What side effects are associated with this type of intervention?

The most common treatments for Type 1 Diabetes, such as automated insulin delivery systems like the MiniMed 780G, which use continuous glucose monitoring (CGM) to adjust insulin delivery, can have several side effects. These include hypoglycemia, which can occur if too much insulin is delivered, and hyperglycemia or diabetic ketoacidosis if the system fails or insulin delivery is interrupted. Users may also experience skin irritation or infection at the infusion site. Additionally, there is a need for extensive training and vigilance to manage these systems effectively. General side effects of insulin therapy include weight gain and, less commonly, allergic reactions.

What prior FDA approvals exist?

The FDA has approved several automated insulin delivery systems for the treatment of Type 1 Diabetes, which integrate continuous glucose monitoring (CGM) with insulin pumps to automate insulin delivery. Notable systems include the MiniMed 670G and 770G, which are predecessors to the MiniMed 780G system. These systems use algorithms to adjust insulin delivery based on real-time glucose readings from the CGM. Additionally, insulin analogs such as insulin aspart (Fiasp) are commonly used in these systems to manage blood glucose levels effectively.

What other types of research exist?

Promising alternatives to the MiniMed 780G system for Type 1 Diabetes patients in 2024 include other artificial pancreas systems currently under development and evaluation by NIH-funded research consortia. These systems aim to improve glycemic outcomes and user experience through advanced closed-loop insulin delivery and decision support technologies.

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Insulin Delivery Device

MiniMed 780G System for Type 1 Diabetes

Q: What is the mechanism of action of this treatment?

The most common treatments for Type 1 Diabetes involve insulin therapy, which replaces the insulin that the body no longer produces. This can be administered through multiple daily injections or via an insulin pump. Automated insulin delivery systems, such as the MiniMed 780G, integrate continuous glucose monitoring (CGM) with an insulin pump to automatically adjust insulin delivery based on real-time glucose levels. This helps maintain blood glucose within a target range, reducing the risk of both hyperglycemia and hypoglycemia. These mechanisms are vital for Type 1 Diabetes patients as they enhance the ability to manage blood glucose levels effectively, thereby improving overall health and quality of life.

N/A

Waitlist Available

Led By Bruce Perkins, MD

Research Sponsored by Medtronic Diabetes

Eligibility Criteria Checklist

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

Must have

2 - 6 years of age: A clinical diagnosis of type 1 diabetes for 6 months or more, as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis

Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units and maximum total daily dose of 250 units or less

Must not have

Has any unresolved adverse skin condition in the area of sensor placement

Is being treated for hyperthyroidism at time of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the MiniMed 780G system, which uses fast-acting Fiasp insulin, in people aged 7-80 with type 1 diabetes. The system automatically adjusts insulin delivery based on continuous blood sugar monitoring to help keep levels stable. The MiniMed 780G system has been shown to improve blood sugar control in people with type 1 diabetes.

Who is the study for?

This trial is for children and adults aged 2-80 with Type 1 Diabetes who have been using a pump therapy for at least 6 months. Participants must not be planning pregnancy, surgeries requiring general anesthesia during the study, or have untreated celiac disease. They should not have used MiniMed 780G before and must agree to use Fiasp insulin provided by the sponsor.

What is being tested?

The MiniMed™ 780G System, an advanced insulin delivery system for Type 1 Diabetes management, is being tested with Fiasp® insulin in a home setting across multiple countries to assess its safety and effectiveness in both adult and pediatric subjects.

What are the potential side effects?

Potential side effects may include skin irritation from sensor adhesive, hypoglycemia (low blood sugar), hyperglycemia (high blood sugar), allergic reactions to Fiasp insulin or infusion set issues related to the pump therapy.

Eligibility Criteria

Inclusion Criteria

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

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I am between 2 and 6 years old and have been diagnosed with type 1 diabetes for at least 6 months.

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I use between 8 and 250 units of insulin daily.

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I am between 2 and 80 years old.

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I have been diagnosed with type 1 diabetes.

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I have been using a pump for my condition for over 6 months.

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I can make my own medical decisions.

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I am willing to use Fiasp insulin provided for the study.

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I am between 7 and 80 years old.

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I can make my own medical decisions.

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I am willing to use Fiasp insulin provided for the study.

Exclusion Criteria

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

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I have skin issues where a medical sensor would be placed.

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I am currently receiving treatment for an overactive thyroid.

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I am currently taking certain medications.

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I have been diagnosed with adrenal insufficiency.

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I have a planned surgery that will need general anesthesia during the study.

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I am currently receiving dialysis.

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I am a woman who could get pregnant and am not using birth control.

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

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I am a woman and plan to become pregnant during the study.

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

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 for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])

Primary Effectiveness Endpoint for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])

Primary Safety Endpoint for Age 18-80 - Change in HbA1c

+1 more

Secondary study objectives

Secondary Effectiveness Endpoint 1 for Age 18-80 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L])

Secondary Effectiveness Endpoint 1 for Age 7-17 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L])

Secondary Effectiveness Endpoint 2 for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])

+1 more

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 System Utilizing Insulin FiaspExperimental Treatment1 Intervention

Subjects with insulin-requiring type 1 diabetes age 7-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MiniMed 780G System

2022

N/A

~490

0 / 20Eligibility 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 1 Diabetes involve insulin therapy, which replaces the insulin that the body no longer produces. This can be administered through multiple daily injections or via an insulin pump. Automated insulin delivery systems, such as the MiniMed 780G, integrate continuous glucose monitoring (CGM) with an insulin pump to automatically adjust insulin delivery based on real-time glucose levels. This helps maintain blood glucose within a target range, reducing the risk of both hyperglycemia and hypoglycemia. These mechanisms are vital for Type 1 Diabetes patients as they enhance the ability to manage blood glucose levels effectively, thereby improving overall health and quality of life.

The road from intermittently scanned continuous glucose monitoring to hybrid closed-loop systems. Part B: results from randomized controlled trials.Technology in the management of type 1 diabetes mellitus - current status and future prospects.