Current partner codePEPTIDESDE
NCT03993366·Not applicable·INTERVENTIONAL

Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement

Status

Completed

Phase

Not applicable

Enrollment

8

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The aim of this pilot study is to generate preliminary data of (i) Fiasp-plus-Pramlintide closed-loop system with a simple meal announcement, compared to (ii) Fiasp-alone closed-loop system with full carbohydrate counting, in preparation for an outpatient study over two weeks

Interventions

Treatment arms and agents.

COMBINATION_PRODUCT

Fiasp+Pramlintide Closed-Loop System

Closed-loop insulin delivery with Fiasp insulin and pramlintide

DEVICE

Fiasp Closed-Loop System

Closed-loop insulin delivery with Fiasp insulin alone

Timeline

From registration to results.

  1. First posted

    Jun 20, 2019

  2. Study start

    Mar 1, 2019

  3. Primary completion

    Aug 6, 2019

  4. Study completion

    Aug 6, 2019

  5. Results posted

    Not reported

  6. Registry updated

    Apr 1, 2021

Outcomes

What the study measures.

Primary outcomes

Time in target

Time frame · 24 hours

Time spent in target range (between 4.0 mmol/L and 10 mmol/L)

Time in hypoglycemia

Time frame · 24 hours

Time spent in hypoglycemic range (below 4.0 mmol/L)

Time in hyperglycemia

Time frame · 24 hours

Time spent in hyperglycemic range (above 10.0 mmol/L)

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
12 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

Canada. Showing up to 24 locations stored in the fast local snapshot.

McGill University Health Center

Montreal, Quebec, Canada

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.