NCT05746286

Remote Monitoring of Vital Signs With Telehealth to Prevent Readmissions for Dysglycemia

Continuous, Real-time, Remote Monitoring of Vital Signs With Telehealth to Prevent Readmissions for Dysglycemia: Discharge Remote Monitoring System (DIREMOS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: DexCom, Inc. · Industry
• Sex: All
• Age: 21 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

Patients who have experienced dysglycemia in hospital (either from diabetes, post-solid organ transplantation, medication titration, or other causes) may struggle to manage their blood glucose when discharged home. This may lead to ER visits or readmissions that could have been prevented if glucose variations were detected before reaching extremes, and the variations were contextualized with other vital sign parameters. Remote monitoring via Dexcom G6 and Current Health (vital signs) used concomitantly after discharged for the purpose of remote monitoring will be evaluated with respect to ER visits and readmissions while considering the impact and usability of the potential integrated system on the healthcare staff.

Detailed description

This is a single-site, open label, non-randomized, pilot and feasibility study. Participants will include post-hospitalized patients who experienced inpatient dysglycemia that required management from the endocrine service (including those newly diagnosed with T1 or T2 diabetes solid organ transplantation, COPD, post respiratory infections (i.e. COVID-19), chemo patients. Approximately 40 participants will be enrolled and assigned to receive the study intervention of real time-remote monitoring (rt-RM) using the Dexcom and Current Health integrated solution. Potential participants will be identified via the EMR by the Endocrine Team and consented prior to enrollment, 2-48 hours prior to discharge. The study team will issue them Current Health and Dexcom CGM kits and provide the necessary training. Once discharged, the patients will be monitored by the endocrine team via routine "dashboard rounds" during working hours (8AM-5PM). Outside of dashboard rounds, management will be by exception, based on platform alarms directed to the endocrinology service. Alarms will be triaged and actioned according to pre-agreed protocols, including escalation to the appropriate specialists (endocrinologist, transplant surgeon, oncologist, pneumonologist, infectious disease specialist etc.). Participants will remain enrolled in the trial until either of the two endpoints: ER visits/ readmission or 30 days post discharge.

Conditions

• Dysglycemia

Interventions

Type	Name	Description
DEVICE	Dexcom G6 CGM	Once discharged, the patients will be monitored by the endocrine team via routine "dashboard rounds" during working hours (8AM-5PM). Outside of dashboard rounds, management will be by exception, based on platform alarms directed to the endocrinology service.

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-11-29
• Completion: 2024-06-24
• First posted: 2023-02-27
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study