Hybrid Closed Loop System for Type 1 Diabetes

Recruiting at 35 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

280 Participants Needed

Trial Summary

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 data supports the effectiveness of the Hybrid Closed Loop System for Type 1 Diabetes treatment?

Research shows that using hybrid closed-loop insulin delivery systems, like the 670G and 770G pumps, can improve quality of life and glucose control in people with type 1 diabetes by keeping blood sugar levels within the target range more effectively than previous methods. ^{1 2 3 4 5}

Is the hybrid closed-loop insulin delivery system safe for people with type 1 diabetes?

The hybrid closed-loop insulin delivery system, including the Medtronic MiniMed 670G, has been shown to be safe for people with type 1 diabetes, with no episodes of severe low blood sugar or ketoacidosis (a serious diabetes complication) reported in studies. ^{1 3 4 6 7}

How is the hybrid closed-loop insulin pump treatment different from other treatments for type 1 diabetes?

The hybrid closed-loop insulin pump treatment, like the 670G and 770G systems, automatically adjusts insulin delivery based on continuous glucose monitoring, providing more precise control of blood sugar levels compared to traditional insulin pumps that require manual adjustments. ^{1 3 4 8 9}

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting. A diverse population of patients with type 1 diabetes will be studied. The study population will have a large range for duration of diabetes and glycemic control, as measured by glycosylated hemoglobin (A1C). They will be enrolled in the study regardless of their prior diabetes regimen, including using Multiple Daily Injections (MDI), Continuous Subcutaneous Insulin Infusion (CSII) or Sensor-Augmented Pump therapy (SAP)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Patient reported outcome measures in children and adolescents with type 1 diabetes using advanced hybrid closed loop insulin delivery. [2022]

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

Hybrid Closed-Loop Therapy in Adults With Type 1 Diabetes and Above-Target HbA1c: A Real-world Observational Study. [2023]

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

Optimizing Hybrid Closed-Loop Therapy in Adolescents and Emerging Adults Using the MiniMed 670G System. [2020]

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

Efficacy of Hybrid Closed-Loop Insulin Delivery System in a Hospital Setting: A Case Series. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Outcomes of hybrid closed-loop insulin delivery activated 24/7 versus evening and night in free-living prepubertal children with type 1 diabetes: A multicentre, randomized clinical trial. [2022]

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

Glucose Control Using a Standard Versus an Enhanced Hybrid Closed Loop System: A Randomized Crossover Study. [2022]

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

Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. [2022]

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

Day and Night Closed-Loop Control Using the Integrated Medtronic Hybrid Closed-Loop System in Type 1 Diabetes at Diabetes Camp. [2022]