Mount Sinai School of Medicine
New York, 10029, United States
NCT Number: NCT05746286
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.
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Notify Me21 year–110 year
All sexes
Interventional
Not applicable
New York, 10029, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Current Health Monitoring System
Time frame: 30 days
Number of participants with ER visits or readmissions as assessed by the evaluation of real time-remote monitoring (rt-RM) of blood glucose and vital signs after hospital discharge on unplanned service utilization
Time frame: 30 days or less per patient
Questionnaire or provided summary to evaluate patient and provider satisfaction of the remote monitoring technology.
DexCom, Inc.
Industry
Continuous, Real-time, Remote Monitoring of Vital Signs With Telehealth to Prevent Readmissions for Dysglycemia: Discharge Remote Monitoring System (DIREMOS)
Acronym: DIREMOS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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