Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas
1 other identifier
interventional
36
1 country
1
Brief Summary
One of the main challenges in maintaining tight glucose control in a closed-loop system occurs at meal times. Amylin is a gluco-regulatory beta-cell hormone that is co-secreted with insulin in response to nutrient stimuli, and is deficient in patients with type 1 diabetes. Amylin, in the postprandial period, contributes to regulating glucose levels by delaying gastric emptying, suppressing nutrient-stimulated glucagon secretion, and increasing satiety. Pramlintide is a synthetic analog of the hormone amylin. A closed-loop system that delivers both insulin and pramlintide, based on glucose sensor readings, has the potential to better normalize glucose levels, especially during the post-prandial period. The aim of this project is to assess whether co-administration of pramlintide with the improved insulin aspart formulation - Fiasp, in an artificial pancreas system, will alleviate the need for carb counting by replacing it with a simple meal announcement, without degrading the quality of glycemic control in a closed-loop therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2020
Typical duration for not_applicable
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
August 26, 2019
CompletedFirst Posted
Study publicly available on registry
November 15, 2019
CompletedStudy Start
First participant enrolled
February 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2022
CompletedOctober 10, 2022
October 1, 2022
2 years
August 26, 2019
October 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Each participant's time in target range
Time in target range (3.9-10mmol/L)
12 days
Mean score of the Emotional Burden section of the Diabetes Distress Scale
Average of all question's scores (from 1-6). Higher score means more emotional burden.
12 days
Secondary Outcomes (9)
Each participant's percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L
12 days
Each participant's percentage of time of glucose levels spent between 3.9 and 10 mmol/L
12 days
Each participant's percentage of time of glucose levels spent below 3.9, 3.3, and 2.8 mmol/L
12 days
Each participant's percentage of time of glucose levels spent above 7.8, 10, 13.9 and 16.7 mmol/L
12 days
Each participant's mean glucose level
12 days
- +4 more secondary outcomes
Study Arms (3)
Fiasp-plus-Placebo with Full Carbohydrate Counting
EXPERIMENTALFiasp insulin and placebo insulin infusion in two insulin pumps with full carbohydrate counting.
Fiasp-plus-placebo with Simple Meal Announcement
PLACEBO COMPARATORFiasp insulin and placebo (saline) insulin infusion in two insulin pumps using the simple meal announcement system.
Fiasp-plus-Pramlintide with Simple Meal Announcement
ACTIVE COMPARATORFiasp insulin and pramlintide insulin infusion in two insulin pumps using the simple meal announcement system.
Interventions
Fiasp Insulin delivered in a basal-bolus manner.
Pramlintide delivered in a basal-bolus manner with a fixed ratio with insulin.
Placebo delivered in a basal-bolus manner with a fixed ratio with insulin.
Tandem insulin pump, dexcom G5 sensor, Nexus 5 cellphone running the iMAP algorithm.
Eligibility Criteria
You may qualify if:
- Signed and dated written informed consent
- Males and females ≥ 12 years of age
- HbA1c ≤ 12%
- Insulin pump use for at least 3 months
- Clinical diagnosis with type 1 diabetes for at least 12 months. The diagnosis of T1D is based on the investigator's clinical judgment; C peptide level and antibody determinations are not planned.
- Women of child-bearing potential must be ready and able to use a highly effective method of birth control. Women of childbearing potential are females who have experienced \[the first occurrence of menstruation\] and do not meet the criteria for women not of childbearing potential. Women not of childbearing potential are females who are permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
You may not qualify if:
- Participants who meet any of the following criteria are not eligible for the study:
- Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 inhibitors, GLP-1 agonists, 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 ketoacidosis 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.
- Individuals with confirmed gastroparesis.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Unable to travel to research center within 3h if needed during study interventions
- Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McGill Universitylead
- Juvenile Diabetes Research Foundationcollaborator
Study Sites (1)
3555 University Street
Montreal, Quebec, H3A 2B1, Canada
Related Publications (1)
Cohen E, Tsoukas MA, Legault L, Vallis M, Von Oettingen JE, Palisaitis E, Odabassian M, Yale JF, Garfield N, Gouchie-Provencher N, Rutkowski J, Jafar A, Ghanbari M, Haidar A. Simple meal announcements and pramlintide delivery versus carbohydrate counting in type 1 diabetes with automated fast-acting insulin aspart delivery: a randomised crossover trial in Montreal, Canada. Lancet Digit Health. 2024 Jul;6(7):e489-e499. doi: 10.1016/S2589-7500(24)00092-X.
PMID: 38906614DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- This study will be a double-blinded study, where the participants and researchers will be blinded to the study drugs. Participants will wear two pumps for all interventions, one for insulin and the other for pramlintide/placebo (saline solution).
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2019
First Posted
November 15, 2019
Study Start
February 14, 2020
Primary Completion
January 30, 2022
Study Completion
January 30, 2022
Last Updated
October 10, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
The raw data (i.e., insulin delivery, glucose levels, individual participant data) and informed consent form could be shared by the corresponding author, ahmad.haidar@mcgill.ca, upon reasonable request for academic purposes, subject to Material Transfer Agreement and approval of McGill University Health Center's Research Ethics Board. All data shared will be deidentified. Study protocol is available with publication.