New Interventions for Controlling Diabetes

Diabetes Intervention

As a complex metabolic disease, diabetes does not lend itself to a wide variety of interventions and concurring the disease does not appear to be an event that medicine will see in the near horizon. For these reasons, and because diabetes can be such a devastating disease, research that shows promise of positively impacting the course of the disease is greeted with enthusiasm by the medical community and the public.

Blood glucose levels must be strictly regulated in order to avoid the complications that diabetes can create. A substantive stumbling block is the difficulty of achieving consistent glycemic control without occurrences of hypoglycemia. Indeed, this factor is a primary obstacle to obtaining regulatory approval of an artificial pancreas. Earlier research has focused on automatic systems that monitor the levels of glucose and stop insulin flow when the blood glucose drops too low. While this is a viable approach, it can only limit -- but not eliminate -- the impact of hypoglycemia. Dr. Steven Russell at Massachusetts General Hospital is taking another tack: his research focuses on automated systems that use glucagon to prevent hypoglycemia. The systems Russell is developing combine closed-loop glucagon and closed-loop insulin delivery -- in effect, the Russell system functions as a bionic pancreas.

The Research

Russell, et al. (2014) are conducting a line of research that is receiving considerable attention: automated glycemic management through the use of an automated, wearable "bionic" pancreas. The effectiveness and safety of this type of system has just recently been subjected to multiday, random-order, crossover studies. Russell, et al. (2014) developed and compared two interventions: 1) Glycemic control with a wearable, bihormonal, automated, "bionic" pancreas; and, 2)glycemic control with an insulin pump. Over a period of five days, 20 adults and 32 adolescents with type 1 diabetes mellitus participated in the study. The bionic pancreas automatically adapted to the stream of continuous data sent by the glucose monitor in order to control the appropriate delivery of subcutaneous glucagon and insulin.

Results

The wearable, automated, biohormonal, bionic pancreas was found to improve the mean glycemic levels in both the adults and the adolescents with type 1 diabetes mellitus. In addition, there were less frequency hypoglycemic episodes than occurred with the insulin pump. The specific results for the comparison, which are shown separately for the adults and the adolescents, study follow.

Findings for adults. "[T]he mean plasma glucose level over the 5-day bionic-pancreas period was 138 mg per deciliter (7.7 mmol per liter), and the mean percentage of time with a low glucose level (

Findings for adolescents. "[T]he mean plasma glucose level was also lower during the bionic-pancreas period than during the control period (138±18 vs. 157±27 mg per deciliter [7.7±1.0 vs. 8.7±1.5 mmol per liter], P=0.004), but the percentage of time with a low plasma glucose reading was similar during the two periods (6.1% and 7.6%, respectively; P=0.23)" (Russell, et al., 2014). "The mean frequency of interventions for hypoglycemia among the adolescents was lower during the bionic-pancreas period than during the control period (one per 1.6 days vs. one per 0.8 days, P

Background

The results of the Russell, et al. (2014) research are compelling and will be expanded to studies that engage larger numbers of subjects and for longer multiday periods ("ADA," 2014). Additional research is necessary to for more refined development of the intervention and for obtaining regulatory approval of an artificial pancreas that consistently prevents hypoglycemia.