Trials / Unknown
UnknownNCT04243629
Co-administration of Pramlintide and Insulin Via an Automated Dual-hormone Artificial Pancreas System in Adults With Type 1 Diabetes
Co-administration of Pramlintide and Insulin Via an Automated Dual-hormone Artificial Pancreas System to Regulate Glucose Levels in Adults Living With Type 1 Diabetes: a Randomized, Controlled, Crossover Trial.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- Sponsor
- McGill University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 rapid insulin in an artificial pancreas system will improve glycemic control in adults with Type 1 Diabetes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rapid-Acting Insulin | Novorapid or Humalog insulin delivered in a basal-bolus manner. |
| DRUG | Placebo | Placebo (saline) delivered in a basal-bolus manner at a fixed ratio with insulin. |
| DRUG | Pramlintide Acetate | Pramlintide acetate delivered in a basal-bolus manner at a fixed ratio with insulin. |
| DEVICE | Artificial Pancreas | Tandem insulin pump, Dexcom G6 sensor, study smartphone running the iMAP algorithm. |
Timeline
- Start date
- 2021-11-12
- Primary completion
- 2024-04-01
- Completion
- 2024-04-01
- First posted
- 2020-01-28
- Last updated
- 2023-03-15
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT04243629. Inclusion in this directory is not an endorsement.