Actively Recruiting

Age: 18Years +
All Genders
NCT06460558

T1D Closed-loop and Physical Activity

Led by Centre Hospitalier Universitaire de Nice · Updated on 2024-06-14

65

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

"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).

CONDITIONS

Official Title

T1D Closed-loop and Physical Activity

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with type 1 diabetes for more than 6 months confirmed by clinical history and positive autoantibodies (anti-GAD or IA2)
  • Treated with an insulin pump for at least 6 months
  • Meets criteria for automated insulin delivery based on poor glycemic control (HbA1c  8%), significant glucose variability, severe hypoglycemia, or poor quality of life
  • For women, use effective contraception and have no plans for pregnancy during the study
  • Have health care insurance
Not Eligible

You will not qualify if you...

  • Currently participating in another experimental study
  • In a situation deemed incompatible with the study by the investigator
  • Living outside the Alpes-Maritimes or Var departments
  • Pregnant women
  • Have any contraindications to physical activity
  • Unable to understand written information due to language or psychological issues
  • Refuse to give consent
  • Deprived of liberty by administrative or judicial decision, or under guardianship or trusteeship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU NiICE

Nice, Alpes Maritimes, France, 0600

Actively Recruiting

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Research Team

N

Nicolas CHEVALIER, MD

CONTACT

E

Enzo PINI

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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