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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 belowSelect...
You are currently being treated for diabetes with diet, insulin injections or oral medications.
Select...
You have either type 1 or type 2 diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days post discharge from hospital.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post discharge from hospital.
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have either type 1 or type 2 diabetes.You have an infection at the site where the sensor is placed, and it needs to be removed.Patients who have changes in their ability to think clearly or remember things.You are currently being treated for diabetes with diet, insulin injections or oral medications.You cannot scan your continuous glucose monitor (CGM) at least every 8 hours.You have COVID-19.
Research Study Groups:
This trial has the following groups:- Group 1: CGM Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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