Pathway to Artificial Pancreas Systems Revisited: Moving Downstream
Article Figures & Tables
Figures
- Figure 1
2009 AP road map. A target-product profile-based approach to envision iterative steps of increasing automation of insulin delivery initially toward a more physiological multihormone delivery eventually.
- Figure 2
For new technologies to succeed, they must demonstrate value to key stakeholders. An example/nonexhaustive list of areas of importance is shown.
- Figure 3
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 (AID) and multihormone approaches (MH), which may utilize insulin and glucagon, insulin and amylin, or insulin and other glucose-modulating agents.
Tables
- Table 1
AP road map in 2015: proof of concept of five of six steps of iteratively more sophisticated AP systems has been demonstrated in outpatient trials
Step 1 2 3 4 5 6 Name LGS Predictive LGS (PLGS) Hypoglycemia hyperglycemic minimizer (HHM) Hybrid closed loop (HCL) Fully automated insulin delivery Multihormone (MH) Synonyms Threshold suspend (TS) Predictive low-glucose management system (PLGM) Treat-to-range system (TTR) Treat-to-target system (TTT) Fully closed loop (FCL) Insulin-glucagon system, bionic pancreas Description Insulin shuts off upon crossing preset threshold such as 70 mg/dL and resumes after 2 h Insulin shuts off or is attenuated upon prediction of impending hypoglycemia and resumes delivery when hypoglycemia risk is gone Same as step 2 but with automatic insulin dosing to reduce hyperglycemia exposure. Does not target euglycemia, rather the minimization of time spent above a certain threshold, i.e., 180 mg/dL Algorithm aims for euglycemic target, not range, but relies on mealtime insulin bolus Fully automated insulin delivery with minimal human interaction Fully automated multihormone approach; insulin plus glucagon, amylin, or other hormones/analogs 2015 status Commercialized globally Regulatory approval outside U.S., commercial availability in Australia In commercial development In commercial development Proof of concept In commercial development Example of supporting data Reduction in hypoglycemia, reduction in severe hypoglycemia, maintenance of A1C (29,43) Reduction in severe and moderate hypoglycemia (20,44) Reduction in time spent hyperglycemic and hypoglycemic and increased time in target range in outpatient settings (45) Reduction in time spent hyperglycemic and hypoglycemic and increased time in target range in outpatient settings (24,46) Reduction in hyperglycemia and hypoglycemia and increase in time in target in an inpatient settings (42,46) Reduction in hyperglycemia and hypoglycemia and increase time in target in outpatient setting (9)
In this Issue
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- Article
- Abstract
- Introduction
- Key Question: What is an AP?
- Key Questions: Do We Need AP Systems? Is There an Unmet Need? Are Diabetes Outcomes Suboptimal Because Tools Are Lacking or Because of Lack of Compliance With Today’s Therapies?
- Key Questions: Are AP Systems Technically Feasible Today? Can an AP System Replicate the Function of the Islet?
- Key Question: Must AP Systems Use Glucagon?
- Key Questions: Where Do We Go From Here? What AP Systems Will Reach the Clinic and When?
- Key Question: Where Will the AP Field Head in the Next 10 Years?
- Summary
- Article Information
- Footnotes
- References
- Figures & Tables
- Info & Metrics