Medtronic 780G Insulin Pump for Type 1 Diabetes

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Viral N. Shah
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Medtronic 780G insulin pump to determine if it improves blood sugar control in adults with type 1 diabetes and gastroparesis, a condition where the stomach empties slowly. Researchers aim to assess whether this automated insulin pump manages blood sugar more effectively than usual care, which may involve daily injections or other insulin pumps. Participants will either use the Medtronic 780G system or continue their regular insulin routine for three months. The trial seeks participants who have managed type 1 diabetes for at least a year, have had gastroparesis for two years, and have an HbA1c level of 8.0% or higher. As an unphased trial, this study provides a unique opportunity to explore new treatment options and contribute to advancing diabetes care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using inhaled insulin or any glucose-lowering medications other than insulin. Also, you cannot use steroidal medications for more than 2 weeks continuously during the study.

What prior data suggests that the Medtronic 780G insulin pump is safe for adults with type 1 diabetes and gastroparesis?

Research shows that the Medtronic 780G insulin pump is generally well-tolerated by people with type 1 diabetes. Approved for individuals aged 7 and older, including adults, it has met safety standards for these age groups.

In one study, users of the MiniMed 780G reported better sleep quality, suggesting the system may positively affect overall well-being. No major safety concerns have been identified so far, but following all usage instructions carefully remains important.

Since the trial focuses on the Medtronic 780G, participants can feel confident that the treatment has undergone thorough safety checks. However, discussing any specific concerns with a healthcare provider is always advisable.12345

Why are researchers excited about this trial?

The Medtronic 780G insulin pump is unique because it offers an advanced, automated insulin delivery system for people with Type 1 diabetes. Unlike traditional insulin pumps or multiple daily injections, the 780G includes a smart algorithm that automatically adjusts insulin delivery based on continuous glucose monitoring. This means it can better maintain blood sugar levels within the target range, potentially reducing the risk of highs and lows. Researchers are excited about this treatment because it promises more precise blood sugar control, which can significantly improve the quality of life for individuals managing Type 1 diabetes.

What evidence suggests that the Medtronic 780G insulin pump is effective for type 1 diabetes with gastroparesis?

Research has shown that the Medtronic 780G insulin pump can help people with type 1 diabetes better control their blood sugar. One study found it lowered HbA1c levels by 1.54%, an important measure of long-term blood sugar control. This trial will compare the Medtronic 780G group with a usual care group, where participants will continue either multiple daily injections or other insulin pumps in non-automated mode. The Medtronic 780G system outperforms older models, like the MiniMed 670G, by maintaining blood sugar levels in the target range more often, reducing the risks linked to high blood sugar. Overall, the Medtronic 780G appears promising for managing blood sugar in people with type 1 diabetes.678910

Are You a Good Fit for This Trial?

Adults with type 1 diabetes and gastroparesis, who are currently managing their condition through multiple daily insulin injections or other insulin pumps. Participants must be willing to use the Medtronic 780G system or continue their usual care for three months and attend clinic visits.

Inclusion Criteria

I have had Type 1 Diabetes for over a year and my insulin treatment has been stable for the last 2 months.
HbA1c ≥8.0%
I am 18 years old or older.
See 4 more

Exclusion Criteria

Pregnancy, breast feeding, or wanting to become pregnant
I am under 18 years old.
I am currently using Afrezza, an inhaled insulin.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Randomization

Participants are randomized to either the Medtronic 780G system or usual care

Within 2 weeks from screening
1 visit (in-person)

Treatment

Participants use the Medtronic 780G system or continue with usual care for 12 weeks

12 weeks
3 visits (in-person), 4 visits (phone)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Medtronic 780G

Trial Overview

The trial is testing if the Medtronic 780G automated insulin delivery system can better maintain blood glucose levels in adults with type 1 diabetes and gastroparesis compared to usual care over a period of three months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Medtronic 780G groupExperimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Viral N. Shah

Lead Sponsor

Trials
1
Recruited
120+

Medtronic

Industry Sponsor

Trials
627
Recruited
767,000+
Geoff Martha profile image

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz profile image

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Citations

Studies show promising results for individuals with type 2 ...

Studies show promising results for individuals with type 2 diabetes and young children with type 1 diabetes on MiniMed™ 780G system. Data ...

Real-World Performance of the MiniMed™ 780G System

The current cohort of MiniMed 780G system users showed better outcomes than those reported for real-world MiniMed 670G system users. We speculate that the ...

Three independent studies demonstrate the cost ...

All analyses leveraged data from the peer reviewed ADAPT study,v which found a 1.54% reduction in HbA1c with the MiniMed™ 780G system, compared ...

MiniMed™ 780G Health Economics | Medtronic Diabetes EMEA

Use of the MiniMed™ 780G system can lead to better glycaemic outcomes in people living with type 1 diabetes, leading to reduction in costly diabetes related ...

To Study the Efficacy and Safety of Medtronic 780G Insulin ...

The goal of this clinical trial is to learn if Medtronic 780G automated insulin delivery system improves high blood sugars in adult persons ...

Important Safety Information

Do not use the Simplera Sync™ sensor in the abdomen or other body sites, including the buttocks, due to unknown or different performance that ...

summary of safety and effectiveness data (ssed)

The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring ...

MiniMed™ 780G Insulin Pump

The MiniMed™ 780G system is approved for people with type 1 diabetes age 7 and above (using Instinct sensor, Simplera Sync™, or Guardian™ 4 sensor) and adults ...

Safety, Metabolic and Psychological Outcomes of ...

The MiniMed™ 780G has been associated with an improvement in sleep quality in subjects living with diabetes and their caregivers, along with an ...

Safety Evaluation of MiniMed™ 780G System With DS5 ...

The purpose of this study is to evaluate the safety of the MiniMed 780G insulin pump used in combination with the DS5 CGM in type 1 pediatric subjects (2-6 ...