What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes similar to the MiniMed™ 780G system, which involves automated insulin delivery, include insulin therapy and GLP-1 receptor agonists like exenatide and liraglutide. Known side effects of insulin therapy can include hypoglycemia (low blood sugar), weight gain, and injection site reactions. GLP-1 receptor agonists, such as exenatide and liraglutide, may cause gastrointestinal issues like nausea, vomiting, and diarrhea, as well as a risk of hypoglycemia, especially when used with other glucose-lowering medications. Additionally, there may be concerns about delayed gastric emptying and potential cardiovascular effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 2 Diabetes, including GLP-1 receptor agonists like liraglutide and extended-release exenatide, which help improve glycemic control. Additionally, automated insulin delivery systems, such as the MiniMed™ 780G, are being studied for their effectiveness in managing Type 2 Diabetes by using continuous glucose monitoring to adjust insulin delivery. These systems aim to improve glycemic outcomes and quality of life for patients requiring insulin therapy.

What other types of research exist?

Promising alternatives to the MiniMed™ 780G system for Type 2 Diabetes patients include: 1) Open-source automated insulin delivery (OS-AID) systems, which have shown efficacy and safety in real-world studies. 2) Advanced hybrid closed-loop systems that are currently being tested in underserved populations and during pregnancy. These systems aim to improve glycemic control without increasing hypoglycemia. 3) The ongoing development and potential approval of other artificial pancreas systems funded by the NIH, which are expected to offer enhanced decision support and automated insulin delivery features.

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Insulin Pump

MiniMed™ 780G System for Type 2 Diabetes

N/A

Waitlist Available

Research Sponsored by Medtronic Diabetes

Eligibility Criteria Checklist

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

Must have

Clinical diagnosis of type 2 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis

Willing to take one of the specified insulins and can financially support the use of insulin preparations as required by the study

Must not have

Sickle cell disease, hemoglobinopathy, or received red blood cell transfusion or erythropoietin within 3 months prior to screening

Elective surgery planned that requires general anesthesia during the course of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the MiniMed™ 780G system, which includes an insulin pump and sensors, in adults aged 18-80 with type 2 diabetes who need insulin. The device continuously checks blood sugar levels and automatically adjusts insulin delivery to keep blood sugar stable. The study will last several months and involve up to 575 participants across the United States. The MiniMed™ 780G system is an advanced hybrid closed-loop system that has been previously tested in various populations, including adolescents and adults with type 1 diabetes, showing improvements in blood sugar control.

Who is the study for?

Adults aged 18-80 with type 2 diabetes for at least 2 years, able to use technology and perform blood glucose measurements. They must have stable insulin requirements, an HbA1c less than 10%, access to the internet, and be willing to wear the MiniMed™ 780G system continuously. Exclusions include drug abuse, severe hypoglycemia history, extreme insulin doses, certain medical conditions like adrenal insufficiency or uncontrolled celiac disease.

What is being tested?

The trial is testing the safety and effectiveness of the MiniMed™ 780G Insulin Pump system in managing blood sugar levels in adults with type 2 diabetes over approximately a four-and-a-half-month period in their home environment.

What are the potential side effects?

While specific side effects are not listed for this device-based intervention, potential issues may include skin irritation from adhesive tape used for sensor placement or inaccuracies leading to hypo- or hyperglycemia due 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 been diagnosed with type 2 diabetes for at least 2 years.

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I am willing and able to use and pay for the specified insulin for the study.

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I am between 18 and 80 years old.

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I can make my own medical decisions without needing a legal guardian.

Exclusion Criteria

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

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I have sickle cell, a blood disorder, or received a blood transfusion or erythropoietin recently.

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I am scheduled for surgery that needs general anesthesia during the study.

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I plan to try for a pregnancy during the study.

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My daily medication dose is either below 8 units or above 250 units.

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I am a woman who can have children and am not using birth control.

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I was hospitalized or visited the ER for uncontrolled diabetes in the last 6 months.

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I have been diagnosed with an eating disorder like anorexia or bulimia.

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I am currently using hydroxyurea or plan to use it during the study.

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I have chronic kidney disease with chronic anemia.

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I've had 2 or more severe low blood sugar episodes needing medical help in the last 6 months.

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I am a woman who can have children and my pregnancy test was positive.

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I have been diagnosed with adrenal insufficiency.

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I have celiac disease that has not been treated.

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I am currently being treated for an overactive thyroid.

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I plan to get a red blood cell transfusion or take erythropoietin during the study.

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I am currently on dialysis.

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I tested positive for GAD antibodies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

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

Primary Effectiveness Endpoint - Percent of time in range (TIR 70-180 mg/dL)

Primary Safety Endpoint - Change in HbA1c

Secondary study objectives

Secondary Effectiveness Endpoint - Percent of time in range (TIR 70-180 mg/dL)

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: MiniMed 780G SystemExperimental Treatment1 Intervention

Adult participants with insulin-requiring type 2 diabetes age 18-80 using the MiniMed 780G system for a combined run-in period and study period will be approximately 135 days long.

0 / 21Eligibility 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 lifestyle modifications, oral medications, and insulin therapy. Lifestyle changes such as diet and exercise improve insulin sensitivity and glycemic control. Oral medications like metformin reduce glucose production in the liver, while SGLT2 inhibitors increase glucose excretion through urine. Incretin-based therapies, including GLP-1 receptor agonists and DPP-4 inhibitors, enhance insulin secretion and inhibit glucagon release. The MiniMed™ 780G system represents an advanced treatment involving automated insulin delivery based on continuous glucose monitoring, which helps maintain optimal blood glucose levels with minimal patient intervention. Understanding these mechanisms is crucial for patients as it allows for personalized treatment plans that can effectively manage blood sugar levels and reduce the risk of complications.

Incretin therapies: highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors.A patient-centered approach to managing patients with type 2 diabetes.Assessing the impact of a new delivery method of insulin on glycemic control using a novel trial design.