Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas
NCT ID: NCT04163874
Last Updated: 2022-10-10
Study Results
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Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2020-02-14
2022-01-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
(i) Fiasp-plus-Pramlintide closed-loop delivery with a simple meal announcement (pressing a button, no carbohydrate counting) (ii) Fiasp-plus-placebo closed-loop delivery with conventional carbohydrate counting (iii) Fiasp-plus-placebo closed-loop delivery with a simple meal announcement
TREATMENT
TRIPLE
Study Groups
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Fiasp-plus-Placebo with Full Carbohydrate Counting
Fiasp insulin and placebo insulin infusion in two insulin pumps with full carbohydrate counting.
Fiasp
Fiasp Insulin delivered in a basal-bolus manner.
Placebo
Placebo delivered in a basal-bolus manner with a fixed ratio with insulin.
Artificial Pancreas
Tandem insulin pump, dexcom G5 sensor, Nexus 5 cellphone running the iMAP algorithm.
Fiasp-plus-placebo with Simple Meal Announcement
Fiasp insulin and placebo (saline) insulin infusion in two insulin pumps using the simple meal announcement system.
Fiasp
Fiasp Insulin delivered in a basal-bolus manner.
Placebo
Placebo delivered in a basal-bolus manner with a fixed ratio with insulin.
Artificial Pancreas
Tandem insulin pump, dexcom G5 sensor, Nexus 5 cellphone running the iMAP algorithm.
Fiasp-plus-Pramlintide with Simple Meal Announcement
Fiasp insulin and pramlintide insulin infusion in two insulin pumps using the simple meal announcement system.
Fiasp
Fiasp Insulin delivered in a basal-bolus manner.
Pramlintide Acetate
Pramlintide delivered in a basal-bolus manner with a fixed ratio with insulin.
Artificial Pancreas
Tandem insulin pump, dexcom G5 sensor, Nexus 5 cellphone running the iMAP algorithm.
Interventions
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Fiasp
Fiasp Insulin delivered in a basal-bolus manner.
Pramlintide Acetate
Pramlintide delivered in a basal-bolus manner with a fixed ratio with insulin.
Placebo
Placebo delivered in a basal-bolus manner with a fixed ratio with insulin.
Artificial Pancreas
Tandem insulin pump, dexcom G5 sensor, Nexus 5 cellphone running the iMAP algorithm.
Eligibility Criteria
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Inclusion Criteria
2. Males and females ≥ 12 years of age
3. HbA1c ≤ 12%
4. Insulin pump use for at least 3 months
5. 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.
6. 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.
Exclusion Criteria
1. Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 inhibitors, GLP-1 agonists, Metformin, Acarbose, etc.…).
2. Current use of glucocorticoid medication.
3. Use of medication that alters gastrointestinal motility.
4. Planned or ongoing pregnancy.
5. Breastfeeding individuals.
6. Severe hypoglycemic episode within one month of admission.
7. Severe diabetes ketoacidosis episode within one month of admission.
8. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
9. Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
10. Known hypersensitivity to any of the study drugs or their excipients.
11. Individuals with confirmed gastroparesis.
12. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
13. Unable to travel to research center within 3h if needed during study interventions
14. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).
Study Discontinuation/Withdrawal
1. Failure to comply with the protocol.
2. Pregnancy.
3. After an event which the PI believes it is not in the best interest for the patient to continue the trial.
12 Years
ALL
No
Sponsors
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Juvenile Diabetes Research Foundation
OTHER
McGill University
OTHER
Responsible Party
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Locations
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3555 University Street
Montreal, Quebec, Canada
Countries
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References
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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.
Other Identifiers
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2020-5712
Identifier Type: -
Identifier Source: org_study_id
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