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

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

March 31, 2020

Study Completion Date

March 31, 2020

Conditions
Diabetes Mellitus, Type IAdjustment of Basal Insulin Flow Rate During Physical ActivityAdjustment 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

Trial Locations (17)

13005

Hôpital de la Conception, Marseille

25030

Hôpital Jean Minjoz, Besançon

29609

Hôpital Universitaire, Brest

33700

Mérignac

35056

Centre Hospitalier Universitaire, Rennes

38043

Hôpital Universitaire, Grenoble

39108

Centre Hospitalier Louis Pasteur, Dole

49933

Hôpital Universitaire, Angers

59037

Centre Hospitalier Régional Universitaire, Lille

59322

Hôpital Jean Bernard, Valenciennes

59507

Centre Hospitalier, Douai

67000

Centre Hospitalier Régional Universitaire, Strasbourg

69310

Centre Hospitalier Universitaire, Lyon

71200

Fondation Hôtel Dieu du Creusot, Le Creusot

84902

Hôpital Henri Duffaut, Avignon

88187

Centre Hospitalier, Saint-Dié

91100

Centre Hospitalier Sud-Francilien, Corbeil-Essonnes

All Listed Sponsors
lead

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

OTHER

NCT02521675 - Validation of Algorithms for Basal Insulin Rate Reductions in Type 1 Diabetic Patients Practising Physical Activity in Real Life Conditions | Biotech Hunter | Biotech Hunter