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real-time CGM for Type 2 Diabetes (TIGHT Trial)

N/A
Waitlist Available
Led By Judy Sibayan, MPH, CCRP
Research Sponsored by Jaeb Center for Health Research
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 4-10 days
Awards & highlights

TIGHT Trial Summary

This trial will study whether intensive management of glycemia in people with diabetes, using continuous glucose monitoring technology, is safe and feasible.

TIGHT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-10 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-10 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
Co-: CGM-measured mean glucose (superiority)
Co-: CGM-measured percent time <54 mg/dL (non-inferiority)
Secondary outcome measures
CGM Metrics by daytime only (06:00 AM to 00:00 AM)
CGM Metrics by nighttime only (00:00 AM to 06:00 AM)
Other outcome measures
CGM metrics related to hyperglycemia
CGM metrics related to hypoglycemia
Glucose Variability

TIGHT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intensive Target GroupExperimental Treatment1 Intervention
Intensive therapy with glucose target 90-130 mg/dL with real-time CGM
Group II: Standard Target GroupActive Control1 Intervention
Standard therapy with glucose target 140-180 mg/dL (ADA guidelines) and masked CGM
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
real-time CGM
2014
N/A
~200

Find a Location

Who is running the clinical trial?

DexCom, Inc.Industry Sponsor
137 Previous Clinical Trials
29,681 Total Patients Enrolled
Jaeb Center for Health ResearchLead Sponsor
152 Previous Clinical Trials
34,500 Total Patients Enrolled
Judy Sibayan, MPH, CCRPPrincipal InvestigatorJaeb Center for Health Research

Frequently Asked Questions

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

How many patients are being allowed to participate in this clinical trial?

"That is correct, the online information regarding this clinical trial confirms that it is actively recruiting patients. This specific trial was posted on May 10th, 2020 and was last updated on July 21st, 2020. The goal is to have 120 people participate at 5 different locations."

Answered by AI

Are there multiple hospitals conducting this study in Canada?

"The University of Washington Medical Center, University of Colorado, Anschutz Inpatient Pavilion 1 and 2, and University of North carolina Hospitals are running this trial out of Seattle, Washington, Aurora, Colorado, and Chapel Hill, North Carolina respectively. In addition, there are 5 other locations conducting this study."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Georgia
How old are they?
18 - 65
What site did they apply to?
Emory University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

Difficulty in maintaining target BS’s. I have tried several different medications, currently on Rybelsys . Hoping for something that will keep me level.
PatientReceived no prior treatments
Recent research and studies
Intensive Care MedicineJournal
A Prospective Randomised Multi-centre Controlled Trial on Tight Glucose Control by Intensive Insulin Therapy in Adult Intensive Care Units: The Glucontrol Study
Preiser, Jean-Charles, Philippe Devos, Sergio Ruiz-Santana, Christian Mélot, Djillali Annane, Johan Groeneveld, Gaetano Iapichino, et al.. 2009. “A Prospective Randomised Multi-centre Controlled Trial on Tight Glucose Control by Intensive Insulin Therapy in Adult Intensive Care Units: The Glucontrol Study”. Intensive Care Medicine. Springer Science and Business Media LLC. doi:10.1007/s00134-009-1585-2.
New England Journal of MedicineJournal
The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-term Complications in Insulin-dependent Diabetes Mellitus
“The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-term Complications in Insulin-dependent Diabetes Mellitus”. 1993. “The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-term Complications in Insulin-dependent Diabetes Mellitus”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm199309303291401.
Diabetes CareJournal
Comparison of the Freestyle Libre Pro Flash Continuous Glucose Monitoring (CGM) System and Point-of-care Capillary Glucose Testing in Hospitalized Patients with Type 2 Diabetes Treated with Basal-bolus Insulin Regimen
Galindo, Rodolfo J., Alexandra L. Migdal, Georgia M. Davis, Maria A. Urrutia, Bonnie Albury, Cesar Zambrano, Priyathama Vellanki, et al.. 2020. “Comparison of the Freestyle Libre Pro Flash Continuous Glucose Monitoring (CGM) System and Point-of-care Capillary Glucose Testing in Hospitalized Patients with Type 2 Diabetes Treated with Basal-bolus Insulin Regimen”. Diabetes Care. American Diabetes Association. doi:10.2337/dc19-2073.
Journal of Diabetes Science and TechnologyJournal
Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline
Galindo, Rodolfo J., Guillermo E. Umpierrez, Robert J. Rushakoff, Ananda Basu, Suzanne Lohnes, James H. Nichols, Elias K. Spanakis, et al.. 2020. “Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline”. Journal of Diabetes Science and Technology. SAGE Publications. doi:10.1177/1932296820954163.
~58 spots leftby Apr 2025
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