Actively Recruiting
A Randomized Controlled Trial Comparing Dexcom Continuous Glucose Monitoring to Point of Care Glucose Testing for Hospital and Post-Discharge Management of Type 1 Diabetes
Led by Emory University · Updated on 2025-10-08
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
D
DexCom, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare two methods of glucose monitoring for hospitalized adults with poorly controlled Type 1 Diabetes Mellitus. It evaluates whether the Dexcom G7 Continuous Glucose Monitoring (CGM) system offers better control of blood sugar levels and reduces low blood sugar episodes compared to the standard Point of Care (POC) Blood Glucose Testing. The study addresses a significant gap in understanding the best glucose monitoring method for hospitalized patients with this condition. Participants will be randomly assigned to one of two groups. One group will receive standard care with POC glucose testing before meals and at bedtime, with insulin adjusted based on these readings, while wearing a blinded CGM device that does not display data during hospitalization for up to 10 days. The other group will wear the Dexcom G7 real-time CGM device for up to 10 days, with insulin therapy adjusted using detailed CGM data including average glucose levels and hypoglycemic episodes. Both groups start after severe hyperglycemia resolves. Throughout the study, researchers will monitor blood sugar control and track hypoglycemic events up to 10 days or until the hospital stay ends. They will assess various outcomes such as time spent in target glucose range, blood sugar variability, and hospital complications. Data collection involves glucose readings uploaded to medical records, with insulin adjustments guided by either POC or CGM results. The study includes follow-up during hospitalization and post-discharge periods.
CONDITIONS
Brief Title
A Study Comparing Dexcom Continuous Glucose Monitoring to Point of Care Glucose Testing for the Management of Hospital and Post-Discharge Subjects With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Known history of Type 1 Diabetes treated with insulin therapy (including rapid-acting, intermediate-acting, or long-acting formulations)
- Admission diagnosis of Type 1 Diabetes with poorly controlled blood glucose (greater than 180 mg/dl) or HbA1c over 7%, including diabetic ketoacidosis or hyperglycemic hyperosmolar state
- Expected hospital stay longer than three days at time of randomization
You will not qualify if you...
- Patients admitted to the intensive care unit (ICU)
- Use of continuous glucose monitoring technology before admission
- Diagnosis of type 2 diabetes
- Treatment with systemic immunosuppressive agents
- Presence of cystic fibrosis
- Prisoners
- Patients expected to need MRI procedures during hospitalization
- Female subjects who are pregnant or breastfeeding at enrollment
- Unwillingness to wear a continuous glucose monitoring device
- Clinically relevant liver disease (such as liver cirrhosis and portal hypertension) or end-stage kidney disease (eGFR below 30 ml/min), or terminal illness
- History of cognitive impairment, dementia, or mental condition preventing understanding of the study's nature and consequences
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 days or length of hospital stay
Participants are assigned to either continuous glucose monitoring with the Dexcom G7 device or point-of-care capillary blood glucose testing to guide insulin therapy during hospitalization for up to 10 days.
Daily glucose monitoring during hospital stay
Duration - Through study completion (Day 10 or length of admission)
Participants continue to be monitored for glucose control and related outcomes through the end of their hospital admission up to Day 10.
Ongoing assessments during hospitalization
Trial Site Locations
Total: 1 location
1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Actively Recruiting
Research Team
G
Guillermo Umpierrez, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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