MiniMed™ 780G System for Type 2 Diabetes

Recruiting at 30 trial locations

Overseen By Bruce Bode, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Diabetes

Must be taking: Insulin analogs

Must not be taking: Glucocorticoids, Hydroxyurea

Disqualifiers: Severe hypoglycemia, Uncontrolled diabetes, DKA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

574 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on a stable insulin regimen and cannot take certain medications like glucocorticoids or hydroxyurea during the study.

What data supports the effectiveness of the MiniMed™ 780G Insulin Pump system for treating type 2 diabetes?

The MiniMed™ 780G Insulin Pump system has shown promising results in people with type 1 diabetes, helping them maintain better blood sugar levels and reducing severe low blood sugar episodes. It also improves sleep quality and treatment satisfaction, which may suggest potential benefits for people with type 2 diabetes as well. ^{1 2 3 4 5}

Is the MiniMed™ 780G System safe for use in humans?

The MiniMed™ 780G System has been shown to be safe in people with type 1 diabetes, with studies indicating it helps prevent severe low blood sugar and diabetic ketoacidosis (a serious diabetes complication). It also improves sleep quality and treatment satisfaction, with no major safety concerns reported. ^{1 2 4 5 6}

How does the MiniMed™ 780G Insulin Pump system differ from other treatments for type 2 diabetes?

The MiniMed™ 780G Insulin Pump system is unique because it is an advanced automated insulin delivery system that can automatically adjust insulin delivery every 5 minutes and allows users to set personalized glucose targets. This system is designed to improve both metabolic control and psychological well-being, offering a more tailored and responsive approach compared to traditional insulin therapy. ^{1 2 4 5 6}

Eligibility Criteria

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.

Inclusion Criteria

I have been on a specific insulin regimen or pump therapy for at least 3 months.

I have been diagnosed with type 2 diabetes for at least 2 years.

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

Exclusion Criteria

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

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

I plan to try for a pregnancy during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in Period

Participants use the MiniMed™ 780G Insulin pump with Guardian 4 sensor to acclimate to the system

Approximately 4 weeks

Study Period

Participants continue using the MiniMed™ 780G system to assess safety and effectiveness

3 months

Follow-up

Participants are monitored for safety and effectiveness after the study period

4 weeks

Optional Continued Access

Participants may continue using the MiniMed™ 780G system beyond the study period

Treatment Details

Interventions

• MiniMed™ 780G Insulin Pump system

Trial Overview 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.

Participant Groups

Group I: MiniMed 780G System Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Medtronic Diabetes

Lead Sponsor

Trials

73

Recruited

11,800+

Geoff Martha

Medtronic Diabetes

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Kweli Thompson

Medtronic Diabetes

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

The MiniMed™ 780 G, an advanced hybrid closed-loop insulin delivery system, has shown promising results in improving metabolic goals for people with Type 1 Diabetes (T1D), particularly in reducing HbA1c levels and increasing time in range (TIR).

Initial trials indicate that the MiniMed™ 780 G is safe, with low rates of diabetic ketoacidosis and severe hypoglycemia, but further real-world data and long-term studies are necessary to confirm its effectiveness and ease of use in daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MiniMedTM780G Insulin pump system with smartphone connectivity for the treatment of type 1 diabetes: overview of its safety and efficacy. McVean, J., Miller, J.[2021]

The MiniMed™ 780G automated insulin delivery system is safe for children and young adults with type 1 diabetes, showing low rates of severe hypoglycemia and diabetic ketoacidosis, while effectively lowering glycated hemoglobin levels to around 7% and maintaining glucose levels within target ranges.

This second-generation system not only improves metabolic control but also enhances psychological well-being, leading to better sleep quality and treatment satisfaction for both patients and caregivers, indicating a holistic benefit in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Metabolic and Psychological Outcomes of Medtronic MiniMed 780G™ in Children, Adolescents and Young Adults: A Systematic Review. Passanisi, S., Lombardo, F., Mameli, C., et al.[2023]

In a study of 21 children with Type 1 Diabetes Mellitus (T1DM) using the MiniMed 640G-SmartGuard® system for an average of 5 months, there was a significant reduction in hypoglycemia frequency from 10.4% to 7.6%, indicating improved safety in glucose management.

The use of the 640G-SG system did not significantly alter metabolic control, as measured by HbA1c and mean blood glucose levels, and no cases of diabetic ketoacidosis or severe hypoglycemia were reported, demonstrating its efficacy in maintaining stable glucose levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of MiniMed 640G with SmartGuard® System for prevention of hypoglycemia in pediatric patients with type 1 diabetes mellitus. Villafuerte Quispe, B., Martín Frías, M., Roldán Martín, MB., et al.[2022]

The MiniMed 640G insulin pump system effectively prevented hypoglycemia in type 1 diabetes patients, with 83.1% of predictive suspensions avoiding the preset low glucose limit, based on a study of 40 subjects over 4 weeks.

User acceptance was high, as participants felt confident in the system's ability to protect them from low blood sugar, indicating that the automatic suspension feature is both effective and well-received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglycemia Prevention and User Acceptance of an Insulin Pump System with Predictive Low Glucose Management. Choudhary, P., Olsen, BS., Conget, I., et al.[2022]

The MiniMed™ 780G advanced hybrid closed loop (AHCL) system effectively maintained glycemic control in 42 type 1 diabetes patients during Ramadan fasting, achieving an impressive 82.0% time in the target glucose range without increasing hypoglycemic events.

The study showed that the system allowed for safe fasting with minimal user intervention, as there were no severe hypoglycemic or diabetic ketoacidosis events reported, highlighting its safety and efficacy for managing diabetes during fasting periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycemic control during Ramadan fasting in adolescents and young adults with type 1 diabetes on MiniMed™ 780G advanced hybrid closed‑loop system: A randomized controlled trial. Elbarbary, NS., Ismail, EAR.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

MiniMedTM780G Insulin pump system with smartphone connectivity for the treatment of type 1 diabetes: overview of its safety and efficacy. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Safety, Metabolic and Psychological Outcomes of Medtronic MiniMed 780G™ in Children, Adolescents and Young Adults: A Systematic Review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Patient Perception and Satisfaction With Insulin Pump System: Pilot User Experience Survey. [2020]

4. Spain pubmed.ncbi.nlm.nih.gov

Effectiveness of MiniMed 640G with SmartGuard® System for prevention of hypoglycemia in pediatric patients with type 1 diabetes mellitus. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Hypoglycemia Prevention and User Acceptance of an Insulin Pump System with Predictive Low Glucose Management. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Glycemic control during Ramadan fasting in adolescents and young adults with type 1 diabetes on MiniMed™ 780G advanced hybrid closed‑loop system: A randomized controlled trial. [2022]