Lise Loerup

Development of a real-time smartphone solution for the management of women with or at high risk of gestational diabetes.

Background: Gestational diabetes mellitus (GDM) is defined as new onset or recognition of glucose intolerance in pregnancy. Evidence supports tight blood glucose regulation to prevent adverse maternal and fetal outcomes. Finger-prick blood glucose (BG) testing with frequent clinic review remains the most common method of managing diabetes in pregnancy. The prevalence of GDM is rising globally, pressuring resource-limited services. Objectives: We have developed an intuitive, interactive, reliable, and accurate management system to record BG measurements and deliver management of GDM remotely. Methods: Following an initial scoping phase, a prototype software application was developed using an Android smartphone with BG meter linkage via Bluetooth. A custom website was built for clinician review of the data transmitted by the smartphone. After system refinement, further evaluation was undertaken for usability and reliability in a 48-patient service development project. Results: Women used the system for an average of 13.1 weeks. In all, 19 686 BG measures were transmitted, 98.6% of which had a meal tag. A total of 466 text messages were transmitted. A mean of 30 BG readings per woman per week were transmitted, and 85% of women submitted the minimum requirement of 18 readings per week. Discussion: We have developed a novel, real-time, smartphone-based BG monitoring management system that allows clinician review of real-time patient-annotated BG results. Results indicate high usage and excellent compliance by women. Conclusion: Robust clinical, economic, and satisfaction evaluations are required. To address these requirements, we are currently conducting a randomized controlled pilot trial.

Acceptability and User Satisfaction of a Smartphone-Based, Interactive Blood Glucose Management System in Women With Gestational Diabetes Mellitus

Background: The increase in gestational diabetes mellitus (GDM) is challenging maternity services. We have developed an interactive, smartphone-based, remote blood glucose (BG) monitoring system, GDm-health. Aims: The objective was to determine women’s satisfaction with using the GDm-health system and their attitudes toward their diabetes care. Methods: In a service development program involving 52 pregnant women (September 2012 to June 2013), BG was monitored using GDm-health from diagnosis until delivery. Following birth, women completed a structured questionnaire assessing (1) general satisfaction, (2) equipment issues, and (3) relationship with the diabetes care team. Responses were scored on a 7-point Likert-type scale. Reliability and validity of the questionnaire were assessed using statistical methods. Results: Of 52 women, 49 completed the questionnaire; 32 had glucose tolerance test confirmed GDM (gestation at recruitment 29 ± 4 weeks (mean ± SD), and 17 women previous GDM recommended for BG monitoring (18 ± 6 weeks). In all, 45 of 49 women agreed their care was satisfactory and the best for them, 47 of 49 and 43 of 49 agreed the equipment was convenient and reliable respectively, 42 of 49 agreed GDm-health fitted into their lifestyle, and 46 of 49 agreed they had a good relationship with their care team. Written comments supported these findings, with very positive reactions from the majority of women. Cronbach’s alpha was .89 with factor analysis corresponding with question thematic trends. Conclusions: This pilot demonstrates that GDm-health is acceptable and convenient for a large proportion of women. Effects on clinical and economic outcomes are currently under investigation in a randomized trial (clinicaltrials.gov NCT01916694).

Telemedicine Technologies for Diabetes in Pregnancy: A Systematic Review and Meta-Analysis

Background Diabetes in pregnancy is a global problem. Technological innovations present exciting opportunities for novel approaches to improve clinical care delivery for gestational and other forms of diabetes in pregnancy. Objective To perform an updated and comprehensive systematic review and meta-analysis of the literature to determine whether telemedicine solutions offer any advantages compared with the standard care for women with diabetes in pregnancy. Methods The review was developed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) framework. Randomized controlled trials (RCT) in women with diabetes in pregnancy that compared telemedicine blood glucose monitoring with the standard care were identified. Searches were performed in SCOPUS and PubMed, limited to English language publications between January 2000 and January 2016. Trials that met the eligibility criteria were scored for risk of bias using the Cochrane Collaborations Risk of Bias Tool. A meta-analysis was performed using Review Manager software version 5.3 (Nordic Cochrane Centre, Cochrane Collaboration). Results A total of 7 trials were identified. Meta-analysis demonstrated a modest but statistically significant improvement in HbA1c associated with the use of a telemedicine technology. The mean HbA1c of women using telemedicine was 5.33% (SD 0.70) compared with 5.45% (SD 0.58) in the standard care group, representing a mean difference of −0.12% (95% CI −0.23% to −0.02%). When this comparison was limited to women with gestational diabetes mellitus (GDM) only, the mean HbA1c of women using telemedicine was 5.22% (SD 0.70) compared with 5.37% (SD 0.61) in the standard care group, mean difference −0.14% (95% CI −0.25% to −0.04%). There were no differences in other maternal and neonatal outcomes reported. Conclusions There is currently insufficient evidence that telemedicine technology is superior to standard care for women with diabetes in pregnancy; however, there was no evidence of harm. No trials were identified that assessed patient satisfaction or cost of care delivery, and it may be in these areas where these technologies may be found most valuable.

Trial protocol to compare the efficacy of a smartphone-based blood glucose management system with standard clinic care in the gestational diabetic population

Introduction 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 and analysis 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. Ethics and dissemination 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. Trial registration number NCT01916694; Pre-results.

GDm-Health: a pilot study demonstrating the feasibility of mobile phone assisted treatment advice and medication adjustment for women with gestational diabetes

To describe change in self‐reported diet and plasma vitamin C, and to examine associations between change in diet and cardiovascular disease risk factors and modelled 10‐year cardiovascular disease risk in the year following diagnosis of Type 2 diabetes.

Pregnancy physiology pattern prediction study (4P study): protocol of an observational cohort study collecting vital sign information to inform the development of an accurate centile-based obstetric early warning score.

Introduction Successive confidential enquiries into maternal deaths in the UK have identified an urgent need to develop a national early warning score (EWS) specifically for pregnant or recently pregnant women to aid more timely recognition, referral and treatment of women who are developing life-threatening complications in pregnancy or the puerperium. Although many local EWS are in use in obstetrics, most have been developed heuristically. No current obstetric EWS has defined the thresholds at which an alert should be triggered using evidence-based normal ranges, nor do they reflect the changing physiology that occurs with gestation during pregnancy. Methods and analysis An observational cohort study involving 1000 participants across three UK sites in Oxford, London and Newcastle. Pregnant women will be recruited at approximately 14 weeks’ gestation and have their vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation and temperature) measured at 4 to 6-week intervals during pregnancy. Vital signs recorded during labour and delivery will be extracted from hospital records. After delivery, participants will measure and record their own vital signs daily for 2 weeks. During the antenatal and postnatal periods, vital signs will be recorded on an Android tablet computer through a custom software application and transferred via mobile internet connection to a secure database. The data collected will be used to define reference ranges of vital signs across normal pregnancy, labour and the immediate postnatal period. This will inform the design of an evidence-based obstetric EWS. Ethics and dissemination The study has been approved by the NRES committee South East Coast–Brighton and Sussex (14/LO/1312) and is registered with the ISRCTN (10838017). All participants will provide written informed consent and can withdraw from the study at any point. All data collected will be managed anonymously. The findings will be disseminated in international peer-reviewed journals and through research conferences.

Digital blood glucose monitoring could provide new objective assessments of blood glucose control in women with gestational diabetes

Assessing blood glucose (BG) control in women with gestational diabetes mellitus is challenging, as routine tests, for example HbA1c assessment, are an insensitive measure of response to the progressive changes of glucose regulation in pregnancy [1,2]. Consequently, the standard of care remains visual inspection of BG paper diaries of self-performed capillary monitoring. Numerous telehealth solutions to record BG readings have been developed, but their clinical superiority over standard care is yet to be shown [3]. Whilst several of the studies on telehealth solutions assess digital systems, decision-making still relies on visual inspection of BG trends. We have developed a digital BG management system, GDm-health, in which BG readings are automatically transferred via Bluetooth to a smartphone app, which also allows women to add a meal label and comments (e.g. medications and diet). These annotated readings are then transmitted by the smartphone via the 3G network to a secure website. Feedback messages can be sent to the woman through the website by clinicians reviewing her data, or by telephone call as required. Full details describing the system development and user satisfaction are available [4,5]. We hypothesized that the annotated BG data could provide novel measures of glycaemic control predictive of pregnancy outcomes. We therefore assessed the ability of selected measures to predict the most common pregnancy outcome associated with gestational diabetes, large-forgestational-age (LGA) babies [6]. A 49-patient service development project was carried out in a tertiary centre in the UK (June 2012 to August 2013). Gestational diabetes screening, diagnosis and management was in keeping with NICE 2008 [7] and local guidelines. GDm-health was used for all self-monitoring. Women performed fasting, preand 2-h postprandial capillary testing. Targets were to maintain all readings between 4.0 and 6.0 mmol/l. If readings were within target, monitoring was reduced from 7 to 3 days/week. Birth weight was classified as LGA or non-LGA (NGA). LGA was defined as birth weight ≥90 centile for gestational age and gender [8]. Anonymized baseline characteristics and annotated BG data were extracted from the website after delivery. This project was conducted as a service improvement project. Participation was voluntary and not remunerated. All pregnant women in the Oxford University Hospitals NHS Trust provide consent at the start of pregnancy for anonymized clinical data to be used for research. Maternal characteristics were compared using chi-squared and Mann–Whitney U-tests. Differences between mean, fasting and 2-h postprandial monitoring between NGA and LGA were compared using Student’s t-tests. Two-weekly moving mean BG values with standard errors (SEM) were calculated and presented graphically from 30 weeks until delivery. Odds ratios (ORs) with 95% CIs for LGA babies were calculated using logistic regression, adjusting for maternal factors where P < 0.05. All analyses were performed using SPSS version 21.0 (IBM) and MATLAB version r2014b (Mathworks Inc.). Outcome data were available for 41 women, of whom 12 (29%) delivered LGA babies. These women transmitted 14,222 BG readings, 98.6% of which were annotated. A

Trends of vital signs with gestational age in normal pregnancies: a systematic review protocol

Introduction Vital signs (blood pressure, heart rate, temperature, oxygen saturation and respiratory rate) are thought to undergo changes during and immediately after pregnancy. However, these physiological changes are not taken into account in the normal ranges, which themselves are not evidence-based, used in routine and acute care monitoring. We aim to synthesise the existing evidence base for changes in vital signs during pregnancy, in order to derive new centile charts for each stage of pregnancy and the immediate postpartum period. Methods and analysis We will search the MEDLINE, EMBASE and CINAHL databases from their inception to April 2015 for vital signs from pregnant, intrapartum or postpartum women who were recruited as ‘healthy’. Assessment of bias will be conducted using a predefined set of independently agreed methodological criteria, which assigns an overall quality score to each study. We will record whether the vital sign measurements were made with measurement devices validated for use in pregnancy and in a standard posture. We will use regression methods to construct centile charts of vital signs across pregnancy and the immediate postpartum period for each vital sign. We will compare existing reference ranges to those derived from our centile charts. Dissemination The systematic review will be published in a peer-reviewed journal and disseminated electronically and in print. PROSPERO reference CRD42014009673.

Clinical Implications of the NICE 2015 Criteria for Gestational Diabetes Mellitus

Background: In response to concerns that the International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria labeled too many women with gestational diabetes mellitus (GDM) without evidence of clinical or economic benefit, NICE recommended a change in diagnostic criteria in 2015. Aim: To compare diabetes associated maternal and neonatal complications in pregnancies complicated by GDM diagnosed using IADPSG criteria only, to those with GDM diagnosed using both IADPSG and NICE 2015 criteria. GDM screening was risk factor based. Methods: This was a secondary analysis of a trial of women with GDM diagnosed by the IADPSG criteria (fasting blood glucose (BG) ≥ 5.1 mmol/L, 1 h ≥ 10.0 mmol/L and 2 h ≥ 8.5 mmol/L). Outcomes were compared for two groups: NICE + IADPSG defined as those with GDM diagnosed by both the NICE 2015 and IADPSG criteria (fasting BG ≥ 5.6 mmol/L, 2 h ≥ 8.5 mmol/L); and IADPSG-ONLY (fasting BG 5.1 mmol/L to 5.5 mmol/L, and/or 1-hour ≥10.0 mmol/L, and 2 h ≥ 8.5 mmol/L). We were not able to obtain data for women with a 2-h value between BG 7.8–8.4 mmol/L (i.e., NICE-ONLY; NICE 2015 positive and IADPSG negative). All women were treated for GDM using targets of fasting BG < 5.3 mmol/L and 1-h post prandial BG < 7.8 mmol/L respectively. Results: Of 159 women, 65 (40.9%) were NICE + IADPSG and 94 (59.1%) IADPSG-ONLY. Hypoglycaemic medication use was similar in both groups: 52.3% NICE + IADPSG, 46.8% IADPSG-ONLY, OR 1.0 (0.5–1.9). The IADPSG-ONLY group delivered later than the NICE + IADPSG group; 39.0 weeks (sd 1.4) compared to 38.2 weeks (sd 2.5), p value 0.02. Fewer caesarean sections occurred in IADPSG-ONLY group 30.9% vs. 52.3%, OR 0.4 (0.2–0.9). Birthweight, large for gestational age, and other neonatal complications were not significantly different between groups. Conclusions: Gestational diabetes-associated perinatal complications were similar in both groups. The IADPSG criteria detect women with evidence of ongoing hyperglycaemia who may benefit from treatment during pregnancy.