A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes
NCT ID: NCT06046417
Last Updated: 2024-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2023-11-30
2025-06-30
Brief Summary
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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.
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Detailed Description
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Design-
All participants will undergo three interventions in a random order:
(i) Fully automated Lyumjev insulin-pramlintide delivery system. Ratio of 1 unit of inulin for 8μg of pramlintide.
(ii) Fully automated Lyumjev insulin-pramlintide delivery system. Ratio of 1 unit of insulin for 10μg of pramlintide.
(iii) Hybrid automated Lyumjev insulin-placebo delivery system with carbohydrate-matched boluses.
Study drugs-
Lyumjev is a Health Canada insulin for treatment of type 1 diabetes. Participants who do not currently use Lyumjev will be switched to it for the duration of the study.
Pramlintide is an FDA-approved drug used in the treatment of type 1 diabetes. It contributes to regulating glucose levels by delaying gastric emptying, suppressing nutrient-stimulated glucagon secretion and increasing satiety. It is not approved for commercial use by Health Canada, but has been approved for the purpose of the study.
Study Devices-
For the duration of the study, participants will use a Dexcom G6 Continuous Glucose Monitor (GCM), two YpsoPumps (for insulin and pramlintide) as well as a study smartphone with the Euglide application installed. The automated insulin delivery (AID) system will integrate these sets of devices to automate insulin (and pramlintide) delivery in response to an individual's glucose levels.
Treatment Period-
Each intervention will last three weeks and be preceded by a 5-day at-home run-in period. After both the second and third interventions, there will be a 14-45 day washout period. Participants will be followed-up with remotely on days 2 (+/-1) and 5 of each run-in and on days 2(+/-1), 3(+/-1) and 7(+/-2) of each intervention. Remote contact can be performed via phone, email, text message or another reasonable communication channel. After each intervention, participants will be interviewed and asked to complete questionnaires assessing diabetes control and quality of life. Participants will need approximately 15-30 weeks to complete the study.
The study will enroll up to 4 pilot participants, as well as 26 main study participants who meet the eligibility criteria.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
Pramlintide
Pramlintide delivered in a basal-bolus manner.
Lyumjev
Lyumjev delivered in a basal-bolus manner.
Automated Insulin Delivery (AID) system
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.
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.
Pramlintide
Pramlintide delivered in a basal-bolus manner.
Lyumjev
Lyumjev delivered in a basal-bolus manner.
Automated Insulin Delivery (AID) system
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.
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.
Lyumjev
Lyumjev delivered in a basal-bolus manner.
Interventions
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Pramlintide
Pramlintide delivered in a basal-bolus manner.
Lyumjev
Lyumjev delivered in a basal-bolus manner.
Automated Insulin Delivery (AID) system
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
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Juvenile Diabetes Research Foundation
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Michael Tsoukas
Assistant Professor, Endocrinology & Metabolism
Principal Investigators
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Michael Tsoukas, M.D.
Role: PRINCIPAL_INVESTIGATOR
Research Institute of the McGill University Health Center
Ahmad Haidar, Ph.D.
Role: STUDY_CHAIR
Research Institute of the McGill University Health Center
Laurent Legault, M.D.
Role: STUDY_CHAIR
Montreal's Children's Hospital Division of Endocrinology
Michael Vallis, Ph.D.
Role: STUDY_CHAIR
Dalhousie University Psychologist
Natasha Garfield, M.D.
Role: STUDY_CHAIR
Royal Victoria Hospital Division of Endocrinology
Melissa-Rosina Pasqua, M.D.
Role: STUDY_CHAIR
Research Institute of the McGill University Health Center
Locations
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Research Institute of the McGill University Health Center
Montreal, Quebec, Canada
Countries
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Central Contacts
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Ahmad Haidar, PhD.
Role: CONTACT
Facility Contacts
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Other Identifiers
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2023-9373
Identifier Type: -
Identifier Source: org_study_id
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