Gestational Diabetes App Approval
Gestational diabetes patient group gives evidence to support app approval for Gestational Diabetes app
Patient advocacy organisations worldwide have become increasingly sophisticated in how they contribute evidence to improve treatments, pathways and health technologies.
Yet, contributing evidence on health and wellness apps has proved challenging in some cases, in part because of a lack of a robust governmental health department review process, and lack of resources to conduct a review.
The patient organisation Diabetes UK played an active role in contributing to the UK’s National Health Service assessment of an app designed to enable remote monitoring of blood glucose levels and communication with healthcare professionals, for women with gestational diabetes.
The app, GDm-Health:
- downloads data from the patient’s blood glucose meter and sends it to a secure website, which is monitored by healthcare professionals
- enables midwives to send SMS text messages to patients and record notes on the website for other healthcare staff
- is free to download, offers convenience for patients, and may contribute savings by reducing the number of face-to-face clinic appointments.
The app has been widely tested with patients and clinicians, and at one pilot site at the Royal Berkshire NHS Foundation Trust, a 4-month independent review identified:
- Firstly, a 26% reduction in clinic visits for patients using GDm-Health compared with patients having standard care
- And secondly, time spent by diabetes midwives on administrative tasks decreased by 50%.
Patients reported that the app was reliable and easy to use and that they felt they had “greater control over their own care.”
Contributing expert evidence
Following on, the evidence from the patient organisation Diabetes UK has a prominent role in the assessment of the app by the UK’s National Institute for Health and Care Excellence (NICE).
The group concluded that:
“GDm-Health has the potential to positively affect patient care, because people with gestational diabetes would be better able to interact with their healthcare team. GDm-Health removes bias in patient reporting of blood glucose levels, helping to improve trust. It can potentially decrease unnecessary hospital visits and provide the midwife with more information for clinical decisions.” – Diabetes UK.
Developing app assessment guidelines
The app was one of the first to pass the beta version of the NHS Digital Assessment Questions. This is available as a pilot tool and assess an app against criteria in 7 domains:
- Firstly, clinical safety
- Secondly, security and privacy
- Thirdly, confidentiality (information governance)
- Fourthly, usability and accessibility
- Another being, technical stability
- Following on, change management (updates and version control)
- And lastly, regulatory approval.
Approved apps can then be considered in the revised version of the NHS app library, currently in beta-testing.