Personalized Postprandial Glucose Response-Targeting Diet Versus Mediterranean Diet for Glycemic Control in Prediabetes

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.

Effects of personalized diets by prediction of glycemic responses on glycemic control and metabolic health in newly diagnosed T2DM: a randomized dietary intervention pilot trial — Rein et al., BMC medicine · source ↗

• dct
• multimodal
• cgm
• rpm
• microbiome
• digital-biomarker
• interstitial-fluid

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.

Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 2 Diabetes in the Setting of a Clinical Trial — Ali et al., Journal of diabetes science and technology (paywalled) · source ↗

• dct
• actigraphy
• wearable
• multimodal
• cgm
• rpm
• self-collection
• digital-biomarker
• interstitial-fluid

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.

Operational and Clinical Insights from a Fully Decentralized Clinical Study Evaluating Protocol Adherence, Participant Satisfaction, and Connected Device Data in Individuals with Type 2 Diabetes on Different Treatment Regimens — Nørgaard et al., Diabetes technology & therapeutics (paywalled) · source ↗

• dct
• actigraphy
• wearable
• multimodal
• cgm
• rpm
• interstitial-fluid

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.

Advancing Early Clinical Trials: The Transformative Potential of Decentralized Designs and Digital Technologies in Phase 1 Clinical Trial — Malhotra et al., Clinical pharmacology and therapeutics · source ↗

• blood
• capillary
• self-collection
• venous-agreement
• dct
• wearable
• rpm
• digital-biomarker
• multimodal

This review assesses wearable sensors for the continuous biochemical monitoring of body fluids such as sweat, saliva and interstitial fluid, confirming their potential for decentralised healthcare through pilot trials. It emphasises that successful clinical translation depends on large-scale validation and the integration of ethical and sociocultural considerations.

Applied body-fluid analysis by wearable devices — Brasier et al., Nature (paywalled) · source ↗

• wearable
• multimodal
• sweat
• rpm
• digital-biomarker
• interstitial-fluid
• validation
• saliva