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Automated Insulin + Pramlintide Delivery for Type 1 Diabetes (FCL Trial)

Phase 2 & 3

Recruiting

Led By Michael Tsoukas, M.D.

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

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

Must have

Using insulin pump therapy for at least three months

Be older than 18 years old

Must not have

Severe hypoglycemia requiring hospitalization in the past month. Severe hypoglycemia is defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions

Use of medication that alters gastrointestinal motility (ex: domperidone)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate how an automated delivery system of insulin and pramlintide can help adults with Type 1 Diabetes to better manage their blood sugar levels.

Who is the study for?

Adults over 18 with type 1 diabetes using insulin pump therapy for at least three months can join. They must not have had diabetic ketoacidosis or severe hypoglycemia recently, be pregnant or breastfeeding, use certain diabetes medications like SGLT2I or GLP1-RA, and should agree to effective birth control if applicable.

What is being tested?

The trial tests a fully automated system delivering insulin and pramlintide in different ratios (8 μg/u and 10 μg/u) against an automated system with insulin and placebo. The goal is to see which method keeps blood sugar levels within the target range best using two Ypsomed pumps.

What are the potential side effects?

Possible side effects include low blood sugar (hypoglycemia), skin reactions at the infusion site, weight changes, nausea, headaches, potential allergic reactions to pramlintide or insulins lispro/aspart.

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 3 months.

Exclusion Criteria

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

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I have been hospitalized for severe low blood sugar in the last month.

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I am taking medication that affects how my stomach and intestines move.

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I am not on high doses of glucocorticoid medication, except for low, stable doses or inhaled steroids.

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I am currently taking hydroxyurea.

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I had a diabetic ketoacidosis episode within the last month.

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I have been diagnosed with gastroparesis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 days for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Mean score on a Treatment Satisfaction Questionnaire (TSQ) taken from Marrero et al.

Mean score on selected items from The Diabetes Bowel Symptoms Questionnaire (DBSQ).

Mean score on the Hypoglycemia Fear Survey - II (Worry Subscale) (HSF2).

+3 more

Other study objectives

Safety Endpoints

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Fully automated Lyumjev-and-pramlintide delivery system (8 μg/u)Experimental Treatment3 Interventions

Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 8 μg of pramlintide.

Group II: Fully automated Lyumjev-and-pramlintide delivery system (10 μg/u)Experimental Treatment3 Interventions

Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 10 μg of pramlintide.

Group III: Hybrid automated Lyumjev-and-placebo delivery system with carbohydrate-matched bolusesActive Control1 Intervention

Lyumjev and saline placebo hybrid automated delivery system with meal announcement. Participants must input the carbohydrate content of their meals to inform the insulin bolus doses based on their pre-programmed insulin-to-carbohydrate ratios.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pramlintide

2022

Completed Phase 4

~110

0 / 7Eligibility criteria met