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CompletedPhase NA

Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement

A Preliminary Pilot Study to Assess Insulin-plus-Pramlintide Closed-loop Delivery System in Pump Treated Patients With Type 1 Diabetes Mellitus

Lead sponsor

McGill University

Asset

Pramlintide

Amylin analog

Listed sites

1

Recruiting sites

Enrollment

8

actual

Study population

Type 1 diabetes

Key I/E criterion

HbA1c ≤12%

Primary endpoints

CGM time-in-rangeCGM time-below-rangeCGM time-above-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 IDNCT03993366
Org study ID2019-4947

Timeline

Milestones

Study start2019-03-01actual
Study first posted2019-06-20actual
Primary completion2019-08-06actual
Study completion2019-08-06actual
Last update posted2021-04-01actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age12 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Males and females ≥ 12 years of age.

2. Clinical diagnosis of type 1 diabetes for at least 12 months according to the Diabetes Canada Clinical Practice Guidelines Expert Committee diagnostic criteria.

3. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.

4. Insulin pump therapy for at least 6 months.

5. HbA1c ≤ 12%.

Exclusion criteria

1. Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 (Sodium-glucose Cotransporter-2), GLP-1 (glucagon-like peptide 1), Metformin, Acarbose, etc.…).

2. Current use of glucocorticoid medication.

3. Use of medication that alters gastrointestinal motility.

4. Planned or ongoing pregnancy.

5. Breastfeeding individuals.

6. Severe hypoglycemic episode within one month of admission.

7. Severe diabetes keto-acidosis episode within one month of admission.

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

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

10. Known hypersensitivity to any of the study drugs or their excipients.

11. Individuals with hypoglycemia unawareness.

12. Individuals with confirmed gastroparesis.

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

14. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).

Study Discontinuation/Withdrawal

1. Failure to comply with the protocol.

2. Pregnancy.

3. After an event which the PI believes it is not in the best interest for the patient to continue the trial.

Endpoints (7)

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

Safety / tolerability / PK
5
Glycemic / diabetes
2

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Time in target

Time frame:24 hours

CGM time-in-range

descriptive, improvement

Primary/protocol endpoint

Time in hyperglycemia

Time frame:24 hours

CGM time-above-range

descriptive, improvement

Safety / tolerability / PK

5 endpoints
Primary/protocol endpoint

Time in hypoglycemia

Time frame:24 hours

CGM time-below-range

descriptive, event

Other/protocol endpoint

Hypoglycemia treatment

Time frame:24 hrs

event count, event

Other/protocol endpoint

Hypoglycemia treatment

Time frame:During the night of the 24 hour intervention (11pm-7am)

Documented hypoglycemia

event count, event

Other/protocol endpoint

Hypoglycemia treatment

Time frame:During the day of the 24 hour intervention (7am-11pm)

Documented hypoglycemia

event count, event

Other/protocol endpoint

Gastrointestinal symptoms

Time frame:24 hours

categorical status, event

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.