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Device

Continuous Glucose Monitoring for Diabetes

N/A
Waitlist Available
Led By Adrian Dumitrascu, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients treated with diet alone, insulin (SQ, insulin pump) or oral hypoglycemic medications
Patients with Type 1 or 2 Diabetes Mellitus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post discharge from hospital.
Awards & highlights

Study Summary

This trial will test how well CGMs compare to finger-pricking for blood sugar monitoring in non-ICU hospital patients, as well as whether CGMs can prevent hypo- and hyperglycemic episodes.

Who is the study for?
This trial is for adults with Type 1 or 2 Diabetes Mellitus who are hospitalized but not in the ICU. They must have their own Continuous Glucose Monitor (CGM) and be treated with diet, insulin, or oral medications. Excluded are those unable to scan CGMs every 8 hours, hospitalized under 24 hours, with COVID-19, skin infections at CGM site, altered mental status, or unable to consent.Check my eligibility
What is being tested?
The study tests if patients' own CGMs can accurately monitor blood glucose levels compared to standard point-of-care testing in a non-ICU hospital setting. It also examines whether CGM alerts can prevent extreme high and low blood sugar episodes.See study design
What are the potential side effects?
While this trial focuses on device accuracy rather than medication side effects, potential issues may include skin irritation from the CGM adhesive or inaccurate readings leading to mismanagement of diabetes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are currently being treated for diabetes with diet, insulin injections or oral medications.
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You have either type 1 or type 2 diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post discharge from hospital.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post discharge from hospital. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CGM accuracy - mean absolute relative difference (MARD)
Secondary outcome measures
CGM recorded hyperglycemia episodes.
CGM recorded hypoglycemia episodes
Hospitalization length of stay
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CGM PatientsExperimental Treatment1 Intervention
Patients with diabetes mellitus admitted to the hospital and using a CGM will be encouraged to continue to use these devices in inpatient setting. The device alarms of high or low glucose levels will be communicated to the nursing staff.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Glucose Monitor (CGM)
2017
Completed Phase 3
~650

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,757,901 Total Patients Enrolled
22 Trials studying Diabetes
6,803 Patients Enrolled for Diabetes
Adrian Dumitrascu, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
170 Total Patients Enrolled

Media Library

Continuous Glucose Monitor (CGM) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04653454 — N/A
Diabetes Research Study Groups: CGM Patients
Diabetes Clinical Trial 2023: Continuous Glucose Monitor (CGM) Highlights & Side Effects. Trial Name: NCT04653454 — N/A
Continuous Glucose Monitor (CGM) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04653454 — N/A

Frequently Asked Questions

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~36 spots leftby Mar 2025