Type 1 DiabetesACTIVE-T1DNCT07596160
Individualized Exercise Consultation in Type 1 Diabetes
A study testing Exercise consultations in people with Type 1 Diabetes, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Exercise consultations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 1 diabetes
- Age ≥18 years
- Willingness to participate
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Steno Diabetes Center Aarhus
Aarhus, 8200
Rakel F Johansen, MD Phd, +4540530612, rfjohansen@clin.au.dk
About this study
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.
Read the detailed description
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
- Conditions
- Type 1 Diabetes
- Being tested
- Exercise consultations
- Keywords
- exercise, type 1 diabetes, intervention, consultations
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise consultationsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Exercise Consultations | Experimental | Not described Receives: Other: Exercise consultations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective single-arm quality improvement study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596160
- Sponsor's protocol ID
- 1-20-72-8-26
- Acronym
- ACTIVE-T1D
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Exercise Consultation in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07596160
- Acronym / sponsor ID
- ACTIVE-T1D / 1-20-72-8-26
- Conditions
- Type 1 Diabetes
- Keywords
- exercise, type 1 diabetes, intervention, consultations
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective single-arm quality improvement study
| Arm | Type | Receives |
|---|---|---|
| Exercise Consultations | Experimental | Other: Exercise consultations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of type 1 diabetes
- Age ≥18 years
- Willingness to participate
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise consultationsParticipants 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 | Other | Exercise Consultations |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
RecruitingPhase 3
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
Obesity or Overweight
Not yet recruitingPhase 1/2
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
Sarcoma, Osteoid Sarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise consultations in people with Type 1 Diabetes, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rakel F Johansen, MD, PhD (+4540530612, rfjohansen@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.