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Will 2017 Bring Us the First Artificial Pancreas for Type 1 Diabetes?

System shows significant improvement in HbA1c compared to current best therapy available.

With several trials under way this year, we may see an artificial pancreas come to market as early as 2017. The artificial pancreas system, which replicates the organ and mimics a normal glucose regulating system, consists of an insulin pump, a continuous blood glucose monitor, and cell phone software that detects the patient’s insulin needs based on activity, sleep, metabolism, and other factors. Systems under development range from fully automated systems that require little user input to determine insulin needs to systems that use active user input.

Prior studies report that artificial pancreas (AP), also known as closed-loop insulin delivery systems, is comprised of a continuous subcutaneous glucose monitor (CGM), a continuous subcutaneous insulin infusion (CSII) and a mathematical control algorithm, which showed that CSII pumps can control blood glucose in subjects with type 1 diabetes.

The objective of this study was to assess that an artificial pancreas prevents hypo- and hyperglycemia related to complications as well as ease the regular burden of repeated blood glucose measurement and insulin management. A pilot study comprised of (n=17) subjects were recruited and 18 studies were performed. Patients allowed in the study were those with a minimum age of 18 or 21 depending on their group, having type 1 diabetes for at least a year with no comorbidity and having been on insulin pump for at least 6 months.

The primary outcomes of measurement were the interstitial glucose concentrations. Intravenous blood glucose levels were also measured every 30 minutes using a short-acting insulin analog used in clinical trials. Patients were admitted with a prior insertion of two CGMs 1-2 days before and patients were also required fast from 10 p.m. the previous day. Patients were refrained from giving insulin at 3 a.m. before the admission date unless they were hypoglycemic with a glucose level of <70 mg/dL. The insulin pump was replaced with the OmniPod system when they were admitted and then connected to APS. Normalizing glycemia and maintaining euglycemia at target of 110± 30 mg/dL and overcoming an unannounced meal of 30 ± 5g carbohydrates.

Glucose concentration from outpatient and inpatient CGM data provided P<0.05, which were statistically significant and showed that closed-loop control minimized hypoglycemia <70 mg/dL and improved the near normal range of >250 mg/dL. The meal size of inpatient and outpatient were almost alike. There was no hypoglycemia reported by YSI with only 2% reporting <70 mg/dL by CGM and postprandial peaks of 251 and 263 mg/dL from two trials.

The purpose of this study was to demonstrate that a fully automated AP device, connected to MPS with personalized safety component is capable of controlling glycemia by delivering insulin without postprandial hypoglycemia. However future studies to design AP so it follows a top –down approach that addresses control challenges like issues with CGM accuracy to overcome insulin kinetics and control for physical activity needs to be addressed.

 

Practice Pearls:

  • The artificial pancreas is a device that automatically prevents both hypo and hyperglycemia associated with complications in people with type 1 diabetes and does not rely on user’s involvement to regulate blood glucose.
  • It relieves the regular load of glucose measurement and insulin administration.
  • It is able to control and successfully adjust glycemia and initial hyperglycemia even with unannounced meals.

 

Atlas, Eran et al. “MD- Logic Artificial Pancreas System: A Pilot Study in Adults with Type 1 Diabetes” Diabetes Care 33.5 (2010): 1072-1076. PMC Web. 5 June 2016.

Bruttomesso, Daniela et al. “Closed- Loop Artificial Pancreas Using Subcutaneous Glucose Sensing and Insulin Delivery and a Model Predictive Control Algorithm: Preliminary Studies in Padova and Montpellier. “ Journal of diabetes science and technology (online) 3.5 (2009): 1014-1021. Print.