Validation of Algorithms for Basal Insulin Rate Reductions in Type 1 Diabetic Patients Practising Physical Activity in Real Life Conditions
NCT ID: NCT02521675
Last Updated: 2021-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2016-01-31
2020-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Diabrasport then Rest
Between each period, the patient should respect a wash-out period of at least one week, during which they will be asked not to practice physical activity.
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
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
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
Holter Glycemic Ipro2, Medtronic
Rest then Diabrasport
Between each period, the patient should respect a wash-out period of at least one week, during which they will be asked not to practice physical activity.
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
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
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
Holter Glycemic Ipro2, Medtronic
Interventions
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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
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
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
Holter Glycemic Ipro2, Medtronic
Eligibility Criteria
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Inclusion Criteria
* Patient with type 1 diabetes for at least 1 year
* Patient receiving insulin pump under basal-prandial regimen for at least 3 months
* Patient practicing functional insulin therapy, or using a fixed plane defined food
* Patients with a stable basal rate for at least 1 week
* Patient practicing regular physical activity and reproducible identically
* Patient with HbA1c older than 3 months between 6.5% and 9.5% (HbA1c ≤ 6.5% ≤ 9.5%)
* Patients with BMI ≤ 35
* Patient who agreed to participate in the study and who signed an informed consent
* Patient not participating in another protocol
* Patient covered by social security
Exclusion Criteria
* Patient not receiving its hypoglycaemia below the threshold of 0.5 g / L
* Patient with perforating foot ulcer or a known history of heart disease or obliterative arteriopathy of the lower limbs, or a history of cerebrovascular accident, or ongoing proliferative retinopathy or renal failure
* Patient with poorly controlled hypertension
* Pregnant woman
* Patients deprived of liberty by judicial or administrative decision, patients placed under legal guardianship
18 Years
ALL
No
Sponsors
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Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
OTHER
Responsible Party
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Locations
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Hôpital Universitaire
Angers, , France
Hôpital Henri Duffaut
Avignon, , France
Hôpital Jean Minjoz
Besançon, , France
Hôpital Universitaire
Brest, , France
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes, , France
Centre Hospitalier Louis Pasteur
Dole, , France
Centre Hospitalier
Douai, , France
Hôpital Universitaire
Grenoble, , France
Fondation Hôtel Dieu du Creusot
Le Creusot, , France
Centre Hospitalier Régional Universitaire
Lille, , France
Centre Hospitalier Universitaire
Lyon, , France
Hôpital de la Conception
Marseille, , France
Mérignac, , France
Centre Hospitalier Universitaire
Rennes, , France
Centre Hospitalier
Saint-Dié, , France
Centre Hospitalier Régional Universitaire
Strasbourg, , France
Hôpital Jean Bernard
Valenciennes, , France
Countries
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Other Identifiers
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2015-A00709-40
Identifier Type: -
Identifier Source: org_study_id
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