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Automated Insulin Delivery System

AIDANET for Type 1 Diabetes (MiniNET Trial)

N/A

Recruiting

Led By Sue Brown, MD

Research Sponsored by Marc Breton

Eligibility Criteria Checklist

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

Must have

Currently using insulin pump for at least three months (any pump, either open loop or hybrid closed loop may be used)

Age must be ≥18.0 and ≤60 years old at time of consent

Must not have

History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months

History of chronic renal disease (Stage 4 or unstable Stage 3b)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new system called AIDANET in adults with type 1 diabetes to see if it is safe and feasible to use.

Who is the study for?

This trial is for adults with type 1 diabetes interested in a new automated insulin delivery system. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors that could impact the study or their safety.

What is being tested?

The trial is testing AIDANET, an Automated Insulin Delivery as Adaptive NETwork system in a smaller network version. It's designed to manage insulin levels automatically and will be compared using a crossover method where participants switch between treatments.

What are the potential side effects?

While specific side effects are not listed, similar systems can cause issues like low or high blood sugar if the device malfunctions or calculates incorrect insulin doses.

Eligibility Criteria

Inclusion Criteria

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

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I have been using an insulin pump for at least three months.

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I am between 18 and 60 years old.

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I have been using insulin for at least 6 months.

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I have been diagnosed with type 1 diabetes for over a year.

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I have someone who knows what to do if my blood sugar gets too low.

Exclusion Criteria

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

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I have had a severe low blood sugar episode with seizure or unconsciousness in the past year.

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I have severe or unstable kidney disease.

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I have not used oral or injectable steroids in the last 4 weeks.

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I am scheduled for surgery during the study.

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I am currently taking medication for diabetes that belongs to the SGLT-2 or SGLT-1/2 inhibitor class.

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I have a history of adrenal insufficiency.

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I have had a diabetic ketoacidosis event in the past year.

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I have not treated my underactive or overactive thyroid.

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I am currently receiving treatment for seizures.

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I have a bleeding disorder such as hemophilia.

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I have a heart condition that stops me from doing moderate exercise.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in the mean Continuous Glucose Monitor (CGM) between the week of the Usual Care observational period and the week of AIDANET at-home.

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Usual Care→AIDANETActive Control1 Intervention

Participants will complete 7 days/6 nights at home usual care period using their personal equipment. Participants will then use the AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights.

Group II: AIDANET→Usual CareActive Control1 Intervention

Participants will use AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights and then will complete 7 days/6 nights at home usual care period using their personal equipment.

0 / 16Eligibility criteria met