What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include insulin therapy, sulfonylureas, GLP-1 receptor agonists, and SGLT2 inhibitors. Insulin therapy can cause hypoglycemia and weight gain. Sulfonylureas, such as glimepiride, also carry a risk of hypoglycemia and weight gain. GLP-1 receptor agonists, like liraglutide, may cause gastrointestinal side effects such as nausea and vomiting, and have a lower risk of hypoglycemia. SGLT2 inhibitors, such as dapagliflozin, can lead to urinary tract infections, genital infections, and dehydration. Continuous glucose monitoring (CGM) and self-monitoring of blood glucose (SMBG) are used to manage these treatments and monitor blood glucose levels effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 2 Diabetes that align with glucose monitoring strategies. Notably, GLP-1 receptor agonists such as liraglutide and exenatide have been approved and are known for their efficacy in glycemic control. Additionally, basal insulins like insulin glargine have been approved and are often used in combination with oral agents like metformin. These treatments are relevant to the glucose monitoring strategies being studied, as they require regular monitoring of blood glucose levels to manage and adjust dosages effectively.

What other types of research exist?

Promising novel alternatives to traditional glucose monitoring strategies for Type 2 Diabetes patients include: 1) Flash Glucose Monitoring (FGM), which provides real-time glucose readings without the need for finger pricks, 2) Smart Insulin Pens, which track insulin doses and provide dosing recommendations, and 3) Mobile Health (mHealth) applications that integrate with wearable devices to offer comprehensive diabetes management, including glucose monitoring, diet tracking, and physical activity monitoring.

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CGM vs. SMBG for Type 2 Diabetes (GluCoCare Trial)

N/A

Waitlist Available

Led By Richard M Bergenstal, MD

Research Sponsored by HealthPartners Institute

Eligibility Criteria Checklist

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

Must have

Diagnosis of type 2 diabetes

Insulin use with or without other classes of glycemia medication use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two ways of checking blood sugar in people with type 2 diabetes who use insulin. One method involves pricking the finger, and the other uses a sensor that continuously monitors blood sugar. The study will see which method is better at managing blood sugar over time.

Who is the study for?

This trial is for adults aged 18-75 with Type 2 Diabetes, using insulin and possibly other medications, who have an A1C level between 7.5% to 12%. Participants should be receiving care within the HealthPartners Care Group, not planning to move or become pregnant in the next year, and able to follow study procedures for a year.

What is being tested?

The trial compares two glucose monitoring methods: Self-Monitoring Blood Glucose (SMBG) versus Continuous Glucose Monitoring (CGM). It's conducted in primary care clinics over a year to see which method works better in regular healthcare settings.

What are the potential side effects?

While this study focuses on monitoring rather than medication side effects, participants may experience discomfort from frequent blood glucose testing or wearing CGM devices.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with type 2 diabetes.

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I use insulin for my diabetes, with or without other diabetes medications.

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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months 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 A1C

Change in Diabetes Distress

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CGM (continuous glucose monitoring)Experimental Treatment1 Intervention

Use CGM, with availability of Ambulatory Glucose Profile (AGP) data, to monitor and manage glucose over 12 months, in individuals with type 2 diabetes on insulin with or without other glycemic therapies. Glucose management over the 12 months study period will be in primary care, using "usual care" resources.

Group II: SMBG (Self-monitoring of blood glucose)Active Control1 Intervention

Use SMBG, as currently used in primary care, to monitor and manage glucose over 12 months, in individuals with type 2 diabetes on insulin with or without other glycemic therapies. Glucose management over the 12 months study period will be in primary care, using "usual care" resources.

0 / 3Eligibility 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

The most common treatments for Type 2 Diabetes include metformin, which decreases hepatic glucose production and increases insulin sensitivity; sulfonylureas, which stimulate insulin secretion from pancreatic beta cells; and SGLT2 inhibitors, which reduce glucose reabsorption in the kidneys, leading to increased glucose excretion. GLP-1 receptor agonists enhance insulin secretion, inhibit glucagon release, and slow gastric emptying. These mechanisms are crucial for Type 2 Diabetes patients as they help maintain blood glucose levels within a target range, reducing the risk of complications. Effective glucose monitoring, whether through SMBG or CGM, allows patients and healthcare providers to tailor these treatments to individual needs, optimizing glycemic control and improving overall health outcomes.

What next after basal insulin? Treatment intensification with lixisenatide in Asian patients with type 2 diabetes mellitus.A patient-centered approach to managing patients with type 2 diabetes.Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals.