100 Participants Needed

Continuous Glucose Monitoring for Type 1 Diabetes

GU
Overseen ByGuillermo Umpierrez, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Emory University
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the Dexcom G7 Continuous Glucose Monitor (CGM) manages blood sugar levels more effectively than the usual finger-prick test for people with Type 1 Diabetes in the hospital. Researchers aim to determine if the CGM can maintain blood sugar within the target range and reduce episodes of low blood sugar. Participants will be divided into two groups: one using the CGM and the other using the standard finger-prick method. This trial suits those with Type 1 Diabetes who have struggled to control their blood sugar levels and are hospitalized for at least three days. As an unphased trial, it offers a unique opportunity to explore innovative diabetes management strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you are treated with insulin therapy. It might be best to discuss your specific medications with the trial coordinators.

What prior data suggests that the Dexcom G7 Continuous Glucose Monitoring is safe for use in Type 1 Diabetes patients?

Research has shown that the Dexcom G7 Continuous Glucose Monitor (CGM) is accurate and safe for people with diabetes. In one study, participants used the Dexcom G7 for over 10 days, and it provided reliable blood sugar readings without major issues. Another study focused on pregnant individuals with diabetes and confirmed the device's safety and accuracy throughout pregnancy.

The device continuously tracks blood sugar levels, helping to reduce the risk of very low or very high blood sugar. Overall, the Dexcom G7 has been well-received, with no significant safety concerns reported, making it a promising option for effective blood sugar management.12345

Why are researchers excited about this trial?

Unlike the standard of care for managing type 1 diabetes, which often involves periodic point-of-care (POC) glucose testing and insulin adjustments, the Dexcom G7 Continuous Glucose Monitor (CGM) offers a real-time, dynamic approach. This wearable device provides continuous glucose readings, allowing for more precise insulin therapy based on detailed glucose trends rather than sporadic checks. Researchers are excited about the Dexcom G7 because it can potentially improve glucose control by identifying glycemic excursions and preventing severe hyperglycemia more effectively. This real-time monitoring could lead to better overall diabetes management and improved patient outcomes.

What evidence suggests that the Dexcom G7 CGM is effective for glycemic control in Type 1 Diabetes?

Studies have shown that the Dexcom G7 Continuous Glucose Monitoring (CGM) system can significantly aid people with Type 1 Diabetes in managing their blood sugar levels. Specifically, users of the Dexcom CGM spend more time with their blood sugar in the healthy range of 70-180 mg/dl. Research also indicates that these users experience fewer instances of both low and high blood sugar. One study found that users reduced their A1C levels, a measure of long-term blood sugar control, by an average of 1%. This trial will compare the Dexcom G7 CGM system with standard glucose monitoring. Evidence suggests that the Dexcom G7 effectively helps people with Type 1 Diabetes maintain better blood sugar control.13467

Who Is on the Research Team?

GU

Guillermo Umpierrez, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for people with poorly controlled Type 1 Diabetes Mellitus. Participants should be hospitalized or recently discharged and need to manage their blood sugar levels. Specific criteria for joining or reasons you can't join are not provided here.

Inclusion Criteria

Expected length of hospital stay > three days at the time of randomization
I have Type 1 Diabetes and am on insulin therapy.
I was diagnosed with Type 1 Diabetes and have high blood sugar or HbA1c over 7%.

Exclusion Criteria

Patients expected to require MRI procedures during hospitalization
Subjects using CGM technology before admission
I am currently admitted to the ICU.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are hospitalized and receive either POC testing or Dexcom G7 CGM for glucose monitoring and insulin therapy adjustment

Up to 10 days
Daily monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dexcom G7
Trial Overview The study compares two ways of monitoring blood sugar: the Dexcom G7 Continuous Glucose Monitoring (CGM) system versus traditional fingerstick tests that measure at specific times (POC). It looks at how well each method keeps blood sugar within a safe range and prevents low blood sugar episodes in the hospital.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Dexcom CGMExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

DexCom, Inc.

Industry Sponsor

Trials
151
Recruited
35,700+
Kevin Sayer profile image

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane profile image

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Published Research Related to This Trial

In a real-world setting, the blinded Dexcom G6 Pro continuous glucose monitor (CGM) demonstrated a mean absolute relative difference (MARD) of 11.0% over a median wear time of 50 hours, indicating reliable accuracy for glucose monitoring in individuals with type 1 diabetes.
The accuracy of the Dexcom G6 Pro improved after the first 12 hours of use, stabilizing at around 10.1% MARD thereafter, which aligns with previous laboratory-based accuracy findings.
Testing the Real-World Accuracy of the Dexcom G6 Pro CGM During the Insulin-Only Bionic Pancreas Pivotal Trial.Marak, MC., Calhoun, P., Damiano, ER., et al.[2023]
In a study involving 11 patients with type 1 diabetes, the Dexcom G5 Mobile (DG5) continuous glucose monitor demonstrated significantly better accuracy than the Eversense (EVS) implantable sensor during controlled clinical conditions, particularly when blood glucose levels were decreasing.
While both devices showed similar accuracy during home monitoring, DG5 had a lower median absolute relative difference (ARD) of 7.91% compared to EVS's 11.4% during glucose excursions in a clinical setting, indicating it may be more reliable for detecting rapid changes in glucose levels.
Comparing the accuracy of transcutaneous sensor and 90-day implantable glucose sensor.Boscari, F., Vettoretti, M., Amato, AML., et al.[2021]
Continuous glucose monitoring (CGM) is becoming a standard tool for managing type 1 diabetes, with advancements that may lead to its integration into closed-loop artificial beta-cell systems.
The review highlights the accuracy and performance of the two currently approved CGM devices, discussing their clinical trial results, limitations, and best practices for use in diabetes care.
Continuous glucose monitoring in type 1 diabetes.Weinzimer, SA., Tamborlane, WV., Chase, HP., et al.[2019]

Citations

Accuracy and Safety of Dexcom G7 Continuous Glucose ...We evaluated the accuracy and safety of a seventh generation (G7) Dexcom continuous glucose monitor (CGM) during 10.5 days of use in adults with diabetes.
CGM for Type 1 Diabetes PatientsDexcom CGM was clinically proven to increase TIR 1,4,5 less frequent hypo- and hyperglycemic events. T1D users at high hypoglycemia risk experienced a 72% ...
Clinical outcomes of a real‐world prospective study using ...This study assessed real-world glycaemic outcomes associated with the use of Dexcom ONE in adults with suboptimally controlled diabetes.
The Dexcom Community Glucose Monitoring Project: 6-Month ...After 6 months of program participation, mean A1C decreased by 2.4 ± 1.9% from baseline to 6-month follow-up (from 9.4 ± 1.7 to 7.1 ± 1.2%, P <0.001).
Clinical Evidence - Dexcom CGM Improves Glucose ControlDexcom CGM use resulted in a significant A1C reduction in patients with T1D on insulin injections. In study participants using Dexcom CGM: Overall: an average 1 ...
New Study Concludes Dexcom G7 is “Accurate and Safe ...The researchers concluded that Dexcom G7 provides accurate readings across all gestational ages in pregnant individuals with T1D, T2D, or GDM.
Study Details | NCT04794478 | Evaluation of the Safety ...The objective of this study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method. Official Title.
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