Pilot Study Evaluating Safety of ExOlin® in Patients With Poorly Controlled Type 1 Diabetes

What Was Tested

The trial (not phased) is built around Insulin Aspart.

First in Human, pilot investigation An Open Label, Monocentric, Pilot Study Evaluating Safety of ExOlin® in Patients with Poorly Controlled Type 1 Diabetes with High Glucose Fluctuations, Prone to Severe Hypoglycemia.

It had 1 arm (groups): test arm (experimental).

All patients will be enrolled in same arm which contains the two interventions (device + drug) and follow mandatory phases of trial: screening, implantation, treatment with ExOlin, explantation.

The registry classes the interventions as device and drug.

Who Took Part

8 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult men or women (age ≥ 18 years);. Diagnosis of Type 1 Diabetes (T1D) for more than 2 years at the start of screening;. Body mass index (BMI) \> 16 kg/m2 and \< 35 kg/m2;. Well managed intensive SubCutaneous (SC) insulin therapy, i.e. patient using for at least 3 months:. CSII, whatever the insulin pump used, and.

The full record lists 15 inclusion and 25 exclusion criteria; among the exclusions: immunocompromised patient;; local or systemic acute or chronic inflammation (rheumatoid arthritis, sclerodermia);; active infection or inflammation;.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2022-05-05 with completion listed for 2026-12.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Safety: Percentage of patients who will experience at least one relevant adverse event (AE) judged by the investigator as probably or highly probably related to ExOlin® for the duration of mandatory phases of the study. Safety: Percentage of patients who will experience at least one relevant adverse event (AE) judged by the investigator as probably or highly probably related to ExOlin® for the whole duration of the study (extension phase included).

It also tracked 7 secondary outcomes, for example Safety: Percentage of participants with abnormal vital signs or physical findings, Early Performance: Glycemic control, Early Performance: Glycemic control, Early Performance: Glycemic control, Early Performance and Quality of Life: Overall score and subscores of the Diabetes Quality of Life (DQOL) questionnaire.

What This Means in Plain Language

Put simply, this is a not phased trial of Insulin Aspart in 8 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Aspart compound page, all human trials.