Single Site Pilot Clinical Investigation of a Novel App-assisted Self-management Programme for Gestational Diabetes

Background: There has been an exponential growth in the prevalence of gestational diabetes (GDM) in the past decade, due in part to internationally adopted changes in the diagnostic criteria. Other important factors driving this trend include increasing rates of obesity, advancing maternal age and women embarking on pregnancy with progressively more complex background medical conditions. The significance of the increased rates of GDM is confronting healthcare systems that are striving to continue the provision of exemplary maternal and perinatal care in the context of ever more limited resources and over-burdened infrastructure. The advent of telemedicine, and its many branches, provides an opportunity to alleviate the pressure applied by the rising prevalence of many chronic health conditions. I sought to evaluate the impact of smartphone app-assisted care delivery in the context of GDM. To this end, I designed and developed a mobile phone app and hospital portal to facilitate self-management and remote monitoring for a cohort of women with GDM attending the diabetes obstetric clinic at a large tertiary-referral maternity hospital. 

Methods: A comprehensive design and development phase of a prospective smartphone app and medical portal involving focus group discussions with key stakeholders and collaborators from industry and technology led to the eventual deployment of ‘GDMapp’. Women with a first-time diagnosis of GDM, commencing a trial of medical nutrition and lifestyle therapy, were approached for consideration of enrolment to an app-assisted healthcare model as an adjunctive measure of the standard telemedicine diabetes clinic. A proportion of participants additionally consented to acquisition of umbilical cord blood C-peptide levels at delivery. Patient and staff satisfaction with GDMapp-assisted care were evaluated through the distribution of questionnaires following study completion. Glycaemic, maternal, perinatal, and neonatal outcomes were compared between the app-using group and a matched historical control group availing of the standard telemedicine care pathway. A cost minimisation analysis was performed to assess the economic impact of implementation of app-assisted care. Data variables were summarised using univariable descriptive statistics and the groups were compared using statistical hypothesis testing. 

Results: Final analysis involved 168 participants engaging in app-assisted healthcare delivery for GDM and a historical control group of 162 prospectively recruited patients from the telemedicine clinic, which represented the usual standard of care. Patients using the newly developed app had lower overall glycaemic indices across both fasting (p=0.022) and postprandial (p<0.001) parameters than patients in the historical cohort. Overall, participants engaged in app-assisted care had fewer instances of above threshold glycaemic control. Modes of delivery were broadly similar between the groups. There was a similar proportion of emergency caesarean deliveries across both groups. However, fewer elective caesarean sections, offset by more operative vaginal deliveries in the app-assisted care group were identified. Adjunctive use of app-based care demonstrated non-inferiority in terms of adverse maternal, birth and neonatal outcomes although incidence of these events was low in both groups. Significant economic benefit has been outlined when this app-assisted care model was compared to the hospital-based, midwifery-led service previously provided to patients diagnosed with GDM. Acceptability and feasibility of this novel telemedicine solution for GDM care were demonstrated with high satisfaction scores for surveyed patients and staff. 

Conclusions: The development of an app-assisted model of care for GDM has shown promise in alleviating the healthcare burden on an over-stretched, resource limited hospital department. Use of GDMapp has facilitated and encouraged patient centred care, which has been readily adopted by patients, as demonstrated by significantly improved postprandial glycaemic control reflecting the benefit of the educational, motivational, and self-management tools within the app. This pathway of care has taken on increased merit in the face of the COVID-19 pandemic and offers an economically viable, clinically safe, and effective care provision structure for women diagnosed with GDM in Ireland.