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The Effects of Different Exercise Modalities in Adolescents With Type 1 Diabetes Using AID Systems

NCT05619198 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-04-14

No results posted yet for this study

Summary

Objective:

The overall objective of this study is to assess the efficacy of the current recommended guidelines for physical activity (PA) in response to acute moderate intensity continous exercise (MICE) and high intensity interval exercise (HIIE) among adolescents with type 1 diabetes (T1D) using automated insulin delivery (AID) systems (MiniMed 780G and Tandem Control-IQ).

Methods:

This study will be a two-period, cross-over, clinical trial with between and within cohort comparisons of two different exercise modalities among a total of 24 age-, sex-, and insulin-dose-matched adolescents with T1D (12 using MiniMed 780G and 12 using Tandem Control-IQ).

Endpoint:

The primary endpoint is sensor-derived time in range (3.9 mmol/L-10.0 mmol/L) around exercise

Conditions

Interventions

BEHAVIORAL

High Intensity Interval Exercise

High Intensity Interval Exercise: * 5 minutes resting phase @ 0 watts. * 5-minute warm up phase @ 20 watts. * 40 minutes of interval work consisting of eight bouts of 1-minute cycling at a power output corresponding to \~85% of VO2max interspersed with 4-minute recovery periods at 20 watts. * 5 minutes resting phase @ 0 watts.

BEHAVIORAL

Moderate Intensity Continous Exercise

Moderate Intensity Continous Exercise: * 5 minutes resting phase @ 0 watts. * 5-minute warm up phase @ 20 watts. * 40 minutes of MICE 65% VO2max. * 5 minutes resting phase @ 0 watts.

Sponsors & Collaborators

  • Steno Diabetes Center Copenhagen

    lead OTHER

Principal Investigators

  • Emilie Lindkvist, MD · Steno Diabetes Center Copenhagen, Clinical Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-19
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05619198 on ClinicalTrials.gov