Recruiting

Continuous Glucose Monitoring

Sponsor:

Mayo Clinic

Code:

NCT07006480

Conditions

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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 episodes without negatively affecting patients' satisfaction, providers and your nurses satisfaction with how glucose is monitored and treated in the hospital.

Conditions

Diabetes Mellitus

Study ID

NCT07006480

Start date

Oct 1, 2025

Status verified date

Jul, 2026

Completion date

Feb 9, 2027

Anticipated

Primary completion date

Feb 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients with ages above 18 years old at the time of informed consent.
2. Male or female
3. Admitted to non-ICU setting in brick-and-mortar medical and surgical ward or admitted to Advanced Care at Home Program.
4. Admitted under observation or inpatient status.
5. Expected to remain in the hospital for more than 48 hours.
6. Patients that are using a transcutaneous or implantable real time CGM as outpatient and are bringing it to the hospital.
7. 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.

Exclusion Criteria:

1. Participants unable to provide informed medical consent.
2. Participants admitted to Intensive Care Units (ICU). Enrollment is possible after transferring out of the ICU.
3. Actively being treated for DKA (diabetes ketoacidosis) or HHS (hyperosmolar hyperglycemic state)
4. Patients with a diagnosis of liver cirrhosis.
5. Patients with a diagnosis of ESRD or Acute Renal Failure on hemodialysis or peritoneal dialysis.
6. Patients with planned MRI or surgical procedure. Enrollment is possible after MRI or surgery.
7. Participants with allergy to medical grade adhesive or medical tape.
8. Participants who are pregnant, wanting to become pregnant, or nursing during study period.
9. Participants using Medtronic and Dexcom sensors and taking acetaminophen more than 4g per day or more than 1gm every 6 hours.
10. Participants using Dexcom sensors and taking hydroxyurea.
11. Participants using Libre sensors and taking over 500 mg of ascorbic acid.
12. Patients using Eversense sensors and taking tetracycline type of antibiotics.
13. 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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

patients admitted to the hospital wearing a CGM with data not monitored in real time

experimental: Monitored

patients admitted to the hospital wearing a CGM with data monitored in real time

Interventions

Real time CGM data monitoring

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 trends

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 hospital

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

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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Adrian G Dumitrascu, MD

9049532000dumitrascu.adrian@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Adrian Dumitrascu, MD

904-953-2000dumitrascu.adrian@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-15.