Novel system with MDI improves glycaemic control in adults with T2D

Older adults with type 2 diabetes (T2D) who are using multiple daily insulin injections (MDI) and the Bigfoot Unity System demonstrate durable glycaemic improvement at 6 months, reports a study.

The System combines CGM data into a smart insulin pen cap and mobile app, allowing clinician-directed insulin dose recommendations and alerts in real time.

Furthermore, the frequency of hypoglycaemia is substantially lower than the established targets of <4 percent and <1 percent for time below 70 and 54 mg/dL, respectively.

“For this cohort, consisting primarily of older adults with T2D and having suboptimal glycaemic control, using the System resulted in rapid and durable improvement in glycaemic control,” the researchers said. 

“Improvement in glycaemic control, accompanied by psychosocial benefits, did not appear to compromise the cohort in meeting established standards for hypoglycaemia and diabetic ketoacidosis (DKA),” they added. 

A total of 102 participants (median age 59 years, 59 percent female, 62 percent White non-Hispanic) were included in the per protocol cohort. Of these, 87 percent had T2D and 42 percent used CGM. [J Clin Endoc Metab 2025;110:2134-2146]

At 6 months, the mean HbA1c decreased to 8.0 percent from 9.1 percent at baseline (mean difference, –1.1 percent, 95 percent confidence interval, –1.4 to –0.8; p<0.001). Moreover, time in range was 56 percent, time at <70 mg/dL was 1.0 percent, and time at <54 mg/dL was 0.04 percent.

With regard to safety, four participants experienced six severe hypoglycaemia events in total, none of which were related to the System. No diabetic ketoacidosis events were documented in the cohort.

“We found similar glycaemic outcomes regardless of race, age, diabetes duration, presence of baseline diabetes complications, income, education, and prior sensor experience, which speaks to the generalizability of System use,” the researchers said.

Insulin pens

Previous studies suggested the potential benefit of connected or smart insulin pens in enhancing MDI diabetes management and in supporting telemedicine. [J Diabetes Sci Technol 2020;14:801‐802; J Diabetes Sci Technol 2022;16:628‐634]

However, existing literature assessing the effectiveness and safety of this new technology remains scarce. A PubMed search in February 2024 retrieved 55 related articles, of which only 11 had relevant effectiveness- or safety-related data for connected insulin pen systems. Not one addressed the prospective collection of adverse events such as severe hypoglycaemia or DKA, the researchers said.

The current 6-month analysis reported similar results to 3-month data in a previous study and similar glycaemic control to a retrospective cohort using Bigfoot Unity. [Diabetes 2023;72(Suppl 1):936-P]

The present findings showed higher HbA1c at baseline (9.1 percent vs 8.4 percent), potentially indicating the health status or other demographic biases in adults who consented to participate in an ongoing study relative to those who did not. [BMJ 2009;338:b866]

Researchers conducted a 6-month analysis from the BURST study, which included individuals with type 1 diabetes or T2D. Baseline demographics, adverse events, and other survey data were obtained electronically. They also collected either at-home kit or electronic medical record HbA1c.