Validation of Algorithms for Basal Insulin Rate Reductions in Type 1 Diabetic Patients Practising Physical Activity in Real Life Conditions

Summary

There is no specific recommendations on the adjustments of the insulin treatment in the event of physical activity (PA) in T1D patients treated on insulin pump therapy. Patients often prefer additional carbohydrates intake rather than the reduction of their insulin doses because of the lack of specific algorithms.

The DIABRASPORT 2 study aims to demonstrate that using algorithms DIABRASPORT, during a week of physical activity (PA), the incidence of hypoglycaemia is not different from that obtained during a week of rest without physical activity.

It is a multi-center European, controlled, randomized, cross-over, study, in 100 T1D patients practicing an occasional AP.

25 centers involved in this study.

After agreeing to participate in the study, patients will read the information leaflet, ask questions to the investigator physician and they will date and sign the consent form. The investigator physician will do the same.

They will be then drawn randomly via the electronic CRF (eCRF) to determine the order in which they will realize the rest vs DIABRASPORT sessions.

The study will take place in 5 weeks:

During the weeks Baseline and Diabrasport, patients will have to make 3 physical activity of 30 to 60 minutes separated by at least 24 hours:

* moderate activity 3 hours after lunch
* intense activity 3 hours after lunch
* activity moderate 90 min after lunch They will use their usual algorithms (Cho intake or adjustment of the dose of insulin) during the week Baseline and they will use the Diabrasport algorithm during the week Diabrasport.

Patients will be equipped with a holter Glycemic iPro2, Medtronic, whose data are hidden.

During the week of rest, patients should do no physical activity during the week. They will be equipped with the Glycemic holter.

Patients will have to fill a food survey the days they practice PA. Between each period, the patient must respect a period of wash-out for one week at least, during which he will be asked to not practice physical activity.

Validation of algorithms simple, easy to implement, adaptable by patients, could help to improve balance metabolic and practice of sport among the T1D.

Conditions

• Diabetes Mellitus, Type I
• Adjustment of Basal Insulin Flow Rate During Physical Activity
• Adjustment of Prandial Insulin in Case of Physical Activity

Interventions

BEHAVIORAL

Usual algorithm

The patient will be fitted with a CGMS (continuous glucose monitoring system) (data not shown) and it will be given the booklet to collect events + food survey The patient goes home and he must perform 3 physical activities during the week (30-60 minutes) using its usual algorithms (glucose administration or adaptation of the BR), in the afternoon, and spacing them at least 24 hours : * Moderate activity 3 hours after lunch * Intense activity 3 hours after lunch * Moderate activity 90 min after lunch These activities should not exceed 1 hour in wherever possible

BEHAVIORAL

Diabrasport algorithm

The patient will be fitted with a CGMS (data not shown) and it will be given the booklet to collect events + food survey The patient goes home and he must perform 3 physical activities during the week (identical to those carried out during the week "test algorithms usual" and during comparable periods) using DIABRASPORT algorithms, the afternoon and in the spacing at least 24 hours: * Moderate activity 3 hours after lunch * Intense activity 3 hours after lunch * Moderate activity 90min after lunch These activities shall not exceed one hour

BEHAVIORAL

Rest

The patient will be fitted with a CGMS (data not shown) and it will be given the booklet to collect events + food survey. The patient goes home and he will not perform any physical activity during the week

DEVICE

Holter Glycemic Ipro2, Medtronic

Sponsors & Collaborators

• Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2020-03-31

Completion

2020-03-31

Countries

• France

Study Locations