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Continuous Glucose Monitor

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 with previous diagnosis of DM type 1 or type 2.
Patients taking subcutaneous (SQ) insulin either via multidose injections or SQ insulin pump.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 days
Awards & highlights

Study Summary

This trial tests if CGM and diabetes education can help people with diabetes better control their glucose levels than standard care.

Who is the study for?
This trial is for adults with Type 1 or Type 2 diabetes using insulin and admitted to the Mayo Clinic's Advanced Care at Home Program. They must be able to consent, stay in the program for at least 72 hours, and handle a smartphone. It excludes pregnant/nursing individuals, those allergic to medical adhesives, with dementia or altered mental status, on dialysis, using other CGMs or certain medications.Check my eligibility
What is being tested?
The study tests if a Continuous Glucose Monitor (Dexcom G6 PRO) combined with diabetes education improves blood sugar control compared to standard glucose meter checks and education in home care patients.See study design
What are the potential side effects?
Potential side effects may include skin irritation from the adhesive used by the CGM device. There could also be inaccuracies in readings due to interference from other medications like acetaminophen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with diabetes (type 1 or 2).
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I use insulin injections or an insulin pump for my diabetes.
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I am able to understand and sign the consent form.
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I am enrolled in the Advanced Care at Home program for at least 72 hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean daily glucose
Time in Range
Secondary outcome measures
Frequency of hypoglycemia episodes
Mean absolute relative difference (MARD) variation with Arterial blood pressure
Mean absolute relative difference (MARD) variation with Daily hemoglobin.
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Continuous Glucose MonitoringExperimental Treatment1 Intervention
Subjects admitted to the Advanced Care at Home program (home hospital) will have the continuous glucose monitor sensor placed for up to 10 days to monitor and dose insulin.
Group II: Control Arm (Standard of Care)Active Control1 Intervention
Subjects admitted to the Advanced Care at Home program (home hospital) will continue with standard of care glucose monitoring (capillary glucose levels checked via glucometer), insulin dosing, and DM treatment during the 10 day period.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,191 Previous Clinical Trials
3,758,275 Total Patients Enrolled
22 Trials studying Diabetes
6,803 Patients Enrolled for Diabetes
Adrian Dumitrascu, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
220 Total Patients Enrolled

Media Library

Dexcom G6 PRO (Continuous Glucose Monitor) Clinical Trial Eligibility Overview. Trial Name: NCT05880810 — N/A
Diabetes Research Study Groups: Continuous Glucose Monitoring, Control Arm (Standard of Care)
Diabetes Clinical Trial 2023: Dexcom G6 PRO Highlights & Side Effects. Trial Name: NCT05880810 — N/A
Dexcom G6 PRO (Continuous Glucose Monitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05880810 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research currently seeking participants?

"Unfortunately, information on clinicaltrials.gov suggests that the original posting of this study dated back to August 1st 2023 and the last update was 16th May 2023, meaning recruitment is no longer in progress. Nonetheless there are 1165 other trials currently looking for participants around the world."

Answered by AI

What goals does this clinical experiment seek to accomplish?

"This 10 day trial aims to identify daily mean glucose levels. Secondary objectives of the experiment include monitoring changes in oxygen saturation (measured as a percentage), hemoglobin count (measured in g/dl) and glomerular filtration rate (gfr, measured in ml/min)."

Answered by AI
~67 spots leftby Dec 2024