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

NCT05746286 | Completed FDA Device

• 1 other identifier: PTL-1000045
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysglycemia

Outcome Measures

Primary Outcomes (2)

• Reduce amount of ER readmission in first 30 days after discharge

  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

  30 days

• Pilot study satisfaction survey

  Questionnaire or provided summary to evaluate patient and provider satisfaction of the remote monitoring technology.

  30 days or less per patient

Study Arms (1)

Study Criteria Met

OTHER

Participants will be provided continuous vitals and glucose monitors at hospital discharge for their treating physician to have access to the data to review

Device: Dexcom G6 CGM

Interventions

Dexcom G6 CGM DEVICE

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.

Also known as: Current Health Monitoring System

Study Criteria Met

Eligibility Criteria

• Age: 21 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥21 years old
• Treated for dysglycemia while in the acute (inpatient) period
• With or without diabetes including patients with the following:
• newly diagnosed T2D or T1D (LADA or other late onset)
• post solid organ transplant
• receiving or had received chemotherapy
• COPD
• Respiratory infections
• Fit for discharge home in the opinion of the primary treating clinical team
• Able to ambulate, or complete activities of daily living appropriate to their social care setting either on their own or with support

You may not qualify if:

• Acute delirium or any other psychiatric condition that will not allow the person to participate
• Current bleeding disorder
• Lack of appropriate sites for CGM sensor or Current Health placement (sites must be free of large scars, skin irritation, surgical wounds, dressings, burns, anasarca, heavy tattooing etc.)
• Any skin condition that prevents the use of CGM with adhesive
• Known current pregnancy, breast feeding, or plan to become pregnant in the next 30 days
• Unwilling to remove study devices prior to planned MRI and/or CT scan and reapply and wear after procedure(s) has completed.
• Persistent atrial fibrillation
• No access to home internet, cellular service or mobile telephone
• Unwilling to use a study provided commercially available smartphone. The smartphones will be modified so they are only capable of hosting and running the study applications required for data collection. The modified smartphones will not be able to execute standard smartphone functionality such as internet browsing, texting, or making phone calls. Bluetooth functionality will remain intact as it is required for the approved applications to collect data.
• Any other condition that, based on Investigator's judgment, would render the patient unsuitable to take part in the study

Sponsors & Collaborators

• DexCom, Inc.: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 27, 2023
• Study Start: February 1, 2023
• Primary Completion: November 29, 2023
• Study Completion: June 24, 2024
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (1)