Using your personal continuous glucose monitor in the hospital to improve blood sugar control

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized, unblinded, prospective crossover pilot compares two arms in hospitalized adults with diabetes who use personal real-time CGMs: one arm where CGM data are continuously accessed by the care team and used to guide insulin dosing and one arm receiving standard inpatient glucose care without continuous CGM access. All participants will share their recent 14-day outpatient CGM history with treating providers, sign a hospital CGM use agreement, continue to monitor alarms with their own reader/phone, and supply their own CGM consumables. The study aims to see if continuous access to personal CGM data improves glycemic control and reduces episodes of hypoglycemia and hyperglycemia without negatively affecting patient, nurse, or provider satisfaction or safety. Enrollment is limited to adults admitted to non-ICU wards or the Advanced Care at Home program at Mayo Clinic Florida who are expected to stay more than 48 hours and are already using a real-time CGM on admission.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mayo Clinic in Florida
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Adrian G Dumitrascu, MD — Mayo Clinic
• Study coordinator: Adrian G Dumitrascu, MD
• Email: dumitrascu.adrian@mayo.edu
• Phone: 9049532000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.