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Insulin Pump

Hybrid Closed Loop System for Type 1 Diabetes

N/A

Recruiting

Research Sponsored by Medtronic Diabetes

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

US, Canada, Australia and New Zealand: Subjects 2-80 years of age will be allowed to enroll in the post approval study.

Europe: Only subjects ≥7 years of age are allowed to enroll in the post-market study.

Must not have

Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia

Subjects who are currently being actively treated for cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes at home.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin irritation from sensor placement or tape adhesive, low or high blood sugar events due to insulin delivery issues, possible device-related complications like infections at infusion sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 7 years old or older.

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

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I am 7 years old or older.

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

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

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

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I use 8 or more units of insulin daily.

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I am between 2 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am currently receiving treatment for cancer.

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

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I am currently taking specific medications.

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

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

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I am currently being treated for an overactive thyroid.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CSII Cohort: Time in Hypoglycemic Range for subjects with baseline A1c ≤ 8%

CSII Cohort: change of A1C (∆A1C) for subjects with baseline A1c > 8%

MDI Cohort: Time in Hypoglycemic Range for subjects with baseline A1c ≤ 8%

+3 more

Secondary study objectives

CSII Cohort: Change in A1C (∆A1C) for subjects with baseline A1c ≤ 8%

CSII Cohort: Change in A1C for all subjects

CSII Cohort: Time in Hypoglycemic Range during Day and Night for all subjects

+18 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

0 / 17Eligibility criteria met