Effect of type 1 Diabetes on sleep fragmentation clinical trial begins in France

Photo by Gregory Pappas

The University Hospital, Grenoble is conducting the clinical trial effect of type 1 diabetes on sleep fragmentation (DIAPASOM5).

The main objective of this study is the objective evaluation of disease related sleep fragmentation in subjects with type 1 diabetes.

It is planned to include 3100 participants.

Actual study start date is October 19, 2020. The researchers expect to complete the study by June 1, 2021.

The primary outcome measures are objective sleep fragmentation and the number of nocturnal awakenings objectively measured by the number of voluntary glycemia tests performed during the sleep period, according to freestyle recordings.

Among study population are adult patients having a self-reported type 1 diabetes.

The inclusion parameters are self-reported type 1 diabetes and using the freestyle capillary meter.

The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04601519) Grenoble, France.