Smart pen and sensor combo aims to simplify diabetes management

NCT ID NCT06645834

Completed Disease control Sponsor: Medtronic MiniMed, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a smart system that combines a Bluetooth-enabled insulin pen with a continuous glucose monitor to help people with type 1 diabetes manage their blood sugar. 179 participants used either the smart system or standard insulin injections and glucose monitoring for 6 months. The goal was to see if the smart system helped them stay in their target blood sugar range more often.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Smart MDI System (InPen smart insulin pen and Simplera continuous glucose monitor)
What this could lead to: If successful, this smart system could help people with type 1 diabetes spend more time in their target blood sugar range, making daily diabetes management easier and safer.
What could go wrong: This is a completed study comparing a device to standard care, so results are already known. However, the device may not work for everyone, and benefits might be modest.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DIABETES MELLITUS, TYPE 1

Contacts and locations

Locations

ASST Spedali Civili Brescia

Brescia, Italy
Antwerp University Hospital

Antwerp, Belgium
CHRU de Brest service diabetologie endocrinologie

Brest, France
CHU Liege

Liège, Belgium
CHU Nimes

Nîmes, France
Center for DIABeCare, Hospices Civils de Lyon

Lyon, France
General University Hospital

Prague, Czechia
Hannoversche Kinderheilanstalt

Hanover, Germany
Hogsbo Narsjukhus

Västra Frölunda, Sweden
Hospital Rangueil

Toulouse, France
Hospital Universitaire Bruxelles Erasme

Brussels, Belgium
IKEM

Prague, Czechia
MVZ Stoffwechselmedizin Leipzig

Leipzig, Germany
Sahlgrenska University Hospital

Gothenburg, Sweden
UZ Leuven

Leuven, Belgium
Uddevalla Hospital

Uddevalla, Sweden
University of Bari Aldo Moro

Bari, Italy
Zentrum fur digitale Diabetologie Hamburg

Hamburg, Germany

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