People in Colombia with Type 1 diabetes (T1DM) have limited options for treatment. Sensor-Augmented Pump (SAP) therapy is funded by the Colombian health service, with Medtronic having the dominant market share. Non-pump users, on multiple daily injections (MDI), can choose between Freestyle LibreTM flash glucose monitoring or capillary blood-glucose testing with a restricted choice of devices: Freestyle LiteTM, OneTouch® or GlucoQuick.
Clinicians only access T1D subject data during the medical consultation, via the manufacturers’ proprietary web-platforms. So they must master multiple user-interfaces and cannot monitor and advise T1D subjects remotely.
An ambulatory non-randomized 12-week, 4-visit pilot study aims to evaluate the potential to leverage Tidepool as a device-independent, cloud-based platform that could be tailored to facilitate data-sharing between Colombian T1D subjects and clinicians. The specific goals are to evaluate glycaemic outcomes and user-experience, as well eliciting user requirements. The study involves two clinicians and eight adults with T1DM: four on MDI and four on SAP therapy. All participants are initially trained to use the Tidepool web-based data-visualisation platform and to communicate via the Tidepool mobile app.
Ethical approval has been granted for execution of the pilot study in 2019. The highly usable Tidepool platform looks like a promising candidate for customisation. Requirements are already emerging, including the obvious one of language.
This pilot study is novel in offering an alternative to the Colombian population with T1DM that is compatible with existing treatment. The next step is to implement the gathered requirements and conduct a larger clinical trial.