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Continuous Glucose Monitoring
Dexcom CGM for Type 2 Diabetes in Long-term Care
N/A
Waitlist Available
Led By Guillermo Umpierrez
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during hospitalization (up to 60 days of admission)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a device that continuously monitors blood sugar levels and sends alerts if they get too low. It aims to help older adults with type 2 diabetes in care facilities manage their blood sugar better. The device provides real-time data to healthcare providers, allowing for more effective treatment adjustments.
Eligible Conditions
- Type 2 Diabetes
- Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during hospitalization (up to 60 days of admission)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during hospitalization (up to 60 days of admission)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Experiencing Clinically Significant Hypoglycemia (BG<54 mg/dL)
Number of Participants Experiencing Hypoglycemia (BG<70 mg/dL)
Time in Range (TIR) Between 70-180 mg/dL
Secondary study objectives
Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE)
Number of Events of Hyperglycemia > 180 mg/dL
Number of Events of Hyperglycemia > 240 mg/dL
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Dexcom CGM with Glucose Telemetry System (CGM-GTS)Experimental Treatment1 Intervention
Patients in the intervention CGM study arm will have a single daily fasting POC testing and will wear a real-time Dexcom G6 with GTS, and providers will adjust oral or insulin therapy based on CGM-GTS profile information.
Group II: POC testing with Blinded CGM (Standard of Care)Active Control1 Intervention
Patients in the standard of care study arm will wear a blinded CGM and receive POC testing before meals and bedtime, with providers adjusting oral agents or insulin dose based on POC results.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexcom G6 CGM with GTS
2021
N/A
~100
Find a Location
Who is running the clinical trial?
DexCom, Inc.Industry Sponsor
144 Previous Clinical Trials
35,385 Total Patients Enrolled
Emory UniversityLead Sponsor
1,696 Previous Clinical Trials
2,603,641 Total Patients Enrolled
Guillermo UmpierrezPrincipal Investigator - Emory University
Emergency Care of Atlanta Inc, Grady Memorial Hospital
University De Guayaquil (Medical School)
Emory University Hospital (Residency)
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have liver disease, are taking corticosteroids, have end-stage kidney disease requiring dialysis, or have severe swelling in your limbs.
Research Study Groups:
This trial has the following groups:- Group 1: POC testing with Blinded CGM (Standard of Care)
- Group 2: Dexcom CGM with Glucose Telemetry System (CGM-GTS)
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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