NCT07006480 · Mayo Clinic
Inpatient Use of Personal Continuous Glucose Monitor (CGM) to Improve Diabetes Mellitus Control
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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.
DEVICE
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.
DEVICE
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 measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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.
Where
- Jacksonville, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations