An experimental new device called Diabetes Insulin Guidance System (DIGS) from Hygieia, Inc. (Ann Arbor, MI) is being developed to automate insulin dosage titration in patients with type I and type II diabetes, based on measurements of blood glucose and analysis of patterns in the obtained data. The company hopes one day to provide patients with an automatically calculated insulin dosage adjustments between doctor visits, in hopes of improving their glycemic control.
The company’s clinical advisory board is packed with diabetes experts such as Martin Abrahamson, MD from Joslin Diabetes Center in Boston, so they obviously know what they are doing. And the latest data seems to confirm that. A recent publication in Diabetes Technology and Therapeutics is quite positive for the technology, as it demonstrated DIGS’ potential to improve blood glucose control for insulin-using patients with type 2 or type 1 diabetes. Over the 12-week intervention period of the study, investigators observed:
- Out of a total of 1,734 individual dosage adjustments, the study team over-rode the DIGS-instructed dosage only twice.
- Mean HbA1c levels decreased from a baseline of 8.4%(±0.8) to 7.9%(±0.9); (p
- Average patient blood glucose levels improved progressively from a baseline of 174.2 mg/dL(±36.7) to 163.3mg/dL(±35.1); (p
- Glucose levels falling below the hypoglycemic threshold (glucose < 65 mg/dL) during the 12-week active phase were significantly milder than the ones reported during the 4-week run-in period (P = 0.02).
Beth North, Hygieia, Inc.’s VP of Marketing provided us with more details about the system in the following statement:
Without getting stuck in the weeds of too much detail – here’s the logic of how DIGS works. Per our “patient-first” design approach, DIGS communicates with its user in a very simple and logical way. DIGS is about the size of a BlackBerry device and nothing attaches to the patient. The patient uses DIGS to measure their blood glucose, then DIGS recommends the amount of insulin to inject. DIGS is designed to make insulin therapy more effective. If DIGS sees glucose patterns are too high, it increases insulin dosage; if it sees lows, it reduces insulin dosage. The exact specifics of “how” it does this populate about 20,000 lines of code.
From all indications, when applied, these lines of code result in a good outcome. As mentioned in our press release DIGS generated 1734 individual insulin dosage adjustments during the IDC study and in all but two instances the study team gave the DIGS-generated dosage updates directly to the patients to use each week. And over the 12 weeks of the active phase, all the study participants benefited significantly.
As Rich Bergenstal, the PI for the published study said, “This demonstrates the possibility that DIGS could automate weekly dosage adjustment safely and effectively – something that none of our current tools is capable of achieving.”
DIGS is designed to extend the reach of the health care provider when they can’t be with their patients – between office visits. Because Hygieia’s unique approach is self-contained and handheld, DIGS is scalable and works in a way that makes it a feasible solution for thousands of health care professionals treating millions of insulin users (who mainly have type 2 diabetes). It is designed to make insulin therapy more effective and avoid adding burden to an already over-burdened system of diabetes health care delivery.