Hybrid Closed Loop System for Type 1 Diabetes
What You Need to Know Before You Apply
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)
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.
Is the hybrid closed-loop insulin delivery system safe for people with type 1 diabetes?
How is the hybrid closed-loop insulin pump treatment different from other treatments for type 1 diabetes?
What data supports the effectiveness of the Hybrid Closed Loop System for Type 1 Diabetes treatment?
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
Exclusion Criteria
Timeline for a Trial Participant
Run-in
Participants wear a blinded CGM sensor for two weeks to establish baseline data
Study Period
Participants are randomized into two arms: Hybrid Closed Loop system or Control, and monitored for safety and effectiveness
Continuation
All participants use the Hybrid Closed Loop system with Auto Mode
Follow-up
Participants are monitored for safety and effectiveness after the continuation period
What Are the Treatments Tested in This Trial?
Interventions
- 670G and 770G Insulin Pump
- Subject's Current Diabetes Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medtronic Diabetes
Lead Sponsor
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