MiniMed 780G System for Type 1 Diabetes

Recruiting at 21 trial locations

Overseen By Thomas Troub

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Diabetes

Must be taking: Insulins

Must not be taking: Glucocorticoids, Hydroxyurea, SGLT2 inhibitors, others

Disqualifiers: Hypoglycemia, Uncontrolled diabetes, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

244 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new insulin (Lyumjev®) with an advanced insulin pump (MiniMed™ 780G) in people aged 7-80 with type 1 diabetes. The pump helps control blood sugar by adjusting insulin delivery automatically. The MiniMed™ 780G is a second-generation advanced system designed to improve blood sugar control in people with type 1 diabetes.

Will I have to stop taking my current medications?

The trial requires participants to stop using certain medications like pramlintide, DPP-4 inhibitors, GLP-1 agonists, metformin, and SGLT2 inhibitors. Participants must also be willing to switch to specific insulins during the study.

What data supports the effectiveness of the MiniMed 780G System and Lyumjev for treating type 1 diabetes?

Research shows that the MiniMed 780G system helps people with type 1 diabetes keep their blood sugar levels in a healthy range. Additionally, using ultra-rapid insulin lispro (Lyumjev) with a similar system improved blood sugar control without increasing the risk of low blood sugar. ^{1 2 3 4 5}

Is the MiniMed 780G System with Lyumjev® lispro safe for humans?

Research shows that Lyumjev® lispro, used in the MiniMed 780G System, is generally safe for people with type 1 diabetes. Studies found no severe low blood sugar events or ketoacidosis (a serious diabetes complication) when using this insulin. ^{4 5 6 7 8}

How does the drug Lyumjev differ from other treatments for type 1 diabetes?

Lyumjev (ultra-rapid insulin lispro) is unique because it acts faster than standard insulin lispro, helping to increase the time blood sugar levels stay within the target range without increasing the risk of low blood sugar. This makes it particularly effective when used with advanced insulin delivery systems like the MiniMed 780G, which can automatically adjust insulin delivery to improve blood sugar control. ^{2 3 5 9 10}

Eligibility Criteria

Inclusion Criteria

7-13 years of age: A clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.

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

You are willing to participate in the study.

Exclusion Criteria

Is a member of the research staff involved with the study

Your hematocrit level is lower than the normal range.

You are currently receiving dialysis treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants begin using the MiniMed 780G system with Lyumjev® insulin to acclimate before the main study period

4 weeks

Treatment

Participants use the MiniMed 780G system with Lyumjev® insulin for a period of three months

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Lyumjev® lispro-aabc
• MiniMed 780G System

Participant Groups

Group I: MiniMed 780G System Utilizing Insulin Lyumjev® Experimental Treatment 1 Intervention

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

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

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

The MiniMed 780G hybrid closed loop system effectively improved glycemic control in a young male with type 1 diabetes, indicating its potential as a beneficial treatment option.

This case suggests that advanced diabetes management technologies like the MiniMed 780G can help reduce health complications associated with diabetes, particularly in individuals with unique health profiles such as short stature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of advanced hybrid closed loop system on glycated hemoglobin (HbA1c) in a young male with type 1 diabetes mellitus and growth hormone treatment: A case report. Petrovski, G., Al Khalaf, F., Campbell, J., et al.[2023]

In a study involving 1008 patients, short-acting insulin lispro and regular insulin Humulin R showed similar effectiveness in controlling blood sugar levels and had comparable safety profiles, with no significant differences in hypoglycemia incidents.

After a year of continued lispro therapy, glycosylated hemoglobin (HbA1C) levels returned to baseline, indicating that while lispro was well tolerated in the short term, long-term efficacy may need further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lispro insulin as premeal therapy in type 1 diabetes: comparison with Humulin R. Daniels, AR., Bruce, R., McGregor, L.[2022]

In a phase 3 study involving 507 adults with type 1 diabetes, SAR342434 (SAR-Lis) demonstrated similar efficacy to insulin lispro-Humalog (Ly-Lis) in reducing HbA1c levels, confirming its noninferiority as a treatment option.

Both SAR-Lis and Ly-Lis showed comparable safety profiles, with no significant differences in hypoglycemic events, treatment-emergent adverse events, or immunogenicity over a 12-month period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 1 Diabetes Also Using Insulin Glargine-SORELLA 1 Study. Garg, SK., Wernicke-Panten, K., Rojeski, M., 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 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]

References

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

Fast-Acting Insulin Aspart Versus Insulin Aspart Using a Second-Generation Hybrid Closed-Loop System in Adults With Type 1 Diabetes: A Randomized, Open-Label, Crossover Trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Beneficial effects of automated insulin delivery over one-year follow-up in real life for youths and adults with type 1 diabetes irrespective of patient characteristics. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The effect of advanced hybrid closed loop system on glycated hemoglobin (HbA1c) in a young male with type 1 diabetes mellitus and growth hormone treatment: A case report. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ultra-rapid lispro versus lispro in children and adolescents with type 1 diabetes: The PRONTO-Peds trial. [2023]

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

CamAPS FX Hybrid Closed-Loop with Ultra-Rapid Lispro Compared with Standard Lispro in Adults with Type 1 Diabetes: A Double-Blind, Randomized, Crossover Study. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Lispro insulin as premeal therapy in type 1 diabetes: comparison with Humulin R. [2022]

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

Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 1 Diabetes Also Using Insulin Glargine-SORELLA 1 Study. [2022]

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

Fully Closed-Loop Glucose Control Compared With Insulin Pump Therapy With Continuous Glucose Monitoring in Adults With Type 1 Diabetes and Suboptimal Glycemic Control: A Single-Center, Randomized, Crossover Study. [2023]

9. 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]

10. 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]