Dive Brief:
- Bigfoot Biomedical has linked its smart pen cap system to improved control of blood sugar in an analysis of real-world use.
- The system, which attaches to insulin pens and connects to a continuous glucose monitor (CGM), provides recommended meal and correction doses and alerts users when they miss a dose.
- In a retrospective analysis of 58 early adopters of the system, Bigfoot tracked a 1% improvement in glycemic control and generated evidence it helps patients who take multiple daily injections.
Dive Insight:
Bigfoot received 510(k) clearance for its diabetes management system in 2021. The system is designed to address problems such as missed doses, inadequate insulin intensification and dosing errors that affect people with diabetes who require multiple daily injections. Bigfoot’s system integrates with Abbott’s FreeStyle Libre CGM to incorporate glucose data and provide real-time glycemic alerts.
To see how the system performs in the real world, Bigfoot analyzed clinical outcomes data on 58 people with diabetes, mostly Type 2. Using glucose management indicator (GMI) as a proxy for the blood sugar measure HbA1c, the researchers showed improvements in glycemic control. GMI was used as a proxy because limited HbA1c data were available from after the patients started using the system.
The researchers, writing in the journal Clinical Diabetes, reported that the 36 users with prior CGM experience had a baseline HbA1c of 8.2% and GMI at six months of 7.3%. In the 12 users without prior CGM experience, the baseline HbA1c and six-month GMI figures were 9.0% and 7.1%, respectively.
Glucose levels were low 1.4% of the time and very low 0.2% of the time. Treatment guidelines advise that patients have low glucose levels less than 4% of the time and very low glucose levels no more than 1% of the time.
“These data indicate that, for this cohort consisting primarily of older adults with type 2 diabetes who were on [multiple daily injection] therapy with suboptimal glycemic control, using the system has the potential for rapid and durable improvement in glycemic control,” the researchers concluded.
Bigfoot faces competition from manufacturers such as Insulet, Medtronic and Tandem Diabetes Care that are generating evidence showing insulin pumps may provide better glycemic control than multiple daily injections.