Insulin Pump with Continuous Glucose Monitoring for Type 1 Diabetes

(SUCCEED2 Trial)

No longer recruiting at 7 trial locations

Overseen By Angela Sow

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Diabetes

Must be taking: Insulin

Must not be taking: Glucocorticoids, Hydroxyurea, Pramlintide, others

Disqualifiers: Severe hypoglycemia, Uncontrolled diabetes, DKA, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

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 safety of a new insulin pump and continuous glucose monitor (CGM) combination for young children with type 1 diabetes. By using the MiniMed 780G insulin pump with the DS5 CGM, researchers aim to help children manage their diabetes more effectively at home. The trial seeks children aged 2 to 6 who have had type 1 diabetes for at least three months and have experience with CGM. Participants must be willing to use the system continuously and meet specific insulin and blood sugar requirements. As an unphased trial, this study offers families a unique opportunity to contribute to advancements in diabetes management for young children.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop certain medications. The trial excludes participants using glucocorticoids, hydroxyurea, pramlintide, DPP-4 inhibitors, GLP-1 agonists, metformin, and SGLT2 inhibitors at the time of screening.

What prior data suggests that this insulin pump system is safe for pediatric use?

Research has shown that the MiniMed™ 780G system is generally safe to use. This insulin pump, combined with a continuous glucose monitor (CGM), effectively manages blood sugar levels in both children and adults. One study found that children under 15 achieved better blood sugar control with this system. Another study confirmed its safety, demonstrating good results across different age groups.

The FDA has approved this device for managing diabetes, supporting its safety profile. While some side effects might occur with any medical device, these studies indicate that users generally tolerate the MiniMed™ 780G system well. This suggests it could be a safe option for young children with Type 1 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MiniMed™ 780G system with DS5 CGM because it offers a more integrated approach to managing type 1 diabetes in young children. Unlike traditional insulin pumps and separate glucose monitors, this system combines an insulin pump with continuous glucose monitoring, providing real-time data and automated insulin adjustments. This integration can help maintain more stable blood sugar levels and reduce the burden of constant monitoring for both children and their caregivers.

What evidence suggests that the MiniMed™ 780G System with DS5 CGM is effective for type 1 diabetes in young children?

Research has shown that the MiniMed 780G system, when paired with the DS5 Continuous Glucose Monitor (CGM), effectively manages type 1 diabetes. Studies have found that users of this system maintain their blood sugar levels within the target range for over 70% of the day, achieving a good "Time in Range" (TIR). Additionally, users experienced a significant reduction in their HbA1c levels, a measure of long-term blood sugar control. Importantly, these improvements do not increase the risk of low blood sugar (hypoglycemia). This system has proven effective for both older and younger patients, making it a promising option for diabetes management. Participants in this trial will use the MiniMed 780G system with the DS5 CGM to evaluate its effectiveness in young children with type 1 diabetes. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for young children aged 2-6 who have Type 1 Diabetes. It's designed to see if using the MiniMed™ 780G insulin pump along with DS5 Continuous Glucose Monitoring (CGM) is safe in a home environment.

Inclusion Criteria

I am between 2 and 6 years old.

Is willing to wear the system continuously throughout the study

Parent(s)/guardian(s) is/are literate and able to read the language offered in the pump or pump materials

Exclusion Criteria

Has a history of 1 or more episodes of severe hypoglycemia during the 3 months prior to screening

Has had DKA in the last 3 months prior to screening visit

I have skin issues where a medical device would be placed.

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 DS5 CGM to acclimate to the devices

4 weeks

Study Period

Participants use the MiniMed 780G system with DS5 CGM in a home setting to evaluate safety

130 days

Follow-up

Participants are monitored for safety and effectiveness after the study period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MiniMed™ 780G System with DS5 CGM

Trial Overview

The study tests the safety of combining two diabetes management tools: the MiniMed™ 780G insulin pump and DS5 CGM system, which work together to monitor and adjust blood sugar levels in young kids.

How Is the Trial Designed?

Group I: MiniMed™ 780G system with DS5 Experimental Treatment 1 Intervention

Subjects 2-6 years old with type 1 diabetes wearing the MiniMed™ 780G insulin pump in combination with the DS5 CGM.

MiniMed™ 780G System with DS5 CGM is already approved in United States for the following indications:

Approved in United States as MiniMed 780G System for:

• Management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin

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 640G system's 'suspend before low' feature significantly reduces the occurrence of low (≤70 mg/dL) and high (≥240 mg/dL) sensor glucose readings, indicating its effectiveness in managing blood sugar levels.

Users switching from the MiniMed Paradigm Veo to the MiniMed 640G system experienced fewer extreme glucose excursions and showed faster recovery of glucose levels after automatic insulin resumption, highlighting the system's improved safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Automated Insulin Management Features of the MiniMed&#174; 640G Sensor-Augmented Insulin Pump. Zhong, A., Choudhary, P., McMahon, C., et al.[2022]

The use of a next-generation closed-loop insulin pump (MiniMed 780G) significantly improved the patient's glucose control over 4 months, reducing mean daily glucose levels from 201 mg/dL to 141 mg/dL and lowering HbA1c from 121 mmol/mol to 56 mmol/mol.

The patient experienced a marked increase in time spent within the target glucose range (from 43% to 78%) and a decrease in hyperglycemia (from 52% to 20%), demonstrating the efficacy of the advanced hybrid closed-loop system in managing severe type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced technology for type 1 diabetes care in a deaf-mute patient. Pintaudi, B., Nani, A., Gironi, I., et al.[2022]

The Medtronic Mini-Med Paradigm REAL-Time System, which combines real-time continuous glucose monitoring with insulin pump therapy, showed promising results in improving glycemic control in a study of 20 type 1 diabetes patients over an average of 317 days.

Participants experienced a significant reduction in A1C levels by an average of 1.1%, with over three times more individuals achieving A1C levels below 7% after three months of using the device, highlighting its potential effectiveness in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience with an integrated continuous glucose sensor/insulin pump platform: a feasibility study. Mastrototaro, JJ., Cooper, KW., Soundararajan, G., et al.[2022]

The Medtronic Minimed 780G advanced hybrid closed-loop system significantly improved glycemic control in type 1 diabetes patients over 6 months, with HbA1c levels decreasing from 7.6% to 7.0% and time in range increasing from 69% to 74%.

The study included 50 participants with varying previous treatments, and while both groups showed similar improvements, the SAP-PLGS users were more prone to hypoglycemia, highlighting the system's effectiveness in managing different diabetes profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Medtronic 780G advanced hybrid closed-loop system achieves and maintains good glycaemic control in type 1 diabetes adults despite previous treatment. Quirós, C., Alonso-Carril, N., Rodríguez-Rodríguez, S., et al.[2023]

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]

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™ 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™ 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]

Citations

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ajmc.com

ajmc.com/view/cost-effectiveness-of-the-minimed-780g-system-for-type-1-diabetes

Cost-Effectiveness of the MiniMed 780G System for Type 1 ...

Conclusions: MM780G is likely to be cost-effective vs MDI with isCGM in patients with T1D in the US at a willingness-to-pay threshold of ...

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liebertpub.com

liebertpub.com/doi/10.1089/dia.2024.0586

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This pivotal trial of MiniMed 780G AHCL use by more than 90 adults with insulin-requiring T2D demonstrates clinically significant improvement in HbA1c, %TIR, ...

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pmc.ncbi.nlm.nih.gov/articles/PMC8817690/

Real-World Performance of the MiniMed™ 780G System

Conclusion: Most MiniMed 780G system users achieved TIR >70% and GMI <7%, while minimizing hypoglycemia, in a real-world condition. Keywords: Real-world ...

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medtronicdiabetes.com

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

MiniMed™ 780G Insulin Pump System

The MiniMed™ 780G system is intended for the continuous delivery of basal insulin at selectable rates and the administration of insulin boluses at selectable ...

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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 ...

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liebertpub.com/doi/10.1177/15209156251368928

Safety and Glycemic Outcomes of the MiniMed 780G ...

Conclusions: MM780G use with the Simplera Sync sensor is safe and demonstrated improved glycemic outcomes in both pediatric and adult ...

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The purpose of this study is to evaluate the effectiveness of advanced hybrid- closed loop system, Minimed 780G to glycemic control and safety in children ...