Validation of Algorithms for Basal Insulin Rate Reductions in Type 1 Diabetic Patients Practising Physical Activity in Real Life Conditions (Diabrasport2)

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

Status: Completed

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

Treatments: Behavioral: Usual algorithm; Behavioral: Rest; Behavioral: Diabrasport algorithm; Device: Holter Glycemic Ipro2, Medtronic

Study type: Interventional

Funder types: Other

Identifiers

NCT02521675

2015-A00709-40

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient aged over 18 years
• 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

• Patients with a history of severe hypoglycemia without accidental cause in the 6 months preceding the entry in the protocol
• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Diabrasport then Rest

Other group

Description:

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.

Treatment:

Behavioral: Usual algorithm

Device: Holter Glycemic Ipro2, Medtronic

Behavioral: Diabrasport algorithm

Behavioral: Rest

Rest then Diabrasport

Other group

Description:

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.

Treatment:

Behavioral: Usual algorithm

Device: Holter Glycemic Ipro2, Medtronic

Behavioral: Diabrasport algorithm

Behavioral: Rest