NCT07596160

Brief Summary

People with type 1 diabetes often experience challenges managing blood glucose levels during and around physical activity, which may reduce participation in exercise. The ACTIVE-T1D project aims to evaluate whether individualized video-based exercise consultations can improve exercise-related confidence, physical activity levels, and glycemic management in adults with type 1 diabetes. Participants will receive individualized consultations focused on exercise, glucose management, insulin adjustment, and nutrition strategies related to physical activity. Consultations are tailored to the participant's exercise habits, goals, and challenges. The study will assess self-reported exercise management, physical activity, and glucose metrics obtained from continuous glucose monitoring systems. A subgroup of participants will also complete objective physical activity measurements using accelerometers. The study is conducted as a prospective quality improvement project at Steno Diabetes Center Aarhus.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

May 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

May 12, 2026

Last Update Submit

May 12, 2026

Conditions

Keywords

exercisetype 1 diabetesinterventionconsultations

Outcome Measures

Primary Outcomes (1)

  • Eight Likert scale questions regarding the ability of the partipant to handle type 1 diabetes and exercise challenges. Assessed before the first consultation, right after the last consultation and 6 months after the last consultation

    Six months

Study Arms (1)

Exercise Consultations

EXPERIMENTAL
Other: Exercise consultations

Interventions

Participants will receive individualized 30-minute video consultations concerning exercise and type 1 diabetes obstacles. During the consultations, individuals with type 1 diabetes are guided by a physician and, when relevant, an exercise physiologist from Steno Diabetes Center Aarhus (SDCA). The intervention will in most cases consist of two consultations, although an additional consultation may be offered if considered relevant. The first consultation is planned based on information about the individual's exercise habits and specific challenges. All consultations are conducted via video, allowing participants to receive tailored, practical advice adapted to their daily life and preferred physical activities. Consultations will address the topics that the patient presents, which may include, but is not limited to: * Exercise habits and goals * The need for advice concerning insulin adjustments * The need for advice concerning carbohydrate strategies

Exercise Consultations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of type 1 diabetes
  • Age ≥18 years
  • Willingness to participate

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor Activity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Rakel F Johansen, MD, PhD

CONTACT

Jesper F Mortensen, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: A prospective single-arm quality improvement study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 19, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations