Type 1 DiabetesENHANCED1NCT05670366
The Integration of Physical Activity Into the Clinical Decision Process of People with Type 1 Diabetes
A study testing Activity tracker and chest strap and Diary app in people with Type 1 Diabetes, run by prof dr Pieter Gillard at 1 site in Belgium.
Trial summary
Every person with type 1 diabetes needs personalized advice to integrate physical activity into daily diabetes management. The purpose of this study is to collect data on food intake, physical activity, glucose levels and insulin delivery from people with type 1 diabetes who are physically active. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Activity tracker and chest strap and Diary app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Sep 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent
- 18-80 years old
- Type 1 diabetes ≥1 year
- Using a CGM for more than 6 months
- Using insulin (insulin pens, insulin pumps or hybrid closed-loop systems) to manage glycaemia for more than 6 months
- No use of adjunctive therapies, such as SGLT2-inhibitors or GLP-1 analogues
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- No known diabetic gastroparesis
- HbA1c of the last two diabetes consultations are both <10%
- Being physically active at least twice a week on two separate days for 30 consecutive minutes
Who cannot join
- Age <18 years or >80 years
- People with type 2 diabetes, people with secondary diabetes
- Begin treatment with insulin (insulin pens, insulin pumps or hybrid closed-loop systems) less than 6 months before inclusion
- Not using CGM prior to inclusion
- Known diabetic gastroparesis
- HbA1c > 10% during one of the last two diabetes consultations
- Not willing to use an activity tracker, the diary app or the food app
- Not being physically active on a regular basis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proof-of-concept Study for the Integration of Physical Activity Into the Clinical Decision Process of Physically Active People with Type 1 Diabetes
Every person with type 1 diabetes needs personalized advice to integrate physical activity into daily diabetes management. The purpose of this study is to collect data on food intake, physical activity, glucose levels and insulin delivery from people with type 1 diabetes who are physically active. At least 25 people with type 1 diabetes will be asked to perform 25 sports activities of at least half an hour, wear an activity tracker (day and night) and chest strap (during sports activities), and log data on food intake, periods and type of physical activity, and feelings (e.g., sick, stress) in a diary app. Diabetes data such as insulin administration and sensor data will be collected through diabetes management platforms. The primary endpoint involves a database containing data on glucose, insulin administration, physical activity, and food intake of people with type 1 diabetes for statistical analyses and visualizations regarding the relationship between physical activity and blood glucose response.
- Conditions
- Type 1 Diabetes
- Being tested
- Activity tracker and chest strap, Diary app
- Keywords
- Physical activity, Artificial intelligence
- 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.
Activity tracker and chest strapDevice
During the study, the participants will be asked to wear a commercially-available activity tracker during day and night, and a chest strap during sport activities to collect data on physical activity (type, intensity and duration of activity).
Diary appDevice
During the study, the participants will be asked to log the ingestion of carbohydrates, periods and type of physical activity, feelings (e.g. sick, stress, ...) in a diary app.
| Study group | Role | What they receive |
|---|---|---|
| Physically active participants | Other | There is only one study arm, namely all participants are subjected to the same interventions. Receives: Device: Activity tracker and chest strap; Device: Diary app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Database which contains insulin data (insulin dose over time) retrieved from diabetes management platforms.
Measured: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains glucose data (glycemic values over time) retrieved from diabetes management platforms.
Measured: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains physical activity data (type of activity) retrieved from the activity tracker and chest strap.
Measured: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains physical activity data (intensity of activity) retrieved from the activity tracker and chest strap.
Measured: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains physical activity data (duration of activity) retrieved from the activity tracker and chest strap.
Measured: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains food intake data (timing of food) retrieved from the diary app.
Measured: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains food intake data (amount of food in grams) retrieved from the diary app.
Measured: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains food intake data (type of food) retrieved from the diary app.
Measured: Through study completion (after 25 sport activities), an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start26 Sep 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- prof dr Pieter Gillard
- Sponsor type
- University, hospital or other
- Collaborators
- University Colleges Leuven Limburg
- Responsible party
- Sponsor-investigator, prof dr Pieter Gillard, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Pieter Gillard, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670366
- Sponsor's protocol ID
- S64550
- Acronym
- ENHANCED1
- Status last verified
- Mar 2024
- First submitted
- 29 Aug 2022
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-concept Study for the Integration of Physical Activity Into the Clinical Decision Process of Physically Active People with Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05670366
- Acronym / sponsor ID
- ENHANCED1 / S64550
- Conditions
- Type 1 Diabetes
- Keywords
- Physical activity, Artificial intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- prof dr Pieter GillardUniversity, hospital or other
- Collaborators
- University Colleges Leuven Limburg
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 4 Jan 2023 (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.
Every person with type 1 diabetes needs personalized advice to integrate physical activity into daily diabetes management. The purpose of this study is to collect data on food intake, physical activity, glucose levels and insulin delivery from people with type 1 diabetes who are physically active. At least 25 people with type 1 diabetes will be asked to perform 25 sports activities of at least half an hour, wear an activity tracker (day and night) and chest strap (during sports activities), and log data on food intake, periods and type of physical activity, and feelings (e.g., sick, stress) in a diary app. Diabetes data such as insulin administration and sensor data will be collected through diabetes management platforms. The primary endpoint involves a database containing data on glucose, insulin administration, physical activity, and food intake of people with type 1 diabetes for statistical analyses and visualizations regarding the relationship between physical activity and blood glucose response.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physically active participants | Other | Device: Activity tracker and chest strap, Device: Diary appThere is only one study arm, namely all participants are subjected to the same interventions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent
- 18-80 years old
- Type 1 diabetes ≥1 year
- Using a CGM for more than 6 months
- Using insulin (insulin pens, insulin pumps or hybrid closed-loop systems) to manage glycaemia for more than 6 months
Key exclusion criteria (8 listed)
- Age <18 years or >80 years
- People with type 2 diabetes, people with secondary diabetes
- Begin treatment with insulin (insulin pens, insulin pumps or hybrid closed-loop systems) less than 6 months before inclusion
- Not using CGM prior to inclusion
- Known diabetic gastroparesis
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 |
|---|---|---|
| Activity tracker and chest strapDuring the study, the participants will be asked to wear a commercially-available activity tracker during day and night, and a chest strap during sport activities to collect data on physical activity (type, intensity and duration of activity). | Device | Physically active participants |
| Diary appDuring the study, the participants will be asked to log the ingestion of carbohydrates, periods and type of physical activity, feelings (e.g. sick, stress, ...) in a diary app. | Device | Physically active participants |
Primary outcome
Database which contains insulin data (insulin dose over time) retrieved from diabetes management platforms.
Time frame: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains glucose data (glycemic values over time) retrieved from diabetes management platforms.
Time frame: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains physical activity data (type of activity) retrieved from the activity tracker and chest strap.
Time frame: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains physical activity data (intensity of activity) retrieved from the activity tracker and chest strap.
Time frame: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains physical activity data (duration of activity) retrieved from the activity tracker and chest strap.
Time frame: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains food intake data (timing of food) retrieved from the diary app.
Time frame: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains food intake data (amount of food in grams) retrieved from the diary app.
Time frame: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains food intake data (type of food) retrieved from the diary app.
Time frame: Through study completion (after 25 sport activities), an average of 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Pieter Gillard, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity tracker and chest strap and Diary app in people with Type 1 Diabetes, run by prof dr Pieter Gillard at 1 site in Belgium.
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 9 inclusion and 8 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: finished, as of the sponsor's last update on 17 Mar 2025. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Database which contains insulin data (insulin dose over time) retrieved from diabetes management platforms. (time frame: Through study completion (after 25 sport activities), an average of 6 weeks). The study lists 8 primary outcomes in all. 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 17 Mar 2025.