Exercise-induced Glycemic Variations and Hybrid Closed-loop Systems

Summary

Type 1 diabetes is characterized by high risk of hypoglycemia and associated fear of hypoglycemia. Hypoglycemia risk is higher during and after physical activity, especially aerobic activity of long duration. Fear of hypoglycemia can result in avoidance of exercise or overcompensatory eating, both related to worse metabolic control and increased cardiometabolic risk. Hybrid closed-loop (HCL)systems have significantly improved risk of hypoglycemia. They also offer the possibility to set a temporary target for physical activity, further reducing the risk of hypoglycemia during physical activity. Although temporary target seems to work rather well with moderate-intensity aerobic exercise, little data is available for other types of exercise, like resistance exercise, high-intensity interval exercise, combined modalities of exercise, in which the temporary target seems to perform less well. The present study aims to test the performance of current HCL systems under different exercise conditions and evaluate the relationship between different exercise variables (recorded during exercise), physical activity variables (measured by accelerometry) and glycemic variations in HCL system users.

Conditions

• Type 1 Diabetes
• Exercise

Interventions

BEHAVIORAL

Moderate intensity exercise

moderate intensity aerobic exercise trial

BEHAVIORAL

High intensity interval exercise

High intensity interval exercise trial

BEHAVIORAL

Combined exercise

Combined aerobic and resistance exercise trial

BEHAVIORAL

Resistance exercise

Resistance exercise trial

Sponsors & Collaborators

• University of Rome Foro Italico

  collaborator OTHER

• University of Padova

  collaborator OTHER

• University of Roma La Sapienza

  lead OTHER

Principal Investigators

• Giuseppe Pugliese · University of Roma La Sapienza

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-31

Primary Completion

2024-12-22

Completion

2024-12-22

Countries

• Italy

Study Locations