DysglycemiaDIREMOSNCT05746286
Remote Monitoring of Vital Signs With Telehealth to Prevent Readmissions for Dysglycemia
A study testing Dexcom G6 CGM in people with Dysglycemia, run by DexCom, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 110 years
- Conditions the study is for
- Dysglycemia
- What is being tested?
- Dexcom G6 CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 24 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: Continuous, Real-time, Remote Monitoring of Vital Signs With Telehealth to Prevent Readmissions for Dysglycemia: Discharge Remote Monitoring System (DIREMOS)
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.
Read the 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
- Being tested
- Dexcom G6 CGM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G6 CGMDevice
Also called Current Health Monitoring System
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Dexcom G6 CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Pilot study satisfaction survey
Questionnaire or provided summary to evaluate patient and provider satisfaction of the remote monitoring technology.
Measured: 30 days or less per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Feb 2023
- Primary completion29 Nov 2023
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746286
- Sponsor's protocol ID
- PTL-1000045
- Acronym
- DIREMOS
- Status last verified
- Nov 2025
- First submitted
- 7 Feb 2023
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous, Real-time, Remote Monitoring of Vital Signs With Telehealth to Prevent Readmissions for Dysglycemia: Discharge Remote Monitoring System (DIREMOS)
- ClinicalTrials.gov ID
- NCT05746286
- Acronym / sponsor ID
- DIREMOS / PTL-1000045
- Conditions
- Dysglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Criteria Met | Other | Device: Dexcom G6 CGMParticipants will be provided continuous vitals and glucose monitors at hospital discharge for their treating physician to have access to the data to review |
Who may qualify
- Ages
- 21 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults ≥21 years old
- Treated for dysglycemia while in the acute (inpatient) period
- With or without diabetes including patients with the following:
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexcom G6 CGMAlso: Current Health Monitoring SystemOnce 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. | Device | Study Criteria Met |
Primary outcome
Reduce amount of ER readmission in first 30 days after discharge
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
Pilot study satisfaction survey
Time frame: 30 days or less per patient
Questionnaire or provided summary to evaluate patient and provider satisfaction of the remote monitoring technology.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Dysglycemia
Not yet recruitingObservational study
Perioperative Use of Continuous Glucose Monitoring for Scheduled Cesarean Deliveries (PERUSE)
Dysglycemia
Active, not recruiting
Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Dysglycemia
Enrolling by invitation
Pilot Study of Continuous Glucose Monitoring for Postpartum Glucose Screening
Gestational Diabetes
Not yet recruitingPhase 2
Verapamil Effect in Cystic Fibrosis-related Dysglycemia
Cystic Fibrosis Related Diabetes, Cystic Fibrosis (CF)
Not yet recruitingPhase 2
Platform Trial in Stage 1 Diabetes: Comparing Golimumab vs Placebo
Type 1 Diabetes (T1D)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom G6 CGM in people with Dysglycemia, run by DexCom, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce amount of ER readmission in first 30 days after discharge (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.