2023 · Journal of diabetes science and technology · paywalled
Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 2 Diabetes in the Setting of a Clinical Trial
Ali et al.
The finding, in our words
Decentralised monitoring of people with type 2 diabetes using continuous glucose monitoring and a hybrid smartwatch was feasible, with high participant retention and successful collection of glucose, heart rate, activity, sleep and GPS data via a study app.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
A fully remote decentralised clinical trial in Danish adults with type 2 diabetes demonstrated operational feasibility with rapid recruitment, high retention (87 percent), and excellent adherence to continuous glucose monitoring (95 percent achieving ≥70 percent data coverage) and telemedicine visits (97 percent). Activity tracker adherence was poor (12 percent) due to technical issues, but remote safety monitoring was effective with no unexpected adverse events, supporting the viability of remote diabetes management.
In a Phase 1 crossover study of etrasimod, self-collected blood microsamples yielded pharmacokinetic exposures comparable to conventional venous sampling, both with and without participant practice sessions. Continuous wearable sensors concurrently enabled real-time remote monitoring of safety vital signs and electrocardiograms, demonstrating the viability of hybrid decentralised designs in early-phase clinical trials.
In a crossover trial of 23 adults with newly diagnosed type 2 diabetes, a personalised diet based on predicted postprandial glucose responses improved continuous glucose monitoring measures significantly more than a Mediterranean diet, including lower average postprandial glucose response and less time in hyperglycaemia. A six-month follow-up of the personalised diet further improved glycaemic control and metabolic health, supporting its clinical utility for decentralised diabetes management.
A six-month randomised trial in 225 adults with prediabetes showed that a personalised postprandial-targeting diet, guided by a machine-learning algorithm integrating microbiome data, reduced daily time with glucose above 140 mg/dL and HbA1c significantly more than a Mediterranean diet, with benefits persisting at 12 months. The study illustrates how continuous glucose monitoring and smartphone-based dietary logging can enable patient-centric, decentralised nutritional interventions for glycaemic control.
This study found that a decentralised approach using home-based sleep apnoea screening, heart rhythm monitoring and activity tracking in patients with atrial fibrillation is feasible, with high data completeness and low drop-out rates. The results support the use of patient-centric digital tools in decentralised trials for chronic cardiac conditions.