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Automated Insulin Delivery for Type 2 Diabetes (AID-BIT Trial)

N/A

Recruiting

Led By Anas El Fathi, PhD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

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

Must have

Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year

Currently using an approved long-acting insulin for at least six months (e.g., insulin glargine, insulin degludec)

Must not have

Treatment with meglitinides/sulfonylureas

Currently using an approved intermediate (e.g., insulin Neutral Protamine Hagedorn (NPH)) or rapid insulin for at least six months (e.g., insulin aspart, insulin lispro, insulin regular)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if an insulin pump can control diabetes more safely & quickly to improve glycemic control. Participants get randomized to use the insulin pump for 10 days.

Who is the study for?

This trial is for adults over 18 with Type 2 Diabetes, diagnosed for at least a year and currently on long-acting insulin like glargine or degludec. They should have an HbA1c level of at least 7.5% and not be using any rapid or intermediate insulins. Women must use contraception if applicable, and participants can't start new diabetes medications during the study.

What is being tested?

The trial tests an Automated Insulin Device (AID) with Control-IQ Technology in people taking basal insulin injections for Type 2 Diabetes. Participants are randomly placed into two groups: one uses the AID for ten days while the other does not, to compare how well each group controls their blood sugar levels.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include low blood sugar episodes (hypoglycemia), skin irritation from device wear, potential allergic reactions to pump materials or insulin used in the pump.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with type 2 diabetes for at least a year.

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I have been using a long-acting insulin like glargine or degludec for over six months.

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I agree not to start any new diabetes medication except insulin during the trial.

Exclusion Criteria

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

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I am currently taking medication for diabetes.

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I have been using a specific type of insulin for at least six months.

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I am currently receiving treatment for seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percent Time in Range

System Testing survey

Secondary study objectives

Mean glucose reading measured by Continuous Glucose Monitor (CGM)

Percent Time Above Range

Percent Time Above Range (Hyperglycemia)

+3 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: Automated Insulin Delivery in the Basal Insulin Titration PhaseExperimental Treatment1 Intervention

Participants will use Automated Insulin Delivery (AID) for 10 days in the Basal Insulin Titration (BIT) Phase. This group will then return to their original home therapy (basal insulin using pen) using the new setting in the Maintenance Phase (MP) with a blinded CGM. The total daily insulin (TDI) requirement during the BIT Phase will be translated to a basal insulin dose.

Group II: Standard Care with Study Continuous Glucose MonitorActive Control1 Intervention

Participants will use a study Continuous Glucose Monitor (CGM) along with their original home therapy and will be contacted by a study physician as per standard care to adjust their insulin doses if needed. This group will then transition into a 10-day Maintenance Phase (MP) using a blinded CGM, where the basal dose will be maintained.

0 / 6Eligibility criteria met