A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes
FCL
A Randomized, Controlled, Crossover Trial to Assess a Fully Automated, Dual-hormone (Insulin-and-pramlintide) Delivery System Without Carbohydrate Counting in Regulating Glucose Levels in Adults With Type 1 Diabetes.
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2023
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedStudy Start
First participant enrolled
November 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedApril 18, 2024
April 1, 2024
1.3 years
September 12, 2023
April 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L).
18 days
Secondary Outcomes (14)
Percentage of time of glucose levels spent between 3.9-7.8 mmol/L.
18 days
Percentage of time of glucose levels spent between 3.0-3.9 mmol/L.
18 days
Percentage of time of glucose levels spent between 10.0-13.9 mmol/L.
18 days
Mean glucose levels.
18 days
Standard deviation of glucose levels.
18 days
- +9 more secondary outcomes
Other Outcomes (1)
Safety Endpoints
18 days
Study Arms (3)
Fully automated Lyumjev-and-pramlintide delivery system (8 μg/u)
EXPERIMENTALLyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 8 μg of pramlintide.
Fully automated Lyumjev-and-pramlintide delivery system (10 μg/u)
EXPERIMENTALLyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 10 μg of pramlintide.
Hybrid automated Lyumjev-and-placebo delivery system with carbohydrate-matched boluses
ACTIVE COMPARATORLyumjev 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.
Interventions
Pramlintide delivered in a basal-bolus manner.
Lyumjev delivered in a basal-bolus manner.
The AID system consists of a set of devices that work inter-connectedly to automate insulin (and pramlintide) delivery in response to an individual's glucose levels. It consists of a (i) Dexcom G6 glucose sensor, (ii) a smartphone-based algorithm, (iii) an insulin YpsoPump, and (iv) a pramlintide/placebo YpsoPump in a dual hormone configuration.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Institute of the McGill University Health Center
Montreal, Quebec, H4A 3J1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Tsoukas, M.D.
Research Institute of the McGill University Health Center
- STUDY CHAIR
Ahmad Haidar, Ph.D.
Research Institute of the McGill University Health Center
- STUDY CHAIR
Laurent Legault, M.D.
Montreal's Children's Hospital Division of Endocrinology
- STUDY CHAIR
Michael Vallis, Ph.D.
Dalhousie University Psychologist
- STUDY CHAIR
Natasha Garfield, M.D.
Royal Victoria Hospital Division of Endocrinology
- STUDY CHAIR
Melissa-Rosina Pasqua, M.D.
Research Institute of the McGill University Health Center
Central Study Contacts
Ahmad Haidar, PhD.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Endocrinology & Metabolism
Study Record Dates
First Submitted
September 12, 2023
First Posted
September 21, 2023
Study Start
November 30, 2023
Primary Completion
April 1, 2025
Study Completion
June 1, 2025
Last Updated
April 18, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF
The raw data (that is, insulin delivery, glucose levels and individual participant data) and informed consent form will be shared by the corresponding author, for academic purposes, subject to a material transfer agreement and approval of the McGill University Health Center's Research Ethics Board. All data shared will be de-identified. Raw data will be shared for non-commercial use upon reasonable request and a material transfer agreement.