Hybrid Closed Loop System for Type 1 Diabetes

Recruiting in Palo Alto (17 mi)

+35 other locations

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medtronic Diabetes

No Placebo Group

Trial Summary

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 80 years old and live in the US, Canada, Australia, or New Zealand.

I am 7 years old or older.

I have been diagnosed with type 1 diabetes for over three months.

I am 7 years old or older.

I manage my diabetes with multiple daily injections or an insulin pump.

I am willing and able to afford the study's insulin treatments.

I am willing to use the study's glucose meter.

I use 8 or more units of insulin daily.

I am between 2 and 80 years old.

Exclusion Criteria

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

I am currently receiving treatment for cancer.

I am not pregnant and do not plan to become pregnant during the study.

I am currently taking specific medications.

I am currently using hydroxyurea or plan to use it during the study.

I plan to receive a red blood cell transfusion or erythropoietin during the study.

I am currently being treated for an overactive thyroid.

I have been diagnosed with a moderate to severe eating disorder like anorexia or bulimia.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Hybrid Closed Loop ArmExperimental Treatment1 Intervention

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

Group II: Control ArmActive Control1 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).