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NCT Number: NCT07596160

Individualized Exercise Consultation in Type 1 Diabetes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Background Physical activity is a recommended and integral component of T1D treatment, as it confers a range of health benefits, including improved insulin sensitivity, better glycaemic regulation, enhanced cardiovascular fitness, healthier lipid profiles, weight management, reduced blood pressure, and a lower risk of diabetes-related complications (1). Additionally, regular exercise supports psychological well-being and overall quality of life for people living with type 1 diabetes (2). However, despite written guidelines on the topic (3), individuals with type 1 diabetes often experience challenges with blood glucose excursions before, during, and after exercise (4, 5), limiting participation in regular exercise.

In recognition of limited guidance for individuals with type 1 diabetes regarding exercise (6), the Clinic for Athletes with Type One Diabetes (CATOD) was established in 2019 at the Steno Diabetes Center Aarhus (SDCA). CATOD is the first clinic of its kind and has transformed care for individuals with type 1 diabetes who exercise. Initially, the clinic primarily supported highly active athletes with type 1 diabetes through sports camps followed by a 6-12 month consultation programme focused on exercise and diabetes management strategies(7).

Since 2023 the clinic has expanded to provide 1-3 videoconsultations to a broad range of individuals with type 1 diabetes across the nation in order to help them with exercise obstacles. The problems presented span from going for a walk or bicycling to work without getting a low blood glucose to how to manage glucose during marathon training and competition. During the consultations, the individual with type 1 diabetes receives individualized guidance on exercise, glucose management, insulin adjustment, and nutrition.

Evidence from a prior questionnaire administered to participants who received the intervention suggests that many benefited from the advice and were able to modify their exercise habits, facilitating more effective and less burdensome physical activity.

Aim This study aims to expand current knowledge on the effectiveness of individualized exercise consultations in people with type 1 diabetes. Specifically, we will evaluate whether individualized, video-based exercise consultations can improve physical activity levels, glycemic control and patient empowerment.

Objectives

To determine whether individualized, exercise-specific consultations:

  • Increase physical activity levels
  • Improve glycemic control during and around exercise, as well as overall glycemic control
  • Enhance confidence and self-management related to exercise

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Exercise consultations

Other

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

Primary outcomes

  1. Diabetes and Exercise Self-Management Ability Score, assessed using eight Likert-scale questions regarding the participant's perceived ability to manage type 1 diabetes and exercise-related challenges.

    Time frame: Eight months

    Each item is scored on a 5-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree. The total score ranges from 8 to 40, with higher scores indicating greater perceived ability to manage type 1 diabetes during exercise. The score is assessed before the first consultation, immediately after the final consultation, and 6 months after the final consultation.

Study contacts

Contact information is provided by the study sponsor or research team.

Jesper F Mortensen, MSc

CONTACT

[email protected]

+45 23234145

Rakel F Johansen, MD, PhD

CONTACT

[email protected]

+4540530612

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Acronym: ACTIVE-T1D

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 19, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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