What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, such as insulin therapy, GLP-1 receptor agonists, and DPP-4 inhibitors, have various side effects. Insulin therapy can cause hypoglycemia, weight gain, and injection site reactions. GLP-1 receptor agonists may lead to gastrointestinal issues like nausea, vomiting, and diarrhea, as well as a risk of pancreatitis. DPP-4 inhibitors are generally well-tolerated but can cause nasopharyngitis, headaches, and a slight risk of pancreatitis. Continuous glucose monitoring helps manage these side effects by providing real-time data and personalized alerts for hyperglycemia and hypoglycemia, allowing for timely adjustments in therapy.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 2 Diabetes that focus on real-time glucose monitoring and personalized alerts. One such device is the Dexcom Continuous Glucose Monitor (CGM), which provides real-time glucose data and personalized alerts for hyperglycemia and hypoglycemia. Additionally, the FDA has approved various GLP-1 receptor agonists like liraglutide and exenatide, which help manage blood glucose levels and have shown cardiovascular benefits. SGLT2 inhibitors such as dapagliflozin have also been approved, offering glucose control and cardiovascular benefits. These treatments, along with CGM technology, provide comprehensive management options for patients with Type 2 Diabetes.

What other types of research exist?

Promising alternatives to the Dexcom CGM for T2D patients include: 1) Abbott's FreeStyle Libre 3, which offers real-time glucose readings and customizable alerts for glucose levels. 2) Medtronic's Guardian Connect system, which provides predictive alerts for hyperglycemia and hypoglycemia and integrates with smartphone apps for data analysis. 3) Eversense CGM by Senseonics, which features an implantable sensor with long-term wear (up to 180 days) and real-time alerts. These devices offer advanced features that can help T2D patients manage their glucose levels effectively.

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Continuous Glucose Monitoring for Type 2 Diabetes

N/A

Waitlist Available

Led By Kathleen Dungan, MD

Research Sponsored by Kathleen Dungan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Type 2 Diabetes

Age ≥18 years

Must not have

Inability to consent

Discharge to skilled nursing facility

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a device that continuously monitors blood sugar levels in hospitalized patients with type 2 diabetes who need insulin. The device sends data to the patient's smartphone and alerts them and their doctor if their blood sugar is too high or too low. This helps in better managing their diabetes after they leave the hospital. The device allows a person with diabetes to see their glucose levels continuously and to receive predictive alerts.

Who is the study for?

This trial is for adults over 18 with Type 2 Diabetes who use more than 10 units of basal insulin daily, have an A1c level above 8.0%, and own a smartphone compatible with the Clarity App. It's not for those in prison, unable to consent, discharged to nursing facilities, pregnant women, or individuals with Type 1 Diabetes.

What is being tested?

The study tests how using the DexCom G6 continuous glucose monitor (CGM) after hospital discharge affects patients' blood sugar control over a period of 12 weeks. Participants will track their glucose levels via a smartphone app and receive personalized targets and alerts.

What are the potential side effects?

While specific side effects are not listed for CGM devices like DexCom G6, users may experience skin irritation at the sensor site or inaccurate readings that could lead to incorrect insulin dosing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Type 2 Diabetes.

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I am 18 years old or older.

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I use more than 10 units of basal insulin daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give consent for medical procedures.

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I am being discharged to a skilled nursing facility.

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I have Type 1 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in DTSQc scores

The proportion of patients with % wear time >70% will be reported.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dexcom CGMExperimental Treatment1 Intervention

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 2 Diabetes include insulin therapy and continuous glucose monitoring (CGM). Insulin therapy lowers blood glucose levels by promoting glucose uptake into cells, thereby reducing hyperglycemia. CGM offers real-time glucose monitoring and personalized alerts for hyperglycemia and hypoglycemia, enabling timely adjustments in insulin dosing and lifestyle changes. This is vital for T2D patients as it helps prevent complications from fluctuating glucose levels, ensuring better overall glucose control and enhancing quality of life.

Efficacy and Safety of Basal Insulin-Based Treatment Versus Twice-Daily Premixed Insulin After Short-Term Intensive Insulin Therapy in Patients with Type 2 Diabetes Mellitus in China: Study Protocol for a Randomized Controlled Trial (BEYOND V).[Management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. (A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes)].An Overview of Hyperinsulinemic-Euglycemic Therapy in Calcium Channel Blocker and β-blocker Overdose.