The technology

GDm‑Health (Oxford University NHS Foundation Trust and The University of Oxford) comprises 2 parts: a patient-facing mobile app, which is downloaded to the patient's mobile device, and a secure clinician-facing website designed to allow remote blood glucose monitoring.

The mobile app is available for iOS and Android operating systems. The app downloads data from the user's blood glucose meter (through Bluetooth or near-field communication [NFC]). It then automatically sends these blood glucose measurements to the secure website through wifi or a mobile internet connection. The user may also enter notes alongside the measurements, such as explanations of unusually high readings, and these are also sent to the website.

The website displays all collected blood glucose level data for review by healthcare professionals. It highlights any users who need intervention based on their readings, and prioritises those who need midwife review. Clinicians can set up alerts for high or low readings and to identify certain patterns, such as consecutive high readings. The website also allows communication between healthcare professionals and the user through SMS text messages. Different healthcare professionals can communicate with each other by adding notes to the user's online record. Users can also request a callback from a midwife once the data are sent, using a tool in the mobile app.

GDm‑Health has undergone a technical evaluation using the NHS Digital Assessment Questions, a pilot tool currently available to developers in beta form. The tool comprises 7 domains: clinical safety; security and privacy; confidentiality (information governance); usability and accessibility; technical stability; change management (updates and version control); and regulatory approval. NHS Digital has confirmed that GDm‑Health passed this assessment. The completed assessments are not currently published but are available on request.

Table 1 Technology components

Component (first UK launch, version number)

Regulatory status

Cost

GDm‑Health iOS/Android app (for patient users).

(Not yet available across NHS, used in research since 2012 and as pilot in Oxford since 2014, v4.15).

The developer has stated that GDm‑Health does not meet the current eligibility criteria for CE marking as a medical device or for regulation by the Care Quality Commission.

Free to download for patients.

Patients must have a compatible device and internet connection.

GDm‑Health secure website (for healthcare professionals, v4.15).

As above.

Cost incurring to NHS trusts (licensing and phone provision costs).

Novel system benefit

  • Using GDm‑Health allows healthcare professionals to remotely monitor blood glucose levels, and use this information to prioritise users for review.

  • Improved communication using the app could potentially reduce the workload for healthcare professionals and the number of outpatient appointments. This would depend on current local protocols for managing gestational diabetes.

  • Blood glucose and other information are recorded electronically, which allows for efficient data auditing.

Current care pathway

The NICE guideline on diabetes in pregnancy recommends that people with gestational diabetes should have contact with the joint diabetes and antenatal clinic to assess blood glucose control every 1 to 2 weeks throughout pregnancy. Standard clinical practice is paper-based records of patients' blood glucose up to 6 times per day. The readings are reviewed by a healthcare professional and, if needed, medication is adjusted at fortnightly face-to-face check-ups.

Population, setting and intended user

GDm‑Health would be used by pregnant people who monitor their own blood glucose levels. It would be used at home and during usual day-to-day activities.

Results would be monitored by maternity diabetes teams, which may include diabetologists, obstetricians, diabetes specialist nurses, midwives and dieticians, in secondary care settings.

Downloadable videos and information leaflets are available to healthcare professionals and users in how to use GDm‑Health. According to the app developer, healthcare professionals need 30 to 60 minutes of training, whereas users need 10 to 20 minutes of training.

Equality considerations

NICE is committed to promoting equality, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and others. In producing guidance and advice, NICE aims to comply fully with all legal obligations to: promote race and disability equality and equality of opportunity between men and women, eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, marriage and civil partnership, pregnancy and maternity (including women post-delivery), sexual orientation, and religion or belief (these are protected characteristics under the Equality Act 2010).

GDm‑Health is intended for use by people who are pregnant, which is a protected characteristic under the Equality Act 2010. It can only be used by people with an Android or iOS device: the app does not work with other mobile operating systems. GDm‑Health also cannot be downloaded by people with mobile devices which are registered outside the UK.