Insulin Pump with Continuous Glucose Monitoring for Type 1 Diabetes

(SUCCEED2 Trial)

Recruiting at 7 trial locations

Overseen By Angela Sow

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety of the MiniMed 780G insulin pump used in combination with the DS5 CGM in type 1 pediatric subjects (2-6 years of age) in a home setting.

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 data supports the effectiveness of the MiniMed 780G System with DS5 CGM for treating type 1 diabetes?

The MiniMed 780G System has shown to improve blood sugar control in people with type 1 diabetes by automatically adjusting insulin delivery. Studies found that it helps maintain blood sugar levels within the target range and reduces the time spent with high or low blood sugar, leading to better overall diabetes management and increased satisfaction with treatment. ^{1 2 3 4 5}

Is the MiniMed 780G insulin pump system safe for people with type 1 diabetes?

The MiniMed 780G insulin pump system is considered safe for people with type 1 diabetes, as it effectively manages blood sugar levels without causing severe low blood sugar (hypoglycemia) or diabetic ketoacidosis (a serious diabetes complication). It also improves sleep quality and treatment satisfaction for users and their caregivers. ^{1 2 4 6 7}

What makes the MiniMed 780G System treatment unique for type 1 diabetes?

The MiniMed 780G System is unique because it is an advanced insulin pump that automatically adjusts insulin delivery every 5 minutes based on continuous glucose monitoring, allowing for personalized glucose target settings and reducing the risk of severe low blood sugar events. This system also improves sleep quality and treatment satisfaction, making it more effective than earlier insulin delivery systems. ^{2 4 6 8 9}

Eligibility Criteria

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.

Trial 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 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

Treatment Details

Interventions

• MiniMed™ 780G System with DS5 CGM (Insulin Pump)

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.

Participant Groups

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.

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 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™ 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 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 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 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 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 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]

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]

References

1. Spain 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. [2023]

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. England pubmed.ncbi.nlm.nih.gov

Advanced technology for type 1 diabetes care in a deaf-mute patient. [2022]

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

Clinical experience with an integrated continuous glucose sensor/insulin pump platform: a feasibility study. [2022]

5. 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]

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

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

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

Effectiveness of Automated Insulin Management Features of the MiniMed&#174; 640G Sensor-Augmented Insulin Pump. [2022]

8. 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]

9. 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]