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

Inpatient Use of Personal Continuous Glucose Monitor (CGM) to Improve Diabetes Mellitus Control

This will try using the real-time data from your personal CGM to guide insulin while you’re hospitalized to reduce high and low blood sugars for adults with diabetes who bring a CGM.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Locations: 1 site (Jacksonville, Florida)
• Trial ID: NCT07006480 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with diabetes using subcutaneous insulin who are admitted to non-ICU medical or surgical wards or the Advanced Care at Home program and who bring a working real-time personal CGM are ideal candidates.

Not a fit: Patients in the ICU, those being treated for diabetic ketoacidosis or hyperosmolar hyperglycemic state, those unable to consent, those not bringing a personal CGM, or those expected to stay under 48 hours are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could reduce dangerous high and low blood sugar events in hospitalized patients and make inpatient insulin management safer and more efficient.

How similar studies have performed: Prior pilot and observational studies of inpatient CGM use have shown promising reductions in hypoglycemia and improved glucose monitoring, but randomized crossover data remain limited.

Eligibility criteria

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 this trial is running

Jacksonville, Florida

• 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

Conditions Diabetes Mellitus