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

McGill University1 site in 1 country8 target enrollmentMarch 1, 2019

ConditionsType 1 Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 1 Diabetes Mellitus
Sponsor: McGill University
Enrollment: 8
Locations: 1
Primary Endpoint: Time in target
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

March 1, 2019

End Date

August 6, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

McGill University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females ≥ 12 years of age.
•Clinical diagnosis of type 1 diabetes for at least 12 months according to the Diabetes Canada Clinical Practice Guidelines Expert Committee diagnostic criteria.
•The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
•Insulin pump therapy for at least 6 months.
•HbA1c ≤ 12%.

Exclusion Criteria

•Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 (Sodium-glucose Cotransporter-2), GLP-1 (glucagon-like peptide 1), Metformin, Acarbose, etc....).
•Current use of glucocorticoid medication.
•Use of medication that alters gastrointestinal motility.
•Planned or ongoing pregnancy.
•Breastfeeding individuals.
•Severe hypoglycemic episode within one month of admission.
•Severe diabetes keto-acidosis episode within one month of admission.
•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.
•Known hypersensitivity to any of the study drugs or their excipients.