MiniMed 780G System for Type 1 Diabetes

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing Type 1 diabetes by combining the MiniMed 780G insulin pump with a specific insulin called Lyumjev (insulin lispro-aabc). The goal is to assess the safety and effectiveness of this combination for home use. The trial seeks participants who have lived with Type 1 diabetes for at least two years and currently use an insulin pump. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative diabetes management research.

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 prior data suggests that the MiniMed 780G System is safe for use with insulin Lyumjev®?

Research has shown that the MiniMed 780G system is safe and effective for managing blood sugar in people with type 1 diabetes. Studies have found it helps control blood sugar and is easy for both adults and children to use. These studies have not identified any major safety issues.

For the insulin Lyumjev, research also supports its safety. In studies involving people with type 1 diabetes, most participants found it easy to tolerate. Although some experienced severe low blood sugar, such cases were rare. Importantly, there were no serious side effects or deaths, and no participants withdrew from the studies due to side effects.

In summary, research indicates that both the MiniMed 780G system and Lyumjev are safe and generally easy to tolerate, making them promising options for people with type 1 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The MiniMed 780G System using Insulin Lyumjev® is unique because it integrates advanced technology with rapid-acting insulin to manage type 1 diabetes more effectively. Unlike other treatments that rely on traditional insulin delivery, this system uses an automated insulin pump that adjusts insulin levels in real time based on continuous glucose monitoring. Researchers are excited about this because it offers the potential for tighter blood sugar control with less manual intervention, which could improve quality of life for people with diabetes.

What evidence suggests that the MiniMed 780G System utilizing insulin Lyumjev® is effective for Type 1 Diabetes?

Research has shown that the MiniMed 780G system effectively manages type 1 diabetes. Many users maintain healthy blood sugar levels for over 70% of the time without experiencing more low blood sugar episodes.

In this trial, participants will use the MiniMed 780G system with Lyumjev, an insulin that acts faster than regular insulin, helping to control blood sugar spikes after meals. Previous studies have demonstrated that Lyumjev can help people with type 1 diabetes lower their average blood sugar levels, measured by HbA1c, by 0.13 percentage points over six months.

These findings suggest that the MiniMed 780G system with Lyumjev can improve blood sugar control in people with type 1 diabetes. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Lyumjev® lispro-aabc
• MiniMed 780G System

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

Citations

1. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/761109s000lbl.pdf

LYUMJEV (insulin lispro-aabc) - accessdata.fda.gov No overall differences in safety or effectiveness were observed between these elderly patients and younger adult patients.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05262387

A Study of LY900014 (Lyumjev) Versus Insulin Lispro ... This study will be conducted in participants with type 1 diabetes mellitus on continuous subcutaneous insulin infusion (CSII) or pump therapy.

3. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.15307

Ultra rapid lispro (Lyumjev®) shortens time to recovery from ... Ultra rapid lispro (Lyumjev®) shortens time to recovery from hyperglycaemia compared to Humalog® in individuals with type 1 diabetes on ...

4. ema.europa.eu ema.europa.eu/en/medicines/human/EPAR/lyumjev

Lyumjev (previously Liumjev) - European Medicines Agency Over 6 months of treatment, patients with type 1 diabetes experienced a fall of 0.13 percentage points in HbA1c with Lyumjev and 0.05 percentage points with ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38696672/

Multicenter Evaluation of Ultra-Rapid Lispro Insulin with ... Results: The trial included 179 individuals with T1D (age 6-75 years). With URLi, 1.7% (3 participants) had a severe hypoglycemia event over 13 weeks attributed ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05403502

Study Details | NCT05403502 | Safety Evaluation of an ... Prospective, multi-center, single-arm study in adults and children ages 6 to 80 with type 1 diabetes to evaluate the safety of Lyumjev with Control-IQ ...