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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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 rapid insulin in an artificial pancreas system will improve glycemic control in adults with Type 1 Diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid Insulin-Plus-Pramlintide | Experimental | Rapid insulin and pramlintide infusion in two insulin pumps |
|
| Rapid Insulin-Plus-Placebo | Placebo Comparator | Rapid insulin and placebo (saline) infusion in two insulin pumps |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid-Acting Insulin | Drug | Novorapid or Humalog insulin delivered in a basal-bolus manner. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in target range | Time each participant spent with glucose level in target range (3.9 - 10.0 mmol/L) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time between 3.9 - 7.8 mmol/L | Percentage of time each participant spent with glucose levels between 3.9 - 7.8 mmol/L | 4 weeks |
| Time below 3,9, 3.3, and 2.8 mmol/L | Percentage of time each participant spent with glucose levels below 3.9, 3.3, and 2.8 mmol/L |
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Inclusion Criteria:
Exclusion Criteria:
Discontinuation Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisa Cohen, BSs | Contact | 6472372366 | elisa.cohen@mail.mcgill.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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 two-way, randomized, open-label, controlled, crossover trial to compare the following strategies:
(i) Rapid insulin-plus-Pramlintide closed-loop delivery
(ii) Rapid insulin-plus-Placebo closed-loop delivery
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| Placebo | Drug | Placebo (saline) delivered in a basal-bolus manner at a fixed ratio with insulin. |
|
| Pramlintide Acetate | Drug | Pramlintide acetate delivered in a basal-bolus manner at a fixed ratio with insulin. |
|
| Artificial Pancreas | Device | Tandem insulin pump, Dexcom G6 sensor, study smartphone running the iMAP algorithm. |
|
| 4 weeks |
| Time above 7.8, 10.0, 13.9, 16.7 mmol/L | Percentage of time each participant spent with glucose levels above 7.8, 10.0, 13.9, and 16.7 mmol/L | 4 weeks |
| Mean glucose level | Each participant's mean glucose level | 4 weeks |
| Total insulin delivery | Each participant's total insulin delivery | 4 weeks |
| Standard deviation and coefficient of variance | Each participant's standard deviation and coefficient of variance of glucose levels as a measure of glucose variability | 4 weeks |
| Gastrointestinal symptoms | Number of each participant's gastrointestinal symptoms | 4 weeks |
| Number of hypoglycemia events | Each participant's number of hypoglycemia events defined as at least 15 min below 3.0 mmol/L with the end of the event being 15 minutes > 3.9 mmol/L. | 4 weeks |
| 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 |
|---|---|
| D061266 | Insulin, Short-Acting |
| C105254 | pramlintide |
| D019397 | Pancreas, Artificial |
| ID | Term |
|---|---|
| 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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