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Continuous Glucose Monitoring System

Continuous Glucose Monitoring for Type 2 Diabetes

N/A
Recruiting
Led By David Klonoff, MD
Research Sponsored by Palo Alto Medical Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Known history of T2D treated with specified oral antidiabetic agents or insulin therapy
Discharged on insulin therapy consisting of specified basal therapy with or without bolus insulin and with or without other diabetes drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial tests if using a CGM system is safe and effective for managing diabetes compared to current methods. Patients wear sensors & come to the study site 4 times & make 2 phone calls over 12 wks. Results will tell if CGM reduces risk of low blood sugar in T2D.

Who is the study for?
This trial is for adults over 18 with Type 2 Diabetes, recently discharged from the hospital on insulin therapy. They should not have used CGM technology before and must be willing to wear a CGM device and perform finger stick tests if required. People with diabetic ketoacidosis, cognitive impairments, or serious liver/kidney disease cannot join.Check my eligibility
What is being tested?
The study compares the effectiveness of FreeStyle Libre Continuous Glucose Monitoring (CGM) systems in managing blood sugar levels after hospital discharge against standard finger stick testing. Participants will use one or two sensors for about three months and attend four visits plus two phone calls.See study design
What are the potential side effects?
Potential side effects may include skin irritation at the sensor's insertion site, inaccurate readings leading to mismanagement of diabetes (either low or high blood sugar), and possible discomfort from wearing the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have type 2 diabetes and am treated with pills or insulin.
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I am on insulin therapy, which may include other diabetes medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy endpoint
Safety Endpoint

Trial Design

2Treatment groups
Active Control
Group I: Point of Care (POC) Self-Monitoring of Blood Glucose (SMBG) testingActive Control2 Interventions
Subjects randomized to Group 2: Point of Care (POC) Self-Monitoring of Blood Glucose (SMBG) testing will wear one FreeStyle Libre Pro CGM sensor without using the mobile application or reader (blinded). These subjects will have the one sensor inserted under their skin but you will not see sugar values on the CGM. Subjects will wear the CGM for 12-14 days three times over a 12-week (3 month) period but will not use the CGM to monitor and control their blood sugar. Instead, they will monitor their sugar values by the standard method of fingerstick before each meal and at bedtime.
Group II: FreeStyle Libre 2Active Control2 Interventions
Subjects randomized to Group 1: FreeStyle Libre 2 will wear two FreeStyle Libre CGM sensors for 12-14 days three times over a 12-week (3 month) period. They will have two sensors inserted under their skin: FreeStyle Libre 2 sensor with display on, meaning they will be able to see their blood sugar values on the mobile application or a reader. FreeStyle Libre Pro sensor is used without mobile application or reader. This sensor is place as a backup in case the information is missing from the Libre 2 sensor.

Find a Location

Who is running the clinical trial?

Palo Alto Medical FoundationLead Sponsor
26 Previous Clinical Trials
14,851 Total Patients Enrolled
Abbott Diabetes CareIndustry Sponsor
63 Previous Clinical Trials
24,669 Total Patients Enrolled
Emory UniversityOTHER
1,640 Previous Clinical Trials
2,560,596 Total Patients Enrolled

Media Library

FreeStyle Libre 2 CGM (Continuous Glucose Monitoring System) Clinical Trial Eligibility Overview. Trial Name: NCT05822232 — N/A
Type 2 Diabetes Research Study Groups: Point of Care (POC) Self-Monitoring of Blood Glucose (SMBG) testing, FreeStyle Libre 2
Type 2 Diabetes Clinical Trial 2023: FreeStyle Libre 2 CGM Highlights & Side Effects. Trial Name: NCT05822232 — N/A
FreeStyle Libre 2 CGM (Continuous Glucose Monitoring System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05822232 — N/A

Frequently Asked Questions

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

What is the current capacity for enrollment in this trial?

"Affirmative. According to records on clinicaltrials.gov, this medical trial is currently seeking participants; the first posting was made on August 17th 2022 and it was last updated April 7th 2023. 100 individuals are required for enrolment from two sites."

Answered by AI

Are there any available opportunities to join this experiment at the present time?

"Affirmative. According to clinicaltrials.gov, the recruitment phase for this trial is still underway. It was first posted on August 17th 2022 and last updated on April 7th 2023; its purpose is to enlist 100 individuals from two research centres."

Answered by AI

Who else is applying?

What site did they apply to?
Palo Alto Medical Foundation Research Institute
Division of Endocrinology, Department of Medicine, Emory University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Nothing has worked for me.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
FreeStyle Libre 2 Discharge Trial
2022. "FreeStyle Libre 2 Discharge Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05822232.
All > Hypoglycemia > Type 2 Diabetes
~0 spots leftby Apr 2024
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