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FCL

CompletedPhase NA

A Fully-closed Loop, Pramlintide and Insulin, Artificial Pancreas Clinical Trial for Adults With Type 1 Diabetes

A Randomized, Controlled, Crossover Pilot Trial to Assess a Fully Automated, Dual-hormone (Insulin-and-pramlintide) Artificial Pancreas Without Carbohydrate Counting in Regulating Glucose Levels in Adults With Type 1 Diabetes

Lead sponsor

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

Asset

Pramlintide

Amylin analog

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 1 diabetes

Key I/E criterion

—

Primary endpoint

•CGM time-in-range

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05199714

Org study ID2022-8225

Timeline

Milestones

Study first posted2022-01-20actual

Study start2022-02-21actual

Primary completion2023-03-25actual

Study completion2023-03-25actual

Last update posted2023-10-25actual

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Females and males ≥ 18 years of age.

•Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.

•Use of insulin pump therapy for at least 3 months.

•Effective birth-control use in individuals of childbearing potential. Individuals of child-bearing potential must agree to use a highly effective method of birth control.

Exclusion criteria

•Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2I (sodium-glucose transporter), GLP-1(glucagon-like peptide), Metformin, etc.).

•Current use of glucocorticoid medication (except low, stable does and inhaled steroids).

•Individuals with confirmed gastroparesis.

•Use of medication that alters gastrointestinal motility.

•Planned or ongoing pregnancy.

•Breastfeeding individuals.

•Severe hypoglycemia requiring hospitalization in the past three months.

•Severe diabetic ketoacidosis episode in the past three months.

•Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.

•Recent (< 6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.

•Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Other (unclassified)

Glycemic / diabetes

12 endpoints

Primary/protocol endpoint

Each participant's percentage of time glucose levels spent in the target range

Time frame:42 +/- 28 hours

CGM time-in-range

percent change from baseline, improvement

Secondary/protocol endpoint

Each participant's percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L

Time frame:42 +/- 28 hours

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Each participant's percentage of time of glucose levels spent below 3.9 mmol/L

Time frame:42 +/- 28 hours

CGM time-below-range

percent change from baseline, improvement

Secondary/protocol endpoint

Each participant's percentage of time of glucose levels spent below 3.0 mmol/L

Time frame:42 +/- 28 hours

CGM time-below-range

percent change from baseline, improvement

Secondary/protocol endpoint

Each participant's percentage of time of glucose levels spent above 10.0 mmol/L

Time frame:42 +/- 28 hours

CGM time-above-range

percent change from baseline, improvement

Secondary/protocol endpoint

Each participant's percentage of time of glucose levels spent above 13.9 mmol/L

Time frame:42 +/- 28 hours

CGM time-above-range

percent change from baseline, improvement

Secondary/protocol endpoint

Each participant's percentage of time of glucose levels spent above 16.7 mmol/L

Time frame:42 +/- 28 hours

CGM time-above-range

percent change from baseline, improvement

Secondary/protocol endpoint

Each participant's mean glucose levels

Time frame:42 +/- 28 hours

descriptive, improvement

Secondary/protocol endpoint

Each participant's standard deviation of glucose levels

Time frame:42 +/- 28 hours

descriptive

Secondary/protocol endpoint/low confidence

Each participant's coefficient of variance of glucose levels

Time frame:42 +/- 28 hours

descriptive

Secondary/protocol endpoint

Total insulin delivery for each participant

Time frame:42 +/- 28 hours

descriptive

Secondary/protocol endpoint/low confidence

Total bolus insulin delivery for each participant

Time frame:42 +/- 28 hours

descriptive

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Total pramlintide delivery for each participant

Time frame:28 +/- 28 hours

descriptive

Other/protocol endpoint

Safety Endpoints

Time frame:42 +/- 28 hours

Treatment-emergent AEs (any)

descriptive, event

componentsNausea, Vomiting, Diarrhea

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Total basal insulin delivery for each participant

Time frame:42 +/- 28 hours

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.