Diabetes MellitusNCT07006480
Inpatient Use of Personal Continuous Glucose Monitor (CGM) to Improve Diabetes Mellitus Control
A study testing Real time CGM data monitoring, Insulin dose adjustment based on glucometer and CGM glucose data trends and Share CGM data on admission and on discharge from the hospital in people with Diabetes Mellitus, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to prove that data generated by your real-time personal continuous glucose monitors CGMs brought in the hospital at the time of hospitalization can be monitored and safely used to guide insulin therapy aiming to improve glycemic control and to diminish the hypoglycemia and hyperglycemia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Real time CGM data monitoring, Insulin dose adjustment based on glucometer and CGM glucose data trends and Share CGM data on admission and on discharge from the hospital
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 9 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ages above 18 years old at the time of informed consent.
- Male or female
- Admitted to non-ICU setting in brick-and-mortar medical and surgical ward or admitted to Advanced Care at Home Program.
- Admitted under observation or inpatient status.
- Expected to remain in the hospital for more than 48 hours.
- Patients that are using a transcutaneous or implantable real time CGM as outpatient and are bringing it to the hospital.
- Patients with diagnosis of diabetes mellitus or hyperglycemia requiring treatment with SQ insulin in the hospital either with multiple daily injections or subcutaneous infusion of insulin via insulin pump.
Who cannot join
- Participants unable to provide informed medical consent.
- Participants admitted to Intensive Care Units (ICU). Enrollment is possible after transferring out of the ICU.
- Actively being treated for DKA (diabetes ketoacidosis) or HHS (hyperosmolar hyperglycemic state)
- Patients with a diagnosis of liver cirrhosis.
- Patients with a diagnosis of ESRD or Acute Renal Failure on hemodialysis or peritoneal dialysis.
- Patients with planned MRI or surgical procedure. Enrollment is possible after MRI or surgery.
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- Participants with allergy to medical grade adhesive or medical tape.
- Participants who are pregnant, wanting to become pregnant, or nursing during study period.
- Participants using Medtronic and Dexcom sensors and taking acetaminophen more than 4g per day or more than 1gm every 6 hours.
- Participants using Dexcom sensors and taking hydroxyurea.
- Participants using Libre sensors and taking over 500 mg of ascorbic acid.
- Patients using Eversense sensors and taking tetracycline type of antibiotics.
- Participants actively enrolled in other studies addressing their CGM use unless express permission is obtained from prior study research team principal investigator or co-principal investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Adrian Dumitrascu, MD, 904-953-2000, dumitrascu.adrian@mayo.edu
About this study
The purpose of this research is to prove that data generated by your real-time personal continuous glucose monitors CGMs brought in the hospital at the time of hospitalization can be monitored and safely used to guide insulin therapy aiming to improve glycemic control and to diminish the hypoglycemia and hyperglycemia episodes without negatively affecting patients' satisfaction, providers and your nurses satisfaction with how glucose is monitored and treated in the hospital.
Read the detailed description
This study will be a single center, randomized, unblinded, prospective, crossover, 2 arm, pilot study. The study will compare the glucose control in hospitalized patients with diabetes mellitus on insulin therapy and wearing a personal CGM when the CGM data will be continuously accessed versus glucose control for hospitalized patients not having the CGM data continuously accessed and receiving inpatient standard of care for diabetes mellitus.
Population:
Adult patients with diagnosis of diabetes mellitus, receiving subcutaneous insulin therapy in the hospital or in the home hospital program - Advanced Care at Home Program (ACH) and wearing a personal real time CGM at the time of admission.
Eligible subjects will be identified and will be approached for enrollment in person by the research coordinators. After enrollment they will be randomized in 2 arms: intervention and control arms.
Both intervention and control arm subjects:
- Will have their 14-day outpatient CGM data obtained and presented to DM treating providers.
- Will sign a Hospital CGM Use Agreement per hospital protocol.
- Will agree to share CGM device data with Mayo Clinic Research Team and will accept the invitation to share this data.
- Will continue to monitor their CGMs with their personal reader/phone and inform the nursing staff of any alarms.
- Will be responsible for providing their own CGM supplies during hospitalization and inserting the new CGM sensor either after a sensor is removed or at the end of sensor life if this occurs before discharge from the hospital.
- Will be responsible for keeping their reader/phone connected to cellular network and charged in order to retrieve information from CGM and transmit it to CGM manufacturer servers.
- Will have their CGM sensors removed per manufacturer recommendations prior to MRI or surgery that involves diathermy.
- Will have glucose checked with POC glucometer before meals and at bedtime or q4 hours while receiving subcutaneous insulin or every hour while receiving intravenous insulin as ordered by primary team.
- If re-hospitalized after the initial hospitalization, they will be enrolled in the opposite study arm and will continue with intervention.
Control Arm subjects:
- Will continue with current hospital standard of care for IP glucose monitoring and insulin adjustment via POC glucometers.
- Will have their aggregated CGM data for the hospitalization downloaded and analyzed after their discharge from the hospital.
Intervention Arm subjects:
- Will continue to use POC glucometer checks prior to meals per hospital orders.
- Will send a link for active follow of RT-CGM data with hospitalist treatment team and DM inpatient APPs.
- Their aggregated CGM reading per day will be reviewed daily by the HIM treating team or DM inpatient APPs and adjustments to insulin therapy will be made with the aim of diminishing future hypoglycemia and hyperglycemia events. Immediate insulin dosing adjustments will be made also by using POC glucometer readings.
- During working hours (8am to 5pm) if a low or an impending low glucose alert will be received by the devices followed by Endocrinology APPs, ACH or HIM providers, patient RN will be notified to follow the hospital hypoglycemia treatment and prevention protocol (see attached). High glucose alerts will be used by Endocrinology APPs, ACH or HIM providers to make adjustments to insulin regimen.
- On the monitoring devices present with Endocrinology APPs and HIM providers alerts will be set at 90 mg/dl for hypoglycemia and at 350 mg/dl for hyperglycemia. This will allow time for preventative actions to avoid hypoglycemia or severe hyperglycemia.
- Prior to any treatment using medication to address CGM values of hypoglycemia and hyperglycemia, blood glucose confirmation with a POC glucometer will be made and it will be recorded in electronic medical record.
- Conditions
- Diabetes Mellitus
- Being tested
- Real time CGM data monitoring, Insulin dose adjustment based on glucometer and CGM glucose data trends, Share CGM data on admission and on discharge from the hospital
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real time CGM data monitoringDevice
CGM data will be monitored in real time during daytime in the hospital. Alerts about high and low glucose levels will be communicated to patient's nurse and treating providers.
Insulin dose adjustment based on glucometer and CGM glucose data trendsDevice
Insulin dose will be modulate based on glucometer values and previous day glucose trends as recorded on CGM.
Share CGM data on admission and on discharge from the hospitalDevice
Record 14 days' worth of CGM data prior to admission and all CGM data recorded during the hospitalization at the time of discharge from the hospital
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | patients admitted to the hospital wearing a CGM with data not monitored in real time Receives: Device: Share CGM data on admission and on discharge from the hospital |
| Monitored | Experimental | patients admitted to the hospital wearing a CGM with data monitored in real time Receives: Device: Real time CGM data monitoring; Device: Insulin dose adjustment based on glucometer and CGM glucose data trends; Device: Share CGM data on admission and on discharge from the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean glucose levels between subjects in intervention vs control group
Difference in mean glucose levels between subjects in intervention vs control group
Measured: From admission date to discharge date up to 8 weeks.
Difference in Time in Range (time spent with CGM values between 70-180 mg/dl) between subjects in intervention and control cohorts
Difference in Time in Range (time spent with CGM values between 70-180 mg/dl) between subjects in intervention and control cohorts
Measured: From admission date to discharge date up to 8 weeks.
Secondary outcomes (3)
Difference in Time Below Range <54 mg/dl and Time Below Range <70 mg/dl between subjects in intervention and control cohorts
Difference in Time Below Range <54 mg/dl and Time Below Range <70 mg/dl between subjects in intervention and control cohorts
Measured: From admission date to discharge date up to 8 weeks.
Difference in Time Above Rance >180 mg/dl and Time Above Rance >250 mg/dl between subjects in intervention and control cohorts.
Difference in Time Above Rance >180 mg/dl and Time Above Rance >250 mg/dl between subjects in intervention and control cohorts.
Measured: From admission date to discharge date up to 8 weeks.
Measure subjects perceived satisfaction with CGM inpatient monitoring
Percentage of subjects satisfied or very satisfied with inpatient CGM monitoring
Measured: At the time of discharge date assessed up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Oct 2025
- Primary completion9 Feb 2027 (estimated)
- Study completion9 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian G. Dumitrascu, Mayo Clinic
- Investigators
- Adrian G Dumitrascu, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006480
- Sponsor's protocol ID
- 24-009355
- Status last verified
- Jul 2026
- First submitted
- 19 May 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inpatient Use of Personal Continuous Glucose Monitor (CGM) to Improve Diabetes Mellitus Control
- ClinicalTrials.gov ID
- NCT07006480
- Acronym / sponsor ID
- 24-009355
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 9 Feb 2027 (estimated)
- Study completion
- 9 Feb 2027 (estimated)
- First posted
- 5 Jun 2025 (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.
The purpose of this research is to prove that data generated by your real-time personal continuous glucose monitors CGMs brought in the hospital at the time of hospitalization can be monitored and safely used to guide insulin therapy aiming to improve glycemic control and to diminish the hypoglycemia and hyperglycemia episodes without negatively affecting patients' satisfaction, providers and your nurses satisfaction with how glucose is monitored and treated in the hospital.
Detailed description
This study will be a single center, randomized, unblinded, prospective, crossover, 2 arm, pilot study. The study will compare the glucose control in hospitalized patients with diabetes mellitus on insulin therapy and wearing a personal CGM when the CGM data will be continuously accessed versus glucose control for hospitalized patients not having the CGM data continuously accessed and receiving inpatient standard of care for diabetes mellitus.
Population:
Adult patients with diagnosis of diabetes mellitus, receiving subcutaneous insulin therapy in the hospital or in the home hospital program - Advanced Care at Home Program (ACH) and wearing a personal real time CGM at the time of admission.
Eligible subjects will be identified and will be approached for enrollment in person by the research coordinators. After enrollment they will be randomized in 2 arms: intervention and control arms.
Both intervention and control arm subjects:
- Will have their 14-day outpatient CGM data obtained and presented to DM treating providers.
- Will sign a Hospital CGM Use Agreement per hospital protocol.
- Will agree to share CGM device data with Mayo Clinic Research Team and will accept the invitation to share this data.
- Will continue to monitor their CGMs with their personal reader/phone and inform the nursing staff of any alarms.
- Will be responsible for providing their own CGM supplies during hospitalization and inserting the new CGM sensor either after a sensor is removed or at the end of sensor life if this occurs before discharge from the hospital.
- Will be responsible for keeping their reader/phone connected to cellular network and charged in order to retrieve information from CGM and transmit it to CGM manufacturer servers.
- Will have their CGM sensors removed per manufacturer recommendations prior to MRI or surgery that involves diathermy.
- Will have glucose checked with POC glucometer before meals and at bedtime or q4 hours while receiving subcutaneous insulin or every hour while receiving intravenous insulin as ordered by primary team.
- If re-hospitalized after the initial hospitalization, they will be enrolled in the opposite study arm and will continue with intervention.
Control Arm subjects:
- Will continue with current hospital standard of care for IP glucose monitoring and insulin adjustment via POC glucometers.
- Will have their aggregated CGM data for the hospitalization downloaded and analyzed after their discharge from the hospital.
Intervention Arm subjects:
- Will continue to use POC glucometer checks prior to meals per hospital orders.
- Will send a link for active follow of RT-CGM data with hospitalist treatment team and DM inpatient APPs.
- Their aggregated CGM reading per day will be reviewed daily by the HIM treating team or DM inpatient APPs and adjustments to insulin therapy will be made with the aim of diminishing future hypoglycemia and hyperglycemia events. Immediate insulin dosing adjustments will be made also by using POC glucometer readings.
- During working hours (8am to 5pm) if a low or an impending low glucose alert will be received by the devices followed by Endocrinology APPs, ACH or HIM providers, patient RN will be notified to follow the hospital hypoglycemia treatment and prevention protocol (see attached). High glucose alerts will be used by Endocrinology APPs, ACH or HIM providers to make adjustments to insulin regimen.
- On the monitoring devices present with Endocrinology APPs and HIM providers alerts will be set at 90 mg/dl for hypoglycemia and at 350 mg/dl for hyperglycemia. This will allow time for preventative actions to avoid hypoglycemia or severe hyperglycemia.
- Prior to any treatment using medication to address CGM values of hypoglycemia and hyperglycemia, blood glucose confirmation with a POC glucometer will be made and it will be recorded in electronic medical record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Share CGM data on admission and on discharge from the hospitalpatients admitted to the hospital wearing a CGM with data not monitored in real time |
| Monitored | Experimental | Device: Real time CGM data monitoring, Device: Insulin dose adjustment based on glucometer and CGM glucose data trends, Device: Share CGM data on admission and on discharge from the hospitalpatients admitted to the hospital wearing a CGM with data monitored in real time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with ages above 18 years old at the time of informed consent.
- Male or female
- Admitted to non-ICU setting in brick-and-mortar medical and surgical ward or admitted to Advanced Care at Home Program.
- Admitted under observation or inpatient status.
- Expected to remain in the hospital for more than 48 hours.
Key exclusion criteria (13 listed)
- Participants unable to provide informed medical consent.
- Participants admitted to Intensive Care Units (ICU). Enrollment is possible after transferring out of the ICU.
- Actively being treated for DKA (diabetes ketoacidosis) or HHS (hyperosmolar hyperglycemic state)
- Patients with a diagnosis of liver cirrhosis.
- Patients with a diagnosis of ESRD or Acute Renal Failure on hemodialysis or peritoneal dialysis.
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 |
|---|---|---|
| Real time CGM data monitoringCGM data will be monitored in real time during daytime in the hospital. Alerts about high and low glucose levels will be communicated to patient's nurse and treating providers. | Device | Monitored |
| Insulin dose adjustment based on glucometer and CGM glucose data trendsInsulin dose will be modulate based on glucometer values and previous day glucose trends as recorded on CGM. | Device | Monitored |
| Share CGM data on admission and on discharge from the hospitalRecord 14 days' worth of CGM data prior to admission and all CGM data recorded during the hospitalization at the time of discharge from the hospital | Device | Control, Monitored |
Primary outcome
Difference in mean glucose levels between subjects in intervention vs control group
Time frame: From admission date to discharge date up to 8 weeks.
Difference in mean glucose levels between subjects in intervention vs control group
Difference in Time in Range (time spent with CGM values between 70-180 mg/dl) between subjects in intervention and control cohorts
Time frame: From admission date to discharge date up to 8 weeks.
Difference in Time in Range (time spent with CGM values between 70-180 mg/dl) between subjects in intervention and control cohorts
3 secondary outcomes
Difference in Time Below Range <54 mg/dl and Time Below Range <70 mg/dl between subjects in intervention and control cohorts
Time frame: From admission date to discharge date up to 8 weeks.
Difference in Time Above Rance >180 mg/dl and Time Above Rance >250 mg/dl between subjects in intervention and control cohorts.
Time frame: From admission date to discharge date up to 8 weeks.
Measure subjects perceived satisfaction with CGM inpatient monitoring
Time frame: At the time of discharge date assessed up to 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Adrian G Dumitrascu, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real time CGM data monitoring, Insulin dose adjustment based on glucometer and CGM glucose data trends and Share CGM data on admission and on discharge from the hospital in people with Diabetes Mellitus, run by Mayo Clinic 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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 15 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrian G Dumitrascu, MD (9049532000, dumitrascu.adrian@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean glucose levels between subjects in intervention vs control group (time frame: From admission date to discharge date up to 8 weeks.). 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 15 Jul 2026.