Management of Prolonged Aerobic exeRcise in Patients With Type 1 Diabetes on Advanced Technologies

NCT05936203 | Completed

• 1 other identifier: Prot. 14/22
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare three different therapeutic and nutritional approaches during a prolonged aerobic exercise in moderately active type 1 diabetes people using advanced technologies, to identify the best strategy for the management of this type of exercise. Participants will be randomly assigned to different interventions in three different occasions: insulin therapy adjustment; nutritional adjustment; combination of insulin and nutritional adjustment.

Conditions

Type1diabetes

Keywords

prolonged aerobic exercise; hybrid artificial pancreas; carbohydrates supplementation; insulin therapy

Outcome Measures

Primary Outcomes (2)

• Time in Range

  Glucose concentrations at 5-min intervals will be downloaded from dedicated platforms and the percentage of time with a glycemia between 70-180 mg/dl during 4 hours of walks will be derived.

  During 4 hours of walks in 3 different occasions

• Insulin doses delivered

  Total insulin doses delivered by HAP during 4 hours of walks will be downloaded from the dedicated platforms.

  During 4 hours of walks in 3 different occasions

Study Arms (3)

Target

EXPERIMENTAL

Setting a higher glucose target starting from 1 hour before until the end of walk.

Other: Insulin therapy adjustment

Snack

EXPERIMENTAL

Consumption of 15 g of complex carbohydrates as whole grain crackers every 30 minutes, during the 4 hours of walk.

Other: Nutritional adjustment

Target + Snack

EXPERIMENTAL

Combination of both Target and Snack interventions.

Other: Combination of strategies

Interventions

Insulin therapy adjustment OTHER

Strategies used to manage glucose control during a prolonged aerobic exercise

Target

Nutritional adjustment OTHER

Strategies used to manage glucose control during a prolonged aerobic exercise

Snack

Combination of strategies OTHER

Strategies used to manage glucose control during a prolonged aerobic exercise

Target + Snack

Eligibility Criteria

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

You may qualify if:

• Type 1 diabetes
• Using of hybrid artificial pancreas

You may not qualify if:

• Health conditions that may affect the safe performance of physical activity
• Pregnancy

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University Hospital

Naples, 80131, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medical Doctor

Model Details: Randomized crossover clinical trial

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 7, 2023
• Study Start: January 11, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

IT (1)