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

NCT07006480 | Recruiting FDA Device

• 1 other identifier: 24-009355
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Difference in mean glucose levels between subjects in intervention vs control group

  Difference in mean glucose levels between subjects in intervention vs control group

  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

  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

  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.

  From admission date to discharge date up to 8 weeks.

• Measure subjects perceived satisfaction with CGM inpatient monitoring

  At the time of discharge date assessed up to 8 weeks.

Study Arms (2)

Control

ACTIVE COMPARATOR

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

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

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

Interventions

Real time CGM data monitoring DEVICE

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.

Monitored

Insulin dose adjustment based on glucometer and CGM glucose data trends DEVICE

Insulin dose will be modulate based on glucometer values and previous day glucose trends as recorded on CGM.

Monitored

Share CGM data on admission and on discharge from the hospital DEVICE

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

Control; Monitored

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Adrian G Dumitrascu, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian G Dumitrascu, MD

CONTACT

9049532000; dumitrascu.adrian@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 5, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 14, 2026
• Study Completion (Estimated): June 14, 2026
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)