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ORLANDO -- An artificial pancreas that combines two hormones led to better glucose control after meals in patients with type 1 diabetes, researchers reported here.
Patients who used the dual-hormone dual pump system loaded with rapid-acting insulin and Pramlintide (Symlin) spent 86% of the time in glucose control (3.9% mmol/L to 10.0% mmol/L) during the post-meal period (P=0.001), according to Ahmad Haidar, PhD, of McGill University in Montreal, and colleagues.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
That compared with 74% of the time among patients who were treated with a pump loaded with rapid insulin, or 68% of the time with a pump loaded with pramlintide plus regular insulin (P=0.01) , he said at a press conference at the American Diabetes Association (ADA) annual meeting.
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. Amylin is completely absent in individuals with type 1 diabetes.
Pramlintide received FDA approval in 2005 for use in adults with type 1 and type 2 diabetes.
"Insulin-alone artificial pancreas systems improve glucose control compared with conventional pump therapies. However, post-meal control remains a challenge," Haider explained.
The pilot study included 28 patients with type 1 diabetes, and Haidar reported on outcomes among all but one of those patients.
Haidar noted that patients on the dual pump system also lowered their mean glucose level to 7.4 mmol/L compared with mean glucose levels of 7.9 mmol/L among patients in the other two groups.
Each of the participants in the trial underwent three 24-hour experiments with their glucose levels controlled with each of the systems. Their glucose was checked at baseline, at breakfast, at lunch, at dinner, and after and post-dinner snack. Before the intervention, the patients wore the dual pumps for a 2-week period to get them adjusted to the devices. Haider said there were no issues with the drug's stability.
Two participants on the dual-hormone pump experienced moderate versus zero patients on the insulin-only pump. There was no benefits associated with regular insulin-pramlintide pump versus the insulin-only pump during day or night period, the authors reported.
Haidar told ľֱ that future studies will include a larger patient population, but "Our study provides information that using the rapid insulin plus pramlintide is beneficial to patients in controlling post-meal glucose levels...we were impressed 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," he added.
ADA press conference moderator Irl Hirsch, MD, of the University of Washington in Seattle, said new technologies "have clearly improved diabetes control and quality of life, especially for people with type 1 diabetes."
Disclosures
Haidar disclosed relevant relationships with Eli Lilly, AgaMatrix, and Medtronic MiniMed.
Hirsch disclosed relevant relationships with Abbott, ADOCIA, Bigfoot Biomedical, Roche Diabetes Care Health, Digital Solutions and Medtronic MiniMed.
Primary Source
American Diabetes Association
Haidar A, et al "Insulin-plus-Pramlintide Artificial Pancreas in Type 1 Diabetes -- Randomized Controlled Trial" ADA 2018; Abstract 210-OR.