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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
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-range•CGM time-below-range•CGM 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Glycemic / diabetes
2 endpointsTime in target
Time frame:24 hours
CGM time-in-range
descriptive, improvement
Time in hyperglycemia
Time frame:24 hours
CGM time-above-range
descriptive, improvement
Safety / tolerability / PK
5 endpointsTime in hypoglycemia
Time frame:24 hours
CGM time-below-range
descriptive, event
Hypoglycemia treatment
Time frame:24 hrs
event count, event
Hypoglycemia treatment
Time frame:During the night of the 24 hour intervention (11pm-7am)
Documented hypoglycemia
event count, event
Hypoglycemia treatment
Time frame:During the day of the 24 hour intervention (7am-11pm)
Documented hypoglycemia
event count, event
Gastrointestinal symptoms
Time frame:24 hours
categorical status, event
Provenance
Sources
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.