners refer pregnant available. Automatic transfer of blood glucose measure- women with recognised risk factors for GDM to a 2-hour – ments to the app provides a novel way to monitor blood OGTT at weeks 24 28 of gestation. On the basis of glucose levels. Nearly 80% of the adult population in results of the OGTT, women are referred to the special- Norway has a smartphone.13 Pregnant women are mostly ist diabetic OPD at the hospital. Participants in this young adults who are familiar with the use of electronic devices such as smartphones. http://bmjopen.bmj.com/ In a previous review of health behaviour interventions and use of apps, the authors found that apps are highly accepted by mobile phone users and may be a suitable way of providing health interventions. Even though pre- vious smartphone-based randomised controlled trials (RCTs) show promising results for the self-management of diabetes and lifestyle factors,14 15 more research is needed to define the exact efficacy of apps on health on September 30, 2021 by guest. Protected copyright. outcomes.16 Since the prevalence of GDM is higher among certain groups of women from Asia and Africa compared with Norwegians, health information needs to be culture- sensitive, easy understandable and meet the individual’s – needs.31719 A systematic review indicated better blood sugar control with culturally tailored counselling to ethnic minority patients with diabetes compared with standard care.20 We have developed an app for women with GDM, the Pregnancy+ app.21 This app is available in Norwegian, Urdu and Somali and consist of linguistically and cultur- ally adapted information. These two groups of non-Western immigrants in Norway, Pakistani and Somali were selected due to their high number of annual births and high risk for GDM.317The Pregnant+ app automatically transfers blood glucose measurements Figure 1 Design of the randomised controlled trial. 2 Borgen I, et al. BMJ Open 2017;7:e013117. doi:10.1136/bmjopen-2016-013117 Open Access BMJ Open: first published as 10.1136/bmjopen-2016-013117 on 27 March 2017. Downloaded from study are selected among these referred women. The of the app is described in a previous publication.21 The inclusion and the exclusion criteria for the participants Pregnant+ app aims to give women tailored information are provided in table 1. to support their management of GDM by adapted We aim to recruit