NCT07365176

Brief Summary

This randomized crossover trial examined whether exercise modality (high-intensity interval exercise vs. moderate-intensity continuous exercise) and timing relative to meals (postprandial vs. postabsorptive) influence glycemic responses in physically active adults with type 1 diabetes. Participants completed four cycling sessions matched for total mechanical load, and glucose levels were monitored during exercise and for 24 hours afterward while accounting for dietary intake and insulin administration. The study hypothesized that glycemic responses differ according to both exercise type and prandial state.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

December 28, 2025

Last Update Submit

January 15, 2026

Conditions

Keywords

Blood glucoseExerciseHypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Capillary glycemia

    Blood glucose meter

    At rest before exercise, then at 10 and 20 min of exercise, at 2 min of active recovery post-exercise, and at 10 min of passive recovery post-exercise.

Secondary Outcomes (7)

  • Interstitial glucose

    The 24 hours before and the 24 hours after each visit

  • Capillary blood lactate

    At rest before exercise, then at 10 and 20 min of exercise, at 2 min of active recovery post-exercise, and at 10 min of passive recovery post-exercise.

  • Oxygen consumption

    During a 5-min rest before exercise, a 3-min warm-up, 20-min of exercise, a 2-min active recovery post-exercise, and a 10-min passive recovery post-exercise.

  • Rate of Perveived Exertion

    At rest before the exercise, and then at 5-min, 10-min, 15-min and 20-min of exercise, at 2-min active recovery post-exercise and at 5 and 10-min passive recovery post-exercise.

  • Variation of muscle blood volume.

    During a 5-min rest before exercise, a 3-min warm-up, 20-min of exercise, a 2-min active recovery post-exercise, and a 5-min passive recovery post-exercise.

  • +2 more secondary outcomes

Study Arms (4)

A/B/C/D

EXPERIMENTAL

A= High-intensity interval exercise in postabsorptive phase B= High-intensity interval exercise in postprandial phase C= Moderate-intensity continuous exercise in postabsorptive phase D= Moderate-intensity continuous exercise in postprandial phase

Other: High-intensity interval exercise performed in postprandial phaseOther: High-intensity interval exercise performed in postabsorptive phaseOther: Moderate-intensity continuous exercise performed in postprandial phaseOther: Moderate-intensity continuous exercise performed in postabsorptive phase

B/C/D/A

EXPERIMENTAL

A= High-intensity interval exercise in postabsorptive phase B= High-intensity interval exercise in postprandial phase C= Moderate-intensity continuous exercise in postabsorptive phase D= Moderate-intensity continuous exercise in postprandial phase

Other: High-intensity interval exercise performed in postprandial phaseOther: High-intensity interval exercise performed in postabsorptive phaseOther: Moderate-intensity continuous exercise performed in postprandial phaseOther: Moderate-intensity continuous exercise performed in postabsorptive phase

C/D/A/B

EXPERIMENTAL

A= High-intensity interval exercise in postabsorptive phase B= High-intensity interval exercise in postprandial phase C= Moderate-intensity continuous exercise in postabsorptive phase D= Moderate-intensity continuous exercise in postprandial phase

Other: High-intensity interval exercise performed in postprandial phaseOther: High-intensity interval exercise performed in postabsorptive phaseOther: Moderate-intensity continuous exercise performed in postprandial phaseOther: Moderate-intensity continuous exercise performed in postabsorptive phase

D/A/B/C

EXPERIMENTAL

A= High-intensity interval exercise in postabsorptive phase B= High-intensity interval exercise in postprandial phase C= Moderate-intensity continuous exercise in postabsorptive phase D= Moderate-intensity continuous exercise in postprandial phase

Other: High-intensity interval exercise performed in postprandial phaseOther: High-intensity interval exercise performed in postabsorptive phaseOther: Moderate-intensity continuous exercise performed in postprandial phaseOther: Moderate-intensity continuous exercise performed in postabsorptive phase

Interventions

Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.). Exercise began with a 3-min warm-up at 20% of maximum aerobic power (MAP) and ended with a 2-min active recovery at 20% of MAP. The high-intensity interval exercise protocol consisted of ten 1-min intervals at 100% of MAP, each interspersed with 1-min of passive recovery. For the postabsorptive state, exercise began 5 hours after the start of lunch (i.e., in the late afternoon).

A/B/C/DB/C/D/AC/D/A/BD/A/B/C

Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.). Exercise began with a 3-min warm-up at 20% of maximum aerobic power (MAP) and ended with a 2-min active recovery at 20% of MAP. The moderate-intensity continuous exercise protocol consisted of continuous exercise at 50% of MAP for 20 minutes. For the postprandial state, exercise began 1.5 hours after the start of lunch and the corresponding meal-related bolus/rapid-acting insulin (i.e., in the early afternoon).

A/B/C/DB/C/D/AC/D/A/BD/A/B/C

Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.). Exercise began with a 3-min warm-up at 20% of MAP and ended with a 2-min active recovery at 20% of maximum aerobic power (MAP). The CONT protocol consisted of continuous exercise at 50% of MAP for 20 minutes. For the postabsorptive state, exercise began 5 hours after the start of lunch (i.e., in the late afternoon).

A/B/C/DB/C/D/AC/D/A/BD/A/B/C

Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.). Exercise began with a 3-min warm-up at 20% of maximum aerobic power (MAP) and ended with a 2-min active recovery at 20% of MAP. The high-intensity interval exercise protocol consisted of ten 1-min intervals at 100% of MAP, each interspersed with 1-min of passive recovery. For the postprandial state, exercise began 1.5 hours after the start of lunch and the corresponding meal-related bolus/rapid-acting insulin (i.e., in the early afternoon).

A/B/C/DB/C/D/AC/D/A/BD/A/B/C

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18 and 60 years of age
  • Regular practice of physical activity (at least 2 training sessions/week for at least 3 months)
  • Diagnosis of type 1 diabetes for \>1 year
  • No change in insulin delivery method (i.e., multiple daily injections \[MDI\], continuous subcutaneous insulin infusion \[CSII\] in open or closed loop) over the previous 3 months
  • Use of a continuous glucose monitoring (CGM) device in daily life

You may not qualify if:

  • Diabetes-related complications except for background retinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de Recherche Pluridisciplinaire Sport, Santé, Société (URePSSS - ULR 7369)

Loos, 59120, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor ActivityHypoglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 28, 2025

First Posted

January 26, 2026

Study Start

February 8, 2023

Primary Completion

January 17, 2025

Study Completion

May 9, 2025

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The investigators will share on http://recherche.data.gouv.fr all anonymized data presented in the publication of the results

Time Frame
From the acceptance date of publication
Access Criteria
Access on e-mail request to investigators

Locations