Hybrid Closed Loop System for Type 1 Diabetes

No longer recruiting at 38 trial locations

Overseen By Athena Philis-Tsimikas, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Diabetes

Must be taking: Insulin

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

Disqualifiers: Pregnancy, Hyperthyroidism, Drug abuse, 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 safety and effectiveness of a new insulin pump system for home use by people with type 1 diabetes. The study compares the new Hybrid Closed Loop system, which automatically adjusts insulin levels, with current treatments like multiple daily injections or insulin pumps. Specifically, the trial involves the 670G and 770G Insulin Pump. Individuals with type 1 diabetes for at least three months who are on insulin therapy might be suitable candidates. Participants must be willing to use the new system most of the time, regularly check their blood sugar, and frequently upload data. As an unphased trial, this study offers a unique opportunity to contribute to diabetes research and potentially benefit from innovative technology.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors, sulfonylureas, and hydroxyurea. If you are taking any of these, you will need to stop before participating.

What prior data suggests that the Hybrid Closed Loop system is safe for type 1 diabetes patients?

Research has shown that the MiniMed 670G and 770G insulin pumps are safe for people with type 1 diabetes. Studies have found that these pumps effectively control blood sugar levels in both children and adults. The pumps use SmartGuard™ technology to manage diabetes by delivering insulin when needed.

Users of the 670G system reported improved blood sugar levels without increased problems or side effects, indicating good tolerance and acceptance. The pumps have also received breakthrough device status, highlighting their significant benefits over current treatments. Overall, evidence suggests these insulin pumps are effective and well-tolerated for managing diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Hybrid Closed Loop System for Type 1 Diabetes because it offers a new level of automation in insulin delivery. Unlike traditional methods like Continuous Subcutaneous Insulin Infusion (CSII) or Multiple Daily Injections (MDI), the 670G and 770G insulin pumps use advanced algorithms to automatically adjust insulin delivery based on real-time glucose readings. This system, known as Auto Mode, aims to maintain more stable blood glucose levels with less manual intervention. By potentially reducing the burden of constant monitoring and adjustments, these pumps could significantly improve quality of life for people with Type 1 Diabetes.

What evidence suggests that the Hybrid Closed Loop system is effective for type 1 diabetes?

Research has shown that the Hybrid Closed Loop system, which includes the 670G and 770G insulin pumps, effectively manages type 1 diabetes. In this trial, participants in the Hybrid Closed Loop Arm will use the MiniMed System (i.e., using Auto Mode) for 6 months. Data from over 3,000 users in the U.S. revealed that these pumps improved the time users spent with their blood sugar levels in the target range, increasing from 66% to even higher levels. Another study found that the MiniMed 670G pump helped users maintain their blood sugar levels within the desired range. Additionally, a study with young children using the 670G system at home reported no cases of severe low blood sugar or diabetic ketoacidosis, a serious diabetes complication. These findings suggest that these insulin pumps can help better control blood sugar levels in people with type 1 diabetes. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people aged 2-80 with type 1 diabetes, regardless of their previous treatment method. Participants must be willing to do daily blood glucose checks, use the study's insulin and meter system, have internet access for data uploads, and wear the system consistently. It excludes those with certain medical conditions or treatments that could interfere with the study.

Inclusion Criteria

I am between 2 and 21 years old and have the support needed to participate in this study.

I am between 2 and 80 years old and live in the US, Canada, Australia, or New Zealand.

I am between 2 and 80 years old.

Exclusion Criteria

You have already taken part in a Closed Loop study before.

You are not able to handle the sticky tape used to put the sensor in place.

I have chronic kidney disease that needs dialysis or causes constant anemia.

Timeline for a Trial Participant

Run-in

Participants wear a blinded CGM sensor for two weeks to establish baseline data

Up to 8 weeks

Study Period

Participants are randomized into two arms: Hybrid Closed Loop system or Control, and monitored for safety and effectiveness

6 months

Continuation

All participants use the Hybrid Closed Loop system with Auto Mode

6 months

Follow-up

Participants are monitored for safety and effectiveness after the continuation period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 670G and 770G Insulin Pump
• Subject's Current Diabetes Therapy

Trial Overview The trial tests a Hybrid Closed Loop (HCL) insulin pump system in adults and children to see if it safely manages blood sugar levels at home. The HCL will be compared against participants' current diabetes therapies over a diverse range of patients.

How Is the Trial Designed?

Group I: Hybrid Closed Loop Arm Experimental Treatment 1 Intervention

The HCL Arm will use the MiniMed System (i.e., using Auto Mode) for 6 months during the study period.

Group II: Control Arm Active Control 1 Intervention

The Control Arm will use individual subject's current diabetes therapy: CSII (Continuous Subcutaneous Insulin Infusion), MDI (Multiple Daily Injections) or SAP (Sensor Augmented Pump). Each cohort (CSII, MDI, or SAP) will be used as the control arm to be compared to the experimental arm (HCL).

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 enhanced hybrid closed loop (e-HCL) insulin delivery system showed a significant reduction in closed loop exits and alerts compared to the standard hybrid closed loop (s-HCL) system in a study involving 11 adults with type 1 diabetes.

While e-HCL tended to improve time in target glucose range and mean glucose levels, these improvements were not statistically significant, and importantly, no severe hypoglycemia or ketoacidosis episodes occurred, indicating safety in its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucose Control Using a Standard Versus an Enhanced Hybrid Closed Loop System: A Randomized Crossover Study. Paldus, B., Lee, MH., Jones, HM., et al.[2022]

In a 6-month trial with 168 patients, a closed-loop insulin delivery system significantly increased the percentage of time blood glucose levels were within the target range (70-180 mg/dL) by 11 percentage points compared to a sensor-augmented pump, demonstrating improved glycemic control.

The closed-loop system also resulted in a lower mean glycated hemoglobin level and reduced time spent with low blood glucose levels, with no serious hypoglycemic events reported, indicating a safe and effective option for managing type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. Brown, SA., Kovatchev, BP., Raghinaru, D., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9354504/

Review of Automated Insulin Delivery Systems for Type 1 ... While this study did not include HbA1c as a study outcome, the data demonstrate that MiniMed 670G improves TIR for users, while also slightly reducing time ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf16/P160017S076b.pdf

Summary of Safety and Effectivness (SSED)Template Breakthrough Device: Granted breakthrough device status on July 2, 2019 because the device is expected to provide more effective treatment of type 1 diabetes ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0168822721002357

An analysis of Medtronic MiniMed 670G insulin pump use ... This study evaluated the use of the Medtronic MiniMed 670G system in adults with type 1 diabetes mellitus from a large endocrinology practice

4. diabetesjournals.org diabetesjournals.org/care/article/44/4/969/138605/Improved-Glycemic-Outcomes-With-Medtronic-MiniMed

Improved Glycemic Outcomes With Medtronic MiniMed ... Real-world data from 3,141 people with type 1 diabetes living in the U.S. demonstrated improved time spent in target range (TIR) (from 66.0% to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9304187/

Glycemic outcomes of children 2–6 years of age with type 1 ... This study demonstrated that 3‐month at‐home MiniMed™ 670G system use was safe with no DKA or severe hypoglycemia, in a challenging and vulnerable population of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6350071/

Safety Evaluation of the MiniMed 670G System in Children 7 ... This AID system has already been shown to safely improve HbA1c, TIR, and SG variability in adolescents and adults with T1D who used the system for 3 months.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9942055/

Safety, metabolic and psychological outcomes of Medtronic ... Conclusion: The Medtronic MiniMed™ 670G is safe and well accepted, without any increase in the burden for patients. Some papers report an ...

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

Important Safety Information The Medtronic MiniMed™ 670G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin ...

9. medtronic.com medtronic.com/en-ca/diabetes/products/insulin-pumps/minimed-670g.html

minimed tm 670g insulin pump system The MiniMed™ 670G system is an insulin pump that features SmartGuard™ technology and CGM integration to help you manage your diabetes. Learn more.