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Hormone Therapy

Closed-Loop System with Insulin vs. Insulin + Pramlintide for Type 1 Diabetes

N/A

Recruiting

Led By Leah Wilson, MD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

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

Must have

Diagnosis of type 1 diabetes mellitus for at least 1 year

Participants aged 18 to 70 years

Must not have

Liver failure, cirrhosis, or any other liver disease compromising liver function

Adrenal insufficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 hour clinic visit

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new system that can automatically manage blood sugar levels by delivering insulin and pramlintide. Pramlintide is a drug that helps control blood sugar levels by slowing down the

Who is the study for?

This trial is for adults aged 18-70 with Type 1 Diabetes who use insulin pumps or injections and have stable doses. They should understand how to adjust insulin based on carbs eaten, be willing to sign consent forms, and have an HbA1c level of ≤10.5%. It's not suitable for those needing more than 139 units of insulin per day.

What is being tested?

The study tests a new closed loop system that manages blood sugar by delivering both insulin and pramlintide, based on glucose readings from a continuous monitor. Participants will try the system in two modes: one using only insulin and another combining insulin with pramlintide.

What are the potential side effects?

Pramlintide may cause nausea, decreased appetite, or stomach issues due to slower digestion. Insulin side effects can include low blood sugar levels (hypoglycemia), weight gain, or reactions at the injection site.

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 1 diabetes for over a year.

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I am between 18 and 70 years old.

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I use less than 139 units of insulin daily.

Exclusion Criteria

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

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I do not have liver failure, cirrhosis, or any liver disease affecting its function.

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I have been diagnosed with adrenal insufficiency.

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I currently have an open sore on my foot.

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I have not had major surgery in the last 30 days.

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I regularly take medication that weakens my immune system.

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I am currently taking corticosteroids.

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I have not had any life-threatening diseases, including cancer, in the last 5 years.

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I have been diagnosed with gastroparesis.

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I have a history of heart disease or stroke.

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I do not have a bleeding disorder, am not on warfarin, and my platelet count is above 50,000.

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I am allergic to aspart insulin.

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I am currently being treated for an infection.

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I have a seizure disorder.

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I am not pregnant, planning to become pregnant, breastfeeding, or failing to use contraception.

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I am taking medication to lower my blood sugar, but it's not insulin or pramlintide.

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My kidney function is reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 hour clinic visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 hour clinic visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 hour clinic visit for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incremental area under the curve of postprandial glucose following the first meal

Percent of time with sensed glucose between 70 - 180 mg/dl following first meal

Secondary study objectives

Adverse events related to pramlintide

Baxter Retching Faces (BARF)/VAS scale for gastrointestinal issues after the first meal

Baxter Retching Faces (BARF)/VAS scale for gastrointestinal issues after the second meal

+43 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

Group I: Insulin and Pramlintide ArmExperimental Treatment1 Intervention

Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.

Group II: Insulin Only ArmExperimental Treatment1 Intervention

Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.

0 / 19Eligibility criteria met