MiniMed™ 780G System for Type 2 Diabetes

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the MiniMed™ 780G insulin pump system to evaluate its effectiveness and safety for people with type 2 diabetes who need insulin. Participants will use the device at home for approximately 135 days to assess its performance. It suits adults who have had type 2 diabetes for at least two years and currently manage it with regular insulin injections.

As an unphased trial, this study allows participants to contribute to innovative diabetes management research.

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 prior data suggests that the MiniMed™ 780G system is safe for adults with type 2 diabetes?

Research shows that the MiniMed™ 780G system, a smart insulin pump, has been used safely by people with diabetes. It automatically adjusts insulin levels based on continuous glucose monitoring. Studies have found that this system can safely help control blood sugar levels.

However, the safety of the MiniMed™ 780G has not been studied in people with type 2 diabetes until now. Past research with similar groups suggests it could be well-tolerated. This system is already approved for use in other types of diabetes, providing some confidence in its safety.

Like any medical device, some risks might be involved. So far, the MiniMed™ 780G appears to be a safe option for managing insulin. Always discuss any concerns with a healthcare professional before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MiniMed™ 780G System because it offers a novel approach to managing insulin-requiring type 2 diabetes. Unlike traditional methods that rely on manual insulin injections, this system is an advanced insulin pump that automates insulin delivery. It uses smart technology to continuously monitor glucose levels and adjust insulin doses accordingly, potentially leading to more stable blood sugar control. This could mean fewer highs and lows in blood sugar levels, offering users a more convenient and personalized diabetes management experience.

What evidence suggests that the MiniMed™ 780G system is effective for type 2 diabetes?

Research has shown that the MiniMed™ 780G insulin pump, used by participants in this trial, can assist people with type 2 diabetes who require insulin. Studies indicate it can reduce HbA1c levels, a measure of average blood sugar over time, by 0.6%. It also increases "Time in Range" by 9.9%, helping to maintain stable blood sugar levels within a safe range. The MiniMed 780G is considered safe for increasing insulin use without adding extra risks. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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™ 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 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]

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]

Citations

1. news.medtronic.com news.medtronic.com/2025-06-20-Studies-show-promising-results-for-individuals-with-type-2-diabetes-and-young-children-with-type-1-diabetes-on-MiniMed-TM-780G-system

Studies show promising results for individuals with type 2 ... Results showed those using the MiniMed™ 780G system with SmartGuard™ achieved a 0.6% lower HbA1C and 9.9% higher Time in Range when compared to ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39912797/

Safety and Effectiveness of MiniMedTM 780G Advanced ... These findings show that MiniMed 780G AHCL use provides safe insulin intensification in type 2 diabetes and significantly improves mean HbA1c and %TIR.

3. liebertpub.com liebertpub.com/doi/10.1177/15209156251376654

Real-World Effectiveness of the MiniMed™ 780G ... A recent analysis of real-world MM780G system use in people with T1D ≥56 years showed that a TIR >70% was achieved by a majority of the 7415 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05238142

NCT05238142 | In-Home Study With MiniMed™ 780G ... The objective of the study is to assess the safety and effectiveness of MiniMed™ 780G system in adult subjects with insulin-requiring type 2 diabetes in a ...

5. link.springer.com link.springer.com/article/10.1007/s13300-023-01501-6

A Systematic Review | Diabetes Therapy The MiniMed™ 780G has been associated with an improvement in sleep quality in subjects living with diabetes and their caregivers, along with an ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf16/P160017S091B.pdf

summary of safety and effectiveness data (ssed) The MiniMed 780G system includes SmartGuard (SG) technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose ...

7. medtronicdiabetes.com medtronicdiabetes.com/important-safety-information

Important Safety Information The safety of the MiniMed™ 780G system has not been studied in pregnant women, persons with type 2 diabetes, or in persons using other anti- ...

8. medtronicdiabetes.com medtronicdiabetes.com/products/minimed-780g-insulin-pump-system

MiniMed™ 780G Insulin Pump System It is protected against the effects of being underwater to a depth of up to 12 feet (3.6 meters) for up to 24 hours. This is classified as IPX8 rating. See user ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf16/P160017S118b.pdf

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 ...

10. liebertpub.com liebertpub.com/doi/10.1089/dia.2024.0586

Safety and Effectiveness of MiniMed TM 780G Advanced ... These findings show that MiniMed 780G AHCL use provides safe insulin intensification in type 2 diabetes and significantly improves mean HbA1c and %TIR.