A dual-hormone artificial pancreas delivering rapid insulin and the drug pramlintide improved glucose management and reduced glucose variability in adults with type 1 compared to an insulin-only, first-generation artificial pancreas.
The study, “Artificial Pancreas in Type 1 Diabetes—Randomized Controlled Trial,” presented at the American Diabetes Association’s (ADA’s) 78th Scientific Sessions, showed us that managing T1D can be challenging, and maintaining healthy glucose levels is an integral part of preventing diabetes-related complications. Artificial pancreas systems work to automate blood-glucose management using a device that constantly monitors a person’s glucose levels and then delivers insulin or a combination of insulin and other blood-glucose-lowering medications to the body.
Pramlintide is a synthetic, injectable analog of amylin, a hormone that is produced by the pancreas and released into the bloodstream after meals to help regulate blood glucose levels. Like insulin, amylin is absent in individuals with T1D. Apart from insulin analogs, pramlintide is the only drug to lower glucose in people with T1D and approved by the Food and Drug Administration (FDA) since insulin was certified in the early 1920s. Pramlintide was approved by the FDA in March 2005.
This Canadian study was a randomized, crossover comparison of a first-generation, rapid, insulin-only artificial pancreas (AP), and two novel, dual-hormone, artificial pancreas systems: 1) a rapid insulin and amylin (pramlintide) artificial pancreas (DAP), and 2) a regular insulin (Humulin R) and amylin artificial pancreas (R-DAP). The study enrolled 12 adults (7 males and 5 females, average age 43 years) with T1D and an average HbA1c level of 7.6 percent. All participants were studied three times in a clinical research facility for 24 hours (each participant was studied using each of the three artificial pancreas systems). During each 24-hour period, each participant consumed three meals and a bedtime snack. Insulin and amylin were delivered simultaneously in a basal-bolus manner using a dosing algorithm with a fixed ratio, mimicking a co-formulation.
The results showed that, on average, the DAP system improved the patients’ glucose levels more than the AP system. The DAP had a longer time frame that participants spent in the target glucose range of 70-180 mg/dL.(3.9-10.0 mmol/L) (85 percent), compared to the AP system (71 percent; p=.03). The DAP system also decreased glucose variability more (34 percent), compared to the AP system (25 percent; p=.01). Further, the DAP system produced a reduced, mean glucose level of 133 mg/dL(7.4 mmol/L )compared to the AP system’s reduction to 8.2 mmol/L (p=.07), without increasing the risk of hypoglycemia. Overnight, DAP and AP achieved similarly positive rates in the target glucose range of 70-140 mg/dL. (3.9-7.8 mmol/L) (77 percent and 71 percent, respectively). However, moderate nausea was reported by two participants using DAP compared to no reports of nausea using AP. There were no benefits associated with R-DAP compared to AP during either the day or night study periods.
Lead study author Ahmad Haidar, PhD, assistant professor in the department of biomedical engineering, faculty of medicine at McGill University in Montreal, Canada, added that the results with the insulin-plus-pramlintide artificial pancreas were impressive by both the extent of improvements and the lack of side effects, considering these benefits were achieved without increasing the risk of dangerous low-glucose levels. This study shows that the first-generation, insulin-only artificial pancreas can be improved by delivering other hormones along with insulin, which will hopefully encourage the development of insulin-plus-pramlintide co-formulations.
Coming right behind this 2 hormone pump will be another with glucagon and insulin.
- The results showed that, on average, the DAP system improved the patients’ glucose levels more than the AP system.
- The DAP had a longer time frame that participants spent in the target glucose range of 70-180 mg/dL (3.9-10.0 mmol/L) (85 percent), compared to the AP system (71 percent; p=.03).
- The DAP system also decreased glucose variability more (34 percent), compared to the AP system (25 percent; p=.01).
ADA 78th Scientific Meeting June 24, 2018