T1D Closed-loop and Physical Activity

NCT06460558 | Recruiting DMC

• 1 other identifier: 24Endocrino01
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

"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

Diabetes type1

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• BAPAD-1 score "

  At the inclusion

• BREQ-2

  At the inclusion

• ONAPS PAQ

  At the inclusion

Study Arms (1)

Type 1 diabetes with insulin infusion system

Other: Type 1 diabetes with insulin infusion system

Interventions

Type 1 diabetes with insulin infusion system OTHER

No intervention

Also known as: No intervention

Type 1 diabetes with insulin infusion system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Selection visit - Patients with T1DM referred to Nice University Hospital are offered the opportunity to take part in the study without obligation (D0).

You may qualify if:

• Type 1 diabetes defined by clinical history and positive measurement of autoantibodies (anti-GAD or IA2), evolving for more than 6 months and treated by insulin pump for at least 6 months, for whom an indication for automated insulin delivery is retained, by criteria of glycemic control (HbA1c ≥ 8% and/or significant glycemic variability and/or severe hypoglycemia) or poor quality of life, in accordance with reimbursement criteria validated by the CNAM for available systems.
• For women, existence of effective contraception (hormonal or mechanical) and no plans for pregnancy during the study period.
• Having a Health Care insurance."" "

You may not qualify if:

• Patient already involved in another experimental study
• Patient in a particular situation deemed incompatible with the study by the investigator
• Patient living in a department other than Alpes-Maritimes or Var
• Pregnant women
• Presence of a contraindication to physical activity
• Patient with linguistic or psychological incapacity to understand written information
• Patient refusing to give consent
• Patient deprived of liberty by administrative or judicial decision, under guardianship or trusteeship"" "

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU NiICE

Nice, Alpes Maritimes, 0600, France

RECRUITING

MeSH Terms

Interventions

Insulin Infusion Systems

Intervention Hierarchy (Ancestors)

Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Officials

• Nicolas CHEVALIER

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas CHEVALIER, MD

CONTACT

0492035519; chevalier.n@chu-nice.fr

Enzo PINI

CONTACT

0492035519; pini.e2@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: May 6, 2024
• Primary Completion: November 6, 2025
• Study Completion: May 6, 2026
• Last Updated: June 14, 2024

Record last verified: 2024-05

Locations

FR (1)