NCT06752928

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

A Randomized Controlled Trial Comparing Dexcom Continuous Glucose Monitoring to Point of Care Glucose Testing for the Management of Hospital and Post-Discharge Subjects With Type 1 Diabetes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare inpatient glycemic control by measuring the percentage of time in the range of 70-180 mg/dl and the frequency of hypoglycemia between Dexcom G7 Continuous Glucose Monitoring (CGM) and Point of Care (POC) Blood Glucose Testing in poorly controlled subjects with Type 1 Diabetes Mellitus. The main question it aims to answer is: -Whether there is a difference between POC testing (standard of care) and Real-time CGM in glycemic control and hypoglycemic events during hospitalization:

Detailed description

The CDC reports that 1.6 million U.S. adults (5.7%) have type 1 diabetes (T1D), with hospitalization rates three times higher than the general population, primarily due to diabetes-related complications such as ketoacidosis and cardiovascular disease. A study at Emory University found that hospitalized T1D patients are younger, experience longer stays and more admissions, and face worse glycemic control and higher rates of hypoglycemia compared to type 2 diabetes (T2D) patients. Point-of-care (POC) capillary glucose testing is the standard for monitoring hospitalized diabetes patients, but continuous glucose monitoring (CGM) offers more detailed glycemic profiles. Research, including trials using Dexcom CGM systems, has demonstrated CGM's superior ability to detect hypo- and hyperglycemia, reduce hypoglycemic events, and improve insulin therapy adjustments in T2D patients. However, no randomized controlled studies have evaluated the best glucose monitoring system for hospitalized T1D patients. The proposed study aims to compare POC testing with Dexcom G7 CGM for guiding insulin therapy in hospitalized T1D patients. Researchers hypothesize that CGM will better prevent hypoglycemia and improve glycemic management during hospital stays, addressing a critical gap in evidence regarding glucose control's impact on T1D hospital outcomes.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Dexcom G7 rtCGM	The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7) is a glucose monitoring system that continuously measures glucose in the interstitial fluid. It aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments
DIAGNOSTIC_TEST	Capillary Blood glucose Testing (POC)	POC glucose meters measure whole blood and convert the results to plasma glucose concentrations, which is the standardized form used in clinical practice.

Timeline

• Start date: 2025-05-12
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2024-12-31
• Last updated: 2025-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study