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CompletedNCT05670366ENHANCED1Updated Mar 17, 2025

The Integration of Physical Activity Into the Clinical Decision Process of People with Type 1 Diabetes

An interventional study of Activity tracker and chest strap and Diary app in Type 1 Diabetes, sponsored by prof dr Pieter Gillard. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by prof dr Pieter Gillard · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Type 1 Diabetes

Keywords

  • Physical activity
  • Artificial intelligence
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 33 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

prof dr Pieter Gillard is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Other
    Physically active participants

    There is only one study arm, namely all participants are subjected to the same interventions.

    Device: Activity tracker and chest strap · Device: Diary app

Interventions

  • DeviceActivity tracker and chest strap

    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).

  • DeviceDiary app

    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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

07

Study locations

1 site
  • UZ Leuven
    Leuven, 3000, Belgium
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05670366
Lead sponsor
prof dr Pieter Gillard
Collaborators
University Colleges Leuven Limburg
Responsible party
prof dr Pieter Gillard (Principal investigator, Universitaire Ziekenhuizen KU Leuven) — Sponsor-investigator
First posted
Jan 4, 2023
Start date
Sep 26, 2022
Primary completion
Jul 31, 2023
Completion
Jul 31, 2023
Last update
Mar 17, 2025

Study contacts

Pieter Gillard, MD, PhD
principal investigator · UZ Leuven

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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