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
Authors' conclusion
A fully remote study was feasible to set up and conduct in Denmark, with rapid recruitment, high retention, and high compliance with CGM and telemedicine visits. DCTs have the potential to reduce participant burden, improve recruitment, and increase the representativeness of clinical trial populations.
Study context
- Population
- Adults with T2D in Denmark recruited via social media; Continuous glucose monitoring (CGM) devices and activity tracker, data via smartphone apps87% completed
- Participants
- 156 adults
- Outcome
- Proportion consenting via e-signature (weeks −2 to 0); proportion with ≥ 70% unblinded CGM coverage (weeks 2-12); percentage of scheduled telemedicine visits and questionnaires completed (weeks 0-12)
- Follow-up
- 12 weeks
Methodological detailsproof-of-concept, fully decentralized, remote, All visits and support conducted remotely; e-consent
- Proof-of-concept
- Fully decentralized
- Remote
- All visits and support conducted remotely; e-consent
Main finding
As reported in the abstract
- Consented electronically (of 166 invited)
- 100%
- ≥70% unblinded CGM data coverage (among those starting unblinded CGM)
- 95%
- Attended all telemedicine visits
- 97%
- Completed all questionnaires
- 77%
- Completed all scheduled remote interactions
- 72%
Observational data: associations, not effects.
Further findings
Recruitment and retention
- Completed the study
- 87%
- Most study places filled within 2 days of advertisement
Activity tracker adherence
- ≥70% activity tracker coverage (low, owing to technical issues)
- 12%
Satisfaction
- Satisfaction with the study and CGM devices was very high
Safety
Adverse event (AEs) via remote reporting
- Safety monitoring via remote AE reporting revealed no unexpected findings
Original publication
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. Diabetes Technol Ther. Published 17 April 2026. doi:10.
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