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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiasp-plus-Placebo with Full Carbohydrate Counting | Experimental | Fiasp insulin and placebo insulin infusion in two insulin pumps with full carbohydrate counting. |
|
| Fiasp-plus-placebo with Simple Meal Announcement | Placebo Comparator | Fiasp insulin and placebo (saline) insulin infusion in two insulin pumps using the simple meal announcement system. |
|
| Fiasp-plus-Pramlintide with Simple Meal Announcement | Active Comparator | Fiasp insulin and pramlintide insulin infusion in two insulin pumps using the simple meal announcement system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiasp | Drug | Fiasp Insulin delivered in a basal-bolus manner. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Participants who meet any of the following criteria are not eligible for the study:
Study Discontinuation/Withdrawal
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3555 University Street | Montreal | Quebec | H3A 2B1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38906614 | Derived | 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. |
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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.
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This is a three-way, randomized, blinded, crossover trial to compare the following strategies:
(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
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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).
| Pramlintide Acetate | Drug | Pramlintide delivered in a basal-bolus manner with a fixed ratio with insulin. |
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| Placebo | Drug | Placebo delivered in a basal-bolus manner with a fixed ratio with insulin. |
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| Artificial Pancreas | Device | Tandem insulin pump, dexcom G5 sensor, Nexus 5 cellphone running the iMAP algorithm. |
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| 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 |
| Each participant's standard deviation of glucose levels as a measure of glucose variability | 12 days |
| Each participant's number of hypoglycemia events defined as at least 15 min below 3.0 mmol/L | 12 days |
| Each participant's number of Gastrointestinal symptoms | 12 days |
| Each participant's total insulin delivery | 12 days |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| C105254 | pramlintide |
| D019397 | Pancreas, Artificial |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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