A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes

Short name FCL

NCTNCT06046417Other id2023-9373

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Phase 2/3
Enrollment: 30 participants (estimated)
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Canada
Start: 30 Nov 2023
Primary completion: Apr 2025 (estimated)
Completion: Jun 2025 (estimated)
First posted: 21 Sept 2023
Last update posted: 18 Apr 2024
Conditions: type1diabetes · Diabetes Mellitus, Type 1

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2023202420252026

Ph 2/3
FCL
NCT06046417
30 Nov 2023 to est. Jun 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The aim of this clinical trial is to investigate whether a fully automated Lyumjev-and-pramlintide delivery system improves glycemic outcomes in adults with type 1 diabetes. The main question we aim to answer is whether a Lyumjev-pramlintide fully closed loop system improves time in range compared to a hybrid closed loop system with carbohydrate counting. We also aim to find the optimal insulin to pramlintide ratio for glycemic control in the fully automated system. In this cross-over study, patients will undergo the following three interventions in a random order: (i) fully automated Lyumjev insulin-and-pramlintide (8 μg/u) (ii) fully automated Lyumjev insulin-and-pramlintide (10 μg/u) (iii) rapid automated Lyumjev insulin-and-placebo with carbohydrate-matched boluses For all interventions, participants will be required to wear two Ypsomed pumps programmed by our developed EuGlide system.

Interventions

PramlintideDrug
LyumjevDrug
Automated Insulin Delivery (AID) systemDevice

Arms3

Experimental
Fully automated Lyumjev-and-pramlintide delivery system (8 μg/u)
Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 8 μg of pramlintide.
Experimental
Fully automated Lyumjev-and-pramlintide delivery system (10 μg/u)
Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 10 μg of pramlintide.
Active comparator
Hybrid automated Lyumjev-and-placebo delivery system with carbohydrate-matched boluses
Lyumjev and saline placebo hybrid automated delivery system with meal announcement. Participants must input the carbohydrate content of their meals to inform the insulin bolus doses based on their pre-programmed insulin-to-carbohydrate ratios.

Primary outcomes1

Outcomes the sponsor listed as primary.

Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L).
Time frame · 18 days

Secondary outcomes(14)

Percentage of time of glucose levels spent between 3.9-7.8 mmol/L.
Time frame · 18 days
Percentage of time of glucose levels spent between 3.0-3.9 mmol/L.
Time frame · 18 days
Percentage of time of glucose levels spent between 10.0-13.9 mmol/L.
Time frame · 18 days
Mean glucose levels.
Time frame · 18 days
Standard deviation of glucose levels.
Time frame · 18 days
Coefficient of variance of glucose levels.
Time frame · 18 days
Total pramlintide delivery (overall, basal, and bolus).
Time frame · 18 days
Total insulin delivery (overall, basal, and bolus).
Time frame · 18 days
Mean score on the Type 1 Diabetes Distress Scale (T1DDS) excluding the physician subscale.
Time frame · 18 days
Registry description
A scale from 1-6 indicating overall diabetes distress. Higher scores indicate higher levels of diabetes distress. Any total subscale score of \>2.0 is considered clinically significant.
Mean score on the Hypoglycemia Fear Survey - II (Worry Subscale) (HSF2).
Time frame · 18 days
Registry description
A scale from 1-5 with higher scores indicating a greater fear of hypoglycemia.
Mean score on the INSPIRE questionnaire for adults (INSPIRE).
Time frame · 18 days
Registry description
A scale from 1-5 with higher scores reflecting more favorable opinions about using Automated Insulin Delivery (AID).
Mean score on selected items from The Diabetes Bowel Symptoms Questionnaire (DBSQ).
Time frame · 18 days
Registry description
A 1-5 scale with higher values reflecting a greater quantity and severity of diabetes bowel symptoms.
Mean score on a Treatment Satisfaction Questionnaire (TSQ) taken from Marrero et al.
Time frame · 18 days
Registry description
A 1-6 scale with higher values indicating more satisfaction with treatment.
Thematic interview analysis
Time frame · 18 days
Registry description
Semi-structured interviews will be carried out after every intervention. We will analyze their qualitative content.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Individuals ≥ 18 years of age. * A clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes relies on the investigator's judgment; C peptide level and antibody determinations are unnecessary. * Using insulin pump therapy for at least three months. * Individuals of childbearing potential using an effective birth-control method. An individual of childbearing potential must agree to use a highly effective method of birth control. Exclusion Criteria: * Current or recent use of antihyperglycemic agents other than insulin (≤ 2-week use of sodium-glucose cotransporter-2 inhibitor (SGLT2I), Metformin, etc.; ≤ 1-month for glucagon-like peptide-1 receptor agonists (GLP1-RA)). * Current use of glucocorticoid medication (except low, stable doses and inhaled steroids). * Individuals with confirmed gastroparesis. * Use of medication that alters gastrointestinal motility (ex: domperidone). * Use of hydroxyurea. * Planned or ongoing pregnancy. * Breastfeeding individuals. * Severe hypoglycemia requiring hospitalization in the past month. Severe hypoglycemia is defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions. * Diabetic ketoacidosis episode in the past month. * Clinically significant nephropathy, neuropathy, or retinopathy as judged by the investigator. * Recent (\< 6 months) acute macrovascular event, e.g., acute coronary syndrome. * Other serious medical illnesses which are likely to interfere with study participation or the ability to complete the trial by the investigator's judgment. * Known hypersensitivity to the study drugs or their excipients.

PepBank is a research reference. Talk to a doctor before you use any peptide.