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The way forward: the JDRF roadmap to an artificial pancreas  329




                  old, adolescents defined as 14e25 years old, and adults defined as >25 years old),
                  only the adult cohort showed a lowering of HbA1c levels ( 0.5%) with the use of
                  sensor therapy at the end of the 26-week trial [13]. However, secondary analyses
                  of the data confirmed that beneficial impacts of the sensor were documentable in
                  all study participants who, regardless of the age cohort, used the sensor at least
                  6 days per week [13].
                     In recent years, CGM use in persons with T1D has grown exponentially [12].
                  Several factors played a role including increased duration of wear to 1e2 weeks’
                  time and factory calibrations in some of the systems that obviate the need for finger-
                  stick calibration. Similarly, substantial improvements in accuracy have been
                  achieved. Furthermore, the US Food and Drug Administration (FDA) approval of
                  nonadjunctive CGM use, whereby treatment decisions can be made based on sensor
                  glucose values, may have also provided the impetus for patients to embrace this
                  technology [14,15].




                  The way forward: the JDRF roadmap to an artificial pancreas
                  With the building blocks assembled, the quest to automate insulin delivery was
                  undertaken. JDRF created the Artificial Pancreas (AP) Project in 2006, forging a
                  path forward to boost scientific research in creating a commercially available
                  closed-loop system for patients with T1D. Furthermore, a “roadmap” (Fig. 16.1)
                  was created to clearly define the steps in the process of automation, recognizing
                  that insulin suspension based on low sensor glucose values was inherently less risky



















                  FIGURE 16.1
                  Revised AP road map. AP system development can be condensed from six steps to three
                  and has bifurcated into automated insulin delivery approaches utilizing solely insulin and
                  multihormone approaches, which may utilize insulin and glucagon, insulin and amylin, or
                  insulin and other glucose-modulating agents.
                  Used with permission from Kowalski A. Pathway to artificial pancreas systems revisited: moving downstream.
                                                            Diabetes Care 2015;38(6):1036e1043.
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