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Continuous Glucose Monitor
Continuous Glucose Monitoring for Diabetes
N/A
Recruiting
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.
Must not have
Participants taking hydroxyurea.
Actively treated for diabetes ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 days
Awards & highlights
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 belowSelect...
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 enrolled in the Advanced Care at Home program for at least 72 hours.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking hydroxyurea.
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I am currently being treated for a severe diabetes complication.
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I use a continuous glucose monitor for my diabetes management.
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I manage my diabetes with one insulin injection a day.
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I manage my diabetes with pills.
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I have liver cirrhosis.
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I have thoughts of harming myself or have attempted to.
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I am on dialysis for end-stage kidney disease.
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I take more than 4g of acetaminophen daily or more than 1g every 6 hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 40 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 days
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 moreTrial 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.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,255 Previous Clinical Trials
3,835,306 Total Patients Enrolled
23 Trials studying Diabetes
6,750 Patients Enrolled for Diabetes
Adrian Dumitrascu, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
220 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking hydroxyurea.I am currently being treated for a severe diabetes complication.I use a continuous glucose monitor for my diabetes management.I manage my diabetes with one insulin injection a day.I have been diagnosed with diabetes (type 1 or 2).You are already taking part in another study about using continuous glucose monitoring.I use insulin injections or an insulin pump for my diabetes.You have diabetes and only control it with diet.I manage my diabetes with pills.I have liver cirrhosis.I have thoughts of harming myself or have attempted to.You have trouble hearing and can't hear a smartphone alert or alarm.I am able to understand and sign the consent form.You have been diagnosed with dementia.I am enrolled in the Advanced Care at Home program for at least 72 hours.You have changes in your mental abilities or awareness.You are scheduled to have an MRI within 10 days after being admitted to the hospital.I am on dialysis for end-stage kidney disease.I take more than 4g of acetaminophen daily or more than 1g every 6 hours.
Research Study Groups:
This trial has the following groups:- Group 1: Continuous Glucose Monitoring
- Group 2: Control Arm (Standard of Care)
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.
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