Responding more frequently to MiniMed Smart MDI alerts linked to better glucose outcomes for people with diabetes – MiniMed

MiniMed presented new clinical evidence showing that people with type 1 diabetes using the MiniMed Smart MDI system who responded to more missed-dose and high-glucose alerts had, on average, 8.1 percentage points more Time in Range (TIR) and 0.6 percentage points lower HbA1c than lower responders in a six-month randomized controlled trial.

The data, from 143 people with type 1 diabetes and HbA1c above 8%, were presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes.

People who manage diabetes with multiple daily injections carry a large amount of the work in their heads. They monitor glucose, remember injections, calculate doses, and adjust around meals and daily life. Missed or delayed doses can affect glucose outcomes. Research indicates that missing two insulin doses a week can increase HbA1c by 0.4%.

Pump therapy remains recommended for people with type 1 diabetes, but not everyone wants or can access a pump. For people who choose multiple daily injections, the need is not more data alone. It is timely help that makes the next action easier to see and easier to take. Potentially achieving an additional 8% TIR and 0.6 percentage points lower HbA1c, thanks to actionable alerts, matters as it can reduce the risk of long-term complications.

MiniMed’s Smart MDI system connects the InPen smart insulin pen with a continuous glucose monitor through the MiniMed Go app. This smart pen system tracks doses, provides dose calculations, and sends missed-dose and high-glucose alerts alongside glucose insights. It brings those functions into one app instead of asking people to coordinate a pen, a glucose monitor, and dosing decisions separately.

“People managing diabetes with multiple daily injections are making insulin decisions all day, every day. MiniMed Go is designed to lighten that load by remembering, reminding, and recommending when it matters. The goal is to help them achieve better outcomes with less burden. That’s the promise of the MiniMed Go smart MDI system,” said Que Dallara, CEO of MiniMed.

The finding: Better outcomes for higher responders

i) Smart MDI users with a higher response rate to alerts achieved, on average, 8.1 percentage points higher TIR and 0.6 percentage points lower HbA1c compared with lower responders.

ii) Additional real-world analysis of more than 5,500 users found a 9.4 percentage-point difference in Time in Range between higher and lower responders. HbA1c was not analyzed in the real-world dataset.

iii) In this study, responding to at least 28% of missed-dose and high-glucose alerts was associated with improved HbA1c compared with multiple daily injections plus continuous glucose monitoring alone.

iv) The Smart MDI system met the primary endpoint and was non-inferior to multiple daily injections plus continuous glucose monitoring in glycemic outcomes.

v) No severe hypoglycemia or diabetic ketoacidosis events were reported in the Smart MDI arm during the study.

“These findings show a clear association between responding to Smart MDI alerts and better glucose outcomes. For people on multiple daily injections, that can mean more time in range with less day-to-day mental burden,” said Prof. Laurent Crenier, MD, PhD, Head of the Endocrinology Department at HUB – Hôpital Erasme in Brussels.

The results of the randomized controlled trial add to an existing study that showed that with only a minor increase in effort of ~1 additional bolus per week in response to a missed dose alert, users of MiniMed’s Smart MDI system gained an additional 2 hours of Time in Range.

Frequently Asked Questions
Q: What did the randomized controlled trial evaluate?
A: The six-month trial evaluated the effectiveness and safety of the MiniMed Smart MDI system compared with multiple daily injections plus continuous glucose monitoring in 143 people with type 1 diabetes and an HbA1c above 8%.

Q: What were the main findings of the Smart MDI randomized controlled trial?
A: Among Smart MDI users in the study , those with higher alert-response rates achieved, on average, 8.1 percentage points more Time in Range and a 0.6 percentage-point lower HbA1c than users with lower response rates. Real-world data from more than 5,500 users showed a 9.4 percentage-point difference in Time in Range between higher and lower responders. HbA1c was not included for review in the real-world data.

Q: What do the results suggest about responding to Smart MDI alerts?
A: The findings show an association between more consistent responses to missed-bolus and high-glucose alerts and better glucose outcomes. In this study, responding to ≥28% of alerts was associated with improved HbA1c compared with multiple daily injections plus continuous glucose monitoring alone. The Smart MDI system was non-inferior to multiple daily injections plus continuous glucose monitoring alone in glycemic outcomes, and no severe hypoglycemia or diabetic ketoacidosis events were reported in the Smart MDI arm.