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"Physical activity is recognized as beneficial for patients living with type 1 diabetes (T1DM), with a demonstrated effect not only on HbA1c control [1] but also on reducing the incidence of diabetes-related complications [2,3]. It is recommended that patients living with T1DM perform 150 minutes of accumulated physical activity per week, without exceeding two consecutive days without physical activity [4]. Indeed, one meta-analysis reported that moderately vigorous activity (≥4.5 METs) was beneficial compared with lower-intensity activity, while three other studies noted that only vigorous physical activity (≥6 METs) predicted lower all-cause mortality rates [5]. However, T1DM can represent a major obstacle to physical activity because of the occurrence of fairly frequent hypoglycemia, including after physical effort, the need for early resugaring but also the risk of hyperglycemia (rebound or with certain activities) [6]. The advent of automated insulin delivery systems has led to a significant improvement in time on target and a reduction in the frequency of hypoglycemia, including during physical activity in some studies [7-9]. The aim of this study is therefore to evaluate, in a cohort of patients with T1DM, whether the implementation of a closed-loop automated insulin delivery system increases physical activity in patients with T1DM. Based on the interpretation of the ONAPS-PAQ [10], the investigator hypothesize that the implementation of the closed-loop system enables an individual to reach the 3000 MET/min/week threshold (considered ""Active+"" from this threshold onwards).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 diabetes with insulin infusion system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Type 1 diabetes with insulin infusion system | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| IPAQ score | "Measurement of IPAQ in METs/min/week (reflects the amount of physical activity practised using a validated questionnaire). There are seven items whose the result corresponds to the sum of the given figures. " | At the inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| BAPAD-1 score " | The BAPAD-1 score, validated in French, will be used to assess the usual obstacles to physical activity in T1DM. It is a Likert scale (between 0-7) composed by twelve items. Then, a mean is calculated with all the answers. | At the inclusion |
| BREQ-2 |
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Inclusion Criteria:
Exclusion Criteria:
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Selection visit - Patients with T1DM referred to Nice University Hospital are offered the opportunity to take part in the study without obligation (D0).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas CHEVALIER, MD | Contact | 0492035519 | +33 | chevalier.n@chu-nice.fr |
| Enzo PINI | Contact | 0492035519 | +33 | pini.e2@chu-nice.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas CHEVALIER | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU NiICE | Recruiting | Nice | Alpes Maritimes | 0600 | France |
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| ID | Term |
|---|---|
| D007332 | Insulin Infusion Systems |
| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007260 | Infusion Pumps |
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"To assess motivation to engage in physical activity, use the BREQ-2 score, validated by ONAPS. It is a Likert scale (between 0-7) composed by six items. Then, a mean is calculated with all the answers. |
| At the inclusion |
| ONAPS PAQ | To assess sedentary behaviour, use the ONAPS PAQ score with only the sedentary behaviour section. 4 items. Then the sum of the results is calculated | At the inclusion |
| D004864 |
| Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |