Continuous Glucose monitoring for Type 2 Diabetes in Pregnancy: a Feasibility Study

In the CGM unmasked group, participants are able to visualise glucose levels in real time using either a cell-phone app, or a receiver device (supplied by the study) when wearing the CGM. All participants are required to wear a Dexcom One+ continuous glucose monitor (CGM), for 20 days, whilst continuing to undertake routine self-testing of capillary glucose levels throughout the study period. Application of the device (both groups) Each participant will be expected to apply two CGM over the course of the study (a third CGM may be required in the instance where there are sensor issues with one of the earlier CGM that require an early change over after <8 days of use). The first CGM application will be applied by the patient under the supervision of a research midwife/assistant, Subsequent CGM placement will be by the participant. If a participant desires assistance with application, they can contact a study investigator for advice via the phone. Usual activities whilst wearing the device (both groups) Whilst wearing the CGM, participants will go about their usual activities. There is no restriction on activities (eg swimming, bathing, exercising can be done normally). Antenatal care whilst in the study (both groups) Participants continue their usual schedule of antenatal care and appointments. At 34-36 weeks, this is expected (but not mandated) that this will include fortnightly followup with their usual antenatal care provider, and 4-7xs daily self testing blood glucose levels, sending these via email or text to their diabetes in pregnancy midwife. Study contact (both groups) There is only one in-person study encounter which takes place on the day of randomisation. At this encounter information is provided about placing the CGM and using the CGM (unmasked group only), and data is collected about baseline demographics, clinical features and diabetes distress. The CGM is placed under supervision of the research team. Participants are then contacted by telephone 24-48 hrs after CGM placement, and again at day 11 and day 21. At these contacts the research assistant enquires as to if there have been any issues with device use, and/or removal/replacement (day 11, 21). Where a replacement CGM has been required earlier, the participant will be contacted 24-48 hrs after replacement. Viewing of CGM results (unmasked group only) Participants in the unmasked group have the ability of viewing their glucose levels in real time either via a receiver provided by the research team, or their smart phone using the Dexcom Clarity app. The app allows visualisation of glucose levels in real time, and provides summary statistics on glucose metrics. Use of the app or viewing results via receiver is optional. We will enquire at the exit interview as to whether participants used the app or receiver, but no formal measurement of frequency or duration of app usage or adherence will be used. Whilst CGM data from the unmasked arm will be available for participants to view and share with their clinicians, clinical decisions will be based off self-testing results, and therefore randomisation is not anticipated to influence clinical outcomes.