Type 1 Diabetes—Reaping the Rewards of a Targeted Research Investment

Judith E. Fradkin; Julie A. Wallace; Beena Akolkar; Griffin P. Rodgers

Disclosures

Diabetes. 2016;65(2):307-313. 

In This Article

Artificial Pancreas Technologies

Despite the unequivocal evidence of the benefit of early intensive glycemic control, many people, especially teens, are unable to achieve the tight control achieved in the DCCT. Population-based data from the SDP-supported SEARCH for Diabetes in Youth (SEARCH) study found one in five teenagers with type 1 diabetes have HbA1c levels above 9.5% (80 mmol/mol).[5] Data from the T1D Exchange Clinic Registry show that teenagers aged 13–17 years have a mean HbA1c of 9.0% (75 mmol/mol), and only 14% of young adults aged 18–25 years achieve an HbA1c ≤7.0% (53 mmol/mol).[6] Teenagers' mean HbA1c is closer to that achieved by the conventional than the intensive control group in the DCCT, indicating that achieving the recommended intensive glucose control and attaining its long-term protective effects is particularly challenging in this age-group. Thus, new approaches to improve glucose control are urgently needed.

Pragmatic research to develop and test new therapies for type 1 diabetes is a high priority for the SDP. A major investment was made toward the development of an artificial pancreas—technology linking a continuous glucose monitor to an insulin pump with an algorithm that calculates and instructs delivery of an appropriate amount of insulin. Artificial pancreas technology could mitigate the major barriers to intensive glucose control: hypoglycemia and patient burden. SDP funds have been successfully deployed to support improved components of the artificial pancreas as well as a succession of studies testing their combined use, first in animals and then in people. Importantly, some controllers, key components of the artificial pancreas, have been designed to be interoperable with a variety of pumps and sensors and to use off-the-shelf smartphones as computational hubs, facilitating the continual improvement in these individual components.[7] Clinical trials have progressed rapidly from short-duration studies in closely supervised conditions to multiday use in free-living environments. Multidisciplinary teams including clinicians, bioengineers, and behavioral scientists were created to develop and test new devices, culminating in the development of improved devices that are performing well in real-world settings. One small study in adolescents found that the unsupervised, overnight use of an artificial pancreas device for 21 nights led to improved daytime and nighttime glucose control and reduced the number of episodes of nighttime hypoglycemia, even though subjects used standard glucose sensor and pump therapy during the day.[8] In another study, use of an automated, bihormonal, "bionic" pancreas for 5 days and 5 nights by 21 adults and 32 adolescents led to lower mean glucose levels and reduced episodes of hypoglycemia. In fact, the bionic pancreas allowed nearly all subjects to achieve the recommended levels of glucose control.[9] The U.S. Food and Drug Administration (FDA) is working closely with the NIH and investigators to facilitate this research. The NIH is now making awards for clinical trials to further expand the testing of artificial pancreas technologies in order to generate safety and efficacy data toward FDA approval of these devices.

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